[Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]
-----------------------------------------------------------------------
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: [email protected]
RIN: 0991-AB12
[[Page 30226]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
755. CIVIL MONEY PENALTY SAFE HARBOR TO PROTECT PAYMENT OF MEDICARE AND
MEDIGAP PREMIUMS FOR ESRD BENEFICIARIES
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 1003
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Notice 12/09/02 67 FR 72896
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer
Phone: 202 619-0089
RIN: 0991-AB04
_______________________________________________________________________
756. ADMINISTRATIVE WAGE GARNISHMENT
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 32
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 03/28/03 68 FR 15092
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Katherine M. Drews
Phone: 202 619-0150
Related RIN: Previously reported as 0990-AA05
RIN: 0991-AB20
_______________________________________________________________________
757. U.S. EXCHANGE VISITOR PROGRAMS; REQUEST FOR WAIVER OF THE TWO-YEAR
FOREIGN RESIDENCE REQUIREMENT
Priority: Other Significant
CFR Citation: 45 CFR 50
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Interim Final Rule 12/19/02 67 FR 77692
Regulatory Flexibility Analysis Required: No
Government Levels Affected: State
Agency Contact: Joyce Edith Jones
Phone: 202 690-6174
Fax: 202 690-7127
RIN: 0991-AB21
_______________________________________________________________________
758. [bull] CIVIL MONEY PENALTIES: PROCEDURES FOR INVESTIGATIONS,
IMPOSITION OF PENALTIES, AND HEARINGS
Priority: Other Significant
Legal Authority: 42 USC 1320d-5; 42 USC 1302(a)
CFR Citation: 42 CFR 160
Legal Deadline: None
Abstract: The rule will establish procedures for investigations
subpoenas, imposition of penalties, and hearings concerning the
imposition of civil money penalties by the Secretary of Health and
Human Services pursuant to 42 U.S.C. 1320d-5. The rule will establish
procedures that the Secretary will follow and, with respect to
hearings, which regulated entities who challenge the proposed
imposition of a civil money penalty on the entity will follow.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 04/17/03 68 FR 18895
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Agency Contact: Karen Shaw, Para Legal, Department of Health and Human
Services, Office of the Secretary, Rm: 711E, 200 Independence Avenue
SW., Washington, DC 20201
Phone: 202 690-7711
Fax: 202 690-5452
Email: [email protected]
RIN: 0991-AB24
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
759. [bull] SAMHSA CHARITABLE CHOICE
Priority: Other Significant
Legal Authority: Not Yet Determined
CFR Citation: 42 CFR 54, sec 54.1-13; 42 CFR 54a, sec 54a.1-14
Legal Deadline: None
Abstract: This proposed rule would implement the Charitable Choice
statutory provisions of section 581-584 and section 1955 of the Public
Health Service Act, applicable to the Substance Abuse Prevention and
Treatment (SAPT) Block Grant Program, the Project for Assistance in
Transition from Homelessness (PATH) formula grant program, insofar as
recipients provide substance abuse services, and to SAMHSA
discretionary grants for substance abuse treatment or prevention
services, which are all administered by the Substance Abuse and Mental
Health Services Administration (SAMSHA) of the U.S. Department of
Health and Human Services.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/17/02 67 FR 77350
Final Rule 06/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
Federalism: This action may have federalism implications as defined in
EO 13132.
Agency Contact: Winnie Mitchell, Public Health Analyst, Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, 12C-05, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2324
Fax: 301 443-0247
RIN: 0930-AA11
[[Page 30227]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
760. SECLUSION AND RESTRAINT FOR NON-MEDICAL RESIDENTIAL FACILITIES
Priority: Substantive, Nonsignificant
Legal Authority: PL 106-310
CFR Citation: Not Yet Determined
Legal Deadline: NPRM, Statutory, April 2001.
Abstract: The Secretary is required by statute to publish regulations
governing States that license non-medical, community-based residential
facilities for children and youth. The regulation requires States to
develop licensing rules and monitoring requirements concerning behavior
management practice that will ensure compliance; requires States to
develop and implement such licensing rules and implementation
requirements within one year; and ensures that States require such
facilities to have adequate staff, and that the States provide training
for professional staff.
Timetable: Next Action Undetermined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State
Federalism: This action may have federalism implications as defined in
EO 13132.
Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department
of Health and Human Services, Substance Abuse and Mental Health
Services Administration, Room 12C-15, 5600 Fishers Lane, Rockville, MD
20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]
RIN: 0930-AA10
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
761. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION FOR
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Priority: Other Significant
Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30
USC 811; 30 USC 842(h); 30 USC 844
CFR Citation: 42 CFR 84
Legal Deadline: None
Abstract: NIOSH plans to modify the Administrative/Quality Assurance
sections of 42 CFR part 84, Approval of Respiratory Protective Devices.
Areas for potential modification in this module are: 1) upgrade of
Quality Assurance requirements; 2) ability to use private sector
quality auditors and private sector testing laboratories in the
approval program; 3) revised approval label requirements; 4) updated
and restructured fee schedule; and 5) fee retention in the respirator
program.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/03
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Roland Berry Ann, Acting Chief, Respirator Branch,
National Personal Protection Technology Laboratory, Department of
Health and Human Services, Centers for Disease Control and Prevention,
NIOSH, P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236
Phone: 412 386-4000
RIN: 0920-AA04
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
762. PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE
SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEE OCCUPATIONAL ILLNESS
COMPENSATION ACT OF 2000
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 7384g; EO 13179
CFR Citation: 42 CFR 83
Legal Deadline: None
Abstract: Pursuant to the Energy Employees Occupational Illness
Compensation Program Act, HHS plans to finalize procedures to petition
the Secretary to be added to the Special Exposure Cohort.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/25/02 67 FR 42962
Final Rule 06/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Larry Elliott, Director, Office of Compensation
Analysis and Support, Department of Health and Human Services, Centers
for Disease Control and Prevention, NIOSH, R44, 5555 Ridge Avenue,
Cincinnati, OH 45213
Phone: 513 841-4498
RIN: 0920-AA07
[[Page 30228]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
763. CONTROL OF COMMUNICABLE DISEASES
Priority: Other Significant
CFR Citation: 42 CFR 70; 42 CFR 71
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Interim Final Rule 04/10/03 68 FR 17558
Regulatory Flexibility Analysis Required: No
Government Levels Affected: State
Agency Contact: Jennifer Brooks
Phone: 404 639-2763
RIN: 0920-AA03
_______________________________________________________________________
764. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS
Priority: Other Significant
CFR Citation: 42 CFR 72; 42 CFR 72.6
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Interim Final Rule 12/13/02 67 FR 76886
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Stephen M. Ostroff
Phone: 404 639-3967
RIN: 0920-AA08
_______________________________________________________________________
Department of Health and Human Services (HHS) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
765. OVER-THE-COUNTER (OTC) DRUG REVIEW
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21
USC 371
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 350
Legal Deadline: None
Abstract: The OTC drug review establishes conditions under which OTC
drugs are considered generally recognized as safe and effective and not
misbranded. After a final monograph (i.e., final rule) is issued, only
OTC drugs meeting the conditions of the monograph, or having an
approved new drug application, may be legally marketed.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the
individual rulemaking. However, the Agency anticipates that the rules
would not have a significant economic impact on a substantial number of
small entities as defined by the Regulatory Flexibility Act.
