Docstoc

Department of Health and Human Services

Document Sample
Department of Health and Human Services Powered By Docstoc
					                                                                                          Tuesday,
                                                                                          May 27, 2003




                                                                                          Part VIII

                                                                                          Department of
                                                                                          Health and Human
                                                                                          Services
                                                                                          Semiannual Regulatory Agenda




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00001   Fmt 4717   Sfmt 4717   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30214                      Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda


     DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



     DEPARTMENT OF HEALTH AND                                              purpose of this effort is to encourage                                      of notices or final rules within the next
     HUMAN SERVICES                                                        public participation in the Department’s                                    12 months. (Also included, in several
                                                                           regulatory process by providing, at an                                      Long-Term Action sections, are
     Office of the Secretary                                               early stage, summarized information                                         summaries of actions that we will
                                                                           about regulatory actions under                                              probably not take any earlier than 12
     21 CFR Ch. I
                                                                           development. Anyone wishing to                                              months after publication of this agenda.)
                                                                           communicate to the Department their
     42 CFR Chs. I-V                                                                                                                                      We welcome the views of all
                                                                           views on the rulemakings outlined
                                                                           below is invited to do so.                                                  concerned with regard to these planned
     45 CFR Subtitle A; Subtitle B, Chs. II,
                                                                                                                                                       rulemakings. Comments may be
     III, and XIII                                                         FOR FURTHER INFORMATION CONTACT:                                Ann         directed to the agency officials cited in
                                                                           C. Agnew, Executive Secretary,                                              each of the summaries, or, if early
     Unified Agenda of Federal Regulatory                                  Department of Health and Human
     and Deregulatory Actions                                                                                                                          attention at the Secretary’s level is seen
                                                                           Services, Washington, DC 20201.                                             as required, comments should be
     AGENCY: Office of the Secretary, HHS.                                                                                                             directed to: Ann C. Agnew, Executive
                                                                              The
                                                                           SUPPLEMENTARY INFORMATION:
     ACTION: Semiannual agenda.                                                                                                                        Secretary to the Department, Room
                                             capsulized information provided below
                                             reflects an effort to present for public                                                                  603H, 200 Independence Avenue SW.,
     SUMMARY: The Regulatory Flexibility Act scrutiny a forecast of the rulemaking
                                                                                                                                                       Washington, DC 20201.
     of 1980 and Executive Order 12866       activities that the Department expects to
     require the semiannual publication of   undertake over the foreseeable future.                                                                    Dated: April 14, 2003.
     an inventory of all rulemaking actions  We focus primarily on those areas of                                                                      Ann C. Agnew,
     under development or review. The        work expected to result in publication                                                                    Executive Secretary to the Department.

                                                                   Office of the Secretary—Proposed Rule Stage
                                                                                                                                                                                                           Regulation
      Sequence                                                                                            Title                                                                                           Identification
       Number                                                                                                                                                                                               Number

         744          Safe Harbor for Arrangements Involving Federally Qualified Health Centers ...............................................................                                           0991-AB06
         745          Claims Collection ............................................................................................................................................................      0991-AB18
         746          Salary Offset ...................................................................................................................................................................   0991-AB19
         747          Clarification of Terms and Application of Program Exclusion Authority for Submitting Claims Containing Excessive
                       Charges ........................................................................................................................................................................   0991-AB23


                                                                       Office of the Secretary—Final Rule Stage
                                                                                                                                                                                                           Regulation
      Sequence                                                                                            Title                                                                                           Identification
       Number                                                                                                                                                                                               Number

         748          Shared Risk Exception to the Safe Harbor Provisions ..................................................................................................                              0991-AA91
         749          Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a Medicare SELECT Policy ..........                                                                    0991-AB16
         750          Tax Refund Offset ..........................................................................................................................................................        0991-AB17
         751          Implementation of the Equal Access to Justice Act in Agency Proceedings ................................................................                                            0991-AB22


                                                                     Office of the Secretary—Long-Term Actions
                                                                                                                                                                                                           Regulation
      Sequence                                                                                            Title                                                                                           Identification
       Number                                                                                                                                                                                               Number

         752          Revisions to 42 CFR Part 1003 .....................................................................................................................................                 0991-AB03
         753          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 ......................................................................                                         0991-AB10
         754          Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide Requirements for Drug-
                       Free Workplace (Grants) ..............................................................................................................................................             0991-AB12




VerDate May<05>2003    13:51 May 16, 2003          Jkt 200001      PO 00000        Frm 00002        Fmt 1254      Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                     apps41      PsN: UA030408
                                Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                                                                     30215

     HHS



                                                                      Office of the Secretary—Completed Actions
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         755          Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums for ESRD Beneficiaries                                                                            0991-AB04
         756          Administrative Wage Garnishment .................................................................................................................................                     0991-AB20
         757          U.S. Exchange Visitor Programs; Request for Waiver of the Two-Year Foreign Residence Requirement .................                                                                    0991-AB21
         758          Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings .....................................                                                     0991-AB24


                                  Substance Abuse and Mental Health Services Administration—Final Rule Stage
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         759          SAMHSA Charitable Choice ..........................................................................................................................................                   0930-AA11


                                Substance Abuse and Mental Health Services Administration—Long-Term Actions
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         760          Seclusion and Restraint for Non-Medical Residential Facilities ....................................................................................                                   0930-AA10


                                               Centers for Disease Control and Prevention—Proposed Rule Stage
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         761          Amendments to Quality Assurance and Administrative Provision for Approval of Respiratory Protective Devices .....                                                                     0920-AA04


                                                   Centers for Disease Control and Prevention—Final Rule Stage
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         762          Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under the Energy
                       Employee Occupational Illness Compensation Act of 2000 ........................................................................................                                      0920-AA07


                                                 Centers for Disease Control and Prevention—Completed Actions
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         763          Control of Communicable Diseases ...............................................................................................................................                      0920-AA03
         764          Possession, Use, and Transfer of Select Agents ..........................................................................................................                             0920-AA08


                                                                   Food and Drug Administration—Prerule Stage
                                                                                                                                                                                                             Regulation
      Sequence                                                                                             Title                                                                                            Identification
       Number                                                                                                                                                                                                 Number

         765          Over-the-Counter (OTC) Drug Review ..........................................................................................................................                         0910-AA01
         766          Investigational Use New Animal Drug Regulations (Section 610 Review) ..................................................................                                               0910-AB02
         767          Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider Possible Footnote State-
                       ments ............................................................................................................................................................................   0910-AC50



VerDate May<05>2003    13:51 May 16, 2003          Jkt 200001       PO 00000        Frm 00003       Fmt 1254       Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                      apps41      PsN: UA030408
     30216                      Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS



                                                        Food and Drug Administration—Prerule Stage (Continued)
                                                                                                                                                                                                            Regulation
      Sequence                                                                                            Title                                                                                            Identification
       Number                                                                                                                                                                                                Number

         768          Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Section 610
                       Review) ........................................................................................................................................................................    0910-AC58


                                                            Food and Drug Administration—Proposed Rule Stage
                                                                                                                                                                                                            Regulation
      Sequence                                                                                            Title                                                                                            Identification
       Number                                                                                                                                                                                                Number

         769          Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics ......................                                                              0910-AA49
         770          Blood Initiative ................................................................................................................................................................    0910-AB26
         771          Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved
                       Applications ...................................................................................................................................................................    0910-AB34
         772          Current Good Manufacturing Practice for Medicated Feeds .........................................................................................                                    0910-AB70
         773          Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Sup-
                       plements .......................................................................................................................................................................    0910-AB88
         774          Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food                                                                          0910-AB96
         775          Prevention of Salmonella Enteritidis in Shell Eggs ........................................................................................................                          0910-AC14
         776          Institutional Review Boards: Registration Requirements ...............................................................................................                               0910-AC17
         777          Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products .............................................                                                       0910-AC19
         778          Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations ....                                                                         0910-AC21
         779          Requirements for Submission of In Vivo Bioequivalence Data .....................................................................................                                     0910-AC23
         780          Exception From General Requirements for Informed Consent; Request for Comments and Information ...................                                                                   0910-AC25
         781          Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical
                       Oxygen ..........................................................................................................................................................................   0910-AC30
         782          Medical Devices; Patient Examination and Surgeons’ Gloves; Adulteration ................................................................                                             0910-AC32
         783          Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs .........................................................                                                  0910-AC35
         784          Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioter-
                       rorism Preparedness and Response Act of 2002 ........................................................................................................                               0910-AC38
         785          Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness
                       and Response Act of 2002 ...........................................................................................................................................                0910-AC39
         786          Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed ..............................................................                                                 0910-AC43
         787          Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics ..                                                                       0910-AC52
         788          Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements ....................................                                                           0910-AC53
         789          Food Standards: General Principles and Food Standards Modernization ....................................................................                                             0910-AC54
         790          Positron Emission Tomography Drugs; Current Good Manufacturing Practices ..........................................................                                                  0910-AC55
         791          Revision of the Requirements for Spore-Forming Microorganisms ...............................................................................                                        0910-AC57
         792          Reporting Information Regarding Falsification of Data ..................................................................................................                             0910-AC59


                                                                Food and Drug Administration—Final Rule Stage
                                                                                                                                                                                                            Regulation
      Sequence                                                                                            Title                                                                                            Identification
       Number                                                                                                                                                                                                Number

         793          Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Fac-
                       tors, Notification Requirements, and Records and Reports .........................................................................................                                  0910-AA04
         794          Investigational New Drugs: Export Requirements for Unapproved New Drug Products ..............................................                                                       0910-AA61
         795          Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients .........................                                                        0910-AA89
         796          Labeling for Human Prescription Drugs; Revised Format .............................................................................................                                  0910-AA94
         797          Supplements and Other Changes to an Approved Application .....................................................................................                                       0910-AB61
         798          Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims ........................                                                          0910-AB66
         799          CGMP for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood
                       and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) ...............................................                                                     0910-AB76
         800          Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format ...........                                                                  0910-AB91
         801          Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products ...........................................                                                  0910-AC07
         802          Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition ..............................................                                                    0910-AC18
         803          Bar Code Label Requirements for Human Drug Products and Blood ..........................................................................                                             0910-AC26
         804          Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components ................                                                                      0910-AC34



VerDate May<05>2003    13:51 May 16, 2003          Jkt 200001       PO 00000       Frm 00004        Fmt 1254       Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                     apps41      PsN: UA030408
                                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                                                                     30217

     HHS



                                                       Food and Drug Administration—Final Rule Stage (Continued)
                                                                                                                                                                                                               Regulation
      Sequence                                                                                               Title                                                                                            Identification
       Number                                                                                                                                                                                                   Number

         805            Registration of Food and Animal Feed Facilities ...........................................................................................................                           0910-AC40
         806            Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act
                         of 2002 ..........................................................................................................................................................................   0910-AC41
         807            Presubmission Conferences ..........................................................................................................................................                  0910-AC44
         808            Applications for FDA Approval To Market a New Drug: Patent Listing Requirements and Application of 30-Month
                         Stays on Approval of Abbreviated New Drug Applications ..........................................................................................                                    0910-AC48
         809            Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review ..........................................                                                     0910-AC56


                                                                Food and Drug Administration—Long-Term Actions
                                                                                                                                                                                                               Regulation
      Sequence                                                                                               Title                                                                                            Identification
       Number                                                                                                                                                                                                   Number

         810            Safety Reporting Requirements for Human Drug and Biological Products ...................................................................                                              0910-AA97
         811            Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products ....................                                                             0910-AB27
         812            Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Products Establishments;
                         Inspection and Enforcement .........................................................................................................................................                 0910-AB28
         813            Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of ‘‘No Residue’’ ....................                                                                0910-AC45


                                                                Food and Drug Administration—Completed Actions
                                                                                                                                                                                                               Regulation
      Sequence                                                                                               Title                                                                                            Identification
       Number                                                                                                                                                                                                   Number

         814            Revisions to the General Safety Requirements for Biological Products; Final Rule .....................................................                                                0910-AB51
         815            Antibiotic Resistance Labeling .......................................................................................................................................                0910-AB78
         816            Records and Reports Concerning Experience With Approved New Animal Drugs ......................................................                                                       0910-AC42
         817            Bioavailability and Bioequivalence Requirements .........................................................................................................                             0910-AC47


                                                               Food and Drug Administration—Discontinued Entries
        Regulation
       Identification                                                                 Title                                                                      Date                              Comments
         Number

       0910-AC15              Premarket Notice Concerning Bioengineered Foods                                                                               02/13/2003             Withdrawn--Publication not ex-
                                                                                                                                                                                    pected in the next 12
                                                                                                                                                                                    months


                                              Health Resources and Services Administration—Proposed Rule Stage
                                                                                                                                                                                                               Regulation
      Sequence                                                                                               Title                                                                                            Identification
       Number                                                                                                                                                                                                   Number

         818            National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Med-
                         ical Malpractice Payments Reporting Requirements ...................................................................................................                                 0906-AA41
         819            Designation of Medically Underserved Populations and Health Professional Shortage Areas ....................................                                                          0906-AA44




VerDate May<05>2003      13:51 May 16, 2003          Jkt 200001       PO 00000        Frm 00005       Fmt 1254       Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                      apps41      PsN: UA030408
     30218                      Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS



                                              Health Resources and Services Administration—Long-Term Actions
                                                                                                                                                                                                        Regulation
      Sequence                                                                                          Title                                                                                          Identification
       Number                                                                                                                                                                                            Number

         820          National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Re-
                       porting Adverse and Negative Actions .........................................................................................................................                  0906-AA57


                                                                       Indian Health Service—Final Rule Stage
                                                                                                                                                                                                        Regulation
      Sequence                                                                                          Title                                                                                          Identification
       Number                                                                                                                                                                                            Number

         821          Indian Child Protection and Family Violence Prevention Act Minimum Standards of Character ..................................                                                     0917-AA02


                                                             National Institutes of Health—Proposed Rule Stage
                                                                                                                                                                                                        Regulation
      Sequence                                                                                          Title                                                                                          Identification
       Number                                                                                                                                                                                            Number

         822          Undergraduate Scholarship Program Regarding Professions Needed by the National Institutes of Health (NIH) ......                                                                 0925-AA10
         823          National Institutes of Health (NIH) Training Grants .......................................................................................................                      0925-AA28
         824          Standards for a National Chimpanzee Sanctuary System ............................................................................................                                0925-AA31
         825          National Institutes of Health (NIH) AIDS Research Loan Repayment Program ...........................................................                                             0925-AA32
         826          National Institutes of Health Extramural Loan Repayment Program for Clinical Researchers .....................................                                                   0925-AA33
         827          National Institutes of Health Pediatric Research Loan Repayment Program ...............................................................                                          0925-AA34
         828          Loan Repayment Program for Health Disparities Research .........................................................................................                                 0925-AA35
         829          National Institutes of Health Clinical Research Loan Repayment Program for Individuals From Disadvantaged
                       Backgrounds .................................................................................................................................................................   0925-AA36


                                                                  National Institutes of Health—Final Rule Stage
                                                                                                                                                                                                        Regulation
      Sequence                                                                                          Title                                                                                          Identification
       Number                                                                                                                                                                                            Number

         830          National Institutes of Health Loan Repayment Program for Research Generally .........................................................                                            0925-AA18
         831          Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects .............                                                               0925-AA20
         832          National Institutes of Health (NIH) Center Grants .........................................................................................................                      0925-AA24


                                                      Office of Public Health and Science—Proposed Rule Stage
                                                                                                                                                                                                        Regulation
      Sequence                                                                                          Title                                                                                          Identification
       Number                                                                                                                                                                                            Number

         833          Public Health Services Policies on Research Misconduct ............................................................................................                              0940-AA04
         834          Human Subjects Protection Regulations: Institutional Review Boards Registration Requirements .............................                                                       0940-AA06
         835          Human Subjects Protection Regulations: Training and Education Requirements for Institutional Officials, Institu-
                       tional Review Board Members and Staff, Human Protections Administrators, and Investigator ................................                                                      0940-AA08


                                                          Office of Public Health and Science—Final Rule Stage
                                                                                                                                                                                                        Regulation
      Sequence                                                                                          Title                                                                                          Identification
       Number                                                                                                                                                                                            Number

         836          Public Health Service Standards for the Protection of Research Misconduct Whistleblowers .....................................                                                   0940-AA01




VerDate May<05>2003    13:51 May 16, 2003         Jkt 200001       PO 00000       Frm 00006       Fmt 1254       Sfmt 1254      D:\UNIFIED\PRESSD~1\UA030408.TXT                     apps41      PsN: UA030408
                                Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                                                                    30219

     HHS



                                                Centers for Medicare & Medicaid Services—Proposed Rule Stage
                                                                                                                                                                                                            Regulation
      Sequence                                                                                            Title                                                                                            Identification
       Number                                                                                                                                                                                                Number

         837          End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 Review) ..........................                                                                  0938-AG82
         838          Hospital Conditions of Participation: Requirements for Certification and Recertification of Transplant Centers To
                       Perform Organ Transplants (CMS-3835-P) ..................................................................................................................                           0938-AH17
         839          Hospice Care—Conditions of Participation (CMS-3844-P) ...........................................................................................                                    0938-AH27
         840          Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy (CMS-6010-P) .........................                                                                 0938-AJ98
         841          Conditions of Participation of Intermediate Care Facilities for Persons With Mental Retardation (CMS-3046-P) .......                                                                 0938-AK23
         842          Health Insurance Reform: Claims Attachments Standards (CMS-0050-P) ...................................................................                                               0938-AK62
         843          Inpatient Disproportionate Share Hospital (DSH) Adjustment: Calculation of Medicaid Patient and Total Patient
                       Days in the Medicare DSH Adjustment (CMS-1171-P) ...............................................................................................                                    0938-AK77
         844          Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-P) ..........................................                                                     0938-AK79
         845          Organ Procurement Organization Conditions for Coverage (CMS-3064-P) .................................................................                                                0938-AK81
         846          Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of Substantial Gainful Activity
                       (CMS-4018-P) ...............................................................................................................................................................        0938-AK94
         847          Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P) ......................................                                                              0938-AL14
         848          Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That Provide Inpatient or Resi-
                       dential Care (CMS-2130-P) ..........................................................................................................................................                0938-AL26
         849          Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate (CMS-1167-P) .....................                                                                0938-AL27
         850          Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans (CMS-6016-P) ......................                                                                 0938-AL49
         851          Prospective Payment System for Inpatient Psychiatric Facilities FY 2004(CMS-1213-P) ............................................                                                     0938-AL50
         852          Provider Reimbursement Determinations and Appeals (CMS-1727-P) ........................................................................                                              0938-AL54
         853          SCHIP; Purchase of Family Coverage—Benefit Flexibility in Parent Coverage (CMS-2148-P) ...................................                                                           0938-AL62
         854          Request for Information on Benefit-Specific Waiting Periods (CMS-2150-NC) ............................................................                                               0938-AL64
         855          DMERC Service Areas and Related Matters (CMS-1219-P) ........................................................................................                                        0938-AL76
         856          Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P) ..............................................                                                     0938-AL80
         857          Medicaid Coverage Rules for Inmates of Public Institutions (CMS-2077-P) .................................................................                                            0938-AL85
         858          Targeted Case Management (CMS-2061-P) .................................................................................................................                              0938-AL87
         859          Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family and Medical Leave Act
                       (CMS-2158-P) ...............................................................................................................................................................        0938-AL88
         860          Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-1470-P) ........................                                                                 0938-AL89
         861          Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2004 (CMS-
                       1469-P) .........................................................................................................................................................................   0938-AL90
         862          Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 Payment Rates (CMS-
                       1471-P) .........................................................................................................................................................................   0938-AL91
         863          Home Health Prospective Payment System Rate Update for FY 2004 (CMS-1473-NC) .............................................                                                           0938-AL94
         864          Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004 (CMS-1476-P) ..............                                                                    0938-AL96
         865          Medicaid Home and Community-Based Services Waivers (CMS-2162-P) ...................................................................                                                  0938-AM05
         866          Revisions to Average Wholesale Price Methodology (CMS-1229-P) ............................................................................                                           0938-AM12
         867          Criteria for Determining Whether a Drug is Considered Usually Self-Administered (CMS-1228-P) .............................                                                           0938-AM13
         868          Electronic Medicare Claims Submission (CMS-0008-IFC) ............................................................................................                                    0938-AM22
         869          Medicaid Estate Recoveries (CMS-2083-P) ..................................................................................................................                           0938-AM30
         870          Physician Ownership in Specialty Hospitals (CMS-1240-P) ..........................................................................................                                   0938-AM35
         871          Procedures for Maintaining Code Lists in the Negotiated National Coverage Determinations for Clinical Diagnostic
                       Laboratory Services (CMS-3119-P) .............................................................................................................................                      0938-AM36
         872          Hospital Patients’ Rights COP—Standard Safety Compliance Committees (CMS-3120-P) .........................................                                                           0938-AM39
         873          Ambulance Fee Schedule Condition Codes (CMS-1247-P) ..........................................................................................                                       0938-AM45
         874          Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities—Update for FY 2005 (CMS-
                       1249-P) .........................................................................................................................................................................   0938-AM46
         875          Modifications to Electronic Transactions and Code Sets (CMS-0009-P) ......................................................................                                           0938-AM50
         876          Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures (CMS-6146-P) ............                                                                     0938-AM54
         877          Requirements for Nursing Homes To Identify the Number of Licensed and Unlicensed Nursing Staff Per Shift
                       (CMS-3121-P) ...............................................................................................................................................................        0938-AM55


                                                    Centers for Medicare & Medicaid Services—Final Rule Stage
                                                                                                                                                                                                            Regulation
      Sequence                                                                                            Title                                                                                            Identification
       Number                                                                                                                                                                                                Number

         878          Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-FC) .......................................................                                                    0938-AG81



VerDate May<05>2003    13:51 May 16, 2003          Jkt 200001       PO 00000       Frm 00007        Fmt 1254       Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                     apps41      PsN: UA030408
     30220                      Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS



                                         Centers for Medicare & Medicaid Services—Final Rule Stage (Continued)
                                                                                                                                                                                                           Regulation
      Sequence                                                                                            Title                                                                                           Identification
       Number                                                                                                                                                                                               Number

         879          Standard Unique National Health Plan Identifiers (CMS-6017-F) .................................................................................                                     0938-AH87
         880          Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F) .......................................                                                       0938-AH99
         881          Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for Medicare Billing Privileges
                       (CMS-6003-F) ...............................................................................................................................................................       0938-AI49
         882          Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F) ...............................................................                                             0938-AI93
         883          Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements (CMS-3006-F) ...........                                                                        0938-AJ10
         884          Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions, and Establishment of a
                       Quality Assessment and Improvement Program (CMS-1910-F) .................................................................................                                          0938-AJ17
         885          Hospital Conditions of Participation: Laboratory Services (CMS-3014-F) .....................................................................                                        0938-AJ29
         886          Medicare Hospice Care Amendments (CMS-1022-F) ...................................................................................................                                   0938-AJ36
         887          Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric Services to Indi-
                       viduals Under Age 21 (CMS-2065-F) ...........................................................................................................................                      0938-AJ96
         888          All Provider Bad Debt Payment (CMS-1126-F) .............................................................................................................                            0938-AK02
         889          Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications (CMS-2226-CN) .........                                                                    0938-AK24
         890          Review of National Coverage Determinations and Local Coverage Determinations (CMS-3063-F) ............................                                                              0938-AK60
         891          Revised Process for Making Medicare Coverage Determinations (NCDs) (CMS-3062-N) ..........................................                                                          0938-AK61
         892          Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships—Phase II (CMS-
                       1810-FC) .......................................................................................................................................................................   0938-AK67
         893          Rate of Reimbursement of Photocopy Expenses for Quality Improvement Organizations (CMS-3055-F) ..................                                                                   0938-AK68
         894          Modifications to Medicare Managed Care Rules (CMS-4041-F) ...................................................................................                                       0938-AK71
         895          Modifications to the State Children’s Health Insurance Program (CMS-2006-F) ..........................................................                                              0938-AL00
         896          Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-F) ............................................                                                     0938-AL18
         897          Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers (CMS-2151-F) .................                                                                0938-AL43
         898          Interim Final Amendment for Mental Health Parity (CMS-2152-IFC) ............................................................................                                        0938-AL44
         899          Electronic Submission of Cost Reports (CMS-1199-F) .................................................................................................                                0938-AL51
         900          Revisions to the Medicare Appeals Process (CMS-4004-F) .........................................................................................                                    0938-AL67
         901          State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals; Federal Fiscal Year 2002
                       (CMS-2136-FN) ............................................................................................................................................................         0938-AL79
         902          Prospective Payment System for Long-Term Care Hospitals for FY 2004 (CMS-1472-P) ..........................................                                                         0938-AL92
         903          Prospective Payment System for Inpatient Rehabilitation Hospitals for FY 2004 (CMS-1474-F) ................................                                                         0938-AL95
         904          Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities (CMS-1224-F) .................                                                               0938-AM01
         905          Update of the List of Covered Procedures for Ambulatory Surgical Centers (CMS-1885-FC) .....................................                                                        0938-AM02
         906          Nondiscrimination in Health Coverage in the Group Market (CMS-2022-F) .................................................................                                             0938-AM14
         907          Bona Fide Wellness Programs (CMS-2078-F) ..............................................................................................................                             0938-AM15
         908          Time Limitation on Recalculations and Disputes Under the Drug Rebate Program (CMS-2175-FC) ..........................                                                               0938-AM20
         909          Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year
                       2004 (CMS-8016-N) .....................................................................................................................................................            0938-AM31
         910          Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate Beginning January 1, 2004
                       (CMS-8017-N) ...............................................................................................................................................................       0938-AM32
         911          Part A Premiums for Calendar Year 2004 for the Uninsured Aged and for Certain Disabled Individuals Who Have
                       Exhausted Other Entitlement (CMS-8018-N) ...............................................................................................................                           0938-AM33
         912          Application of the Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-F) .......................................                                                          0938-AM34
         913          Approval of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Deeming Authority for
                       Hospices (CMS-2177-FN) ............................................................................................................................................                0938-AM38
         914          Hospital Cost-to-Charge Ratios Used to Calculate Cost Outlier Payments Under the Medicare Short-Term Inpatient
                       Prospective Payment System (CMS-1243-F) ..............................................................................................................                             0938-AM41
         915          Fee Schedule for Payment of Ambulance Services Update for CY 2004 (CMS-1232-N) ............................................                                                         0938-AM44
         916          Exclusion of Medicare Benefits for Aliens Not Lawfully Present in the United States (CMS-1222-IFC) ......................                                                           0938-AM47
         917          Hospice Wage Index for FY 2004 (CMS-1233-N) .........................................................................................................                               0938-AM56
         918          Announcement of Applications From Hospitals Requesting Waivers for Organ Procurement Service Areas in CY
                       2003 (CMS-1246-NC) ...................................................................................................................................................             0938-AM59


                                                  Centers for Medicare & Medicaid Services—Long-Term Actions
                                                                                                                                                                                                           Regulation
      Sequence                                                                                            Title                                                                                           Identification
       Number                                                                                                                                                                                               Number

         919          Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-P) ........................................                                                     0938-AH73



VerDate May<05>2003    13:51 May 16, 2003          Jkt 200001      PO 00000        Frm 00008        Fmt 1254      Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                     apps41      PsN: UA030408
                                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                                                               30221

     HHS



                                        Centers for Medicare & Medicaid Services—Long-Term Actions (Continued)
                                                                                                                                                                                                         Regulation
      Sequence                                                                                            Title                                                                                         Identification
       Number                                                                                                                                                                                             Number

         920            Fire Safety Requirements for Certain Health Care Facilities (CMS-3047-F) ................................................................                                       0938-AK35
         921            Hospital Conditions of Participation: Quality Assessment and Performance Improvements (QAPI) (CMS-3050-F) ....                                                                  0938-AK40
         922            Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003 Payment Rates;
                         Changes to Payment Suspension for Unfiled Cost Reports; Correction to Final Rule (CMS-1206-CN2) ..................                                                             0938-AL19


                                                    Centers for Medicare & Medicaid Services—Completed Actions
                                                                                                                                                                                                         Regulation
      Sequence                                                                                            Title                                                                                         Identification
       Number                                                                                                                                                                                             Number

         923            Security Standards (CMS-0049-F) .................................................................................................................................               0938-AI57
         924            External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F) ....................................................                                                0938-AJ06
         925            Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-FC) ....................................                                                         0938-AK48
         926            Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-0003-FC) ...........................                                                       0938-AK64
         927            Medicaid Managed Care; New Provisions (CMS-2104-F2) ...........................................................................................                                 0938-AK96
         928            Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003 (CMS-1204-F2) ............                                                                0938-AL21
         929            Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year
                         2003 (CMS-8013-N) .....................................................................................................................................................        0938-AL56
         930            Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate Beginning January 1, 2003
                         (CMS-8014-N) ...............................................................................................................................................................   0938-AL63
         931            Part A Premiums for Calendar Year 2003 for the Uninsured Aged and for Certain Disabled Individuals Who Have
                         Exhausted Other Entitlement (CMS-8015-N) ...............................................................................................................                       0938-AL69
         932            Fee Schedule for Payment of Ambulance Services—Update for CY 2003 (CMS-1220-N) .........................................                                                        0938-AL97
         933            Ticket to Work Medicaid Infrastructure Grant (CMS-2165-N) .......................................................................................                               0938-AM11
         934            Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Extension of Partial
                         Delay of Effective Date of the ‘‘Set in Advance’’ Provision (CMS-1809-F2) ...............................................................                                      0938-AM21
         935            Announcement of Applications From Hospitals Requesting Waivers for Organ Procurement Service Areas CY
                         2002 (CMS-1241-NC) ...................................................................................................................................................         0938-AM37
         936            Grants to States for Operation of Qualified High Risk Pools (CMS-2179-FC) .............................................................                                         0938-AM42
         937            Prospective Payment System for Long-Term Care Hospitals: Implementation and FY 2003 Rates; Correcting
                         Amendment (CMS-1177-F2) ........................................................................................................................................               0938-AM49
         938            Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships; Second Extension of
                         Delay of Effective Date of the ‘‘Set in Advance’’ Provision (CMS-1809-F3) ...............................................................                                      0938-AM58
         939            Ambulance Fee Schedule (CMS-1256-N) .....................................................................................................................                       0938-AM60
         940            Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings (CMS-0010-IFC) .........                                                            0938-AM63


                                                  Centers for Medicare & Medicaid Services—Discontinued Entries
        Regulation
       Identification                                                               Title                                                                   Date                             Comments
         Number

       0938-AG79              Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-                                                 03/10/2003             Withdrawn
                               3745-F)
       0938-AH53              Medicare and Medicaid Programs; Terms, Definitions, and Addresses; Tech-                                                 04/21/2003             Withdrawn
                               nical Amendments (CMS-9877-F)
        0938-AI21             Medical Child Support and Health Insurance Coverage of Dependent Chil-                                                   03/12/2003             Withdrawn
                               dren (CMS-2081-P)
        0938-AJ97             Application of Inherent Reasonableness to All Medicare Part B Services                                                   05/06/2003             Withdrawn
                               (Other than Physician Services) (CMS-1908-IFC)
       0938-AL12              Medicare Limits on the Valuation of a Depreciable Asset Recognized as an                                                 02/03/2003             Withdrawn
                               Allowance for Depreciation and Interest on Capital Indebtedness After a
                               Change of Ownership (CMS-1004-F)
       0938-AL33              Self-Declaration of Citizenship (CMS-2085-P)                                                                             03/05/2003             Withdrawn
       0938-AL59              Program for All-Inclusive Care for the Elderly (PACE): Program Revisions                                                 03/05/2003             Withdrawn
                               (CMS-1201-F)
       0938-AM10              Comprehensive Employment Demonstration (CMS-2163-N)                                                                      11/26/2002             Withdrawn
       0938-AM24              Liability of Third Parties To Pay for Care and Services (CMS-2080-P)                                                     01/30/2003             Withdrawn



VerDate May<05>2003      13:51 May 16, 2003         Jkt 200001      PO 00000        Frm 00009       Fmt 1254      Sfmt 1254       D:\UNIFIED\PRESSD~1\UA030408.TXT                    apps41      PsN: UA030408
     30222                       Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS



                                     Centers for Medicare & Medicaid Services—Discontinued Entries (Continued)
        Regulation
       Identification                                                         Title                                                            Date                          Comments
         Number

       0938-AM40             Meeting of the Negotiated Rulemaking Committee on Special Payment Pro-                                        03/12/2003          Withdrawn
                              visions and Requirements for Prosthetics and Certain Custom-Fabricated
                              Orthotics—May 19-20, 2003 and June 2-3, 2003 (CMS-6012-N5)


                                                Administration for Children and Families—Proposed Rule Stage
                                                                                                                                                                                        Regulation
      Sequence                                                                                    Title                                                                                Identification
       Number                                                                                                                                                                            Number

         941            Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) Information .............................                                       0970-AC01
         942            Developmental Disabilities and Bill of Rights Act ..........................................................................................................   0970-AC07
         943            Child Support Enforcement Program; Expenditures for Caseworker Costs ..................................................................                        0970-AC11
         944            Administrative Costs for Children in Title IV-E Foster Care ..........................................................................................         0970-AC14


                                                    Administration for Children and Families—Final Rule Stage
                                                                                                                                                                                        Regulation
      Sequence                                                                                    Title                                                                                Identification
       Number                                                                                                                                                                            Number

         945            Construction and Major Renovation of Head Start and Early Head Start Facilities .....................................................                          0970-AB54
         946            Child Support Enforcement for Indian Tribes ................................................................................................................   0970-AB73
         947            Child Support Enforcement Program Omnibus Conforming Regulation .......................................................................                        0970-AB81
         948            Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory Revisions ....................                                           0970-AC00
         949            Child Support Enforcement Program; Federal Tax Refund Offset ................................................................................                  0970-AC09
         950            Charitable Choice Provisions Applicable to the Temporary Assistance for Needy Families Program .........................                                       0970-AC12
         951            Community Services Block Grant Charitable Choice ....................................................................................................          0970-AC13


                                                   Administration for Children and Families—Completed Actions
                                                                                                                                                                                        Regulation
      Sequence                                                                                    Title                                                                                Identification
       Number                                                                                                                                                                            Number

         952            Family Child Care Program Option for Head Start Programs .......................................................................................               0970-AB90
         953            Child Support Enforcement Program; Customer Service Annual State Self-Assessment ............................................                                  0970-AC10


                                                              Administration on Aging—Proposed Rule Stage
                                                                                                                                                                                        Regulation
      Sequence                                                                                    Title                                                                                Identification
       Number                                                                                                                                                                            Number

         954            Grants for State and Community Programs on Aging, Training, Research, and Discretionary Programs; Vulnerable
                         Elder Rights; Grants to Indians and Native Hawaiians ................................................................................................         0985-AA00




VerDate May<05>2003      13:51 May 16, 2003      Jkt 200001     PO 00000      Frm 00010     Fmt 1254      Sfmt 1254    D:\UNIFIED\PRESSD~1\UA030408.TXT               apps41     PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30223

     Department of Health and Human Services (HHS)                                                                                  Proposed Rule Stage
     Office of the Secretary (OS)

     744. SAFE HARBOR FOR                                   compromise, and suspension or                          Action                   Date
     ARRANGEMENTS INVOLVING                                 termination of debts owed to the                       NPRM Comment            10/00/03
     FEDERALLY QUALIFIED HEALTH                             Department. The proposed rule is                         Period End
     CENTERS                                                required in order to bring the                         Final Rule              01/00/04
     Priority: Substantive, Nonsignificant                  Department’s claims collection                         Regulatory Flexibility Analysis
                                                            provisions in compliance with the                      Required: No
     Legal Authority: PL 100-93, sec 14(a)                  Department of the Treasury regulations.
     CFR Citation: 42 CFR 1001                                                                                     Small Entities Affected: No
                                                            Timetable:
     Legal Deadline: None                                                                                          Government Levels Affected: None
                                                            Action                        Date
     Abstract: This rule would set forth a                                                                         Agency Contact: Katherine M. Drews,
                                                            NPRM                      07/00/03                     Associate General Counsel, Department
     new anti-kickback safe harbor
                                                            NPRM Comment              09/00/03                     of Health and Human Services, Office
     addressing remuneration between                          Period End
     federally qualified health centers and                                                                        of the Secretary, Office of the General
                                                            Final Rule                12/00/03                     Counsel, Room 5362, HHS Cohen
     certain service providers where a
     significant community benefit exists.                  Regulatory Flexibility Analysis                        Building, 330 Independence Avenue
                                                            Required: No                                           SW., Washington, DC 20201
     Timetable:                                                                                                    Phone: 202 619-0150
                                                            Small Entities Affected: No
     Action                     Date
                                                            Government Levels Affected: None                       RIN: 0991–AB19
     NPRM                     10/00/03
     NPRM Comment             12/00/03                      Agency Contact: Katherine M. Drews,
      Period End                                            Associate General Counsel, Department                  747. ∑ CLARIFICATION OF TERMS
                                                            of Health and Human Services, Office                   AND APPLICATION OF PROGRAM
     Regulatory Flexibility Analysis                                                                               EXCLUSION AUTHORITY FOR
                                                            of the Secretary, Office of the General
     Required: No                                                                                                  SUBMITTING CLAIMS CONTAINING
                                                            Counsel, Room 5362, HHS Cohen
     Small Entities Affected: No                            Building, 330 Independence Avenue                      EXCESSIVE CHARGES
     Government Levels Affected: None                       SW., Washington, DC 20201                              Priority: Substantive, Nonsignificant
                                                            Phone: 202 619-0150
     Agency Contact: Joel Jay Schaer,                                                                              Legal Authority: Sec 112B (6) (6)(A) of
     Regulations Officer, Department of                     RIN: 0991–AB18                                         the Social Security Act
     Health and Human Services, Office of
                                                                                                                   CFR Citation: 42 CFR 1001
     the Secretary, Office of Inspector                     746. SALARY OFFSET
     General (OCIG), 330 Independence                                                                              Legal Deadline: None
     Avenue SW., Washington, DC 20201                       Priority: Substantive, Nonsignificant
                                                                                                                   Abstract: This proposed rule would
     Phone: 202 619-0089                                    Unfunded Mandates: Undetermined                        amend the OIG exclusion regulations at
     Related RIN: Related To 0991-AA91                      Legal Authority: 5 USC 5514; 5 CFR                     42 CFR 1001.701, addressing excessive
     RIN: 0991–AB06                                         550                                                    claims, by including definitions for the
                                                                                                                   terms ‘‘substantially in excess’’ and
                                                            CFR Citation: 45 CFR 33                                ‘‘usual charges,’’ and by clarifying the
     745. CLAIMS COLLECTION                                 Legal Deadline: None                                   ‘‘good cause’’ exception set forth in this
     Priority: Substantive, Nonsignificant                                                                         section.
                                                            Abstract: The Department will add a
     Legal Authority: 31 USC 3711; 31 CFR                   new part 33 to title 45 of the Code of                 Timetable:
     900 to 904                                             Federal Regulations (CFR) to implement                 Action                    Date
                                                            the salary offset provisions of the Debt
     CFR Citation: 45 CFR 30                                                                                       NPRM                    08/00/03
                                                            Collection Improvement Act of 1996
     Legal Deadline: None                                   (DCIA), Public Law 104-134, 110 Stat.                  NPRM Comment            10/00/03
                                                            1321 to 1358, codified at 5 U.S.C. 5514,                Period End
     Abstract: The Department will amend
     part 30 of title 45 of the Code of                     as implemented by the Office of                        Regulatory Flexibility Analysis
     Federal Regulations (CFR) to reflect the               Personnel Management at 5 CFR part                     Required: No
     amendments to the Federal Claims                       550, subpart K. The proposed rule is                   Government Levels Affected: None
     Collection Act made by the Debt                        required in order to bring the
     Collection Improvement Act of 1996                     Department’s salary offset provisions in               Agency Contact: Joel Jay Schaer,
     (DCIA), Public Law 104-134, 110 Stat.                  compliance with Governmentwide                         Regulations Officer, Department of
     1321 to 1358, as implemented by the                    regulations published by the Office of                 Health and Human Services, Office of
     Department of the Treasury at 31 CFR                   Personnel Management.                                  the Secretary, Office of Inspector
     900-904. The proposed rule will                                                                               General (OCIG), 330 Independence
                                                            Timetable:                                             Avenue SW., Washington, DC 20201
     prescribe the standards and procedures
     for the Department’s use in the                        Action                        Date                     Phone: 202 619-0089
     administrative collection, offset,                     NPRM                      07/00/03                     RIN: 0991–AB23




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00011   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30224                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     Department of Health and Human Services (HHS)                                                                                          Final Rule Stage
     Office of the Secretary (OS)

     748. SHARED RISK EXCEPTION TO                          waivers of beneficiary coinsurance and                 Timetable:
     THE SAFE HARBOR PROVISIONS                             deductible amounts to benefit the                      Action                    Date
     Priority: Substantive, Nonsignificant                  policyholders of Medicare SELECT
                                                            supplemental insurance. Specifically,                  NPRM                    12/04/02 67 FR 72128
     Legal Authority: 42 USC 1302; 42 USC                   the amended safe harbor will protect                   NPRM Comment            02/03/03
     1320a-7b; 42 USC 1395hh; PL 104-191,                   waivers of coinsurance and deductible                    Period End
     sec 216(b)                                             amounts under part A or part B of the                  Final Rule              08/00/03
     CFR Citation: 42 CFR 1001                              Medicare program owed by                               Regulatory Flexibility Analysis
                                                            beneficiaries covered by a Medicare                    Required: No
     Legal Deadline: Final, Statutory,
                                                            SELECT policy issued in accordance
     January 1, 1997.                                                                                              Small Entities Affected: No
                                                            with section 1882(t)(1) of the Social
     Abstract: This final rule establishes a                Security Act, if the waiver is in                      Government Levels Affected: None
     new statutory exception for risk-sharing               accordance with a price reduction
     arrangements under the Federal health                                                                         Federalism: Undetermined
                                                            agreement covering such policyholders
     care programs’ anti-kickback                           between the Medicare SELECT issuer                     Agency Contact: Katherine M. Drews,
     provisions. The rule sets forth an                     and the provider or supplier offering                  Associate General Counsel, Department
     exception from liability for                           the waiver.                                            of Health and Human Services, Office
     remuneration between an eligible                                                                              of the Secretary, Office of the General
     organization and an individual or entity               Timetable:                                             Counsel, Room 5362, HHS Cohen
     providing items or services in                         Action                        Date                     Building, 330 Independence Avenue
     accordance with a written agreement                    NPRM                      09/25/02 67 FR 60202
                                                                                                                   SW., Washington, DC 20201
     between these parties. The rule allows                 NPRM Comment              10/25/02
                                                                                                                   Phone: 202 619-0150
     remuneration between an organization                     Period End                                           RIN: 0991–AB17
     and an individual or entity if a written               Final Rule                10/00/03
     agreement places the individual or
     entity at ‘‘substantial financial risk’’ for           Regulatory Flexibility Analysis                        751. IMPLEMENTATION OF THE
     the cost or utilization of the items or                Required: No                                           EQUAL ACCESS TO JUSTICE ACT IN
     services that the individual or entity is              Small Entities Affected: No                            AGENCY PROCEEDINGS
     obligated to provide.                                                                                         Priority: Substantive, Nonsignificant
                                                            Government Levels Affected: None
     Timetable:
                                                            Agency Contact: Joel Jay Schaer,                       Legal Authority: 5 USC 504(c)(1)
     Action                     Date                        Regulations Officer, Department of                     CFR Citation: 45 CFR 13
     ANPRM                    05/23/97 62 FR 28410          Health and Human Services, Office of
                                                            the Secretary, Office of Inspector                     Legal Deadline: None
     ANPRM Comment            06/09/97
        Period End                                          General (OCIG), 330 Independence                       Abstract: The Equal Access to Justice
     Interim Final Rule       11/19/99 64 FR 63504          Avenue SW., Washington, DC 20201                       Act requires agencies to pay fees to
     Final Rule               10/00/03                      Phone: 202 619-0089                                    parties prevailing against the
     Regulatory Flexibility Analysis                        RIN: 0991–AB16                                         Government in certain administrative
     Required: No                                                                                                  proceedings. The Act has been
                                                                                                                   amended several times since its 1980
     Government Levels Affected: None                       750. TAX REFUND OFFSET                                 enactment, most recently by the
     Agency Contact: Joel Jay Schaer,                       Priority: Substantive, Nonsignificant                  Contract with America Advancement
     Regulations Officer, Department of                                                                            Act of 1996, which increased the
     Health and Human Services, Office of                   Legal Authority: 31 USC 3720A; 31                      amount of the hourly fees payable. The
     the Secretary, Office of Inspector                     CFR 285.2                                              proposed rule revises 45 CFR part 13
     General (OCIG), 330 Independence                       CFR Citation: 45 CFR 31                                (HHS’s regulation implementing the
     Avenue SW., Washington, DC 20201                                                                              Equal Access to Justice Act) to conform
     Phone: 202 619-0089                                    Legal Deadline: None                                   with statutory changes.
     Related RIN: Related To 0991-AB06                      Abstract: The Department will amend                    Timetable:
                                                            part 31 to title 45 of the Code of
     RIN: 0991–AA91                                         Federal Regulations (CFR) to reflect                   Action                    Date
                                                            amendments to 31 U.S.C. 3720A made                     NPRM                    06/19/87 52 FR 23311
     749. SAFE HARBOR FOR WAIVER OF                         by the tax refund offset provisions of                 NPRM Comment            08/18/87
     BENEFICIARY COINSURANCE AND                            the Debt Collection Improvement Act                      Period End
     DEDUCTIBLE AMOUNTS FOR A                               of 1996 (DCIA), Public Law 104-134,                    Second NPRM             08/13/02 67 FR 52696
     MEDICARE SELECT POLICY                                 110 Stat. 1321-1358, as implemented by                 Second NPRM             10/12/02
                                                            the Department of the Treasury at 31                     Comment Period
     Priority: Substantive, Nonsignificant                                                                           End
                                                            CFR 285.2. The proposed rule revises
     Legal Authority: PL 100-93, sec 14(a)                  the process by which the Department                    Final Rule              11/00/03
     CFR Citation: 42 CFR 1001                              collects its debts. The proposed rule is               Regulatory Flexibility Analysis
                                                            required in order to bring the                         Required: No
     Legal Deadline: None                                   Department’s tax refund offset
     Abstract: This final rule will expand                  provisions in compliance with the                      Small Entities Affected: No
     the existing safe harbor for certain                   Department of the Treasury regulations.                Government Levels Affected: None


