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


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Part VIII





Department of Health and Human Services





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Semiannual Regulatory Agenda

[[Page 30214]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)






_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the semiannual publication of an inventory of all 
rulemaking actions under development or review. The purpose of this 
effort is to encourage public participation in the Department's 
regulatory process by providing, at an early stage, summarized 
information about regulatory actions under development. Anyone wishing 
to communicate to the Department their views on the rulemakings 
outlined below is invited to do so.

FOR FURTHER INFORMATION CONTACT: Ann C. Agnew, Executive Secretary, 
Department of Health and Human Services, Washington, DC 20201.

SUPPLEMENTARY INFORMATION: The capsulized information provided below 
reflects an effort to present for public scrutiny a forecast of the 
rulemaking activities that the Department expects to undertake over the 
foreseeable future. We focus primarily on those areas of work expected 
to result in publication of notices or final rules within the next 12 
months. (Also included, in several Long-Term Action sections, are 
summaries of actions that we will probably not take any earlier than 12 
months after publication of this agenda.)

     We welcome the views of all concerned with regard to these 
planned rulemakings. Comments may be directed to the agency 
officials cited in each of the summaries, or, if early attention at 
the Secretary's level is seen as required, comments should be 
directed to: Ann C. Agnew, Executive Secretary to the Department, 
Room 603H, 200 Independence Avenue SW., Washington, DC 20201.

Dated: April 14, 2003.

 Ann C. Agnew,

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     0991-AB23
            Claims Containing Excessive Charges.................................................
----------------------------------------------------------------------------------------------------------------


                                    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           0991-AB16
            Medicare SELECT Policy..............................................................
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,        0991-AB10
            National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration
            Act of 1987.........................................................................
754         Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide              0991-AB12
            Requirements for Drug-Free Workplace (Grants).......................................
----------------------------------------------------------------------------------------------------------------


[[Page 30215]]


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


                   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             0920-AA04
            Respiratory Protective Devices......................................................
----------------------------------------------------------------------------------------------------------------


                          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       0920-AA07
            Cohort Under the Energy Employee Occupational Illness Compensation Act of 2000......
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
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             0910-AC50
            Consider Possible Footnote Statements...............................................

[[Page 30216]]

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


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
769         Foreign and Domestic Establishment Registration and Listing Requirements for Drugs       0910-AA49
            and Biologics.......................................................................
770         Blood Initiative....................................................................     0910-AB26
771         Applications for FDA Approval To Market a New Drug; Complete Response Letter;            0910-AB34
            Amendments To Unapproved Applications...............................................
772         Current Good Manufacturing Practice for Medicated Feeds.............................     0910-AB70
773         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary        0910-AB88
            Ingredients and Dietary Supplements.................................................
774         Requirements Pertaining to Sampling Services and Private Laboratories Used in            0910-AB96
            Connection With Imported Food.......................................................
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     0910-AC21
            Animal Populations..................................................................
779         Requirements for Submission of In Vivo Bioequivalence Data..........................     0910-AC23
780         Exception From General Requirements for Informed Consent; Request for Comments and       0910-AC25
            Information.........................................................................
781         Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure           0910-AC30
            Regulators for Use With Medical Oxygen..............................................
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        0910-AC38
            Health Security and Bioterrorism Preparedness and Response Act of 2002..............
785         Establishment and Maintenance of Records Pursuant to the Public Health Security and      0910-AC39
            Bioterrorism Preparedness and Response Act of 2002..................................
786         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed...............     0910-AC43
787         Submission of Standardized Electronic Study Data From Clinical Studies Evaluating        0910-AC52
            Human Drugs and Biologics...........................................................
788         Medical Gas Containers and Closures; Current Good Manufacturing Practice                 0910-AC53
            Requirements........................................................................
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          0910-AA04
            Control Procedures, Quality Factors, Notification Requirements, and Records and
            Reports.............................................................................
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             0910-AA89
            Interest of Recipients..............................................................
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     0910-AB66
            Health Claims.......................................................................
799         CGMP for Blood and Blood Components: Notification of Consignees and Transfusion          0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting
            HCV Infection (Lookback)............................................................
800         Requirements for Submission of Labeling for Human Prescription Drugs and Biologics       0910-AB91
            in Electronic Format................................................................
801         Additional Safeguards for Children in Clinical Investigations of FDA-Regulated           0910-AC07
            Products............................................................................
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      0910-AC34
            Components..........................................................................

[[Page 30217]]

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


                                 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           0910-AB27
            Tissue-Based Products...............................................................
812         Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based       0910-AB28
            Products Establishments; Inspection and Enforcement.................................
813         Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of       0910-AC45
            ``No Residue''......................................................................
----------------------------------------------------------------------------------------------------------------


                                 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
                                                                                                                              expected 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          0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
819         Designation of Medically Underserved Populations and Health Professional Shortage        0906-AA44
            Areas...............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 30218]]


                         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          0906-AA57
            Health Care Practitioners: Reporting Adverse and Negative Actions...................
----------------------------------------------------------------------------------------------------------------


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


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
822         Undergraduate Scholarship Program Regarding Professions Needed by the National           0925-AA10
            Institutes of Health (NIH)..........................................................
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             0925-AA33
            Researchers.........................................................................
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               0925-AA36
            Individuals From Disadvantaged Backgrounds..........................................
----------------------------------------------------------------------------------------------------------------


                                 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       0925-AA20
            Contract Projects...................................................................
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          0940-AA06
            Requirements........................................................................
835         Human Subjects Protection Regulations: Training and Education Requirements for           0940-AA08
            Institutional Officials, Institutional Review Board Members and Staff, Human
            Protections Administrators, and Investigator........................................
----------------------------------------------------------------------------------------------------------------


                              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                0940-AA01
            Whistleblowers......................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 30219]]


                          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         0938-AG82
            Review).............................................................................
838         Hospital Conditions of Participation: Requirements for Certification and                 0938-AH17
            Recertification of Transplant Centers To Perform Organ Transplants (CMS-3835-P).....
839         Hospice Care--Conditions of Participation (CMS-3844-P)..............................     0938-AH27
840         Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy (CMS-      0938-AJ98
            6010-P).............................................................................
841         Conditions of Participation of Intermediate Care Facilities for Persons With Mental      0938-AK23
            Retardation (CMS-3046-P)............................................................
842         Health Insurance Reform: Claims Attachments Standards (CMS-0050-P)..................     0938-AK62
843         Inpatient Disproportionate Share Hospital (DSH) Adjustment: Calculation of Medicaid      0938-AK77
            Patient and Total Patient Days in the Medicare DSH Adjustment (CMS-1171-P)..........
844         Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-      0938-AK79
            P)..................................................................................
845         Organ Procurement Organization Conditions for Coverage (CMS-3064-P).................     0938-AK81
846         Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of       0938-AK94
            Substantial Gainful Activity (CMS-4018-P)...........................................
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         0938-AL26
            That Provide Inpatient or Residential Care (CMS-2130-P).............................
849         Payment for Respiratory Assist Devices With Bi-Level Capability and a Back-Up Rate       0938-AL27
            (CMS-1167-P)........................................................................
850         Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans         0938-AL49
            (CMS-6016-P)........................................................................
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-    0938-AL62
            P)..................................................................................
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          0938-AL88
            Family and Medical Leave Act (CMS-2158-P)...........................................
860         Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-     0938-AL89
            1470-P).............................................................................
861         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--     0938-AL90
            Update for FY 2004 (CMS-1469-P).....................................................
862         Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004     0938-AL91
            Payment Rates (CMS-1471-P)..........................................................
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         0938-AL96
            2004 (CMS-1476-P)...................................................................
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-    0938-AM13
            1228-P).............................................................................
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                0938-AM36
            Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-P).............
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--     0938-AM46
            Update for FY 2005 (CMS-1249-P).....................................................
875         Modifications to Electronic Transactions and Code Sets (CMS-0009-P).................     0938-AM50
876         Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals              0938-AM54
            Procedures (CMS-6146-P).............................................................
877         Requirements for Nursing Homes To Identify the Number of Licensed and Unlicensed         0938-AM55
            Nursing Staff Per Shift (CMS-3121-P)................................................
----------------------------------------------------------------------------------------------------------------


                           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

[[Page 30220]]

 
879         Standard Unique National Health Plan Identifiers (CMS-6017-F).......................     0938-AH87
880         Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-      0938-AH99
            F)..................................................................................
881         Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (CMS-6003-F)............................................
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      0938-AJ10
            (CMS-3006-F)........................................................................
884         Rural Health Clinics: Amendments to Participation Requirements and Payment               0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-
            1910-F).............................................................................
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             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).............
888         All Provider Bad Debt Payment (CMS-1126-F)..........................................     0938-AK02
889         Laboratory Requirements Relating to Quality Systems and Certain Personnel                0938-AK24
            Qualifications (CMS-2226-CN)........................................................
890         Review of National Coverage Determinations and Local Coverage Determinations (CMS-       0938-AK60
            3063-F).............................................................................
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             0938-AK67
            Relationships--Phase II (CMS-1810-FC)...............................................
893         Rate of Reimbursement of Photocopy Expenses for Quality Improvement Organizations        0938-AK68
            (CMS-3055-F)........................................................................
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            0938-AL43
            Issuers (CMS-2151-F)................................................................
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;     0938-AL79
            Federal Fiscal Year 2002 (CMS-2136-FN)..............................................
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-      0938-AL95
            1474-F).............................................................................
904         Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other            0938-AM01
            Entities (CMS-1224-F)...............................................................
905         Update of the List of Covered Procedures for Ambulatory Surgical Centers (CMS-1885-      0938-AM02
            FC).................................................................................
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-       0938-AM20
            2175-FC)............................................................................
909         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AM31
            Amounts for Calendar Year 2004 (CMS-8016-N).........................................
910         Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate         0938-AM32
            Beginning January 1, 2004 (CMS-8017-N)..............................................
911         Part A Premiums for Calendar Year 2004 for the Uninsured Aged and for Certain            0938-AM33
            Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8018-N)..............
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            0938-AM38
            (JCAHO) for Deeming Authority for Hospices (CMS-2177-FN)............................
914         Hospital Cost-to-Charge Ratios Used to Calculate Cost Outlier Payments Under the         0938-AM41
            Medicare Short-Term Inpatient Prospective Payment System (CMS-1243-F)...............
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      0938-AM47
            (CMS-1222-IFC)......................................................................
917         Hospice Wage Index for FY 2004 (CMS-1233-N).........................................     0938-AM56
918         Announcement of Applications From Hospitals Requesting Waivers for Organ Procurement     0938-AM59
            Service Areas in CY 2003 (CMS-1246-NC)..............................................
----------------------------------------------------------------------------------------------------------------


                           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-     0938-AH73
            P)..................................................................................

[[Page 30221]]

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


                           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-    0938-AK64
            0003-FC)............................................................................
927         Medicaid Managed Care; New Provisions (CMS-2104-F2).................................     0938-AK96
928         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AL21
            2003 (CMS-1204-F2)..................................................................
929         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AL56
            Amounts for Calendar Year 2003 (CMS-8013-N).........................................
930         Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate         0938-AL63
            Beginning January 1, 2003 (CMS-8014-N)..............................................
931         Part A Premiums for Calendar Year 2003 for the Uninsured Aged and for Certain            0938-AL69
            Disabled Individuals Who Have Exhausted Other Entitlement (CMS-8015-N)..............
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             0938-AM21
            Relationships; Extension of Partial Delay of Effective Date of the ``Set in
            Advance'' Provision (CMS-1809-F2)...................................................
935         Announcement of Applications From Hospitals Requesting Waivers for Organ Procurement     0938-AM37
            Service Areas CY 2002 (CMS-1241-NC).................................................
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      0938-AM49
            Rates; Correcting Amendment (CMS-1177-F2)...........................................
938         Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AM58
            Relationships; Second Extension of Delay of Effective Date of the ``Set in Advance''
            Provision (CMS-1809-F3).............................................................
939         Ambulance Fee Schedule (CMS-1256-N).................................................     0938-AM60
940         Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and       0938-AM63
            Hearings (CMS-0010-IFC).............................................................
----------------------------------------------------------------------------------------------------------------


                                             Centers for Medicare & Medicaid Services--Discontinued Entries
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Regulation
Identification                                             Title                                                  Date                 Comments
    Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-AG79        Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F)                03/10/2003   Withdrawn
0938-AH53        Medicare and Medicaid Programs; Terms, Definitions, and Addresses; Technical Amendments        04/21/2003   Withdrawn
                 (CMS-9877-F)
0938-AI21        Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-P)         03/12/2003   Withdrawn
0938-AJ97        Application of Inherent Reasonableness to All Medicare Part B Services (Other than             05/06/2003   Withdrawn
                 Physician Services) (CMS-1908-IFC)
0938-AL12        Medicare Limits on the Valuation of a Depreciable Asset Recognized as an Allowance for         02/03/2003   Withdrawn
                 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 (CMS-1201-F)          03/05/2003   Withdrawn
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

[[Page 30222]]

 
0938-AM40        Meeting of the Negotiated Rulemaking Committee on Special Payment Provisions and               03/12/2003   Withdrawn
                 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)           0970-AC01
            Information.........................................................................
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              0970-AC00
            Statutory Revisions.................................................................
949         Child Support Enforcement Program; Federal Tax Refund Offset........................     0970-AC09
950         Charitable Choice Provisions Applicable to the Temporary Assistance for Needy            0970-AC12
            Families Program....................................................................
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                0985-AA00
            Discretionary Programs; Vulnerable Elder Rights; Grants to Indians and Native
            Hawaiians...........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 30223]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




744. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would set forth a new anti-kickback safe harbor 
addressing remuneration between federally qualified health centers and 
certain service providers where a significant community benefit exists.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/03
NPRM Comment Period End         12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

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




745. CLAIMS COLLECTION

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3711; 31 CFR 900 to 904

CFR Citation: 45 CFR 30

Legal Deadline: None

Abstract: The Department will amend part 30 of title 45 of the Code of 
Federal Regulations (CFR) to reflect the amendments to the Federal 
Claims Collection Act made by the Debt Collection Improvement Act of 
1996 (DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, as implemented 
by the Department of the Treasury at 31 CFR 900-904. The proposed rule 
will prescribe the standards and procedures for the Department's use in 
the administrative collection, offset, compromise, and suspension or 
termination of debts owed to the Department. The proposed rule is 
required in order to bring the Department's claims collection 
provisions in compliance with the Department of the Treasury 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03
NPRM Comment Period End         09/00/03
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB18
_______________________________________________________________________




746. SALARY OFFSET

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 5514; 5 CFR 550

CFR Citation: 45 CFR 33

Legal Deadline: None

Abstract: The Department will add a new part 33 to title 45 of the Code 
of Federal Regulations (CFR) to implement the salary offset provisions 
of the Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-
134, 110 Stat. 1321 to 1358, codified at 5 U.S.C. 5514, as implemented 
by the Office of Personnel Management at 5 CFR part 550, subpart K. The 
proposed rule is required in order to bring the Department's salary 
offset provisions in compliance with Governmentwide regulations 
published by the Office of Personnel Management.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03
NPRM Comment Period End         10/00/03
Final Rule                      01/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB19
_______________________________________________________________________