Timetable:
________________________________________________________________________
Anorectal Products Final Action (Amendment) 12/00/03
Antidiarrheal Products Final Action 04/17/03 (68 FR 18869) NPRM
(Amendment) (Trav.Diar) 04/17/03 (68 FR 18915)
Antiemetic Products Final Action (Amendment) (Warning) 12/06/02 (67 FR
72555)
Antiperspirant Products Final Action 08/00/03
Cough/Cold (Antihistamine) Products Final Action (Amendment)(Warning)
12/06/02 (67 FR 72555)
Cough/Cold (Antitussive) Products Final Action (Amendment)(Warning)
12/06/02 (67 FR 72555)
Cough/Cold (Bronchodilator) Products Final Action (Amendment) 02/00/04
Cough/Cold (Combination) Products Final Action 12/23/02 (67 FR
78158) NPRM (Amendment) 02/00/04
Cough/Cold (Nasal Decongestant) Products NPRM (Phenylpropanolamine)
10/00/03
External Analgesic Products Final Action (Amendment)(Warning) 12/06/02
(67 FR 72555) NPRM (Amendment) (Patches) 12/00/03
Ingrown Toenail Relief Products NPRM 10/04/02 (67 FR 62218) Final
Action 06/00/03
Internal Analgesic Products NPRM (Amendment)(Ibuprofen) 08/21/02 (67
FR 54139) NPRM (Amendment) (Pediatric) 10/00/03 NPRM (Amendment)
(Labeling) 12/00/03
Labeling of Drug Products for OTC Human Use Final Action (Ca/Mg/K/Na)
07/00/03 Final Action (Sodium Labeling) 07/00/03 NPRM (Sodium
Labeling) 07/00/03 NPRM (Convenience Sizes) 09/00/03
Laxative Drug Products NPRM (Amendment) (Psyllium Granular Dosage
Form) 10/00/03
Nighttime Sleep Aid Products Final Action (Amendment)(Warning) 12/06/
02 (67 FR 72555)
Ophthalmic Products Final Action (Technical Amendment) 02/19/03 (68 FR
7919) NPRM (Emergency First Aid Eyewashes) 02/19/03 (68 FR
7951) Final Action (Name Change) 06/00/03
Oral Health Care Products ANPRM (Plaque/Gingivitis) 06/00/03
Pediculicide Products NPRM (Labeling Amendment) 05/10/02 (67 FR
31739) Final Action (Labeling Amendment) 02/00/04
Salicylate (Reye's Syndrome) Final Action (Warning) 04/17/03 (68 FR
18861)
Skin Protectant Products Final Action 07/00/03 NPRM (Astringent) 09/
00/03 Final Action (Astringent) 09/00/03
Sunscreen Products Final Action (Names) 06/20/02 (67 FR 41821) ANPRM
(and Insect Repellent) 10/00/03 NPRM (UVA/UVB) 12/00/03
Vaginal Contraceptive Products NPRM (Amendment) 01/16/03 (68 FR 2254)
Weight Control Products NPRM (Phenylpropanolamine) 10/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
Over-the-Counter Drug Products, Department of Health and Human
Services, Food and Drug Administration, HFD-560, Center for Drug
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]
RIN: 0910-AA01
_______________________________________________________________________
766. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS (SECTION 610
REVIEW)
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 5 USC 610; 21 USC 351; 21 USC 353; 21 USC 360b; 21 USC
371; 21 USC 321; 21 USC 352
CFR Citation: 21 CFR 511
Legal Deadline: None
[[Page 30229]]
Abstract: FDA is initiating a review of 21 CFR 511.1 under section 610
of the Regulatory Flexibility Act. The purpose of the section 610
review is to determine if the rule should be amended to minimize
adverse economic impacts on small entities. FDA will solicit and
consider comments on the following: 1) the continued need for the rule;
2) the nature of complaints or comments received concerning the rule;
3) the complexity of the rule; 4) the extent to which the rule
overlaps, duplicates, or conflicts with other Federal, State, or local
government rules; and 5) the degree to which technology, economic
conditions, or other factors have changed in the area affected by the
rule.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/21/96 61 FR 59209
ANPRM Comment Period End 01/21/97
Begin Review 04/03/00
End Review 12/00/03
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Marty Schoenemann, Department of Health and Human
Services, Food and Drug Administration, HFV-126, Center for Veterinary
Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220
RIN: 0910-AB02
_______________________________________________________________________
767. [bull] FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING:
CONSUMER RESEARCH TO CONSIDER POSSIBLE FOOTNOTE STATEMENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: This advance notice of proposed rulemaking (ANPRM) is
intended to publish in the same issue of the Federal Register as the
trans fat final rule that would require that the quantitative amount of
trans fat be declared in the nutrition label of conventional foods and
dietary supplements on a separate line immediately under the line for
saturated fat. This ANPRM would solicit information and data on whether
to consider footnote statements for possible use in the nutrition label
about trans fat, either alone or in combination with saturated fat and
cholesterol, to enhance consumers' understanding about such fat in
foods and how to use the information to make healthy food choices. FDA
is soliciting information and data on language in any such statements
and the impact on consumers from such statements. Information obtained
from this solicitation and that resulting from consumer studies
conducted by FDA may be used to help draft a proposed rule that would
require the use of a footnote in the Nutrition Facts panel about one or
more of the cholesterol-raising lipids to increase consumer
understanding of the relative significance of these lipids in foods.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 06/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Federal
Agency Contact: Susan Thompson, Chemist, Department of Health and Human
Services, Food and Drug Administration, (HFS-832), Center for Food
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park,
MD 20740
Phone: 301 436-1450
Fax: 301 436-2639
Email: [email protected]
Related RIN: Related To 0910-AB66
RIN: 0910-AC50
_______________________________________________________________________
768. [bull] PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD (SECTION 610 REVIEW)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 342; 21 USC 371; 21 USC 374; 42 USC 264
CFR Citation: 21 CFR 110
Legal Deadline: None
Abstract: Part 110 (21 CFR part 110) describes regulations for current
good manufacturing practice in manufacturing, packing, and holding
human food. Part 110 contains regulations describing sanitary practices
for personnel, buildings and facilities, and equipment. It also
includes regulations on production and process controls for
manufacturing practices and on defect action levels for natural or
unavoidable defects in food for human use that present no health
hazard. FDA is undertaking a review of part 110 under section 610 of
the Regulatory Flexibility Act. The purpose of this review is to
determine whether the regulations in part 110 should be continued
without change, or whether they should be amended or rescinded, to
minimize adverse impacts on a substantial number of small entities. FDA
will consider, and is soliciting comments on, the following: (1) the
continued need for the regulations in part 110; (2) the nature of
complaints or comments received concerning the regulations in part 110;
(3) the complexity of the regulations in part 110; (4) the extent to
which the regulations in part 110 overlap, duplicate, or conflict with
other Federal, State, or governmental rules; and (5) the degree to
which technology, economic conditions, or other factors have changed in
the area affected by the regulations in part 110.
The section 610 review will be carried out along with a regulatory
review under section 5 of Executive Order 12866, which calls for
agencies to periodically review existing regulations to determine
whether any should be modified or eliminated so as to make the agency's
regulatory program more effective in achieving its goals, less
burdensome, or in greater alignment with the President's priorities and
the princples set forth in the Executive order. The combined effect of
the two reviews will be to determine if it is possible to redesign
current good manufacturing practices in ways that will maintain or
increase the effectiveness of preventive and sanitary controls, and, at
the same time, reduce compliance and other costs associated with the
regulations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review 05/00/03
Regulatory Flexibility Analysis Required: Undetermined
[[Page 30230]]
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Richard A. Williams, Director, Division of Market
Studies, OSAS, CFSAN, FDA, HHS, Department of Health and Human
Services, Food and Drug Administration, HFS-725, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1989
Fax: 301 436-2626
Email: [email protected]
RIN: 0910-AC58
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
769. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING
REQUIREMENTS FOR DRUGS AND BIOLOGICS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262
CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR
514; 21 CFR 601; 21 CFR 607; 21 CFR 1271
Legal Deadline: None
Abstract: The proposed rule would amend FDA regulations on the
registration of producers of drugs and the listing of drugs in
commercial distribution. The proposed revisions would reorganize,
consolidate, clarify, and modify current regulations concerning who
must register establishments and list drug or biologics regulated as
drugs. The proposal describes when, how, and where to register and
list, and what information must be submitted for registration and
listing. The proposed regulations would also revise the requirements
for the NDC number and would require the electronic submission of most
registration and listing information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Howard P. Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA49
_______________________________________________________________________
770. BLOOD INITIATIVE
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263;
42 USC 263a; 42 USC 264
CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR
610; 21 CFR 630; 21 CFR 640; 21 CFR 660; 21 CFR 680
Legal Deadline: None
Abstract: In multiple rulemakings, the Food and Drug Administration is
amending the biologics regulations by removing, revising, or updating
specific regulations applicable to blood, blood components, Source
Plasma, and blood-derivative products to be more consistent with
current practices and to remove unnecessary or outdated requirements.
This action is based on FDA's comprehensive review of the biologics
regulations. It is also based on reports by the U.S. House of
Representatives Committee on Government Reform and Oversight's,
Subcommittee on House Resources and Intergovernmental Relations, the
General Accounting Office, and the Institute of Medicine, as well as on
public comments. The remaining subjects intended to be addressed in the
rulemakings include: labeling, and donor suitability and testing. These
actions are intended to help ensure the continued safety of the
Nation's blood supply.
Timetable:
________________________________________________________________________
Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin
(Human); Revision of Requirements Direct Final Rule 05/14/99 (64 FR
26282) NPRM 05/14/99 (64 FR 26344) Direct Final Rule - Confirmation
in Part and Technical Amendment 03/14/00 (65 FR 13678) Final Action
08/28/00 (65 FR 52016)
General Requirements for Blood, Blood Components, and Plasma
Derivatives; Notification of Deferred Donors NPRM 08/19/99 (64 FR
45355) Final Action 06/11/01 (66 FR 31165)
Regulations for Human Blood and Blood Components Intended for
Transfusion or For Further Manufacturing Use NPRM 01/00/04
Requirements for Testing Human Blood Donors for Evidence of Infection
Due to Communicable Disease Agents NPRM 08/19/99 (64 FR 45340) Final
Action 06/11/01 (66 FR 31146)
Revisions to Labeling and Storage Requirements for Blood and Blood
Components, Including Source Plasma NPRM 12/00/03
Revisions to the Requirements Applicable to Blood, Blood Components,
and Source Plasma Direct Final Rule 08/19/99 (64 FR 45366) NPRM 08/
19/99 (64 FR 45375) Direct Final Rule - Confirmation in Part and
Technical Amendment 01/10/01 (66 FR 1834) Final Action 08/06/01 (66 FR
40886)
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Related RIN: Related To 0910-AB76
RIN: 0910-AB26
_______________________________________________________________________
771. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE
RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
[[Page 30231]]
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 312; 21 CFR 314
Legal Deadline: None
Abstract: The proposed rule would amend the regulations on marketing
approval of new drugs to discontinue the use of approvable and not
approvable letters when taking action on a marketing application and
instead use complete response letters. The proposed rule would also
amend the regulations on extension of the review clock because of
amendments to applications.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/03
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Office of
Regulatory Policy, Department of Health and Human Services, Food and
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB34
_______________________________________________________________________
772. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360b; 21 USC 371; 21
USC 374
CFR Citation: 21 CFR 225
Legal Deadline: None
Abstract: This proposal is in response to a citizen petition request to
merge the separate requirements of the current good manufacturing
practice (CGMP) regulations, 21 CFR part 225 applicable to licensed and
unlicensed feed manufacturing facilities, respectively. The merger
would produce a single set of updated, streamlined CGMPs that apply to
all medicated feed manufacturers. This consolidation of existing CGMPs
would preserve and strengthen food safety, be more appropriate given
the changing structure of the medicated feed industry, and enhance
uniformity and enforcement.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: George Graber, Director, Division of Animal Feeds,
Department of Health and Human Services, Food and Drug Administration,
HFV-220, Center for Veterinary Medicine, 7500 Standish Place,
Rockville, MD 20855
Phone: 301 827-6651
Email: [email protected]
RIN: 0910-AB70
_______________________________________________________________________
773. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264
CFR Citation: 21 CFR 111
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) announced in an
advance notice of proposed rulemaking (ANPRM) on February 6, 1997 (62
FR 5700), its plans to consider developing regulations establishing
current good manufacturing practices (CGMP) for dietary supplements and
dietary ingredients. The ANPRM was published in order for FDA to
solicit comments on whether it should initiate action to establish CGMP
regulations, and if so, what constitutes CGMP for these products. FDA
announced that this effort was in response to the section of the
Federal Food, Drug and Cosmetic Act (the Act) that provides authority
to the Secretary of Health and Human Services to promulgate CGMP
regulations and to a submission from the dietary supplement industry
asking that FDA consider an industry-proposed CGMP framework as a basis
for CGMP regulations. The ANPRM also responds to concerns that such
regulations are necessary to ensure that consumers are provided with
dietary supplement products which have not been adulterated as a result
of manufacturing, packing, or holding; which have the identity and
provide the quantity of dietary ingredients declared in labeling; and
which meet the quality specifications that the supplements are
represented to meet.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 02/06/97 62 FR 5700
ANPRM Comment Period End 06/06/97
NPRM 05/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Karen Strauss, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, (HFS-820),
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1774
Fax: 301 436-2610
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
774. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD
Priority: Routine and Frequent
Legal Authority: 21 USC 331 to 334; 21 USC 335b; 21 USC 335c; 21 USC
341 to 344; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360;
21 USC 360c-360f; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21
USC 374; 21 USC 376; 21 USC 381; 21 USC 393; 42 USC 262; 42 USC 264
CFR Citation: 21 CFR 59
Legal Deadline: None
[[Page 30232]]
Abstract: The proposed rule would establish requirements for importers
and other persons who use sampling services and private laboratories in
connection with imported food. For example, the proposal would pertain
to persons who use sample collection services and private laboratories,
and would describe some responsibilities for such persons, sample
collection services, and private laboratories. These responsibilities
would include recordkeeping requirements to ensure that the correct
sample is collected and analyzed, and a notification requirement if a
person intends to use a private laboratory in connection with imported
food. The proposed rule is intended to help insure the integrity and
scientific validity of data and results submitted to FDA.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/03
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: Undetermined
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB96
_______________________________________________________________________
775. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC
393; 42 USC 243; 42 USC 264; 42 USC 271; ...
CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118
Legal Deadline: None
Abstract: In July 1999, the Food and Drug Administration (FDA) and the
Food Safety Inspection Service (FSIS) committed to developing an action
plan to address the presence of salmonella enteritidis (SE) in shell
eggs and egg products using a farm-to-table approach. FDA and FSIS held
a public meeting on August 26, 1999, to obtain stakeholder input on the
draft goals, as well as to further develop the objectives and action
items for the action plan. The Egg Safety Action Plan was announced on
December 11, 1999. The goal of the Action Plan is to reduce egg-related
SE illnesses by 50 percent by 2005 and eliminate egg-related SE
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all
stages of the farm-to-table continuum as well as support functions. On
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July
31, 2000 (Washington, DC), joint public meetings were held by FDA and
FSIS to solicit and discuss information related to the implementation
of the objectives in the Egg Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to
publish a proposed rule to require that shell eggs be produced under a
plan that is designed to prevent transovarian SE from contaminating
eggs at the farm during production.
FDA intends to discuss in its proposal certain provisions of the 1999
Food Code that are relevant to how eggs are handled, prepared, and
served at certain retail establishments. In addition, the agency plans
to consider whether it should require provisions for certain retail
establishments that serve populations most at risk of egg-related
illness (i.e., the elderly, children, and the immunocompromised).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, HFS-306,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AC14
_______________________________________________________________________
776. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS
Priority: Info./Admin./Other
Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21
USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC
360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC
241; 42 USC 262; 42 USC 263b to 263n
CFR Citation: 21 CFR 56.106
Legal Deadline: None
Abstract: The proposed rule would require institutional review boards
(IRB) to register with FDA. The registration information would include
the name of the IRB, the name of the institution operating the IRB, and
names, addresses, phone numbers, facsimile (fax) numbers, and
electronic mail (e-mail) addresses of the senior officer of the
institution and IRB chair or contact, the range of active protocols
(small, medium, or large) involving FDA-regulated products reviewed in
the previous calendar year, and a description of the types of FDA-
regulated products reviewed. The proposed rule would make it easier for
FDA to inspect IRBs and to convey information to IRBs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/03
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AC17
[[Page 30233]]
_______________________________________________________________________
777. USE OF MATERIALS DERIVED FROM BOVINE AND OVINE ANIMALS IN FDA-
REGULATED PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: Not Yet Determined
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The U.S. Department of Agriculture's Animal and Plant Health
Inspection Service maintains, by regulation in 9 CFR 94.18(a), a list
of countries: 1) where bovine spongiform encephalopathy (BSE) exists;
and 2) that present an undue risk of introducing BSE into the United
States. This proposed rule would restrict, in FDA-regulated products,
the use of most materials derived from bovine and ovine animals born,
raised, or slaughtered in a country listed in 9 CFR 94.18(a). In
addition, there would be a waiver provision that could be used under
appropriate criteria.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/00/04
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, HFS-306,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AC19
_______________________________________________________________________
778. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS
DERIVED FROM EXPOSED ANIMAL POPULATIONS
Priority: Other Significant
Legal Authority: 42 USC 264; 21 USC 301 et seq
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to
prohibit the use of cervids (deer, elk) for food, including dietary
supplements, and cosmetics if the cervids have been exposed to chronic
wasting disease (CWD). FDA is proposing this regulation because of
potential risks to health.
In addition to this proposed rule, FDA intends to issue guidance within
the next few months on the use in animal feed or material from deer and
elk that are positive for CWD or are at high risk of CWD.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group
of fatal, neurodegenerative diseases that include bovine spongiform
encephalopathy (BSE) in cattle, scrapie in sheep and goats, and
Creutzfeldt-Jakob disease (CJD) in humans. The disease has been
identified in wild and farmed elk and wild deer populations.
CWD has been found in cervid populations in certain areas of Wisconsin,
Colorado, Nebraska, Wyoming, Kansas, Montana, Oklahoma, South Dakota,
New Mexico, Minnesota, and Canada. In 1999, the World Health
Organization (WHO) said there is no evidence that CWD transmits to
humans. However, it also suggested any part of a deer or elk believed
to be diseased should not be eaten. Results of some studies using in
vitro techniques have suggested that transmission to humans could
possibly occur. However, if it does occur, it is likely to be through a
very inefficient process.
Currently, there are no validated analytical tests to identify animals
in the pre-clinical phase of CWD, or any other TSE. In addition, no
test exists to ensure food safety. CWD typically exhibits a long
incubation period, during which time animals appear normal but are
potentially infectious. Therefore, FDA is proposing to require that
food or cosmetic products derived from animals exposed to CWD not enter
into commerce.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, HFS-306,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]
RIN: 0910-AC21
_______________________________________________________________________
779. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 355a; 21 USC 356; 21 USC 356a; 21 USC 356b; 21 USC 356c; 21 USC
371; 21 USC 374; 21 USC 379
CFR Citation: 21 CFR 314.96(a)(1); 21 CFR 314.94(a)(7); 21 CFR
320.21(b)(1)
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations on submission of bioequivalence (BE) data to require an
abbreviated new drug application (ANDA) applicant to submit data from
all BE studies the applicant conducts on a drug product formulation
submitted for approval. In the past, ANDA applicants have submitted BE
studies demonstrating that a generic product meets BE criteria for FDA
to approve the ANDA but have not typically submitted additional BE
studies conducted on the same drug product formulation. FDA is
proposing to require ANDA applicants to submit information, in either a
complete or summary report, from all additional passing and nonpassing
BE studies conducted on the same drug product formulation submitted for
approval.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Aileen Ciampa, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, HFD-7, Center for
Drug Evaluation and Research, 1451 Rockville Pike, Rockville, MD 20857
[[Page 30234]]
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC23
_______________________________________________________________________
780. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST
FOR COMMENTS AND INFORMATION
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC
360; 21 USC 360bbb; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f;
21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 381
CFR Citation: 21 CFR 50.23
Legal Deadline: None
Abstract: FDA is proposing an amendment to the exception from the
general requirement for informed consent in certain circumstances
involving the use of investigational in vitro diagnostic devices to
identify chemical, biological, radiological, or nuclear threat agents.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Catherine Lorraine, Director, Policy Development and
Coordination Group, Department of Health and Human Services, Food and
Drug Administration, 14-101-11, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 827-6777
RIN: 0910-AC25
_______________________________________________________________________
781. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION
OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 351; 21 USC 360c(e)(1); 21 USC 371
CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905
Legal Deadline: None
Abstract: The Food and Drug Administration is proposing to reclassify
pressure regulators for use with medical oxygen from class I to class
II and to establish a special control for oxygen pressure regulators to
address problems of fire and explosion associated with use of these
devices. The special control will be a guidance document that includes
standardized testing, performance, and labeling guidance for industry.
Devices that meet the special control will be exempt from the premarket
notification requirements of the act. The agency believes it is taking
a least burdensome approach for industry. This proposed rule will
phase-in a compliance approach that will minimize the cost. FDA seeks
to reclassify these devices under section 513(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/03
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, HFZ-215,
Center for Devices and Radiological Health, 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]
RIN: 0910-AC30
_______________________________________________________________________
782. MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES;
ADULTERATION
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
371; 21 USC 374
CFR Citation: 21 CFR 800.20
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
the sampling plans, test method, and acceptable quality levels in 21
CFR 800.20. As prescribed by this regulation, FDA samples patient
examination and surgeons' gloves and examines them for visual defects
and water leaks. Glove lots are considered adulterated if they do not
meet specified quality levels. This proposal would clarify sampling
plans and the scoring of defects, lower acceptance rates for leaking
gloves, raise rejection rates for leaking gloves, and add tightened
inspection schemes for reexamined glove lots. The rule is intended to
facilitate industry compliance and enhance the safety and effectiveness
of gloves.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/31/03 68 FR 15404
NPRM Comment Period End 06/30/03
Final Rule 12/00/04
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, HFZ-215,
Center for Devices and Radiological Health, 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]
RIN: 0910-AC32
_______________________________________________________________________
783. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN
DRUGS
Priority: Other Significant
Legal Authority: 21 USC 355a
CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 209
Legal Deadline: Final, Statutory, January 4, 2003.