VerDate May<05>2003   14:02 May 20, 2003   Jkt 200001   PO 00000   Frm 00012   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30225

     HHS—OS                                                                                                                                Final Rule Stage


     Additional Information: Transferred                    of Health and Human Services, Office                   Phone: 202 619-0150
     from RIN 0990-AA02                                     of the Secretary, Office of the General
                                                                                                                   Related RIN: Previously reported as
                                                            Counsel, Room 5362, HHS Cohen
     Agency Contact: Katherine M. Drews,                                                                           0990-AA02
                                                            Building, 330 Independence Avenue
     Associate General Counsel, Department                  SW., Washington, DC 20201                              RIN: 0991–AB22

     Department of Health and Human Services (HHS)                                                                                       Long-Term Actions
     Office of the Secretary (OS)

     752. REVISIONS TO 42 CFR PART                          753. AMENDING THE REGULATIONS                          754. GOVERNMENTWIDE
     1003                                                   GOVERNING NONDISCRIMINATION                            DEBARMENT AND SUSPENSION
                                                            ON THE BASIS OF RACE, COLOR,                           (NONPROCUREMENT) AND
     Priority: Substantive, Nonsignificant
                                                            NATIONAL ORIGIN, HANDICAP, SEX,                        GOVERNMENTWIDE REQUIREMENTS
     Legal Authority: 42 USC 1320a-7a; 42                   AND AGE TO CONFORM TO THE                              FOR DRUG-FREE WORKPLACE
     USC 1395mm; 42 USC 1395w-27; 42                        CIVIL RIGHTS RESTORATION ACT OF                        (GRANTS)
     USC 1396b; 42 USC 1396u-2                              1987                                                   Priority: Substantive, Nonsignificant.
     CFR Citation: 42 CFR 1003                              Priority: Other Significant                            Major status under 5 USC 801 is
                                                            Legal Authority: PL 100-259, Civil                     undetermined.
     Legal Deadline: None
                                                            Rights Restoration Act of 1987                         Legal Authority: 5 USC 301; 41 USC
     Abstract: This proposed rule would                                                                            701 et seq, sec 2455; PL 103-355; 31
     revise part 1003, addressing the Office                CFR Citation: 45 CFR 80; 45 CFR 84;
                                                            45 CFR 86; 45 CFR 90; 45 CFR 91                        USC 6101 note; EO 12689; EO 12549
     of Inspector General’s authority to
     propose the imposition of civil money                  Legal Deadline: None                                   CFR Citation: 45 CFR 76; 45 CFR 82
     penalties and assessments, by                                                                                 Legal Deadline: None
                                                            Abstract: The Secretary proposes to
     reorganizing and simplifying existing
                                                            amend the Department’s regulations                     Abstract: This proposed common rule
     regulatory text and eliminating obsolete
                                                            implementing title VI of the Civil                     is revised to simplify and streamline
     references contained in the current
                                                            Rights Act of 1964, as amended, section                nonprocurement debarment and
     regulations. Among the proposed
                                                            504 of the Rehabilitation Act of 1973,                 suspension requirements, as well as
     revisions, this rule would establish
                                                            as amended, title IX of the Education                  correspond to procurement regulations
     separate subparts within part 1003 for
                                                            Amendments of 1972, and the Age                        where possible. The revision will
     various categories of violations; modify
                                                            Discrimination Act of 1975, as                         separate the debarment and suspension
     the current definition for the term
                                                            amended. The principal proposed                        and Drug-Free Workplace regulations,
     ‘‘claim;’’ update various references to
                                                            conforming change is to amend the                      and will be written in the plain
     managed care organization authorities;
                                                            regulations to add the definitions of                  language format.
     and clarify the application of section
                                                            ‘‘program or activity’’ or ‘‘program’’ that
     1140 of the Social Security Act with                                                                          Timetable:
                                                            correspond to the statutory definitions
     respect to the misuse of certain                                                                              Action                    Date
                                                            enacted under the Civil Rights
     Departmental symbols, emblems or
                                                            Restoration Act of 1987.                               NPRM                 01/23/02 67 FR 3315
     names through Internet and e-mail
     communications.                                        Timetable:                                             NPRM Comment         03/25/02
                                                                                                                     Period End
     Timetable:                                             Action                        Date                     Next Action Undetermined
     Action                     Date                        NPRM                 12/06/00 65 FR 76460              Regulatory Flexibility Analysis
                                                            Next Action Undetermined                               Required: No
     NPRM                        To Be Determined
                                                            Regulatory Flexibility Analysis                        Small Entities Affected: No
     Regulatory Flexibility Analysis                        Required: Undetermined
     Required: No                                                                                                  Government Levels Affected: None
                                                            Small Entities Affected: Businesses,
     Small Entities Affected: No                            Governmental Jurisdictions,                            Agency Contact: Diane Osterhus,
     Government Levels Affected: None                       Organizations                                          Federal Assistance Policy Specialist,
                                                                                                                   Department of Health and Human
     Agency Contact: Joel Jay Schaer,                       Government Levels Affected: State,                     Services, Office of the Secretary, Room
     Regulations Officer, Department of                     Local, Federal, Tribal                                 517D, Office of Grants and Acquisition
     Health and Human Services, Office of                   Agency Contact: Robinsue Frohboese,                    Management, 200 Independence
     the Secretary, Office of Inspector                     Principal Deputy Director, Office for                  Avenue SW., Washington, DC 20201
     General (OCIG), 330 Independence                       Civil Rights, Department of Health and                 Phone: 202 690-5729
     Avenue SW., Washington, DC 20201                       Human Services, Office of the Secretary                Fax: 202 690-6901
     Phone: 202 619-0089                                    Phone: 202 619-0403                                    Email: diane.osterhus@hhs.gov
     RIN: 0991–AB03                                         RIN: 0991–AB10                                         RIN: 0991–AB12




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00013   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30226                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     Department of Health and Human Services (HHS)                                                                                       Completed Actions
     Office of the Secretary (OS)

     755. CIVIL MONEY PENALTY SAFE                          Phone: 202 619-0150                                    Legal Deadline: None
     HARBOR TO PROTECT PAYMENT OF                           Related RIN: Previously reported as                    Abstract: The rule will establish
     MEDICARE AND MEDIGAP PREMIUMS                          0990-AA05                                              procedures for investigations
     FOR ESRD BENEFICIARIES
                                                            RIN: 0991–AB20                                         subpoenas, imposition of penalties, and
     Priority: Substantive, Nonsignificant                                                                         hearings concerning the imposition of
                                                                                                                   civil money penalties by the Secretary
     CFR Citation: 42 CFR 1003                              757. U.S. EXCHANGE VISITOR                             of Health and Human Services pursuant
     Completed:                                             PROGRAMS; REQUEST FOR WAIVER                           to 42 U.S.C. 1320d-5. The rule will
                                                            OF THE TWO-YEAR FOREIGN                                establish procedures that the Secretary
     Reason                     Date                        RESIDENCE REQUIREMENT                                  will follow and, with respect to
     Notice                   12/09/02 67 FR 72896          Priority: Other Significant                            hearings, which regulated entities who
     Regulatory Flexibility Analysis                        CFR Citation: 45 CFR 50                                challenge the proposed imposition of a
     Required: No                                                                                                  civil money penalty on the entity will
                                                            Completed:                                             follow.
     Government Levels Affected: None                       Reason                        Date
                                                                                                                   Timetable:
     Agency Contact: Joel Jay Schaer                        Interim Final Rule        12/19/02 67 FR 77692
     Phone: 202 619-0089                                                                                           Action                    Date
                                                            Regulatory Flexibility Analysis
     RIN: 0991–AB04                                         Required: No                                           Interim Final Rule      04/17/03 68 FR 18895

                                                            Government Levels Affected: State                      Regulatory Flexibility Analysis
     756. ADMINISTRATIVE WAGE                               Agency Contact: Joyce Edith Jones                      Required: No
     GARNISHMENT                                            Phone: 202 690-6174                                    Small Entities Affected: No
                                                            Fax: 202 690-7127
     Priority: Substantive, Nonsignificant                                                                         Government Levels Affected: Federal
                                                            RIN: 0991–AB21
     CFR Citation: 45 CFR 32                                                                                       Agency Contact: Karen Shaw, Para
     Completed:                                                                                                    Legal, Department of Health and
                                                            758. ∑ CIVIL MONEY PENALTIES:                          Human Services, Office of the
     Reason                     Date                        PROCEDURES FOR INVESTIGATIONS,                         Secretary, Rm: 711E, 200 Independence
                                                            IMPOSITION OF PENALTIES, AND                           Avenue SW., Washington, DC 20201
     Final Rule               03/28/03 68 FR 15092
                                                            HEARINGS                                               Phone: 202 690-7711
     Regulatory Flexibility Analysis                        Priority: Other Significant                            Fax: 202 690-5452
     Required: No                                                                                                  Email: karen.shaw@hhs.gov
                                                            Legal Authority: 42 USC 1320d-5; 42
     Government Levels Affected: None                       USC 1302(a)                                            RIN: 0991–AB24
     Agency Contact: Katherine M. Drews                     CFR Citation: 42 CFR 160

     Department of Health and Human Services (HHS)                                                                                          Final Rule Stage
     Substance Abuse and Mental Health Services Administration (SAMHSA)

     759. ∑ SAMHSA CHARITABLE CHOICE                        grant program, insofar as recipients                   Small Entities Affected: No
                                                            provide substance abuse services, and
     Priority: Other Significant                                                                                   Government Levels Affected: Federal
                                                            to SAMHSA discretionary grants for
     Legal Authority: Not Yet Determined                    substance abuse treatment or
                                                                                                                   Federalism: This action may have
     CFR Citation: 42 CFR 54, sec 54.1-13;                  prevention services, which are all
                                                                                                                   federalism implications as defined in
     42 CFR 54a, sec 54a.1-14                               administered by the Substance Abuse
                                                            and Mental Health Services                             EO 13132.
     Legal Deadline: None                                   Administration (SAMSHA) of the U.S.                    Agency Contact: Winnie Mitchell,
     Abstract: This proposed rule would                     Department of Health and Human                         Public Health Analyst, Department of
     implement the Charitable Choice                        Services.                                              Health and Human Services, Substance
     statutory provisions of section 581-584                Timetable:                                             Abuse and Mental Health Services
     and section 1955 of the Public Health                  Action                        Date                     Administration, 12C-05, 5600 Fishers
     Service Act, applicable to the                                                                                Lane, Rockville, MD 20857
     Substance Abuse Prevention and                         NPRM                      12/17/02 67 FR 77350
                                                                                                                   Phone: 301 443-2324
     Treatment (SAPT) Block Grant Program,                  Final Rule                06/00/03
                                                                                                                   Fax: 301 443-0247
     the Project for Assistance in Transition               Regulatory Flexibility Analysis
     from Homelessness (PATH) formula                       Required: No                                           RIN: 0930–AA11




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00014   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30227

     Department of Health and Human Services (HHS)                                                                                       Long-Term Actions
     Substance Abuse and Mental Health Services Administration (SAMHSA)

     760. SECLUSION AND RESTRAINT                           rules and monitoring requirements                      Federalism: This action may have
     FOR NON-MEDICAL RESIDENTIAL                            concerning behavior management                         federalism implications as defined in
     FACILITIES                                             practice that will ensure compliance;                  EO 13132.
                                                            requires States to develop and
     Priority: Substantive, Nonsignificant                                                                         Agency Contact: Joseph Denis Faha,
                                                            implement such licensing rules and
     Legal Authority: PL 106-310                            implementation requirements within                     Director, DLEA, SAMHSA, Department
                                                            one year; and ensures that States                      of Health and Human Services,
     CFR Citation: Not Yet Determined                                                                              Substance Abuse and Mental Health
                                                            require such facilities to have adequate
     Legal Deadline: NPRM, Statutory, April                 staff, and that the States provide                     Services Administration, Room 12C-15,
     2001.                                                  training for professional staff.                       5600 Fishers Lane, Rockville, MD
                                                                                                                   20857
     Abstract: The Secretary is required by                 Timetable: Next Action Undetermined                    Phone: 301 443-7017
     statute to publish regulations governing               Regulatory Flexibility Analysis                        Fax: 301 443-1450
     States that license non-medical,                       Required: Yes                                          Email: jfaha@samhsa.gov
     community-based residential facilities
     for children and youth. The regulation                 Small Entities Affected: Businesses                    RIN: 0930–AA10
     requires States to develop licensing                   Government Levels Affected: State


     Department of Health and Human Services (HHS)                                                                                  Proposed Rule Stage
     Centers for Disease Control and Prevention (CDC)

     761. AMENDMENTS TO QUALITY                             for potential modification in this                     Small Entities Affected: Businesses
     ASSURANCE AND ADMINISTRATIVE                           module are: 1) upgrade of Quality
     PROVISION FOR APPROVAL OF                              Assurance requirements; 2) ability to                  Government Levels Affected: None
     RESPIRATORY PROTECTIVE DEVICES                         use private sector quality auditors and                Agency Contact: Roland Berry Ann,
     Priority: Other Significant                            private sector testing laboratories in the
                                                                                                                   Acting Chief, Respirator Branch,
                                                            approval program; 3) revised approval
     Legal Authority: 29 USC 651 et seq;                                                                           National Personal Protection
                                                            label requirements; 4) updated and
     30 USC 3; 30 USC 5; 30 USC 7; 30                       restructured fee schedule; and 5) fee                  Technology Laboratory, Department of
     USC 811; 30 USC 842(h); 30 USC 844                     retention in the respirator program.                   Health and Human Services, Centers for
     CFR Citation: 42 CFR 84                                                                                       Disease Control and Prevention,
                                                            Timetable:                                             NIOSH, P.O. Box 18070, 626 Cochrans
     Legal Deadline: None                                                                                          Mill Road, Pittsburgh, PA 15236
                                                            Action                        Date
     Abstract: NIOSH plans to modify the                                                                           Phone: 412 386-4000
                                                            NPRM                      12/00/03
     Administrative/Quality Assurance
     sections of 42 CFR part 84, Approval                   Regulatory Flexibility Analysis                        RIN: 0920–AA04
     of Respiratory Protective Devices. Areas               Required: Undetermined


     Department of Health and Human Services (HHS)                                                                                          Final Rule Stage
     Centers for Disease Control and Prevention (CDC)

     762. PROCEDURES FOR                                    Abstract: Pursuant to the Energy                       Small Entities Affected: No
     DESIGNATING CLASSES OF                                 Employees Occupational Illness
     EMPLOYEES AS MEMBERS OF THE                            Compensation Program Act, HHS plans                    Government Levels Affected: None
     SPECIAL EXPOSURE COHORT                                to finalize procedures to petition the
                                                                                                                   Agency Contact: Larry Elliott, Director,
     UNDER THE ENERGY EMPLOYEE                              Secretary to be added to the Special
                                                                                                                   Office of Compensation Analysis and
     OCCUPATIONAL ILLNESS                                   Exposure Cohort.
                                                                                                                   Support, Department of Health and
     COMPENSATION ACT OF 2000                               Timetable:                                             Human Services, Centers for Disease
     Priority: Substantive, Nonsignificant                  Action                        Date                     Control and Prevention, NIOSH, R44,
     Legal Authority: 42 USC 7384g; EO                                                                             5555 Ridge Avenue, Cincinnati, OH
                                                            NPRM                      06/25/02 67 FR 42962
     13179                                                                                                         45213
                                                            Final Rule                06/00/03
     CFR Citation: 42 CFR 83                                                                                       Phone: 513 841-4498
                                                            Regulatory Flexibility Analysis
     Legal Deadline: None                                   Required: No                                           RIN: 0920–AA07




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00015   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30228                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     Department of Health and Human Services (HHS)                                                                                       Completed Actions
     Centers for Disease Control and Prevention (CDC)

     763. CONTROL OF COMMUNICABLE                           Agency Contact: Jennifer Brooks                        Completed:
     DISEASES                                               Phone: 404 639-2763                                    Reason                    Date
     Priority: Other Significant
                                                            RIN: 0920–AA03                                         Interim Final Rule      12/13/02 67 FR 76886
     CFR Citation: 42 CFR 70; 42 CFR 71
                                                                                                                   Regulatory Flexibility Analysis
     Completed:                                                                                                    Required: No
                                                            764. POSSESSION, USE, AND
     Reason                     Date                        TRANSFER OF SELECT AGENTS                              Government Levels Affected: None
     Interim Final Rule       04/10/03 68 FR 17558                                                                 Agency Contact: Stephen M. Ostroff
                                                            Priority: Other Significant
     Regulatory Flexibility Analysis                                                                               Phone: 404 639-3967
     Required: No                                           CFR Citation: 42 CFR 72; 42 CFR 72.6
                                                                                                                   RIN: 0920–AA08
     Government Levels Affected: State


     Department of Health and Human Services (HHS)                                                                                                Prerule Stage
     Food and Drug Administration (FDA)

     765. OVER-THE-COUNTER (OTC)                            Cough/Cold (Antitussive) Products                      Skin Protectant Products
     DRUG REVIEW                                                 Final Action (Amendment)(Warning)                     Final Action 07/00/03
                                                                   12/06/02 (67 FR 72555)                              NPRM (Astringent) 09/00/03
     Priority: Routine and Frequent                         Cough/Cold (Bronchodilator) Products                       Final Action (Astringent) 09/00/03
                                                                 Final Action (Amendment) 02/00/04                 Sunscreen Products
     Legal Authority: 21 USC 321p; 21 USC                   Cough/Cold (Combination) Products                          Final Action (Names) 06/20/02 (67 FR
     351 to 353; 21 USC 355; 21 USC 360a;                        Final Action 12/23/02 (67 FR 78158)                     41821)
     21 USC 371a; 21 USC 331; 21 USC 360;                        NPRM (Amendment) 02/00/04                             ANPRM (and Insect Repellent) 10/00/03
     21 USC 360b; 21 USC 361; 21 USC 371                    Cough/Cold (Nasal Decongestant) Products                   NPRM (UVA/UVB) 12/00/03
                                                                 NPRM (Phenylpropanolamine) 10/00/03               Vaginal Contraceptive Products
     CFR Citation: 21 CFR 201; 21 CFR 310;                  External Analgesic Products                                NPRM (Amendment) 01/16/03 (68 FR
     21 CFR 330 to 350                                           Final Action (Amendment)(Warning)                       2254)
                                                                   12/06/02 (67 FR 72555)                          Weight Control Products
     Legal Deadline: None                                                                                              NPRM (Phenylpropanolamine) 10/00/03
                                                                 NPRM (Amendment) (Patches) 12/00/03
     Abstract: The OTC drug review                          Ingrown Toenail Relief Products                        Regulatory Flexibility Analysis
     establishes conditions under which                          NPRM 10/04/02 (67 FR 62218)                       Required: Yes
     OTC drugs are considered generally                          Final Action 06/00/03
                                                            Internal Analgesic Products                            Small Entities Affected: Businesses
     recognized as safe and effective and not
     misbranded. After a final monograph                         NPRM (Amendment)(Ibuprofen) 08/21/02              Government Levels Affected: None
                                                                   (67 FR 54139)
     (i.e., final rule) is issued, only OTC                                                                        Agency Contact: Gerald M. Rachanow,
                                                                 NPRM (Amendment) (Pediatric) 10/00/03
     drugs meeting the conditions of the                         NPRM (Amendment) (Labeling) 12/00/03              Regulatory Counsel, Division of Over-
     monograph, or having an approved new                   Labeling of Drug Products for OTC Human                the-Counter Drug Products, Department
     drug application, may be legally                         Use                                                  of Health and Human Services, Food
     marketed.                                                   Final Action (Ca/Mg/K/Na) 07/00/03                and Drug Administration, HFD-560,
                                                                 Final Action (Sodium Labeling) 07/00/03           Center for Drug Evaluation and
     SMALL ENTITIES AFFECTED: The                                NPRM (Sodium Labeling) 07/00/03
     effects, if any, vary depending on the                                                                        Research, 5600 Fishers Lane, Rockville,
                                                                 NPRM (Convenience Sizes) 09/00/03                 MD 20857
     individual rulemaking. However, the                    Laxative Drug Products
     Agency anticipates that the rules would                                                                       Phone: 301 827-2241
                                                                 NPRM (Amendment) (Psyllium Granular
     not have a significant economic impact                                                                        Fax: 301 827-2315
                                                                   Dosage Form) 10/00/03
     on a substantial number of small                       Nighttime Sleep Aid Products
                                                                                                                   Email: rachanow@cder.fda.gov
     entities as defined by the Regulatory                       Final Action (Amendment)(Warning)                 RIN: 0910–AA01
     Flexibility Act.                                              12/06/02 (67 FR 72555)
                                                            Ophthalmic Products
     Timetable:                                                  Final Action (Technical Amendment)                766. INVESTIGATIONAL USE NEW
     Anorectal Products                                            02/19/03 (68 FR 7919)                           ANIMAL DRUG REGULATIONS
         Final Action (Amendment) 12/00/03                       NPRM (Emergency First Aid Eyewashes)              (SECTION 610 REVIEW)
     Antidiarrheal Products                                        02/19/03 (68 FR 7951)
                                                                 Final Action (Name Change) 06/00/03
                                                                                                                   Priority: Substantive, Nonsignificant.
         Final Action 04/17/03 (68 FR 18869)
                                                            Oral Health Care Products                              Major status under 5 USC 801 is
         NPRM (Amendment) (Trav.Diar) 04/17/03
           (68 FR 18915)                                         ANPRM (Plaque/Gingivitis) 06/00/03                undetermined.
     Antiemetic Products                                    Pediculicide Products                                  Unfunded Mandates: Undetermined
         Final Action (Amendment) (Warning)                      NPRM (Labeling Amendment) 05/10/02
           12/06/02 (67 FR 72555)                                  (67 FR 31739)                                   Legal Authority: 5 USC 610; 21 USC
     Antiperspirant Products                                     Final Action (Labeling Amendment)                 351; 21 USC 353; 21 USC 360b; 21 USC
         Final Action 08/00/03                                     02/00/04                                        371; 21 USC 321; 21 USC 352
     Cough/Cold (Antihistamine) Products                    Salicylate (Reye’s Syndrome)
                                                                                                                   CFR Citation: 21 CFR 511
         Final Action (Amendment)(Warning)                       Final Action (Warning) 04/17/03 (68 FR
           12/06/02 (67 FR 72555)                                  18861)                                          Legal Deadline: None


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00016   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30229

     HHS—FDA                                                                                                                                      Prerule Stage


     Abstract: FDA is initiating a review of                conventional foods and dietary                         manufacturing practice in
     21 CFR 511.1 under section 610 of the                  supplements on a separate line                         manufacturing, packing, and holding
     Regulatory Flexibility Act. The purpose                immediately under the line for                         human food. Part 110 contains
     of the section 610 review is to                        saturated fat. This ANPRM would                        regulations describing sanitary practices
     determine if the rule should be                        solicit information and data on whether                for personnel, buildings and facilities,
     amended to minimize adverse                            to consider footnote statements for                    and equipment. It also includes
     economic impacts on small entities.                    possible use in the nutrition label about              regulations on production and process
     FDA will solicit and consider                          trans fat, either alone or in combination              controls for manufacturing practices
     comments on the following: 1) the                      with saturated fat and cholesterol, to                 and on defect action levels for natural
     continued need for the rule; 2) the                    enhance consumers’ understanding                       or unavoidable defects in food for
     nature of complaints or comments                       about such fat in foods and how to use                 human use that present no health
     received concerning the rule; 3) the                   the information to make healthy food                   hazard. FDA is undertaking a review
     complexity of the rule; 4) the extent                  choices. FDA is soliciting information                 of part 110 under section 610 of the
     to which the rule overlaps, duplicates,                and data on language in any such                       Regulatory Flexibility Act. The purpose
     or conflicts with other Federal, State,                statements and the impact on                           of this review is to determine whether
     or local government rules; and 5) the                  consumers from such statements.                        the regulations in part 110 should be
     degree to which technology, economic                   Information obtained from this                         continued without change, or whether
     conditions, or other factors have                      solicitation and that resulting from                   they should be amended or rescinded,
     changed in the area affected by the                    consumer studies conducted by FDA                      to minimize adverse impacts on a
     rule.                                                  may be used to help draft a proposed                   substantial number of small entities.
     Timetable:                                             rule that would require the use of a                   FDA will consider, and is soliciting
                                                            footnote in the Nutrition Facts panel                  comments on, the following: (1) the
     Action                     Date                        about one or more of the cholesterol-                  continued need for the regulations in
     ANPRM                    11/21/96 61 FR 59209          raising lipids to increase consumer                    part 110; (2) the nature of complaints
     ANPRM Comment            01/21/97                      understanding of the relative                          or comments received concerning the
       Period End                                           significance of these lipids in foods.                 regulations in part 110; (3) the
     Begin Review             04/03/00                      Timetable:                                             complexity of the regulations in part
     End Review               12/00/03                                                                             110; (4) the extent to which the
                                                            Action                        Date                     regulations in part 110 overlap,
     Regulatory Flexibility Analysis
     Required: Undetermined                                 ANPRM                     06/00/03                     duplicate, or conflict with other
                                                            Regulatory Flexibility Analysis                        Federal, State, or governmental rules;
     Small Entities Affected: Businesses                                                                           and (5) the degree to which technology,
                                                            Required: No
     Government Levels Affected:                                                                                   economic conditions, or other factors
     Undetermined                                           Government Levels Affected: Federal                    have changed in the area affected by
     Federalism: Undetermined                               Agency Contact: Susan Thompson,                        the regulations in part 110.
                                                            Chemist, Department of Health and
     Agency Contact: Marty Schoenemann,                     Human Services, Food and Drug                          The section 610 review will be carried
     Department of Health and Human                         Administration, (HFS-832), Center for                  out along with a regulatory review
     Services, Food and Drug                                Food Safety and Applied Nutrition,                     under section 5 of Executive Order
     Administration, HFV-126, Center for                    5100 Paint Branch Parkway, College                     12866, which calls for agencies to
     Veterinary Medicine, 7500 Standish                     Park, MD 20740                                         periodically review existing regulations
     Place, Rockville, MD 20855                             Phone: 301 436-1450                                    to determine whether any should be
     Phone: 301 827-0220                                    Fax: 301 436-2639                                      modified or eliminated so as to make
     RIN: 0910–AB02                                         Email: sthomps1@cfsan.fda.gov                          the agency’s regulatory program more
                                                                                                                   effective in achieving its goals, less
                                                            Related RIN: Related To 0910-AB66                      burdensome, or in greater alignment
     767. ∑ FOOD LABELING: TRANS                            RIN: 0910–AC50                                         with the President’s priorities and the
     FATTY ACIDS IN NUTRITION                                                                                      princples set forth in the Executive
     LABELING: CONSUMER RESEARCH                                                                                   order. The combined effect of the two
     TO CONSIDER POSSIBLE FOOTNOTE                          768. ∑ PART 110—CURRENT GOOD
                                                                                                                   reviews will be to determine if it is
     STATEMENTS                                             MANUFACTURING PRACTICE IN
                                                                                                                   possible to redesign current good
                                                            MANUFACTURING, PACKING, OR
     Priority: Other Significant                                                                                   manufacturing practices in ways that
                                                            HOLDING HUMAN FOOD (SECTION
     Legal Authority: 21 USC 321; 21 USC                                                                           will maintain or increase the
                                                            610 REVIEW)
     343; 21 USC 371                                                                                               effectiveness of preventive and sanitary
                                                            Priority: Other Significant. Major status              controls, and, at the same time, reduce
     CFR Citation: 21 CFR 101                               under 5 USC 801 is undetermined.                       compliance and other costs associated
     Legal Deadline: None                                   Unfunded Mandates: Undetermined                        with the regulations.
     Abstract: This advance notice of                       Legal Authority: 21 USC 342; 21 USC                    Timetable:
     proposed rulemaking (ANPRM) is                         371; 21 USC 374; 42 USC 264
     intended to publish in the same issue                                                                         Action                    Date
                                                            CFR Citation: 21 CFR 110
     of the Federal Register as the trans fat                                                                      Begin Review            05/00/03
     final rule that would require that the                 Legal Deadline: None
     quantitative amount of trans fat be                    Abstract: Part 110 (21 CFR part 110)                   Regulatory Flexibility Analysis
     declared in the nutrition label of                     describes regulations for current good                 Required: Undetermined


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00017   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30230                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                                      Prerule Stage


     Government Levels Affected:                            OSAS, CFSAN, FDA, HHS, Department                      Phone: 301 436-1989
     Undetermined                                           of Health and Human Services, Food                     Fax: 301 436-2626
     Federalism: Undetermined                               and Drug Administration, HFS-725,                      Email: richard.williams@cfsan.fda.gov
                                                            5100 Paint Branch Parkway, College
     Agency Contact: Richard A. Williams,                                                                          RIN: 0910–AC58
                                                            Park, MD 20740
     Director, Division of Market Studies,

     Department of Health and Human Services (HHS)                                                                                  Proposed Rule Stage
     Food and Drug Administration (FDA)

     769. FOREIGN AND DOMESTIC                              770. BLOOD INITIATIVE                                  General Requirements for Blood, Blood
     ESTABLISHMENT REGISTRATION                                                                                      Components, and Plasma Derivatives;
     AND LISTING REQUIREMENTS FOR                           Priority: Other Significant. Major status                Notification of Deferred Donors
                                                            under 5 USC 801 is undetermined.                           NPRM 08/19/99 (64 FR 45355)
     DRUGS AND BIOLOGICS                                                                                               Final Action 06/11/01 (66 FR 31165)
     Priority: Other Significant                            Legal Authority: 21 USC 321; 21 USC                    Regulations for Human Blood and Blood
                                                            331; 21 USC 351 to 353; 21 USC 355;                      Components Intended for Transfusion or
     Legal Authority: 21 USC 321; 21 USC                                                                             For Further Manufacturing Use
     331; 21 USC 351; 21 USC 352; 21 USC                    21 USC 360; 21 USC 371; 21 USC 374;
                                                                                                                       NPRM 01/00/04
     355; 21 USC 360; 21 USC 360b; 21 USC                   42 USC 216; 42 USC 262; 42 USC 263;                    Requirements for Testing Human Blood
     371; 21 USC 374; 42 USC 262                            42 USC 263a; 42 USC 264                                  Donors for Evidence of Infection Due to
                                                                                                                     Communicable Disease Agents
     CFR Citation: 21 CFR 20; 21 CFR 201;                   CFR Citation: 21 CFR 600; 21 CFR 601;                      NPRM 08/19/99 (64 FR 45340)
     21 CFR 207; 21 CFR 314; 21 CFR 514;                    21 CFR 606; 21 CFR 607; 21 CFR 610;                        Final Action 06/11/01 (66 FR 31146)
     21 CFR 601; 21 CFR 607; 21 CFR 1271                    21 CFR 630; 21 CFR 640; 21 CFR 660;                    Revisions to Labeling and Storage
                                                            21 CFR 680                                               Requirements for Blood and Blood
     Legal Deadline: None                                                                                            Components, Including Source Plasma
     Abstract: The proposed rule would                      Legal Deadline: None                                       NPRM 12/00/03
     amend FDA regulations on the                                                                                  Revisions to the Requirements Applicable
                                                            Abstract: In multiple rulemakings, the                   to Blood, Blood Components, and Source
     registration of producers of drugs and
                                                            Food and Drug Administration is                          Plasma
     the listing of drugs in commercial                                                                                Direct Final Rule 08/19/99 (64 FR 45366)
                                                            amending the biologics regulations by
     distribution. The proposed revisions                                                                              NPRM 08/19/99 (64 FR 45375)
                                                            removing, revising, or updating specific
     would reorganize, consolidate, clarify,                                                                           Direct Final Rule - Confirmation in Part
                                                            regulations applicable to blood, blood
     and modify current regulations                                                                                      and Technical Amendment 01/10/01 (66
                                                            components, Source Plasma, and blood-
     concerning who must register                                                                                        FR 1834)
                                                            derivative products to be more                             Final Action 08/06/01 (66 FR 40886)
     establishments and list drug or
                                                            consistent with current practices and to
     biologics regulated as drugs. The                                                                             Regulatory Flexibility Analysis
                                                            remove unnecessary or outdated
     proposal describes when, how, and                                                                             Required: No
                                                            requirements. This action is based on
     where to register and list, and what
                                                            FDA’s comprehensive review of the                      Small Entities Affected: Businesses
     information must be submitted for
                                                            biologics regulations. It is also based                Government Levels Affected: None
     registration and listing. The proposed
                                                            on reports by the U.S. House of
     regulations would also revise the                                                                             Agency Contact: Paula S. McKeever,
                                                            Representatives Committee on
     requirements for the NDC number and                                                                           Regulatory Policy Analyst, Department
                                                            Government Reform and Oversight’s,
     would require the electronic                                                                                  of Health and Human Services, Food
                                                            Subcommittee on House Resources and
     submission of most registration and                                                                           and Drug Administration, Suite 200N
                                                            Intergovernmental Relations, the
     listing information.                                                                                          (HFM-17), Center for Biologics
                                                            General Accounting Office, and the
     Timetable:                                                                                                    Evaluation and Research, 1401
                                                            Institute of Medicine, as well as on
                                                                                                                   Rockville Pike, Rockville, MD 20852-
     Action                     Date                        public comments. The remaining
                                                                                                                   1448
                                                            subjects intended to be addressed in
     NPRM                     12/00/03                                                                             Phone: 301 827-6210
                                                            the rulemakings include: labeling, and
                                                                                                                   Fax: 301 594-1944
     Regulatory Flexibility Analysis                        donor suitability and testing. These
     Required: No                                           actions are intended to help ensure the                Related RIN: Related To 0910-AB76
                                                            continued safety of the Nation’s blood                 RIN: 0910–AB26
     Government Levels Affected: None
                                                            supply.
     Agency Contact: Howard P. Muller,
     Office of Regulatory Policy, Department                Timetable:                                             771. APPLICATIONS FOR FDA
     of Health and Human Services, Food                     Albumin (Human), Plasma Protein Fraction
                                                                                                                   APPROVAL TO MARKET A NEW
     and Drug Administration, Suite 3037                      (Human) and Immune Globulin (Human);                 DRUG; COMPLETE RESPONSE
     (HFD-7), Center for Drug Evaluation                      Revision of Requirements                             LETTER; AMENDMENTS TO
     and Research, 1451 Rockville Pike,                         Direct Final Rule 05/14/99 (64 FR 26282)           UNAPPROVED APPLICATIONS
     Rockville, MD 20852                                        NPRM 05/14/99 (64 FR 26344)                        Priority: Substantive, Nonsignificant.
     Phone: 301 594-2041                                        Direct Final Rule - Confirmation in Part           Major status under 5 USC 801 is
     Fax: 301 827-5562                                            and Technical Amendment 03/14/00 (65
                                                                  FR 13678)
                                                                                                                   undetermined.
     RIN: 0910–AA49                                             Final Action 08/28/00 (65 FR 52016)                Unfunded Mandates: Undetermined


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00018   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30231

     HHS—FDA                                                                                                                        Proposed Rule Stage


     Legal Authority: 21 USC 321; 21 USC                    apply to all medicated feed                            section of the Federal Food, Drug and
     331; 21 USC 351 to 353; 21 USC 355;                    manufacturers. This consolidation of                   Cosmetic Act (the Act) that provides
     21 USC 371; 21 USC 374; 21 USC 379e                    existing CGMPs would preserve and                      authority to the Secretary of Health and
     CFR Citation: 21 CFR 312; 21 CFR 314                   strengthen food safety, be more                        Human Services to promulgate CGMP
                                                            appropriate given the changing                         regulations and to a submission from
     Legal Deadline: None                                   structure of the medicated feed                        the dietary supplement industry asking
     Abstract: The proposed rule would                      industry, and enhance uniformity and                   that FDA consider an industry-
     amend the regulations on marketing                     enforcement.                                           proposed CGMP framework as a basis
     approval of new drugs to discontinue                   Timetable:                                             for CGMP regulations. The ANPRM also
     the use of approvable and not                                                                                 responds to concerns that such
     approvable letters when taking action                  Action                        Date                     regulations are necessary to ensure that
     on a marketing application and instead                 NPRM                      09/00/03                     consumers are provided with dietary
     use complete response letters. The                                                                            supplement products which have not
                                                            Regulatory Flexibility Analysis                        been adulterated as a result of
     proposed rule would also amend the                     Required: Undetermined
     regulations on extension of the review                                                                        manufacturing, packing, or holding;
     clock because of amendments to                         Government Levels Affected:                            which have the identity and provide
     applications.                                          Undetermined                                           the quantity of dietary ingredients
                                                            Federalism: Undetermined                               declared in labeling; and which meet
     Timetable:
                                                                                                                   the quality specifications that the
     Action                     Date                        Agency Contact: George Graber,                         supplements are represented to meet.
                                                            Director, Division of Animal Feeds,
     NPRM                     12/00/03
                                                            Department of Health and Human                         Timetable:
     Regulatory Flexibility Analysis                        Services, Food and Drug                                Action                    Date
     Required: Undetermined                                 Administration, HFV-220, Center for                    ANPRM                   02/06/97 62 FR 5700
     Government Levels Affected:                            Veterinary Medicine, 7500 Standish                     ANPRM Comment           06/06/97
     Undetermined                                           Place, Rockville, MD 20855                              Period End
                                                            Phone: 301 827-6651                                    NPRM                    05/00/03
     Federalism: Undetermined                               Email: ggraber@cvm.fda.gov
     Agency Contact: Brian L. Pendleton,                                                                           Regulatory Flexibility Analysis
                                                            RIN: 0910–AB70                                         Required: Yes
     Regulatory Counsel, Office of
     Regulatory Policy, Department of                                                                              Small Entities Affected: Businesses
     Health and Human Services, Food and                    773. CURRENT GOOD                                      Government Levels Affected:
     Drug Administration, Suite 3037 (HFD-                  MANUFACTURING PRACTICE IN                              Undetermined
     7), Center for Drug Evaluation and                     MANUFACTURING, PACKING, OR
     Research, 1451 Rockville Pike,                         HOLDING DIETARY INGREDIENTS                            Federalism: Undetermined
     Rockville, MD 20852                                    AND DIETARY SUPPLEMENTS                                Agency Contact: Karen Strauss,
     Phone: 301 594-2041                                    Priority: Economically Significant.                    Consumer Safety Officer, Department of
     Fax: 301 827-5562                                      Major under 5 USC 801.                                 Health and Human Services, Food and
     Email: pendletonb@cder.fda.gov                                                                                Drug Administration, (HFS-820), Center
                                                            Unfunded Mandates: This action may                     for Food Safety and Applied Nutrition,
     RIN: 0910–AB34                                         affect the private sector under PL 104-                5100 Paint Branch Parkway, College
                                                            4.                                                     Park, MD 20740
     772. CURRENT GOOD                                      Legal Authority: 21 USC 321; 21 USC                    Phone: 301 436-1774
     MANUFACTURING PRACTICE FOR                             342; 21 USC 343; 21 USC 348; 21 USC                    Fax: 301 436-2610
     MEDICATED FEEDS                                        371; 21 USC 374; 21 USC 381; 21 USC                    Email: kstrauss@cfsan.fda.gov
     Priority: Other Significant. Major status              393; 42 USC 264                                        RIN: 0910–AB88
     under 5 USC 801 is undetermined.                       CFR Citation: 21 CFR 111
     Unfunded Mandates: Undetermined                        Legal Deadline: None                                   774. REQUIREMENTS PERTAINING TO
     Legal Authority: 21 USC 351; 21 USC                    Abstract: The Food and Drug                            SAMPLING SERVICES AND PRIVATE
     352; 21 USC 360b; 21 USC 371; 21 USC                   Administration (FDA) announced in an                   LABORATORIES USED IN
     374                                                    advance notice of proposed rulemaking                  CONNECTION WITH IMPORTED FOOD
     CFR Citation: 21 CFR 225                               (ANPRM) on February 6, 1997 (62 FR                     Priority: Routine and Frequent
                                                            5700), its plans to consider developing                Legal Authority: 21 USC 331 to 334;
     Legal Deadline: None                                   regulations establishing current good                  21 USC 335b; 21 USC 335c; 21 USC
     Abstract: This proposal is in response                 manufacturing practices (CGMP) for                     341 to 344; 21 USC 348; 21 USC 351;
     to a citizen petition request to merge                 dietary supplements and dietary                        21 USC 352; 21 USC 355; 21 USC 360;
     the separate requirements of the current               ingredients. The ANPRM was                             21 USC 360c-360f; 21 USC 361; 21 USC
     good manufacturing practice (CGMP)                     published in order for FDA to solicit                  362; 21 USC 371; 21 USC 372; 21 USC
     regulations, 21 CFR part 225 applicable                comments on whether it should initiate                 374; 21 USC 376; 21 USC 381; 21 USC
     to licensed and unlicensed feed                        action to establish CGMP regulations,                  393; 42 USC 262; 42 USC 264
     manufacturing facilities, respectively.                and if so, what constitutes CGMP for
     The merger would produce a single set                  these products. FDA announced that                     CFR Citation: 21 CFR 59
     of updated, streamlined CGMPs that                     this effort was in response to the                     Legal Deadline: None


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00019   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30232                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                        Proposed Rule Stage