747. [bull] CLARIFICATION OF TERMS AND APPLICATION OF PROGRAM EXCLUSION 
AUTHORITY FOR SUBMITTING CLAIMS CONTAINING EXCESSIVE CHARGES

Priority: Substantive, Nonsignificant

Legal Authority: Sec 112B (6) (6)(A) of the Social Security Act

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/03
NPRM Comment Period End         10/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AB23

[[Page 30224]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




748. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              11/19/99                    64 FR 63504
Final Rule                      10/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

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




749. SAFE HARBOR FOR WAIVER OF BENEFICIARY COINSURANCE AND DEDUCTIBLE 
AMOUNTS FOR A MEDICARE SELECT POLICY

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This final rule will expand the existing safe harbor for 
certain waivers of beneficiary coinsurance and deductible amounts to 
benefit the policyholders of Medicare SELECT supplemental insurance. 
Specifically, the amended safe harbor will protect waivers of 
coinsurance and deductible amounts under part A or part B of the 
Medicare program owed by beneficiaries covered by a Medicare SELECT 
policy issued in accordance with section 1882(t)(1) of the Social 
Security Act, if the waiver is in accordance with a price reduction 
agreement covering such policyholders between the Medicare SELECT 
issuer and the provider or supplier offering the waiver.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/25/02                    67 FR 60202
NPRM Comment Period End         10/25/02
Final Rule                      10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB16
_______________________________________________________________________




750. TAX REFUND OFFSET

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3720A; 31 CFR 285.2

CFR Citation: 45 CFR 31

Legal Deadline: None

Abstract: The Department will amend part 31 to title 45 of the Code of 
Federal Regulations (CFR) to reflect amendments to 31 U.S.C. 3720A made 
by the tax refund offset provisions of the Debt Collection Improvement 
Act of 1996 (DCIA), Public Law 104-134, 110 Stat. 1321-1358, as 
implemented by the Department of the Treasury at 31 CFR 285.2. The 
proposed rule revises the process by which the Department collects its 
debts. The proposed rule is required in order to bring the Department's 
tax refund offset provisions in compliance with the Department of the 
Treasury regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/04/02                    67 FR 72128
NPRM Comment Period End         02/03/03
Final Rule                      08/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

RIN: 0991-AB17
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 13

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/18/87
Second NPRM                     08/13/02                    67 FR 52696
Second NPRM Comment Period End  10/12/02
Final Rule                      11/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

[[Page 30225]]

Additional Information: Transferred from RIN 0990-AA02

Agency Contact: Katherine M. Drews, Associate General Counsel, 
Department of Health and Human Services, Office of the Secretary, 
Office of the General Counsel, Room 5362, HHS Cohen Building, 330 
Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0150

Related RIN: Previously reported as 0990-AA02
RIN: 0991-AB22
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




752. REVISIONS TO 42 CFR PART 1003

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 
USC 1396b; 42 USC 1396u-2

CFR Citation: 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB03
_______________________________________________________________________




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

Priority: Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/06/00                    65 FR 76460


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal, Tribal

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

RIN: 0991-AB10
_______________________________________________________________________




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

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

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

CFR Citation: 45 CFR 76; 45 CFR 82

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB12

[[Page 30226]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          12/09/02                    67 FR 72896

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AB04
_______________________________________________________________________




756. ADMINISTRATIVE WAGE GARNISHMENT

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 32

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/28/03                    68 FR 15092

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Katherine M. Drews
Phone: 202 619-0150

Related RIN: Previously reported as 0990-AA05
RIN: 0991-AB20
_______________________________________________________________________




757. U.S. EXCHANGE VISITOR PROGRAMS; REQUEST FOR WAIVER OF THE TWO-YEAR 
FOREIGN RESIDENCE REQUIREMENT

Priority: Other Significant

CFR Citation: 45 CFR 50

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/19/02                    67 FR 77692

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Joyce Edith Jones
Phone: 202 690-6174
Fax: 202 690-7127

RIN: 0991-AB21
_______________________________________________________________________




758. [bull] CIVIL MONEY PENALTIES: PROCEDURES FOR INVESTIGATIONS, 
IMPOSITION OF PENALTIES, AND HEARINGS

Priority: Other Significant

Legal Authority: 42 USC 1320d-5; 42 USC 1302(a)

CFR Citation: 42 CFR 160

Legal Deadline: None

Abstract: The rule will establish procedures for investigations 
subpoenas, imposition of penalties, and hearings concerning the 
imposition of civil money penalties by the Secretary of Health and 
Human Services pursuant to 42 U.S.C. 1320d-5. The rule will establish 
procedures that the Secretary will follow and, with respect to 
hearings, which regulated entities who challenge the proposed 
imposition of a civil money penalty on the entity will follow.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/17/03                    68 FR 18895

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Karen Shaw, Para Legal, Department of Health and Human 
Services, Office of the Secretary, Rm: 711E, 200 Independence Avenue 
SW., Washington, DC 20201
Phone: 202 690-7711
Fax: 202 690-5452
Email: [email protected]

RIN: 0991-AB24

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




759. [bull] SAMHSA CHARITABLE CHOICE

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 54, sec 54.1-13; 42 CFR 54a, sec 54a.1-14

Legal Deadline: None

Abstract: This proposed rule would implement the Charitable Choice 
statutory provisions of section 581-584 and section 1955 of the Public 
Health Service Act, applicable to the Substance Abuse Prevention and 
Treatment (SAPT) Block Grant Program, the Project for Assistance in 
Transition from Homelessness (PATH) formula grant program, insofar as 
recipients provide substance abuse services, and to SAMHSA 
discretionary grants for substance abuse treatment or prevention 
services, which are all administered by the Substance Abuse and Mental 
Health Services Administration (SAMSHA) of the U.S. Department of 
Health and Human Services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/02                    67 FR 77350
Final Rule                      06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

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

Agency Contact: Winnie Mitchell, Public Health Analyst, Department of 
Health and Human Services, Substance Abuse and Mental Health Services 
Administration, 12C-05, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2324
Fax: 301 443-0247

RIN: 0930-AA11

[[Page 30227]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




760. SECLUSION AND RESTRAINT FOR NON-MEDICAL RESIDENTIAL FACILITIES

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 2001.

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

RIN: 0930-AA10

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 84

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Roland Berry Ann, Acting Chief, Respirator Branch, 
National Personal Protection Technology Laboratory, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
NIOSH, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-4000

RIN: 0920-AA04
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




762. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE 
SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEE OCCUPATIONAL ILLNESS 
COMPENSATION ACT OF 2000

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 7384g; EO 13179

CFR Citation: 42 CFR 83

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/25/02                    67 FR 42962
Final Rule                      06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Elliott, Director, Office of Compensation 
Analysis and Support, Department of Health and Human Services, Centers 
for Disease Control and Prevention, NIOSH, R44, 5555 Ridge Avenue, 
Cincinnati, OH 45213
Phone: 513 841-4498

RIN: 0920-AA07

[[Page 30228]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




763. CONTROL OF COMMUNICABLE DISEASES

Priority: Other Significant

CFR Citation: 42 CFR 70; 42 CFR 71

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/10/03                    68 FR 17558

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Jennifer Brooks
Phone: 404 639-2763

RIN: 0920-AA03
_______________________________________________________________________




764. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS

Priority: Other Significant

CFR Citation: 42 CFR 72; 42 CFR 72.6

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/13/02                    67 FR 76886

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen M. Ostroff
Phone: 404 639-3967

RIN: 0920-AA08

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 350

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the Agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

Timetable:
________________________________________________________________________

Anorectal Products  Final Action (Amendment) 12/00/03

Antidiarrheal Products  Final Action 04/17/03 (68 FR 18869)  NPRM 
(Amendment) (Trav.Diar) 04/17/03 (68 FR 18915)

Antiemetic Products  Final Action (Amendment) (Warning) 12/06/02 (67 FR 
72555)

Antiperspirant Products  Final Action 08/00/03

Cough/Cold (Antihistamine) Products  Final Action (Amendment)(Warning) 
12/06/02 (67 FR 72555)

Cough/Cold (Antitussive) Products  Final Action (Amendment)(Warning) 
12/06/02 (67 FR 72555)

Cough/Cold (Bronchodilator) Products  Final Action (Amendment) 02/00/04

Cough/Cold (Combination) Products  Final Action 12/23/02 (67 FR 
78158)  NPRM (Amendment) 02/00/04

Cough/Cold (Nasal Decongestant) Products  NPRM (Phenylpropanolamine) 
10/00/03

External Analgesic Products  Final Action (Amendment)(Warning) 12/06/02 
(67 FR 72555)  NPRM (Amendment) (Patches) 12/00/03

Ingrown Toenail Relief Products  NPRM 10/04/02 (67 FR 62218)  Final 
Action 06/00/03

Internal Analgesic Products  NPRM (Amendment)(Ibuprofen) 08/21/02 (67 
FR 54139)  NPRM (Amendment) (Pediatric) 10/00/03  NPRM (Amendment) 
(Labeling) 12/00/03

Labeling of Drug Products for OTC Human Use  Final Action (Ca/Mg/K/Na) 
07/00/03  Final Action (Sodium Labeling) 07/00/03  NPRM (Sodium 
Labeling) 07/00/03  NPRM (Convenience Sizes) 09/00/03

Laxative Drug Products  NPRM (Amendment) (Psyllium Granular Dosage 
Form) 10/00/03

Nighttime Sleep Aid Products  Final Action (Amendment)(Warning) 12/06/
02 (67 FR 72555)

Ophthalmic Products  Final Action (Technical Amendment) 02/19/03 (68 FR 
7919)  NPRM (Emergency First Aid Eyewashes) 02/19/03 (68 FR 
7951)  Final Action (Name Change) 06/00/03

Oral Health Care Products  ANPRM (Plaque/Gingivitis) 06/00/03

Pediculicide Products  NPRM (Labeling Amendment) 05/10/02 (67 FR 
31739)  Final Action (Labeling Amendment) 02/00/04

Salicylate (Reye's Syndrome)  Final Action (Warning) 04/17/03 (68 FR 
18861)

Skin Protectant Products  Final Action 07/00/03  NPRM (Astringent) 09/
00/03  Final Action (Astringent) 09/00/03

Sunscreen Products  Final Action (Names) 06/20/02 (67 FR 41821)  ANPRM 
(and Insect Repellent) 10/00/03  NPRM (UVA/UVB) 12/00/03

Vaginal Contraceptive Products  NPRM (Amendment) 01/16/03 (68 FR 2254)

Weight Control Products  NPRM (Phenylpropanolamine) 10/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AA01
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 511

Legal Deadline: None

[[Page 30229]]

Abstract: FDA is initiating a review of 21 CFR 511.1 under section 610 
of the Regulatory Flexibility Act. The purpose of the section 610 
review is to determine if the rule should be amended to minimize 
adverse economic impacts on small entities. FDA will solicit and 
consider comments on the following: 1) the continued need for the rule; 
2) the nature of complaints or comments received concerning the rule; 
3) the complexity of the rule; 4) the extent to which the rule 
overlaps, duplicates, or conflicts with other Federal, State, or local 
government rules; and 5) the degree to which technology, economic 
conditions, or other factors have changed in the area affected by the 
rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
Begin Review                    04/03/00
End Review                      12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB02
_______________________________________________________________________




767. [bull] FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: 
CONSUMER RESEARCH TO CONSIDER POSSIBLE FOOTNOTE STATEMENTS

Priority: Other Significant

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

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: This advance notice of proposed rulemaking (ANPRM) is 
intended to publish in the same issue of the Federal Register as the 
trans fat final rule that would require that the quantitative amount of 
trans fat be declared in the nutrition label of conventional foods and 
dietary supplements on a separate line immediately under the line for 
saturated fat. This ANPRM would solicit information and data on whether 
to consider footnote statements for possible use in the nutrition label 
about trans fat, either alone or in combination with saturated fat and 
cholesterol, to enhance consumers' understanding about such fat in 
foods and how to use the information to make healthy food choices. FDA 
is soliciting information and data on language in any such statements 
and the impact on consumers from such statements. Information obtained 
from this solicitation and that resulting from consumer studies 
conducted by FDA may be used to help draft a proposed rule that would 
require the use of a footnote in the Nutrition Facts panel about one or 
more of the cholesterol-raising lipids to increase consumer 
understanding of the relative significance of these lipids in foods.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           06/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Susan Thompson, Chemist, Department of Health and Human 
Services, Food and Drug Administration, (HFS-832), Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1450
Fax: 301 436-2639
Email: [email protected]

Related RIN: Related To 0910-AB66
RIN: 0910-AC50
_______________________________________________________________________




768. [bull] PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN 
MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD (SECTION 610 REVIEW)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 110

Legal Deadline: None

Abstract: Part 110 (21 CFR part 110) describes regulations for current 
good manufacturing practice in manufacturing, packing, and holding 
human food. Part 110 contains regulations describing sanitary practices 
for personnel, buildings and facilities, and equipment. It also 
includes regulations on production and process controls for 
manufacturing practices and on defect action levels for natural or 
unavoidable defects in food for human use that present no health 
hazard. FDA is undertaking a review of part 110 under section 610 of 
the Regulatory Flexibility Act. The purpose of this review is to 
determine whether the regulations in part 110 should be continued 
without change, or whether they should be amended or rescinded, to 
minimize adverse impacts on a substantial number of small entities. FDA 
will consider, and is soliciting comments on, the following: (1) the 
continued need for the regulations in part 110; (2) the nature of 
complaints or comments received concerning the regulations in part 110; 
(3) the complexity of the regulations in part 110; (4) the extent to 
which the regulations in part 110 overlap, duplicate, or conflict with 
other Federal, State, or governmental rules; and (5) the degree to 
which technology, economic conditions, or other factors have changed in 
the area affected by the regulations in part 110.
The section 610 review will be carried out along with a regulatory 
review under section 5 of Executive Order 12866, which calls for 
agencies to periodically review existing regulations to determine 
whether any should be modified or eliminated so as to make the agency's 
regulatory program more effective in achieving its goals, less 
burdensome, or in greater alignment with the President's priorities and 
the princples set forth in the Executive order. The combined effect of 
the two reviews will be to determine if it is possible to redesign 
current good manufacturing practices in ways that will maintain or 
increase the effectiveness of preventive and sanitary controls, and, at 
the same time, reduce compliance and other costs associated with the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    05/00/03

Regulatory Flexibility Analysis Required: Undetermined

[[Page 30230]]

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Richard A. Williams, Director, Division of Market 
Studies, OSAS, CFSAN, FDA, HHS, Department of Health and Human 
Services, Food and Drug Administration, HFS-725, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]

RIN: 0910-AC58
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




769. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR DRUGS AND BIOLOGICS

Priority: Other Significant

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

CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 
514; 21 CFR 601; 21 CFR 607; 21 CFR 1271

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AA49
_______________________________________________________________________




770. BLOOD INITIATIVE

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

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

CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 680

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration is 
amending the biologics regulations by removing, revising, or updating 
specific regulations applicable to blood, blood components, Source 
Plasma, and blood-derivative products to be more consistent with 
current practices and to remove unnecessary or outdated requirements. 
This action is based on FDA's comprehensive review of the biologics 
regulations. It is also based on reports by the U.S. House of 
Representatives Committee on Government Reform and Oversight's, 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as on 
public comments. The remaining subjects intended to be addressed in the 
rulemakings include: labeling, and donor suitability and testing. These 
actions are intended to help ensure the continued safety of the 
Nation's blood supply.