Abstract: To require the labeling of human drugs approved under section
505 of the Federal Food, Drug, and Cosmetic Act to include a toll-free
number for reports of adverse events, and a statement that the number
is to be used for reporting purposes only and not to receive medical
advice.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
[[Page 30235]]
Agency Contact: Carol Drew, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Suite 3037 (HFD-7),
Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC35
_______________________________________________________________________
784. ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION
UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND
RESPONSE ACT OF 2002
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 107-188, sec 303
CFR Citation: 21 CFR 1
Legal Deadline: None
Abstract: This rulemaking is one of a number of actions being taken to
improve FDA's ability to respond to threats of bioterrorism. Section
303 of the Bioterrorism Act authorizes the Secretary, through FDA, to
order the detention of food if an officer or qualified employee of FDA
has credible evidence or information indicating an article of food
presents a threat of serious adverse health consequences or death to
humans or animals. The Act requires the Secretary, through FDA, to
issue final regulations to expedite certain enforcement actions (i.e.,
seizures and injunctions) against perishable foods.
FDA intends to implement section 303 of the Act by proposing a
regulation to provide for: 1) a detention procedure; 2) expedited
procedures for enforcement actions with respect to perishable foods;
and 3) an appeals procedure for detained goods.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Marquita Steadman, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, HFS-007,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 827-6733
Fax: 301 480-5730
Email: [email protected]
RIN: 0910-AC38
_______________________________________________________________________
785. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: PL 107-188, sec 306
CFR Citation: 21 CFR 1
Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 306, directs the Secretary, through FDA, to issue
final regulations establishing recordkeeping requirements by December
12, 2003.
Abstract: This rulemaking is one of a number of actions being taken to
improve FDA's ability to respond to threats of bioterrorism. Section
414(b) of the Federal Food, Drug and Cosmetic Act (FFDCA), which was
added by section 306 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Act), authorizes the
Secretary, through FDA, to promulgate final regulations by December 12,
2003. The Act authorizes regulations that require the establishment and
maintenance of records, for not longer than two years, that would allow
the Secretary to identify the immediate previous sources and the
immediate subsequent recipients of food, including its packaging. The
required records would be those that are needed by FDA in order to
address credible threats of serious adverse health consequences or
death to humans or animals. Specific covered entities are those that
manufacture, process, pack, transport, distribute, receive, hold, or
import food. Farms and restaurants are excluded. The Secretary is
directed to take into account the size of a business in promulgating
these regulations. Section 306 of the Act also added section 414(a) and
amended section 704(a) of FFDCA to permit FDA to inspect these records
and other information if the Secretary has a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse
health consequences or death to humans or animals.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Nega Beru, Supervisory Chemist, Office of Plant, Dairy
Foods and Beverages, Department of Health and Human Services, Food and
Drug Administration, HFS-305, Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-1400
Fax: 301 436-2651
Email: [email protected]
RIN: 0910-AC39
_______________________________________________________________________
786. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED
FEED
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-250; 21 USC 360b
CFR Citation: 21 CFR 558.5; 21 CFR 510.455
Legal Deadline: None
Abstract: In response to a citizen petition filed by the American Feed
Industry Association, the Food and Drug Administration (FDA) is
proposing to amend the requirements for liquid medicated animal feed to
clarify what information and data are required to demonstrate chemical
and positional stability. The amended regulations would also clarify
the provisions for the submission of such data through a master file
and the reference to master files by subsequent applicants.
Additionally, FDA is proposing to amend the regulations for free-choice
medicated feed to ensure consistency with the requirements for liquid
medicated feed. Finally, FDA is
[[Page 30236]]
proposing to amend the regulations for free-choice medicated feed and
liquid medicated feed so that these provisions comply with the terms of
the Animal Drug Availability Act of 1996.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: William D. Price, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, HFV-200,
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD
20855
Phone: 301 827-6652
Fax: 301 594-4512
Related RIN: Previously reported as 0910-AB50
RIN: 0910-AC43
_______________________________________________________________________
787. [bull] SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM
CLINICAL STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 355; 21 USC 371; 42 USC 262
CFR Citation: 21 CFR 314.50; 21 CFR 601.14; 21 CFR 314.94
Legal Deadline: None
Abstract: The Food and Drug Administration is proposing to amend the
regulations governing the format in which clinical study data (CSD) are
required to be submitted for new drug applications (NDAs), biological
license applications (BLAs), and abbreviated new drug applications
(ANDAs). The proposal would revise our regulations to require CSD
submitted for NDAs, ANDAs, BLAs, and their supplements and amendments
be provided in electronic format and require the use of standard data
structure, terminology, and code sets. The proposal would improve the
efficiency of the exchange of information from clinical studies through
the adoption of standards for study data submitted in an electronic
form that FDA can process, review, and archive.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Room 3037,
(HFD-7), 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]
RIN: 0910-AC52
_______________________________________________________________________
788. [bull] MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD
MANUFACTURING PRACTICE REQUIREMENTS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 353
CFR Citation: 21 CFR 201.161(a); 21 CFR 210.3(b); 21 CFR 211.94
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its current good manufacturing practice (CGMP) regulations and other
regulations to clarify and strengthen requirements for the label,
color, dedication, and design of medical gas containers and closures.
Despite existing regulatory requirements and industry standards for
medical gases, there have been repeated incidents in which cryogenic
containers of harmful industrial gases have been connected to medical
oxygen supply systems in hospitals and nursing homes, and subsequently
administered to patients. These incidents have resulted in death and
serious injury. There have also been several incidents involving high-
pressure medical gas cylinders that have resulted in death and injuries
to patients. These proposed amendments, together with existing
regulations, are intended to ensure that the types of incidents that
have occurred in the past, as well as other types of foreseeable and
potentially deadly medical gas mixups, do not occur in the future.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/00/04
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Howard P. Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC53
_______________________________________________________________________
789. [bull] FOOD STANDARDS: GENERAL PRINCIPLES AND FOOD STANDARDS
MODERNIZATION
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 USC
371
CFR Citation: 21 CFR 130.5
Legal Deadline: None
Abstract: In 1995, the FDA and FSIS reviewed their regulatory
procedures and requirements for food standards to determine whether any
were still needed, and if so, whether any should be modified or
streamlined. To request public comment to assist them in their review
of the need for food standards, both agencies published advance notices
of proposed rulemaking (ANPRMs) on food standards in December, 1995 (60
FR 47453 and 60 FR 67492). These ANPRMs discussed the agencies'
regulations and policy governing food standards, the history of food
standards, and the possible need to revise the food standards. Several
comments in response to the ANPRMs recommended that the agencies
establish general principles or a fundamental philosophy for reviewing
food standards and revising them. The agencies agreed with these
comments and determined that it would be appropriate to develop general
principles for reviewing and revising food standards regulations. The
agencies also agreed with the comments that stated that the agencies
should work in concert to develop consistent food standards
regulations. FDA and FSIS are now proposing a set of general principles
that define how modern food standards should be structured. If this
[[Page 30237]]
proposed rule is adopted, FDA and FSIS will require that a citizen
petition for establishing, revising, or eliminating a food standard in
21 CFR parts 130 to 169 and 7 CFR part 410 be submitted in accordance
with the general principles. Conversely, the agencies may find
deficient a petition to establish, revise, or eliminate a food standard
that does not follow these general principles.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 12/29/95 60 FR 67492
ANPRM Comment Period End 04/29/96
NPRM 12/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Ritu Nalubola, Staff Fellow, Department of Health and
Human Services, Food and Drug Administration, HFS-820, Center for Food
Safety and Applied Nutrition, Harvey Wiley Building, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-2371
Fax: 301 436-2636
Email: [email protected]
RIN: 0910-AC54
_______________________________________________________________________
790. [bull] POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD
MANUFACTURING PRACTICES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 121
CFR Citation: 21 CFR 220
Legal Deadline: Final, Statutory, November 21, 1999.
Abstract: Section 121 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for
current good manufacturing practices (CGMPs) for positron emission
tomography (PET) drugs, a type of radiopharmaceutical. The proposed
rule would adopt CGMPs that reflect the unique characteristics of PET
drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/03
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of
Regulatory Policy, Department of Health and Human Services, Food and
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
Related RIN: Previously reported as 0910-AB63
RIN: 0910-AC55
_______________________________________________________________________
791. [bull] REVISION OF THE REQUIREMENTS FOR SPORE-FORMING
MICROORGANISMS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC
355; 21 USC 360; 21 USC 360i; 21 USC 371; 21 USC 374; 42 USC 216; 42
USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25
CFR Citation: 21 CFR 600.10(c); 21 CFR 600.11(e)
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is issuing a direct
final rule and a companion proposed rule to amend the biologics
regulations by providing options to the existing requirement for
separate, dedicated facilities and equipment for work with spore-
forming microorganisms. FDA is taking this action due to advances in
facility, system and equipment design, and sterilization technologies,
that would allow work with spore-forming microorganisms to be performed
in multi-product manufacturing areas.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM-Companion to Direct Final
Rule 01/00/04
Direct Final Rule 01/00/04
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Valerie Butler, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Suite 200N
(HFM-17), 1401 Rockville Pike, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 594-1944
RIN: 0910-AC57
_______________________________________________________________________
792. REPORTING INFORMATION REGARDING FALSIFICATION OF DATA
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 341 to 343; 21 USC 348; 21 USC 349;
21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 360c; 21 USC
360e; 21 USC 360i; 21 USC 360j; 21 USC 360k; 21 USC 361; 21 USC 371; 21
USC 379e; 42 USC 262
CFR Citation: 21 CFR 70.3; 21 CFR 71.1; 21 CFR 170.3; 21 CFR 171.1; 21
CFR 312.3; 21 CFR 312.56; 21 CFR 510.3; 21 CFR 511.1; 21 CFR 812.46
Legal Deadline: None
Abstract: The proposed rule would require sponsors to promptly report
any information indicating that any person has or may have falsified
data in the course of proposing, designing, performing, recording,
supervising, or reviewing research, or in reporting research results.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/03
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Related RIN: Previously reported as 0910-AC02
RIN: 0910-AC59
[[Page 30238]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
793. INFANT FORMULA: REQUIREMENTS PERTAINING TO GOOD MANUFACTURING
PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, NOTIFICATION
REQUIREMENTS, AND RECORDS AND REPORTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 350a; 21 USC 371; ...
CFR Citation: 21 CFR 106; 21 CFR 107
Legal Deadline: None
Abstract: The agency published a proposed rule on July 9, 1996 that
would establish current good manufacturing practice regulations,
quality control procedures, quality factors, notification requirements,
and records and reports for the production of infant formula. This
proposal was issued in response to the 1986 Amendments to the Infant
Formula Act of 1980.