     Abstract: The proposed rule would                      committed to developing an action plan                 Phone: 301 436-1486
     establish requirements for importers                   to address the presence of salmonella                  Fax: 301 436-2632
     and other persons who use sampling                     enteritidis (SE) in shell eggs and egg                 Email: rebecca.buckner@cfsan.fda.gov
     services and private laboratories in                   products using a farm-to-table
     connection with imported food. For                     approach. FDA and FSIS held a public                   RIN: 0910–AC14
     example, the proposal would pertain to                 meeting on August 26, 1999, to obtain
     persons who use sample collection                      stakeholder input on the draft goals, as
     services and private laboratories, and                 well as to further develop the objectives              776. INSTITUTIONAL REVIEW
     would describe some responsibilities                   and action items for the action plan.                  BOARDS: REGISTRATION
     for such persons, sample collection                    The Egg Safety Action Plan was                         REQUIREMENTS
     services, and private laboratories. These              announced on December 11, 1999. The                    Priority: Info./Admin./Other
     responsibilities would include                         goal of the Action Plan is to reduce
     recordkeeping requirements to ensure                   egg-related SE illnesses by 50 percent                 Legal Authority: 21 USC 321; 21 USC
     that the correct sample is collected and               by 2005 and eliminate egg-related SE                   346; 21 USC 346a; 21 USC 348; 21 USC
     analyzed, and a notification                           illnesses by 2010.                                     351 to 353; 21 USC 355; 21 USC 360;
     requirement if a person intends to use                 The Egg Safety Action Plan consists of                 21 USC 360c to 360f; 21 USC 360h to
     a private laboratory in connection with                eight objectives covering all stages of                360j; 21 USC 371; 21 USC 379e; 21
     imported food. The proposed rule is                    the farm-to-table continuum as well as                 USC 381; 42 USC 216; 42 USC 241;
     intended to help insure the integrity                  support functions. On March 30, 2000                   42 USC 262; 42 USC 263b to 263n
     and scientific validity of data and                    (Columbus, OH), April 6, 2000
     results submitted to FDA.                                                                                     CFR Citation: 21 CFR 56.106
                                                            (Sacramento, CA), and July 31, 2000
     Timetable:                                             (Washington, DC), joint public meetings                Legal Deadline: None
     Action                     Date
                                                            were held by FDA and FSIS to solicit
                                                            and discuss information related to the                 Abstract: The proposed rule would
     NPRM                     08/00/03                      implementation of the objectives in the                require institutional review boards
     Regulatory Flexibility Analysis                        Egg Safety Action Plan.                                (IRB) to register with FDA. The
     Required: Undetermined                                                                                        registration information would include
                                                            In accordance with discussions at the
                                                                                                                   the name of the IRB, the name of the
     Small Entities Affected: No                            public meetings, FDA intends to
                                                                                                                   institution operating the IRB, and
                                                            publish a proposed rule to require that
     Government Levels Affected:                                                                                   names, addresses, phone numbers,
                                                            shell eggs be produced under a plan
     Undetermined                                                                                                  facsimile (fax) numbers, and electronic
                                                            that is designed to prevent transovarian
                                                                                                                   mail (e-mail) addresses of the senior
     Agency Contact: Philip L. Chao, Senior                 SE from contaminating eggs at the farm
                                                                                                                   officer of the institution and IRB chair
     Policy Analyst, Department of Health                   during production.
                                                                                                                   or contact, the range of active protocols
     and Human Services, Food and Drug                      FDA intends to discuss in its proposal                 (small, medium, or large) involving
     Administration, Room 15-61 (HF-23),                    certain provisions of the 1999 Food                    FDA-regulated products reviewed in
     Office of Policy, Planning and                         Code that are relevant to how eggs are                 the previous calendar year, and a
     Legislation, 5600 Fishers Lane,                        handled, prepared, and served at                       description of the types of FDA-
     Rockville, MD 20857                                    certain retail establishments. In                      regulated products reviewed. The
     Phone: 301 827-0587                                    addition, the agency plans to consider                 proposed rule would make it easier for
     Fax: 301 827-4774                                      whether it should require provisions for               FDA to inspect IRBs and to convey
     Email: pchao@oc.fda.gov                                certain retail establishments that serve               information to IRBs.
     RIN: 0910–AB96                                         populations most at risk of egg-related
                                                            illness (i.e., the elderly, children, and              Timetable:
                                                            the immunocompromised).                                Action                    Date
     775. PREVENTION OF SALMONELLA
     ENTERITIDIS IN SHELL EGGS                              Timetable:
                                                                                                                   NPRM                    08/00/03
     Priority: Economically Significant.                    Action                        Date
     Major under 5 USC 801.                                                                                        Regulatory Flexibility Analysis
                                                            NPRM                      09/00/03
                                                                                                                   Required: Undetermined
     Unfunded Mandates: This action may                     Regulatory Flexibility Analysis
     affect the private sector under PL 104-                Required: Yes                                          Government Levels Affected: None
     4.
                                                            Small Entities Affected: Businesses                    Agency Contact: Philip L. Chao, Senior
     Legal Authority: 21 USC 321; 21 USC                                                                           Policy Analyst, Department of Health
                                                            Government Levels Affected:
     342; 21 USC 371; 21 USC 381; 21 USC                                                                           and Human Services, Food and Drug
                                                            Undetermined
     393; 42 USC 243; 42 USC 264; 42 USC                                                                           Administration, Room 15-61 (HF-23),
     271; ...                                               Federalism: Undetermined                               Office of Policy, Planning and
     CFR Citation: 21 CFR 16; 21 CFR 116;                   Agency Contact: Rebecca Buckner,                       Legislation, 5600 Fishers Lane,
     21 CFR 118                                             Consumer Safety Officer, Department of                 Rockville, MD 20857
                                                            Health and Human Services, Food and                    Phone: 301 827-0587
     Legal Deadline: None                                   Drug Administration, HFS-306, Center                   Fax: 301 827-4774
     Abstract: In July 1999, the Food and                   for Food Safety and Applied Nutrition,                 Email: pchao@oc.fda.gov
     Drug Administration (FDA) and the                      5100 Paint Branch Parkway, College
     Food Safety Inspection Service (FSIS)                  Park, MD 20740                                         RIN: 0910–AC17


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00020   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30233

     HHS—FDA                                                                                                                        Proposed Rule Stage


     777. USE OF MATERIALS DERIVED                          supplements, and cosmetics if the                      Agency Contact: Rebecca Buckner,
     FROM BOVINE AND OVINE ANIMALS                          cervids have been exposed to chronic                   Consumer Safety Officer, Department of
     IN FDA-REGULATED PRODUCTS                              wasting disease (CWD). FDA is                          Health and Human Services, Food and
     Priority: Other Significant. Major status              proposing this regulation because of                   Drug Administration, HFS-306, Center
     under 5 USC 801 is undetermined.                       potential risks to health.                             for Food Safety and Applied Nutrition,
                                                                                                                   5100 Paint Branch Parkway, College
     Legal Authority: Not Yet Determined                    In addition to this proposed rule, FDA
                                                                                                                   Park, MD 20740
                                                            intends to issue guidance within the
     CFR Citation: Not Yet Determined                                                                              Phone: 301 436-1486
                                                            next few months on the use in animal
     Legal Deadline: None                                                                                          Fax: 301 436-2632
                                                            feed or material from deer and elk that
                                                                                                                   Email: rebecca.buckner@cfsan.fda.gov
     Abstract: The U.S. Department of                       are positive for CWD or are at high risk
                                                            of CWD.                                                RIN: 0910–AC21
     Agriculture’s Animal and Plant Health
     Inspection Service maintains, by                       CWD is a type of transmissible
     regulation in 9 CFR 94.18(a), a list of                spongiform encephalopathy (TSE), a                     779. REQUIREMENTS FOR
     countries: 1) where bovine spongiform                  group of fatal, neurodegenerative                      SUBMISSION OF IN VIVO
     encephalopathy (BSE) exists; and 2)                    diseases that include bovine                           BIOEQUIVALENCE DATA
     that present an undue risk of                          spongiform encephalopathy (BSE) in                     Priority: Substantive, Nonsignificant
     introducing BSE into the United States.                cattle, scrapie in sheep and goats, and
     This proposed rule would restrict, in                  Creutzfeldt-Jakob disease (CJD) in                     Legal Authority: 21 USC 321; 21 USC
     FDA-regulated products, the use of                     humans. The disease has been                           331; 21 USC 351 to 353; 21 USC 355;
     most materials derived from bovine and                 identified in wild and farmed elk and                  21 USC 355a; 21 USC 356; 21 USC
     ovine animals born, raised, or                         wild deer populations.                                 356a; 21 USC 356b; 21 USC 356c; 21
     slaughtered in a country listed in 9 CFR                                                                      USC 371; 21 USC 374; 21 USC 379
     94.18(a). In addition, there would be                  CWD has been found in cervid
                                                                                                                   CFR Citation: 21 CFR 314.96(a)(1); 21
     a waiver provision that could be used                  populations in certain areas of
                                                                                                                   CFR 314.94(a)(7); 21 CFR 320.21(b)(1)
     under appropriate criteria.                            Wisconsin, Colorado, Nebraska,
                                                            Wyoming, Kansas, Montana, Oklahoma,                    Legal Deadline: None
     Timetable:                                             South Dakota, New Mexico, Minnesota,                   Abstract: The Food and Drug
     Action                     Date                        and Canada. In 1999, the World Health                  Administration (FDA) is proposing to
                                                            Organization (WHO) said there is no                    amend its regulations on submission of
     NPRM                     03/00/04
                                                            evidence that CWD transmits to                         bioequivalence (BE) data to require an
     Regulatory Flexibility Analysis                        humans. However, it also suggested any                 abbreviated new drug application
     Required: Undetermined                                 part of a deer or elk believed to be                   (ANDA) applicant to submit data from
     Government Levels Affected:                            diseased should not be eaten. Results                  all BE studies the applicant conducts
     Undetermined                                           of some studies using in vitro                         on a drug product formulation
                                                            techniques have suggested that                         submitted for approval. In the past,
     Federalism: Undetermined                               transmission to humans could possibly                  ANDA applicants have submitted BE
     Agency Contact: Rebecca Buckner,                       occur. However, if it does occur, it is                studies demonstrating that a generic
     Consumer Safety Officer, Department of                 likely to be through a very inefficient                product meets BE criteria for FDA to
     Health and Human Services, Food and                    process.                                               approve the ANDA but have not
     Drug Administration, HFS-306, Center                                                                          typically submitted additional BE
                                                            Currently, there are no validated
     for Food Safety and Applied Nutrition,                                                                        studies conducted on the same drug
                                                            analytical tests to identify animals in
     5100 Paint Branch Parkway, College                                                                            product formulation. FDA is proposing
                                                            the pre-clinical phase of CWD, or any
     Park, MD 20740                                                                                                to require ANDA applicants to submit
                                                            other TSE. In addition, no test exists
     Phone: 301 436-1486                                                                                           information, in either a complete or
                                                            to ensure food safety. CWD typically
     Fax: 301 436-2632                                                                                             summary report, from all additional
                                                            exhibits a long incubation period,
     Email: rebecca.buckner@cfsan.fda.gov                                                                          passing and nonpassing BE studies
                                                            during which time animals appear
     RIN: 0910–AC19                                         normal but are potentially infectious.                 conducted on the same drug product
                                                            Therefore, FDA is proposing to require                 formulation submitted for approval.
     778. CHRONIC WASTING DISEASE:                          that food or cosmetic products derived                 Timetable:
     CONTROL OF FOOD PRODUCTS AND                           from animals exposed to CWD not enter                  Action                    Date
     COSMETICS DERIVED FROM                                 into commerce.
                                                                                                                   NPRM                    11/00/03
     EXPOSED ANIMAL POPULATIONS                             Timetable:
                                                                                                                   Regulatory Flexibility Analysis
     Priority: Other Significant                            Action                        Date                     Required: Yes
     Legal Authority: 42 USC 264; 21 USC                    NPRM                      03/00/04                     Small Entities Affected: Businesses
     301 et seq
                                                            Regulatory Flexibility Analysis                        Government Levels Affected: None
     CFR Citation: Not Yet Determined                       Required: Yes                                          Agency Contact: Aileen Ciampa,
     Legal Deadline: None                                   Small Entities Affected: Businesses                    Regulatory Counsel, Department of
     Abstract: The Food and Drug                                                                                   Health and Human Services, Food and
                                                            Government Levels Affected:
     Administration (FDA) is proposing to                                                                          Drug Administration, HFD-7, Center for
                                                            Undetermined
     prohibit the use of cervids (deer, elk)                                                                       Drug Evaluation and Research, 1451
     for food, including dietary                            Federalism: Undetermined                               Rockville Pike, Rockville, MD 20857


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00021   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30234                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                        Proposed Rule Stage


     Phone: 301 594-2041                                    with medical oxygen from class I to                    specified quality levels. This proposal
     Fax: 301 827-5562                                      class II and to establish a special                    would clarify sampling plans and the
     RIN: 0910–AC23                                         control for oxygen pressure regulators                 scoring of defects, lower acceptance
                                                            to address problems of fire and                        rates for leaking gloves, raise rejection
                                                            explosion associated with use of these                 rates for leaking gloves, and add
     780. EXCEPTION FROM GENERAL                            devices. The special control will be a                 tightened inspection schemes for
     REQUIREMENTS FOR INFORMED                              guidance document that includes                        reexamined glove lots. The rule is
     CONSENT; REQUEST FOR                                   standardized testing, performance, and                 intended to facilitate industry
     COMMENTS AND INFORMATION                               labeling guidance for industry. Devices                compliance and enhance the safety and
     Priority: Other Significant                            that meet the special control will be                  effectiveness of gloves.
                                                            exempt from the premarket notification                 Timetable:
     Legal Authority: 21 USC 321; 21 USC                    requirements of the act. The agency
     351; 21 USC 352; 21 USC 355; 21 USC                    believes it is taking a least burdensome               Action                    Date
     360; 21 USC 360bbb; 21 USC 360c; 21                    approach for industry. This proposed                   NPRM                    03/31/03 68 FR 15404
     USC 360d; 21 USC 360e; 21 USC 360f;                    rule will phase-in a compliance                        NPRM Comment            06/30/03
     21 USC 360h; 21 USC 360i; 21 USC                       approach that will minimize the cost.                    Period End
     360j; 21 USC 371; 21 USC 381                           FDA seeks to reclassify these devices                  Final Rule              12/00/04
     CFR Citation: 21 CFR 50.23                             under section 513(e)(1) of the Federal                 Regulatory Flexibility Analysis
     Legal Deadline: None                                   Food, Drug, and Cosmetic Act (21                       Required: No
                                                            U.S.C. 360c(e)(1)).
     Abstract: FDA is proposing an                                                                                 Government Levels Affected:
     amendment to the exception from the                    Timetable:                                             Undetermined
     general requirement for informed                       Action                        Date                     Federalism: Undetermined
     consent in certain circumstances                       NPRM                      12/00/03
     involving the use of investigational in                                                                       Agency Contact: Joseph M. Sheehan,
     vitro diagnostic devices to identify                   Regulatory Flexibility Analysis                        Chief, Regulations Staff, Department of
     chemical, biological, radiological, or                 Required: Undetermined                                 Health and Human Services, Food and
     nuclear threat agents.                                                                                        Drug Administration, HFZ-215, Center
                                                            Government Levels Affected:
                                                                                                                   for Devices and Radiological Health,
     Timetable:                                             Undetermined
                                                                                                                   1350 Piccard Drive, Rockville, MD
     Action                     Date                        Federalism: Undetermined                               20850
                                                            Agency Contact: Joseph M. Sheehan,                     Phone: 301 827-2974
     NPRM                     12/00/03
                                                            Chief, Regulations Staff, Department of                Fax: 301 594-4795
     Regulatory Flexibility Analysis                        Health and Human Services, Food and                    Email: jms@cdrh.fda.gov
     Required: No                                           Drug Administration, HFZ-215, Center                   RIN: 0910–AC32
     Small Entities Affected: No                            for Devices and Radiological Health,
                                                            1350 Piccard Drive, Rockville, MD
     Government Levels Affected: None                                                                              783. TOLL-FREE NUMBER FOR
                                                            20850
     Agency Contact: Catherine Lorraine,                    Phone: 301 827-2974                                    REPORTING ADVERSE EVENTS ON
     Director, Policy Development and                       Fax: 301 594-4795                                      LABELING FOR HUMAN DRUGS
     Coordination Group, Department of                      Email: jms@cdrh.fda.gov                                Priority: Other Significant
     Health and Human Services, Food and
                                                            RIN: 0910–AC30                                         Legal Authority: 21 USC 355a
     Drug Administration, 14-101-11, 5600
     Fishers Lane, Rockville, MD 20857                                                                             CFR Citation: 21 CFR 201; 21 CFR 208;
     Phone: 301 827-3360                                    782. MEDICAL DEVICES; PATIENT                          21 CFR 209
     Fax: 301 827-6777                                      EXAMINATION AND SURGEONS’                              Legal Deadline: Final, Statutory,
     RIN: 0910–AC25                                         GLOVES; ADULTERATION                                   January 4, 2003.
                                                            Priority: Substantive, Nonsignificant                  Abstract: To require the labeling of
     781. MEDICAL DEVICES;                                  Legal Authority: 21 USC 321; 21 USC                    human drugs approved under section
     ANESTHESIOLOGY DEVICES;                                331; 21 USC 351; 21 USC 352; 21 USC                    505 of the Federal Food, Drug, and
     PROPOSED RECLASSIFICATION OF                           371; 21 USC 374                                        Cosmetic Act to include a toll-free
     PRESSURE REGULATORS FOR USE                                                                                   number for reports of adverse events,
                                                            CFR Citation: 21 CFR 800.20
     WITH MEDICAL OXYGEN                                                                                           and a statement that the number is to
                                                            Legal Deadline: None                                   be used for reporting purposes only and
     Priority: Substantive, Nonsignificant                                                                         not to receive medical advice.
                                                            Abstract: The Food and Drug
     Legal Authority: 21 USC 351; 21 USC                    Administration (FDA) is proposing to                   Timetable:
     360c(e)(1); 21 USC 371                                 amend the sampling plans, test method,
                                                                                                                   Action                    Date
     CFR Citation: 21 CFR 868.2700; 21 CFR                  and acceptable quality levels in 21 CFR
     868.5905                                               800.20. As prescribed by this                          NPRM                    09/00/03
                                                            regulation, FDA samples patient                        Regulatory Flexibility Analysis
     Legal Deadline: None                                   examination and surgeons’ gloves and                   Required: Yes
     Abstract: The Food and Drug                            examines them for visual defects and
     Administration is proposing to                         water leaks. Glove lots are considered                 Small Entities Affected: Businesses
     reclassify pressure regulators for use                 adulterated if they do not meet                        Government Levels Affected: None


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00022   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30235

     HHS—FDA                                                                                                                        Proposed Rule Stage


     Agency Contact: Carol Drew,                            Health and Human Services, Food and                    excluded. The Secretary is directed to
     Regulatory Counsel, Department of                      Drug Administration, HFS-007, Center                   take into account the size of a business
     Health and Human Services, Food and                    for Food Safety and Applied Nutrition,                 in promulgating these regulations.
     Drug Administration, Suite 3037 (HFD-                  5100 Paint Branch Parkway, College                     Section 306 of the Act also added
     7), Center for Drug Evaluation and                     Park, MD 20740                                         section 414(a) and amended section
     Research, 1451 Rockville Pike,                         Phone: 301 827-6733                                    704(a) of FFDCA to permit FDA to
     Rockville, MD 20852                                    Fax: 301 480-5730                                      inspect these records and other
     Phone: 301 594-2041                                    Email:                                                 information if the Secretary has a
     Fax: 301 827-5562                                      marquita.steadman@cfsan.fda.gov                        reasonable belief that an article of food
     RIN: 0910–AC35                                         RIN: 0910–AC38                                         is adulterated and presents a threat of
                                                                                                                   serious adverse health consequences or
                                                                                                                   death to humans or animals.
     784. ADMINISTRATIVE DETENTION OF                       785. ESTABLISHMENT AND                                 Timetable:
     FOOD FOR HUMAN OR ANIMAL                               MAINTENANCE OF RECORDS
     CONSUMPTION UNDER THE PUBLIC                           PURSUANT TO THE PUBLIC HEALTH                          Action                    Date
     HEALTH SECURITY AND                                    SECURITY AND BIOTERRORISM                              NPRM                    05/00/03
     BIOTERRORISM PREPAREDNESS                              PREPAREDNESS AND RESPONSE
     AND RESPONSE ACT OF 2002                               ACT OF 2002                                            Regulatory Flexibility Analysis
                                                                                                                   Required: Yes
     Priority: Other Significant. Major status              Priority: Economically Significant.
     under 5 USC 801 is undetermined.                       Major under 5 USC 801.                                 Small Entities Affected: Businesses
     Unfunded Mandates: Undetermined                                                                               Government Levels Affected: None
                                                            Unfunded Mandates: This action may
     Legal Authority: PL 107-188, sec 303                   affect the private sector under PL 104-                Agency Contact: Nega Beru,
                                                            4.                                                     Supervisory Chemist, Office of Plant,
     CFR Citation: 21 CFR 1                                                                                        Dairy Foods and Beverages, Department
                                                            Legal Authority: PL 107-188, sec 306
     Legal Deadline: None                                                                                          of Health and Human Services, Food
                                                            CFR Citation: 21 CFR 1                                 and Drug Administration, HFS-305,
     Abstract: This rulemaking is one of a
     number of actions being taken to                       Legal Deadline: Final, Statutory,                      Center for Food Safety and Applied
     improve FDA’s ability to respond to                    December 12, 2003.                                     Nutrition, 5100 Paint Branch Parkway,
     threats of bioterrorism. Section 303 of                The Public Health Security and                         College Park, MD 20740
     the Bioterrorism Act authorizes the                    Bioterrorism Preparedness and                          Phone: 301 436-1400
     Secretary, through FDA, to order the                   Response Act of 2002, section 306,                     Fax: 301 436-2651
     detention of food if an officer or                     directs the Secretary, through FDA, to                 Email: nberu@cfsan.fda.gov
     qualified employee of FDA has credible                 issue final regulations establishing                   RIN: 0910–AC39
     evidence or information indicating an                  recordkeeping requirements by
     article of food presents a threat of                   December 12, 2003.
                                                                                                                   786. REQUIREMENTS FOR LIQUID
     serious adverse health consequences or                 Abstract: This rulemaking is one of a                  MEDICATED FEED AND FREE-CHOICE
     death to humans or animals. The Act                    number of actions being taken to                       MEDICATED FEED
     requires the Secretary, through FDA, to                improve FDA’s ability to respond to
     issue final regulations to expedite                    threats of bioterrorism. Section 414(b)                Priority: Substantive, Nonsignificant
     certain enforcement actions (i.e.,                     of the Federal Food, Drug and Cosmetic                 Legal Authority: PL 104-250; 21 USC
     seizures and injunctions) against                      Act (FFDCA), which was added by                        360b
     perishable foods.                                      section 306 of the Public Health                       CFR Citation: 21 CFR 558.5; 21 CFR
     FDA intends to implement section 303                   Security and Bioterrorism Preparedness                 510.455
     of the Act by proposing a regulation                   and Response Act of 2002 (the Act),
                                                            authorizes the Secretary, through FDA,                 Legal Deadline: None
     to provide for: 1) a detention
     procedure; 2) expedited procedures for                 to promulgate final regulations by                     Abstract: In response to a citizen
     enforcement actions with respect to                    December 12, 2003. The Act authorizes                  petition filed by the American Feed
     perishable foods; and 3) an appeals                    regulations that require the                           Industry Association, the Food and
     procedure for detained goods.                          establishment and maintenance of                       Drug Administration (FDA) is
                                                            records, for not longer than two years,                proposing to amend the requirements
     Timetable:
                                                            that would allow the Secretary to                      for liquid medicated animal feed to
     Action                     Date                        identify the immediate previous                        clarify what information and data are
     NPRM                     05/00/03                      sources and the immediate subsequent                   required to demonstrate chemical and
                                                            recipients of food, including its                      positional stability. The amended
     Regulatory Flexibility Analysis                        packaging. The required records would                  regulations would also clarify the
     Required: Yes                                          be those that are needed by FDA in                     provisions for the submission of such
     Small Entities Affected: Businesses                    order to address credible threats of                   data through a master file and the
     Government Levels Affected:                            serious adverse health consequences or                 reference to master files by subsequent
     Undetermined                                           death to humans or animals. Specific                   applicants. Additionally, FDA is
                                                            covered entities are those that                        proposing to amend the regulations for
     Federalism: Undetermined                               manufacture, process, pack, transport,                 free-choice medicated feed to ensure
     Agency Contact: Marquita Steadman,                     distribute, receive, hold, or import                   consistency with the requirements for
     Senior Policy Analyst, Department of                   food. Farms and restaurants are                        liquid medicated feed. Finally, FDA is


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00023   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30236                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                        Proposed Rule Stage


     proposing to amend the regulations for                 Timetable:                                             Timetable:
     free-choice medicated feed and liquid                  Action                        Date                     Action                    Date
     medicated feed so that these provisions
     comply with the terms of the Animal                    NPRM                      09/00/03                     NPRM                    02/00/04
     Drug Availability Act of 1996.                         Regulatory Flexibility Analysis                        Regulatory Flexibility Analysis
                                                            Required: Yes                                          Required: Undetermined
     Timetable:
                                                            Small Entities Affected: Businesses                    Government Levels Affected: None
     Action                     Date
                                                            Government Levels Affected:                            Agency Contact: Howard P. Muller,
     NPRM                     06/00/03                      Undetermined                                           Office of Regulatory Policy, Department
     Regulatory Flexibility Analysis                        Agency Contact: Nicole K. Mueller,                     of Health and Human Services, Food
     Required: No                                           Regulatory Counsel, Department of                      and Drug Administration, Suite 3037
                                                            Health and Human Services, Food and                    (HFD-7), Center for Drug Evaluation
     Government Levels Affected: None                                                                              and Research, 1451 Rockville Pike,
                                                            Drug Administration, Room 3037,
     Agency Contact: William D. Price,                      (HFD-7), 1451 Rockville Pike,                          Rockville, MD 20852
     Special Assistant, Department of Health                Rockville, MD 20852                                    Phone: 301 594-2041
     and Human Services, Food and Drug                      Phone: 301 594-2041                                    Fax: 301 827-5562
     Administration, HFV-200, Center for                    Fax: 301 594-6197                                      RIN: 0910–AC53
     Veterinary Medicine, 7500 Standish                     Email: muellern@cder.fda.gov
     Place, Rockville, MD 20855                             RIN: 0910–AC52
     Phone: 301 827-6652                                                                                           789. ∑ FOOD STANDARDS: GENERAL
     Fax: 301 594-4512                                                                                             PRINCIPLES AND FOOD STANDARDS
                                                            788. ∑ MEDICAL GAS CONTAINERS                          MODERNIZATION
     Related RIN: Previously reported as                    AND CLOSURES; CURRENT GOOD                             Priority: Other Significant
     0910-AB50                                              MANUFACTURING PRACTICE                                 Legal Authority: 21 USC 321; 21 USC
     RIN: 0910–AC43                                         REQUIREMENTS
                                                                                                                   336; 21 USC 341; 21 USC 343; 21 USC
                                                            Priority: Substantive, Nonsignificant.                 371
                                                            Major status under 5 USC 801 is
     787. ∑ SUBMISSION OF                                                                                          CFR Citation: 21 CFR 130.5
                                                            undetermined.
     STANDARDIZED ELECTRONIC STUDY                                                                                 Legal Deadline: None
     DATA FROM CLINICAL STUDIES                             Legal Authority: 21 USC 321; 21 USC
     EVALUATING HUMAN DRUGS AND                             351; 21 USC 353                                        Abstract: In 1995, the FDA and FSIS
     BIOLOGICS                                                                                                     reviewed their regulatory procedures
                                                            CFR Citation: 21 CFR 201.161(a); 21
                                                                                                                   and requirements for food standards to
     Priority: Substantive, Nonsignificant.                 CFR 210.3(b); 21 CFR 211.94
                                                                                                                   determine whether any were still
     Major status under 5 USC 801 is                        Legal Deadline: None                                   needed, and if so, whether any should
     undetermined.                                          Abstract: The Food and Drug                            be modified or streamlined. To request
     Legal Authority: 21 USC 355; 21 USC                    Administration (FDA) is proposing to                   public comment to assist them in their
     371; 42 USC 262                                        amend its current good manufacturing                   review of the need for food standards,
                                                            practice (CGMP) regulations and other                  both agencies published advance
     CFR Citation: 21 CFR 314.50; 21 CFR                    regulations to clarify and strengthen                  notices of proposed rulemaking
     601.14; 21 CFR 314.94                                  requirements for the label, color,                     (ANPRMs) on food standards in
                                                            dedication, and design of medical gas                  December, 1995 (60 FR 47453 and 60
     Legal Deadline: None
                                                            containers and closures. Despite                       FR 67492). These ANPRMs discussed
     Abstract: The Food and Drug                            existing regulatory requirements and                   the agencies’ regulations and policy
     Administration is proposing to amend                   industry standards for medical gases,                  governing food standards, the history of
     the regulations governing the format in                there have been repeated incidents in                  food standards, and the possible need
     which clinical study data (CSD) are                    which cryogenic containers of harmful                  to revise the food standards. Several
     required to be submitted for new drug                  industrial gases have been connected to                comments in response to the ANPRMs
     applications (NDAs), biological license                medical oxygen supply systems in                       recommended that the agencies
     applications (BLAs), and abbreviated                   hospitals and nursing homes, and                       establish general principles or a
     new drug applications (ANDAs). The                     subsequently administered to patients.                 fundamental philosophy for reviewing
     proposal would revise our regulations                  These incidents have resulted in death                 food standards and revising them. The
     to require CSD submitted for NDAs,                     and serious injury. There have also                    agencies agreed with these comments
     ANDAs, BLAs, and their supplements                     been several incidents involving high-                 and determined that it would be
     and amendments be provided in                          pressure medical gas cylinders that                    appropriate to develop general
     electronic format and require the use                  have resulted in death and injuries to                 principles for reviewing and revising
     of standard data structure, terminology,               patients. These proposed amendments,                   food standards regulations. The
     and code sets. The proposal would                      together with existing regulations, are                agencies also agreed with the comments
     improve the efficiency of the exchange                 intended to ensure that the types of                   that stated that the agencies should
     of information from clinical studies                   incidents that have occurred in the                    work in concert to develop consistent
     through the adoption of standards for                  past, as well as other types of                        food standards regulations. FDA and
     study data submitted in an electronic                  foreseeable and potentially deadly                     FSIS are now proposing a set of general
     form that FDA can process, review, and                 medical gas mixups, do not occur in                    principles that define how modern food
     archive.                                               the future.                                            standards should be structured. If this


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00024   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30237

     HHS—FDA                                                                                                                        Proposed Rule Stage


     proposed rule is adopted, FDA and                      Timetable:                                             Government Levels Affected: None
     FSIS will require that a citizen petition              Action                        Date                     Agency Contact: Valerie Butler,
     for establishing, revising, or eliminating
                                                            NPRM                      12/00/03                     Consumer Safety Officer, Department of
     a food standard in 21 CFR parts 130
                                                                                                                   Health and Human Services, Food and
     to 169 and 7 CFR part 410 be submitted                 Regulatory Flexibility Analysis
                                                                                                                   Drug Administration, Suite 200N
     in accordance with the general                         Required: Undetermined
                                                                                                                   (HFM-17), 1401 Rockville Pike,
     principles. Conversely, the agencies                   Government Levels Affected:                            Rockville, MD 20852
     may find deficient a petition to                       Undetermined                                           Phone: 301 827-6210
     establish, revise, or eliminate a food
                                                            Federalism: Undetermined                               Fax: 301 594-1944
     standard that does not follow these
     general principles.                                    Agency Contact: Wayne H. Mitchell,                     RIN: 0910–AC57
                                                            Regulatory Counsel, Office of
     Timetable:
                                                            Regulatory Policy, Department of
     Action                     Date                        Health and Human Services, Food and                    792. REPORTING INFORMATION
                                                            Drug Administration, Suite 3037 (HFD-                  REGARDING FALSIFICATION OF
     ANPRM                    12/29/95 60 FR 67492                                                                 DATA
     ANPRM Comment            04/29/96                      7), Center for Drug Evaluation and
      Period End                                            Research, 1451 Rockville Pike,                         Priority: Other Significant. Major status
     NPRM                     12/00/03                      Rockville, MD 20852                                    under 5 USC 801 is undetermined.
                                                            Phone: 301 594-2041
     Regulatory Flexibility Analysis                        Fax: 301 827-5562                                      Unfunded Mandates: Undetermined
     Required: Yes                                          Email: mitchellw@cder.fda.gov                          Legal Authority: 21 USC 321; 21 USC
     Small Entities Affected: Businesses                    Related RIN: Previously reported as                    341 to 343; 21 USC 348; 21 USC 349;
                                                            0910-AB63                                              21 USC 351; 21 USC 352; 21 USC 355;
     Government Levels Affected:
                                                            RIN: 0910–AC55                                         21 USC 360b; 21 USC 360c; 21 USC
     Undetermined
                                                                                                                   360e; 21 USC 360i; 21 USC 360j; 21
     Federalism: Undetermined                                                                                      USC 360k; 21 USC 361; 21 USC 371;
                                                            791. ∑ REVISION OF THE                                 21 USC 379e; 42 USC 262
     Agency Contact: Ritu Nalubola, Staff                   REQUIREMENTS FOR SPORE-
     Fellow, Department of Health and                       FORMING MICROORGANISMS                                 CFR Citation: 21 CFR 70.3; 21 CFR
     Human Services, Food and Drug                                                                                 71.1; 21 CFR 170.3; 21 CFR 171.1; 21
     Administration, HFS-820, Center for                    Priority: Other Significant                            CFR 312.3; 21 CFR 312.56; 21 CFR
     Food Safety and Applied Nutrition,                     Legal Authority: 21 USC 321; 21 USC                    510.3; 21 CFR 511.1; 21 CFR 812.46
     Harvey Wiley Building, 5100 Paint                      351; 21 USC 352; 21 USC 353; 21 USC
     Branch Parkway, College Park, MD                       355; 21 USC 360; 21 USC 360i; 21 USC                   Legal Deadline: None
     20740                                                  371; 21 USC 374; 42 USC 216; 42 USC                    Abstract: The proposed rule would
     Phone: 301 436-2371                                    262; 42 USC 263; 42 USC 263a; 42 USC                   require sponsors to promptly report any
     Fax: 301 436-2636                                      264; 42 USC 300aa-25                                   information indicating that any person
     Email: ritu.nalubola@cfsan.fda.gov                     CFR Citation: 21 CFR 600.10(c); 21                     has or may have falsified data in the
     RIN: 0910–AC54                                         CFR 600.11(e)                                          course of proposing, designing,
                                                            Legal Deadline: None                                   performing, recording, supervising, or
                                                                                                                   reviewing research, or in reporting
     790. ∑ POSITRON EMISSION                               Abstract: The Food and Drug                            research results.
     TOMOGRAPHY DRUGS; CURRENT                              Administration (FDA) is issuing a
     GOOD MANUFACTURING PRACTICES                           direct final rule and a companion                      Timetable:
                                                            proposed rule to amend the biologics                   Action                    Date
     Priority: Other Significant. Major status              regulations by providing options to the
     under 5 USC 801 is undetermined.                       existing requirement for separate,                     NPRM                    11/00/03

     Unfunded Mandates: Undetermined                        dedicated facilities and equipment for                 Regulatory Flexibility Analysis
                                                            work with spore-forming                                Required: Undetermined
     Legal Authority: PL 105-115, sec 121                   microorganisms. FDA is taking this
                                                            action due to advances in facility,                    Government Levels Affected: None
     CFR Citation: 21 CFR 220
                                                            system and equipment design, and                       Agency Contact: Christine F. Rogers,
     Legal Deadline: Final, Statutory,                      sterilization technologies, that would                 Regulatory Counsel, Department of
     November 21, 1999.                                     allow work with spore-forming                          Health and Human Services, Food and
     Abstract: Section 121 of the Food and                  microorganisms to be performed in                      Drug Administration, Suite 3059 (HFD-
     Drug Administration Modernization Act                  multi-product manufacturing areas.                     7), Center for Drug Evaluation and
     of 1997 (Pub. L. 105-115) directs FDA                  Timetable:                                             Research, 1451 Rockville Pike,
     to establish requirements for current                                                                         Rockville, MD 20852
                                                            Action                        Date
     good manufacturing practices (CGMPs)                                                                          Phone: 301 594-2041
     for positron emission tomography (PET)                 NPRM-Companion to 01/00/04                             Fax: 301 827-5562
     drugs, a type of radiopharmaceutical.                    Direct Final Rule
                                                            Direct Final Rule   01/00/04                           Related RIN: Previously reported as
     The proposed rule would adopt CGMPs
                                                                                                                   0910-AC02
     that reflect the unique characteristics of             Regulatory Flexibility Analysis
     PET drugs.                                             Required: No                                           RIN: 0910–AC59



VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00025   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30238                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     Department of Health and Human Services (HHS)                                                                                          Final Rule Stage
     Food and Drug Administration (FDA)

     793. INFANT FORMULA:                                   331; 21 USC 351 to 353; 21 USC 355;                    Administration, Room 15-61 (HF-23),
     REQUIREMENTS PERTAINING TO                             21 USC 371                                             Office of Policy, Planning and
     GOOD MANUFACTURING PRACTICE,                           CFR Citation: 21 CFR 312.110                           Legislation, 5600 Fishers Lane,
     QUALITY CONTROL PROCEDURES,                                                                                   Rockville, MD 20857
     QUALITY FACTORS, NOTIFICATION                          Legal Deadline: None                                   Phone: 301 827-0587
     REQUIREMENTS, AND RECORDS AND                          Abstract: The final rule would amend                   Fax: 301 827-4774
     REPORTS                                                the regulations on the exportation of                  Email: pchao@oc.fda.gov
     Priority: Other Significant                            unapproved new drug products,
                                                            including biological products, for                     RIN: 0910–AA61
     Legal Authority: 21 USC 321; 21 USC                    investigational use. In general, the rule
     350a; 21 USC 371; ...                                  would provide four different routes for                795. DETERMINATION THAT
     CFR Citation: 21 CFR 106; 21 CFR 107                   exporting an unapproved new drug                       INFORMED CONSENT IS INFEASIBLE
     Legal Deadline: None                                   product for investigational use. One                   OR IS CONTRARY TO THE BEST
                                                            route would permit exportation, if the                 INTEREST OF RECIPIENTS
     Abstract: The agency published a                       drug is the subject of an investigational
     proposed rule on July 9, 1996 that                     new drug application (IND) and is                      Priority: Other Significant
     would establish current good                           being exported for use in the
     manufacturing practice regulations,                                                                           Legal Authority: 21 USC 321; 21 USC
                                                            investigation. A second route would                    346; 21 USC 346a; 21 USC 348; 21 USC
     quality control procedures, quality                    permit exportation, without prior Food
     factors, notification requirements, and                                                                       352; 21 USC 353; 21 USC 355; 21 USC
                                                            and Drug Administration (FDA)                          360; 21 USC 360c to 360f; 21 USC 360h
     records and reports for the production                 approval and without an IND, if the
     of infant formula. This proposal was                                                                          to 360j; 21 USC 371; 21 USC 379e; 21
                                                            product is to be exported for use in                   USC 381; 42 USC 216; 42 USC 241;
     issued in response to the 1986                         a clinical investigation and has
     Amendments to the Infant Formula Act                                                                          42 USC 262; 42 USC 263b to 263n
                                                            received marketing authorization in
     of 1980.                                               certain developed countries. The third                 CFR Citation: 21 CFR 50; 21 CFR 312
     Timetable:                                             route would permit exportation,
                                                            without prior FDA approval and                         Legal Deadline: None
     Current Good Mfg. Practices; Qual. Control
       Proc.; Quality Factors                               without an IND, if the product is to                   Abstract: The final rule would
         NPRM 07/09/96 (61 FR 36154)                        be exported for use in a clinical                      establish criteria and standards for the
         NPRM Comment Period End 12/06/96                   investigation in certain specified                     President to apply in making a
         Final Action 12/00/03                              developed countries. The fourth route                  determination that informed consent is
     Infant Form Cons Comp, Micro Test & Recd               would permit exportation without an                    not feasible or is contrary to the best
       Retention Req                                        IND, to any country provided that the
         NPRM 01/26/89 (54 FR 3783)
                                                                                                                   interest of military personnel engaged
                                                            exporter sends a written certification to              in specific military operations. Under
         NPRM Comment Period End 03/27/89
                                                            FDA at the time the drug is first                      Federal law, the President is authorized
         Final Rule 12/24/91 (56 FR 66566)
     Infant Formula Quality Factors                         exported. Drugs exported under any of                  to waive the Federal Food, Drug, and
         NPRM Comment Period End 12/06/96                   the first three routes would, however,                 Cosmetic Act’s informed consent
         Final Action 12/00/03                              be subject to certain statutory                        requirements in military operations, if
                                                            requirements, such as not conflicting                  the President finds that obtaining
     Regulatory Flexibility Analysis
                                                            with the foreign country’s laws and not                consent is infeasible, contrary to the
     Required: No
                                                            being sold or offered for sale in the                  best interests of recipients, or contrary
     Small Entities Affected: No                            United States. Drugs exported under                    to national security interests.
     Government Levels Affected: None                       either the second or third routes would
                                                            be subject to additional statutory                     Timetable:
     Agency Contact: Shellee Anderson,                      requirements, such as being in
     Food Technologist, Department of                                                                              Action                    Date
                                                            substantial conformity with the current
     Health and Human Services, Food and                    good manufacturing practices and                       Interim Final Rule      10/05/99 64 FR 54180
     Drug Administration, HFS-800, Center                   certain labeling requirements. These                   Final Action            09/00/03
     for Food Safety and Applied Nutrition,                 provisions would implement changes
     5100 Paint Branch Parkway, College                                                                            Regulatory Flexibility Analysis
                                                            in FDA’s export authority resulting                    Required: No
     Park, MD 20740                                         from the FDA Export Reform and
     Phone: 301 436-1491                                    Enhancement Act of 1996.                               Government Levels Affected: Federal
     Email: shellee.anderson@cfsan.fda.gov
                                                            Timetable:                                             Agency Contact: Philip L. Chao, Senior
     RIN: 0910–AA04
                                                            Action                        Date                     Policy Analyst, Department of Health
                                                                                                                   and Human Services, Food and Drug
     794. INVESTIGATIONAL NEW DRUGS:                        NPRM                      06/19/02 67 FR 41642
                                                                                                                   Administration, Room 15-61 (HF-23),
     EXPORT REQUIREMENTS FOR                                Final Action              09/00/03
                                                                                                                   Office of Policy, Planning and
     UNAPPROVED NEW DRUG                                    Regulatory Flexibility Analysis                        Legislation, 5600 Fishers Lane,
     PRODUCTS                                               Required: No                                           Rockville, MD 20857
     Priority: Routine and Frequent                         Government Levels Affected: None                       Phone: 301 827-0587
                                                                                                                   Fax: 301 827-4774
     Legal Authority: 21 USC 321; 21 USC                    Agency Contact: Philip L. Chao, Senior                 Email: pchao@oc.fda.gov
     381; 21 USC 382; 21 USC 393; 42 USC                    Policy Analyst, Department of Health
     241; 42 USC 243; 42 USC 262; 21 USC                    and Human Services, Food and Drug                      RIN: 0910–AA89


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00026   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30239

     HHS—FDA                                                                                                                               Final Rule Stage