Timetable:
________________________________________________________________________

Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin 
(Human); Revision of Requirements  Direct Final Rule 05/14/99 (64 FR 
26282)  NPRM 05/14/99 (64 FR 26344)  Direct Final Rule - Confirmation 
in Part and Technical Amendment 03/14/00 (65 FR 13678)  Final Action 
08/28/00 (65 FR 52016)

General Requirements for Blood, Blood Components, and Plasma 
Derivatives; Notification of Deferred Donors  NPRM 08/19/99 (64 FR 
45355)  Final Action 06/11/01 (66 FR 31165)

Regulations for Human Blood and Blood Components Intended for 
Transfusion or For Further Manufacturing Use  NPRM 01/00/04

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

Revisions to Labeling and Storage Requirements for Blood and Blood 
Components, Including Source Plasma  NPRM 12/00/03

Revisions to the Requirements Applicable to Blood, Blood Components, 
and Source Plasma  Direct Final Rule 08/19/99 (64 FR 45366)  NPRM 08/
19/99 (64 FR 45375)  Direct Final Rule - Confirmation in Part and 
Technical Amendment 01/10/01 (66 FR 1834)  Final Action 08/06/01 (66 FR 
40886)

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

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

Unfunded Mandates: Undetermined

[[Page 30231]]

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

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB34
_______________________________________________________________________




772. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 225

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB70
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

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

CFR Citation: 21 CFR 111

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/06/97                     62 FR 5700
ANPRM Comment Period End        06/06/97
NPRM                            05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Karen Strauss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, (HFS-820), 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1774
Fax: 301 436-2610
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 331 to 334; 21 USC 335b; 21 USC 335c; 21 USC 
341 to 344; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 
21 USC 360c-360f; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 
USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 USC 262; 42 USC 264

CFR Citation: 21 CFR 59

Legal Deadline: None

[[Page 30232]]

Abstract: The proposed rule would establish requirements for importers 
and other persons who use sampling services and private laboratories in 
connection with imported food. For example, the proposal would pertain 
to persons who use sample collection services and private laboratories, 
and would describe some responsibilities for such persons, sample 
collection services, and private laboratories. These responsibilities 
would include recordkeeping requirements to ensure that the correct 
sample is collected and analyzed, and a notification requirement if a 
person intends to use a private laboratory in connection with imported 
food. The proposed rule is intended to help insure the integrity and 
scientific validity of data and results submitted to FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

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

RIN: 0910-AB96
_______________________________________________________________________




775. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS

Priority: Economically Significant. Major under 5 USC 801.

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

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

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

Legal Deadline: None

Abstract: In July 1999, the Food and Drug Administration (FDA) and the 
Food Safety Inspection Service (FSIS) committed to developing an action 
plan to address the presence of salmonella enteritidis (SE) in shell 
eggs and egg products using a farm-to-table approach. FDA and FSIS held 
a public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all 
stages of the farm-to-table continuum as well as support functions. On 
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 
31, 2000 (Washington, DC), joint public meetings were held by FDA and 
FSIS to solicit and discuss information related to the implementation 
of the objectives in the Egg Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to 
publish a proposed rule to require that shell eggs be produced under a 
plan that is designed to prevent transovarian SE from contaminating 
eggs at the farm during production.
FDA intends to discuss in its proposal certain provisions of the 1999 
Food Code that are relevant to how eggs are handled, prepared, and 
served at certain retail establishments. In addition, the agency plans 
to consider whether it should require provisions for certain retail 
establishments that serve populations most at risk of egg-related 
illness (i.e., the elderly, children, and the immunocompromised).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC14
_______________________________________________________________________




776. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21 
USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 
360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 
241; 42 USC 262; 42 USC 263b to 263n

CFR Citation: 21 CFR 56.106

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AC17

[[Page 30233]]

_______________________________________________________________________




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

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC19
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
prohibit the use of cervids (deer, elk) for food, including dietary 
supplements, and cosmetics if the cervids have been exposed to chronic 
wasting disease (CWD). FDA is proposing this regulation because of 
potential risks to health.
In addition to this proposed rule, FDA intends to issue guidance within 
the next few months on the use in animal feed or material from deer and 
elk that are positive for CWD or are at high risk of CWD.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group 
of fatal, neurodegenerative diseases that include bovine spongiform 
encephalopathy (BSE) in cattle, scrapie in sheep and goats, and 
Creutzfeldt-Jakob disease (CJD) in humans. The disease has been 
identified in wild and farmed elk and wild deer populations.
CWD has been found in cervid populations in certain areas of Wisconsin, 
Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota, 
New Mexico, Minnesota, and Canada. In 1999, the World Health 
Organization (WHO) said there is no evidence that CWD transmits to 
humans. However, it also suggested any part of a deer or elk believed 
to be diseased should not be eaten. Results of some studies using in 
vitro techniques have suggested that transmission to humans could 
possibly occur. However, if it does occur, it is likely to be through a 
very inefficient process.
Currently, there are no validated analytical tests to identify animals 
in the pre-clinical phase of CWD, or any other TSE. In addition, no 
test exists to ensure food safety. CWD typically exhibits a long 
incubation period, during which time animals appear normal but are 
potentially infectious. Therefore, FDA is proposing to require that 
food or cosmetic products derived from animals exposed to CWD not enter 
into commerce.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC21
_______________________________________________________________________




779. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Aileen Ciampa, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, HFD-7, Center for 
Drug Evaluation and Research, 1451 Rockville Pike, Rockville, MD 20857

[[Page 30234]]

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

RIN: 0910-AC23
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; 
21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381

CFR Citation: 21 CFR 50.23

Legal Deadline: None

Abstract: FDA is proposing an amendment to the exception from the 
general requirement for informed consent in certain circumstances 
involving the use of investigational in vitro diagnostic devices to 
identify chemical, biological, radiological, or nuclear threat agents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Catherine Lorraine, Director, Policy Development and 
Coordination Group, Department of Health and Human Services, Food and 
Drug Administration, 14-101-11, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 827-6777

RIN: 0910-AC25
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC30
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 800.20

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/31/03                    68 FR 15404
NPRM Comment Period End         06/30/03
Final Rule                      12/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AC32
_______________________________________________________________________




783. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN 
DRUGS

Priority: Other Significant

Legal Authority: 21 USC 355a

CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209

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

Abstract: To require the labeling of human drugs approved under section 
505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free 
number for reports of adverse events, and a statement that the number 
is to be used for reporting purposes only and not to receive medical 
advice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 30235]]

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

RIN: 0910-AC35
_______________________________________________________________________




784. ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION 
UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND 
RESPONSE ACT OF 2002

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

Unfunded Mandates: Undetermined

Legal Authority: PL 107-188, sec 303

CFR Citation: 21 CFR 1

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
303 of the Bioterrorism Act authorizes the Secretary, through FDA, to 
order the detention of food if an officer or qualified employee of FDA 
has credible evidence or information indicating an article of food 
presents a threat of serious adverse health consequences or death to 
humans or animals. The Act requires the Secretary, through FDA, to 
issue final regulations to expedite certain enforcement actions (i.e., 
seizures and injunctions) against perishable foods.
FDA intends to implement section 303 of the Act by proposing a 
regulation to provide for: 1) a detention procedure; 2) expedited 
procedures for enforcement actions with respect to perishable foods; 
and 3) an appeals procedure for detained goods.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Marquita Steadman, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, HFS-007, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 827-6733
Fax: 301 480-5730
Email: [email protected]

RIN: 0910-AC38
_______________________________________________________________________




785. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC 
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 107-188, sec 306

CFR Citation: 21 CFR 1

Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 306, directs the Secretary, through FDA, to issue 
final regulations establishing recordkeeping requirements by December 
12, 2003.

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
414(b) of the Federal Food, Drug and Cosmetic Act (FFDCA), which was 
added by section 306 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Act), authorizes the 
Secretary, through FDA, to promulgate final regulations by December 12, 
2003. The Act authorizes regulations that require the establishment and 
maintenance of records, for not longer than two years, that would allow 
the Secretary to identify the immediate previous sources and the 
immediate subsequent recipients of food, including its packaging. The 
required records would be those that are needed by FDA in order to 
address credible threats of serious adverse health consequences or 
death to humans or animals. Specific covered entities are those that 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food. Farms and restaurants are excluded. The Secretary is 
directed to take into account the size of a business in promulgating 
these regulations. Section 306 of the Act also added section 414(a) and 
amended section 704(a) of FFDCA to permit FDA to inspect these records 
and other information if the Secretary has a reasonable belief that an 
article of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Nega Beru, Supervisory Chemist, Office of Plant, Dairy 
Foods and Beverages, Department of Health and Human Services, Food and 
Drug Administration, HFS-305, Center for Food Safety and Applied 
Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1400
Fax: 301 436-2651
Email: [email protected]

RIN: 0910-AC39
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

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

[[Page 30236]]

proposing to amend the regulations for free-choice medicated feed and 
liquid medicated feed so that these provisions comply with the terms of 
the Animal Drug Availability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William D. Price, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, HFV-200, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6652
Fax: 301 594-4512

Related RIN: Previously reported as 0910-AB50
RIN: 0910-AC43
_______________________________________________________________________




787. [bull] SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM 
CLINICAL STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS

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

Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262

CFR Citation: 21 CFR 314.50; 21 CFR 601.14; 21 CFR 314.94

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend the 
regulations governing the format in which clinical study data (CSD) are 
required to be submitted for new drug applications (NDAs), biological 
license applications (BLAs), and abbreviated new drug applications 
(ANDAs). The proposal would revise our regulations to require CSD 
submitted for NDAs, ANDAs, BLAs, and their supplements and amendments 
be provided in electronic format and require the use of standard data 
structure, terminology, and code sets. The proposal would improve the 
efficiency of the exchange of information from clinical studies through 
the adoption of standards for study data submitted in an electronic 
form that FDA can process, review, and archive.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 3037, 
(HFD-7), 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AC52
_______________________________________________________________________




788. [bull] MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD 
MANUFACTURING PRACTICE REQUIREMENTS

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

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 353

CFR Citation: 21 CFR 201.161(a); 21 CFR 210.3(b); 21 CFR 211.94

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its current good manufacturing practice (CGMP) regulations and other 
regulations to clarify and strengthen requirements for the label, 
color, dedication, and design of medical gas containers and closures. 
Despite existing regulatory requirements and industry standards for 
medical gases, there have been repeated incidents in which cryogenic 
containers of harmful industrial gases have been connected to medical 
oxygen supply systems in hospitals and nursing homes, and subsequently 
administered to patients. These incidents have resulted in death and 
serious injury. There have also been several incidents involving high-
pressure medical gas cylinders that have resulted in death and injuries 
to patients. These proposed amendments, together with existing 
regulations, are intended to ensure that the types of incidents that 
have occurred in the past, as well as other types of foreseeable and 
potentially deadly medical gas mixups, do not occur in the future.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AC53
_______________________________________________________________________




789. [bull] FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS 
MODERNIZATION

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC 
371

CFR Citation: 21 CFR 130.5

Legal Deadline: None

Abstract: In 1995, the FDA and FSIS reviewed their regulatory 
procedures and requirements for food standards to determine whether any 
were still needed, and if so, whether any should be modified or 
streamlined. To request public comment to assist them in their review 
of the need for food standards, both agencies published advance notices 
of proposed rulemaking (ANPRMs) on food standards in December, 1995 (60 
FR 47453 and 60 FR 67492). These ANPRMs discussed the agencies' 
regulations and policy governing food standards, the history of food 
standards, and the possible need to revise the food standards. Several 
comments in response to the ANPRMs recommended that the agencies 
establish general principles or a fundamental philosophy for reviewing 
food standards and revising them. The agencies agreed with these 
comments and determined that it would be appropriate to develop general 
principles for reviewing and revising food standards regulations. The 
agencies also agreed with the comments that stated that the agencies 
should work in concert to develop consistent food standards 
regulations. FDA and FSIS are now proposing a set of general principles 
that define how modern food standards should be structured. If this

[[Page 30237]]

proposed rule is adopted, FDA and FSIS will require that a citizen 
petition for establishing, revising, or eliminating a food standard in 
21 CFR parts 130 to 169 and 7 CFR part 410 be submitted in accordance 
with the general principles. Conversely, the agencies may find 
deficient a petition to establish, revise, or eliminate a food standard 
that does not follow these general principles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/29/95                    60 FR 67492
ANPRM Comment Period End        04/29/96
NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and 
Human Services, Food and Drug Administration, HFS-820, Center for Food 
Safety and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]

RIN: 0910-AC54
_______________________________________________________________________




790. [bull] POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD 
MANUFACTURING PRACTICES

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 121

CFR Citation: 21 CFR 220

Legal Deadline: Final, Statutory, November 21, 1999.