Timetable:
________________________________________________________________________
Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors NPRM
07/09/96 (61 FR 36154) NPRM Comment Period End 12/06/96 Final Action
12/00/03
Infant Form Cons Comp, Micro Test & Recd Retention Req NPRM 01/26/89
(54 FR 3783) NPRM Comment Period End 03/27/89 Final Rule 12/24/91 (56
FR 66566)
Infant Formula Quality Factors NPRM Comment Period End 12/06/96 Final
Action 12/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Shellee Anderson, Food Technologist, Department of
Health and Human Services, Food and Drug Administration, HFS-800,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1491
Email: [email protected]
RIN: 0910-AA04
_______________________________________________________________________
794. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW
DRUG PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC
241; 42 USC 243; 42 USC 262; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 371
CFR Citation: 21 CFR 312.110
Legal Deadline: None
Abstract: The final rule would amend the regulations on the exportation
of unapproved new drug products, including biological products, for
investigational use. In general, the rule would provide four different
routes for exporting an unapproved new drug product for investigational
use. One route would permit exportation, if the drug is the subject of
an investigational new drug application (IND) and is being exported for
use in the investigation. A second route would permit exportation,
without prior Food and Drug Administration (FDA) approval and without
an IND, if the product is to be exported for use in a clinical
investigation and has received marketing authorization in certain
developed countries. The third route would permit exportation, without
prior FDA approval and without an IND, if the product is to be exported
for use in a clinical investigation in certain specified developed
countries. The fourth route would permit exportation without an IND, to
any country provided that the exporter sends a written certification to
FDA at the time the drug is first exported. Drugs exported under any of
the first three routes would, however, be subject to certain statutory
requirements, such as not conflicting with the foreign country's laws
and not being sold or offered for sale in the United States. Drugs
exported under either the second or third routes would be subject to
additional statutory requirements, such as being in substantial
conformity with the current good manufacturing practices and certain
labeling requirements. These provisions would implement changes in
FDA's export authority resulting from the FDA Export Reform and
Enhancement Act of 1996.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/19/02 67 FR 41642
Final Action 09/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AA61
_______________________________________________________________________
795. DETERMINATION THAT INFORMED CONSENT IS INFEASIBLE OR IS CONTRARY TO
THE BEST INTEREST OF RECIPIENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21
USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21
USC 360h to 360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42
USC 241; 42 USC 262; 42 USC 263b to 263n
CFR Citation: 21 CFR 50; 21 CFR 312
Legal Deadline: None
Abstract: The final rule would establish criteria and standards for the
President to apply in making a determination that informed consent is
not feasible or is contrary to the best interest of military personnel
engaged in specific military operations. Under Federal law, the
President is authorized to waive the Federal Food, Drug, and Cosmetic
Act's informed consent requirements in military operations, if the
President finds that obtaining consent is infeasible, contrary to the
best interests of recipients, or contrary to national security
interests.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 10/05/99 64 FR 54180
Final Action 09/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Federal
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AA89
[[Page 30239]]
_______________________________________________________________________
796. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371;
21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: This regulation is one component of the Secretary's
initiative to reduce medical errors. The regulation would amend the
regulations governing the format and content of professional labeling
for human prescription drug and biologic products, 21 CFR 201.56 and
201.57. The regulation would require that professional labeling include
a section containing highlights of prescribing information, and a
section containing an index to prescribing information; reorder
currently required information and make minor changes to its content,
and establish minimum graphical requirements for professional labeling.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/22/00 65 FR 81082
NPRM Comment Period End 03/22/01
NPRM Comment Period Reopened 03/30/01
NPRM Comment Period Reopening
End 06/22/01
Final Action 10/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Office of
Regulatory Policy, Department of Health and Human Services, Food and
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA94
_______________________________________________________________________
797. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION
Priority: Other Significant
Legal Authority: 21 USC 356a
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: Section 116 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 506A to the Food, Drug, and
Cosmetic Act (21 U.S.C. 356a). Pursuant to section 116, the rulemaking
will revise current procedures for approving manufacturing changes and
generally classify such changes into four categories. Major
manufacturing changes, which are of a type determined by the Secretary
to have a substantial potential to adversely affect the identity,
strength, quality, purity, and potency of the drug as they may relate
to the safety and effectiveness of a drug, require prior approval of a
supplemental application. A second category of changes may be made if
FDA has not notified the company within 30 days after the submission of
a supplement that prior approval is required. A third category of
changes may be made upon submission of a supplement to the agency. The
rule will also identify another category of changes that may be made
without the submission of a supplement but which must be reported in an
annual report.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/28/99 64 FR 34608
Final Action 10/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Howard P. Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 1451
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB61
_______________________________________________________________________
798. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT
CONTENT CLAIMS, AND HEALTH CLAIMS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC
348; 21 USC 371; ...
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act,
which was added by the Nutrition Labeling and Education Act of 1990
(NLEA), requires that the label or labeling of food products bear
nutrition information. Among other things, section 403(q) of the Act
authorizes the Food and Drug Administration (FDA) to add or delete
nutrients that are to be declared on the labels or labeling of food
products by regulation if it finds such action necessary to assist
consumers in maintaining healthy dietary practices. FDA issued final
regulations implementing NLEA in 1993. FDA subsequently received a
citizen petition requesting that FDA amend its regulations on food
labeling to require that the amount of trans fatty acids be listed in
the nutrition label and be limited wherever saturated fat limits are
placed on nutrient content claims, health claims, or disqualifying
levels and disclosure levels. In response to this petition and based on
new evidence, FDA proposed the actions requested in the petition on
November 17, 1999 (64 FR 62746). In addition, FDA proposed to define
the claim ``trans fat free.''
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/17/99 64 FR 62746
NPRM Comment Period Reopened 12/05/00 65 FR 75887
NPRM Comment Period End 01/19/01
NPRM Comment Period Reopened 11/15/02
NPRM Comment Period End 12/16/02
Final Rule 06/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
[[Page 30240]]
Government Levels Affected: State, Tribal, Local
Federalism: This action may have federalism implications as defined in
EO 13132.
Agency Contact: Susan Thompson, Chemist, Department of Health and Human
Services, Food and Drug Administration, (HFS-832), Center for Food
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park,
MD 20740
Phone: 301 436-1450
Fax: 301 436-2639
Email: [email protected]
RIN: 0910-AB66
_______________________________________________________________________
799. CGMP FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES AND
TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT INCREASED
RISK OF TRANSMITTING HCV INFECTION (LOOKBACK)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC
263a; 42 USC 264
CFR Citation: 21 CFR 606; 21 CFR 610
Legal Deadline: None
Abstract: This rulemaking is one of a number of actions being taken to
amend the biologics regulations to remove, revise, or update the
regulations applicable to blood, blood components, and blood
derivatives. These actions are based on FDA's comprehensive review of
the biologics regulations and on reports by the U.S. House of
Representatives Committee on Government Reform and Oversight's,
Subcommittee on House Resources and Intergovernmental Relations, the
General Accounting Office, and the Institute of Medicine, as well as on
public comments. In this rulemaking, FDA will amend the biologics
regulations to require that blood establishments prepare and follow
written procedures for appropriate action when it is determined that
blood and blood components pose an increased risk for transmitting
hepatitis C virus (HCV) infection because they have been collected from
a donor who, at a later date, tested reactive for evidence of HCV. The
HCV lookback regulations will be amended for consistency.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/16/00 65 FR 69377
NPRM Comment Period End 02/14/01
Final Action 12/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Related RIN: Related To 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________
800. REQUIREMENTS FOR SUBMISSION OF LABELING FOR HUMAN PRESCRIPTION
DRUGS AND BIOLOGICS IN ELECTRONIC FORMAT
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 353; 21 USC
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e; ...
CFR Citation: 21 CFR 314; 21 CFR 601
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations governing the format in which certain labeling in new
drug applications, abbreviated new drug applications, certain
biological license applications, supplements, and annual reports is
required to be submitted. The rule would require that certain labeing
content described under section 201.160(d)(3) be submitted to FDA in
electronic format.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/03/02 67 FR 22367
Final Action 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: Nicole K. Mueller, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Room 3037,
(HFD-7), 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]
RIN: 0910-AB91
_______________________________________________________________________
801. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF
FDA-REGULATED PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC
379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to
263n
CFR Citation: 21 CFR 50; 21 CFR 56
Legal Deadline: Other, Statutory, April 17, 2001, The Children's Health
Act of 2000 requires that, within six months of the date of its
enactment on October 17, 2000, FDA adopt existing HHS regulations
providing additional protections for children involved as subjects in
research. FDA published an interim rule in April 2001.
Abstract: The final rule will finalize the interim rule that published
in April 2001, providing additional protections for children involved
as subjects in clinical investigations of FDA-regulated products, as
required by the Children's Health Act of 2000.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Rule 04/24/01 66 FR 20589
Final Rule 12/00/03
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Carol Drew, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Suite 3037 (HFD-7),
Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
[[Page 30241]]
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC07
_______________________________________________________________________
802. ALUMINUM IN LARGE- AND SMALL-VOLUME PARENTERALS USED IN TOTAL
PARENTERAL NUTRITION
Priority: Other Significant
Legal Authority: 21 USC 321(n); 21 USC 352; 21 USC 355; 21 USC 371(a);
21 CFR 201.51; 21 CFR 201.100; 21 CFR 314.125
CFR Citation: 21 CFR 201.323(c)
Legal Deadline: None
Abstract: The final rule will revise 21 CFR 323(c) to permit small-
volume parenterals and pharmacy bulk packages that contain 25 mcg/L or
less of aluminum to state ``contains no more than 25 mcg/L'' rather
than the exact amount of aluminum.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/12/02 67 FR 52429
Final Action 06/00/03
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC18
_______________________________________________________________________
803. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS AND BLOOD
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371;
21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
CFR Citation: 21 CFR 201.25; 21 CFR 601.67
Legal Deadline: None
Abstract: This regulation is one component of the Secretary's
initiative to reduce medical errors. The final rule would require human
drug products and biological products to have a bar code. The bar code
would contain certain information about the product, and when used in
conjunction with bar code scanners and computer equipment, would help
reduce the number of medication errors. The final rule would also
require the use of machine-readable information on blood and blood
component container labels.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/14/03 68 FR 12500
Final Rule 12/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AC26
_______________________________________________________________________
804. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY SYSTEMS
AND THEIR MAJOR COMPONENTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 301 et seq; 21 USC 360kk et seq
CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32
Legal Deadline: None
Abstract: This rule amends the performance standard for diagnostic x-
ray systems and their components in 21 CFR 1020.30, 1020.31, and
1020.32 to address the changes in technology and practice and to fully
utilize the currently accepted metric system.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/10/02 67 FR 76056
Final Action 12/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, HFZ-215,
Center for Devices and Radiological Health, 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]
RIN: 0910-AC34
_______________________________________________________________________
805. REGISTRATION OF FOOD AND ANIMAL FEED FACILITIES
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: PL 107-188, sec 305
CFR Citation: 21 CFR 1
Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 305, directs the Secretary, through FDA, to issue
a final regulation establishing registration requirements by December
12, 2003. The statute is self-implementing on this date if FDA does not
issue a final regulation that is effective by December 12, 2003.