     796. LABELING FOR HUMAN                                797. SUPPLEMENTS AND OTHER                             798. FOOD LABELING: TRANS FATTY
     PRESCRIPTION DRUGS; REVISED                            CHANGES TO AN APPROVED                                 ACIDS IN NUTRITION LABELING,
     FORMAT                                                 APPLICATION                                            NUTRIENT CONTENT CLAIMS, AND
     Priority: Other Significant. Major status                                                                     HEALTH CLAIMS
                                                            Priority: Other Significant
     under 5 USC 801 is undetermined.                                                                              Priority: Economically Significant.
     Unfunded Mandates: Undetermined                        Legal Authority: 21 USC 356a                           Major under 5 USC 801.
     Legal Authority: 21 USC 321; 21 USC                    CFR Citation: 21 CFR 314                               Unfunded Mandates: This action may
     331; 21 USC 351 to 353; 21 USC 355;                                                                           affect the private sector under PL 104-
     21 USC 358; 21 USC 360; 21 USC 360b;                   Legal Deadline: None                                   4.
     21 USC 360gg to 360ss; 21 USC 371;                                                                            Legal Authority: 21 USC 321; 21 USC
     21 USC 374; 21 USC 379e; 42 USC 216;                   Abstract: Section 116 of the Food and
                                                                                                                   331; 21 USC 342; 21 USC 343; 21 USC
     42 USC 241; 42 USC 262; 42 USC 264                     Drug Administration Modernization Act
                                                                                                                   348; 21 USC 371; ...
                                                            of 1997 (Pub. L. 105-115) added section
     CFR Citation: 21 CFR 201                               506A to the Food, Drug, and Cosmetic                   CFR Citation: 21 CFR 101
     Legal Deadline: None                                   Act (21 U.S.C. 356a). Pursuant to                      Legal Deadline: None
     Abstract: This regulation is one                       section 116, the rulemaking will revise
                                                            current procedures for approving                       Abstract: Section 403(q) of the Federal
     component of the Secretary’s initiative                                                                       Food, Drug, and Cosmetic Act, which
     to reduce medical errors. The                          manufacturing changes and generally
                                                                                                                   was added by the Nutrition Labeling
     regulation would amend the regulations                 classify such changes into four
                                                                                                                   and Education Act of 1990 (NLEA),
     governing the format and content of                    categories. Major manufacturing                        requires that the label or labeling of
     professional labeling for human                        changes, which are of a type                           food products bear nutrition
     prescription drug and biologic                         determined by the Secretary to have a                  information. Among other things,
     products, 21 CFR 201.56 and 201.57.                    substantial potential to adversely affect              section 403(q) of the Act authorizes the
     The regulation would require that                      the identity, strength, quality, purity,               Food and Drug Administration (FDA)
     professional labeling include a section                and potency of the drug as they may                    to add or delete nutrients that are to
     containing highlights of prescribing                   relate to the safety and effectiveness of              be declared on the labels or labeling
     information, and a section containing                  a drug, require prior approval of a                    of food products by regulation if it
     an index to prescribing information;                   supplemental application. A second                     finds such action necessary to assist
     reorder currently required information                 category of changes may be made if                     consumers in maintaining healthy
     and make minor changes to its content,                 FDA has not notified the company                       dietary practices. FDA issued final
     and establish minimum graphical                        within 30 days after the submission of                 regulations implementing NLEA in
     requirements for professional labeling.                a supplement that prior approval is                    1993. FDA subsequently received a
     Timetable:                                             required. A third category of changes                  citizen petition requesting that FDA
     Action                     Date                        may be made upon submission of a                       amend its regulations on food labeling
                                                            supplement to the agency. The rule will                to require that the amount of trans fatty
     NPRM                     12/22/00 65 FR 81082          also identify another category of                      acids be listed in the nutrition label
     NPRM Comment             03/22/01                                                                             and be limited wherever saturated fat
                                                            changes that may be made without the
       Period End                                                                                                  limits are placed on nutrient content
                                                            submission of a supplement but which
     NPRM Comment             03/30/01                                                                             claims, health claims, or disqualifying
       Period Reopened                                      must be reported in an annual report.
                                                                                                                   levels and disclosure levels. In
     NPRM Comment             06/22/01                                                                             response to this petition and based on
                                                            Timetable:
       Period Reopening
       End
                                                                                                                   new evidence, FDA proposed the
                                                            Action                        Date
     Final Action             10/00/03
                                                                                                                   actions requested in the petition on
                                                            NPRM                      06/28/99 64 FR 34608         November 17, 1999 (64 FR 62746). In
     Regulatory Flexibility Analysis                        Final Action              10/00/03                     addition, FDA proposed to define the
     Required: Yes                                                                                                 claim ‘‘trans fat free.’’
     Small Entities Affected: Businesses                    Regulatory Flexibility Analysis
                                                                                                                   Timetable:
                                                            Required: No
     Government Levels Affected:                                                                                   Action                    Date
     Undetermined                                           Government Levels Affected: None
                                                                                                                   NPRM                    11/17/99 64 FR 62746
     Federalism: Undetermined                                                                                      NPRM Comment            12/05/00 65 FR 75887
                                                            Agency Contact: Howard P. Muller,
     Agency Contact: Audrey Thomas,                         Office of Regulatory Policy, Department                  Period Reopened
     Regulatory Policy Analyst, Office of                   of Health and Human Services, Food                     NPRM Comment            01/19/01
     Regulatory Policy, Department of                                                                                Period End
                                                            and Drug Administration, Suite 3037
     Health and Human Services, Food and                                                                           NPRM Comment            11/15/02
                                                            (HFD-7), Center for Drug Evaluation                      Period Reopened
     Drug Administration, Suite 3037 (HFD-                  and Research, 1451 Rockville Pike,
     7), Center for Drug Evaluation and                                                                            NPRM Comment            12/16/02
                                                            Rockville, MD 20852                                      Period End
     Research, 1451 Rockville Pike,                         Phone: 301 594-2041                                    Final Rule              06/00/03
     Rockville, MD 20852
                                                            Fax: 301 827-5562                                      Regulatory Flexibility Analysis
     Phone: 301 594-2041
     Fax: 301 827-5562                                      RIN: 0910–AB61                                         Required: Yes
     RIN: 0910–AA94                                                                                                Small Entities Affected: Businesses


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00027   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30240                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                               Final Rule Stage


     Government Levels Affected: State,                     regulations will be amended for                        Agency Contact: Nicole K. Mueller,
     Tribal, Local                                          consistency.                                           Regulatory Counsel, Department of
                                                            Timetable:                                             Health and Human Services, Food and
     Federalism: This action may have
                                                                                                                   Drug Administration, Room 3037,
     federalism implications as defined in                  Action                        Date                     (HFD-7), 1451 Rockville Pike,
     EO 13132.
                                                            NPRM                      11/16/00 65 FR 69377         Rockville, MD 20852
     Agency Contact: Susan Thompson,                        NPRM Comment              02/14/01                     Phone: 301 594-2041
     Chemist, Department of Health and                        Period End                                           Fax: 301 594-6197
     Human Services, Food and Drug                          Final Action              12/00/03                     Email: muellern@cder.fda.gov
     Administration, (HFS-832), Center for
                                                            Regulatory Flexibility Analysis                        RIN: 0910–AB91
     Food Safety and Applied Nutrition,
                                                            Required: No
     5100 Paint Branch Parkway, College
     Park, MD 20740                                         Small Entities Affected: Businesses                    801. ADDITIONAL SAFEGUARDS FOR
     Phone: 301 436-1450                                    Government Levels Affected: None                       CHILDREN IN CLINICAL
     Fax: 301 436-2639                                                                                             INVESTIGATIONS OF FDA-
     Email: sthomps1@cfsan.fda.gov                          Agency Contact: Paula S. McKeever,                     REGULATED PRODUCTS
                                                            Regulatory Policy Analyst, Department
     RIN: 0910–AB66                                         of Health and Human Services, Food                     Priority: Other Significant. Major status
                                                            and Drug Administration, Suite 200N                    under 5 USC 801 is undetermined.
     799. CGMP FOR BLOOD AND BLOOD                          (HFM-17), Center for Biologics                         Unfunded Mandates: Undetermined
     COMPONENTS: NOTIFICATION OF                            Evaluation and Research, 1401
                                                                                                                   Legal Authority: 21 USC 321; 21 USC
     CONSIGNEES AND TRANSFUSION                             Rockville Pike, Rockville, MD 20852-
                                                                                                                   343; 21 USC 346; 21 USC 346a; 21 USC
     RECIPIENTS RECEIVING BLOOD AND                         1448
                                                                                                                   348; 21 USC 350a; 21 USC 350b; 21
     BLOOD COMPONENTS AT                                    Phone: 301 827-6210
                                                                                                                   USC 351 to 353; 21 USC 355; 21 USC
     INCREASED RISK OF TRANSMITTING                         Fax: 301 594-1944
                                                                                                                   360; 21 USC 360c to 360f; 21 USC 360h
     HCV INFECTION (LOOKBACK)                               Related RIN: Related To 0910-AB26                      to 360j; 21 USC 371; 21 USC 379e; 21
     Priority: Economically Significant.                    RIN: 0910–AB76                                         USC 381; 41 USC 216; 41 USC 241;
     Major under 5 USC 801.                                                                                        41 USC 262; 41 USC 263b to 263n
     Legal Authority: 21 USC 321; 21 USC                    800. REQUIREMENTS FOR                                  CFR Citation: 21 CFR 50; 21 CFR 56
     331; 21 USC 351 to 353; 21 USC 355;                    SUBMISSION OF LABELING FOR                             Legal Deadline: Other, Statutory, April
     21 USC 360; 21 USC 371; 21 USC 374;                    HUMAN PRESCRIPTION DRUGS AND                           17, 2001, The Children’s Health Act of
     42 USC 216; 42 USC 262; 42 USC 263a;                   BIOLOGICS IN ELECTRONIC FORMAT                         2000 requires that, within six months
     42 USC 264                                                                                                    of the date of its enactment on October
                                                            Priority: Other Significant
     CFR Citation: 21 CFR 606; 21 CFR 610                                                                          17, 2000, FDA adopt existing HHS
                                                            Legal Authority: 21 USC 321; 21 USC                    regulations providing additional
     Legal Deadline: None                                   331; 21 USC 351; 21 USC 353; 21 USC                    protections for children involved as
                                                            355; 21 USC 360; 21 USC 371; 21 USC                    subjects in research. FDA published an
     Abstract: This rulemaking is one of a
                                                            374; 21 USC 379e; ...                                  interim rule in April 2001.
     number of actions being taken to
     amend the biologics regulations to                     CFR Citation: 21 CFR 314; 21 CFR 601                   Abstract: The final rule will finalize
     remove, revise, or update the                          Legal Deadline: None                                   the interim rule that published in April
     regulations applicable to blood, blood                                                                        2001, providing additional protections
     components, and blood derivatives.                     Abstract: The Food and Drug
                                                                                                                   for children involved as subjects in
     These actions are based on FDA’s                       Administration (FDA) is proposing to
                                                                                                                   clinical investigations of FDA-regulated
     comprehensive review of the biologics                  amend its regulations governing the
                                                                                                                   products, as required by the Children’s
     regulations and on reports by the U.S.                 format in which certain labeling in new
                                                                                                                   Health Act of 2000.
     House of Representatives Committee on                  drug applications, abbreviated new
     Government Reform and Oversight’s,                     drug applications, certain biological                  Timetable:
     Subcommittee on House Resources and                    license applications, supplements, and                 Action                    Date
     Intergovernmental Relations, the                       annual reports is required to be
                                                            submitted. The rule would require that                 Interim Rule            04/24/01 66 FR 20589
     General Accounting Office, and the                                                                            Final Rule              12/00/03
     Institute of Medicine, as well as on                   certain labeing content described under
     public comments. In this rulemaking,                   section 201.160(d)(3) be submitted to                  Regulatory Flexibility Analysis
     FDA will amend the biologics                           FDA in electronic format.                              Required: Undetermined
     regulations to require that blood                      Timetable:                                             Small Entities Affected: No
     establishments prepare and follow
                                                            Action                        Date                     Government Levels Affected: None
     written procedures for appropriate
     action when it is determined that blood                NPRM                      05/03/02 67 FR 22367         Agency Contact: Carol Drew,
     and blood components pose an                           Final Action              09/00/03                     Regulatory Counsel, Department of
     increased risk for transmitting hepatitis              Regulatory Flexibility Analysis                        Health and Human Services, Food and
     C virus (HCV) infection because they                   Required: No                                           Drug Administration, Suite 3037 (HFD-
     have been collected from a donor who,                                                                         7), Center for Drug Evaluation and
     at a later date, tested reactive for                   Small Entities Affected: Businesses                    Research, 1451 Rockville Pike,
     evidence of HCV. The HCV lookback                      Government Levels Affected: Federal                    Rockville, MD 20852


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00028   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30241

     HHS—FDA                                                                                                                               Final Rule Stage


     Phone: 301 594-2041                                    to reduce medical errors. The final rule               Agency Contact: Joseph M. Sheehan,
     Fax: 301 827-5562                                      would require human drug products                      Chief, Regulations Staff, Department of
     RIN: 0910–AC07                                         and biological products to have a bar                  Health and Human Services, Food and
                                                            code. The bar code would contain                       Drug Administration, HFZ-215, Center
                                                            certain information about the product,                 for Devices and Radiological Health,
     802. ALUMINUM IN LARGE- AND                            and when used in conjunction with bar                  1350 Piccard Drive, Rockville, MD
     SMALL-VOLUME PARENTERALS                               code scanners and computer                             20850
     USED IN TOTAL PARENTERAL                               equipment, would help reduce the                       Phone: 301 827-2974
     NUTRITION                                              number of medication errors. The final                 Fax: 301 594-4795
     Priority: Other Significant                            rule would also require the use of                     Email: jms@cdrh.fda.gov
     Legal Authority: 21 USC 321(n); 21                     machine-readable information on blood                  RIN: 0910–AC34
     USC 352; 21 USC 355; 21 USC 371(a);                    and blood component container labels.
     21 CFR 201.51; 21 CFR 201.100; 21                      Timetable:
                                                                                                                   805. REGISTRATION OF FOOD AND
     CFR 314.125                                            Action                        Date                     ANIMAL FEED FACILITIES
     CFR Citation: 21 CFR 201.323(c)                        NPRM                      03/14/03 68 FR 12500         Priority: Economically Significant.
     Legal Deadline: None                                   Final Rule                12/00/03                     Major under 5 USC 801.
     Abstract: The final rule will revise 21                Regulatory Flexibility Analysis                        Unfunded Mandates: This action may
     CFR 323(c) to permit small-volume                      Required: Yes                                          affect the private sector under PL 104-
     parenterals and pharmacy bulk                          Small Entities Affected: Businesses                    4.
     packages that contain 25 mcg/L or less
     of aluminum to state ‘‘contains no more                Government Levels Affected: None                       Legal Authority: PL 107-188, sec 305
     than 25 mcg/L’’ rather than the exact                  Agency Contact: Philip L. Chao, Senior                 CFR Citation: 21 CFR 1
     amount of aluminum.                                    Policy Analyst, Department of Health                   Legal Deadline: Final, Statutory,
     Timetable:                                             and Human Services, Food and Drug                      December 12, 2003.
                                                            Administration, Room 15-61 (HF-23),                    The Public Health Security and
     Action                     Date                        Office of Policy, Planning and                         Bioterrorism Preparedness and
     NPRM                     08/12/02 67 FR 52429          Legislation, 5600 Fishers Lane,                        Response Act of 2002, section 305,
     Final Action             06/00/03                      Rockville, MD 20857                                    directs the Secretary, through FDA, to
     Regulatory Flexibility Analysis                        Phone: 301 827-0587                                    issue a final regulation establishing
     Required: Undetermined                                 Fax: 301 827-4774                                      registration requirements by December
                                                            Email: pchao@oc.fda.gov                                12, 2003. The statute is self-
     Small Entities Affected: No
                                                            RIN: 0910–AC26                                         implementing on this date if FDA does
     Government Levels Affected: None                                                                              not issue a final regulation that is
     Agency Contact: Christine F. Rogers,                                                                          effective by December 12, 2003.
     Regulatory Counsel, Department of                      804. AMENDMENTS TO THE
                                                            PERFORMANCE STANDARD FOR                               Abstract: This rulemaking is one of a
     Health and Human Services, Food and                                                                           number of actions being taken to
     Drug Administration, Suite 3059 (HFD-                  DIAGNOSTIC X-RAY SYSTEMS AND
                                                            THEIR MAJOR COMPONENTS                                 improve FDA’s ability to respond to
     7), Center for Drug Evaluation and                                                                            threats of bioterrorism. Section 415 of
     Research, 1451 Rockville Pike,                         Priority: Substantive, Nonsignificant                  the Federal Food, Drug, and Cosmetic
     Rockville, MD 20852                                    Legal Authority: 21 USC 301 et seq;                    Act (FFDCA), which was added by
     Phone: 301 594-2041                                    21 USC 360kk et seq                                    section 305 of the Public Health
     Fax: 301 827-5562                                                                                             Security and Bioterrorism Preparedness
                                                            CFR Citation: 21 CFR 1020.30; 21 CFR
     RIN: 0910–AC18                                         1020.31; 21 CFR 1020.32                                and Response Act of 2002 (the
                                                                                                                   Bioterrorism Act), directs the Secretary
                                                            Legal Deadline: None                                   to require any facility engaged in
     803. BAR CODE LABEL
                                                            Abstract: This rule amends the                         manufacturing, processing, packing, or
     REQUIREMENTS FOR HUMAN DRUG
                                                            performance standard for diagnostic x-                 holding of food for consumption by
     PRODUCTS AND BLOOD
                                                            ray systems and their components in                    humans or animals in the United States
     Priority: Economically Significant.                    21 CFR 1020.30, 1020.31, and 1020.32                   to be registered with the Secretary
     Major under 5 USC 801.                                 to address the changes in technology                   through FDA. Section 415 directs the
     Legal Authority: 21 USC 321; 21 USC                    and practice and to fully utilize the                  Secretary, through FDA, to promulgate
     331; 21 USC 351 to 353; 21 USC 355;                    currently accepted metric system.                      final regulations implementing the
     21 USC 358; 21 USC 360; 21 USC 360b;                   Timetable:                                             requirements by December 12, 2003.
     21 USC 360gg to 360ss; 21 USC 371;                                                                            The owner, operator, or agent in charge
                                                            Action                        Date                     of the facility must submit the
     21 USC 374; 21 USC 379e; 42 USC 216;
     42 USC 241; 42 USC 262; 42 USC 264                     NPRM                      12/10/02 67 FR 76056         registration. Foreign facilities must
     CFR Citation: 21 CFR 201.25; 21 CFR                    Final Action              12/00/03                     include the name of the United States
     601.67                                                 Regulatory Flexibility Analysis                        agent for the facility. The registration
                                                            Required: Yes                                          must include the name and address of
     Legal Deadline: None                                                                                          each facility at which, and all trade
     Abstract: This regulation is one                       Small Entities Affected: Businesses                    names under which, the registrant
     component of the Secretary’s initiative                Government Levels Affected: None                       conducts business. If FDA determines


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00029   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30242                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                               Final Rule Stage


     it is necessary through guidance, the                  Email: leslye.fraser@cfsan.fda.gov                     Timetable:
     registration must include the general                                                                         Action                    Date
     food category (as identified under 21                  RIN: 0910–AC40
     CFR 170.3) of foods manufactured,                                                                             NPRM                    02/03/03 68 FR 5428
     processed, packed, or held at the                      806. PRIOR NOTICE OF IMPORTED                          Final Rule              10/00/03
     facility. The registrant is required to                FOOD UNDER THE PUBLIC HEALTH                           Regulatory Flexibility Analysis
     notify the Secretary of changes to the                 SECURITY AND BIOTERRORISM                              Required: Yes
     registration in a timely manner. Under                 PREPAREDNESS AND RESPONSE
     the proposed rule, upon receipt of the                                                                        Small Entities Affected: Businesses
                                                            ACT OF 2002
     completed registration form, FDA                                                                              Government Levels Affected: Federal
     would notify the registrant of receipt                 Priority: Economically Significant.
                                                                                                                   URL For More Information:
     of the registration and assign a unique                Major under 5 USC 801.
                                                                                                                   http://www.fda.gov/ohrms/dockets/
     registration number to the facility. The                                                                      98fr/03-2444.pdf
                                                            Legal Authority: PL 107-188, sec 307
     Bioterrorism Act requires the Secretary
     to compile and maintain an up-to-date                  CFR Citation: 21 CFR 1.276 et seq                      URL For Public Comments:
     list of registered facilities. This list and                                                                  http://www.fda.gov/dockets/ecomments
     any registration documents submitted                   Legal Deadline: Final, Statutory,
                                                                                                                   Agency Contact: Mary Ayling, Lead,
     to the Secretary are not subject to                    December 12, 2003.
                                                                                                                   Inspection and Compliance Team, Food
     disclosure under the Freedom of                        The Public Health Security and
                                                                                                                   Safety Staff, Department of Health and
     Information Act. For purposes of                       Bioterrorism Preparedness and
                                                                                                                   Human Services, Food and Drug
     section 415, ‘‘facility’’ includes any                 Response Act of 2002, section 307,
                                                                                                                   Administration, HFS-32, Center for
     factory, warehouse, or establishment                   directs the Secretary, through FDA, to
                                                                                                                   Food Safety and Applied Nutrition,
     engaged in the manufacturing,                          issue final regulations establishing prior
                                                                                                                   5100 Paint Branch Parkway, College
     processing, packing, or holding of food.               notice requirements for all imported
                                                                                                                   Park, MD 20740
     Exempt from the registration                           food by December 12, 2003. If FDA fails
                                                                                                                   Phone: 301 436-2131
     requirement are farms, restaurants,                    to issue final regulations by this date,
                                                                                                                   Fax: 301 436-2605
     other retail food establishments,                      the statute is self-executing on this
                                                                                                                   Email: mary.ayling@cfsan.fda.gov
     nonprofit food establishments in which                 date, and requires FDA to receive prior
     food is prepared for or served directly                notice of not less than eight hours, nor               RIN: 0910–AC41
     to the consumer, and fishing vessels                   more than five days until final
     (except those engaged in processing as                 regulations are issued.                                807. PRESUBMISSION CONFERENCES
     defined in 21 CFR 123.3(k)). Foreign                   Abstract: This rulemaking is one of a                  Priority: Substantive, Nonsignificant
     facilities required to register include                number of actions being taken to
     only those from which food is exported                 improve FDA’s ability to respond to                    Legal Authority: 21 USC 360b
     to the United States without further                   threats of bioterrorism. Section 801(m)                CFR Citation: 21 CFR 514
     processing or packaging outside the                    of the Federal Food, Drug, and
     United States. The Bioterrorism Act                                                                           Legal Deadline: None
                                                            Cosmetic Act (FFDCA), which was
     provides that if a foreign facility                    added by section 307 of the Public                     Abstract: This rule will implement
     attempts to import food into the United                Health Security and Bioterrorism                       section 512(b)(3) of the Federal Food,
     States without having registered, the                  Preparedness and Response Act of                       Drug, and Cosmetic Act (the Act). This
     food will be held at the port of entry                 2002, authorizes the Secretary, through                section of the Act states that any person
     or at a secure facility, until the foreign             FDA, to promulgate final regulations by                intending to file a new animal drug
     facility has registered.                               December 12, 2003. Section 801(m)                      application or supplemental new
     Timetable:                                             requires notification to FDA prior to the              animal drug application, or to
                                                            entry of imported food. The required                   investigate a new animal drug is
     Action                     Date                                                                               entitled to one or more conferences
                                                            prior notice would provide the identity
     NPRM                     02/03/03 68 FR 5377           of the article of food; the manufacturer;              with the agency prior to submission to
     Final Rule               10/00/03                      the shipper; the grower, if known at                   reach an agreement establishing a
     Regulatory Flexibility Analysis                        the time of notification; the originating              submission or investigational
     Required: Yes                                          country; the shipping country; and the                 requirement. This rule would describe
                                                            anticipated port of entry. The                         how to request a presubmission
     Small Entities Affected: Businesses                                                                           conference and describe the procedures
                                                            regulation identifies the parties
     Government Levels Affected: None                       responsible for providing the notice                   for the conduct of presubmission
     Agency Contact: Leslye M. Fraser,                      and explains the information that the                  conferences.
     Associate Director for Regulations,                    prior notice is required to contain, the               Timetable:
     Office of Regulations and Policy,                      method of submission of the notice,
                                                                                                                   Action                    Date
     Department of Health and Human                         and the minimum and maximum
     Services, Food and Drug                                period of advance notice required.                     NPRM                    08/25/00 65 FR 51782
     Administration, Center for Food Safety                 Section 307 also states that if FDA does               Final Action            03/00/04
     and Applied Nutrition, 5100 Paint                      not receive prior notice or receives                   Regulatory Flexibility Analysis
     Branch Parkway, College Park, MD                       inadequate prior notice, the imported                  Required: No
     20740                                                  food shall be refused admission and
     Phone: 301 436-2378                                    held at the port of entry until proper                 Government Levels Affected: None
     Fax: 301 436-2637                                      notice is provided.                                    Federalism: Undetermined


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00030   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30243

     HHS—FDA                                                                                                                               Final Rule Stage


     Agency Contact: Gail Schmerfeld,                       only one opportunity for a 30-month                    Legal Deadline: None
     Special Assistant, Department of Health                stay in the approval date of an ANDA
     and Human Services, Food and Drug                      or 505(b)(2) application.                              Abstract: The final rule amends the
     Administration, HFV-100, Center for                                                                           FDA biologics regulations in response
                                                            Timetable:                                             to the report and recommendations of
     Veterinary Medicine, 7500 Standish
     Place, Rockville, MD 20855                             Action                        Date                     the Panel on Review of Bacterial
     Phone: 301 827-0205                                    NPRM                      10/24/02 67 FR 65448         Vaccines and Toxoids with Standards
                                                            NPRM Comment              12/23/02                     of Potency (the Panel). The Panel
     Related RIN: Previously reported as                                                                           reviewed the safety, efficacy, and
     0910-AB68                                                Period End
                                                            Final Rule                05/00/03                     labeling of bacterial vaccines and
     RIN: 0910–AC44                                                                                                toxoids with standards of potency,
                                                            Regulatory Flexibility Analysis                        bacterial antitoxins, and immune
                                                            Required: No                                           globulins. On the basis of the Panel’s
     808. APPLICATIONS FOR FDA
                                                            Small Entities Affected: No                            findings and recommendations, FDA is
     APPROVAL TO MARKET A NEW
     DRUG: PATENT LISTING                                   Government Levels Affected: None                       classifying these products as Category
     REQUIREMENTS AND APPLICATION                                                                                  I (safe, effective, and not misbranded),
                                                            Agency Contact: Jarilyn Dupont,
     OF 30-MONTH STAYS ON APPROVAL                                                                                 Category II (unsafe, ineffective, or
                                                            Department of Health and Human
     OF ABBREVIATED NEW DRUG                                                                                       misbranded), or Category IIIB (off the
                                                            Services, Food and Drug
     APPLICATIONS                                                                                                  market pending completion of studies
                                                            Administration, Office of Policy,
                                                                                                                   permitting a determination of
     Priority: Economically Significant.                    Planning and Legislation (HF-11), 5600
                                                                                                                   effectiveness).
     Major under 5 USC 801.                                 Fishers Lane, Rockville, MD 20857
                                                            Phone: 301 827-3360                                    Timetable:
     Unfunded Mandates: This action may
                                                            Fax: 301 594-6777
     affect the private sector under PL 104-                                                                       Action                    Date
                                                            Email: jdupont@oc.fda.gov
     4.
                                                            RIN: 0910–AC48                                         NPRM                    12/13/85 50 FR 51002
     Legal Authority: 21 USC 321; 21 USC                                                                           NPRM Comment            03/13/86
     331; 21 USC 351 to 353; 21 USC 355;                                                                             Period End
     21 USC 355a; 21 USC 356; 21 USC                        809. ∑ BIOLOGICAL PRODUCTS;                            Final Action            03/00/04
     356a; 21 USC 356b; 21 USC 356c; 21                     BACTERIAL VACCINES AND
     USC 371; 21 USC 374; 21 USC 379e                       TOXOIDS; IMPLEMENTATION OF                             Regulatory Flexibility Analysis
                                                            EFFICACY REVIEW                                        Required: No
     CFR Citation: 21 CFR 314.52(a)(3); 21
     CFR 314.53(b); 21 CFR 314.53(c)(1); 21                 Priority: Substantive, Nonsignificant                  Government Levels Affected: None
     CFR 314.53(c)(2); 21 CFR 314.95(a)(3)                  Legal Authority: 21 USC 321; 21 USC
     Legal Deadline: None                                   331; 21 USC 351; 21 USC 352; 21 USC                    Agency Contact: Astrid L. Szeto,
                                                            353; 21 USC 355; 21 USC 358; 21 USC                    Senior Reguatory Review Officer,
     Abstract: The final rule would clarify                                                                        Department of Health and Human
     the types of patents for which                         360; 21 USC 360b; 21 USC 360c; 21
                                                            USC 360d; 21 USC 360h; 21 USC 360i;                    Services, Food and Drug
     information must or must not be                                                                               Administration, Suite 200N (HFM-17),
     submitted to FDA. The final rule would                 21 USC 360gg-360ss; 21 USC 371; 21
                                                            USC 372; 21 USC 374; 21 USC 379e;                      Center for Biologics Evaluation and
     also revise the patent declaration to                                                                         Research, 1401 Rockville Pike,
     make it more detailed. The rule would                  21 USC 381; 42 USC 216; 42 USC 241;
                                                            42 USC 262; 42 USC 263; 42 USC 263a;                   Rockville, MD 20852-1448
     also revise the regulations regarding the                                                                     Phone: 301 827-6210
     approval date for certain abbreviated                  42 USC 264
                                                                                                                   Fax: 301 594-1944
     new drug applications or ‘‘505(b)(2)                   CFR Citation: 21 CFR 201.59; 21 CFR
     applications’’ by stating that there is                610.21                                                 RIN: 0910–AC56


     Department of Health and Human Services (HHS)                                                                                       Long-Term Actions
     Food and Drug Administration (FDA)

     810. SAFETY REPORTING                                  21 USC 371; 21 USC 374; 21 USC 375;                    to revise certain definitions and
     REQUIREMENTS FOR HUMAN DRUG                            21 USC 379e; 21 USC 381                                reporting formats as recommended by
     AND BIOLOGICAL PRODUCTS                                                                                       the International Conference on
                                                            CFR Citation: 21 CFR 310; 21 CFR 312;
     Priority: Other Significant. Major status              21 CFR 314; 21 CFR 320; 21 CFR 600;                    Harmonisation and to define new
     under 5 USC 801 is undetermined.                       21 CFR 601; 21 CFR 606                                 terms; to add to or revise current
                                                                                                                   reporting requirements; to revise certain
     Unfunded Mandates: Undetermined                        Legal Deadline: None                                   reporting time frames; and propose
     Legal Authority: 42 USC 216; 42 USC                    Abstract: This regulation is one                       other revisions to these regulations to
     241; 42 USC 242a; 42 USC 262; 42 USC                   component of the Secretary’s initiative                enhance the quality of safety reports
     263; 42 USC 263a-n; 42 USC 264; 42                     to reduce medical errors. The proposed                 received by FDA.
     USC 300aa; 21 USC 321; 21 USC 331;                     rule would amend the expedited and
     21 USC 351 to 353; 21 USC 355; 21                      periodic safety reporting regulations for
     USC 360; 21 USC 360b-j; 21 USC 361a;                   human drugs and biological products


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00031   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30244                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—FDA                                                                                                                             Long-Term Actions


     Timetable:                                             Action                     Date                        and Drug Administration, Suite 200N
     Action                     Date
                                                            NPRM Comment              07/17/00                     (HFM-17), Center for Biologics
                                                              Period Reopened                                      Evaluation and Research, 1401
     NPRM                     03/14/03 68 FR 12406            End                                                  Rockville Pike, Rockville, MD 20852-
     Final Rule                 To Be Determined            Final Action                  To Be Determined         1448
     Regulatory Flexibility Analysis                        Regulatory Flexibility Analysis                        Phone: 301 827-6210
     Required: Yes                                          Required: No                                           Fax: 301 594-1944
     Small Entities Affected: Businesses                    Small Entities Affected: Businesses                    RIN: 0910–AB28
     Government Levels Affected:                            Government Levels Affected: State
     Undetermined                                           Agency Contact: Paula S. McKeever,                     813. REGULATION OF
                                                            Regulatory Policy Analyst, Department                  CARCINOGENIC COMPOUNDS USED
     Agency Contact: Audrey Thomas,                                                                                IN FOOD-PRODUCING ANIMALS;
     Regulatory Policy Analyst, Office of                   of Health and Human Services, Food
                                                            and Drug Administration, Suite 200N                    DEFINITION OF ‘‘NO RESIDUE’’
     Regulatory Policy, Department of
     Health and Human Services, Food and                    (HFM-17), Center for Biologics                         Priority: Substantive, Nonsignificant
     Drug Administration, Suite 3037 (HFD-                  Evaluation and Research, 1401                          Legal Authority: 21 USC 321; 21 USC
     7), Center for Drug Evaluation and                     Rockville Pike, Rockville, MD 20852-                   331; 21 USC 342; 21 USC 343; 21 USC
     Research, 1451 Rockville Pike,                         1448                                                   348; 21 USC 351 to 353; 21 USC 360b;
     Rockville, MD 20852                                    Phone: 301 827-6210                                    21 USC 371
     Phone: 301 594-2041                                    Fax: 301 594-1944
                                                                                                                   CFR Citation: 21 CFR 500.80; 21 CFR
     Fax: 301 827-5562                                      RIN: 0910–AB27                                         500.82; 21 CFR 500.84; 21 CFR 500.88
     RIN: 0910–AA97                                                                                                Legal Deadline: None
                                                            812. CURRENT GOOD TISSUE                               Abstract: The Food and Drug
     811. ELIGIBILITY DETERMINATION                         PRACTICE FOR HUMAN CELL,                               Administration (FDA) amended its
     FOR DONORS OF HUMAN CELLS,                             TISSUE, AND CELLULAR AND                               regulations relating to the operational
     TISSUES, AND CELLULAR AND                              TISSUE-BASED PRODUCTS                                  definition of the term ‘‘no residue.’’
     TISSUE-BASED PRODUCTS                                  ESTABLISHMENTS; INSPECTION AND                         The definition is used in determining
                                                            ENFORCEMENT                                            whether any residue of carcinogenic
     Priority: Other Significant
                                                            Priority: Other Significant                            compounds used in food-producing
     Legal Authority: 42 USC 216; 42 USC                                                                           animals would ‘‘be found in the food
     243; 42 USC 263a; 42 USC 264; 42 USC                   Legal Authority: 42 USC 216; 42 USC
                                                            243; 42 USC 264; 42 USC 271                            produced from those animals under
     271                                                                                                           conditions of use reasonably certain to
     CFR Citation: 21 CFR 210.1(c); 21 CFR                  CFR Citation: 21 CFR 1270 and 1271                     be followed in practice’’ (21 CFR
     210.2(a); 21 CFR 210.2(b); 21 CFR                      Legal Deadline: None                                   500.80(a)). Under the previous
     211.1(b); 21 CFR 820.1(a)(1); 21 CFR                   Abstract: The Food and Drug                            operational definition of no residue, it
     820.1(c); 21 CFR 1271                                  Administration (FDA) is requiring                      was possible for a residue detected by
                                                            human cell, tissue, and cellular and                   a method approved by FDA to be
     Legal Deadline: None
                                                            tissue-based products (HCT/P)                          considered ‘‘no residue.’’ FDA revised
     Abstract: The Food and Drug                                                                                   its regulations to make them consistent
                                                            establishments to follow current good
     Administration is requiring certain                                                                           with a 1995 Department of Justice
                                                            tissue practice (CGTP), which governs
     manufacturers of human cells, tissues,                                                                        opinion regarding this definition. The
                                                            the methods used in, and the facilities
     and cellular and tissue-based products                                                                        changes revised the definition of ‘‘no
                                                            and controls used for, the manufacture
     (HCT/Ps) to take actions to screen and                                                                        residue’’ to mean that no residue is
                                                            of HCT/Ps, recordkeeping, and the
     test the donors of cells and tissues used                                                                     detected with an approved regulatory
                                                            establishment of a quality program.
     in those products for evidence of, or                                                                         method. The rule has several
                                                            FDA is also issuing regulations
     risk factors for, relevant communicable                                                                       conditions that sponsors of
                                                            pertaining to labeling, reporting,
     disease. As part of this action, the                                                                          carcinogenic compounds must satisfy
                                                            inspections, and enforcement.
     agency is amending the current good                                                                           with respect to the sponsors’ proposed
     manufacturing practice regulations that                Timetable:                                             regulatory methods.
     apply to HCT/Ps regulated as drugs,                    Action                        Date                     Timetable:
     medical devices, and/or biological
     products to incorporate the new donor                  NPRM                      01/08/01 66 FR 1508          Action                    Date
     eligibility requirements into existing                 NPRM Comment              05/08/01
                                                              Period End                                           NPRM                 01/17/02 67 FR 2384
     good manufacturing practice                                                                                   NPRM Comment         04/17/02
                                                            Final Action                  To Be Determined
     regulations for those products.                                                                                 Period Ends
     Timetable:                                             Regulatory Flexibility Analysis                        Final Action         12/23/02 67 FR 78172
                                                            Required: No                                           Next Action Undetermined
     Action                     Date
                                                            Small Entities Affected: Businesses                    Regulatory Flexibility Analysis
     NPRM                     09/30/99 64 FR 52696                                                                 Required: No
                                                            Government Levels Affected: State
     NPRM Comment             12/29/99
      Period End                                            Agency Contact: Paula S. McKeever,                     Government Levels Affected: None
     NPRM Comment             04/18/00 65 FR 20774          Regulatory Policy Analyst, Department                  Agency Contact: Steven Brynes,
      Period Reopened                                       of Health and Human Services, Food                     Regulatory Scientist, Department of


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00032   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30245

     HHS—FDA                                                                                                                             Long-Term Actions


     Health and Human Services, Food and                    Phone: 301 827-6975                                    Email: sbrynes@cvm.fda.gov
     Drug Administration, HFV-151, Center                                                                          Related RIN: Previously reported as
     for Veterinary Medicine, 7500 Standish                                                                        0910-AC13
     Place, Rockville, MD 20855
                                                                                                                   RIN: 0910–AC45

     Department of Health and Human Services (HHS)                                                                                       Completed Actions
     Food and Drug Administration (FDA)

     814. REVISIONS TO THE GENERAL                          Regulatory Flexibility Analysis                        Email: gpeterso@cvm.fda.gov
     SAFETY REQUIREMENTS FOR                                Required: No
                                                                                                                   Related RIN: Previously reported as
     BIOLOGICAL PRODUCTS; FINAL
                                                            Government Levels Affected: None                       0910-AA02
     RULE
     Priority: Substantive, Nonsignificant                  Agency Contact: Christine F. Rogers                    RIN: 0910–AC42
                                                            Phone: 301 594-2041
     CFR Citation: 21 CFR 610.11(g)                         Fax: 301 827-5562
     Completed:                                                                                                    817. BIOAVAILABILITY AND
                                                            RIN: 0910–AB78                                         BIOEQUIVALENCE REQUIREMENTS
     Reason                     Date
                                                                                                                   Priority: Substantive, Nonsignificant
     Final Action             03/04/03 68 FR 10157
                                                            816. RECORDS AND REPORTS                               CFR Citation: 21 CFR 320
     Regulatory Flexibility Analysis                        CONCERNING EXPERIENCE WITH
     Required: No                                           APPROVED NEW ANIMAL DRUGS                              Completed:
     Government Levels Affected: None                       Priority: Other Significant                            Reason                    Date
     Agency Contact: Stephen M. Ripley                                                                             Final Rule              12/19/02 67 FR 77668
     Phone: 301 827-6210                                    CFR Citation: 21 CFR 514.80
                                                                                                                   Regulatory Flexibility Analysis
     RIN: 0910–AB51                                         Completed:
                                                                                                                   Required: No
                                                            Reason                        Date
                                                                                                                   Government Levels Affected: None
     815. ANTIBIOTIC RESISTANCE                             Final Action              03/31/03 68 FR 15255
     LABELING                                                                                                      Agency Contact: Christine F. Rogers
                                                            Regulatory Flexibility Analysis                        Phone: 301 594-2041
     Priority: Other Significant                            Required: No                                           Fax: 301 827-5562
     CFR Citation: 21 CFR 201.24
                                                            Government Levels Affected: None                       Related RIN: Previously reported as
     Completed:                                                                                                    0910-AA51
                                                            Agency Contact: Glenn Peterson
     Reason                     Date                        Phone: 301 827-0224                                    RIN: 0910–AC47
     Final Rule               02/06/03 68 FR 6062           Fax: 301 827-1485


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

     818. NATIONAL PRACTITIONER DATA                        judgments, or settlements, payments be                 to report why the practitioner could not
     BANK FOR ADVERSE INFORMATION                           reported where they are made for the                   be identified, and to provide the name
     ON PHYSICIANS AND OTHER HEALTH                         benefit of physicians or other health                  of the corporate health care entity.
     CARE PRACTITIONERS: MEDICAL                            care practitioners not named in the                    Timetable:
     MALPRACTICE PAYMENTS                                   judgments or settlements but who
     REPORTING REQUIREMENTS                                 furnished or failed to furnish the health              Action                    Date

     Priority: Substantive, Nonsignificant                  care services upon which the actions                   NPRM                    12/24/98 63 FR 71255
                                                            or claims were based. The purpose of                   NPRM Comment            02/22/99
     Legal Authority: 42 USC 11131                          this NPRM is to prevent the evasion                      Period End
     CFR Citation: 45 CFR 60.7                              of the medical malpractice payment                     Second NPRM             05/00/03
                                                            reporting requirement of the Data Bank                 Regulatory Flexibility Analysis
     Legal Deadline: None                                   through the agreement of the parties to                Required: No
     Abstract: This notice of proposed                      a lawsuit to use the corporate health
     rulemaking (NPRM) proposes to require                  care entity to ‘‘shield’’ practitioners. It            Government Levels Affected: None
     that, in addition to reporting to the                  would also require malpractice payers,                 Agency Contact: John M. Heyob,
     National Practitioner Data Bank                        in very limited circumstances, when it                 Director, Division of Practitioner Data
     medical malpractice payments made                      is impossible to identify the                          Banks, Department of Health and
     where physicians or other health care                  practitioner who furnished or failed to                Human Services, Public Health Service,
     practitioners are named in medical                     furnish the health care services upon                  Suite 300, 7519 Standish Place,
     malpractice actions or claims,                         which the actions or claims were based,                Rockville, MD 20957


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00033   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30246                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—HRSA                                                                                                                       Proposed Rule Stage


     Phone: 301 443-2300                                    medical underservice that apply in                     Regulatory Flexibility Analysis
     Fax: 301 443-6725                                      several department programs, and                       Required: No
     RIN: 0906–AA41                                         would improve the criteria for
                                                            designating medically underserved                      Government Levels Affected: None
                                                            populations (MUPs) and Primary Care
     819. DESIGNATION OF MEDICALLY                                                                                 Agency Contact: Andy Jordan, Acting
                                                            Health Professional Shortage Areas
     UNDERSERVED POPULATIONS AND                                                                                   Chief, Shortage Designation Branch,
                                                            (HPSAs). This notice of proposed
     HEALTH PROFESSIONAL SHORTAGE                           rulemaking (NPRM) will address issues                  Department of Health and Human
     AREAS                                                  raised by comments received in a                       Services, Health Resources and Services
                                                            previous NPRM, dated September 1,                      Administration, Room 8C26, National
     Priority: Substantive, Nonsignificant
                                                            1998.                                                  Center for Health Workforce Analysis,
     Legal Authority: 42 USC 254b; 42 USC                                                                          Bureau of Health Professions, Parklawn
     254e                                                   Timetable:                                             Building, Rockville, MD 20857
     CFR Citation: 42 CFR 5; 42 CFR 51c                     Action                        Date                     Phone: 301 594-0197
     Legal Deadline: None                                                                                          Email: dsd@hrsa.gov
                                                            NPRM                      09/01/98 63 FR 46538
     Abstract: This rule would consolidate                  NPRM Comment              01/04/99                     RIN: 0906–AA44
     the process for designating areas of                     Period End
     health professional shortage and                       Second NPRM               10/00/03


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

     820. NATIONAL PRACTITIONER DATA                        any negative action or finding that a                  Regulatory Flexibility Analysis
     BANK FOR ADVERSE INFORMATION                           peer review organization, private                      Required: No
     ON PHYSICIANS AND OTHER HEALTH                         accreditation entity, or a State has
     CARE PRACTITIONERS: REPORTING                          concluded against a health care                        Small Entities Affected: No
     ADVERSE AND NEGATIVE ACTIONS                           practitioner or entity. Section 1921
                                                                                                                   Government Levels Affected: State
                                                            directs the Secretary to provide for
     Priority: Substantive, Nonsignificant
                                                            maximum appropriate coordination in                    Agency Contact: John M. Heyob,
     Legal Authority: 42 USC 1396r-2                        the implementation of these reporting                  Director, Division of Practitioner Data
     CFR Citation: 45 CFR 60                                requirements with those of the Health                  Banks, Department of Health and
                                                            Care Quality Improvement Act of 1986                   Human Services, Public Health Service,
     Legal Deadline: None                                   (title IV of Pub. L. 99-660). Section                  Suite 300, 7519 Standish Place,
     Abstract: Public Law 100-93 amended                    1921 requirements will be incorporated
                                                                                                                   Rockville, MD 20957
     section 1921 of the Social Security Act                into the National Practitioner Data Bank
                                                                                                                   Phone: 301 443-2300
     to require that each State have in effect              (NPDB).
     a system of reporting disciplinary                                                                            Fax: 301 443-6725
                                                            Timetable:
     licensure actions taken against all                                                                           RIN: 0906–AA57
     licensed health care practitioners and                 Action                        Date
     entities. It also requires States to report            NPRM                          To Be Determined