Abstract: Section 121 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for 
current good manufacturing practices (CGMPs) for positron emission 
tomography (PET) drugs, a type of radiopharmaceutical. The proposed 
rule would adopt CGMPs that reflect the unique characteristics of PET 
drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

Related RIN: Previously reported as 0910-AB63
RIN: 0910-AC55
_______________________________________________________________________




791. [bull] REVISION OF THE REQUIREMENTS FOR SPORE-FORMING 
MICROORGANISMS

Priority: Other Significant

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

CFR Citation: 21 CFR 600.10(c); 21 CFR 600.11(e)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is issuing a direct 
final rule and a companion proposed rule to amend the biologics 
regulations by providing options to the existing requirement for 
separate, dedicated facilities and equipment for work with spore-
forming microorganisms. FDA is taking this action due to advances in 
facility, system and equipment design, and sterilization technologies, 
that would allow work with spore-forming microorganisms to be performed 
in multi-product manufacturing areas.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM-Companion to Direct Final 
Rule                            01/00/04
Direct Final Rule               01/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Valerie Butler, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Suite 200N 
(HFM-17), 1401 Rockville Pike, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 594-1944

RIN: 0910-AC57
_______________________________________________________________________




792. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 341 to 343; 21 USC 348; 21 USC 349; 
21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360c; 21 USC 
360e; 21 USC 360i; 21 USC 360j; 21 USC 360k; 21 USC 361; 21 USC 371; 21 
USC 379e; 42 USC 262

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

Related RIN: Previously reported as 0910-AC02
RIN: 0910-AC59

[[Page 30238]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors  NPRM 
07/09/96 (61 FR 36154)  NPRM Comment Period End 12/06/96  Final Action 
12/00/03

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

Infant Formula Quality Factors  NPRM Comment Period End 12/06/96  Final 
Action 12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Shellee Anderson, Food Technologist, Department of 
Health and Human Services, Food and Drug Administration, HFS-800, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-1491
Email: [email protected]

RIN: 0910-AA04
_______________________________________________________________________




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

Priority: Routine and Frequent

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

CFR Citation: 21 CFR 312.110

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/02                    67 FR 41642
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AA61
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 50; 21 CFR 312

Legal Deadline: None

Abstract: The final rule would establish criteria and standards for the 
President to apply in making a determination that informed consent is 
not feasible or is contrary to the best interest of military personnel 
engaged in specific military operations. Under Federal law, the 
President is authorized to waive the Federal Food, Drug, and Cosmetic 
Act's informed consent requirements in military operations, if the 
President finds that obtaining consent is infeasible, contrary to the 
best interests of recipients, or contrary to national security 
interests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/05/99                    64 FR 54180
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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

RIN: 0910-AA89

[[Page 30239]]

_______________________________________________________________________




796. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/22/00                    65 FR 81082
NPRM Comment Period End         03/22/01
NPRM Comment Period Reopened    03/30/01
NPRM Comment Period Reopening 
End                             06/22/01
Final Action                    10/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AA94
_______________________________________________________________________




797. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/28/99                    64 FR 34608
Final Action                    10/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB61
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

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

CFR Citation: 21 CFR 101

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/17/99                    64 FR 62746
NPRM Comment Period Reopened    12/05/00                    65 FR 75887
NPRM Comment Period End         01/19/01
NPRM Comment Period Reopened    11/15/02
NPRM Comment Period End         12/16/02
Final Rule                      06/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

[[Page 30240]]

Government Levels Affected: State, Tribal, Local

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

Agency Contact: Susan Thompson, Chemist, Department of Health and Human 
Services, Food and Drug Administration, (HFS-832), Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1450
Fax: 301 436-2639
Email: [email protected]

RIN: 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)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 21 CFR 606; 21 CFR 610

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

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




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

Priority: Other Significant

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

CFR Citation: 21 CFR 314; 21 CFR 601

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/02                    67 FR 22367
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 3037, 
(HFD-7), 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]

RIN: 0910-AB91
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 50; 21 CFR 56

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/24/01                    66 FR 20589
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Suite 3037 (HFD-7), 
Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852

[[Page 30241]]

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

RIN: 0910-AC07
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 201.323(c)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/02                    67 FR 52429
Final Action                    06/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AC18
_______________________________________________________________________




803. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS AND BLOOD

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 21 CFR 201.25; 21 CFR 601.67

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The final rule would require human 
drug products and biological products to have a bar code. The bar code 
would contain certain information about the product, and when used in 
conjunction with bar code scanners and computer equipment, would help 
reduce the number of medication errors. The final rule would also 
require the use of machine-readable information on blood and blood 
component container labels.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12500
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AC26
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/02                    67 FR 76056
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AC34
_______________________________________________________________________




805. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 107-188, sec 305

CFR Citation: 21 CFR 1

Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 305, directs the Secretary, through FDA, to issue 
a final regulation establishing registration requirements by December 
12, 2003. The statute is self-implementing on this date if FDA does not 
issue a final regulation that is effective by December 12, 2003.

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
415 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was 
added by section 305 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (the Bioterrorism Act), directs 
the Secretary to require any facility engaged in manufacturing, 
processing, packing, or holding of food for consumption by humans or 
animals in the United States to be registered with the Secretary 
through FDA. Section 415 directs the Secretary, through FDA, to 
promulgate final regulations implementing the requirements by December 
12, 2003. The owner, operator, or agent in charge of the facility must 
submit the registration. Foreign facilities must include the name of 
the United States agent for the facility. The registration must include 
the name and address of each facility at which, and all trade names 
under which, the registrant conducts business. If FDA determines

[[Page 30242]]

it is necessary through guidance, the registration must include the 
general food category (as identified under 21 CFR 170.3) of foods 
manufactured, processed, packed, or held at the facility. The 
registrant is required to notify the Secretary of changes to the 
registration in a timely manner. Under the proposed rule, upon receipt 
of the completed registration form, FDA would notify the registrant of 
receipt of the registration and assign a unique registration number to 
the facility. The Bioterrorism Act requires the Secretary to compile 
and maintain an up-to-date list of registered facilities. This list and 
any registration documents submitted to the Secretary are not subject 
to disclosure under the Freedom of Information Act. For purposes of 
section 415, ``facility'' includes any factory, warehouse, or 
establishment engaged in the manufacturing, processing, packing, or 
holding of food. Exempt from the registration requirement are farms, 
restaurants, other retail food establishments, nonprofit food 
establishments in which food is prepared for or served directly to the 
consumer, and fishing vessels (except those engaged in processing as 
defined in 21 CFR 123.3(k)). Foreign facilities required to register 
include only those from which food is exported to the United States 
without further processing or packaging outside the United States. The 
Bioterrorism Act provides that if a foreign facility attempts to import 
food into the United States without having registered, the food will be 
held at the port of entry or at a secure facility, until the foreign 
facility has registered.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5377
Final Rule                      10/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Leslye M. Fraser, Associate Director for Regulations, 
Office of Regulations and Policy, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2378
Fax: 301 436-2637
Email: [email protected]

RIN: 0910-AC40
_______________________________________________________________________




806. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND 
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 107-188, sec 307

CFR Citation: 21 CFR 1.276 et seq

Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, section 307, directs the Secretary, through FDA, to issue 
final regulations establishing prior notice requirements for all 
imported food by December 12, 2003. If FDA fails to issue final 
regulations by this date, the statute is self-executing on this date, 
and requires FDA to receive prior notice of not less than eight hours, 
nor more than five days until final regulations are issued.

Abstract: This rulemaking is one of a number of actions being taken to 
improve FDA's ability to respond to threats of bioterrorism. Section 
801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was 
added by section 307 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, authorizes the Secretary, 
through FDA, to promulgate final regulations by December 12, 2003. 
Section 801(m) requires notification to FDA prior to the entry of 
imported food. The required prior notice would provide the identity of 
the article of food; the manufacturer; the shipper; the grower, if 
known at the time of notification; the originating country; the 
shipping country; and the anticipated port of entry. The regulation 
identifies the parties responsible for providing the notice and 
explains the information that the prior notice is required to contain, 
the method of submission of the notice, and the minimum and maximum 
period of advance notice required. Section 307 also states that if FDA 
does not receive prior notice or receives inadequate prior notice, the 
imported food shall be refused admission and held at the port of entry 
until proper notice is provided.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/03/03                     68 FR 5428
Final Rule                      10/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

URL For More Information:
http://www.fda.gov/ohrms/dockets/98fr/03-2444.pdf

URL For Public Comments:
http://www.fda.gov/dockets/ecomments

Agency Contact: Mary Ayling, Lead, Inspection and Compliance Team, Food 
Safety Staff, Department of Health and Human Services, Food and Drug 
Administration, HFS-32, Center for Food Safety and Applied Nutrition, 
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2605
Email: [email protected]

RIN: 0910-AC41
_______________________________________________________________________




807. PRESUBMISSION CONFERENCES

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b

CFR Citation: 21 CFR 514

Legal Deadline: None

Abstract: This rule will implement section 512(b)(3) of the Federal 
Food, Drug, and Cosmetic Act (the Act). This section of the Act states 
that any person intending to file a new animal drug application or 
supplemental new animal drug application, or to investigate a new 
animal drug is entitled to one or more conferences with the agency 
prior to submission to reach an agreement establishing a submission or 
investigational requirement. This rule would describe how to request a 
presubmission conference and describe the procedures for the conduct of 
presubmission conferences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/25/00                    65 FR 51782
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

[[Page 30243]]

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, HFV-100, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-0205

Related RIN: Previously reported as 0910-AB68
RIN: 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

Priority: Economically Significant. Major under 5 USC 801.

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

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

CFR Citation: 21 CFR 314.52(a)(3); 21 CFR 314.53(b); 21 CFR 
314.53(c)(1); 21 CFR 314.53(c)(2); 21 CFR 314.95(a)(3)

Legal Deadline: None

Abstract: The final rule would clarify the types of patents for which 
information must or must not be submitted to FDA. The final rule would 
also revise the patent declaration to make it more detailed. The rule 
would also revise the regulations regarding the approval date for 
certain abbreviated new drug applications or ``505(b)(2) applications'' 
by stating that there is only one opportunity for a 30-month stay in 
the approval date of an ANDA or 505(b)(2) application.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/24/02                    67 FR 65448
NPRM Comment Period End         12/23/02
Final Rule                      05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jarilyn Dupont, Department of Health and Human 
Services, Food and Drug Administration, Office of Policy, Planning and 
Legislation (HF-11), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777
Email: [email protected]

RIN: 0910-AC48
_______________________________________________________________________




809. [bull] BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS; 
IMPLEMENTATION OF EFFICACY REVIEW

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360c; 21 
USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 360gg-360ss; 21 USC 371; 21 
USC 372; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 
42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264

CFR Citation: 21 CFR 201.59; 21 CFR 610.21

Legal Deadline: None

Abstract: The final rule amends the FDA biologics regulations in 
response to the report and recommendations of the Panel on Review of 
Bacterial Vaccines and Toxoids with Standards of Potency (the Panel). 
The Panel reviewed the safety, efficacy, and labeling of bacterial 
vaccines and toxoids with standards of potency, bacterial antitoxins, 
and immune globulins. On the basis of the Panel's findings and 
recommendations, FDA is classifying these products as Category I (safe, 
effective, and not misbranded), Category II (unsafe, ineffective, or 
misbranded), or Category IIIB (off the market pending completion of 
studies permitting a determination of effectiveness).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/13/85                    50 FR 51002
NPRM Comment Period End         03/13/86
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Astrid L. Szeto, Senior Reguatory Review Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944

RIN: 0910-AC56
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




810. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The proposed rule would amend the 
expedited and periodic safety reporting regulations for human drugs and 
biological products to revise certain definitions and reporting formats 
as recommended by the International Conference on Harmonisation and to 
define new terms; to add to or revise current reporting requirements; 
to revise certain reporting time frames; and propose other revisions to 
these regulations to enhance the quality of safety reports received by 
FDA.

[[Page 30244]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/03                    68 FR 12406
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

RIN: 0910-AA97
_______________________________________________________________________




811. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND 
CELLULAR AND TISSUE-BASED PRODUCTS

Priority: Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AB27
_______________________________________________________________________




812. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR 
AND TISSUE-BASED PRODUCTS ESTABLISHMENTS; INSPECTION AND ENFORCEMENT

Priority: Other Significant

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

CFR Citation: 21 CFR 1270 and 1271

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is requiring human 
cell, tissue, and cellular and tissue-based products (HCT/P) 
establishments to follow current good tissue practice (CGTP), which 
governs the methods used in, and the facilities and controls used for, 
the manufacture of HCT/Ps, recordkeeping, and the establishment of a 
quality program. FDA is also issuing regulations pertaining to 
labeling, reporting, inspections, and enforcement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AB28
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 500.80; 21 CFR 500.82; 21 CFR 500.84; 21 CFR 
500.88

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/17/02                     67 FR 2384
NPRM Comment Period Ends        04/17/02
Final Action                    12/23/02                    67 FR 78172


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steven Brynes, Regulatory Scientist, Department of

[[Page 30245]]

Health and Human Services, Food and Drug Administration, HFV-151, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6975
Email: [email protected]

Related RIN: Previously reported as 0910-AC13
RIN: 0910-AC45
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 610.11(g)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/04/03                    68 FR 10157

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley
Phone: 301 827-6210

RIN: 0910-AB51
_______________________________________________________________________




815. ANTIBIOTIC RESISTANCE LABELING

Priority: Other Significant

CFR Citation: 21 CFR 201.24

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      02/06/03                     68 FR 6062

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB78
_______________________________________________________________________




816. RECORDS AND REPORTS CONCERNING EXPERIENCE WITH APPROVED NEW ANIMAL 
DRUGS

Priority: Other Significant

CFR Citation: 21 CFR 514.80

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/31/03                    68 FR 15255

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Glenn Peterson
Phone: 301 827-0224
Fax: 301 827-1485
Email: [email protected]

Related RIN: Previously reported as 0910-AA02
RIN: 0910-AC42
_______________________________________________________________________




817. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 320

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      12/19/02                    67 FR 77668

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

Related RIN: Previously reported as 0910-AA51
RIN: 0910-AC47

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
NPRM Comment Period End         02/22/99
Second NPRM                     05/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

[[Page 30246]]

Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA41
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 5; 42 CFR 51c

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
NPRM Comment Period End         01/04/99
Second NPRM                     10/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Andy Jordan, Acting Chief, Shortage Designation Branch, 
Department of Health and Human Services, Health Resources and Services 
Administration, Room 8C26, National Center for Health Workforce 
Analysis, Bureau of Health Professions, Parklawn Building, Rockville, 
MD 20857
Phone: 301 594-0197
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0906-AA57

_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




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

Priority: Info./Admin./Other

Legal Authority: 25 USC 3201 et seq

CFR Citation: 42 CFR 36

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/99                    64 FR 14559
NPRM Comment Period End         07/26/99
Final Action                    10/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Ramona D. Williams, Child Protection Coordinator, 
Department of Health and Human Services, Indian Health Service, Suite 
605, 12300 Twinbrook Parkway, Rockville, MD 20852
Phone: 301 443-1589

RIN: 0917-AA02


[[Page 30247]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




822. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NATIONAL INSTITUTES OF HEALTH (NIH)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68b

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA10
_______________________________________________________________________




823. NATIONAL INSTITUTES OF HEALTH (NIH) TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 285g-10

CFR Citation: 42 CFR 63a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA28
_______________________________________________________________________




824. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 59

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA31
_______________________________________________________________________




825. NATIONAL INSTITUTES OF HEALTH (NIH) AIDS RESEARCH LOAN REPAYMENT 
PROGRAM

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 68

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA32
_______________________________________________________________________




826. [bull] NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT 
PROGRAM FOR CLINICAL RESEARCHERS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-5a

CFR Citation: 42 CFR 68g

Legal Deadline: None

[[Page 30248]]

Abstract: The National Institutes of Health proposes to establish 
implementing regulations for the Extramural Loan Repayment Program for 
Clinical Researchers, authorized under section 487F of the Public 
Health Service Act. The program provides for the repayment of the 
existing educational loan debt of qualified health professionals who 
agree to conduct clinical research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA33
_______________________________________________________________________




827. [bull] NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN 
REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-6

CFR Citation: 42 CFR 68e

Legal Deadline: None

Abstract: The National Institutes of Health proposes to establish 
implementing regulations for Pediatric Research Loan Repayment Program, 
authorized under section 487F of the Public Health Service Act. The 
program provides for the repayment of the existing educational loan 
debt of qualified health professionals who agree to conduct pediatric 
research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA34
_______________________________________________________________________




828. [bull] LOAN REPAYMENT PROGRAM FOR HEALTH DISPARITIES RESEARCH

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 287c-33

CFR Citation: 42 CFR 68f

Legal Deadline: None

Abstract: The National Institutes of Health proposes to establish 
implementing regulations for the Loan Repayment Program for Health 
Disparities Research, authorized under section 485G of the Public 
Health Service Act. The program provides for the repayment of the 
existing educational loan debt of qualified health professionals who 
agree to conduct research on minority health or other health 
disparities for a minimum of two years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA35
_______________________________________________________________________




829. [bull] NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN 
REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-5