Abstract: This rulemaking is one of a number of actions being taken to
improve FDA's ability to respond to threats of bioterrorism. Section
415 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was
added by section 305 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (the Bioterrorism Act), directs
the Secretary to require any facility engaged in manufacturing,
processing, packing, or holding of food for consumption by humans or
animals in the United States to be registered with the Secretary
through FDA. Section 415 directs the Secretary, through FDA, to
promulgate final regulations implementing the requirements by December
12, 2003. The owner, operator, or agent in charge of the facility must
submit the registration. Foreign facilities must include the name of
the United States agent for the facility. The registration must include
the name and address of each facility at which, and all trade names
under which, the registrant conducts business. If FDA determines
[[Page 30242]]
it is necessary through guidance, the registration must include the
general food category (as identified under 21 CFR 170.3) of foods
manufactured, processed, packed, or held at the facility. The
registrant is required to notify the Secretary of changes to the
registration in a timely manner. Under the proposed rule, upon receipt
of the completed registration form, FDA would notify the registrant of
receipt of the registration and assign a unique registration number to
the facility. The Bioterrorism Act requires the Secretary to compile
and maintain an up-to-date list of registered facilities. This list and
any registration documents submitted to the Secretary are not subject
to disclosure under the Freedom of Information Act. For purposes of
section 415, ``facility'' includes any factory, warehouse, or
establishment engaged in the manufacturing, processing, packing, or
holding of food. Exempt from the registration requirement are farms,
restaurants, other retail food establishments, nonprofit food
establishments in which food is prepared for or served directly to the
consumer, and fishing vessels (except those engaged in processing as
defined in 21 CFR 123.3(k)). Foreign facilities required to register
include only those from which food is exported to the United States
without further processing or packaging outside the United States. The
Bioterrorism Act provides that if a foreign facility attempts to import
food into the United States without having registered, the food will be
held at the port of entry or at a secure facility, until the foreign
facility has registered.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/03/03 68 FR 5377
Final Rule 10/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Leslye M. Fraser, Associate Director for Regulations,
Office of Regulations and Policy, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2378
Fax: 301 436-2637
Email: [email protected]
RIN: 0910-AC40
_______________________________________________________________________
806. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: PL 107-188, sec 307
CFR Citation: 21 CFR 1.276 et seq
Legal Deadline: Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 307, directs the Secretary, through FDA, to issue
final regulations establishing prior notice requirements for all
imported food by December 12, 2003. If FDA fails to issue final
regulations by this date, the statute is self-executing on this date,
and requires FDA to receive prior notice of not less than eight hours,
nor more than five days until final regulations are issued.
Abstract: This rulemaking is one of a number of actions being taken to
improve FDA's ability to respond to threats of bioterrorism. Section
801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was
added by section 307 of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, authorizes the Secretary,
through FDA, to promulgate final regulations by December 12, 2003.
Section 801(m) requires notification to FDA prior to the entry of
imported food. The required prior notice would provide the identity of
the article of food; the manufacturer; the shipper; the grower, if
known at the time of notification; the originating country; the
shipping country; and the anticipated port of entry. The regulation
identifies the parties responsible for providing the notice and
explains the information that the prior notice is required to contain,
the method of submission of the notice, and the minimum and maximum
period of advance notice required. Section 307 also states that if FDA
does not receive prior notice or receives inadequate prior notice, the
imported food shall be refused admission and held at the port of entry
until proper notice is provided.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/03/03 68 FR 5428
Final Rule 10/00/03
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
URL For More Information:
http://www.fda.gov/ohrms/dockets/98fr/03-2444.pdf
URL For Public Comments:
http://www.fda.gov/dockets/ecomments
Agency Contact: Mary Ayling, Lead, Inspection and Compliance Team, Food
Safety Staff, Department of Health and Human Services, Food and Drug
Administration, HFS-32, Center for Food Safety and Applied Nutrition,
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2131
Fax: 301 436-2605
Email: [email protected]
RIN: 0910-AC41
_______________________________________________________________________
807. PRESUBMISSION CONFERENCES
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 514
Legal Deadline: None
Abstract: This rule will implement section 512(b)(3) of the Federal
Food, Drug, and Cosmetic Act (the Act). This section of the Act states
that any person intending to file a new animal drug application or
supplemental new animal drug application, or to investigate a new
animal drug is entitled to one or more conferences with the agency
prior to submission to reach an agreement establishing a submission or
investigational requirement. This rule would describe how to request a
presubmission conference and describe the procedures for the conduct of
presubmission conferences.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/25/00 65 FR 51782
Final Action 03/00/04
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Federalism: Undetermined
[[Page 30243]]
Agency Contact: Gail Schmerfeld, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, HFV-100,
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD
20855
Phone: 301 827-0205
Related RIN: Previously reported as 0910-AB68
RIN: 0910-AC44
_______________________________________________________________________
808. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG: PATENT LISTING
REQUIREMENTS AND APPLICATION OF 30-MONTH STAYS ON APPROVAL OF
ABBREVIATED NEW DRUG APPLICATIONS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 355a; 21 USC 356; 21 USC 356a; 21 USC 356b; 21 USC 356c; 21 USC
371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 314.52(a)(3); 21 CFR 314.53(b); 21 CFR
314.53(c)(1); 21 CFR 314.53(c)(2); 21 CFR 314.95(a)(3)
Legal Deadline: None
Abstract: The final rule would clarify the types of patents for which
information must or must not be submitted to FDA. The final rule would
also revise the patent declaration to make it more detailed. The rule
would also revise the regulations regarding the approval date for
certain abbreviated new drug applications or ``505(b)(2) applications''
by stating that there is only one opportunity for a 30-month stay in
the approval date of an ANDA or 505(b)(2) application.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/24/02 67 FR 65448
NPRM Comment Period End 12/23/02
Final Rule 05/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jarilyn Dupont, Department of Health and Human
Services, Food and Drug Administration, Office of Policy, Planning and
Legislation (HF-11), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 594-6777
Email: [email protected]
RIN: 0910-AC48
_______________________________________________________________________
809. [bull] BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXOIDS;
IMPLEMENTATION OF EFFICACY REVIEW
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360c; 21
USC 360d; 21 USC 360h; 21 USC 360i; 21 USC 360gg-360ss; 21 USC 371; 21
USC 372; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241;
42 USC 262; 42 USC 263; 42 USC 263a; 42 USC 264
CFR Citation: 21 CFR 201.59; 21 CFR 610.21
Legal Deadline: None
Abstract: The final rule amends the FDA biologics regulations in
response to the report and recommendations of the Panel on Review of
Bacterial Vaccines and Toxoids with Standards of Potency (the Panel).
The Panel reviewed the safety, efficacy, and labeling of bacterial
vaccines and toxoids with standards of potency, bacterial antitoxins,
and immune globulins. On the basis of the Panel's findings and
recommendations, FDA is classifying these products as Category I (safe,
effective, and not misbranded), Category II (unsafe, ineffective, or
misbranded), or Category IIIB (off the market pending completion of
studies permitting a determination of effectiveness).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/13/85 50 FR 51002
NPRM Comment Period End 03/13/86
Final Action 03/00/04
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Astrid L. Szeto, Senior Reguatory Review Officer,
Department of Health and Human Services, Food and Drug Administration,
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
RIN: 0910-AC56
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
810. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL
PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42
USC 263; 42 USC 263a-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC
331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b-j; 21 USC
361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381
CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR
600; 21 CFR 601; 21 CFR 606
Legal Deadline: None
Abstract: This regulation is one component of the Secretary's
initiative to reduce medical errors. The proposed rule would amend the
expedited and periodic safety reporting regulations for human drugs and
biological products to revise certain definitions and reporting formats
as recommended by the International Conference on Harmonisation and to
define new terms; to add to or revise current reporting requirements;
to revise certain reporting time frames; and propose other revisions to
these regulations to enhance the quality of safety reports received by
FDA.