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

     821. INDIAN CHILD PROTECTION AND                       Protection Act, Public Law 101-630, 25                 Regulatory Flexibility Analysis
     FAMILY VIOLENCE PREVENTION ACT                         U.S.C. 3201 to 3211, that prescribe                    Required: No
     MINIMUM STANDARDS OF                                   minimum standards of character for
                                                                                                                   Government Levels Affected: Tribal
     CHARACTER                                              individuals whose duties and
     Priority: Info./Admin./Other                           responsibilities involve regular contact               Agency Contact: Ramona D. Williams,
                                                            with, or control over, Indian children.                Child Protection Coordinator,
     Legal Authority: 25 USC 3201 et seq                                                                           Department of Health and Human
     CFR Citation: 42 CFR 36                                Timetable:                                             Services, Indian Health Service, Suite
     Legal Deadline: None                                   Action                        Date                     605, 12300 Twinbrook Parkway,
                                                                                                                   Rockville, MD 20852
     Abstract: The Indian Health Service                    NPRM                      03/25/99 64 FR 14559
                                                                                                                   Phone: 301 443-1589
     (IHS) is proposing to establish                        NPRM Comment              07/26/99
     regulations as mandated by the Indian                    Period End                                           RIN: 0917–AA02
     Child Protection and Family Violence                   Final Action              10/00/03




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00034   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30247

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

     822. UNDERGRADUATE                                     Abstract: NIH proposes to amend the                    Agency Contact: Jerry Moore, NIH
     SCHOLARSHIP PROGRAM                                    training grants regulations to                         Regulations Officer, Department of
     REGARDING PROFESSIONS NEEDED                           implement the new authority under                      Health and Human Services, National
     BY THE NATIONAL INSTITUTES OF                          section 452G of the PHS Act. This                      Institutes of Health, Room 601 MSC
     HEALTH (NIH)                                           action is necessitated by enactment of                 7669, 6011 Executive Boulevard,
     Priority: Substantive, Nonsignificant                  the Children’s Act of 2000. Section                    Rockville, MD 20852
                                                            1002 of this act adds a new section                    Phone: 301 496-4606
     Legal Authority: 42 USC 216; 42 USC                    452G that authorizes the Director of                   Fax: 301 402-0169
     288-4                                                  National Institute of Child Health and                 Email: jm40z@nih.gov
     CFR Citation: 42 CFR 68b                               Human Development (NICHHD) in                          RIN: 0925–AA31
                                                            consultation with the Administrator of
     Legal Deadline: None                                   Health Resources and Services
     Abstract: Section 487D of the Public                   Administration (HRSA), to support                      825. NATIONAL INSTITUTES OF
     Health Service Act, as added by the                    activities to provide for an increase in               HEALTH (NIH) AIDS RESEARCH LOAN
     National Institutes of Health                          the number and size of institutional                   REPAYMENT PROGRAM
     Revitalization Act of 1993, creates a                  training grants supporting pediatric                   Priority: Substantive, Nonsignificant
     program offering scholarships, in an                   training.
     amount not to exceed $20,000 per year                                                                         Unfunded Mandates: Undetermined
                                                            Timetable:
     of academic study, to individuals from                                                                        Legal Authority: 42 USC 216; 42 USC
     disadvantaged backgrounds who are                      Action                        Date                     288-1
     enrolled as full-time students at                      NPRM                      09/00/03                     CFR Citation: 42 CFR 68
     accredited institutions pursuing
                                                            Regulatory Flexibility Analysis                        Legal Deadline: None
     academic programs appropriate for
                                                            Required: No
     careers in professions needed by the                                                                          Abstract: Section 487A of the Public
     NIH. For each year of scholarship                      Small Entities Affected: No                            Health Service Act creates a program
     support, the recipient agrees to service               Government Levels Affected: None                       through which appropriately qualified
     (employment) after graduation, at the                                                                         health professionals may obtain
     NIH, for one year. Additionally, the                   Agency Contact: Jerry Moore, NIH                       federally funded repayment of
     individual agrees to at least 10                       Regulations Officer, Department of                     educational loans by conducting AIDS
     consecutive weeks of service                           Health and Human Services, National                    research as NIH employees. NIH is
     (employment) at the NIH during which                   Institutes of Health, Room 601 MSC                     issuing regulations that will govern the
     the individual is attending the                        7669, 6011 Executive Boulevard,                        program.
     educational institution and receiving                  Rockville, MD 20852
                                                            Phone: 301 496-4606                                    Timetable:
     the NIH scholarship. The proposed new
     regulations will cover this program.                   Fax: 301 402-0169                                      Action                    Date
                                                            Email: jm40z@nih.gov
     Timetable:                                                                                                    NPRM                    09/00/03
                                                            RIN: 0925–AA28                                         Regulatory Flexibility Analysis
     Action                     Date
                                                                                                                   Required: No
     NPRM                     09/00/03
                                                            824. STANDARDS FOR A NATIONAL                          Small Entities Affected: No
     Regulatory Flexibility Analysis                        CHIMPANZEE SANCTUARY SYSTEM
     Required: No                                                                                                  Government Levels Affected: None
                                                            Priority: Substantive, Nonsignificant
     Government Levels Affected: None                                                                              Agency Contact: Jerry Moore, NIH
                                                            Legal Authority: 42 USC 287a-3a                        Regulations Officer, Department of
     Agency Contact: Jerry Moore, NIH                       CFR Citation: 42 CFR 59                                Health and Human Services, National
     Regulations Officer, Department of                                                                            Institutes of Health, Room 601 MSC
     Health and Human Services, National                    Legal Deadline: NPRM, Statutory, June                  7669, 6011 Executive Boulevard,
     Institutes of Health, Room 601 MSC                     18, 2001.                                              Rockville, MD 20852
     7669, 6011 Executive Boulevard,                        Abstract: The National Institutes of                   Phone: 301 496-4606
     Rockville, MD 20852                                    Health proposes to establish standards                 Fax: 301 402-0169
     Phone: 301 496-4606                                    for operating a national chimpanzee                    Email: jm40z@nih.gov
     Fax: 301 402-0169                                      sanctuary system to provide for the
     Email: jm40z@nih.gov                                                                                          RIN: 0925–AA32
                                                            permanent retirement of federally-
     RIN: 0925–AA10                                         owned or supported chimpanzees no
                                                            longer needed for research.                            826. ∑ NATIONAL INSTITUTES OF
                                                                                                                   HEALTH EXTRAMURAL LOAN
     823. NATIONAL INSTITUTES OF                            Timetable:
                                                                                                                   REPAYMENT PROGRAM FOR
     HEALTH (NIH) TRAINING GRANTS                           Action                        Date                     CLINICAL RESEARCHERS
     Priority: Substantive, Nonsignificant                  NPRM                      09/00/03                     Priority: Substantive, Nonsignificant
     Legal Authority: 42 USC 216; 42 USC                    Regulatory Flexibility Analysis                        Legal Authority: 42 USC 216; 42 USC
     285g-10                                                Required: No                                           288-5a
     CFR Citation: 42 CFR 63a                               Small Entities Affected: No                            CFR Citation: 42 CFR 68g
     Legal Deadline: None                                   Government Levels Affected: None                       Legal Deadline: None


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00035   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30248                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—NIH                                                                                                                        Proposed Rule Stage


     Abstract: The National Institutes of                   Timetable:                                             Health and Human Services, National
     Health proposes to establish                           Action                        Date                     Institutes of Health, Room 601 MSC
     implementing regulations for the                                                                              7669, 6011 Executive Boulevard,
     Extramural Loan Repayment Program                      NPRM                      09/00/03                     Rockville, MD 20852
     for Clinical Researchers, authorized                   Regulatory Flexibility Analysis                        Phone: 301 496-4606
     under section 487F of the Public Health                Required: No                                           Fax: 301 402-0169
     Service Act. The program provides for                  Small Entities Affected: No                            Email: jm40z@nih.gov
     the repayment of the existing
                                                            Government Levels Affected: None                       RIN: 0925–AA35
     educational loan debt of qualified
     health professionals who agree to                      Agency Contact: Jerry Moore, NIH
     conduct clinical research.                             Regulations Officer, Department of                     829. ∑ NATIONAL INSTITUTES OF
                                                            Health and Human Services, National                    HEALTH CLINICAL RESEARCH LOAN
     Timetable:                                             Institutes of Health, Room 601 MSC                     REPAYMENT PROGRAM FOR
     Action                     Date                        7669, 6011 Executive Boulevard,                        INDIVIDUALS FROM
     NPRM                     09/00/03                      Rockville, MD 20852                                    DISADVANTAGED BACKGROUNDS
                                                            Phone: 301 496-4606
     Regulatory Flexibility Analysis                        Fax: 301 402-0169                                      Priority: Substantive, Nonsignificant
     Required: No                                           Email: jm40z@nih.gov                                   Legal Authority: 42 USC 216; 42 USC
     Small Entities Affected: No                            RIN: 0925–AA34                                         288-5

     Government Levels Affected: None                                                                              CFR Citation: 42 CFR 68a
                                                            828. ∑ LOAN REPAYMENT PROGRAM                          Legal Deadline: None
     Agency Contact: Jerry Moore, NIH                       FOR HEALTH DISPARITIES
     Regulations Officer, Department of                     RESEARCH                                               Abstract: The National Institutes of
     Health and Human Services, National                    Priority: Substantive, Nonsignificant                  Health proposes to amend the
     Institutes of Health, Room 601 MSC                                                                            regulations governing the Clinical
     7669, 6011 Executive Boulevard,                        Legal Authority: 42 USC 216; 42 USC                    Research Loan Repayment Program for
     Rockville, MD 20852                                    287c-33                                                Individuals from Disadvantaged
     Phone: 301 496-4606                                    CFR Citation: 42 CFR 68f                               Backgrounds to reflect the new
     Fax: 301 402-0169                                      Legal Deadline: None                                   maximum annual loan amount of
     Email: jm40z@nih.gov                                                                                          $35,000 and a change in program
                                                            Abstract: The National Institutes of                   eligibility to include qualified health
     RIN: 0925–AA33                                         Health proposes to establish                           professionals who are not NIH
                                                            implementing regulations for the Loan                  employees.
     827. ∑ NATIONAL INSTITUTES OF                          Repayment Program for Health
                                                            Disparities Research, authorized under                 Timetable:
     HEALTH PEDIATRIC RESEARCH
                                                            section 485G of the Public Health                      Action                    Date
     LOAN REPAYMENT PROGRAM
                                                            Service Act. The program provides for
     Priority: Substantive, Nonsignificant                  the repayment of the existing                          NPRM                    09/00/03
                                                            educational loan debt of qualified                     Regulatory Flexibility Analysis
     Legal Authority: 42 USC 216; 42 USC                    health professionals who agree to
     288-6                                                                                                         Required: No
                                                            conduct research on minority health or
     CFR Citation: 42 CFR 68e                               other health disparities for a minimum                 Small Entities Affected: No
                                                            of two years.                                          Government Levels Affected: None
     Legal Deadline: None
                                                            Timetable:
                                                                                                                   Agency Contact: Jerry Moore, NIH
     Abstract: The National Institutes of                   Action                        Date                     Regulations Officer, Department of
     Health proposes to establish
                                                            NPRM                      09/00/03                     Health and Human Services, National
     implementing regulations for Pediatric
                                                                                                                   Institutes of Health, Room 601 MSC
     Research Loan Repayment Program,                       Regulatory Flexibility Analysis                        7669, 6011 Executive Boulevard,
     authorized under section 487F of the                   Required: No                                           Rockville, MD 20852
     Public Health Service Act. The program                 Small Entities Affected: No                            Phone: 301 496-4606
     provides for the repayment of the
                                                            Government Levels Affected: None                       Fax: 301 402-0169
     existing educational loan debt of
                                                                                                                   Email: jm40z@nih.gov
     qualified health professionals who                     Agency Contact: Jerry Moore, NIH
     agree to conduct pediatric research.                   Regulations Officer, Department of                     RIN: 0925–AA36




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00036   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30249

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

     830. NATIONAL INSTITUTES OF                            831. SCIENTIFIC PEER REVIEW OF                         CFR Citation: 42 CFR 52a
     HEALTH LOAN REPAYMENT                                  RESEARCH GRANT APPLICATIONS
     PROGRAM FOR RESEARCH                                   AND RESEARCH AND DEVELOPMENT                           Legal Deadline: None
     GENERALLY                                              CONTRACT PROJECTS
                                                                                                                   Abstract: NIH proposes to amend the
                                                            Priority: Substantive, Nonsignificant                  current center grants regulations to
     Priority: Substantive, Nonsignificant
                                                            Legal Authority: 42 USC 216; 42 USC                    reflect new authorities set forth in
     Legal Authority: 42 USC 216; 42 USC                    282(b)(6); 42 USC 284(c)(3); 42 USC                    sections 409C, 445I, 452E, and 485F of
     288-3                                                  289a; 42 USC 290aa-3                                   the Public Health Service Act (PHS
                                                                                                                   Act). Section 409C concerns centers of
     CFR Citation: 42 CFR 68d                               CFR Citation: 42 CFR 52h
                                                                                                                   excellence regarding research on
                                                            Legal Deadline: None                                   autism; section 445I concerns centers
     Legal Deadline: None                                                                                          of excellence in Alzheimer’s disease
                                                            Abstract: NIH staff have found
     Abstract: Regulations will be issued to                ambiguities, misstatements, and voids                  research and treatment; section 452E
     govern the awarding of educational                     in the existing regulations on research                concerns centers regarding research on
     loan repayments to qualified health                    misconduct. These regulations, which                   ‘‘fragile X;’’ and section 485F concerns
     professionals who agree to conduct                     govern the first level of review, are                  centers of excellence for research
                                                            being amended to reflect current                       education and training for individuals
     research as employees of the National
                                                            policies and procedures.                               who are members of minority health
     Institutes of Health.
                                                            Timetable:                                             disparity populations.
     Timetable:
                                                            Action                        Date                     Timetable:
     Action                     Date                        NPRM                      09/21/00 65 FR 57132         Action                    Date
     NPRM                     08/05/02 67 FR 50622          Final Rule                09/00/03
                                                                                                                   NPRM                    11/12/02 67 FR 68548
     Final Rule               09/00/03                      Regulatory Flexibility Analysis                        Final Rule              09/00/03
                                                            Required: No
     Regulatory Flexibility Analysis                                                                               Regulatory Flexibility Analysis
     Required: No                                           Government Levels Affected: None
                                                                                                                   Required: No
                                                            Agency Contact: Jerry Moore, NIH
     Government Levels Affected: None                       Regulations Officer, Department of                     Small Entities Affected: Governmental
                                                            Health and Human Services, National                    Jurisdictions
     Agency Contact: Jerry Moore, NIH
                                                            Institutes of Health, Room 601 MSC
     Regulations Officer, Department of                     7669, 6011 Executive Boulevard,                        Government Levels Affected: None
     Health and Human Services, National                    Rockville, MD 20852
     Institutes of Health, Room 601 MSC                                                                            Agency Contact: Jerry Moore, NIH
                                                            Phone: 301 496-4606
     7669, 6011 Executive Boulevard,                        Fax: 301 402-0169                                      Regulations Officer, Department of
     Rockville, MD 20852                                    Email: jm40z@nih.gov                                   Health and Human Services, National
     Phone: 301 496-4606                                                                                           Institutes of Health, Room 601 MSC
                                                            RIN: 0925–AA20                                         7669, 6011 Executive Boulevard,
     Fax: 301 402-0169
     Email: jm40z@nih.gov                                                                                          Rockville, MD 20852
                                                            832. NATIONAL INSTITUTES OF                            Phone: 301 496-4606
     RIN: 0925–AA18                                         HEALTH (NIH) CENTER GRANTS                             Fax: 301 402-0169
                                                            Priority: Substantive, Nonsignificant                  Email: jm40z@nih.gov
                                                            Legal Authority: 42 USC 216; PL 106-                   RIN: 0925–AA24
                                                            310; PL 106-505; PL 106-525

     Department of Health and Human Services (HHS)                                                                                  Proposed Rule Stage
     Office of Public Health and Science (OPHS)

     833. PUBLIC HEALTH SERVICES                            ‘‘Responsibilities of Awardee and                      affected the ORI’s operations. In
     POLICIES ON RESEARCH                                   Applicant Institutions for Dealing With                addition, the Office of Science and
     MISCONDUCT                                             and Reporting Possible Misconduct in                   Technology Policy (OSTP) published a
     Priority: Substantive, Nonsignificant                  Science,’’ 54 FR 32449, August 8, 1989.                Governmentwide policy that applies to
                                                            The National Institutes of Health                      federally-funded research and proposals
     Legal Authority: 42 USC 216; 42 USC
                                                            Revitalization Act of 1993 (NIH Act),                  submitted to the Federal agencies for
     241; 42 USC 289b
                                                            Public Law 103-43, contains provisions                 research funding, 65 FR 76260,
     CFR Citation: 42 CFR 93                                that affect the current rule. For                      December 6, 2000. The proposed
     Legal Deadline: None                                   example, section 161 of the NIH Act                    revised regulation will implement this
     Abstract: This notice of proposed                      established the Office of Research                     OSTP policy, which contains a
     rulemaking proposes substantial                        Integrity (ORI) as an independent entity               definition of research misconduct and
     revisions to the existing regulations at               reporting to the Secretary, and recent                 basic guidelines for the response of
     42 CFR part 50, subpart A,                             organizational changes have also                       Federal agencies and research


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00037   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30250                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—OPHS                                                                                                                       Proposed Rule Stage


     institutions to allegations of research                information to IRBs and will support                   CFR Citation: 45 CFR 46
     misconduct. The current regulation,                    the current IRB registration operated by
     which implemented section 493(e) of                    OHRP. Under the current OHRP IRB                       Legal Deadline: None
     the Public Health Service Act, would                   registration system, the submission of
                                                                                                                   Abstract: This notice of proposed
     be deleted, and a new part 93, subparts                certain registration information is
                                                                                                                   rulemaking proposes to add subpart E
     A, B, C, D, and E would be added.                      required by human subjects protection
                                                            regulations, and certain other                         to Department of Health and Human
     Timetable:                                                                                                    Services (DHHS) regulations for
                                                            information may be submitted
     Action                     Date                        voluntarily. This proposed information                 protection of human subjects, 45 CFR
                                                            collection was submitted to the Office                 part 46, and would require that
     NPRM                     08/00/03
                                                            of Management and Budget under the                     institutions engaged in human subjects
     NPRM Comment             10/00/03
      Period End                                            Paperwork Reduction Act. Under the                     research covered by an assurance of
                                                            proposed rule, all registration                        compliance filed with the Office for
     Regulatory Flexibility Analysis                                                                               Human Research Protections ensure
                                                            information will be required, making
     Required: No
                                                            the IRB registration system uniform                    that Institutional officials, institutional
     Small Entities Affected: No                            with IRB registration requirements of                  review board (IRB) chairpersons, and
     Government Levels Affected: None                       the Food and Drug Administration                       human protection administrators
                                                            (FDA), and creating a single, HHS IRB                  receive appropriate training and
     Agency Contact: Chris Pascal, Director,                Registration system. FDA will
     Office of Research Integrity, Department                                                                      education about the institution’s
                                                            simultaneously publish a proposed rule                 assurance and that IRB chairpersons
     of Health and Human Services, Office                   regarding FDA IRB registration
     of Public Health and Science, Suite                                                                           and members, IRB staff, investigators,
                                                            requirements.                                          and other personnel involved in the
     750, 1101 Wootten Parkway, Rockville,
     MD 20852                                               Timetable:                                             conduct or oversight of human subjects
     Phone: 301 443-3400                                    Action                        Date                     research receive appropriate training
     Fax: 301 443-5351                                                                                             and education about relevant human
                                                            NPRM                      07/00/03
                                                                                                                   subjects protection requirements. The
     Related RIN: Related To 0940-AA01                      NPRM Comment              09/00/03
                                                             Period End
                                                                                                                   proposed training and education
     RIN: 0940–AA04                                                                                                requirements will help to ensure that
                                                            Regulatory Flexibility Analysis                        responsible individuals at assured
                                                            Required: No                                           institutions understand and meet their
     834. HUMAN SUBJECTS PROTECTION
     REGULATIONS: INSTITUTIONAL                             Small Entities Affected: No                            regulatory responsibilities for human
     REVIEW BOARDS REGISTRATION                             Government Levels Affected: None                       subjects protection.
     REQUIREMENTS                                           Agency Contact: Irene Stith-Coleman                    Timetable:
     Priority: Substantive, Nonsignificant                  Ph.D, Department of Health and Human
                                                            Services, Office of Public Health and                  Action                    Date
     Legal Authority: 5 USC 301; 42 USC
     289                                                    Science, Suite 200, The Tower                          NPRM                    07/00/03
                                                            Building, 1101 Wootten Parkway,                        NPRM Comment            09/00/03
     CFR Citation: 45 CFR 46                                Rockville, MD 20852                                     Period End
     Legal Deadline: None                                   Phone: 301 496-7005
     Abstract: This notice of proposed                      Fax: 301 402-0527                                      Regulatory Flexibility Analysis
                                                            Email: istithco@osophs.dhhs.gov                        Required: No
     rulemaking proposes to add subpart F
     to Department of Health and Human                      RIN: 0940–AA06
                                                                                                                   Small Entities Affected: No
     Services (HHS) regulations for
     protection of human subjects, 45 CFR                   835. ∑ HUMAN SUBJECTS                                  Government Levels Affected: None
     part 46, to require registration of                    PROTECTION REGULATIONS:
     institutional review boards (IRBs) with                                                                       Agency Contact: Michael A. Carome
                                                            TRAINING AND EDUCATION
     HHS. The registration information                                                                             MD, Department of Health and Human
                                                            REQUIREMENTS FOR INSTITUTIONAL
     would include contact information,                                                                            Services, Office of Public Health and
                                                            OFFICIALS, INSTITUTIONAL REVIEW
     approximate numbers of active                          BOARD MEMBERS AND STAFF,                               Science, Suite 200, The Tower
     protocols involving research conducted                 HUMAN PROTECTIONS                                      Building, 1101 Wootten Parkway,
     or supported by HHS and other Federal                  ADMINISTRATORS, AND                                    Rockville, MD 20852
     agencies, accreditation status, IRB                    INVESTIGATOR                                           Phone: 301 496-7005
     membership, and staffing for the IRB.                                                                         Fax: 301 402-0527
     The proposed registration requirements                 Priority: Other Significant
     will make it easier for Office for Human               Legal Authority: 5 USC 301; 42 USC                     RIN: 0940–AA08
     Research Protections (OHRP) to convey                  289




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00038   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30251

     Department of Health and Human Services (HHS)                                                                                          Final Rule Stage
     Office of Public Health and Science (OPHS)

     836. PUBLIC HEALTH SERVICE                             covered institutions must follow certain               Regulatory Flexibility Analysis
     STANDARDS FOR THE PROTECTION                           requirements for preventing and                        Required: No
     OF RESEARCH MISCONDUCT                                 responding to occurrences of retaliation
     WHISTLEBLOWERS                                         against whistleblowers. The purpose of                 Small Entities Affected: No
     Priority: Substantive, Nonsignificant                  this part is to protect: (1) persons who
                                                                                                                   Government Levels Affected: None
                                                            make a good faith allegation that a
     Legal Authority: 42 USC 216; 42 USC                    covered institution or member thereof                  Agency Contact: Chris Pascal, Director,
     241; 42 USC 289b                                       engaged in, or failed to respond                       Office of Research Integrity, Department
     CFR Citation: 42 CFR 94                                adequately to an allegation of research                of Health and Human Services, Office
                                                            misconduct; and (2) persons who                        of Public Health and Science, Suite
     Legal Deadline: None
                                                            cooperate in good faith with an                        750, 1101 Wootten Parkway, Rockville,
     Abstract: To implement section 493(e)                  investigation of research misconduct.                  MD 20852
     of the Public Health Service Act (added                Timetable:                                             Phone: 301 443-3400
     by section 163 of the National Institutes
                                                            Action                        Date                     Fax: 301 443-5351
     of Health Revitalization Act of 1993,
     Pub. L. 103-43), the Department is                     NPRM                      11/28/00 65 FR 70830         Related RIN: Related To 0940-AA04
     proposing to add a new part 94 to title                NPRM Comment              01/29/01
     42 of the Code of Federal Regulations.                   Period End                                           RIN: 0940–AA01
     Under this proposed regulation,                        Final Action              12/00/03


     Department of Health and Human Services (HHS)                                                                                  Proposed Rule Stage
     Centers for Medicare & Medicaid Services (CMS)

     837. END STAGE RENAL DISEASE                           Security Boulevard, Baltimore, MD                      Aucha Prachanronarong, Health
     (ESRD) CONDITIONS FOR COVERAGE                         21244                                                  Insurance Specialist, Department of
     (CMS-3818-P) (SECTION 610 REVIEW)                      Phone: 410 786-7215                                    Health and Human Services, Centers for
     Priority: Other Significant                            RIN: 0938–AG82                                         Medicare & Medicaid Services, 7500
                                                                                                                   Security Boulevard, Baltimore, MD
     Legal Authority: 42 USC 1395rr                                                                                21244
     CFR Citation: 42 CFR 400; 42 CFR 405;                  838. HOSPITAL CONDITIONS OF                            Phone: 410 786-9614
     42 CFR 406; 42 CFR 409; 42 CFR 410;                    PARTICIPATION: REQUIREMENTS                            RIN: 0938–AH17
     42 CFR 412, 42 CFR 413, 414; 42 CFR                    FOR CERTIFICATION AND
     488; 42 CFR 489; 42 CFR 494                            RECERTIFICATION OF TRANSPLANT
     Legal Deadline: None                                   CENTERS TO PERFORM ORGAN                               839. HOSPICE CARE—CONDITIONS
                                                            TRANSPLANTS (CMS-3835-P)                               OF PARTICIPATION (CMS-3844-P)
     Abstract: This proposed rule would
     revise the requirements that end stage                 Priority: Other Significant                            Priority: Other Significant
     renal disease (ESRD) facilities must                   Legal Authority: 42 USC 1302; 42 USC                   Legal Authority: 42 USC 1302; 42 USC
     meet to be certified under the Medicare                1395hh                                                 1395x(dd); 42 USC 1395hh
     program.
                                                            CFR Citation: 42 CFR 482                               CFR Citation: 42 CFR 418
     Timetable:
                                                            Legal Deadline: None                                   Legal Deadline: None
     Action                     Date
                                                            Abstract: This proposed rule would                     Abstract: This proposed rule revises
     NPRM                     09/00/03                      establish conditions of participation for              existing conditions of participation that
     Regulatory Flexibility Analysis                        Medicare-covered transplants.                          hospices must meet to participate in
     Required: Yes                                                                                                 the Medicare program. The proposed
                                                            Timetable:
                                                                                                                   requirements focus on the actual care
     Small Entities Affected: Businesses
                                                            Action                        Date                     delivered to patients and patients’
     Government Levels Affected: None                                                                              families by hospices and the results of
                                                            NPRM                      09/00/03
     Agency Contact: Robert Miller, Health                                                                         that care, reflect an interdisciplinary
     Insurance Specialist, Department of                    Regulatory Flexibility Analysis                        view of patient care, allow hospices
     Health and Human Services, Centers for                 Required: No                                           greater flexibility in meeting quality
     Medicare & Medicaid Services, S3-02-                   Small Entities Affected: Businesses,                   standards, and eliminate unnecessary
     01, Office of Clinical Standards and                   Organizations                                          procedural requirements.
     Quality, 7500 Security Boulevard,                      Government Levels Affected: None                       Timetable:
     Baltimore, MD 21244-1850
     Phone: 410 786-6797                                    Agency Contact: Eva Fung, Health                       Action                    Date
     Email: rmiller@cms.hhs.gov                             Insurance Specialist, Department of                    NPRM                    10/00/03
                                                            Health and Human Services, Centers for
     Teresa Casey, Health Insurance                         Medicare & Medicaid Services, S3-06-                   Regulatory Flexibility Analysis
     Specalist, Department of Health and                    6, 7500 Security Boulevard, Baltimore,                 Required: Undetermined
     Human Services, Centers for Medicare                   MD 21244-1850                                          Small Entities Affected: Businesses,
     & Medicaid Services, S3-05-04, 7500                    Phone: 410 786-7539                                    Organizations


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00039   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30252                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                        Proposed Rule Stage


     Government Levels Affected: None                       841. CONDITIONS OF PARTICIPATION                       Accountability Act (HIPAA) of 1966. It
                                                            OF INTERMEDIATE CARE FACILITIES                        would be used to transmit clinical data,
     Federalism: Undetermined                               FOR PERSONS WITH MENTAL                                beyond those data contained in the
     Agency Contact: Mary Rossi Coajou,                     RETARDATION (CMS-3046-P)                               claims standard, to help establish
     Health Insurance Specialist,                           Priority: Other Significant                            medical necessity for coverage.
     Department of Health and Human                                                                                Timetable:
                                                            Unfunded Mandates: Undetermined
     Services, Centers for Medicare &
                                                            Legal Authority: 42 USC 1302; 42 USC                   Action                    Date
     Medicaid Services, 7500 Security
     Boulevard, Baltimore, MD 21244                         1396d                                                  NPRM                    01/00/04
     Phone: 410 786-6051                                    CFR Citation: 42 CFR 400; 42 CFR 435;                  Regulatory Flexibility Analysis
                                                            42 CFR 440; 42 CFR 441; 42 CFR 483                     Required: No
     Danielle Shearer, Health Insurance
     Specialist, Department of Health and                   Legal Deadline: None                                   Small Entities Affected: Businesses
     Human Services, Centers for Medicare                   Abstract: This proposed rule would                     Government Levels Affected: State,
     & Medicaid Services, 7500 Security                     revise the conditions of participation                 Local, Federal, Tribal
     Boulevard, Baltimore, MD 21244                         for ICFs/MR. We would set forth these                  Federalism: This action may have
     Phone: 410 786-6617                                    new requirements that ICFs/MR must                     federalism implications as defined in
                                                            meet to adhere to current trends in the                EO 13132.
     RIN: 0938–AH27                                         field of developmental disabilities. It
                                                            would address recent developments in                   Agency Contact: James Krall, Health
                                                            some facilities in the District of                     Insurance Specialist, Department of
     840. SUPPLIER STANDARDS FOR
                                                            Columbia to further protect the health                 Health and Human Services, Centers for
     HOME OXYGEN, THERAPEUTIC
                                                            and safety of this vulnerable                          Medicare & Medicaid Services, 7500
     SHOES, HOME NUTRITION THERAPY
                                                            population.                                            Security Boulevard, Baltimore, MD
     (CMS-6010-P)
                                                                                                                   21244
     Priority: Substantive, Nonsignificant                  Timetable:                                             Phone: 410 786-6999
                                                            Action                        Date                     RIN: 0938–AK62
     Legal Authority: Not Yet Determined
                                                            NPRM                      12/00/03
     CFR Citation: 42 CFR 424.57
                                                            Regulatory Flexibility Analysis                        843. INPATIENT DISPROPORTIONATE
     Legal Deadline: None                                   Required: No                                           SHARE HOSPITAL (DSH)
                                                            Small Entities Affected: No                            ADJUSTMENT: CALCULATION OF
     Abstract: This proposed rule would                                                                            MEDICAID PATIENT AND TOTAL
     implement certain provisions in the                    Government Levels Affected: None                       PATIENT DAYS IN THE MEDICARE
     statute relating to DMEPOS suppliers                   Agency Contact: Anita Panicker,                        DSH ADJUSTMENT (CMS-1171-P)
     and establish service standards for                    Department of Health and Human
     suppliers of home oxygen equipment                                                                            Priority: Other Significant
                                                            Services, Centers for Medicare &
     and therapeutic shoes home nutrition                   Medicaid Services, S3-04-26, Office of                 Legal Authority: Not Yet Determined
     therapy. Establishing these standards                  Clinical Standards & Quality, 7500                     CFR Citation: 42 CFR 412106
     would ensure that suppliers are                        Security Boulevard, Baltimore, MD
     qualified to provide the appropriate                                                                          Legal Deadline: None
                                                            21244
     health care services and help safeguard                Phone: 410 786-5646                                    Abstract: This proposed rule would
     the Medicare program and its                           Email: apanicker@cms.hhs.gov                           revise applicable regulations to clarify
     beneficiaries from any instances of                                                                           certain issues in the calculation of
     fraudulent or abusive billing practices.               RIN: 0938–AK23                                         Medicaid patient days and total patient
                                                                                                                   days. It describes the criteria to use in
     Timetable:                                                                                                    calculating the Medicare DSH
                                                            842. HEALTH INSURANCE REFORM:
     Action                     Date                        CLAIMS ATTACHMENTS STANDARDS                           adjustment for hospitals for purposes of
     NPRM                     11/00/03                      (CMS-0050-P)                                           payment under the hospital inpatient
                                                                                                                   prospective payment system.
     Regulatory Flexibility Analysis                        Priority: Other Significant. Major under
                                                            5 USC 801.                                             Timetable:
     Required: Yes
                                                            Unfunded Mandates: This action may                     Action                    Date
     Small Entities Affected: Businesses                    affect State, local or tribal governments.             NPRM                    05/00/03
     Government Levels Affected: None                       Legal Authority: 42 USC 1320d-                         Regulatory Flexibility Analysis
                                                            2(a)(2)(B)                                             Required: No
     Agency Contact: Frank Whelan, Health
     Insurance Specialist, Department of                    CFR Citation: 45 CFR 162                               Small Entities Affected: Businesses
     Health and Human Services, Centers for                 Legal Deadline: Final, Statutory,                      Government Levels Affected: None
     Medicare & Medicaid Services, C3-02-                   August 21, 1998.
     16, 7500 Security Boulevard, Baltimore,                                                                       Agency Contact: Stephen Phillips,
     MD 21244                                               Abstract: This rule proposes an                        Deputy Division Director, Center for
     Phone: 410 786-1302                                    electronic standard for claims                         Health Plans and Providers, Department
                                                            attachments. The standard is required                  of Health and Human Services, Centers
     RIN: 0938–AJ98                                         by the Health Insurance Portability and                for Medicare & Medicaid Services, C4-


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00040   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30253

     HHS—CMS                                                                                                                        Proposed Rule Stage


     07-07, 7500 Security Boulevard,                        for organ procurement costs, and to be                 Federalism: Undetermined
     Baltimore, MD 21244                                    designated by the Secretary for a                      Agency Contact: Denise Cox,
     Phone: 410 786-4548                                    specific geographic service area. The                  Department of Health and Human
     RIN: 0938–AK77                                         Organ Procurement Organization                         Services, Centers for Medicare &
                                                            Certification Act of 2000 requires CMS                 Medicaid Services, 7500 Security
                                                            to increase the certification cycle for                Boulevard, Baltimore, MD 21244
     844. ELIMINATION OF STATEMENT OF                       OPOs from two years to four years and                  Phone: 410 786-3195
     INTENT PROCEDURES FOR FILING                           to promulgate new performance
     MEDICARE CLAIMS (CMS-1185-P)                           standards for OPOs.                                    RIN: 0938–AK94
     Priority: Other Significant. Major status              Timetable:
     under 5 USC 801 is undetermined.                                                                              847. UPDATE INTEREST
                                                            Action                        Date
                                                                                                                   ASSESSMENT ON MEDICARE
     Legal Authority: Not Yet Determined                    Interim Final Rule        12/28/01 66 FR 67109         OVERPAYMENT AND
     CFR Citation: 42 CFR 424                               Proposed Rule             09/00/03                     UNDERPAYMENT (CMS-6014-P)
     Legal Deadline: None                                   Regulatory Flexibility Analysis                        Priority: Other Significant
     Abstract: The proposed rule would                      Required: No                                           Legal Authority: Social Security Act,
     eliminate the written statement of                     Small Entities Affected: Businesses                    sec 1815(d); Social Security Act, sec
     intent procedures for filing Medicare                  Government Levels Affected: None                       1833(j)
     claims from the current Medicare                                                                              CFR Citation: 42 CFR 405.378
     regulation. Providers, suppliers, and                  Agency Contact: Jacqueline Morgan,
     other qualified claimants would still                  Health Insurance Specialist,                           Legal Deadline: None
     have 15 to 27 months to submit valid                   Department of Health and Human                         Abstract: This proposed rule would
     claims to Medicare.                                    Services, Centers for Medicare &                       change the formula for computing
                                                            Medicaid Services, S3-02-01, 7500                      interest on provider and supplier
     Timetable:                                             Security Boulevard, Baltimore, MD                      overpayments and underpayments to
     Action                     Date                        21244                                                  make it consistent with the new CMS
                                                            Phone: 410 786-4282                                    accounting system (HIGLAS).
     NPRM                     07/00/03
                                                            RIN: 0938–AK81                                         Timetable:
     Regulatory Flexibility Analysis
     Required: Undetermined                                                                                        Action                    Date
     Small Entities Affected: No                            846. EXTENDING MEDICARE
                                                            ENTITLEMENT WHEN DISABILITY                            NPRM                    08/00/03
     Government Levels Affected: State,                     BENEFIT ENTITLEMENT ENDS                               Regulatory Flexibility Analysis
     Federal                                                BECAUSE OF SUBSTANTIAL                                 Required: Undetermined
     Federalism: Undetermined                               GAINFUL ACTIVITY (CMS-4018-P)                          Small Entities Affected: Businesses,
     Agency Contact: David Walczak,                         Priority: Substantive, Nonsignificant                  Organizations
     Center for Health Plans and Providers,                 Unfunded Mandates: Undetermined                        Government Levels Affected: None
     Plan and Provider Purchasing Policy
                                                            Legal Authority: Sec 202 of the                        Agency Contact: Paul Thomas Reed,
     Group, Department of Health and
                                                            TWWIIA of 1999; PL 106-170                             Financial Management Specialist,
     Human Services, Centers for Medicare
                                                            CFR Citation: 42 CFR 406.12                            Department of Health and Human
     & Medicaid Services, 7500 Security
                                                                                                                   Services, Centers for Medicare &
     Boulevard, Baltimore, MD 21244-1850                    Legal Deadline: None                                   Medicaid Services, C3-15-07, 7500
     Phone: 410 786-4475
                                                            Abstract: This proposed rule would                     Security Boulevard, Baltimore, MD
     RIN: 0938–AK79                                         implement the Ticket to Work and                       21244
                                                            Work Incentives Improvement Act of                     Phone: 410 786-4001
     845. ORGAN PROCUREMENT                                 1999. It would provide working                         Email: preed2@cms.hhs.gov
     ORGANIZATION CONDITIONS FOR                            disabled individuals with continued                    RIN: 0938–AL14
     COVERAGE (CMS-3064-P)                                  Medicare entitlement for an additional
                                                            54 months beyond the current limit, for
     Priority: Other Significant                            a total of 78 months of Medicare                       848. USE OF RESTRAINT AND
     Legal Authority: 42 USC 1320b-                         coverage following the 15th month of                   SECLUSION IN MEDICARE AND
     8(b)(1)(A)(i); 42 USC 273(b)(2)                        the extended period of eligibility.                    MEDICAID PARTICIPATING
                                                                                                                   FACILITIES THAT PROVIDE
     CFR Citation: 42 CFR 486.301                           Timetable:
                                                                                                                   INPATIENT OR RESIDENTIAL CARE
     Legal Deadline: Final, Statutory,                      Action                        Date                     (CMS-2130-P)
     January 1, 2002, Requires promulgation                 NPRM                      07/00/03                     Priority: Other Significant. Major status
     of new conditions.                                                                                            under 5 USC 801 is undetermined.
                                                            Regulatory Flexibility Analysis
     Abstract: This rule would establish                    Required: Undetermined                                 Unfunded Mandates: Undetermined
     conditions for coverage for organ
     procurement organizations (OPOs) to be                 Small Entities Affected: No                            Legal Authority: PL 105-554, Children’s
     certified by the Secretary to receive                  Government Levels Affected:                            Health Act of 2000
     payment from Medicare and Medicaid                     Undetermined                                           CFR Citation: Not Yet Determined


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00041   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30254                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                        Proposed Rule Stage


     Legal Deadline: None                                   Timetable:                                             851. PROSPECTIVE PAYMENT
                                                            Action                        Date
                                                                                                                   SYSTEM FOR INPATIENT
     Abstract: This proposed rule would
                                                                                                                   PSYCHIATRIC FACILITIES FY
     implement provisions of the Children’s                 NPRM                      07/00/03                     2004(CMS-1213-P)
     Health Act (CHA) related to the use of
     restraints or seclusion for individuals                Regulatory Flexibility Analysis                        Priority: Other Significant. Major status
     receiving services in health care                      Required: No                                           under 5 USC 801 is undetermined.
     facilities that receive Federal funding.               Small Entities Affected: Businesses                    Legal Authority: PL 106-113, sec 124
     The rule would establish common
                                                                                                                   CFR Citation: 42 CFR 412, subpart N
     terminology and basic expectations for                 Government Levels Affected: None
     the use of restraints and seclusion for                                                                       Legal Deadline: NPRM, Statutory,
                                                            Federalism: Undetermined                               October 1, 2002, Public Law 106-113,
     health care facilities that furnish
     inpatient or residential care and receive              Agency Contact: Joel Kaiser, Center for                sec 124.
     Medicare or Medicaid funding.                          Medicare Management, Department of                     Abstract: This proposed rule would set
     Timetable:                                             Health and Human Services, Centers for                 forth a prospective payment system for
                                                            Medicare & Medicaid Services, 7500                     inpatient psychiatric facilities and
     Action                     Date                        Security Boulevard, Baltimore, MD                      psychiatric units.
     NPRM                     11/00/03                      21244                                                  Timetable:
                                                            Phone: 410 786-4499
     Regulatory Flexibility Analysis                                                                               Action                    Date
     Required: Undetermined                                 RIN: 0938–AL27
                                                                                                                   NPRM                    05/00/03
     Small Entities Affected: Businesses                                                                           Regulatory Flexibility Analysis
                                                            850. PERMITTING PREMIUM                                Required: No
     Government Levels Affected:                            REDUCTIONS AS ADDITIONAL
     Undetermined                                           BENEFITS UNDER                                         Small Entities Affected: No
     Federalism: Undetermined                               MEDICARE+CHOICE PLANS (CMS-                            Government Levels Affected: State,
                                                            6016-P)                                                Local, Federal
     Agency Contact: Frank Sokolik, Center
     for Medicaid and State Operations,                     Priority: Substantive, Nonsignificant.                 Agency Contact: Lana Price, Director,
     Department of Health and Human                         Major status under 5 USC 801 is                        Division of Chronic Care Management,
     Services, Centers for Medicare &                       undetermined.                                          Chronic Policy Group, Department of
     Medicaid Services, S2-13-23, 7500                                                                             Health and Human Services, Centers for
                                                            Unfunded Mandates: Undetermined                        Medicare & Medicaid Services, C5-05-
     Security Boulevard, Baltimore, MD
     21244-1850                                             Legal Authority: Not Yet Determined                    27, 7500 Security Boulevard, Baltimore,
     Phone: 410 786-7089                                                                                           MD 21244-1850
                                                            CFR Citation: 42 CFR 408.ff                            Phone: 410 786-4533
     RIN: 0938–AL26
                                                            Legal Deadline: Final, Statutory,                      RIN: 0938–AL50
                                                            January 1, 2003.
     849. PAYMENT FOR RESPIRATORY
                                                            Abstract: This proposed rule                           852. PROVIDER REIMBURSEMENT
     ASSIST DEVICES WITH BI-LEVEL
                                                            implements section 606 of BIPA to                      DETERMINATIONS AND APPEALS
     CAPABILITY AND A BACK-UP RATE
                                                            allow M+C organizations to elect a                     (CMS-1727-P)
     (CMS-1167-P)
                                                            reduction in capitation payments so                    Priority: Substantive, Nonsignificant
     Priority: Other Significant                            that these organizations could offer
                                                            Medicare part B premium reductions to                  Legal Authority: Sec 1878 of the Social
     Legal Authority: 42 CFR 1302; 42 CFR                   enrollees.                                             Security Act
     1395hh; 42 CFR 1395rr(b)(1); PL 103-                                                                          CFR Citation: Not Yet Determined
     66                                                     Timetable:
                                                                                                                   Legal Deadline: None
     CFR Citation: 42 CFR 414                               Action                        Date
                                                                                                                   Abstract: This proposed rule would
     Legal Deadline: None                                   NPRM                      08/00/03                     redefine, clarify, and update the
                                                            Regulatory Flexibility Analysis                        guidelines and procedures for Provider
     Abstract: This rule would remove
                                                            Required: No                                           Reimbursement Review Board appeals,
     respiratory assist devices with bi-level
                                                                                                                   based on recent court decisions.
     capability and a back-up rate from the                 Small Entities Affected: No
     category of items requiring frequent and                                                                      Timetable:
     substantial servicing, as defined in                   Government Levels Affected: State,                     Action                    Date
     section 1834 (a)(3) of the Act, and place              Local, Federal
     them in the category for other items,                                                                         NPRM                    11/00/03
                                                            Agency Contact: Michele Sanders,
     or capped rental items, as defined in                  Department of Health and Human
                                                                                                                   Regulatory Flexibility Analysis
     section 1834(a)(7) of the Act. This rule                                                                      Required: No
                                                            Services, Centers for Medicare &
     would correct an error that occurred in                Medicaid Services, 7500 Security                       Small Entities Affected: Businesses
     1992, when these devices were                          Boulevard, Baltimore, MD 21244
     inappropriately placed in the category                                                                        Government Levels Affected: None
                                                            Phone: 410 786-0808
     for items requiring frequent and                                                                              Agency Contact: Morton Marcus,
     substantial servicing.                                 RIN: 0938–AL49                                         Department of Health and Human