CFR Citation: 42 CFR 68a

Legal Deadline: None

Abstract: The National Institutes of Health proposes to amend the 
regulations governing the Clinical Research Loan Repayment Program for 
Individuals from Disadvantaged Backgrounds to reflect the new maximum 
annual loan amount of $35,000 and a change in program eligibility to 
include qualified health professionals who are not NIH employees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA36

[[Page 30249]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




830. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH 
GENERALLY

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68d

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/05/02                    67 FR 50622
Final Rule                      09/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA18
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 52h

Legal Deadline: None

Abstract: NIH staff have found ambiguities, misstatements, and voids in 
the existing regulations on research misconduct. These regulations, 
which govern the first level of review, are being amended to reflect 
current policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/00                    65 FR 57132
Final Rule                      09/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA20
_______________________________________________________________________




832. NATIONAL INSTITUTES OF HEALTH (NIH) CENTER GRANTS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 52a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/12/02                    67 FR 68548
Final Rule                      09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA24

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




833. PUBLIC HEALTH SERVICES POLICIES ON RESEARCH MISCONDUCT

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 93

Legal Deadline: None

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

[[Page 30250]]

institutions to allegations of research misconduct. The current 
regulation, which implemented section 493(e) of the Public Health 
Service Act, would be deleted, and a new part 93, subparts A, B, C, D, 
and E would be added.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/03
NPRM Comment Period End         10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal, Director, Office of Research Integrity, 
Department of Health and Human Services, Office of Public Health and 
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 443-3400
Fax: 301 443-5351

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




834. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS 
REGISTRATION REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart F 
to Department of Health and Human Services (HHS) regulations for 
protection of human subjects, 45 CFR part 46, to require registration 
of institutional review boards (IRBs) with HHS. The registration 
information would include contact information, approximate numbers of 
active protocols involving research conducted or supported by HHS and 
other Federal agencies, accreditation status, IRB membership, and 
staffing for the IRB. The proposed registration requirements will make 
it easier for Office for Human Research Protections (OHRP) to convey 
information to IRBs and will support the current IRB registration 
operated by OHRP. Under the current OHRP IRB registration system, the 
submission of certain registration information is required by human 
subjects protection regulations, and certain other information may be 
submitted voluntarily. This proposed information collection was 
submitted to the Office of Management and Budget under the Paperwork 
Reduction Act. Under the proposed rule, all registration information 
will be required, making the IRB registration system uniform with IRB 
registration requirements of the Food and Drug Administration (FDA), 
and creating a single, HHS IRB Registration system. FDA will 
simultaneously publish a proposed rule regarding FDA IRB registration 
requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03
NPRM Comment Period End         09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and 
Human Services, Office of Public Health and Science, Suite 200, The 
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527
Email: [email protected]

RIN: 0940-AA06
_______________________________________________________________________




835. [bull] HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND 
EDUCATION REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW 
BOARD MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND 
INVESTIGATOR

Priority: Other Significant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes to add subpart E 
to Department of Health and Human Services (DHHS) regulations for 
protection of human subjects, 45 CFR part 46, and would require that 
institutions engaged in human subjects research covered by an assurance 
of compliance filed with the Office for Human Research Protections 
ensure that Institutional officials, institutional review board (IRB) 
chairpersons, and human protection administrators receive appropriate 
training and education about the institution's assurance and that IRB 
chairpersons and members, IRB staff, investigators, and other personnel 
involved in the conduct or oversight of human subjects research receive 
appropriate training and education about relevant human subjects 
protection requirements. The proposed training and education 
requirements will help to ensure that responsible individuals at 
assured institutions understand and meet their regulatory 
responsibilities for human subjects protection.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03
NPRM Comment Period End         09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael A. Carome MD, Department of Health and Human 
Services, Office of Public Health and Science, Suite 200, The Tower 
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527

RIN: 0940-AA08

[[Page 30251]]

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




836. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH 
MISCONDUCT WHISTLEBLOWERS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 94

Legal Deadline: None

Abstract: To implement section 493(e) of the Public Health Service Act 
(added by section 163 of the National Institutes of Health 
Revitalization Act of 1993, Pub. L. 103-43), the Department is 
proposing to add a new part 94 to title 42 of the Code of Federal 
Regulations. Under this proposed regulation, covered institutions must 
follow certain requirements for preventing and responding to 
occurrences of retaliation against whistleblowers. The purpose of this 
part is to protect: (1) persons who make a good faith allegation that a 
covered institution or member thereof engaged in, or failed to respond 
adequately to an allegation of research misconduct; and (2) persons who 
cooperate in good faith with an investigation of research misconduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Action                    12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Chris Pascal, Director, Office of Research Integrity, 
Department of Health and Human Services, Office of Public Health and 
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 443-3400
Fax: 301 443-5351

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

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1395rr

CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 
410; 42 CFR 412, 42 CFR 413, 414; 42 CFR 488; 42 CFR 489; 42 CFR 494

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

RIN: 0938-AG82
_______________________________________________________________________




838. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR 
CERTIFICATION AND RECERTIFICATION OF TRANSPLANT CENTERS TO PERFORM ORGAN 
TRANSPLANTS (CMS-3835-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

Aucha Prachanronarong, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9614

RIN: 0938-AH17
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 418

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

[[Page 30252]]

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Rossi Coajou, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051

Danielle Shearer, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6617

RIN: 0938-AH27
_______________________________________________________________________




840. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, HOME 
NUTRITION THERAPY (CMS-6010-P)

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: This proposed rule would implement certain provisions in the 
statute relating to DMEPOS suppliers and establish service standards 
for suppliers of home oxygen equipment and therapeutic shoes home 
nutrition therapy. Establishing these standards would ensure that 
suppliers are qualified to provide the appropriate health care services 
and help safeguard the Medicare program and its beneficiaries from any 
instances of fraudulent or abusive billing practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AJ98
_______________________________________________________________________




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

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1396d

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Anita Panicker, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S3-04-26, Office of 
Clinical Standards & Quality, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-5646
Email: [email protected]

RIN: 0938-AK23
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 162

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

Abstract: This rule proposes an electronic standard for claims 
attachments. The standard is required by the Health Insurance 
Portability and Accountability Act (HIPAA) of 1966. It would be used to 
transmit clinical data, beyond those data contained in the claims 
standard, to help establish medical necessity for coverage.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Federal, Tribal

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

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

RIN: 0938-AK62
_______________________________________________________________________




843. INPATIENT DISPROPORTIONATE SHARE HOSPITAL (DSH) ADJUSTMENT: 
CALCULATION OF MEDICAID PATIENT AND TOTAL PATIENT DAYS IN THE MEDICARE 
DSH ADJUSTMENT (CMS-1171-P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 412106

Legal Deadline: None

Abstract: This proposed rule would revise applicable regulations to 
clarify certain issues in the calculation of Medicaid patient days and 
total patient days. It describes the criteria to use in calculating the 
Medicare DSH adjustment for hospitals for purposes of payment under the 
hospital inpatient prospective payment system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Deputy Division Director, Center for 
Health Plans and Providers, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-

[[Page 30253]]

07-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4548

RIN: 0938-AK77
_______________________________________________________________________




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

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

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: The proposed rule would eliminate the written statement of 
intent procedures for filing Medicare claims from the current Medicare 
regulation. Providers, suppliers, and other qualified claimants would 
still have 15 to 27 months to submit valid claims to Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Federal

Federalism:  Undetermined

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

RIN: 0938-AK79
_______________________________________________________________________




845. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-P)

Priority: Other Significant

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

CFR Citation: 42 CFR 486.301

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

Abstract: This rule would establish conditions for coverage for organ 
procurement organizations (OPOs) to be certified by the Secretary to 
receive payment from Medicare and Medicaid for organ procurement costs, 
and to be designated by the Secretary for a specific geographic service 
area. The Organ Procurement Organization Certification Act of 2000 
requires CMS to increase the certification cycle for OPOs from two 
years to four years and to promulgate new performance standards for 
OPOs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/28/01                    66 FR 67109
Proposed Rule                   09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AK81
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 406.12

Legal Deadline: None

Abstract: This proposed rule would implement the Ticket to Work and 
Work Incentives Improvement Act of 1999. It would provide working 
disabled individuals with continued Medicare entitlement for an 
additional 54 months beyond the current limit, for a total of 78 months 
of Medicare coverage following the 15th month of the extended period of 
eligibility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AK94
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 405.378

Legal Deadline: None

Abstract: This proposed rule would change the formula for computing 
interest on provider and supplier overpayments and underpayments to 
make it consistent with the new CMS accounting system (HIGLAS).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AL14
_______________________________________________________________________




848. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-554, Children's Health Act of 2000

CFR Citation: Not Yet Determined

[[Page 30254]]

Legal Deadline: None

Abstract: This proposed rule would implement provisions of the 
Children's Health Act (CHA) related to the use of restraints or 
seclusion for individuals receiving services in health care facilities 
that receive Federal funding. The rule would establish common 
terminology and basic expectations for the use of restraints and 
seclusion for health care facilities that furnish inpatient or 
residential care and receive Medicare or Medicaid funding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Frank Sokolik, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-13-23, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-7089

RIN: 0938-AL26
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This rule would remove respiratory assist devices with bi-
level capability and a back-up rate from the category of items 
requiring frequent and substantial servicing, as defined in section 
1834 (a)(3) of the Act, and place them in the category for other items, 
or capped rental items, as defined in section 1834(a)(7) of the Act. 
This rule would correct an error that occurred in 1992, when these 
devices were inappropriately placed in the category for items requiring 
frequent and substantial servicing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AL27
_______________________________________________________________________




850. PERMITTING PREMIUM REDUCTIONS AS ADDITIONAL BENEFITS UNDER 
MEDICARE+CHOICE PLANS (CMS-6016-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 408.ff

Legal Deadline: Final, Statutory, January 1, 2003.

Abstract: This proposed rule implements section 606 of BIPA to allow 
M+C organizations to elect a reduction in capitation payments so that 
these organizations could offer Medicare part B premium reductions to 
enrollees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Agency Contact: Michele Sanders, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0808

RIN: 0938-AL49
_______________________________________________________________________




851. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES FY 
2004(CMS-1213-P)

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

Legal Authority: PL 106-113, sec 124

CFR Citation: 42 CFR 412, subpart N

Legal Deadline: NPRM, Statutory, October 1, 2002, Public Law 106-113, 
sec 124.

Abstract: This proposed rule would set forth a prospective payment 
system for inpatient psychiatric facilities and psychiatric units.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Agency Contact: Lana Price, Director, Division of Chronic Care 
Management, Chronic Policy Group, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-05-27, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4533

RIN: 0938-AL50
_______________________________________________________________________




852. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would redefine, clarify, and update the 
guidelines and procedures for Provider Reimbursement Review Board 
appeals, based on recent court decisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, Department of Health and Human

[[Page 30255]]

Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4477

RIN: 0938-AL54
_______________________________________________________________________




853. SCHIP; PURCHASE OF FAMILY COVERAGE--BENEFIT FLEXIBILITY IN PARENT 
COVERAGE (CMS-2148-P)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 2110

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This proposed rule would provide flexibility to States in 
defining their benefit package for adults covered under the State 
Children's Health Insurance Program (SCHIP) family coverage options.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Stacey Bush, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-6102

RIN: 0938-AL62
_______________________________________________________________________




854. REQUEST FOR INFORMATION ON BENEFIT-SPECIFIC WAITING PERIODS (CMS-
2150-NC)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL64
_______________________________________________________________________




855. DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1842; Social Security Act, 
sec 1834(a)(12); Social Security Act, sec 1834(h)(3); Social Security 
Act, sec 1834(j)(1)(E)

CFR Citation: 42 CFR 421.210

Legal Deadline: None

Abstract: This proposed rule would allow flexibility in making changes 
to the DMERC contractor structure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kim Nyland, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S1-14-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2289

RIN: 0938-AL76
_______________________________________________________________________




856. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1832; Social Security Act, sec 1871

CFR Citation: 42 CFR 410; 42 CFR 424; 42 CFR 416; 42 CFR 488; 42 CFR 
489

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Brooks, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5526

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

RIN: 0938-AL80
_______________________________________________________________________




857. MEDICAID COVERAGE RULES FOR INMATES OF PUBLIC INSTITUTIONS (CMS-
2077-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1905(a)(A)

CFR Citation: 42 CFR 435.1008; 42 CFR 435.1009; 42 CFR 435.1012; 42 CFR 
436.1004

Legal Deadline: None

Abstract: This proposed rule would provide a new interpretation of the 
statute in order to eliminate confusion among the States and to ensure 
consistent application of the FFP exclusionary rules for services 
provided to inmates of a public institution.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: No

[[Page 30256]]

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: Tom Shenk, Center for Medicaid and State Operations, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295

RIN: 0938-AL85
_______________________________________________________________________




858. TARGETED CASE MANAGEMENT (CMS-2061-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1915(g) of the Social Security Act

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

Legal Deadline: None

Abstract: This proposed rule would amend the Medicaid regulations to 
provide for optional coverage of case management services furnished to 
specific groups, geographic areas, or political subdivisions within a 
State. This proposed rule rescinds the proposed rule that was published 
on October 15, 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kathy Poisal, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5940

RIN: 0938-AL87
_______________________________________________________________________




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

Priority: Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local, Federal

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

RIN: 0938-AL88
_______________________________________________________________________




860. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND FY 
2004 RATES (CMS-1470-P)

Priority: Economically Significant. Major under 5 USC 801.

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

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

Legal Deadline: NPRM, Statutory, April 1, 2003.
Final, Statutory, August 1, 2003.

Abstract: This proposed rule would revise the Medicare acute hospital 
inpatient prospective payment systems for operating and capital related 
costs to implement changes arising from our continuing experience with 
these systems. These changes apply to discharges occurring on or after 
October 1, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1304

Steve Miller, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6656

RIN: 0938-AL89
_______________________________________________________________________




861. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2004 (CMS-1469-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Sec 1888(e) of the Social Security Act

CFR Citation: 42 CFR 413.330 to 413.350

Legal Deadline: NPRM, Statutory, April 1, 2003.
Final, Statutory, July 31, 2003, final rule to be published before 
August 1, 2003.

Abstract: This annual proposed rule would update the payment rates used 
under the skilled nursing facilities prospective payment system 
beginning October 1, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL90

[[Page 30257]]

_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule proposes to revise the Medicare hospital 
outpatient payment system beginning January 1, 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Cindy Read, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-1852

RIN: 0938-AL91
_______________________________________________________________________




863. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 2004 
(CMS-1473-NC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, June 28, 2003, notice must be 
published by the June 28, 2003, deadline in order to meet the statutory 
effective date of October 1, 2003.