[[Page 30244]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/14/03 68 FR 12406
Final Rule To Be Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Office of
Regulatory Policy, Department of Health and Human Services, Food and
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
811. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND
CELLULAR AND TISSUE-BASED PRODUCTS
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42
USC 271
CFR Citation: 21 CFR 210.1(c); 21 CFR 210.2(a); 21 CFR 210.2(b); 21 CFR
211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271
Legal Deadline: None
Abstract: The Food and Drug Administration is requiring certain
manufacturers of human cells, tissues, and cellular and tissue-based
products (HCT/Ps) to take actions to screen and test the donors of
cells and tissues used in those products for evidence of, or risk
factors for, relevant communicable disease. As part of this action, the
agency is amending the current good manufacturing practice regulations
that apply to HCT/Ps regulated as drugs, medical devices, and/or
biological products to incorporate the new donor eligibility
requirements into existing good manufacturing practice regulations for
those products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/30/99 64 FR 52696
NPRM Comment Period End 12/29/99
NPRM Comment Period Reopened 04/18/00 65 FR 20774
NPRM Comment Period Reopened End07/17/00
Final Action To Be Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
RIN: 0910-AB27
_______________________________________________________________________
812. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR
AND TISSUE-BASED PRODUCTS ESTABLISHMENTS; INSPECTION AND ENFORCEMENT
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 264; 42 USC 271
CFR Citation: 21 CFR 1270 and 1271
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is requiring human
cell, tissue, and cellular and tissue-based products (HCT/P)
establishments to follow current good tissue practice (CGTP), which
governs the methods used in, and the facilities and controls used for,
the manufacture of HCT/Ps, recordkeeping, and the establishment of a
quality program. FDA is also issuing regulations pertaining to
labeling, reporting, inspections, and enforcement.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/08/01 66 FR 1508
NPRM Comment Period End 05/08/01
Final Action To Be Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
RIN: 0910-AB28
_______________________________________________________________________
813. REGULATION OF CARCINOGENIC COMPOUNDS USED IN FOOD-PRODUCING
ANIMALS; DEFINITION OF ``NO RESIDUE''
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC
348; 21 USC 351 to 353; 21 USC 360b; 21 USC 371
CFR Citation: 21 CFR 500.80; 21 CFR 500.82; 21 CFR 500.84; 21 CFR
500.88
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) amended its
regulations relating to the operational definition of the term ``no
residue.'' The definition is used in determining whether any residue of
carcinogenic compounds used in food-producing animals would ``be found
in the food produced from those animals under conditions of use
reasonably certain to be followed in practice'' (21 CFR 500.80(a)).
Under the previous operational definition of no residue, it was
possible for a residue detected by a method approved by FDA to be
considered ``no residue.'' FDA revised its regulations to make them
consistent with a 1995 Department of Justice opinion regarding this
definition. The changes revised the definition of ``no residue'' to
mean that no residue is detected with an approved regulatory method.
The rule has several conditions that sponsors of carcinogenic compounds
must satisfy with respect to the sponsors' proposed regulatory methods.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/17/02 67 FR 2384
NPRM Comment Period Ends 04/17/02
Final Action 12/23/02 67 FR 78172
Next Action Undetermined
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Steven Brynes, Regulatory Scientist, Department of
[[Page 30245]]
Health and Human Services, Food and Drug Administration, HFV-151,
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD
20855
Phone: 301 827-6975
Email: [email protected]
Related RIN: Previously reported as 0910-AC13
RIN: 0910-AC45
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
814. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL
PRODUCTS; FINAL RULE
Priority: Substantive, Nonsignificant
CFR Citation: 21 CFR 610.11(g)
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 03/04/03 68 FR 10157
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Stephen M. Ripley
Phone: 301 827-6210
RIN: 0910-AB51
_______________________________________________________________________
815. ANTIBIOTIC RESISTANCE LABELING
Priority: Other Significant
CFR Citation: 21 CFR 201.24
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 02/06/03 68 FR 6062
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Christine F. Rogers
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB78
_______________________________________________________________________
816. RECORDS AND REPORTS CONCERNING EXPERIENCE WITH APPROVED NEW ANIMAL
DRUGS
Priority: Other Significant
CFR Citation: 21 CFR 514.80
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 03/31/03 68 FR 15255
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Glenn Peterson
Phone: 301 827-0224
Fax: 301 827-1485
Email: [email protected]
Related RIN: Previously reported as 0910-AA02
RIN: 0910-AC42
_______________________________________________________________________
817. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Priority: Substantive, Nonsignificant
CFR Citation: 21 CFR 320
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 12/19/02 67 FR 77668
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Christine F. Rogers
Phone: 301 594-2041
Fax: 301 827-5562
Related RIN: Previously reported as 0910-AA51
RIN: 0910-AC47
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
818. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE
PAYMENTS REPORTING REQUIREMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 11131
CFR Citation: 45 CFR 60.7
Legal Deadline: None
Abstract: This notice of proposed rulemaking (NPRM) proposes to require
that, in addition to reporting to the National Practitioner Data Bank
medical malpractice payments made where physicians or other health care
practitioners are named in medical malpractice actions or claims,
judgments, or settlements, payments be reported where they are made for
the benefit of physicians or other health care practitioners not named
in the judgments or settlements but who furnished or failed to furnish
the health care services upon which the actions or claims were based.
The purpose of this NPRM is to prevent the evasion of the medical
malpractice payment reporting requirement of the Data Bank through the
agreement of the parties to a lawsuit to use the corporate health care
entity to ``shield'' practitioners. It would also require malpractice
payers, in very limited circumstances, when it is impossible to
identify the practitioner who furnished or failed to furnish the health
care services upon which the actions or claims were based, to report
why the practitioner could not be identified, and to provide the name
of the corporate health care entity.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/24/98 63 FR 71255
NPRM Comment Period End 02/22/99
Second NPRM 05/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: John M. Heyob, Director, Division of Practitioner Data
Banks, Department of Health and Human Services, Public Health Service,
Suite 300, 7519 Standish Place, Rockville, MD 20957
[[Page 30246]]
Phone: 301 443-2300
Fax: 301 443-6725
RIN: 0906-AA41
_______________________________________________________________________
819. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH
PROFESSIONAL SHORTAGE AREAS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 254b; 42 USC 254e
CFR Citation: 42 CFR 5; 42 CFR 51c
Legal Deadline: None
Abstract: This rule would consolidate the process for designating areas
of health professional shortage and medical underservice that apply in
several department programs, and would improve the criteria for
designating medically underserved populations (MUPs) and Primary Care
Health Professional Shortage Areas (HPSAs). This notice of proposed
rulemaking (NPRM) will address issues raised by comments received in a
previous NPRM, dated September 1, 1998.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/01/98 63 FR 46538
NPRM Comment Period End 01/04/99
Second NPRM 10/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Andy Jordan, Acting Chief, Shortage Designation Branch,
Department of Health and Human Services, Health Resources and Services
Administration, Room 8C26, National Center for Health Workforce
Analysis, Bureau of Health Professions, Parklawn Building, Rockville,
MD 20857
Phone: 301 594-0197
Email: [email protected]
RIN: 0906-AA44
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Health Resources and Services Administration (HRSA)
_______________________________________________________________________
820. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND
NEGATIVE ACTIONS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1396r-2
CFR Citation: 45 CFR 60
Legal Deadline: None
Abstract: Public Law 100-93 amended section 1921 of the Social Security
Act to require that each State have in effect a system of reporting
disciplinary licensure actions taken against all licensed health care
practitioners and entities. It also requires States to report any
negative action or finding that a peer review organization, private
accreditation entity, or a State has concluded against a health care
practitioner or entity. Section 1921 directs the Secretary to provide
for maximum appropriate coordination in the implementation of these
reporting requirements with those of the Health Care Quality
Improvement Act of 1986 (title IV of Pub. L. 99-660). Section 1921
requirements will be incorporated into the National Practitioner Data
Bank (NPDB).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: State
Agency Contact: John M. Heyob, Director, Division of Practitioner Data
Banks, Department of Health and Human Services, Public Health Service,
Suite 300, 7519 Standish Place, Rockville, MD 20957
Phone: 301 443-2300
Fax: 301 443-6725
RIN: 0906-AA57
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Indian Health Service (IHS)
_______________________________________________________________________
821. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM
STANDARDS OF CHARACTER
Priority: Info./Admin./Other
Legal Authority: 25 USC 3201 et seq
CFR Citation: 42 CFR 36
Legal Deadline: None
Abstract: The Indian Health Service (IHS) is proposing to establish
regulations as mandated by the Indian Child Protection and Family
Violence Protection Act, Public Law 101-630, 25 U.S.C. 3201 to 3211,
that prescribe minimum standards of character for individuals whose
duties and responsibilities involve regular contact with, or control
over, Indian children.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/25/99 64 FR 14559
NPRM Comment Period End 07/26/99
Final Action 10/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Tribal
Agency Contact: Ramona D. Williams, Child Protection Coordinator,
Department of Health and Human Services, Indian Health Service, Suite
605, 12300 Twinbrook Parkway, Rockville, MD 20852
Phone: 301 443-1589
RIN: 0917-AA02
[[Page 30247]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________
822. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY
THE NATIONAL INSTITUTES OF HEALTH (NIH)
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-4
CFR Citation: 42 CFR 68b
Legal Deadline: None
Abstract: Section 487D of the Public Health Service Act, as added by
the National Institutes of Health Revitalization Act of 1993, creates a
program offering scholarships, in an amount not to exceed $20,000 per
year of academic study, to individuals from disadvantaged backgrounds
who are enrolled as full-time students at accredited institutions
pursuing academic programs appropriate for careers in professions
needed by the NIH. For each year of scholarship support, the recipient
agrees to service (employment) after graduation, at the NIH, for one
year. Additionally, the individual agrees to at least 10 consecutive
weeks of service (employment) at the NIH during which the individual is
attending the educational institution and receiving the NIH
scholarship. The proposed new regulations will cover this program.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA10
_______________________________________________________________________
823. NATIONAL INSTITUTES OF HEALTH (NIH) TRAINING GRANTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 285g-10
CFR Citation: 42 CFR 63a
Legal Deadline: None
Abstract: NIH proposes to amend the training grants regulations to
implement the new authority under section 452G of the PHS Act. This
action is necessitated by enactment of the Children's Act of 2000.
Section 1002 of this act adds a new section 452G that authorizes the
Director of National Institute of Child Health and Human Development
(NICHHD) in consultation with the Administrator of Health Resources and
Services Administration (HRSA), to support activities to provide for an
increase in the number and size of institutional training grants
supporting pediatric training.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA28
_______________________________________________________________________
824. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 287a-3a
CFR Citation: 42 CFR 59
Legal Deadline: NPRM, Statutory, June 18, 2001.