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00042   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30255

     HHS—CMS                                                                                                                        Proposed Rule Stage


     Services, Centers for Medicare &                       Government Levels Affected: None                       innovations in healthcare delivery,
     Medicaid Services, 7500 Security                       Agency Contact: David Mlawsky,                         quality assessment, and performance
     Boulevard, Baltimore, MD 21244-1850                    Health Insurance Specialist,                           improvement. The focus would be to
     Phone: 410 786-4477                                    Department of Health and Human                         improve outcomes of health care and
     RIN: 0938–AL54                                         Services, Centers for Medicare &                       satisfaction for Medicare beneficiaries,
                                                            Medicaid Services, S3-16-26, 7500                      while streamlining structural and
                                                            Security Boulevard, Baltimore, MD                      procedural requirements where
     853. SCHIP; PURCHASE OF FAMILY                         21244                                                  possible.
     COVERAGE—BENEFIT FLEXIBILITY IN                        Phone: 410 786-6851                                    Timetable:
     PARENT COVERAGE (CMS-2148-P)
                                                            RIN: 0938–AL64                                         Action                    Date
     Priority: Substantive, Nonsignificant
                                                                                                                   NPRM                    04/00/04
     Unfunded Mandates: Undetermined
                                                            855. DMERC SERVICE AREAS AND                           Regulatory Flexibility Analysis
     Legal Authority: 42 USC 2110                           RELATED MATTERS (CMS-1219-P)                           Required: No
     CFR Citation: 42 CFR 457                               Priority: Substantive, Nonsignificant                  Small Entities Affected: Businesses
     Legal Deadline: None                                   Legal Authority: Social Security Act,                  Government Levels Affected: State
     Abstract: This proposed rule would                     sec 1842; Social Security Act, sec
                                                            1834(a)(12); Social Security Act, sec                  Agency Contact: Joan Brooks, Health
     provide flexibility to States in defining                                                                     Insurance Specialist, Department of
     their benefit package for adults covered               1834(h)(3); Social Security Act, sec
                                                            1834(j)(1)(E)                                          Health and Human Services, Centers for
     under the State Children’s Health                                                                             Medicare & Medicaid Services, 7500
     Insurance Program (SCHIP) family                       CFR Citation: 42 CFR 421.210                           Security Boulevard, Baltimore, MD
     coverage options.                                                                                             21244-1850
                                                            Legal Deadline: None
     Timetable:                                                                                                    Phone: 410 786-5526
                                                            Abstract: This proposed rule would
     Action                     Date                        allow flexibility in making changes to                 Jacqueline Morgan, Health Insurance
     NPRM                     01/00/04                      the DMERC contractor structure.                        Specialist, Department of Health and
                                                            Timetable:                                             Human Services, Centers for Medicare
     Regulatory Flexibility Analysis
                                                                                                                   & Medicaid Services, S3-02-01, 7500
     Required: No                                           Action                        Date
                                                                                                                   Security Boulevard, Baltimore, MD
     Small Entities Affected: No                            NPRM                      12/00/03                     21244
     Government Levels Affected: None                       Regulatory Flexibility Analysis                        Phone: 410 786-4282
     Agency Contact: Stacey Bush,                           Required: No                                           RIN: 0938–AL80
     Department of Health and Human                         Small Entities Affected: Businesses
     Services, Centers for Medicare &                       Government Levels Affected: None                       857. MEDICAID COVERAGE RULES
     Medicaid Services, 7500 Security                                                                              FOR INMATES OF PUBLIC
     Boulevard, Baltimore, MD 21244-1850                    Agency Contact: Kim Nyland, Health
                                                                                                                   INSTITUTIONS (CMS-2077-P)
     Phone: 410 786-6102                                    Insurance Specialist, Department of
                                                            Health and Human Services, Centers for                 Priority: Substantive, Nonsignificant.
     RIN: 0938–AL62                                         Medicare & Medicaid Services, S1-14-                   Major status under 5 USC 801 is
                                                            27, 7500 Security Boulevard, Baltimore,                undetermined.
     854. REQUEST FOR INFORMATION                           MD 21244                                               Unfunded Mandates: Undetermined
     ON BENEFIT-SPECIFIC WAITING                            Phone: 410 786-2289
                                                                                                                   Legal Authority: Social Security Act,
     PERIODS (CMS-2150-NC)                                  RIN: 0938–AL76                                         sec 1905(a)(A)
     Priority: Info./Admin./Other                                                                                  CFR Citation: 42 CFR 435.1008; 42 CFR
     Legal Authority: None                                  856. REVISIONS TO CONDITIONS FOR                       435.1009; 42 CFR 435.1012; 42 CFR
                                                            COVERAGE FOR AMBULATORY                                436.1004
     CFR Citation: None
                                                            SURGICAL CENTERS (CMS-3887-P)                          Legal Deadline: None
     Legal Deadline: None
                                                            Priority: Other Significant. Major under               Abstract: This proposed rule would
     Abstract: This notice requests                         5 USC 801.                                             provide a new interpretation of the
     information on the use of benefit-
                                                            Unfunded Mandates: Undetermined                        statute in order to eliminate confusion
     specific waiting periods by group
                                                            Legal Authority: Social Security Act,                  among the States and to ensure
     health plan and group health insurance
                                                            sec 1102; Social Security Act, sec 1832;               consistent application of the FFP
     issuers.
                                                            Social Security Act, sec 1871                          exclusionary rules for services provided
     Timetable:                                                                                                    to inmates of a public institution.
                                                            CFR Citation: 42 CFR 410; 42 CFR 424;
     Action                     Date
                                                            42 CFR 416; 42 CFR 488; 42 CFR 489                     Timetable:
     NPRM                     09/00/03                                                                             Action                    Date
                                                            Legal Deadline: None
     Regulatory Flexibility Analysis                        Abstract: This rule would revise the                   NPRM                    03/00/04
     Required: No                                           ambulatory surgical center conditions                  Regulatory Flexibility Analysis
     Small Entities Affected: No                            for coverage to reflect current                        Required: No


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00043   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30256                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                        Proposed Rule Stage


     Small Entities Affected: No                            Legal Deadline: None                                   Regulatory Flexibility Analysis
     Government Levels Affected: State,                     Abstract: This proposed rule would                     Required: Yes
     Local                                                  clarify certain portability requirements               Small Entities Affected: Businesses
     Agency Contact: Tom Shenk, Center                      for group health plans and issuers of
                                                                                                                   Government Levels Affected: None
     for Medicaid and State Operations,                     health insurance coverage offered in
     Department of Health and Human                         connection with a group health plan.                   Agency Contact: Tzvi Hefter,
     Services, Centers for Medicare &                       This proposed rule would implement                     Department of Health and Human
     Medicaid Services, 7500 Security                       changes made to the Internal Revenue                   Services, Centers for Medicare &
     Boulevard, Baltimore, MD 21244                         Code, the Employee Retirement Income                   Medicaid Services, C4-07-07, 7500
     Phone: 410 786-3295                                    Security Act, and the Public Health                    Security Boulevard, Baltimore, MD
                                                            Service Act enacted as part of the                     21244-1850
     RIN: 0938–AL85                                         Health Insurance Portability and                       Phone: 410 786-1304
                                                            Accountability Act of 1996.
     858. TARGETED CASE MANAGEMENT                                                                                 Steve Miller, Health Insurance
                                                            Timetable:
     (CMS-2061-P)                                                                                                  Specialist, Department of Health and
                                                            Action                        Date                     Human Services, Centers for Medicare
     Priority: Substantive, Nonsignificant                                                                         & Medicaid Services, 7500 Security
                                                            NPRM                      09/00/03
     Legal Authority: Sec 1915(g) of the                                                                           Boulevard, Baltimore, MD 21244
     Social Security Act                                    Regulatory Flexibility Analysis                        Phone: 410 786-6656
                                                            Required: No
     CFR Citation: 42 CFR 431; 42 CFR 440;                                                                         RIN: 0938–AL89
     42 CFR 441                                             Small Entities Affected: Businesses,
                                                            Organizations
     Legal Deadline: None                                                                                          861. PROSPECTIVE PAYMENT
                                                            Government Levels Affected: State,
     Abstract: This proposed rule would                     Local, Federal                                         SYSTEM AND CONSOLIDATED
     amend the Medicaid regulations to                                                                             BILLING FOR SKILLED NURSING
     provide for optional coverage of case                  Agency Contact: David Mlawsky,                         FACILITIES—UPDATE FOR FY 2004
     management services furnished to                       Health Insurance Specialist,                           (CMS-1469-P)
     specific groups, geographic areas, or                  Department of Health and Human
                                                            Services, Centers for Medicare &                       Priority: Other Significant. Major under
     political subdivisions within a State.                                                                        5 USC 801.
     This proposed rule rescinds the                        Medicaid Services, S3-16-26, 7500
     proposed rule that was published on                    Security Boulevard, Baltimore, MD                      Legal Authority: Sec 1888(e) of the
     October 15, 1993.                                      21244                                                  Social Security Act
                                                            Phone: 410 786-6851
     Timetable:                                                                                                    CFR Citation: 42 CFR 413.330 to
                                                            RIN: 0938–AL88                                         413.350
     Action                     Date
                                                                                                                   Legal Deadline: NPRM, Statutory, April
     NPRM                     03/00/04
                                                            860. CHANGES TO THE HOSPITAL                           1, 2003.
     Regulatory Flexibility Analysis                        INPATIENT PROSPECTIVE PAYMENT                          Final, Statutory, July 31, 2003, final
     Required: No                                           SYSTEM AND FY 2004 RATES (CMS-                         rule to be published before August 1,
     Small Entities Affected: No                            1470-P)                                                2003.
     Government Levels Affected: None                       Priority: Economically Significant.                    Abstract: This annual proposed rule
                                                            Major under 5 USC 801.                                 would update the payment rates used
     Agency Contact: Kathy Poisal, Health
                                                            Legal Authority: Sec 1886(d) of the                    under the skilled nursing facilities
     Insurance Specialist, Department of
                                                            Social Security Act                                    prospective payment system beginning
     Health and Human Services, Centers for
                                                                                                                   October 1, 2003.
     Medicare & Medicaid Services, S2-14-                   CFR Citation: 42 CFR 412; 42 CFR 413;
     26, 7500 Security Boulevard, Baltimore,                42 CFR 485; 42 CFR 489                                 Timetable:
     MD 21244
                                                            Legal Deadline: NPRM, Statutory, April                 Action                    Date
     Phone: 410 786-5940
                                                            1, 2003.                                               NPRM                    05/00/03
     RIN: 0938–AL87                                         Final, Statutory, August 1, 2003.
                                                                                                                   Regulatory Flexibility Analysis
                                                            Abstract: This proposed rule would                     Required: No
     859. HEALTH COVERAGE                                   revise the Medicare acute hospital
     PORTABILITY: TOLLING CERTAIN                           inpatient prospective payment systems                  Small Entities Affected: No
     TIME PERIODS AND INTERACTIONS                          for operating and capital related costs                Government Levels Affected: None
     WITH FAMILY AND MEDICAL LEAVE                          to implement changes arising from our
     ACT (CMS-2158-P)                                       continuing experience with these                       Agency Contact: William Ullman,
                                                            systems. These changes apply to                        Department of Health and Human
     Priority: Other Significant                                                                                   Services, Centers for Medicare &
                                                            discharges occurring on or after October
     Legal Authority: 42 USC 300 gg; PL                     1, 2003.                                               Medicaid Services, C4-13-15, 7500
     104-191                                                                                                       Security Boulevard, Baltimore, MD
                                                            Timetable:                                             21244-1850
     CFR Citation: 45 CFR 146.113; 45 CFR
     146.115; 45 CFR 146.117; 45 CFR                        Action                        Date                     Phone: 401 786-5667
     146.120; 45 CFR 146.145                                NPRM                      05/00/03                     RIN: 0938–AL90


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00044   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30257

     HHS—CMS                                                                                                                        Proposed Rule Stage


     862. CHANGES TO THE HOSPITAL                           Government Levels Affected: None                       Regulatory Flexibility Analysis
     OUTPATIENT PROSPECTIVE                                 Agency Contact: Susan Levy, Health                     Required: No
     PAYMENT SYSTEM AND CALENDAR                            Insurance Specialist, Department of
     YEAR 2004 PAYMENT RATES (CMS-                                                                                 Small Entities Affected: No
                                                            Health and Human Services, Centers for
     1471-P)                                                Medicare & Medicaid Services, C5-08-                   Government Levels Affected: None
     Priority: Other Significant. Major status              27, 7500 Security Boulevard, Baltimore,
     under 5 USC 801 is undetermined.                       MD 21244                                               Agency Contact: Mary Clarkson,
                                                            Phone: 410 786-9364                                    Health Insurance Specialist,
     Unfunded Mandates: Undetermined
                                                            RIN: 0938–AL94                                         Department of Health and Human
     Legal Authority: 42 USC 1395L;                                                                                Services, Centers for Medicare &
     BBA’97; BBRA’99; BIPA’00                                                                                      Medicaid Services, S2-14-26, 7500
     CFR Citation: Not Yet Determined                       864. REVISIONS TO PAYMENT                              Security Boulevard, Baltimore, MD
                                                            POLICIES UNDER THE PHYSICIAN                           21244
     Legal Deadline: None                                   FEE SCHEDULE FOR CALENDAR                              Phone: 410 786-5918
     Abstract: This proposed rule proposes                  YEAR 2004 (CMS-1476-P)
     to revise the Medicare hospital                        Priority: Other Significant. Major under               RIN: 0938–AM05
     outpatient payment system beginning                    5 USC 801.
     January 1, 2004.
                                                            Legal Authority: 42 USC 1395W-4                        866. REVISIONS TO AVERAGE
     Timetable:                                                                                                    WHOLESALE PRICE METHODOLOGY
                                                            CFR Citation: 42 CFR 410; 42 CFR 414
     Action                     Date                                                                               (CMS-1229-P)
                                                            Legal Deadline: None
     NPRM                     06/00/03                      Abstract: This rule would make several                 Priority: Economically Significant.
     Regulatory Flexibility Analysis                        changes affecting Medicare part B                      Major status under 5 USC 801 is
     Required: Yes                                          payment.                                               undetermined.
     Small Entities Affected: Businesses                    Timetable:                                             Unfunded Mandates: Undetermined
     Government Levels Affected: Federal                    Action                        Date
                                                                                                                   Legal Authority: Sec 1842(o) of the
     Agency Contact: Cindy Read,                            NPRM                      06/00/03                     Social Security Act
     Department of Health and Human                         Regulatory Flexibility Analysis
     Services, Centers for Medicare &                       Required: Yes                                          CFR Citation: Not Yet Determined
     Medicaid Services, 7500 Security
                                                            Small Entities Affected: Businesses                    Legal Deadline: None
     Boulevard, Baltimore, MD 21244
     Phone: 410 786-1852                                    Government Levels Affected: Federal                    Abstract: This proposed rule would
     RIN: 0938–AL91                                         Agency Contact: Latesha Walker,                        propose revisions to the source and
                                                            Department of Health and Human                         methodology for determining the
                                                            Services, Centers for Medicare &                       average wholesale price (AWP) of drugs
     863. HOME HEALTH PROSPECTIVE                           Medicaid Services, 7500 Security                       covered by Medicare incident to a
     PAYMENT SYSTEM RATE UPDATE                             Boulevard, Baltimore, MD 21244
     FOR FY 2004 (CMS-1473-NC)                                                                                     physician’s service.
                                                            Phone: 410 786-1101
     Priority: Other Significant                            RIN: 0938–AL96                                         Timetable:
     Legal Authority: Not Yet Determined                                                                           Action                    Date
     CFR Citation: Not Yet Determined                       865. MEDICAID HOME AND                                 NPRM                    07/00/03
     Legal Deadline: Other, Statutory, June                 COMMUNITY-BASED SERVICES
                                                            WAIVERS (CMS-2162-P)                                   Regulatory Flexibility Analysis
     28, 2003, notice must be published by
                                                            Priority: Substantive, Nonsignificant                  Required: Undetermined
     the June 28, 2003, deadline in order
     to meet the statutory effective date of                Legal Authority: Sec 1915(c) of the                    Small Entities Affected: Businesses
     October 1, 2003.                                       Social Security Act
                                                                                                                   Government Levels Affected:
     Abstract: This notice with comment                     CFR Citation: 42 CFR 441.300
     period sets forth an update to the 60-                                                                        Undetermined
                                                            Legal Deadline: None
     day national episode rates and the                                                                            Federalism: Undetermined
     national per-visit amounts under the                   Abstract: This proposed rule
     Medicare prospective payment system                    incorporates New Freedom Initiative                    Agency Contact: Robert Niemann,
     for home health agencies for FY 2004.                  recommendations/proposals into the                     Department of Health and Human
                                                            HCBS waiver program to allow States                    Services, Centers for Medicare &
     Timetable:
                                                            greater flexibility in creating                        Medicaid Services, 7500 Security
     Action                     Date                        community-based long term care                         Boulevard, Baltimore, MD 21244
     Notice                   06/00/03                      alternatives for eligible persons.                     Phone: 410 786-4569
     Regulatory Flexibility Analysis                        Timetable:
                                                                                                                   RIN: 0938–AM12
     Required: Yes                                          Action                        Date
     Small Entities Affected: Businesses                    NPRM                      03/00/04



VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00045   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30258                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                        Proposed Rule Stage


     867. CRITERIA FOR DETERMINING                          Department of Health and Human                         specialty hospitals would not qualify
     WHETHER A DRUG IS CONSIDERED                           Services, Centers for Medicare &                       for the ‘‘whole hospital’’ exception. In
     USUALLY SELF-ADMINISTERED                              Medicaid Services, 7500 Security                       addition, this proposed rule would
     (CMS-1228-P)                                           Boulevard, Baltimore, MD 21244                         amend the definitions of ‘‘radiology
     Priority: Economically Significant.                    Phone: 410 786-1309                                    and certain other imaging services’’ and
     Major status under 5 USC 801 is                        RIN: 0938–AM22                                         ‘‘radiation therapy services and
     undetermined.                                                                                                 supplies’’ to include diagnostic and
                                                                                                                   therapeutic nuclear medicine services
     Legal Authority: Social Security Act,                  869. MEDICAID ESTATE RECOVERIES                        and supplies, respectively.
     sec 1861(s)(2)(B)                                      (CMS-2083-P)                                           Timetable:
     CFR Citation: Not Yet Determined                       Priority: Other Significant. Major status              Action                    Date
     Legal Deadline: None                                   under 5 USC 801 is undetermined.
                                                                                                                   NPRM                    07/00/03
     Abstract: This proposed rule would                     Unfunded Mandates: Undetermined
     solicit comments on the criteria to                                                                           Regulatory Flexibility Analysis
                                                            Legal Authority: Not Yet Determined                    Required: No
     determine whether a drug is considered
     usually self-administered and therefore,               CFR Citation: Not Yet Determined                       Small Entities Affected: Businesses
     not covered under part B of Medicare.                  Legal Deadline: None                                   Government Levels Affected: None
     Timetable:                                             Abstract: This proposed rule would                     Agency Contact: Jackie Proctor,
     Action                     Date                        require States to seek adjustment or                   Technical Advisor, Department of
     NPRM                     11/00/03
                                                            recovery from the estates of Medicaid                  Health and Human Services, Centers for
                                                            beneficiaries for amounts correctly                    Medicare & Medicaid Services, C4-25-
     Regulatory Flexibility Analysis                        spent by Medicaid on permanently                       02, 7500 Security Boulevard, Baltimore,
     Required: Undetermined                                 institutionalized individuals (any age)                MD 21244
     Small Entities Affected: No                            and aged 55 or older for certain                       Phone: 410 786-8852
     Government Levels Affected:                            services.
                                                                                                                   RIN: 0938–AM35
     Undetermined                                           Timetable:
     Federalism: Undetermined                               Action                        Date
                                                                                                                   871. ∑ PROCEDURES FOR
     Agency Contact: Robert Niemann,                        NPRM                      01/00/04                     MAINTAINING CODE LISTS IN THE
     Department of Health and Human                                                                                NEGOTIATED NATIONAL COVERAGE
                                                            Regulatory Flexibility Analysis
     Services, Centers for Medicare &                                                                              DETERMINATIONS FOR CLINICAL
                                                            Required: Undetermined
     Medicaid Services, 7500 Security                                                                              DIAGNOSTIC LABORATORY
     Boulevard, Baltimore, MD 21244                         Government Levels Affected:                            SERVICES (CMS-3119-P)
     Phone: 410 786-4569                                    Undetermined
                                                                                                                   Priority: Routine and Frequent
     RIN: 0938–AM13                                         Federalism: Undetermined
                                                                                                                   Legal Authority: 42 USC 1395h(a); 42
                                                            Agency Contact: Ingrid Osborne,                        USC 1395e; 42 USC 1395u(a); 42 USC
     868. ELECTRONIC MEDICARE CLAIMS                        Center for Medicaid and State                          1395x; 42 USC 1395y(a)(1)(A); 42 USC
     SUBMISSION (CMS-0008-IFC)                              Operations, Department of Health and                   1395y(a)(7)
                                                            Human Services, Centers for Medicare
     Priority: Other Significant                                                                                   CFR Citation: Not Yet Determined
                                                            & Medicaid Services, S2-16-25, 7500
     Legal Authority: PL 107-105                            Security Boulevard, Baltimore, MD                      Legal Deadline: None
     CFR Citation: Not Yet Determined                       21244-1850                                             Abstract: This proposed rule would
                                                            Phone: 410 786-4461                                    establish the procedures to be used for
     Legal Deadline: None
                                                            RIN: 0938–AM30                                         maintaining the lists of codes that were
     Abstract: This proposed rule
                                                                                                                   included in the national coverage
     implements the requirements for
                                                                                                                   determinations (NCDs) announced in
     electronic submission of Medicare                      870. ∑ PHYSICIAN OWNERSHIP IN                          the Federal Register on November 25,
     claims, submitted on or after October                  SPECIALTY HOSPITALS (CMS-1240-P)                       2001 (66 FR 58788).
     16, 2003. In addition, this rule also
                                                            Priority: Substantive, Nonsignificant                  Timetable:
     implements the conditions upon which
     a waiver could be granted for these                    Legal Authority: PL 101-239, OBRA                      Action                    Date
     requirements.                                          1989; PL 101-508, OBRA 1990; PL 103-
                                                            66, OBRA 1993; PL 103-432, Social                      NPRM                    09/00/03
     Timetable:
                                                            Security Act Amendments of 1994                        Regulatory Flexibility Analysis
     Action                     Date                                                                               Required: Undetermined
                                                            CFR Citation: 42 CFR 411
     NPRM                     07/00/03                                                                             Government Levels Affected:
                                                            Legal Deadline: None
     Regulatory Flexibility Analysis                                                                               Undetermined
     Required: Undetermined                                 Abstract: This proposed rule would
                                                            revise the regulations to specify that,                Federalism: Undetermined
     Government Levels Affected: None                       for purposes of the physician self-                    Agency Contact: Jacqueline Sheridan,
     Agency Contact: Elizabeth Holland,                     referral prohibition, certain physician                Office of Clinical Standards and
     Center for Health Plans and Providers,                 ownership or investment interests in                   Quality, Department of Health and


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00046   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30259

     HHS—CMS                                                                                                                        Proposed Rule Stage


     Human Services, Centers for Medicare                   Legal Authority: Sec 1834(l) of the                    Medicaid Services, C4-13-15, 7500
     . Medicaid Services, 7500 Security                     Social Security Act                                    Security Boulevard, Baltimore, MD
     Boulevard, Baltimore, MD 21244                         CFR Citation: Not Yet Determined                       21244-1850
     Phone: 410 786-4635                                                                                           Phone: 401 786-5667
                                                            Legal Deadline: None
     RIN: 0938–AM36                                                                                                RIN: 0938–AM46
                                                            Abstract: This rule would propose the
                                                            creation of condition codes to be used
     872. ∑ HOSPITAL PATIENTS’ RIGHTS                       in billing for ambulance services.                     875. ∑ MODIFICATIONS TO
     COP—STANDARD SAFETY                                                                                           ELECTRONIC TRANSACTIONS AND
                                                            Timetable:
     COMPLIANCE COMMITTEES (CMS-                                                                                   CODE SETS (CMS-0009-P)
     3120-P)                                                Action                        Date                     Priority: Other Significant. Major status
     Priority: Economically Significant.                    NPRM                      03/00/04                     under 5 USC 801 is undetermined.
     Major under 5 USC 801.                                 Regulatory Flexibility Analysis                        Unfunded Mandates: Undetermined
     Legal Authority: 42 USC 1395bb; 42                     Required: Undetermined                                 Legal Authority: Social Security Act,
     USC 1395x; 42 USC 1396d                                Government Levels Affected:                            sec 1171 to 1179
     CFR Citation: 42 CFR 482                               Undetermined                                           CFR Citation: 42 CFR 162.1002; 42 CFR
     Legal Deadline: None                                   Federalism: Undetermined                               162.1802
     Abstract: This proposed rule would                     Agency Contact: Don Thompson,                          Legal Deadline: None
     allow hospitals to waive the current                   Office of Physician & Ambulatory Care                  Abstract: This proposed rule would
     requirement that a physician or                        Policy, Bureau of Policy Development,                  revise the electronic transactions and
     licensed independent practitioner                      Department of Health and Human                         code set standards mandated by HIPPA.
     perform a one-hour face-to-face                        Services, Centers for Medicare &
     evaluation of a patient in restraint or                Medicaid Services, C4-10-26, 7500                      Timetable:
     seclusion for the purpose of behavior                  Security Boulevard, Baltimore, MD                      Action                    Date
     management. Under this proposed rule,                  21244-1850                                             NPRM                    02/00/04
     a hospital could choose to have the                    Phone: 410 786-4586
     one-hour assessment performed by                                                                              Regulatory Flexibility Analysis
                                                            RIN: 0938–AM45                                         Required: Undetermined
     another practitioner, such as a
     registered nurse, if that hospital                                                                            Small Entities Affected: Businesses,
     established a Protections Compliance                   874. ∑ PROSPECTIVE PAYMENT                             Governmental Jurisdictions,
     Committee to oversee the use of                        SYSTEM AND CONSOLIDATED                                Organizations
     restraint or seclusion                                 BILLING FOR SKILLED NURSING
                                                                                                                   Government Levels Affected: State,
     Timetable:                                             FACILITIES—UPDATE FOR FY 2005
                                                                                                                   Local, Tribal, Federal
                                                            (CMS-1249-P)
     Action                     Date                                                                               Federalism: This action may have
                                                            Priority: Other Significant. Major under
     NPRM                     07/00/03                                                                             federalism implications as defined in
                                                            5 USC 801.
                                                                                                                   EO 13132.
     Regulatory Flexibility Analysis                        Legal Authority: Sec 1888(e) of the
     Required: Yes                                                                                                 Agency Contact: Stanley B.
                                                            Social Security Act
                                                                                                                   Nachimson, Senior Technical Advisor,
     Small Entities Affected: Businesses,                   CFR Citation: 42 CFR 413.330 to                        Department of Health and Human
     Organizations                                          413.350                                                Services, Centers for Medicare &
     Government Levels Affected:                            Legal Deadline: NPRM, Statutory, July                  Medicaid Services, N2-16-03, 7500
     Undetermined                                           30, 2004, Requires the final rule to be                Security Boulevard, Baltimore, MD
     Federalism: Undetermined                               published by August 1, 2004.                           21244
                                                                                                                   Phone: 410 786-6153
     Agency Contact: Nancy Archer, Office                   Abstract: This annual proposed rule
     of Clinical Standards and Quality,                     updates the payment rates used under                   RIN: 0938–AM50
     Department of Health and Human                         the skilled nursing facilities prospective
     Services, Centers for Medicare &                       payment system beginning October 1,                    876. ∑ REVISED CIVIL MONEY
     Medicaid Services, S3-05-27, 7500                      2004.                                                  PENALTIES, ASSESSMENTS,
     Security Boulevard, Baltimore, MD                      Timetable:                                             EXCLUSIONS, AND RELATED
     21244-1850                                                                                                    APPEALS PROCEDURES (CMS-6146-
     Phone: 401 786-0596                                    Action                        Date
                                                                                                                   P)
     RIN: 0938–AM39                                         NPRM                      03/00/04
                                                                                                                   Priority: Other Significant
                                                            Regulatory Flexibility Analysis                        Unfunded Mandates: Undetermined
     873. ∑ AMBULANCE FEE SCHEDULE                          Required: Yes
                                                                                                                   Legal Authority: PL 97-35, sec 2105;
     CONDITION CODES (CMS-1247-P)                           Small Entities Affected: Businesses                    PL 104-191, sec 231(C); PL 105-33, sec
     Priority: Substantive, Nonsignificant.                 Government Levels Affected: None                       4311(b); PL 105-33, sec 4317; PL 105-
     Major status under 5 USC 801 is                        Agency Contact: William Ullman,                        33, sec 4031(a)(2); PL 105-33, sec
     undetermined.                                          Department of Health and Human                         4531(b)(2)
     Unfunded Mandates: Undetermined                        Services, Centers for Medicare &                       CFR Citation: 42 CFR 402, subpart C


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00047   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30260                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                        Proposed Rule Stage


     Legal Deadline: None                                   Health and Human Services, Centers for                 for each shift, the number of licensed
     Abstract: This rule proposes revisions                 Medicare & Medicaid Services, C3-04-                   and unlicensed nursing staff directly
     to the CMS civil money penalty                         06, 7500 Security Boulevard, Baltimore,                responsible for resident care.
     authorities. These proposed revisions                  MD 21244-1850
                                                                                                                   Timetable:
     are intended to add the specific                       Phone: 410 786-3349
                                                                                                                   Action                    Date
     exclusion sanction authorities as                      RIN: 0938–AM54
     established in the procedures for                                                                             NPRM                    12/00/03
     imposing civil money penalties,
                                                            877. ∑ REQUIREMENTS FOR NURSING                        Regulatory Flexibility Analysis
     assessments, and exclusions for certain
                                                            HOMES TO IDENTIFY THE NUMBER                           Required: No
     violations of the Medicare and
     Medicaid programs.                                     OF LICENSED AND UNLICENSED                             Small Entities Affected: No
                                                            NURSING STAFF PER SHIFT (CMS-
     Timetable:                                             3121-P)                                                Government Levels Affected: None
     Action                     Date                        Priority: Other Significant                            Agency Contact: Nancy Archer, Office
     NPRM                     10/00/03                      Legal Authority: Sec. 1819(b) of the                   of Clinical Standards and Quality,
                                                            Social Security Act; 42 USC 1395i-3(b)                 Department of Health and Human
     Regulatory Flexibility Analysis
                                                                                                                   Services, Centers for Medicare &
     Required: No                                           CFR Citation: 42 CFR 483                               Medicaid Services, S3-05-27, 7500
     Small Entities Affected: No                            Legal Deadline: None                                   Security Boulevard, Baltimore, MD
     Government Levels Affected: None                                                                              21244-1850
                                                            Abstract: This proposed rule will
                                                                                                                   Phone: 401 786-0596
     Agency Contact: Joel Cohen, Office of                  implement section 941 of BIPA, which
     Financial Management, Department of                    requires nursing homes to post daily,                  RIN: 0938–AM55

     Department of Health and Human Services (HHS)                                                                                          Final Rule Stage
     Centers for Medicare & Medicaid Services (CMS)

     878. HOME HEALTH AGENCY (HHA)                          Regulatory Flexibility Analysis                        Legal Deadline: Final, Statutory,
     CONDITIONS OF PARTICIPATION                            Required: Undetermined                                 February 21, 1998.
     (COPS) (CMS-3819-FC)                                   Small Entities Affected: Businesses,                   Abstract: This final rule implements a
     Priority: Other Significant                            Organizations                                          standard identifier to identify health
     Legal Authority: 42 USC 1302; 42 USC                   Government Levels Affected: None                       plans that process and pay certain
     1395x; 42 USC 1395cc(a); 42 USC                        Federalism: Undetermined                               electronic health care transactions. It
     1395hh; 42 USC 1395bb                                                                                         implements one of the requirements for
                                                            Agency Contact: Mercedes Benitex-
                                                                                                                   administrative simplification in section
     CFR Citation: 42 CFR 484                               McCray, Health Insurance Specialist,
                                                            Department of Health and Human                         262 of the Health Insurance Portability
     Legal Deadline: None                                   Services, Centers for Medicare &                       & Accountability Act of 1996.
     Abstract: This final rule revises the                  Medicaid Services, 7500 Security                       Timetable:
     existing CoPs that HHAs must meet to                   Boulevard, Baltimore, MD 21244
     participate in the Medicare program.                   Phone: 410 786-5716                                    Action                    Date
     The requirements focus on the actual                                                                          Final Action            08/00/03
     care delivered to patients by HHAs,                    Steve Miller, Health Insurance
     reflect an interdisciplinary view of                   Specialist, Department of Health and                   Regulatory Flexibility Analysis
     patient care, allow HHAs greater                       Human Services, Centers for Medicare                   Required: Yes
     flexibility in meeting quality standards,              & Medicaid Services, 7500 Security
     and eliminate unnecessary procedural                   Boulevard, Baltimore, MD 21244                         Small Entities Affected: Businesses
     requirements. These changes are an                     Phone: 410 786-6656
                                                                                                                   Government Levels Affected: State
     integral part of the Administration’s                  RIN: 0938–AG81
     efforts to achieve broad-based                                                                                Federalism: This action may have
     improvements and measurements of the                                                                          federalism implications as defined in
     quality of care furnished through                      879. STANDARD UNIQUE NATIONAL
                                                            HEALTH PLAN IDENTIFIERS (CMS-                          EO 13132.
     Federal programs while at the same
     time reducing procedural burdens on                    6017-F)                                                Agency Contact: Helen Dietrick,
     providers.                                             Priority: Other Significant. Major under               Department of Health and Human
     Timetable:                                             5 USC 801.                                             Services, Centers for Medicare &
                                                            Unfunded Mandates: This action may                     Medicaid Services, S1-07-17, 7500
     Action                     Date                                                                               Security Boulevard, Baltimore, MD
                                                            affect State, local or tribal governments.
     NPRM                     03/10/97 62 FR 11005                                                                 21244-1850
                                                            Legal Authority: 42 USC 1320d to
     NPRM Comment             06/09/97                                                                             Phone: 410 786-7448
       Period End                                           1320d-8
     Final Rule               12/00/03                      CFR Citation: 45 CFR 160; 45 CFR 162                   RIN: 0938–AH87


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00048   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30261

     HHS—CMS                                                                                                                               Final Rule Stage


     880. HEALTH INSURANCE REFORM:                          billing privileges are disallowed by a                 Small Entities Affected: Businesses
     STANDARD UNIQUE HEALTH CARE                            carrier or whose Medicare billing
     PROVIDER IDENTIFIER (CMS-0045-F)                       privileges are revoked, except for those               Government Levels Affected: None
     Priority: Other Significant. Major under               suppliers covered under other existing                 Agency Contact: Jean Marie Moore,
     5 USC 801.                                             appeals provisions of our regulations.
                                                                                                                   Center for Medicare Management,
                                                            In addition, we will revise certain
     Legal Authority: 42 USC 1320D-2(b)(1)                                                                         Department of Health and Human
                                                            appeal provisions to correspond with
                                                            the existing appeal provisions in those                Services, Centers for Medicare &
     CFR Citation: 42 CFR 160; 42 CFR 162
                                                            other sections of our regulations. We                  Medicaid Services, 7500 Security
     Legal Deadline: Final, Statutory,                                                                             Boulevard, Baltimore, MD 21244
                                                            will also extend appeal rights to all
     February 21, 1998.                                                                                            Phone: 410 786-3508
                                                            suppliers not covered by existing
     Abstract: This final rule establishes a                regulations to ensure they have a full                 RIN: 0938–AI93
     standard unique ID for all health care                 and fair opportunity to be heard.
     providers under the Health Insurance                   Timetable:
     Portability and Accountability Act                                                                            883. MEDICARE OUTCOME AND
     (HIPAA) of 1966 (Pub. L. 104-191). The                 Action                        Date
                                                                                                                   ASSESSMENT INFORMATION SET
     rule implements administrative                         NPRM                      10/25/99 64 FR 57431         (OASIS) DATA REPORTING
     simplification initiatives that have a                 Final Rule                01/00/04                     REQUIREMENTS (CMS-3006-F)
     national scope beyond Medicare and
                                                            Regulatory Flexibility Analysis
     Medicaid.                                                                                                     Priority: Other Significant. Major under
                                                            Required: No
     Timetable:                                                                                                    5 USC 801.
                                                            Small Entities Affected: Businesses
     Action                     Date                        Government Levels Affected: None                       Unfunded Mandates: This action may
     NPRM                     05/07/98 63 FR 25320                                                                 affect State, local or tribal governments
                                                            Agency Contact: Ralph Goldberg,
     NPRM Comment             07/06/98                                                                             and the private sector.
                                                            Division of Provider and Supplier
       Period End                                           Enrollment, Department of Health and
     Final Action             07/00/03
                                                                                                                   Legal Authority: 42 USC 1302; 42 USC
                                                            Human Services, Centers for Medicare                   1395(hh)
     Regulatory Flexibility Analysis                        & Medicaid Services, 7500 Security
     Required: Yes                                          Boulevard, Baltimore, MD 21244                         CFR Citation: 42 CFR 484.11; 42 CFR
     Small Entities Affected: Businesses                    Phone: 410 786-4870                                    484.20; 42 CFR 488.68
                                                            Email: rgoldberg@cms.hhs.gov
     Government Levels Affected: Federal,                                                                          Legal Deadline: None
                                                            RIN: 0938–AI49
     State, Local, Tribal
                                                                                                                   Abstract: This final rule requires home
     Federalism: This action may have                                                                              health agencies to electronically report
     federalism implications as defined in                  882. COVERAGE OF RELIGIOUS NON-
                                                            MEDICAL HEALTH CARE                                    OASIS data as a condition of
     EO 13132.                                                                                                     participation in the Medicare program.
                                                            INSTITUTIONS (CMS-1909-F)
     Additional Information: None
                                                            Priority: Substantive, Nonsignificant                  Timetable:
     Agency Contact: Patricia Peyton,
                                                            Legal Authority: 42 USC 1395i-5; 42                    Action                    Date
     Office of Information Services,
                                                            USC 1395x(e); 42 USC 1395x(y); 42
     Department of Health and Human
                                                            USC 1395x(ss); 42 USC 1302                             Interim Final Rule      01/25/99 64 FR 3748
     Services, Centers for Medicare &
                                                            CFR Citation: 42 CFR 403; 42 CFR                       Final Rule              12/00/03
     Medicaid Services, N3-20-05, 7500
     Security Boulevard, Baltimore, MD                      440.170; 42 CFR 488.2; 42 CFR 488.6;                   Regulatory Flexibility Analysis
     21224-1850                                             42 CFR 489.102; 42 CFR 412.90; 42                      Required: Undetermined
     Phone: 410 786-1812                                    CFR 412.98; 42 CFR 431.610; 42 CFR
                                                            440.155; 42 CFR 442.12; 42 CFR                         Small Entities Affected: Businesses
     RIN: 0938–AH99                                         456.351; 42 CFR 456.601; 42 CFR 476.1
                                                            Legal Deadline: Final, Statutory, July                 Government Levels Affected: State,
     881. APPEALS OF CARRIER                                1, 1998, BBA, section 4454(d).                         Local, Tribal
     DETERMINATION THAT A SUPPLIER
                                                            Abstract: This final rule follows an                   Federalism: This action may have
     FAILS TO MEET THE REQUIREMENTS
                                                            interm final rule with comment that                    federalism implications as defined in
     FOR MEDICARE BILLING PRIVILEGES
                                                            removed all references in the Medicare                 EO 13132.
     (CMS-6003-F)
                                                            regulations to specific religious
     Priority: Substantive, Nonsignificant                  institutions to include all religious                  Agency Contact: Mercedes Benitex-
     Legal Authority: 42 USC 1302; 42 USC                   nonmedical institutions.                               McCray, Health Insurance Specialist,
     1395u(b)(3)(C); 42 USC 1395ff(b)                       Timetable:                                             Department of Health and Human
                                                                                                                   Services, Centers for Medicare &
     CFR Citation: 42 CFR 405.874                           Action                        Date                     Medicaid Services, 7500 Security
     Legal Deadline: None                                   Interim Final Rule        11/30/99 64 FR 67028         Boulevard, Baltimore, MD 21244
     Abstract: This final rule will extend                  Final Action              09/00/03                     Phone: 410 786-5716
     appeal rights to all suppliers whose                   Regulatory Flexibility Analysis                        RIN: 0938–AJ10
     enrollment applications for Medicare                   Required: No


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00049   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30262                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                                Final Rule Stage


