[May 27, 2003 (Volume 68, Number 101)] [Unified Agenda] From the Federal Register Online via GPO Access [frwais.access.gpo.gov] [Page 30214-30277] ----------------------------------------------------------------------- Part VIII Department of Health and Human Services ----------------------------------------------------------------------- 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: diane.osterhus@hhs.gov 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: karen.shaw@hhs.gov 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: jfaha@samhsa.gov 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: rachanow@cder.fda.gov 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: sthomps1@cfsan.fda.gov 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: richard.williams@cfsan.fda.gov 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: pendletonb@cder.fda.gov 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: ggraber@cvm.fda.gov 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: kstrauss@cfsan.fda.gov 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: pchao@oc.fda.gov 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: rebecca.buckner@cfsan.fda.gov 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: pchao@oc.fda.gov 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: rebecca.buckner@cfsan.fda.gov 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: rebecca.buckner@cfsan.fda.gov 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 ______________________________________________________________