Abstract: The National Institutes of Health proposes to establish
standards for operating a national chimpanzee sanctuary system to
provide for the permanent retirement of federally-owned or supported
chimpanzees no longer needed for research.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA31
_______________________________________________________________________
825. NATIONAL INSTITUTES OF HEALTH (NIH) AIDS RESEARCH LOAN REPAYMENT
PROGRAM
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
Legal Authority: 42 USC 216; 42 USC 288-1
CFR Citation: 42 CFR 68
Legal Deadline: None
Abstract: Section 487A of the Public Health Service Act creates a
program through which appropriately qualified health professionals may
obtain federally funded repayment of educational loans by conducting
AIDS research as NIH employees. NIH is issuing regulations that will
govern the program.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA32
_______________________________________________________________________
826. [bull] NATIONAL INSTITUTES OF HEALTH EXTRAMURAL LOAN REPAYMENT
PROGRAM FOR CLINICAL RESEARCHERS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-5a
CFR Citation: 42 CFR 68g
Legal Deadline: None
[[Page 30248]]
Abstract: The National Institutes of Health proposes to establish
implementing regulations for the Extramural Loan Repayment Program for
Clinical Researchers, authorized under section 487F of the Public
Health Service Act. The program provides for the repayment of the
existing educational loan debt of qualified health professionals who
agree to conduct clinical research.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA33
_______________________________________________________________________
827. [bull] NATIONAL INSTITUTES OF HEALTH PEDIATRIC RESEARCH LOAN
REPAYMENT PROGRAM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-6
CFR Citation: 42 CFR 68e
Legal Deadline: None
Abstract: The National Institutes of Health proposes to establish
implementing regulations for Pediatric Research Loan Repayment Program,
authorized under section 487F of the Public Health Service Act. The
program provides for the repayment of the existing educational loan
debt of qualified health professionals who agree to conduct pediatric
research.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA34
_______________________________________________________________________
828. [bull] LOAN REPAYMENT PROGRAM FOR HEALTH DISPARITIES RESEARCH
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 287c-33
CFR Citation: 42 CFR 68f
Legal Deadline: None
Abstract: The National Institutes of Health proposes to establish
implementing regulations for the Loan Repayment Program for Health
Disparities Research, authorized under section 485G of the Public
Health Service Act. The program provides for the repayment of the
existing educational loan debt of qualified health professionals who
agree to conduct research on minority health or other health
disparities for a minimum of two years.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA35
_______________________________________________________________________
829. [bull] NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN
REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-5
CFR Citation: 42 CFR 68a
Legal Deadline: None
Abstract: The National Institutes of Health proposes to amend the
regulations governing the Clinical Research Loan Repayment Program for
Individuals from Disadvantaged Backgrounds to reflect the new maximum
annual loan amount of $35,000 and a change in program eligibility to
include qualified health professionals who are not NIH employees.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA36
[[Page 30249]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________
830. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH
GENERALLY
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 288-3
CFR Citation: 42 CFR 68d
Legal Deadline: None
Abstract: Regulations will be issued to govern the awarding of
educational loan repayments to qualified health professionals who agree
to conduct research as employees of the National Institutes of Health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/05/02 67 FR 50622
Final Rule 09/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA18
_______________________________________________________________________
831. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH
AND DEVELOPMENT CONTRACT PROJECTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 282(b)(6); 42 USC 284(c)(3); 42 USC
289a; 42 USC 290aa-3
CFR Citation: 42 CFR 52h
Legal Deadline: None
Abstract: NIH staff have found ambiguities, misstatements, and voids in
the existing regulations on research misconduct. These regulations,
which govern the first level of review, are being amended to reflect
current policies and procedures.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/21/00 65 FR 57132
Final Rule 09/00/03
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA20
_______________________________________________________________________
832. NATIONAL INSTITUTES OF HEALTH (NIH) CENTER GRANTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; PL 106-310; PL 106-505; PL 106-525
CFR Citation: 42 CFR 52a
Legal Deadline: None
Abstract: NIH proposes to amend the current center grants regulations
to reflect new authorities set forth in sections 409C, 445I, 452E, and
485F of the Public Health Service Act (PHS Act). Section 409C concerns
centers of excellence regarding research on autism; section 445I
concerns centers of excellence in Alzheimer's disease research and
treatment; section 452E concerns centers regarding research on
``fragile X;'' and section 485F concerns centers of excellence for
research education and training for individuals who are members of
minority health disparity populations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/12/02 67 FR 68548
Final Rule 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: None
Agency Contact: Jerry Moore, NIH Regulations Officer, Department of
Health and Human Services, National Institutes of Health, Room 601 MSC
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]
RIN: 0925-AA24
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Office of Public Health and Science (OPHS)
_______________________________________________________________________
833. PUBLIC HEALTH SERVICES POLICIES ON RESEARCH MISCONDUCT
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b
CFR Citation: 42 CFR 93
Legal Deadline: None
Abstract: This notice of proposed rulemaking proposes substantial
revisions to the existing regulations at 42 CFR part 50, subpart A,
``Responsibilities of Awardee and Applicant Institutions for Dealing
With and Reporting Possible Misconduct in Science,'' 54 FR 32449,
August 8, 1989. The National Institutes of Health Revitalization Act of
1993 (NIH Act), Public Law 103-43, contains provisions that affect the
current rule. For example, section 161 of the NIH Act established the
Office of Research Integrity (ORI) as an independent entity reporting
to the Secretary, and recent organizational changes have also affected
the ORI's operations. In addition, the Office of Science and Technology
Policy (OSTP) published a Governmentwide policy that applies to
federally-funded research and proposals submitted to the Federal
agencies for research funding, 65 FR 76260, December 6, 2000. The
proposed revised regulation will implement this OSTP policy, which
contains a definition of research misconduct and basic guidelines for
the response of Federal agencies and research
[[Page 30250]]
institutions to allegations of research misconduct. The current
regulation, which implemented section 493(e) of the Public Health
Service Act, would be deleted, and a new part 93, subparts A, B, C, D,
and E would be added.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/03
NPRM Comment Period End 10/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Chris Pascal, Director, Office of Research Integrity,
Department of Health and Human Services, Office of Public Health and
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 443-3400
Fax: 301 443-5351
Related RIN: Related To 0940-AA01
RIN: 0940-AA04
_______________________________________________________________________
834. HUMAN SUBJECTS PROTECTION REGULATIONS: INSTITUTIONAL REVIEW BOARDS
REGISTRATION REQUIREMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 5 USC 301; 42 USC 289
CFR Citation: 45 CFR 46
Legal Deadline: None
Abstract: This notice of proposed rulemaking proposes to add subpart F
to Department of Health and Human Services (HHS) regulations for
protection of human subjects, 45 CFR part 46, to require registration
of institutional review boards (IRBs) with HHS. The registration
information would include contact information, approximate numbers of
active protocols involving research conducted or supported by HHS and
other Federal agencies, accreditation status, IRB membership, and
staffing for the IRB. The proposed registration requirements will make
it easier for Office for Human Research Protections (OHRP) to convey
information to IRBs and will support the current IRB registration
operated by OHRP. Under the current OHRP IRB registration system, the
submission of certain registration information is required by human
subjects protection regulations, and certain other information may be
submitted voluntarily. This proposed information collection was
submitted to the Office of Management and Budget under the Paperwork
Reduction Act. Under the proposed rule, all registration information
will be required, making the IRB registration system uniform with IRB
registration requirements of the Food and Drug Administration (FDA),
and creating a single, HHS IRB Registration system. FDA will
simultaneously publish a proposed rule regarding FDA IRB registration
requirements.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/03
NPRM Comment Period End 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Irene Stith-Coleman Ph.D, Department of Health and
Human Services, Office of Public Health and Science, Suite 200, The
Tower Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527
Email: [email protected]
RIN: 0940-AA06
_______________________________________________________________________
835. [bull] HUMAN SUBJECTS PROTECTION REGULATIONS: TRAINING AND
EDUCATION REQUIREMENTS FOR INSTITUTIONAL OFFICIALS, INSTITUTIONAL REVIEW
BOARD MEMBERS AND STAFF, HUMAN PROTECTIONS ADMINISTRATORS, AND
INVESTIGATOR
Priority: Other Significant
Legal Authority: 5 USC 301; 42 USC 289
CFR Citation: 45 CFR 46
Legal Deadline: None
Abstract: This notice of proposed rulemaking proposes to add subpart E
to Department of Health and Human Services (DHHS) regulations for
protection of human subjects, 45 CFR part 46, and would require that
institutions engaged in human subjects research covered by an assurance
of compliance filed with the Office for Human Research Protections
ensure that Institutional officials, institutional review board (IRB)
chairpersons, and human protection administrators receive appropriate
training and education about the institution's assurance and that IRB
chairpersons and members, IRB staff, investigators, and other personnel
involved in the conduct or oversight of human subjects research receive
appropriate training and education about relevant human subjects
protection requirements. The proposed training and education
requirements will help to ensure that responsible individuals at
assured institutions understand and meet their regulatory
responsibilities for human subjects protection.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/03
NPRM Comment Period End 09/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Michael A. Carome MD, Department of Health and Human
Services, Office of Public Health and Science, Suite 200, The Tower
Building, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 496-7005
Fax: 301 402-0527
RIN: 0940-AA08
[[Page 30251]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Office of Public Health and Science (OPHS)
_______________________________________________________________________
836. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH
MISCONDUCT WHISTLEBLOWERS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b
CFR Citation: 42 CFR 94
Legal Deadline: None
Abstract: To implement section 493(e) of the Public Health Service Act
(added by section 163 of the National Institutes of Health
Revitalization Act of 1993, Pub. L. 103-43), the Department is
proposing to add a new part 94 to title 42 of the Code of Federal
Regulations. Under this proposed regulation, covered institutions must
follow certain requirements for preventing and responding to
occurrences of retaliation against whistleblowers. The purpose of this
part is to protect: (1) persons who make a good faith allegation that a
covered institution or member thereof engaged in, or failed to respond
adequately to an allegation of research misconduct; and (2) persons who
cooperate in good faith with an investigation of research misconduct.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/28/00 65 FR 70830
NPRM Comment Period End 01/29/01
Final Action 12/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Chris Pascal, Director, Office of Research Integrity,
Department of Health and Human Services, Office of Public Health and
Science, Suite 750, 1101 Wootten Parkway, Rockville, MD 20852
Phone: 301 443-3400
Fax: 301 443-5351
Related RIN: Related To 0940-AA04
RIN: 0940-AA01
_______________________________________________________________________