Abstract: This notice with comment period sets forth an update to the 
60-day national episode rates and the national per-visit amounts under 
the Medicare prospective payment system for home health agencies for FY 
2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AL94
_______________________________________________________________________




864. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2004 (CMS-1476-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0938-AL96
_______________________________________________________________________




865. MEDICAID HOME AND COMMUNITY-BASED SERVICES WAIVERS (CMS-2162-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1915(c) of the Social Security Act

CFR Citation: 42 CFR 441.300

Legal Deadline: None

Abstract: This proposed rule incorporates New Freedom Initiative 
recommendations/proposals into the HCBS waiver program to allow States 
greater flexibility in creating community-based long term care 
alternatives for eligible persons.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mary Clarkson, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5918

RIN: 0938-AM05
_______________________________________________________________________




866. REVISIONS TO AVERAGE WHOLESALE PRICE METHODOLOGY (CMS-1229-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1842(o) of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would propose revisions to the source and 
methodology for determining the average wholesale price (AWP) of drugs 
covered by Medicare incident to a physician's service.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Robert Niemann, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4569

RIN: 0938-AM12

[[Page 30258]]

_______________________________________________________________________




867. CRITERIA FOR DETERMINING WHETHER A DRUG IS CONSIDERED USUALLY SELF-
ADMINISTERED (CMS-1228-P)

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

Legal Authority: Social Security Act, sec 1861(s)(2)(B)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would solicit comments on the criteria to 
determine whether a drug is considered usually self-administered and 
therefore, not covered under part B of Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Robert Niemann, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4569

RIN: 0938-AM13
_______________________________________________________________________




868. ELECTRONIC MEDICARE CLAIMS SUBMISSION (CMS-0008-IFC)

Priority: Other Significant

Legal Authority: PL 107-105

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule implements the requirements for electronic 
submission of Medicare claims, submitted on or after October 16, 2003. 
In addition, this rule also implements the conditions upon which a 
waiver could be granted for these requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Elizabeth Holland, Center for Health Plans and 
Providers, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-1309

RIN: 0938-AM22
_______________________________________________________________________




869. MEDICAID ESTATE RECOVERIES (CMS-2083-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would require States to seek adjustment or 
recovery from the estates of Medicaid beneficiaries for amounts 
correctly spent by Medicaid on permanently institutionalized 
individuals (any age) and aged 55 or older for certain services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AM30
_______________________________________________________________________




870. [bull] PHYSICIAN OWNERSHIP IN SPECIALTY HOSPITALS (CMS-1240-P)

Priority: Substantive, Nonsignificant

Legal Authority: PL 101-239, OBRA 1989; PL 101-508, OBRA 1990; PL 103-
66, OBRA 1993; PL 103-432, Social Security Act Amendments of 1994

CFR Citation: 42 CFR 411

Legal Deadline: None

Abstract: This proposed rule would revise the regulations to specify 
that, for purposes of the physician self-referral prohibition, certain 
physician ownership or investment interests in specialty hospitals 
would not qualify for the ``whole hospital'' exception. In addition, 
this proposed rule would amend the definitions of ``radiology and 
certain other imaging services'' and ``radiation therapy services and 
supplies'' to include diagnostic and therapeutic nuclear medicine 
services and supplies, respectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jackie Proctor, Technical Advisor, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, C4-25-02, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-8852

RIN: 0938-AM35
_______________________________________________________________________




871. [bull] PROCEDURES FOR MAINTAINING CODE LISTS IN THE NEGOTIATED 
NATIONAL COVERAGE DETERMINATIONS FOR CLINICAL DIAGNOSTIC LABORATORY 
SERVICES (CMS-3119-P)

Priority: Routine and Frequent

Legal Authority: 42 USC 1395h(a); 42 USC 1395e; 42 USC 1395u(a); 42 USC 
1395x; 42 USC 1395y(a)(1)(A); 42 USC 1395y(a)(7)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would establish the procedures to be used 
for maintaining the lists of codes that were included in the national 
coverage determinations (NCDs) announced in the Federal Register on 
November 25, 2001 (66 FR 58788).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Jacqueline Sheridan, Office of Clinical Standards and 
Quality, Department of Health and

[[Page 30259]]

Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AM36
_______________________________________________________________________




872. [bull] HOSPITAL PATIENTS' RIGHTS COP--STANDARD SAFETY COMPLIANCE 
COMMITTEES (CMS-3120-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395bb; 42 USC 1395x; 42 USC 1396d

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This proposed rule would allow hospitals to waive the current 
requirement that a physician or licensed independent practitioner 
perform a one-hour face-to-face evaluation of a patient in restraint or 
seclusion for the purpose of behavior management. Under this proposed 
rule, a hospital could choose to have the one-hour assessment performed 
by another practitioner, such as a registered nurse, if that hospital 
established a Protections Compliance Committee to oversee the use of 
restraint or seclusion

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Nancy Archer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-05-27, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 401 786-0596

RIN: 0938-AM39
_______________________________________________________________________




873. [bull] AMBULANCE FEE SCHEDULE CONDITION CODES (CMS-1247-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1834(l) of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would propose the creation of condition codes to be 
used in billing for ambulance services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Don Thompson, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-10-26, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4586

RIN: 0938-AM45
_______________________________________________________________________




874. [bull] PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES--UPDATE FOR FY 2005 (CMS-1249-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Sec 1888(e) of the Social Security Act

CFR Citation: 42 CFR 413.330 to 413.350

Legal Deadline: NPRM, Statutory, July 30, 2004, Requires the final rule 
to be published by August 1, 2004.

Abstract: This annual proposed rule updates the payment rates used 
under the skilled nursing facilities prospective payment system 
beginning October 1, 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AM46
_______________________________________________________________________




875. [bull] MODIFICATIONS TO ELECTRONIC TRANSACTIONS AND CODE SETS (CMS-
0009-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1171 to 1179

CFR Citation: 42 CFR 162.1002; 42 CFR 162.1802

Legal Deadline: None

Abstract: This proposed rule would revise the electronic transactions 
and code set standards mandated by HIPPA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/04

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

Agency Contact: Stanley B. Nachimson, Senior Technical Advisor, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, N2-16-03, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6153

RIN: 0938-AM50
_______________________________________________________________________




876. [bull] REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 402, subpart C

[[Page 30260]]

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AM54
_______________________________________________________________________




877. [bull] REQUIREMENTS FOR NURSING HOMES TO IDENTIFY THE NUMBER OF 
LICENSED AND UNLICENSED NURSING STAFF PER SHIFT (CMS-3121-P)

Priority: Other Significant

Legal Authority: Sec. 1819(b) of the Social Security Act; 42 USC 1395i-
3(b)

CFR Citation: 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule will implement section 941 of BIPA, which 
requires nursing homes to post daily, for each shift, the number of 
licensed and unlicensed nursing staff directly responsible for resident 
care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Nancy Archer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-05-27, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 401 786-0596

RIN: 0938-AM55
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 484

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mercedes Benitex-McCray, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716

Steve Miller, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6656

RIN: 0938-AG81
_______________________________________________________________________




879. STANDARD UNIQUE NATIONAL HEALTH PLAN IDENTIFIERS (CMS-6017-F)

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 160; 45 CFR 162

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

RIN: 0938-AH87

[[Page 30261]]

_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 160; 42 CFR 162

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

Abstract: This final rule establishes a standard unique ID for all 
health care providers under the Health Insurance Portability and 
Accountability Act (HIPAA) of 1966 (Pub. L. 104-191). The rule 
implements administrative simplification initiatives that have a 
national scope beyond Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25320
NPRM Comment Period End         07/06/98
Final Action                    07/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State, Local, Tribal

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

Additional Information: None

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

RIN: 0938-AH99
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 405.874

Legal Deadline: None

Abstract: This final rule will extend appeal rights to all suppliers 
whose enrollment applications for Medicare billing privileges are 
disallowed by a carrier or whose Medicare billing privileges are 
revoked, except for those suppliers covered under other existing 
appeals provisions of our regulations. In addition, we will revise 
certain appeal provisions to correspond with the existing appeal 
provisions in those other sections of our regulations. We will also 
extend appeal rights to all suppliers not covered by existing 
regulations to ensure they have a full and fair opportunity to be 
heard.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Final Rule                      01/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AI49
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 403; 42 CFR 440.170; 42 CFR 488.2; 42 CFR 488.6; 
42 CFR 489.102; 42 CFR 412.90; 42 CFR 412.98; 42 CFR 431.610; 42 CFR 
440.155; 42 CFR 442.12; 42 CFR 456.351; 42 CFR 456.601; 42 CFR 476.1

Legal Deadline: Final, Statutory, July 1, 1998, BBA, section 4454(d).

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/30/99                    64 FR 67028
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jean Marie Moore, Center for Medicare Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




883. MEDICARE OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA 
REPORTING REQUIREMENTS (CMS-3006-F)

Priority: Other Significant. Major under 5 USC 801.

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Tribal

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

Agency Contact: Mercedes Benitex-McCray, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5716

RIN: 0938-AJ10

[[Page 30262]]

_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405; 42 CFR 491

Legal Deadline: None

Abstract: This rule amends the Medicare certification and payment 
requirements for rural health clinics (RHCs), as required by section 
4205 of the Balanced Budget Act of 1997. It changes the definition of a 
qualifying rural shortage area in which a Medicare RHC must be located; 
establishes criteria for identifying RHCs essential to delivery of 
primary care services that we can continue to approve as Medicare RHCs 
in areas no longer designated as medically underserved; and limits 
nonphysician practitioner staffing requirements. This rule imposes 
payment limits on provider-based RHCs and prohibits the use of RHC 
space, professional staff, equipment, and other RHC resources by 
another Medicare entity. The rule also requires RHCs to establish a 
quality assessment and performance improvement program. (The statute 
required that this rule be published by January 1, 1999.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/28/00                    65 FR 10450
Final Rule                      06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Worgo, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-15-18, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5919

RIN: 0938-AJ17
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

Abstract: This rule requires hospitals that transfuse blood and blood 
products to prepare and follow written procedures for appropriate 
action when it is determined that blood and blood products the hospital 
received and transfused are at increased risk for transmitting HCV; 
quarantine prior collections from a donor who is at increased risk for 
transmitting HCF infection; notify transfusion recipients, as 
appropriate, of the need for HCV testing and counseling; and maintain 
records for at least 10 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Final Rule                      11/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AJ29
_______________________________________________________________________




886. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-F)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: PL 105-33, sec 1961(dd); PL 105-33, sec 1814(i); PL 
105-33, sec 4441 to 4444; PL 105-33, sec 4448 to 4449; PL 106-113, sec 
131; PL 106-554, sec 321 to 322

CFR Citation: 42 CFR 418

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70363
Final Action                    01/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Saltz, Bureau of Policy Development, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4480

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




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

Priority: Economically Significant

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 441; 42 CFR 483

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 30263]]

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

RIN: 0938-AJ96
_______________________________________________________________________




888. ALL PROVIDER BAD DEBT PAYMENT (CMS-1126-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 42 USC 1395f(b); 42 USC 1395g; 42 USC 
1395.l(a); 42 USC 1395.l(i); 42 USC 1395.l(n); 42 USC 1395x(v); 42 USC 
1395cc; 42 USC 1395hh; 42 USC 1395rr; 42 USC 1395tt

CFR Citation: 42 CFR 413.80; 42 CFR 413.178

Legal Deadline: None

Abstract: This final rule will achieve a consistent bad debt 
reimbursement policy for all providers currently eligible to receive 
payments from Medicare for bad debt. It implements a court settlement 
agreement and removes the cap on End Stage Renal Disease (ESRD) bad 
debt reimbursement, which limits payment of allowable bad debts to the 
facility's unrecovered costs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/03                     68 FR 6682
NPRM Comment Period End         04/11/03
Final Action                    11/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AK02
_______________________________________________________________________




889. LABORATORY REQUIREMENTS RELATING TO QUALITY SYSTEMS AND CERTAIN 
PERSONNEL QUALIFICATIONS (CMS-2226-CN)

Priority: Other Significant

Legal Authority: PL 100-578

CFR Citation: 42 CFR 493

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/24/03                     68 FR 3640
Notice                          06/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Cecelia Hinkel, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services
Phone: 410 786-3347

RIN: 0938-AK24
_______________________________________________________________________




890. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-F)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA 2000

CFR Citation: 42 CFR 405

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

Abstract: This final rule would announce a new process for 
beneficiaries to appeal national and local coverage determinations 
(LCDs), including the role that the Department Appeals Board and, in 
the case of LCDs, Administrative Law Judges, will have in reviewing the 
decisions. It implements section 522 of the Benefits Improvement and 
Protection Act of 2000 (BIPA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/02                    67 FR 54534
NPRM Comment Period End         10/21/02
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AK60
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA

CFR Citation: None

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

Abstract: This notice will announce a revised process for making 
Medicare NCDs. It implements section 522 of the Medicare, Medicaid, and 
SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). (The 
statute requires this notice be effective by October 1, 2001.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal

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

RIN: 0938-AK61
_______________________________________________________________________




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

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

Legal Authority: 42 USC 1877

CFR Citation: 42 CFR 411

[[Page 30264]]

Legal Deadline: None

Abstract: This final rule incorporates into regulation certain 
statutory provisions that preclude payment for services under Medicare 
if a physician makes a referral to a facility in which he/she has a 
financial interest. It addresses comments from the January 9, 1998, 
proposed rule concerning the ownership, investment, and compensation 
exceptions. It also addresses comments from the January 4, 2001, final 
rule with comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AK67
_______________________________________________________________________




893. RATE OF REIMBURSEMENT OF PHOTOCOPY EXPENSES FOR QUALITY IMPROVEMENT 
ORGANIZATIONS (CMS-3055-F)

Priority: Economically Significant

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

CFR Citation: 42 CFR 476.78

Legal Deadline: None

Abstract: This rule increases the rate of reimbursement of photocopy 
expenses as required by the regulations governing Utilization and 
Quality Control Quality Improvement Organizations (QIOs). Our current 
regulations identify the photocopying reimbursement methodology for 
prospective payment system hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70358
Final Rule                      10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Les Caplan, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7223

RIN: 0938-AK68
_______________________________________________________________________




894. MODIFICATIONS TO MEDICARE MANAGED CARE RULES (CMS-4041-F)

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

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

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

Legal Deadline: None

Abstract: This final rule implements certain Medicare payment 
provisions of the Benefits and Improvement Act of 2000. Policy changes 
include premium reductions for M+C enrollees, uniform coverage for M+C 
plans in multiple locations, eliminating health disparities, ESRD 
enrollees, and increased civil money penalties for M+C organizations 
that terminate contracts mid-year. It also describes CMS's authority to 
waive or modify requirements that hinder the design of, or enrollment, 
in the M+C plans offered to employees or labor unions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/02                    67 FR 65672
Final Rule                      07/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

Agency Contact: Patricia Kurtz, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4670

RIN: 0938-AK71
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33

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

Legal Deadline: None

Abstract: This final rule finalizes the June 25, 2001, interim final 
rule that revised certain provisions of the January 11, 2001, final 
rule on the State Children's Health Insurance Program (SCHIP). This 
final rule responds to public comments and makes further refinements to 
the SCHIP.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/25/01                    66 FR 33810
Interim Final Rule Comment 
Period End                      07/26/01
Interim Final Rule Effective    08/24/01
Final Rule                      08/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

Agency Contact: Cheryl Austein-Casnoff, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4196

RIN: 0938-AL00
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1819(a) to (f) of the Social Security Act; sec 
1919(a) to (g) of the Social Security Act; PL 100-203

CFR Citation: 42 CFR 483.73; 42 CFR 483.75(c)

Legal Deadline: None

Abstract: This rule will allow long-term care facilities to use paid 
feeding assistants to supplement the services of

[[Page 30265]]

certified nurse aides. If facilities choose this option, feeding 
assistants must complete a specified training program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/29/02                    67 FR 15149
NPRM Comment Period End         05/28/02
Final Rule                      08/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Nola Petrovich, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4671

RIN: 0938-AL18
_______________________________________________________________________




897. HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP HEALTH 
INSURANCE ISSUERS (CMS-2151-F)

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 45 CFR 144.103; 45 CFR 146.111; 45 CFR 146.113; 45 CFR 
146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 146.120; 45 CFR 
146.125; 45 CFR 146.143; ...