     884. RURAL HEALTH CLINICS:                             885. HOSPITAL CONDITIONS OF                            Timetable:
     AMENDMENTS TO PARTICIPATION                            PARTICIPATION: LABORATORY                              Action                     Date
     REQUIREMENTS AND PAYMENT                               SERVICES (CMS-3014-F)
                                                                                                                   NPRM                     11/22/02 67 FR 70363
     PROVISIONS, AND ESTABLISHMENT                          Priority: Substantive, Nonsignificant                  Final Action             01/00/04
     OF A QUALITY ASSESSMENT AND
     IMPROVEMENT PROGRAM (CMS-                              Legal Authority: 42 USC 1302; 42 USC                   Regulatory Flexibility Analysis
                                                            1395hh                                                 Required: No
     1910-F)
                                                            CFR Citation: 42 CFR 482.27                            Small Entities Affected: Businesses
     Priority: Other Significant
                                                            Legal Deadline: None                                   Government Levels Affected: None
     Legal Authority: 42 USC 1302; 42 USC                   Abstract: This rule requires hospitals                 Agency Contact: Thomas Saltz, Bureau
     1395hh                                                 that transfuse blood and blood products                of Policy Development, Department of
     CFR Citation: 42 CFR 405; 42 CFR 491                   to prepare and follow written                          Health and Human Services, Centers for
                                                            procedures for appropriate action when                 Medicare & Medicaid Services, C4-05-
     Legal Deadline: None                                   it is determined that blood and blood                  27, 7500 Security Boulevard, Baltimore,
                                                            products the hospital received and                     MD 21244-1850
     Abstract: This rule amends the                         transfused are at increased risk for                   Phone: 410 786-4480
     Medicare certification and payment                     transmitting HCV; quarantine prior                     Related RIN: Previously reported as
     requirements for rural health clinics                  collections from a donor who is at                     0938-AH73
     (RHCs), as required by section 4205 of                 increased risk for transmitting HCF
     the Balanced Budget Act of 1997. It                    infection; notify transfusion recipients,              RIN: 0938–AJ36
     changes the definition of a qualifying                 as appropriate, of the need for HCV
     rural shortage area in which a Medicare                testing and counseling; and maintain                   887. USE OF RESTRAINT AND
     RHC must be located; establishes                       records for at least 10 years.                         SECLUSION IN RESIDENTIAL
     criteria for identifying RHCs essential                Timetable:                                             TREATMENT FACILITIES PROVIDING
     to delivery of primary care services that                                                                     INPATIENT PSYCHIATRIC SERVICES
     we can continue to approve as                          Action                        Date                     TO INDIVIDUALS UNDER AGE 21
     Medicare RHCs in areas no longer                       NPRM                      11/16/00 65 FR 69416         (CMS-2065-F)
     designated as medically underserved;                   Final Rule                11/00/03                     Priority: Economically Significant
     and limits nonphysician practitioner                   Regulatory Flexibility Analysis                        Legal Authority: 42 USC 1302; 42 USC
     staffing requirements. This rule                       Required: No                                           1396d
     imposes payment limits on provider-
     based RHCs and prohibits the use of                    Small Entities Affected: Businesses                    CFR Citation: 42 CFR 441; 42 CFR 483
     RHC space, professional staff,                         Government Levels Affected: None                       Legal Deadline: None
     equipment, and other RHC resources by                  Federalism: Undetermined                               Abstract: This final rule addresses
     another Medicare entity. The rule also                                                                        standards of practices that residential
     requires RHCs to establish a quality                   Agency Contact: Mary Collins, OCSQ,                    treatment facilities providing inpatient
     assessment and performance                             Department of Health and Human                         psychiatric services for individuals
     improvement program. (The statute                      Services, Centers for Medicare &                       under age 21 must meet with regard
     required that this rule be published by                Medicaid Services, 7500 Security                       to the use of restraints and seclusion.
     January 1, 1999.)                                      Boulevard, Baltimore, MD 21244
                                                            Phone: 410 786-3189                                    Timetable:
     Timetable:                                             RIN: 0938–AJ29                                         Action                     Date
     Action                     Date                                                                               Interim Final Rule       01/22/01 66 FR 7148
                                                                                                                   60-Day Delay of          03/21/01 66 FR 15800
     NPRM                     02/28/00 65 FR 10450          886. MEDICARE HOSPICE CARE                                Effective Date To
     Final Rule               06/00/03                      AMENDMENTS (CMS-1022-F)                                   05/22/2001
                                                            Priority: Substantive, Nonsignificant                  Interim Final Rule       03/23/01
     Regulatory Flexibility Analysis                                                                                  Comment Period
     Required: No                                           Unfunded Mandates: Undetermined                           End
                                                            Legal Authority: PL 105-33, sec                        Interim Final Rule       03/23/01
     Small Entities Affected: Businesses                                                                              Effective
                                                            1961(dd); PL 105-33, sec 1814(i); PL
                                                            105-33, sec 4441 to 4444; PL 105-33,                   Interim Final Rule       05/22/01 66 FR 28110
     Government Levels Affected: Federal                                                                              Amendment with
                                                            sec 4448 to 4449; PL 106-113, sec 131;
     Agency Contact: David Worgo,                                                                                     Clarification
                                                            PL 106-554, sec 321 to 322
                                                                                                                   Interim Final Rule       07/23/01
     Department of Health and Human
                                                            CFR Citation: 42 CFR 418                                  Comment Period
     Services, Centers for Medicare &                                                                                 End
     Medicaid Services, C4-15-18, 7500                      Legal Deadline: None                                   Final Action             09/00/03
     Security Boulevard, Baltimore, MD                      Abstract: This final rule revises certain
     21244-1850                                                                                                    Regulatory Flexibility Analysis
                                                            regulations governing coverage and                     Required: No
     Phone: 410 786-5919                                    payments for hospice care under the
                                                            Medicare program as required by the                    Small Entities Affected: Businesses
     RIN: 0938–AJ17                                         Balanced Budget Act of 1997.                           Government Levels Affected: None


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00050   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT    apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30263

     HHS—CMS                                                                                                                               Final Rule Stage


     Agency Contact: Larry Cutler, Health                   CFR Citation: 42 CFR 493                               Federalism: Undetermined
     Insurance Specialist, Department of                    Legal Deadline: None                                   Agency Contact: James Bossenmeyer,
     Health and Human Services, Centers for                                                                        Health Insurance Specialist,
     Medicare & Medicaid Services, S2-14-                   Abstract: This rule finalizes certain
                                                            laboratory requirements under the                      Department of Health and Human
     26, 7500 Security Boulevard, Baltimore,                                                                       Services, Centers for Medicare &
     MD 21244-1850                                          Clinical Laboratory Improvement
                                                            Amendments of 1988 (CLIA).                             Medicaid Services, C5-16-26, 7500
     Phone: 410 786-5903                                                                                           Security Boulevard, Baltimore, MD
     RIN: 0938–AJ96                                         Timetable:                                             21244
                                                            Action                        Date                     Phone: 410 786-9317
                                                                                                                   Email: jbossenmeyer@hcfa.gov
     888. ALL PROVIDER BAD DEBT                             Final Rule                01/24/03 68 FR 3640
     PAYMENT (CMS-1126-F)                                   Notice                    06/00/03                     RIN: 0938–AK60
     Priority: Other Significant. Major under               Regulatory Flexibility Analysis
     5 USC 801.                                             Required: No                                           891. REVISED PROCESS FOR
     Legal Authority: 42 USC 1302; 42 USC                   Small Entities Affected: Businesses,                   MAKING MEDICARE COVERAGE
     1395f(b); 42 USC 1395g; 42 USC                         Organizations                                          DETERMINATIONS (NCDS) (CMS-3062-
     1395.l(a); 42 USC 1395.l(i); 42 USC                                                                           N)
                                                            Government Levels Affected: None
     1395.l(n); 42 USC 1395x(v); 42 USC                                                                            Priority: Other Significant
     1395cc; 42 USC 1395hh; 42 USC                          Agency Contact: Cecelia Hinkel,
                                                            Health Insurance Specialist,                           Legal Authority: Sec 522 of the BIPA
     1395rr; 42 USC 1395tt
                                                            Department of Health and Human                         CFR Citation: None
     CFR Citation: 42 CFR 413.80; 42 CFR
                                                            Services, Centers for Medicare &                       Legal Deadline: Other, Statutory,
     413.178
                                                            Medicaid Services                                      October 1, 2001, Revision notice.
     Legal Deadline: None                                   Phone: 410 786-3347
                                                                                                                   Abstract: This notice will announce a
     Abstract: This final rule will achieve                 RIN: 0938–AK24                                         revised process for making Medicare
     a consistent bad debt reimbursement                                                                           NCDs. It implements section 522 of the
     policy for all providers currently                                                                            Medicare, Medicaid, and SCHIP
     eligible to receive payments from                      890. REVIEW OF NATIONAL
                                                            COVERAGE DETERMINATIONS AND                            Benefits Improvement and Protection
     Medicare for bad debt. It implements                                                                          Act of 2000 (BIPA). (The statute
     a court settlement agreement and                       LOCAL COVERAGE
                                                            DETERMINATIONS (CMS-3063-F)                            requires this notice be effective by
     removes the cap on End Stage Renal                                                                            October 1, 2001.)
     Disease (ESRD) bad debt                                Priority: Other Significant
     reimbursement, which limits payment                                                                           Timetable:
                                                            Legal Authority: Sec 522 of the BIPA
     of allowable bad debts to the facility’s                                                                      Action                    Date
                                                            2000
     unrecovered costs.
                                                            CFR Citation: 42 CFR 405                               Notice                  07/00/03
     Timetable:
                                                            Legal Deadline: NPRM, Statutory,                       Regulatory Flexibility Analysis
     Action                     Date                                                                               Required: No
                                                            October 1, 2001, The effective date for
     NPRM                     02/10/03 68 FR 6682           regulation changes is October 1, 2001.                 Small Entities Affected: Businesses,
     NPRM Comment             04/11/03                                                                             Governmental Jurisdictions,
       Period End                                           Abstract: This final rule would
                                                            announce a new process for                             Organizations
     Final Action             11/00/03
                                                            beneficiaries to appeal national and                   Government Levels Affected: Federal
     Regulatory Flexibility Analysis                        local coverage determinations (LCDs),
     Required: Yes                                                                                                 Agency Contact: Vadim Lubarsky,
                                                            including the role that the Department                 Health Insurance Specialist,
     Small Entities Affected: Businesses                    Appeals Board and, in the case of                      Department of Health and Human
     Government Levels Affected: None                       LCDs, Administrative Law Judges, will                  Services, Centers for Medicare &
                                                            have in reviewing the decisions. It                    Medicaid Services, C5-16-03, 7500
     Agency Contact: Katie Walker,                          implements section 522 of the Benefits
     Department of Health and Human                                                                                Security Boulevard, Baltimore, MD
                                                            Improvement and Protection Act of                      21244
     Services, Centers for Medicare &                       2000 (BIPA).
     Medicaid Services, C5-03-03, 7500                                                                             Phone: 410 786-0840
     Security Boulevard, Baltimore, MD                      Timetable:                                             RIN: 0938–AK61
     21244-1850                                             Action                        Date
     Phone: 410 786-7278
                                                            NPRM                      08/22/02 67 FR 54534         892. PHYSICIANS’ REFERRALS TO
     RIN: 0938–AK02                                         NPRM Comment              10/21/02                     HEALTH CARE ENTITIES WITH WHICH
                                                              Period End                                           THEY HAVE FINANCIAL
                                                            Final Action              09/00/03                     RELATIONSHIPS—PHASE II (CMS-
     889. LABORATORY REQUIREMENTS
     RELATING TO QUALITY SYSTEMS                            Regulatory Flexibility Analysis                        1810-FC)
     AND CERTAIN PERSONNEL                                  Required: No                                           Priority: Other Significant. Major status
     QUALIFICATIONS (CMS-2226-CN)                           Small Entities Affected: No                            under 5 USC 801 is undetermined.
     Priority: Other Significant                            Government Levels Affected:                            Legal Authority: 42 USC 1877
     Legal Authority: PL 100-578                            Undetermined                                           CFR Citation: 42 CFR 411


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00051   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30264                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                               Final Rule Stage


     Legal Deadline: None                                   Small Entities Affected: No                            895. MODIFICATIONS TO THE STATE
     Abstract: This final rule incorporates                 Government Levels Affected:                            CHILDREN’S HEALTH INSURANCE
     into regulation certain statutory                      Undetermined                                           PROGRAM (CMS-2006-F)
     provisions that preclude payment for                   Agency Contact: Les Caplan, Health                     Priority: Substantive, Nonsignificant
     services under Medicare if a physician                 Insurance Specialist, Department of                    Legal Authority: PL 105-33
     makes a referral to a facility in which                Health and Human Services, Centers for
     he/she has a financial interest. It                                                                           CFR Citation: 42 CFR 435; 42 CFR 436;
                                                            Medicare & Medicaid Services, 7500
     addresses comments from the January                                                                           42 CFR 457
                                                            Security Boulevard, Baltimore, MD
     9, 1998, proposed rule concerning the                  21244                                                  Legal Deadline: None
     ownership, investment, and                             Phone: 410 786-7223
     compensation exceptions. It also                                                                              Abstract: This final rule finalizes the
     addresses comments from the January                    RIN: 0938–AK68                                         June 25, 2001, interim final rule that
     4, 2001, final rule with comment                                                                              revised certain provisions of the
     period.                                                                                                       January 11, 2001, final rule on the State
                                                            894. MODIFICATIONS TO MEDICARE
                                                                                                                   Children’s Health Insurance Program
     Timetable:                                             MANAGED CARE RULES (CMS-4041-
                                                                                                                   (SCHIP). This final rule responds to
                                                            F)
     Action                     Date                                                                               public comments and makes further
     Final Action             06/00/03
                                                            Priority: Other Significant. Major status              refinements to the SCHIP.
                                                            under 5 USC 801 is undetermined.
     Regulatory Flexibility Analysis                                                                               Timetable:
     Required: Yes                                          Legal Authority: BIPA, sec 605; BIPA,
                                                            sec 606; BIPA, sec 612; BIPA, sec 615                  Action                    Date
     Small Entities Affected: Businesses,                   to 617; BIPA, sec 620; BIPA, sec 621;                  Interim Final Rule      06/25/01 66 FR 33810
     Organizations                                          BIPA, sec 623                                          Interim Final Rule      07/26/01
     Government Levels Affected: None                                                                                 Comment Period
                                                            CFR Citation: 42 CFR 409; 42 CFR 417;
                                                                                                                      End
     Agency Contact: Joanne Sinsheimer,                     42 CFR 422
                                                                                                                   Interim Final Rule      08/24/01
     Technical Advisor, CMM, Department                     Legal Deadline: None                                      Effective
     of Health and Human Services, Centers                                                                         Final Rule              08/00/03
     for Medicare & Medicaid Services, 7500                 Abstract: This final rule implements
     Security Boulevard, Baltimore, MD                      certain Medicare payment provisions of                 Regulatory Flexibility Analysis
     21244-1850                                             the Benefits and Improvement Act of                    Required: No
     Phone: 410 786-4620                                    2000. Policy changes include premium
                                                                                                                   Small Entities Affected: No
                                                            reductions for M+C enrollees, uniform
     RIN: 0938–AK67                                         coverage for M+C plans in multiple                     Government Levels Affected: State
                                                            locations, eliminating health                          Federalism: This action may have
     893. RATE OF REIMBURSEMENT OF                          disparities, ESRD enrollees, and                       federalism implications as defined in
     PHOTOCOPY EXPENSES FOR                                 increased civil money penalties for                    EO 13132.
     QUALITY IMPROVEMENT                                    M+C organizations that terminate
     ORGANIZATIONS (CMS-3055-F)                             contracts mid-year. It also describes                  Agency Contact: Cheryl Austein-
                                                            CMS’s authority to waive or modify                     Casnoff, Department of Health and
     Priority: Economically Significant                                                                            Human Services, Centers for Medicare
                                                            requirements that hinder the design of,
     Legal Authority: Social Security Act,                  or enrollment, in the M+C plans offered                & Medicaid Services, 7500 Security
     sec 1102; Social Security Act, sec 1154;               to employees or labor unions.                          Boulevard, Baltimore, MD 21244
     Social Security Act, sec 1159; Social                                                                         Phone: 410 786-4196
     Security Act, sec 1866; Social Security                Timetable:
                                                                                                                   RIN: 0938–AL00
     Act, sec 1871                                          Action                        Date
     CFR Citation: 42 CFR 476.78                            NPRM                      10/25/02 67 FR 65672
                                                                                                                   896. REQUIREMENTS FOR PAID
     Legal Deadline: None                                   Final Rule                07/00/03
                                                                                                                   FEEDING ASSISTANTS IN LONG-
     Abstract: This rule increases the rate                 Regulatory Flexibility Analysis                        TERM CARE FACILITIES (CMS-2131-F)
     of reimbursement of photocopy                          Required: Yes
                                                                                                                   Priority: Other Significant. Major status
     expenses as required by the regulations                Small Entities Affected: Businesses                    under 5 USC 801 is undetermined.
     governing Utilization and Quality                      Government Levels Affected: Federal
     Control Quality Improvement                                                                                   Unfunded Mandates: Undetermined
     Organizations (QIOs). Our current                      Additional Information: CMS-4041-P                     Legal Authority: Sec 1819(a) to (f) of
     regulations identify the photocopying                  was previously identified as CMS-1180-                 the Social Security Act; sec 1919(a) to
     reimbursement methodology for                          P.                                                     (g) of the Social Security Act; PL 100-
     prospective payment system hospitals.                  Agency Contact: Patricia Kurtz, Health                 203
     Timetable:                                             Insurance Specialist, Department of
                                                                                                                   CFR Citation: 42 CFR 483.73; 42 CFR
                                                            Health and Human Services, Centers for
     Action                     Date                                                                               483.75(c)
                                                            Medicare & Medicaid Services, 7500
     NPRM                     11/22/02 67 FR 70358          Security Boulevard, Baltimore, MD                      Legal Deadline: None
     Final Rule               10/00/03                      21244                                                  Abstract: This rule will allow long-
     Regulatory Flexibility Analysis                        Phone: 410 786-4670                                    term care facilities to use paid feeding
     Required: No                                           RIN: 0938–AK71                                         assistants to supplement the services of


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00052   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30265

     HHS—CMS                                                                                                                               Final Rule Stage


     certified nurse aides. If facilities choose            Agency Contact: David Mlawsky,                         hospices, rural health clinics, federally
     this option, feeding assistants must                   Health Insurance Specialist,                           qualified health centers, and
     complete a specified training program.                 Department of Health and Human                         community mental health centers to file
     Timetable:                                             Services, Centers for Medicare &                       cost reports in a standardized electronic
                                                            Medicaid Services, S3-16-26, 7500                      format. It provides a delay or waiver
     Action                     Date                        Security Boulevard, Baltimore, MD                      of this requirement if implementation
     NPRM                     03/29/02 67 FR 15149          21244                                                  would result in financial hardship. The
     NPRM Comment             05/28/02                      Phone: 410 786-6851                                    provisions of this rule allow for more
       Period End                                           RIN: 0938–AL43                                         accurate preparation and more efficient
     Final Rule               08/00/03                                                                             processing of each cost report.
     Regulatory Flexibility Analysis                                                                               Timetable:
                                                            898. INTERIM FINAL AMENDMENT
     Required: Undetermined                                 FOR MENTAL HEALTH PARITY (CMS-                         Action                    Date
     Small Entities Affected: Businesses                    2152-IFC)                                              NPRM                    07/26/02 67 FR 48840
     Government Levels Affected: State,                     Priority: Substantive, Nonsignificant                  Final Action            05/00/03
     Federal                                                Legal Authority: 42 USC 2705; PL 107-                  Regulatory Flexibility Analysis
     Agency Contact: Nola Petrovich,                        116; PL 104-191                                        Required: No
     Department of Health and Human                         CFR Citation: 45 CFR 146.136                           Small Entities Affected: Businesses
     Services, Centers for Medicare &                       Legal Deadline: None                                   Government Levels Affected: None
     Medicaid Services, S2-14-26, 7500
     Security Boulevard, Baltimore, MD                      Abstract: This final notice requests                   Agency Contact: Thomas Talbott,
     21244                                                  information on the use of benefit-                     Center for Medicare Management,
     Phone: 410 786-4671                                    specific waiting periods by group                      Department of Health and Human
                                                            health plans and group health                          Services, Centers for Medicare &
     RIN: 0938–AL18                                         insurance issuers.                                     Medicaid Services, C5-01-01, 7500
                                                            Timetable:                                             Security Boulevard, Baltimore, MD
     897. HEALTH COVERAGE                                                                                          21244-1850
                                                            Action                        Date
     PORTABILITY FOR GROUP HEALTH                                                                                  Phone: 410 786-4592
     PLANS AND GROUP HEALTH                                 Interim Final Rule        11/22/97 62 FR 66932
                                                                                                                   RIN: 0938–AL51
     INSURANCE ISSUERS (CMS-2151-F)                         Interim Final Rule        01/01/98
                                                               Effective
     Priority: Other Significant. Major under               Interim Final Rule        03/23/98                     900. REVISIONS TO THE MEDICARE
     5 USC 801.                                                Comment Period                                      APPEALS PROCESS (CMS-4004-F)
     Legal Authority: 42 USC 300gg; PL                         End
                                                            Interim Final Rule        07/00/03                     Priority: Other Significant
     104-191
                                                            Regulatory Flexibility Analysis                        Legal Authority: Sec 521 of BIPA
     CFR Citation: 45 CFR 144.103; 45 CFR
                                                            Required: No                                           CFR Citation: 42 CFR 405
     146.111; 45 CFR 146.113; 45 CFR
     146.115; 45 CFR 146.117; 45 CFR                        Small Entities Affected: No                            Legal Deadline: NPRM, Statutory,
     146.119; 45 CFR 146.120; 45 CFR                        Government Levels Affected: State,                     October 1, 2002, Statutory effective date
     146.125; 45 CFR 146.143; ...                           Local                                                  October 1, 2002.
     Legal Deadline: None                                   Agency Contact: David Mlawsky,                         Abstract: This final regulation
     Abstract: This final notice requests                   Health Insurance Specialist,                           incorporates recommendations from an
     information on the use of benefit-                     Department of Health and Human                         SSA/HHS workgroup to improve the
     specific waiting periods by group                      Services, Centers for Medicare &                       Administrative Law Judge (ALJ) hearing
     health plans and group health                          Medicaid Services, S3-16-26, 7500                      process. ALJ-conducted hearings for
     insurance issuers.                                     Security Boulevard, Baltimore, MD                      Medicare fee-for-service and managed
                                                            21244                                                  care cases are governed by SSA
     Timetable:                                             Phone: 410 786-6851                                    disability regulations which apply to
     Action                     Date                        RIN: 0938–AL44                                         SSA disability cases, not to Medicare.
                                                                                                                   Regulations improve the integrity of the
     Interim Final Rule       04/08/97 62 FR 16894                                                                 appeals process, because they are
     Interim Final Rule       07/07/97                      899. ELECTRONIC SUBMISSION OF                          specific to the adjudication of Medicare
        Comment Period
                                                            COST REPORTS (CMS-1199-F)                              cases. They also incorporate the
        End
     Interim Final Rule       07/07/97                      Priority: Substantive, Nonsignificant                  revisions to appeals policy required by
        Effective                                                                                                  section 521 of BIPA.
                                                            Legal Authority: Social Security Act,
     Final Action             09/00/03                      sec 1815(a); Social Security Act, sec                  Timetable:
     Regulatory Flexibility Analysis                        1833(e)                                                Action                    Date
     Required: No                                           CFR Citation: 42 CFR 413.24                            NPRM                    11/15/02 67 FR 69312
     Small Entities Affected: No                            Legal Deadline: None                                   Final Rule              09/00/03
     Government Levels Affected: State,                     Abstract: This final rule establishes the              Regulatory Flexibility Analysis
     Local, Federal                                         requirement for ESRD facilities,                       Required: Undetermined


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00053   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30266                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                               Final Rule Stage


     Small Entities Affected: No                            CFR Citation: 42 CFR 412; 42 CFR 413                   Phone: 410 786-4597
     Government Levels Affected:                            Legal Deadline: None                                   Related RIN: Related To 0938-AM57
     Undetermined                                           Abstract: This rule updates the                        RIN: 0938–AL95
     Agency Contact: Michale Edmondson,                     Prospective Payment System for
     Health Insurance Specialist,                           Medicare payment of long-term care
     Department of Health and Human                         hospitals. It implements section 123 of                904. NONDISCRIMINATION IN POST-
     Services, Centers for Medicare &                       the Medicare, Medicaid, and SCHIP                      HOSPITAL REFERRAL TO HOME
     Medicaid Services, 7500 Security                       Balanced Budget Refinement Act of                      HEALTH AGENCIES AND OTHER
     Boulevard, Baltimore, MD 21244                         1999 and section 307(b) of the                         ENTITIES (CMS-1224-F)
     Phone: 410 786-6478                                    Medicare, Medicaid, and SCHIP                          Priority: Substantive, Nonsignificant
                                                            Benefits Improvement and Protection
     RIN: 0938–AL67                                                                                                Legal Authority: PL 105-33, Sec 4321
                                                            Act of 2000.
                                                                                                                   of the BBA
                                                            Timetable:
     901. STATE ALLOTMENTS FOR                                                                                     CFR Citation: 42 CFR 482
     PAYMENT OF MEDICARE PART B                             Action                        Date
     PREMIUMS FOR QUALIFYING                                NPRM                      03/07/03 68 FR 11234         Legal Deadline: None
     INDIVIDUALS; FEDERAL FISCAL                            Final Rule                05/00/03                     Abstract: This final rule establishes a
     YEAR 2002 (CMS-2136-FN)                                Regulatory Flexibility Analysis                        process for collecting and maintaining
     Priority: Other Significant. Major under               Required: No                                           information about hospitals referring
     5 USC 801.                                                                                                    Medicare patients to home health
                                                            Small Entities Affected: No
                                                                                                                   agencies (HHAs) with which the
     Legal Authority: Social Security Act,                  Government Levels Affected: None                       hospitals have a financial interest.
     sec 1902(a)(10); Social Security Act, sec
                                                            Agency Contact: Tzvi Hefter,                           Moreover, collected information will be
     1933; 42 USC 139; PL 105-33
                                                            Department of Health and Human                         available to the public to enhance its
     CFR Citation: None                                     Services, Centers for Medicare &                       understanding and awareness of the
     Legal Deadline: None                                   Medicaid Services, C4-07-07, 7500                      availability of Medicare-certified HHAs
                                                            Security Boulevard, Baltimore, MD                      to serve the Medicare population.
     Abstract: This final notice announces
                                                            21244-1850                                             Timetable:
     the Federal FY 2002 allotments that are
                                                            Phone: 410 786-1304
     available for State agencies to pay                                                                           Action                    Date
     Medicare part B premiums for two                       RIN: 0938–AL92
     distinct categories of low-income                                                                             NPRM                    11/22/02 67 FR 70373
     Medicare beneficiaries. The eligible                                                                          Final Action            10/00/03
                                                            903. PROSPECTIVE PAYMENT
     groups are called qualified individuals.               SYSTEM FOR INPATIENT                                   Regulatory Flexibility Analysis
     Timetable:                                             REHABILITATION HOSPITALS FOR FY                        Required: No
     Action                     Date
                                                            2004 (CMS-1474-F)                                      Government Levels Affected: None
                                                            Priority: Substantive, Nonsignificant                  Agency Contact: Elizabeth Carmody,
     Notice                   08/30/02 67 FR 55851
     Final Action             08/00/03                      Legal Authority: Social Security Act,                  Department of Health and Human
                                                            sec 1886(j); PL 105-33; PL 106-554; PL                 Services, Centers for Medicare &
     Regulatory Flexibility Analysis                        106-113                                                Medicaid Services, C4-10-07, 7500
     Required: No
                                                            CFR Citation: 42 CFR 412 to 413                        Security Boulevard, Baltimore, MD
     Small Entities Affected: No                                                                                   21244
                                                            Legal Deadline: None                                   Phone: 410 786-7533
     Government Levels Affected: None
                                                            Abstract: This proposed rule will
     Agency Contact: Robert Nakielny,                                                                              RIN: 0938–AM01
                                                            update rates for the prospective
     Center for Medicaid and State                          payment system for inpatient
     Operations, Department of Health and                   rehabilitation facilities for FY 2004.                 905. UPDATE OF THE LIST OF
     Human Services, Centers for Medicare                                                                          COVERED PROCEDURES FOR
     & Medicaid Services, S2-14-26, 7500                    Timetable:
                                                                                                                   AMBULATORY SURGICAL CENTERS
     Security Boulevard, Baltimore, MD                      Action                        Date                     (CMS-1885-FC)
     21244-1850                                             Final Rule                08/00/03
     Phone: 410 786-4466                                                                                           Priority: Other Significant
                                                            Regulatory Flexibility Analysis
     RIN: 0938–AL79                                         Required: No                                           Legal Authority: 1883(i)(l) and (2) of
                                                                                                                   the Social Security Act
                                                            Small Entities Affected: No
     902. PROSPECTIVE PAYMENT                                                                                      CFR Citation: 42 CFR 416
                                                            Government Levels Affected: None
     SYSTEM FOR LONG-TERM CARE                                                                                     Legal Deadline: None
     HOSPITALS FOR FY 2004 (CMS-1472-                       Agency Contact: Robert Kuhl,
     P)                                                     Department of Health and Human                         Abstract: This final rule makes final
                                                            Services, Centers for Medicare &                       the proposed additions to, and
     Priority: Substantive, Nonsignificant                  Medicaid Services, C4-11-06, 7500                      deletions from, the current list of
     Legal Authority: BBRA 1999, sec 123;                   Security Boulevard, Baltimore, MD                      Medicare covered Ambulatory Surgical
     BIPA 2000, sec 307(b)                                  21244-1850                                             Centers procedures.


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00054   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30267

     HHS—CMS                                                                                                                               Final Rule Stage


     Timetable:                                             Department of Health and Human                         908. TIME LIMITATION ON
     Action                     Date
                                                            Services, Centers for Medicare &                       RECALCULATIONS AND DISPUTES
                                                            Medicaid Services, S3-16-26, 7500                      UNDER THE DRUG REBATE
     Final Action             05/00/03                      Security Boulevard, Baltimore, MD                      PROGRAM (CMS-2175-FC)
     Regulatory Flexibility Analysis                        21244                                                  Priority: Substantive, Nonsignificant.
     Required: No                                           Phone: 410 786-6851                                    Major status under 5 USC 801 is
     Small Entities Affected: Businesses                    RIN: 0938–AM14                                         undetermined.
     Government Levels Affected:                                                                                   Legal Authority: 42 USC 1396r-8
     Undetermined                                           907. BONA FIDE WELLNESS                                CFR Citation: 42 CFR 447.534
     Agency Contact: Bob Cereghino,                         PROGRAMS (CMS-2078-F)                                  Legal Deadline: None
     Department of Health and Human
     Services, Centers for Medicare &                       Priority: Substantive, Nonsignificant.                 Abstract: This rule will establish a
     Medicaid Services, C4-03-06, 7500                      Major status under 5 USC 801 is                        three year time limitation on drug
     Security Boulevard, Baltimore, MD                      undetermined.                                          manufacturer’s requests to recalculate
     21244                                                                                                         their drug prices for the purposes of
                                                            Legal Authority: 42 USC 300gg                          reporting data to CMS, as well as
     Phone: 410 786-4645
                                                            CFR Citation: 45 CFR 146.121(f)                        manufacturer’s ability to dispute claims
     Related RIN: Related To 0938-AH81                                                                             for rebates.
     RIN: 0938–AM02                                         Legal Deadline: None                                   Timetable:
                                                            Abstract: This final rule implements                   Action                    Date
     906. NONDISCRIMINATION IN HEALTH                       and clarifies the term ‘‘bona fide
     COVERAGE IN THE GROUP MARKET                                                                                  Final Rule              08/00/03
                                                            wellness program’’ as it relates to
     (CMS-2022-F)                                           regulations implementing the                           Regulatory Flexibility Analysis
     Priority: Substantive, Nonsignificant.                 nondiscrimination provisions of the                    Required: Yes
     Major status under 5 USC 801 is                        Internal Revenue Code, the Employee                    Small Entities Affected: Businesses
     undetermined.                                          Retirement Income Security Act, and
                                                            the Public Health Service Act, as added                Government Levels Affected: State,
     Legal Authority: 42 USC 300gg                                                                                 Federal
                                                            by the Health Insurance Portability and
     CFR Citation: 45 CFR 146.121                           Accountability Act of 1996.                            Federalism: Undetermined
     Legal Deadline: None                                                                                          Agency Contact: Marge Lee Watchorn,
                                                            Timetable:
     Abstract: This document contains final                                                                        Health Insurance Specialist,
     rules governing the provisions                         Action                        Date                     Department of Health and Human
     prohibiting discrimination based on a                  Interim Final Rule        04/08/97 62 FR 16894         Services, Centers for Medicare &
     health factor for group health plans and               Interim Final Rule        07/07/97                     Medicaid Services, S1-01-16, 7500
     issuers of health insurance coverage                      Comment Period                                      Security Boulevard, Baltimore, MD
     offered in connection with a group                        End                                                 21244
     health plan.                                           Interim Final Rule        07/07/97                     Phone: 410 786-4361
                                                               Effective
     Timetable:                                                                                                    RIN: 0938–AM20
                                                            NPRM                      01/08/01 66 FR 1421
     Action                     Date                        NPRM Comment              04/09/01
     Interim Final Rule       04/08/97 62 FR 16894             Period End                                          909. INPATIENT HOSPITAL
     Interim Final Rule       07/17/97                      Final Action              03/00/04                     DEDUCTIBLE AND HOSPITAL AND
        Comment Period                                                                                             EXTENDED CARE SERVICES
                                                            Regulatory Flexibility Analysis
        End                                                                                                        COINSURANCE AMOUNTS FOR
                                                            Required: Yes
     Interim Final Rule       07/17/97                                                                             CALENDAR YEAR 2004 (CMS-8016-N)
        Effective                                           Small Entities Affected: Businesses,                   Priority: Other Significant
     Interim Final Rule       01/08/01 66 FR 1378           Governmental Jurisdictions
     Interim Final Rule       03/09/01                                                                             Legal Authority: 42 USC 1395e-2(b)(2);
        Effective                                           Government Levels Affected: State,                     Sec 1813(b)(2) of the Social Security
     Interim Final Rule       04/09/01                      Local                                                  Act
        Comment Period
        End                                                 Agency Contact: David Mlawsky,                         CFR Citation: None
     Final Action             03/00/04                      Health Insurance Specialist,                           Legal Deadline: NPRM, Statutory,
     Regulatory Flexibility Analysis                        Department of Health and Human                         September 15, 2003.
     Required: No                                           Services, Centers for Medicare &                       Abstract: This final rule implements a
                                                            Medicaid Services, S3-16-26, 7500                      standard identifier to identify health
     Small Entities Affected: Businesses,                   Security Boulevard, Baltimore, MD
     Governmental Jurisdictions                                                                                    plans that process and pay certain
                                                            21244                                                  electronic health care transactions. It
     Government Levels Affected: State,                     Phone: 410 786-6851                                    implements one of the requirements for
     Local                                                                                                         administrative simplification in section
                                                            Related RIN: Related To 0938-AK91
     Agency Contact: David Mlawsky,                                                                                262 of the Health Insurance Portability
     Health Insurance Specialist,                           RIN: 0938–AM15                                         & Accountability Act of 1996.


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00055   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30268                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                               Final Rule Stage


     Timetable:                                             911. PART A PREMIUMS FOR                               Timetable:
     Action                     Date
                                                            CALENDAR YEAR 2004 FOR THE                             Action                    Date
                                                            UNINSURED AGED AND FOR
     Notice                   10/00/03                      CERTAIN DISABLED INDIVIDUALS                           Final Rule              05/00/03
     Regulatory Flexibility Analysis                        WHO HAVE EXHAUSTED OTHER                               Regulatory Flexibility Analysis
     Required: No                                           ENTITLEMENT (CMS-8018-N)                               Required: Undetermined
                                                            Priority: Other Significant
     Small Entities Affected: No                                                                                   Government Levels Affected:
                                                            Legal Authority: 42 USC 1395i-2(d)(2);                 Undetermined
     Government Levels Affected: None                       42 USC 1395i-2a(d)(2); Sec 1818(d)(2)
     Agency Contact: Clare McFarland,                       of the Social Security Act; Sec                        Federalism: Undetermined
     Deputy Director, Medicare and                          1818A(d)(2) of the Social Security Act
                                                                                                                   Agency Contact: Rebecca Hirshorn,
     Medicaid Cost Estimates Group,                         CFR Citation: None                                     Health Insurance Specialist,
     Department of Health and Human                         Legal Deadline: NPRM, Statutory,                       Department of Health and Human
     Services, Centers for Medicare &                       September 30, 2003.                                    Services, Centers for Medicare &
     Medicaid Services, N3-26-00, 7500                                                                             Medicaid Services, C4-06-06, 7500
     Security Boulevard, Baltimore, MD                      Abstract: This notice announces the
                                                                                                                   Security Boulevard, Baltimore, MD
     21244                                                  hospital insurance premium for
                                                                                                                   21244
     Phone: 410 786-6390                                    calendar year 2004 under Medicare’s
                                                                                                                   Phone: 410 786-3411
                                                            hospital insurance program (part A) for
     RIN: 0938–AM31                                         the uninsured aged and for certain                     Related RIN: Related To 0938-AL23
                                                            disabled individuals who have
                                                            exhausted other entitlement.                           RIN: 0938–AM34
     910. MONTHLY ACTUARIAL RATES
     AND MONTHLY SUPPLEMENTARY                              Timetable:
     MEDICAL INSURANCE PREMIUM                                                                                     913. ∑ APPROVAL OF THE JOINT
                                                            Action                        Date
     RATE BEGINNING JANUARY 1, 2004                                                                                COMMISSION ON ACCREDITATION
     (CMS-8017-N)                                           Notice                    10/00/03                     OF HEALTHCARE ORGANIZATIONS
                                                            Regulatory Flexibility Analysis                        (JCAHO) FOR DEEMING AUTHORITY
     Priority: Other Significant                            Required: No                                           FOR HOSPICES (CMS-2177-FN)
     Legal Authority: 42 CFR 1395r; Social                  Small Entities Affected: No                            Priority: Routine and Frequent
     Security Act, Sec 1839
                                                            Government Levels Affected: None                       Legal Authority: 42 USC 139bb
     CFR Citation: 42 CFR 407; 42 CFR 408                   Agency Contact: Clare McFarland,
                                                                                                                   CFR Citation: None
     Legal Deadline: NPRM, Statutory,                       Deputy Director, Medicare and
     September 30, 2003.                                    Medicaid Cost Estimates Group,                         Legal Deadline: None
                                                            Department of Health and Human
     Abstract: This notice announces the                    Services, Centers for Medicare &                       Abstract: This final notice announces
     monthly actuarial rates for aged (age 65               Medicaid Services, N3-26-00, 7500                      our decision to approve JCAHO for
     and over) and disabled (under age 65)                  Security Boulevard, Baltimore, MD                      continued recognition as a national
     enrollees in the Medicare                              21244                                                  accreditation program for hospices that
     Supplementary Medical Insurance                        Phone: 410 786-6390                                    wish to participate in Medicare.
     (SMI) program for 2004. It also
                                                            RIN: 0938–AM33                                         Timetable:
     announces the monthly SMI premium
     to be paid by all enrollees during 2004.                                                                      Action                    Date

     Timetable:                                             912. APPLICATION OF THE                                NPRM                    01/24/03 68 FR 3532
                                                            EMERGENCY MEDICAL TREATMENT                            NPRM Comment            03/24/03
     Action                     Date                        AND LABOR ACT (EMTALA) (CMS-                             Period End
     Notice                   10/00/03                      1063-F)                                                Final Action            05/00/03
                                                            Priority: Other Significant. Major status              Regulatory Flexibility Analysis
     Regulatory Flexibility Analysis
                                                            under 5 USC 801 is undetermined.                       Required: No
     Required: No
                                                            Unfunded Mandates: Undetermined
     Small Entities Affected: No                                                                                   Small Entities Affected: No
                                                            Legal Authority: Not Yet Determined
     Government Levels Affected: None                                                                              Government Levels Affected: None
                                                            CFR Citation: Not Yet Determined
     Agency Contact: Carter S. Warfield,                    Legal Deadline: None                                   Agency Contact: Cindy Melanson,
     Office of Medicare and Medicaid Cost                                                                          Health Insurance Specialist,
     Estimates, Department of Health and                    Abstract: This regulation will clarify                 Department of Health and Human
     Human Services, Centers for Medicare                   special responsibilities of Medicare                   Services, Centers for Medicare &
     & Medicaid Services, N3-26-00, 7500                    hospitals that offer services for                      Medicaid Services, S2-12-25, 7500
     Security Boulevard, Baltimore, MD                      treatment of emergency medical                         Security Boulevard, Baltimore, MD
     21244                                                  conditions, to promote consistent                      21244
     Phone: 410 786-6396                                    application of the Emergency Medical                   Phone: 410 786-0310
                                                            Treatment and Labor Act to situations
     RIN: 0938–AM32                                         not discussed in current regulations.                  RIN: 0938–AM38


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00056   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30269

     HHS—CMS                                                                                                                               Final Rule Stage


     914. ∑ HOSPITAL COST-TO-CHARGE                         915. ∑ FEE SCHEDULE FOR PAYMENT                        Small Entities Affected: No
     RATIOS USED TO CALCULATE COST                          OF AMBULANCE SERVICES UPDATE                           Government Levels Affected:
     OUTLIER PAYMENTS UNDER THE                             FOR CY 2004 (CMS-1232-N)                               Undetermined
     MEDICARE SHORT-TERM INPATIENT                          Priority: Other Significant                            Agency Contact: Frederick William
     PROSPECTIVE PAYMENT SYSTEM
                                                            Legal Authority: 42 USC 1395m(1)(1)                    Grabau, Health Insurance Specialist,
     (CMS-1243-F)
                                                            CFR Citation: None                                     Department of Health and Human
     Priority: Economically Significant.                                                                           Services, Centers for Medicare &
                                                            Legal Deadline: None                                   Medicaid Services, 7500 Security
     Major under 5 USC 801.
                                                            Abstract: This notice updates the fee                  Boulevard, Baltimore, MD
     Legal Authority: 42 USC 1102 of the                    schedule for ambulance services under                  Phone: 410 786-0206
     Social Security Act; 42 USC 1871 of                    the Medicare program, implementing                     RIN: 0938–AM47
     the Social Security Act                                section 1834(1) of the Social Security
                                                            Act.
     CFR Citation: 42 CFR 412.84; 42 CFR                                                                           917. ∑ HOSPICE WAGE INDEX FOR FY
                                                            Timetable:
     412.116                                                                                                       2004 (CMS-1233-N)
                                                            Action                        Date
     Legal Deadline: None                                                                                          Priority: Routine and Frequent
                                                            Notice                    11/00/03
                                                                                                                   Legal Authority: Not Yet Determined
     Abstract: This proposed rule would                     Regulatory Flexibility Analysis
     change the methodology for                                                                                    CFR Citation: 42 CFR 418.306(C)
                                                            Required: Yes
     determining payments for                                                                                      Legal Deadline: None
                                                            Small Entities Affected: Businesses
     extraordinarily high-cost cases (cost                                                                         Abstract: This notice will announce
     outliers) made to Medicare-                            Government Levels Affected: None
                                                                                                                   the annual update to the hospice wage
     participating hospitals under the acute                Agency Contact: Anne Tayloe, Health                    index. The update is effective October
     care hospital inpatient prospective                    Insurance Speacialist, Department of                   1, 2003, through September 30, 2004.
     payment system. We have become                         Health and Human Services, Centers for                 The wage index is used to reflect local
     aware that, in some cases, hospitals’                  Medicare & Medicaid Services, 7500                     differences in wage levels, the hospice
     recent rates of charge increases greatly               Security Boulevard, Baltimore, MD                      wage index methodology and values are
     exceed their rates of cost increases.                  21244                                                  based on recommendations of a
     This disparity results in their cost-to-               Phone: 410 786-0000                                    negotiated rulemaking advisory
     charge ratios being set too high, which                RIN: 0938–AM44                                         committee and was originally
     in turn results in overestimation of                                                                          published on August 8, 1997.
     their current costs per case. Therefore,                                                                      Timetable:
     we need to make revisions to our                       916. ∑ EXCLUSION OF MEDICARE
     outlier payment methodology to correct                 BENEFITS FOR ALIENS NOT                                Action                    Date
     those situations in which hospitals                    LAWFULLY PRESENT IN THE UNITED                         Notice                  08/00/03
     would otherwise receive overpayments                   STATES (CMS-1222-IFC)
                                                                                                                   Regulatory Flexibility Analysis
     for outlier cases due to excessive charge              Priority: Substantive, Nonsignificant                  Required: No
     increases.                                             Legal Authority: Sec 5561 of BBA
                                                                                                                   Government Levels Affected: None
                                                            1997; Sec 401(b) of the Personal
     Timetable:                                                                                                    Agency Contact: Carol Blackford,
                                                            Responsibility and Work Opportunity
     Action                     Date                        Act of 1996; 42 USC 1611(b)                            Center for Health Plans and Providers,
                                                                                                                   Department of Health and Human
     NPRM                     03/05/03 68 FR 10420          CFR Citation: 42 CFR 411.11
                                                                                                                   Services, Centers for Medicare &
     NPRM Comment             04/04/03                      Legal Deadline: None                                   Medicaid Services, 7500 Security
       Period End                                                                                                  Boulevard, Baltimore, MD 21244
                                                            Abstract: This interim final rule
     Final Action             05/00/03                      amends regulations to prohibit                         Phone: 410 786-5909
                                                            Medicare benefits to an alien who is                   Email: cblackford@hcfa.gov
     Regulatory Flexibility Analysis
     Required: Yes                                          not lawfully present in the United                     RIN: 0938–AM56
                                                            States. Section 5561 of the BBA
     Small Entities Affected: Businesses                    amended section 401(b) of the Personal
                                                            Responsibility and Work Opportunity                    918. ∑ ANNOUNCEMENT OF
     Government Levels Affected: None                       Act of 1996 to prohibit Medicare                       APPLICATIONS FROM HOSPITALS
                                                            payments for services furnished to an                  REQUESTING WAIVERS FOR ORGAN
     Agency Contact: Stephen Phillips,                                                                             PROCUREMENT SERVICE AREAS IN
                                                            alien who is not ‘‘lawfully present in
     Deputy Division Director, Center for                   the United States’’ and meets certain                  CY 2003 (CMS-1246-NC)
     Health Plans and Providers, Department                 other conditions.                                      Priority: Routine and Frequent
     of Health and Human Services, Centers
     for Medicare & Medicaid Services, C4-                  Timetable:                                             Legal Authority: 42 USC 1138(2)(A)
     07-07, 7500 Security Boulevard,                        Action                        Date                     CFR Citation: 42 CFR 486.306
     Baltimore, MD 21244
                                                            Interim Final Rule        09/00/03                     Legal Deadline: None
     Phone: 410 786-4548
                                                            Regulatory Flexibility Analysis                        Abstract: This notice announces three
     RIN: 0938–AM41                                         Required: No                                           applications that we have received from