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

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

RIN: 0938-AL43
_______________________________________________________________________




898. INTERIM FINAL AMENDMENT FOR MENTAL HEALTH PARITY (CMS-2152-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 2705; PL 107-116; PL 104-191

CFR Citation: 45 CFR 146.136

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/22/97                    62 FR 66932
Interim Final Rule Effective    01/01/98
Interim Final Rule Comment 
Period End                      03/23/98
Interim Final Rule              07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

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

RIN: 0938-AL44
_______________________________________________________________________




899. ELECTRONIC SUBMISSION OF COST REPORTS (CMS-1199-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 413.24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/26/02                    67 FR 48840
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AL51
_______________________________________________________________________




900. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-F)

Priority: Other Significant

Legal Authority: Sec 521 of BIPA

CFR Citation: 42 CFR 405

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

Abstract: This final regulation incorporates recommendations from an 
SSA/HHS workgroup to improve the Administrative Law Judge (ALJ) hearing 
process. ALJ-conducted hearings for Medicare fee-for-service and 
managed care cases are governed by SSA disability regulations which 
apply to SSA disability cases, not to Medicare. Regulations improve the 
integrity of the appeals process, because they are specific to the 
adjudication of Medicare cases. They also incorporate the revisions to 
appeals policy required by section 521 of BIPA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/15/02                    67 FR 69312
Final Rule                      09/00/03

Regulatory Flexibility Analysis Required: Undetermined

[[Page 30266]]

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Michale Edmondson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6478

RIN: 0938-AL67
_______________________________________________________________________




901. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR 
QUALIFYING INDIVIDUALS; FEDERAL FISCAL YEAR 2002 (CMS-2136-FN)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1902(a)(10); Social Security 
Act, sec 1933; 42 USC 139; PL 105-33

CFR Citation: None

Legal Deadline: None

Abstract: This final notice announces the Federal FY 2002 allotments 
that are available for State agencies to pay Medicare part B premiums 
for two distinct categories of low-income Medicare beneficiaries. The 
eligible groups are called qualified individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/30/02                    67 FR 55851
Final Action                    08/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL79
_______________________________________________________________________




902. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FOR FY 2004 
(CMS-1472-P)

Priority: Substantive, Nonsignificant

Legal Authority: BBRA 1999, sec 123; BIPA 2000, sec 307(b)

CFR Citation: 42 CFR 412; 42 CFR 413

Legal Deadline: None

Abstract: This rule updates the Prospective Payment System for Medicare 
payment of long-term care hospitals. It implements section 123 of the 
Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 
and section 307(b) of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/07/03                    68 FR 11234
Final Rule                      05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1304

RIN: 0938-AL92
_______________________________________________________________________




903. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION HOSPITALS 
FOR FY 2004 (CMS-1474-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 412 to 413

Legal Deadline: None

Abstract: This proposed rule will update rates for the prospective 
payment system for inpatient rehabilitation facilities for FY 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      08/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Related RIN: Related To 0938-AM57
RIN: 0938-AL95
_______________________________________________________________________




904. NONDISCRIMINATION IN POST-HOSPITAL REFERRAL TO HOME HEALTH AGENCIES 
AND OTHER ENTITIES (CMS-1224-F)

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33, Sec 4321 of the BBA

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This final rule establishes a process for collecting and 
maintaining information about hospitals referring Medicare patients to 
home health agencies (HHAs) with which the hospitals have a financial 
interest. Moreover, collected information will be available to the 
public to enhance its understanding and awareness of the availability 
of Medicare-certified HHAs to serve the Medicare population.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/02                    67 FR 70373
Final Action                    10/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Elizabeth Carmody, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-10-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7533

RIN: 0938-AM01
_______________________________________________________________________




905. UPDATE OF THE LIST OF COVERED PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS (CMS-1885-FC)

Priority: Other Significant

Legal Authority: 1883(i)(l) and (2) of the Social Security Act

CFR Citation: 42 CFR 416

Legal Deadline: None

Abstract: This final rule makes final the proposed additions to, and 
deletions from, the current list of Medicare covered Ambulatory 
Surgical Centers procedures.

[[Page 30267]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Bob Cereghino, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-03-06, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4645

Related RIN: Related To 0938-AH81
RIN: 0938-AM02
_______________________________________________________________________




906. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (CMS-2022-
F)

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

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121

Legal Deadline: None

Abstract: This document contains final rules governing the provisions 
prohibiting discrimination based on a health factor for group health 
plans and issuers of health insurance coverage offered in connection 
with a group health plan.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/17/97
Interim Final Rule Effective    07/17/97
Interim Final Rule              01/08/01                     66 FR 1378
Interim Final Rule Effective    03/09/01
Interim Final Rule Comment 
Period End                      04/09/01
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

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

RIN: 0938-AM14
_______________________________________________________________________




907. BONA FIDE WELLNESS PROGRAMS (CMS-2078-F)

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

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 146.121(f)

Legal Deadline: None

Abstract: This final rule implements and clarifies the term ``bona fide 
wellness program'' as it relates to regulations implementing the 
nondiscrimination provisions of the Internal Revenue Code, the Employee 
Retirement Income Security Act, and the Public Health Service Act, as 
added by the Health Insurance Portability and Accountability Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97
NPRM                            01/08/01                     66 FR 1421
NPRM Comment Period End         04/09/01
Final Action                    03/00/04

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

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

Related RIN: Related To 0938-AK91
RIN: 0938-AM15
_______________________________________________________________________




908. TIME LIMITATION ON RECALCULATIONS AND DISPUTES UNDER THE DRUG 
REBATE PROGRAM (CMS-2175-FC)

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

Legal Authority: 42 USC 1396r-8

CFR Citation: 42 CFR 447.534

Legal Deadline: None

Abstract: This rule will establish a three year time limitation on drug 
manufacturer's requests to recalculate their drug prices for the 
purposes of reporting data to CMS, as well as manufacturer's ability to 
dispute claims for rebates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      08/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  Undetermined

Agency Contact: Marge Lee Watchorn, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S1-01-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4361

RIN: 0938-AM20
_______________________________________________________________________




909. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2004 (CMS-8016-N)

Priority: Other Significant

Legal Authority: 42 USC 1395e-2(b)(2); Sec 1813(b)(2) of the Social 
Security Act

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 15, 2003.

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

[[Page 30268]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, N3-26-00, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AM31
_______________________________________________________________________




910. MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL INSURANCE 
PREMIUM RATE BEGINNING JANUARY 1, 2004 (CMS-8017-N)

Priority: Other Significant

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

CFR Citation: 42 CFR 407; 42 CFR 408

Legal Deadline: NPRM, Statutory, September 30, 2003.

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) enrollees in the Medicare 
Supplementary Medical Insurance (SMI) program for 2004. It also 
announces the monthly SMI premium to be paid by all enrollees during 
2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield, Office of Medicare and Medicaid 
Cost Estimates, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, N3-26-00, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6396

RIN: 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)

Priority: Other Significant

Legal Authority: 42 USC 1395i-2(d)(2); 42 USC 1395i-2a(d)(2); Sec 
1818(d)(2) of the Social Security Act; Sec 1818A(d)(2) of the Social 
Security Act

CFR Citation: None

Legal Deadline: NPRM, Statutory, September 30, 2003.

Abstract: This notice announces the hospital insurance premium for 
calendar year 2004 under Medicare's hospital insurance program (part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Director, Medicare and Medicaid 
Cost Estimates Group, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, N3-26-00, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AM33
_______________________________________________________________________




912. APPLICATION OF THE EMERGENCY MEDICAL TREATMENT AND LABOR ACT 
(EMTALA) (CMS-1063-F)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This regulation will clarify special responsibilities of 
Medicare hospitals that offer services for treatment of emergency 
medical conditions, to promote consistent application of the Emergency 
Medical Treatment and Labor Act to situations not discussed in current 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Hirshorn, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-06-06, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3411

Related RIN: Related To 0938-AL23
RIN: 0938-AM34
_______________________________________________________________________




913. [bull] APPROVAL OF THE JOINT COMMISSION ON ACCREDITATION OF 
HEALTHCARE ORGANIZATIONS (JCAHO) FOR DEEMING AUTHORITY FOR HOSPICES 
(CMS-2177-FN)

Priority: Routine and Frequent

Legal Authority: 42 USC 139bb

CFR Citation: None

Legal Deadline: None

Abstract: This final notice announces our decision to approve JCAHO for 
continued recognition as a national accreditation program for hospices 
that wish to participate in Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/03                     68 FR 3532
NPRM Comment Period End         03/24/03
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Cindy Melanson, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0310

RIN: 0938-AM38

[[Page 30269]]

_______________________________________________________________________




914. [bull] HOSPITAL COST-TO-CHARGE RATIOS USED TO CALCULATE COST 
OUTLIER PAYMENTS UNDER THE MEDICARE SHORT-TERM INPATIENT PROSPECTIVE 
PAYMENT SYSTEM (CMS-1243-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1102 of the Social Security Act; 42 USC 1871 of 
the Social Security Act

CFR Citation: 42 CFR 412.84; 42 CFR 412.116

Legal Deadline: None

Abstract: This proposed rule would change the methodology for 
determining payments for extraordinarily high-cost cases (cost 
outliers) made to Medicare-participating hospitals under the acute care 
hospital inpatient prospective payment system. We have become aware 
that, in some cases, hospitals' recent rates of charge increases 
greatly exceed their rates of cost increases. This disparity results in 
their cost-to-charge ratios being set too high, which in turn results 
in overestimation of their current costs per case. Therefore, we need 
to make revisions to our outlier payment methodology to correct those 
situations in which hospitals would otherwise receive overpayments for 
outlier cases due to excessive charge increases.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/05/03                    68 FR 10420
NPRM Comment Period End         04/04/03
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Deputy Division Director, Center for 
Health Plans and Providers, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4548

RIN: 0938-AM41
_______________________________________________________________________




915. [bull] FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES UPDATE FOR CY 
2004 (CMS-1232-N)

Priority: Other Significant

Legal Authority: 42 USC 1395m(1)(1)

CFR Citation: None

Legal Deadline: None

Abstract: This notice updates the fee schedule for ambulance services 
under the Medicare program, implementing section 1834(1) of the Social 
Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Anne Tayloe, Health Insurance Speacialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0000

RIN: 0938-AM44
_______________________________________________________________________




916. [bull] EXCLUSION OF MEDICARE BENEFITS FOR ALIENS NOT LAWFULLY 
PRESENT IN THE UNITED STATES (CMS-1222-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 5561 of BBA 1997; Sec 401(b) of the Personal 
Responsibility and Work Opportunity Act of 1996; 42 USC 1611(b)

CFR Citation: 42 CFR 411.11

Legal Deadline: None

Abstract: This interim final rule amends regulations to prohibit 
Medicare benefits to an alien who is not lawfully present in the United 
States. Section 5561 of the BBA amended section 401(b) of the Personal 
Responsibility and Work Opportunity Act of 1996 to prohibit Medicare 
payments for services furnished to an alien who is not ``lawfully 
present in the United States'' and meets certain other conditions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Frederick William Grabau, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-0206

RIN: 0938-AM47
_______________________________________________________________________




917. [bull] HOSPICE WAGE INDEX FOR FY 2004 (CMS-1233-N)

Priority: Routine and Frequent

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 418.306(C)

Legal Deadline: None

Abstract: This notice will announce the annual update to the hospice 
wage index. The update is effective October 1, 2003, through September 
30, 2004. The wage index is used to reflect local differences in wage 
levels, the hospice wage index methodology and values are based on 
recommendations of a negotiated rulemaking advisory committee and was 
originally published on August 8, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0938-AM56
_______________________________________________________________________




918. [bull] ANNOUNCEMENT OF APPLICATIONS FROM HOSPITALS REQUESTING 
WAIVERS FOR ORGAN PROCUREMENT SERVICE AREAS IN CY 2003 (CMS-1246-NC)

Priority: Routine and Frequent

Legal Authority: 42 USC 1138(2)(A)

CFR Citation: 42 CFR 486.306

Legal Deadline: None

Abstract: This notice announces three applications that we have 
received from

[[Page 30270]]

hospitals requesting waivers from entering into agreements with their 
designated organ procurement organizations (OPOs), in accordance with 
section 1138(a)(2) of the Social Security Act. This notice requests 
comments from OPOs and the general public for our consideration in 
determining whether we should grant these waivers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mark Horney, CHPP, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4554

RIN: 0938-AM59
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/25/03                    68 FR 22064


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Formerly known as HCFA-1023-P

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

RIN: 0938-AH73
_______________________________________________________________________




920. FIRE SAFETY REQUIREMENTS FOR CERTAIN HEALTH CARE FACILITIES (CMS-
3047-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/01                    66 FR 54179
Final Action                    01/10/03                     68 FR 1374


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Danielle Shearer, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6617

RIN: 0938-AK35
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.21

Legal Deadline: None

Abstract: This final rule addresses provisions relating to the 
development and implementation of a QAPI program and its components. It 
imposes several requirements that are designed to increase patient 
safety and track the methodologies, and/or programs or both, used to 
increase patient safety. The final rule requires a hospital in 
collaboration with CMS and other Federal agencies, the Peer Review 
Organizations (PROs), State survey agencies, and accrediting bodies to 
ensure that it is involved in a QAPI program that will track and 
exhibit activities that address all issues related to patient safety 
and medical errors. In addition, hospitals must work with these groups 
to identify errors and potential errors that may affect patient 
outcomes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66725
NPRM Comment Period End         02/17/98
Final Rule                      01/24/03                     68 FR 3435


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Nancy Archer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-05-27, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 401 786-0596

RIN: 0938-AK40

[[Page 30271]]

_______________________________________________________________________




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)

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 405; 42 CFR 419

Legal Deadline: None

Abstract: This notice corrects an error that appeared in the Outpatient 
PPS final rule with comment period published on November 1, 2002 (67 FR 
66719). This notice is a supplement to that rule and sets forth our 
rationale for waiving the notice and comment period for certain 
provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          03/18/02                    67 FR 11969
Proposed Rule                   08/09/02                    67 FR 52092
Comment Period End              10/07/02
Final Action                    11/01/02                    67 FR 66718
Correction Notice               11/15/02                    67 FR 69146
Correction Notice               02/10/03                     68 FR 6636


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Cindy Read, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-1852

Related RIN: Related To 0938-AK59
RIN: 0938-AL19
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




923. SECURITY STANDARDS (CMS-0049-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 162

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      02/20/03                     68 FR 8334

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: Barbara Clark
Phone: 410 786-3017

RIN: 0938-AI57
_______________________________________________________________________




924. EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE ORGANIZATIONS 
(CMS-2015-F)

Priority: Other Significant

CFR Citation: 42 CFR 438

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/24/03                     68 FR 3586