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00057   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30270                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                               Final Rule Stage


     hospitals requesting waivers from                      determining whether we should grant                    Government Levels Affected: None
     entering into agreements with their                    these waivers.
     designated organ procurement                                                                                  Agency Contact: Mark Horney, CHPP,
                                                            Timetable:                                             Department of Health and Human
     organizations (OPOs), in accordance
     with section 1138(a)(2) of the Social
                                                            Action                        Date                     Services, Centers for Medicare &
     Security Act. This notice requests                     Notice                    11/00/03                     Medicaid Services, 7500 Security
     comments from OPOs and the general                                                                            Boulevard, Baltimore, MD 21244
                                                            Regulatory Flexibility Analysis
     public for our consideration in                                                                               Phone: 410 786-4554
                                                            Required: No
                                                            Small Entities Affected: No                            RIN: 0938–AM59


     Department of Health and Human Services (HHS)                                                                                       Long-Term Actions
     Centers for Medicare & Medicaid Services (CMS)

     919. REQUIREMENTS FOR                                  Legal Deadline: None                                   and its components. It imposes several
     ESTABLISHING AND MAINTAINING                           Abstract: This rule adopts the 2000                    requirements that are designed to
     MEDICARE BILLING PRIVILEGES                            edition of the National Fire Protection                increase patient safety and track the
     (CMS-6002-P)                                           Association’s Life Safety Code as the                  methodologies, and/or programs or
     Priority: Other Significant                            fire standards for Religious Non-                      both, used to increase patient safety.
                                                            Medical Health Care Institutions,                      The final rule requires a hospital in
     Legal Authority: 42 USC 1302; 42 USC
                                                            Ambulatory Surgery Centers, Hospices                   collaboration with CMS and other
     1395hh
                                                            that provide in-patient services,                      Federal agencies, the Peer Review
     CFR Citation: 42 CFR 424                               Programs of All-Inclusive Care for the                 Organizations (PROs), State survey
     Legal Deadline: None                                   Elderly (PACE), Hospitals, Long-Term                   agencies, and accrediting bodies to
     Abstract: This proposed regulation is                  Care Facilities, Critical Access                       ensure that it is involved in a QAPI
     needed as part of the Administration’s                 Hospitals, and Intermediate Care                       program that will track and exhibit
     anti-fraud and abuse efforts. It would                 Facilities for the Mentally Retarded.                  activities that address all issues related
     give us the authority to enroll and                    Timetable:                                             to patient safety and medical errors. In
     reenroll providers, with time frames for                                                                      addition, hospitals must work with
                                                            Action                        Date
     re-enrollment.                                                                                                these groups to identify errors and
                                                            NPRM                 10/26/01 66 FR 54179              potential errors that may affect patient
     Timetable:                                             Final Action         01/10/03 68 FR 1374               outcomes.
     Action                     Date                        Next Action Undetermined
                                                                                                                   Timetable:
     NPRM                 04/25/03 68 FR 22064              Regulatory Flexibility Analysis
     Next Action Undetermined                               Required: No                                           Action                    Date
     Regulatory Flexibility Analysis                        Small Entities Affected: Businesses                    NPRM                 12/19/97 62 FR 66725
     Required: No                                           Government Levels Affected: None                       NPRM Comment         02/17/98
     Small Entities Affected: Businesses                                                                             Period End
                                                            Agency Contact: Danielle Shearer,
                                                                                                                   Final Rule           01/24/03 68 FR 3435
     Government Levels Affected: None                       Health Insurance Specialist,
                                                                                                                   Next Action Undetermined
     Additional Information: Formerly                       Department of Health and Human
     known as HCFA-1023-P                                   Services, Centers for Medicare &                       Regulatory Flexibility Analysis
                                                            Medicaid Services, 7500 Security                       Required: Yes
     Agency Contact: Michael Collett, OFM,                  Boulevard, Baltimore, MD 21244
     Department of Health and Human                         Phone: 410 786-6617                                    Small Entities Affected: Businesses
     Services, Centers for Medicare &
     Medicaid Services, 7500 Security                       RIN: 0938–AK35                                         Government Levels Affected: State
     Boulevard, Baltimore, MD 21244
     Phone: 410 786-6121                                    921. HOSPITAL CONDITIONS OF                            Agency Contact: Nancy Archer, Office
                                                            PARTICIPATION: QUALITY                                 of Clinical Standards and Quality,
     RIN: 0938–AH73
                                                            ASSESSMENT AND PERFORMANCE                             Department of Health and Human
                                                            IMPROVEMENTS (QAPI) (CMS-3050-F)                       Services, Centers for Medicare &
     920. FIRE SAFETY REQUIREMENTS                                                                                 Medicaid Services, S3-05-27, 7500
     FOR CERTAIN HEALTH CARE                                Priority: Other Significant                            Security Boulevard, Baltimore, MD
     FACILITIES (CMS-3047-F)                                Legal Authority: 42 USC 1302; 42 USC                   21244-1850
     Priority: Other Significant                            1395hh                                                 Phone: 401 786-0596
     Legal Authority: 42 USC 1302; 42 USC                   CFR Citation: 42 CFR 482.21
                                                                                                                   RIN: 0938–AK40
     1395hh                                                 Legal Deadline: None
     CFR Citation: 42 CFR 403; 42 CFR 416;                  Abstract: This final rule addresses
     42 CFR 418; 42 CFR 460; 42 CFR 482;                    provisions relating to the development
     42 CFR 483                                             and implementation of a QAPI program


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00058   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30271

     HHS—CMS                                                                                                                             Long-Term Actions


     922. CHANGES TO THE HOSPITAL                           Abstract: This notice corrects an error                Action                 Date
     OUTPATIENT PROSPECTIVE                                 that appeared in the Outpatient PPS                    Correction Notice    02/10/03 68 FR 6636
     PAYMENT SYSTEM AND CALENDAR                            final rule with comment period                         Next Action Undetermined
     YEAR 2003 PAYMENT RATES;                               published on November 1, 2002 (67 FR                   Regulatory Flexibility Analysis
     CHANGES TO PAYMENT                                     66719). This notice is a supplement to                 Required: Yes
     SUSPENSION FOR UNFILED COST                            that rule and sets forth our rationale
                                                                                                                   Small Entities Affected: Businesses
     REPORTS; CORRECTION TO FINAL                           for waiving the notice and comment
     RULE (CMS-1206-CN2)                                    period for certain provisions.                         Government Levels Affected: Federal

                                                            Timetable:                                             Agency Contact: Cindy Read,
     Priority: Other Significant. Major under                                                                      Department of Health and Human
     5 USC 801.                                             Action                        Date                     Services, Centers for Medicare &
     Legal Authority: 42 USC 1395(L); BBA                                                                          Medicaid Services, 7500 Security
                                                            Notice                    03/18/02    67 FR 11969
     ‘97; BBRA ‘99; BIPA ‘00                                                                                       Boulevard, Baltimore, MD 21244
                                                            Proposed Rule             08/09/02    67 FR 52092
                                                                                                                   Phone: 410 786-1852
                                                            Comment Period End        10/07/02
     CFR Citation: 42 CFR 405; 42 CFR 419                                                                          Related RIN: Related To 0938-AK59
                                                            Final Action              11/01/02    67 FR 66718
     Legal Deadline: None                                   Correction Notice         11/15/02    67 FR 69146      RIN: 0938–AL19


     Department of Health and Human Services (HHS)                                                                                       Completed Actions
     Centers for Medicare & Medicaid Services (CMS)

     923. SECURITY STANDARDS (CMS-                          925. IMPROVEMENTS TO THE                               927. MEDICAID MANAGED CARE;
     0049-F)                                                MEDICARE+CHOICE APPEALS AND                            NEW PROVISIONS (CMS-2104-F2)
     Priority: Other Significant. Major under               GRIEVANCE PROCEDURES (CMS-                             Priority: Info./Admin./Other
     5 USC 801.                                             4024-FC)
                                                                                                                   CFR Citation: 42 CFR 400
     CFR Citation: 45 CFR 162                               Priority: Other Significant
                                                                                                                   Completed:
     Completed:                                             CFR Citation: 42 CFR 422; 42 CFR 489
                                                                                                                   Reason                    Date
     Reason                     Date                        Completed:                                             Correction Notice       10/25/02 67 FR 65504
     Final Rule               02/20/03 68 FR 8334           Reason                        Date                     Regulatory Flexibility Analysis
     Regulatory Flexibility Analysis                        Final Rule                04/16/03 68 FR 16652         Required: No
     Required: Yes                                                                                                 Government Levels Affected: None
                                                            Regulatory Flexibility Analysis
     Government Levels Affected: State,                     Required: Yes                                          Agency Contact: Bruce Johnson
     Local, Tribal, Federal                                                                                        Phone: 410 786-0615
                                                            Government Levels Affected: None
     Agency Contact: Barbara Clark
     Phone: 410 786-3017                                    Agency Contact: Chrislyn Gayhead                       Deirdre Duzor
                                                            Phone: 410 786-6429                                    Phone: 410 786-4626
     RIN: 0938–AI57
                                                            RIN: 0938–AK48                                         RIN: 0938–AK96
     924. EXTERNAL QUALITY REVIEW OF
     MEDICAID MANAGED CARE                                  926. HEALTH INSURANCE REFORM:                          928. REVISIONS TO PAYMENT
     ORGANIZATIONS (CMS-2015-F)                             MODIFICATIONS TO STANDARDS                             POLICIES UNDER THE PHYSICIAN
                                                            FOR ELECTRONIC TRANSACTIONS                            FEE SCHEDULE FOR CALENDAR
     Priority: Other Significant
                                                            (CMS-0003-FC)                                          YEAR 2003 (CMS-1204-F2)
     CFR Citation: 42 CFR 438
                                                                                                                   Priority: Other Significant. Major under
     Completed:                                             Priority: Other Significant
                                                                                                                   5 USC 801.
     Reason                     Date                        CFR Citation: 45 CFR 162                               CFR Citation: 42 CFR 410; 42 CFR 414
     Final Rule               01/24/03 68 FR 3586           Completed:                                             Completed:
     Regulatory Flexibility Analysis                        Reason                        Date                     Reason                    Date
     Required: No                                           Final Action              02/20/03 68 FR 8381          Notice                  11/05/02 67 FR 67318
     Government Levels Affected: State                                                                             Final Rule with         12/31/02 67 FR 79966
                                                            Regulatory Flexibility Analysis
                                                                                                                     Comment Period
     Federalism: This action may have                       Required: No
                                                                                                                   Final Action            02/28/03 68 FR 9567
     federalism implications as defined in
     EO 13132.                                              Government Levels Affected: None                       Regulatory Flexibility Analysis
     Agency Contact: Sharon Gilles                          Agency Contact: Gladys Wheeler                         Required: Yes
     Phone: 410 786-1177                                    Phone: 410 786-0273                                    Government Levels Affected: Federal
     RIN: 0938–AJ06                                         RIN: 0938–AK64                                         Agency Contact: Marc Hartstein


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00059   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30272                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                             Completed Actions


     Phone: 410 786-4539                                    Phone: 410 786-6390                                    Phone: 410 786-4620
     RIN: 0938–AL21                                         RIN: 0938–AL69                                         Related RIN: Related To 0938-AL29
                                                                                                                   RIN: 0938–AM21
     929. INPATIENT HOSPITAL                                932. FEE SCHEDULE FOR PAYMENT
     DEDUCTIBLE AND HOSPITAL AND                            OF AMBULANCE SERVICES—UPDATE
                                                                                                                   935. ∑ ANNOUNCEMENT OF
     EXTENDED CARE SERVICES                                 FOR CY 2003 (CMS-1220-N)
                                                                                                                   APPLICATIONS FROM HOSPITALS
     COINSURANCE AMOUNTS FOR
                                                            Priority: Other Significant                            REQUESTING WAIVERS FOR ORGAN
     CALENDAR YEAR 2003 (CMS-8013-N)
                                                            CFR Citation: None                                     PROCUREMENT SERVICE AREAS CY
     Priority: Other Significant                                                                                   2002 (CMS-1241-NC)
     CFR Citation: None                                     Completed:
                                                                                                                   Priority: Substantive, Nonsignificant
     Completed:                                             Reason                        Date
                                                                                                                   Legal Authority: 42 USC 1138(2)(A)
     Reason                     Date                        Notice                    11/22/02 67 FR 70442
                                                                                                                   CFR Citation: 42 CFR 486.306
     Notice                   10/21/02 67 FR 64641          Regulatory Flexibility Analysis
                                                            Required: Yes                                          Legal Deadline: None
     Regulatory Flexibility Analysis
                                                            Government Levels Affected: None                       Abstract: This notice announces three
     Required: No
                                                                                                                   applications that we have received from
     Government Levels Affected: None                       Agency Contact: Robert Niemann                         hospitals requesting waivers from
                                                            Phone: 410 786-4569                                    entering into agreements with their
     Agency Contact: Clare McFarland
     Phone: 410 786-6390                                    RIN: 0938–AL97                                         designated organ procurement
                                                                                                                   organizations (OPOs), in accordance
     RIN: 0938–AL56                                                                                                with section 1138(a)(2) of the Social
                                                            933. TICKET TO WORK MEDICAID                           Security Act. This notice requests
                                                            INFRASTRUCTURE GRANT (CMS-                             comments from OPOs and the general
     930. MONTHLY ACTUARIAL RATES                           2165-N)
     AND MONTHLY SUPPLEMENTARY                                                                                     public for our consideration in
     MEDICAL INSURANCE PREMIUM                              Priority: Routine and Frequent                         determining whether we should grant
     RATE BEGINNING JANUARY 1, 2003                                                                                these waivers.
                                                            CFR Citation: None
     (CMS-8014-N)                                                                                                  Timetable:
                                                            Completed:
     Priority: Economically Significant                                                                            Action                    Date
                                                            Reason                        Date
     CFR Citation: None                                                                                            Notice                  11/22/02 67 FR 70435
                                                            Notice                    02/28/03 68 FR 9672
     Completed:                                                                                                    Regulatory Flexibility Analysis
                                                            Regulatory Flexibility Analysis
     Reason                     Date                        Required: No                                           Required: No
     Notice                   10/21/02 67 FR 64643
                                                            Government Levels Affected: None                       Small Entities Affected: No
     Regulatory Flexibility Analysis                                                                               Government Levels Affected: None
                                                            Agency Contact: Joe A Razes
     Required: No
                                                            Phone: 410 786-6126                                    Agency Contact: Mark Horney, CHPP,
     Government Levels Affected: None                       Email: jrazes@cms.hhs.gov                              Department of Health and Human
     Agency Contact: Carter S. Warfield                     RIN: 0938–AM11                                         Services, Centers for Medicare &
     Phone: 410 786-6396                                                                                           Medicaid Services, 7500 Security
                                                                                                                   Boulevard, Baltimore, MD 21244
     RIN: 0938–AL63                                         934. PHYSICIANS’ REFERRALS TO                          Phone: 410 786-4554
                                                            HEALTH CARE ENTITIES WITH WHICH
                                                            THEY HAVE FINANCIAL                                    RIN: 0938–AM37
     931. PART A PREMIUMS FOR
     CALENDAR YEAR 2003 FOR THE                             RELATIONSHIPS; EXTENSION OF
     UNINSURED AGED AND FOR                                 PARTIAL DELAY OF EFFECTIVE DATE                        936. ∑ GRANTS TO STATES FOR
     CERTAIN DISABLED INDIVIDUALS                           OF THE ‘‘SET IN ADVANCE’’                              OPERATION OF QUALIFIED HIGH
     WHO HAVE EXHAUSTED OTHER                               PROVISION (CMS-1809-F2)                                RISK POOLS (CMS-2179-FC)
     ENTITLEMENT (CMS-8015-N)                               Priority: Other Significant                            Priority: Other Significant
     Priority: Other Significant                            CFR Citation: 42 CFR 411.354                           Legal Authority: PL 107-210
     CFR Citation: None                                     Completed:                                             CFR Citation: 45 CFR 148
     Completed:                                             Reason                        Date                     Legal Deadline: None
     Reason                     Date                        Final Action              11/22/02 67 FR 70322         Abstract: This final rule with comment
     Notice                   10/21/02 67 FR 64649          Final Action Effective    11/22/02                     period announces a grant program to
     Regulatory Flexibility Analysis                        Regulatory Flexibility Analysis                        provide $40 million for FY 2003 and
     Required: No                                           Required: No                                           $40 million for FY 2004 to Sates that
                                                                                                                   have qualified high risk pools under
     Government Levels Affected: None                       Government Levels Affected: None                       the Trade Adjustment Assistance
     Agency Contact: Clare McFarland                        Agency Contact: Joanne Sinsheimer                      Reform Act of 2002.


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00060   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30273

     HHS—CMS                                                                                                                             Completed Actions


     Timetable:                                             938. ∑ PHYSICIANS’ REFERRALS TO                        Timetable:
     Action                     Date                        HEALTH CARE ENTITIES WITH WHICH                        Action                    Date
                                                            THEY HAVE FINANCIAL
     Final Action             05/02/03 68 FR 23410          RELATIONSHIPS; SECOND                                  Notice                  04/16/03 68 FR 18654
     Regulatory Flexibility Analysis                        EXTENSION OF DELAY OF                                  Regulatory Flexibility Analysis
     Required: No                                           EFFECTIVE DATE OF THE ‘‘SET IN                         Required: No
     Government Levels Affected: State                      ADVANCE’’ PROVISION (CMS-1809-F3)
                                                                                                                   Government Levels Affected: None
     Federalism: This action may have                       Priority: Other Significant                            Agency Contact: Robert Niemann,
     federalism implications as defined in                  Legal Authority: 42 USC 1302; 42 USC                   Department of Health and Human
     EO 13132.                                              1395hh; 42 USC 1395nn                                  Services, Centers for Medicare &
     Agency Contact: James Mayhew,                                                                                 Medicaid Services, 7500 Security
     Health Insurance Specialist,                           CFR Citation: 42 CFR 411.354                           Boulevard, Baltimore, MD 21244
     Department of Health and Human                         Legal Deadline: None                                   Phone: 410 786-4569
     Services, Centers for Medicare &                                                                              RIN: 0938–AM60
     Medicaid Services, S3-16-26, 7500                      Abstract: This final rule temporarily
     Security Boulevard, Baltimore, MD                      delays for an additional six months or
     Phone: 410 786-9244                                    until publication of phase II the                      940. ∑ CIVIL MONEY PENALTIES:
                                                            effective date of the ‘‘set in advance’’               PROCEDURES FOR INVESTIGATIONS,
     RIN: 0938–AM42                                         provision in section 411.354(d)(1)                     IMPOSITION OF PENALTIES, AND
                                                            contained in the rule entitled                         HEARINGS (CMS-0010-IFC)
     937. ∑ PROSPECTIVE PAYMENT                             ‘‘Medicare and Medicaid Programs;
                                                                                                                   Priority: Other Significant
     SYSTEM FOR LONG-TERM CARE                              Physicians’ Referrals to Health Care
     HOSPITALS: IMPLEMENTATION AND                          Entities With Which They Have                          Legal Authority: 42 USC 1302(a); 42
     FY 2003 RATES; CORRECTING                              Financial Relationships,’’ published in                USC 1320(d)(5)
     AMENDMENT (CMS-1177-F2)                                the Federal Register on January 4, 2001                CFR Citation: 45 CFR 160
     Priority: Substantive, Nonsignificant                  (66 FR 856).
                                                                                                                   Legal Deadline: None
     Legal Authority: None                                  Timetable:                                             Abstract: This interim final rule
     CFR Citation: 42 CFR 442.22                            Action                        Date                     establishes rules of procedures for the
                                                                                                                   imposition, by the Secretary of Health
     Legal Deadline: None                                   Final Action              04/25/03 68 FR 20347
                                                                                                                   and Human Services, of civil money
     Abstract: This correcting amendment                    Regulatory Flexibility Analysis                        penalties on entities that violate
     corrects citation in the regulation text               Required: No                                           standards adopted by the Secretary
     of the August 2002 final rule                                                                                 under the Administrative
     concerning satellite facilities. It will               Small Entities Affected: Businesses
                                                                                                                   Simplification provisions of the Health
     revise section 412.22(h)(3)(ii) so that                Government Levels Affected: None                       Insurance Portability and
     the section will cite 412.23(e)(2)(ii)                                                                        Accountability Act of 1996 (HIPAA).
     instead of 412.23(e)(2).                               Agency Contact: Karen Raschke,
                                                                                                                   We intend that this be the first
                                                            Health Insurance Specalist, Department
     Timetable:                                                                                                    installment of a rule that we term the
                                                            of Health and Human Services, Centers
                                                                                                                   ‘‘Enforcement Rule.’’ The Enforcement
     Action                     Date                        for Medicare & Medicaid Services, 7500
                                                                                                                   Rule, when issued in complete form,
     Final Rule               03/07/03 68 FR 10987          Security Boulevard, Baltimore, MD
                                                                                                                   will set forth procedural and
                                                            21244
     Regulatory Flexibility Analysis                                                                               substantive requirements for imposition
                                                            Phone: 410 786-0016
     Required: No                                                                                                  of civil money penalties. In the interim,
                                                            Related RIN: Related To 0938-AM21                      we are issuing these rules of procedure
     Small Entities Affected: No
                                                                                                                   to inform regulated entities of our
     Government Levels Affected: Federal                    RIN: 0938–AM58
                                                                                                                   approach to enforcement and to advise
     Agency Contact: Judith H. Richter,                                                                            regulated entities of certain procedures
     Department of Health and Human                         939. ∑ AMBULANCE FEE SCHEDULE                          that will be followed as we enforce the
     Services, Centers for Medicare &                       (CMS-1256-N)                                           HIPAA Administrative Simplification
     Medicaid Services, C4-07-07, 7500                                                                             standards (HIPAA standards).
                                                            Priority: Other Significant
     Security Boulevard, Baltimore, MD                                                                             Timetable:
     21244                                                  Legal Authority: None
     Phone: 410 786-2590                                                                                           Action                    Date
                                                            CFR Citation: None
                                                                                                                   Interim Final Rule      04/17/03 68 FR 18895
     Tzvi Hefter, Department of Health and                  Legal Deadline: None                                   Regulatory Flexibility Analysis
     Human Services, Centers for Medicare
                                                            Abstract: The purpose of this notice is                Required: No
     & Medicaid Services, C4-07-07, 7500
     Security Boulevard, Baltimore, MD                      to implement a Federal court order                     Small Entities Affected: No
     21244-1850                                             requiring the retroactive
                                                            implementation of the Ambulance Fee                    Government Levels Affected: None
     Phone: 410 786-1304
                                                            Schedule to be established by the                      Agency Contact: Marilou King,
     Related RIN: Related To 0938-AK69                      statutory effective date of January 1,                 Attorney, Department of Health and
     RIN: 0938–AM49                                         2000.                                                  Human Services, Centers for Medicare


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00061   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
     30274                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—CMS                                                                                                                             Completed Actions


     & Medicaid Services, 7500 Security                     Email: marilou.king@hhs.gov
     Boulevard, Baltimore, MD 21244                         RIN: 0938–AM63
     Phone: 202 260-1486


     Department of Health and Human Services (HHS)                                                                                  Proposed Rule Stage
     Administration for Children and Families (ACF)

     941. SAFEGUARDING CHILD                                Phone: 202 401-5369                                    Abstract: This proposed rule will
     SUPPORT AND EXPANDED FEDERAL                           TDD Phone: 800 877-8339                                revise existing regulations on
     PARENT LOCATOR SERVICES (FPLS)                         Fax: 202 401-4054                                      expenditures for which Federal
     INFORMATION                                            Email: ebrooks@acf.hhs.gov                             Financial Participation is available
     Priority: Substantive, Nonsignificant                  RIN: 0970–AC01                                         under the Child Support Enforcement
                                                                                                                   program. Under the current regulations,
     Legal Authority: 42 USC 652 to 654A;                                                                          Federal Financial Participation is not
     42 USC 663; 42 USC 1302                                942. DEVELOPMENTAL DISABILITIES                        available in any costs of caseworkers
     CFR Citation: 45 CFR 303.3; 45 CFR                     AND BILL OF RIGHTS ACT                                 who are also performing the assistance
     303.21; 45 CFR 303.70                                  Priority: Substantive, Nonsignificant                  payments or social services functions
                                                                                                                   under title IV-A (TANF) or title XX
     Legal Deadline: None                                   Legal Authority: PL 106-402; USC                       (Social Services Block Grants) of the
     Abstract: The Personal Responsibility                  15001 et seq                                           Social Security Act. This proposed
     and Work Opportunity Reconciliation                    CFR Citation: 45 CFR 1385 to 1388                      regulation will remove the prohibition
     Act of 1996 made far-reaching                                                                                 to reflect current business practices of
     amendments to title IV-D of the Social                 Legal Deadline: Final, Statutory,
                                                                                                                   the Department of Health and Human
     Security Act, which governs the child                  October 30, 2001.
                                                                                                                   Services under which costs are
     support enforcement program. The                       Abstract: A notice of proposed                         allocated to the benefiting program.
     Balanced Budget Act of 1997, the                       rulemaking will be published in the
                                                                                                                   Timetable:
     Adoption and Safe Families Act of                      Federal Register to amend current
     1997, and the Child Support                            regulations and to implement changes                   Action                    Date
     Performance and Incentive Act of 1998                  made by the Developmental Disabilities                 NPRM                    12/00/03
     further amended title IV-D. A                          Assistance and Bill of Rights Act of
     significant result of this legislation is              2000.                                                  Regulatory Flexibility Analysis
     an expansion in the scope of                                                                                  Required: No
                                                            Timetable:
     information available to State IV-D                                                                           Small Entities Affected: No
     child support enforcement agencies.                    Action                        Date
                                                                                                                   Government Levels Affected: State
     The legislation has rendered obsolete or               NPRM                      12/00/03
     inconsistent several regulations at 45                                                                        Agency Contact: Sheck Chin, Special
     CFR chapter III, Office of Child Support               Regulatory Flexibility Analysis                        Assistant to the Division Director,
     Enforcement, including the regulations                 Required: No                                           Department of Health and Human
     on the Federal Parent Locator Service,                 Small Entities Affected: Governmental                  Services, Administration for Children
     the State Parent Locator Services, offset              Jurisdictions, Organizations                           and Families, 4th Floor East, 370
     of Federal payments for purposes of                                                                           L’Enfant Promenade SW., Washington,
                                                            Government Levels Affected: State,                     DC 20447
     collecting child support, and                          Local, Tribal
     safeguarding of information. This                                                                             Phone: 202 260-5830
     regulation would update various                        Agency Contact: Elsbeth Wyatt,                         TDD Phone: 800 877-8339
     sections in 45 CFR chapter III to reflect              Program Specialist, Department of                      Fax: 202 401-4054
     the statutory changes.                                 Health and Human Services,                             Email: schin@acf.hhs.gov
                                                            Administration for Children and                        RIN: 0970–AC11
     Timetable:                                             Families, ADD HHH-300F, 370 L’Enfant
     Action                     Date                        Promenade SW., Washington, DC 20447
                                                            Phone: 202 690-5841                                    944. ∑ ADMINISTRATIVE COSTS FOR
     NPRM                     12/00/03                                                                             CHILDREN IN TITLE IV-E FOSTER
     Regulatory Flexibility Analysis                        RIN: 0970–AC07                                         CARE
     Required: No                                                                                                  Priority: Substantive, Nonsignificant
     Government Levels Affected: State,                     943. CHILD SUPPORT ENFORCEMENT
                                                                                                                   Legal Authority: 42 USC 672; 42 USC
     Local, Tribal                                          PROGRAM; EXPENDITURES FOR
                                                                                                                   674; 42 USC 1302
                                                            CASEWORKER COSTS
     Agency Contact: Eileen C. Brooks,                                                                             CFR Citation: 45 CFR 1356.60(c)
     Deputy Director, Policy Division,                      Priority: Substantive, Nonsignificant
     Department of Health and Human                                                                                Legal Deadline: None
                                                            Legal Authority: 42 USC 1302; 42 USC
     Services, Administration for Children                  655                                                    Abstract: This notice of proposed
     and Families, 4th Floor East, OCSE,                                                                           rulemaking implements the title IV-E
     DPP, 370 L’Enfant Promenade SW.,                       CFR Citation: 45 CFR 304.23                            foster care eligibility and administrative
     Washington, DC 20447                                   Legal Deadline: None                                   cost provisions in sections 472 and 474


VerDate May<05>2003   14:02 May 20, 2003   Jkt 200001   PO 00000   Frm 00062   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                    30275

     HHS—ACF                                                                                                                            Proposed Rule Stage


     of the Social Security Act. We propose                 exception of the month prior to a                      Government Levels Affected: State
     to prohibit the reimbursement of                       child’s transition into an allowable                   Agency Contact: Kathleen McHugh,
     administrative costs claimed on behalf                 facility.                                              Divison Director, Children’s Bureau
     of children in unlicensed foster family                                                                       Policy, Department of Health and
                                                            Timetable:
     homes, with the exception of children                                                                         Human Services, Administration for
     in relative foster family homes while                  Action                        Date                     Children and Families, Room 2411, 330
     the State is in the process of licensing               NPRM                      12/00/03                     C Street SW., Washington, DC 20447
     the home. We also propose to prohibit                                                                         Phone: 202 401-5789
     the reimbursement of administrative                    Regulatory Flexibility Analysis                        Fax: 202 205-8221
     costs claimed on behalf of children in                 Required: No                                           Email: kmchugh@acf.hhs.gov
     unallowable facilities, with the                       Small Entities Affected: No                            RIN: 0970–AC14


     Department of Health and Human Services (HHS)                                                                                           Final Rule Stage
     Administration for Children and Families (ACF)

     945. CONSTRUCTION AND MAJOR                            Legal Deadline: None                                   Reconciliation Act of 1996, and its
     RENOVATION OF HEAD START AND                           Abstract: This rule specifies how tribes               technical amendments, the Balanced
     EARLY HEAD START FACILITIES                            can obtain direct payments from the                    Budget Act of 1997, the Adoption and
     Priority: Other Significant                            Department of Health and Human                         Safe Families Act of 1997, and the
                                                            Services for provision of child support                Child Support Performance and
     Legal Authority: 42 USC 9801 et seq                                                                           Incentive Act of 1998.
                                                            enforcement services if they submit a
     CFR Citation: 45 CFR 1309                              plan meeting the objectives of title IV-               Timetable:
     Legal Deadline: None                                   D, including establishment of paternity,               Action                     Date
     Abstract: This rule establishes                        modification and enforcement of
                                                            support orders, and location of absent                 Interim Final Rule       02/09/99 64 FR 6237
     procedures to be used by Head Start
                                                            parents.                                               Final Action             05/00/03
     and Early Head Start agencies in
     requesting to use Head Start grant                     Timetable:                                             Regulatory Flexibility Analysis
     funds to construct or perform major                                                                           Required: No
                                                            Action                        Date
     renovation on a Head Start or Early                                                                           Government Levels Affected: State
     Head Start Facility.                                   NPRM                      08/21/00 65 FR 50800
                                                                                                                   Agency Contact: Eileen C. Brooks,
     Timetable:                                             Final Action              09/00/03
                                                                                                                   Deputy Director, Policy Division,
     Action                     Date                        Regulatory Flexibility Analysis                        Department of Health and Human
                                                            Required: No                                           Services, Administration for Children
     NPRM                     02/08/99 64 FR 6013
                                                            Government Levels Affected: State,                     and Families, 4th Floor East, OCSE,
     NPRM Comment             04/09/99
                                                            Tribal                                                 DPP, 370 L’Enfant Promenade SW.,
       Period End
                                                                                                                   Washington, DC 20447
     Final Action             05/00/03                      Agency Contact: Paige Biava, Division                  Phone: 202 401-5369
     Regulatory Flexibility Analysis                        of Policy and Planning, Department of                  TDD Phone: 800 877-8339
     Required: No                                           Health and Human Services,                             Fax: 202 401-4054
                                                            Administration for Children and                        Email: ebrooks@acf.hhs.gov
     Small Entities Affected: Governmental
                                                            Families, Office of Child Support
     Jurisdictions, Organizations                                                                                  RIN: 0970–AB81
                                                            Enforcement, 370 L’Enfant Promenade
     Government Levels Affected: Local,                     SW., Washington, DC 20447
     Tribal                                                 Phone: 202 401-9386                                    948. TECHNICAL REVISION OF HEAD
     Agency Contact: Douglas Klafehn,                       RIN: 0970–AB73                                         START REGULATIONS TO MAKE
     Deputy Associate Commissioner, Head                                                                           THEM CONFORM TO RECENT
     Start, Department of Health and Human                                                                         STATUTORY REVISIONS
     Services, Administration for Children                  947. CHILD SUPPORT ENFORCEMENT
                                                            PROGRAM OMNIBUS CONFORMING                             Priority: Substantive, Nonsignificant
     and Families, 330 C Street SW.,
     Washington, DC 20447                                   REGULATION                                             Legal Authority: 42 USC 9801 et seq
     Phone: 202 205-8569                                    Priority: Substantive, Nonsignificant                  CFR Citation: 45 CFR 1301 to 1303;
     Email: dklafehn@acf.dhhs.gov                                                                                  45 CFR 1305; 45 CFR 1308
                                                            Legal Authority: 42 USC 1302
     RIN: 0970–AB54                                                                                                Legal Deadline: None
                                                            CFR Citation: 45 CFR 301 to 305
                                                                                                                   Abstract: This rule will make technical
     946. CHILD SUPPORT ENFORCEMENT                         Legal Deadline: None                                   changes and conforming amendments
     FOR INDIAN TRIBES                                      Abstract: This rule eliminates child                   to make the wording of the regulations
     Priority: Other Significant                            support enforcement program                            consistent with amended provisions of
                                                            regulations rendered obsolete or                       the Head Start Act, eliminate obsolete
     Legal Authority: 42 USC 655(f)                         inconsistent with the Personal                         references, and make other necessary
     CFR Citation: 45 CFR 309                               Responsibility and Work Opportunity                    technical changes to the regulations.


VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00063   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT    apps41   PsN: UA030408
     30276                  Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda

     HHS—ACF                                                                                                                               Final Rule Stage


     Timetable:                                             Email: ebrooks@acf.hhs.gov                             951. ∑ COMMUNITY SERVICES BLOCK
     Action                     Date
                                                                                                                   GRANT CHARITABLE CHOICE
                                                            RIN: 0970–AC09
     Interim Final Rule       09/00/03
                                                                                                                   Priority: Substantive, Nonsignificant

     Regulatory Flexibility Analysis                                                                               Legal Authority: 42 USC 9901, sec 672
                                                            950. ∑ CHARITABLE CHOICE                               of PL 105-285; 42 USC 9902, sec 673
     Required: No                                           PROVISIONS APPLICABLE TO THE                           of PL 105-285
     Small Entities Affected: Businesses,                   TEMPORARY ASSISTANCE FOR
                                                            NEEDY FAMILIES PROGRAM                                 CFR Citation: 45 CFR 1050
     Governmental Jurisdictions,
     Organizations                                                                                                 Legal Deadline: None
                                                            Priority: Other Significant
     Government Levels Affected: None                                                                              Abstract: This proposed rule would
                                                            Legal Authority: 42 USC 1302; 42 USC                   implement the Charitable Choice
     Agency Contact: Douglas Klafehn,                       604(a)                                                 statutory provisions at section 679 of
     Deputy Associate Commissioner, Head
                                                                                                                   the Community Services Block Grant
     Start, Department of Health and Human                  CFR Citation: 45 CFR 260.30; 45 CFR                    Act (CSBG Act). These provisions apply
     Services, Administration for Children                  260.34                                                 to programs authorized under the Act,
     and Families, 330 C Street SW.,
                                                            Legal Deadline: None                                   including the Community Services
     Washington, DC 20447
                                                                                                                   Block grant program, Training,
     Phone: 202 205-8569
                                                            Abstract: The proposed rule would                      Technical Assistance and Capacity
     Email: dklafehn@acf.dhhs.gov
                                                            implement the Charitable Choice                        Building program, Community Food
     RIN: 0970–AC00                                         statutory provisions at section 104 of                 and Nutrition Program, National Youth
                                                            the Personal Responsibility and Work                   Sports program, and discretionary
                                                            Opportunity Reconciliation Act of 1996                 grants for economic development, rural
     949. CHILD SUPPORT ENFORCEMENT
                                                            (PRWORA) as amended. It is the policy                  community development, and
     PROGRAM; FEDERAL TAX REFUND
                                                            of the Administration for Children and                 neighborhood innovation, which are all
     OFFSET
                                                            Families that, within constitutional                   administered by the Administration for
     Priority: Substantive, Nonsignificant                  church-state guidelines, faith-based                   Children and Families (ACF). It is
     Legal Authority: 42 USC 664; 42 USC                    organizations should be able to                        ACF’s policy that, within the
     1302                                                   compete on an equal footing for                        framework of constitutional church-
                                                            funding under the Temporary                            State guidelines, faith-based
     CFR Citation: 45 CFR 303.72                            Assistance for Needy Families (TANF)                   organizations should be able to
     Legal Deadline: None                                   program. In addition to giving families                compete on an equal footing for
                                                            a greater choice of TANF-funded                        funding, and ACF supports the
     Abstract: This interim final rule will                 providers, these rules ensure that the                 participation of faith-based
     revise existing regulations on collecting              character of religious providers is not                organizations in these programs.
     child support arrears through the                      impaired and that the religious freedom
     Federal Tax Refund Offset process. The                                                                        Timetable:
                                                            of TANF beneficiaries is not impaired.
     revisions are needed to reflect changes                                                                       Action                    Date
     in data processing protocols with the                  Timetable:
                                                                                                                   NPRM                    12/17/02 67 FR 77364
     Department of the Treasury. We are
     also updating the regulation to reflect                Action                        Date                     NPRM Comment            02/18/03
                                                                                                                     Period End
     current business practices and requests                NPRM                      12/17/02 67 FR 77362         Final Rule              12/00/03
     from the state child support agencies.                 NPRM Comment              02/18/03
                                                              Period End                                           Regulatory Flexibility Analysis
     Timetable:
                                                            Final Rule                12/00/03                     Required: No
     Action                     Date
                                                                                                                   Government Levels Affected: Federal
     Interim Final Rule       09/00/03                      Regulatory Flexibility Analysis
                                                            Required: No                                           URL For More Information:
     Regulatory Flexibility Analysis                                                                               http://www.acf.hhs.gov/hypenews
     Required: No                                           Small Entities Affected: No
                                                                                                                   URL For Public Comments:
     Small Entities Affected: No                            Government Levels Affected: State                      http://www.acf.hhs.gov/
     Government Levels Affected: State                                                                             hypernews.topic822
                                                            Agency Contact: April Kaplan, Deputy                   Agency Contact: Clarence Carter,
     Agency Contact: Eileen C. Brooks,                      Director, Office of Family Assistance,
     Deputy Director, Policy Division,                                                                             Director, Office of Community Services,
                                                            Department of Health and Human                         Department of Health and Human
     Department of Health and Human                         Services, Administration for Children
     Services, Administration for Children                                                                         Services, Administration for Children
                                                            and Families, 5th Floor East, 370                      and Families, 5th Floor East, 370
     and Families, 4th Floor East, OCSE,                    L’Enfant Promenade SW., Washington,
     DPP, 370 L’Enfant Promenade SW.,                                                                              L’Enfant Promenade SW., Washington,
                                                            DC 20447                                               DC 20447
     Washington, DC 20447                                   Phone: 202 401-5138
     Phone: 202 401-5369                                                                                           Phone: 202 401-9333
                                                            Email: akaplan@acf.hhs.gov                             Email: ccarter@acf.hhs.gov
     TDD Phone: 800 877-8339
     Fax: 202 401-4054                                      RIN: 0970–AC12                                         RIN: 0970–AC13




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00064   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408
                            Federal Register / Vol. 68, No. 101 / Tuesday, May 27, 2003 / Unified Agenda                                                   30277

     Department of Health and Human Services (HHS)                                                                                       Completed Actions
     Administration for Children and Families (ACF)

     952. FAMILY CHILD CARE PROGRAM                         Agency Contact: Douglas Klafehn                        Completed:
     OPTION FOR HEAD START                                  Phone: 202 205-8569                                    Reason                    Date
     PROGRAMS                                               Email: dklafehn@acf.dhhs.gov
                                                                                                                   Withdrawn                03/07/03
     Priority: Substantive, Nonsignificant
                                                            RIN: 0970–AB90                                         Regulatory Flexibility Analysis
     CFR Citation: 45 CFR 1304; 45 CFR
     1306                                                                                                          Required: No
     Completed:                                             953. CHILD SUPPORT ENFORCEMENT                         Government Levels Affected: State
                                                            PROGRAM; CUSTOMER SERVICE                              Agency Contact: Annie Miller
     Reason                     Date                        ANNUAL STATE SELF-ASSESSMENT                           Phone: 202 401-1467
     Withdrawn                03/07/03                                                                             TDD Phone: 800 877-8339
                                                            Priority: Substantive, Nonsignificant
     Regulatory Flexibility Analysis                                                                               Fax: 202 401-4054
     Required: No                                           CFR Citation: 45 CFR 308.2; 45 CFR                     Email: anmiller@acf.hhs.gov
     Government Levels Affected: State,                     308.3                                                  RIN: 0970–AC10
     Local, Tribal


     Department of Health and Human Services (HHS)                                                                                   Proposed Rule Stage
     Administration on Aging (AOA)

     954. GRANTS FOR STATE AND                              Abstract: In response to the                           Government Levels Affected: State,
     COMMUNITY PROGRAMS ON AGING,                           reauthorization of the Older Americans                 Tribal
     TRAINING, RESEARCH, AND                                Act, Public Law 106-501, the
     DISCRETIONARY PROGRAMS;                                Administration on Aging (AoA)                          Federalism: Undetermined
     VULNERABLE ELDER RIGHTS;                               proposes to issue a notice of proposed                 Agency Contact: Edwin Walker,
     GRANTS TO INDIANS AND NATIVE                           rulemaking by spring of 2003.                          Deputy Assistant Secretary for Policy
     HAWAIIANS                                              Timetable:                                             and Programs, Department of Health
     Priority: Substantive, Nonsignificant                                                                         and Human Services, Administration
                                                            Action                        Date
                                                                                                                   on Aging, Washington, DC 20201
     Legal Authority: 42 USC 3001 et seq                    NPRM                      05/00/03                     Phone: 202 401-4634
     CFR Citation: 45 CFR 1321; 45 CFR                      Regulatory Flexibility Analysis                        RIN: 0985–AA00
     1326; 45 CFR 1328                                      Required: Yes                                          [FR Doc. 03–10366 Filed 05/16/03; 8:45 am]
     Legal Deadline: None                                   Small Entities Affected: Businesses,                   BILLING CODE 4150–24–S
                                                            Governmental Jurisdictions




VerDate May<05>2003   13:51 May 16, 2003   Jkt 200001   PO 00000   Frm 00065   Fmt 1254   Sfmt 1254   D:\UNIFIED\PRESSD~1\UA030408.TXT   apps41   PsN: UA030408

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:27
posted:10/1/2011
language:English
pages:65