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

Agency Contact: Sharon Gilles
Phone: 410 786-1177

RIN: 0938-AJ06
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 42 CFR 422; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/16/03                    68 FR 16652

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Chrislyn Gayhead
Phone: 410 786-6429

RIN: 0938-AK48
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 45 CFR 162

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/20/03                     68 FR 8381

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Gladys Wheeler
Phone: 410 786-0273

RIN: 0938-AK64
_______________________________________________________________________




927. MEDICAID MANAGED CARE; NEW PROVISIONS (CMS-2104-F2)

Priority: Info./Admin./Other

CFR Citation: 42 CFR 400

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Correction Notice               10/25/02                    67 FR 65504

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bruce Johnson
Phone: 410 786-0615

Deirdre Duzor
Phone: 410 786-4626

RIN: 0938-AK96
_______________________________________________________________________




928. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2003 (CMS-1204-F2)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 410; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          11/05/02                    67 FR 67318
Final Rule with Comment Period  12/31/02                    67 FR 79966
Final Action                    02/28/03                     68 FR 9567

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Marc Hartstein

[[Page 30272]]

Phone: 410 786-4539

RIN: 0938-AL21
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/21/02                    67 FR 64641

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AL56
_______________________________________________________________________




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

Priority: Economically Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/21/02                    67 FR 64643

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield
Phone: 410 786-6396

RIN: 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)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/21/02                    67 FR 64649

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AL69
_______________________________________________________________________




932. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES--UPDATE FOR CY 2003 
(CMS-1220-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          11/22/02                    67 FR 70442

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Robert Niemann
Phone: 410 786-4569

RIN: 0938-AL97
_______________________________________________________________________




933. TICKET TO WORK MEDICAID INFRASTRUCTURE GRANT (CMS-2165-N)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          02/28/03                     68 FR 9672

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joe A Razes
Phone: 410 786-6126
Email: [email protected]

RIN: 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)

Priority: Other Significant

CFR Citation: 42 CFR 411.354

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/22/02                    67 FR 70322
Final Action Effective          11/22/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer
Phone: 410 786-4620

Related RIN: Related To 0938-AL29
RIN: 0938-AM21
_______________________________________________________________________




935. [bull] ANNOUNCEMENT OF APPLICATIONS FROM HOSPITALS REQUESTING 
WAIVERS FOR ORGAN PROCUREMENT SERVICE AREAS CY 2002 (CMS-1241-NC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1138(2)(A)

CFR Citation: 42 CFR 486.306

Legal Deadline: None

Abstract: This notice announces three applications that we have 
received from hospitals requesting waivers from entering into 
agreements with their designated organ procurement organizations 
(OPOs), in accordance with section 1138(a)(2) of the Social Security 
Act. This notice requests comments from OPOs and the general public for 
our consideration in determining whether we should grant these waivers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/22/02                    67 FR 70435

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mark Horney, CHPP, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4554

RIN: 0938-AM37
_______________________________________________________________________




936. [bull] GRANTS TO STATES FOR OPERATION OF QUALIFIED HIGH RISK POOLS 
(CMS-2179-FC)

Priority: Other Significant

Legal Authority: PL 107-210

CFR Citation: 45 CFR 148

Legal Deadline: None

Abstract: This final rule with comment period announces a grant program 
to provide $40 million for FY 2003 and $40 million for FY 2004 to Sates 
that have qualified high risk pools under the Trade Adjustment 
Assistance Reform Act of 2002.

[[Page 30273]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/02/03                    68 FR 23410

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

Agency Contact: James Mayhew, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-9244

RIN: 0938-AM42
_______________________________________________________________________




937. [bull] PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS: 
IMPLEMENTATION AND FY 2003 RATES; CORRECTING AMENDMENT (CMS-1177-F2)

Priority: Substantive, Nonsignificant

Legal Authority: None

CFR Citation: 42 CFR 442.22

Legal Deadline: None

Abstract: This correcting amendment corrects citation in the regulation 
text of the August 2002 final rule concerning satellite facilities. It 
will revise section 412.22(h)(3)(ii) so that the section will cite 
412.23(e)(2)(ii) instead of 412.23(e)(2).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/07/03                    68 FR 10987

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

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

Tzvi Hefter, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-07-07, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-1304

Related RIN: Related To 0938-AK69
RIN: 0938-AM49
_______________________________________________________________________




938. [bull] 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)

Priority: Other Significant

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

CFR Citation: 42 CFR 411.354

Legal Deadline: None

Abstract: This final rule temporarily delays for an additional six 
months or until publication of phase II the effective date of the ``set 
in advance'' provision in section 411.354(d)(1) contained in the rule 
entitled ``Medicare and Medicaid Programs; Physicians' Referrals to 
Health Care Entities With Which They Have Financial Relationships,'' 
published in the Federal Register on January 4, 2001 (66 FR 856).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/25/03                    68 FR 20347

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Karen Raschke, Health Insurance Specalist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0016

Related RIN: Related To 0938-AM21
RIN: 0938-AM58
_______________________________________________________________________




939. [bull] AMBULANCE FEE SCHEDULE (CMS-1256-N)

Priority: Other Significant

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: The purpose of this notice is to implement a Federal court 
order requiring the retroactive implementation of the Ambulance Fee 
Schedule to be established by the statutory effective date of January 
1, 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/16/03                    68 FR 18654

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Niemann, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4569

RIN: 0938-AM60
_______________________________________________________________________




940. [bull] CIVIL MONEY PENALTIES: PROCEDURES FOR INVESTIGATIONS, 
IMPOSITION OF PENALTIES, AND HEARINGS (CMS-0010-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1302(a); 42 USC 1320(d)(5)

CFR Citation: 45 CFR 160

Legal Deadline: None

Abstract: This interim final rule establishes rules of procedures for 
the imposition, by the Secretary of Health and Human Services, of civil 
money penalties on entities that violate standards adopted by the 
Secretary under the Administrative Simplification provisions of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). We 
intend that this be the first installment of a rule that we term the 
``Enforcement Rule.'' The Enforcement Rule, when issued in complete 
form, will set forth procedural and substantive requirements for 
imposition of civil money penalties. In the interim, we are issuing 
these rules of procedure to inform regulated entities of our approach 
to enforcement and to advise regulated entities of certain procedures 
that will be followed as we enforce the HIPAA Administrative 
Simplification standards (HIPAA standards).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/17/03                    68 FR 18895

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marilou King, Attorney, Department of Health and Human 
Services, Centers for Medicare

[[Page 30274]]

 & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 202 260-1486
Email: [email protected]

RIN: 0938-AM63

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




941. SAFEGUARDING CHILD SUPPORT AND EXPANDED FEDERAL PARENT LOCATOR 
SERVICES (FPLS) INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652 to 654A; 42 USC 663; 42 USC 1302

CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997, and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various 
sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5369
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________




942. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001.

Abstract: A notice of proposed rulemaking will be published in the 
Federal Register to amend current regulations and to implement changes 
made by the Developmental Disabilities Assistance and Bill of Rights 
Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, ADD HHH-
300F, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07
_______________________________________________________________________




943. CHILD SUPPORT ENFORCEMENT PROGRAM; EXPENDITURES FOR CASEWORKER 
COSTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 655

CFR Citation: 45 CFR 304.23

Legal Deadline: None

Abstract: This proposed rule will revise existing regulations on 
expenditures for which Federal Financial Participation is available 
under the Child Support Enforcement program. Under the current 
regulations, Federal Financial Participation is not available in any 
costs of caseworkers who are also performing the assistance payments or 
social services functions under title IV-A (TANF) or title XX (Social 
Services Block Grants) of the Social Security Act. This proposed 
regulation will remove the prohibition to reflect current business 
practices of the Department of Health and Human Services under which 
costs are allocated to the benefiting program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Sheck Chin, Special Assistant to the Division Director, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, 370 L'Enfant Promenade SW., Washington, 
DC 20447
Phone: 202 260-5830
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC11
_______________________________________________________________________




944. [bull] ADMINISTRATIVE COSTS FOR CHILDREN IN TITLE IV-E FOSTER CARE

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 672; 42 USC 674; 42 USC 1302

CFR Citation: 45 CFR 1356.60(c)

Legal Deadline: None

Abstract: This notice of proposed rulemaking implements the title IV-E 
foster care eligibility and administrative cost provisions in sections 
472 and 474

[[Page 30275]]

of the Social Security Act. We propose to prohibit the reimbursement of 
administrative costs claimed on behalf of children in unlicensed foster 
family homes, with the exception of children in relative foster family 
homes while the State is in the process of licensing the home. We also 
propose to prohibit the reimbursement of administrative costs claimed 
on behalf of children in unallowable facilities, with the exception of 
the month prior to a child's transition into an allowable facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Divison Director, Children's Bureau 
Policy, Department of Health and Human Services, Administration for 
Children and Families, Room 2411, 330 C Street SW., Washington, DC 
20447
Phone: 202 401-5789
Fax: 202 205-8221
Email: [email protected]

RIN: 0970-AC14
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




945. CONSTRUCTION AND MAJOR RENOVATION OF HEAD START AND EARLY HEAD 
START FACILITIES

Priority: Other Significant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1309

Legal Deadline: None

Abstract: This rule establishes procedures to be used by Head Start and 
Early Head Start agencies in requesting to use Head Start grant funds 
to construct or perform major renovation on a Head Start or Early Head 
Start Facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/08/99                     64 FR 6013
NPRM Comment Period End         04/09/99
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB54
_______________________________________________________________________




946. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority: Other Significant

Legal Authority: 42 USC 655(f)

CFR Citation: 45 CFR 309

Legal Deadline: None

Abstract: This rule specifies how tribes can obtain direct payments 
from the Department of Health and Human Services for provision of child 
support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity, 
modification and enforcement of support orders, and location of absent 
parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/21/00                    65 FR 50800
Final Action                    09/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Paige Biava, Division of Policy and Planning, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Child Support Enforcement, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-9386

RIN: 0970-AB73
_______________________________________________________________________




947. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 301 to 305

Legal Deadline: None

Abstract: This rule eliminates child support enforcement program 
regulations rendered obsolete or inconsistent with the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996, and its 
technical amendments, the Balanced Budget Act of 1997, the Adoption and 
Safe Families Act of 1997, and the Child Support Performance and 
Incentive Act of 1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/09/99                     64 FR 6237
Final Action                    05/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5369
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1301 to 1303; 45 CFR 1305; 45 CFR 1308

Legal Deadline: None

Abstract: This rule will make technical changes and conforming 
amendments to make the wording of the regulations consistent with 
amended provisions of the Head Start Act, eliminate obsolete 
references, and make other necessary technical changes to the 
regulations.

[[Page 30276]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AC00
_______________________________________________________________________




949. CHILD SUPPORT ENFORCEMENT PROGRAM; FEDERAL TAX REFUND OFFSET

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 664; 42 USC 1302

CFR Citation: 45 CFR 303.72

Legal Deadline: None

Abstract: This interim final rule will revise existing regulations on 
collecting child support arrears through the Federal Tax Refund Offset 
process. The revisions are needed to reflect changes in data processing 
protocols with the Department of the Treasury. We are also updating the 
regulation to reflect current business practices and requests from the 
state child support agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Deputy Director, Policy Division, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5369
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC09
_______________________________________________________________________




950. [bull] CHARITABLE CHOICE PROVISIONS APPLICABLE TO THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES PROGRAM

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 604(a)

CFR Citation: 45 CFR 260.30; 45 CFR 260.34

Legal Deadline: None

Abstract: The proposed rule would implement the Charitable Choice 
statutory provisions at section 104 of the Personal Responsibility and 
Work Opportunity Reconciliation Act of 1996 (PRWORA) as amended. It is 
the policy of the Administration for Children and Families that, within 
constitutional church-state guidelines, faith-based organizations 
should be able to compete on an equal footing for funding under the 
Temporary Assistance for Needy Families (TANF) program. In addition to 
giving families a greater choice of TANF-funded providers, these rules 
ensure that the character of religious providers is not impaired and 
that the religious freedom of TANF beneficiaries is not impaired.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/02                    67 FR 77362
NPRM Comment Period End         02/18/03
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: April Kaplan, Deputy Director, Office of Family 
Assistance, Department of Health and Human Services, Administration for 
Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5138
Email: [email protected]

RIN: 0970-AC12
_______________________________________________________________________




951. [bull] COMMUNITY SERVICES BLOCK GRANT CHARITABLE CHOICE

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9901, sec 672 of PL 105-285; 42 USC 9902, sec 
673 of PL 105-285

CFR Citation: 45 CFR 1050

Legal Deadline: None

Abstract: This proposed rule would implement the Charitable Choice 
statutory provisions at section 679 of the Community Services Block 
Grant Act (CSBG Act). These provisions apply to programs authorized 
under the Act, including the Community Services Block grant program, 
Training, Technical Assistance and Capacity Building program, Community 
Food and Nutrition Program, National Youth Sports program, and 
discretionary grants for economic development, rural community 
development, and neighborhood innovation, which are all administered by 
the Administration for Children and Families (ACF). It is ACF's policy 
that, within the framework of constitutional church-State guidelines, 
faith-based organizations should be able to compete on an equal footing 
for funding, and ACF supports the participation of faith-based 
organizations in these programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/17/02                    67 FR 77364
NPRM Comment Period End         02/18/03
Final Rule                      12/00/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

URL For More Information:
http://www.acf.hhs.gov/hypenews

URL For Public Comments:
http://www.acf.hhs.gov/hypernews.topic822

Agency Contact: Clarence Carter, Director, Office of Community 
Services, Department of Health and Human Services, Administration for 
Children and Families, 5th Floor East, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9333
Email: [email protected]

RIN: 0970-AC13

[[Page 30277]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




952. FAMILY CHILD CARE PROGRAM OPTION FOR HEAD START PROGRAMS

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1304; 45 CFR 1306

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/07/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB90
_______________________________________________________________________




953. CHILD SUPPORT ENFORCEMENT PROGRAM; CUSTOMER SERVICE ANNUAL STATE 
SELF-ASSESSMENT

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 308.2; 45 CFR 308.3

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/07/03

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Annie Miller
Phone: 202 401-1467
TDD Phone: 800 877-8339
Fax: 202 401-4054
Email: [email protected]

RIN: 0970-AC10

_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




954. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, TRAINING, 
RESEARCH, AND DISCRETIONARY PROGRAMS; VULNERABLE ELDER RIGHTS; GRANTS TO 
INDIANS AND NATIVE HAWAIIANS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 3001 et seq

CFR Citation: 45 CFR 1321; 45 CFR 1326; 45 CFR 1328

Legal Deadline: None

Abstract: In response to the reauthorization of the Older Americans 
Act, Public Law 106-501, the Administration on Aging (AoA) proposes to 
issue a notice of proposed rulemaking by spring of 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Edwin Walker, Deputy Assistant Secretary for Policy and 
Programs, Department of Health and Human Services, Administration on 
Aging, Washington, DC 20201
Phone: 202 401-4634

RIN: 0985-AA00
[FR Doc. 03-10366 Filed 05-23-03; 8:45 am]
BILLING CODE 4150-24-S