[Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]
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Part VIII
Department of Health and Human Services
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Semiannual Regulatory Agenda
[[Page 37428]]
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
Regulatory Agenda
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 by Federal departments
and agencies. The purpose is to encourage public participation in the
regulatory process by providing, at as early a stage as possible,
summarized information about regulatory actions under consideration.
Anyone wishing to communicate to the Department their views on the
potential rulemakings outlined below is invited to do so.
When the Department publishes a regulatory proposal,
information about it automatically becomes available to the public
at www.regulations.gov, the Governmentwide Web site for submission
of comments on proposed regulations. Citizens may submit comments
by clicking the Submit a Comment on the Regulation link on this
site, which will open a blank comment form that includes
instructions on how to submit the comment and what information must
be provided for the comment to be considered. Comments submitted
via www.regulations.gov are transmitted to the Department daily,
and, as legally required, all comments are reviewed and taken into
account if a final regulation is developed.
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 of proposed rulemaking, 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 sent to: Ann C. Agnew,
Executive Secretary to the Department, Room 603H, 200 Independence
Avenue SW., Washington, DC 20201.
Dated: June 9, 2004.
Ann C. Agnew,
Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
813 Safe Harbor for Arrangements Involving Federally Qualified Health Centers............. 0991-AB06
814 Claims Collection..................................................................... 0991-AB18
815 Salary Offset......................................................................... 0991-AB19
816 Medicare and Federal Health Care Programs: Fraud and Abuse; Revisions to the Waiver 0991-AB33
Provisions of the OIG's Exclusion Authorities.........................................
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
817 Shared Risk Exception to the Safe Harbor Provisions................................... 0991-AA91
818 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...............................................................................
819 Safe Harbor for Waiver of Beneficiary Coinsurance and Deductible Amounts for a 0991-AB16
Medicare SELECT Policy................................................................
820 Clarification of Terms and Application of Program Exclusion Authority for Submitting 0991-AB23
Claims Containing Excessive Charges...................................................
821 Technical Revisions to HIPDB Data Collection Activities............................... 0991-AB31
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
822 Revisions to Regulations Addressing the OIG's Authority to Impose Civil Money 0991-AB03
Penalties and Assessments.............................................................
823 Health Insurance Portability and Accountability Act--Enforcement...................... 0991-AB29
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[[Page 37429]]
Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
824 Tax Refund Offset..................................................................... 0991-AB17
825 Implementation of the Equal Access to Justice Act in Agency Proceedings............... 0991-AB22
826 OIG Civil Money Penalties Under the Medicare Prescription Drug Discount Card Program.. 0991-AB30
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Substance Abuse and Mental Health Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
827 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10
Community-Based Facilities for Children and Youth.....................................
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
828 Mandatory Guidelines for the Federal Workplace Drug Testing Program................... 0930-AA12
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
829 Substance Abuse and Mental Health Services Administration (SAMHSA) Charitable Choice.. 0930-AA11
830 Mandatory Guidelines for Federal Workplace Drug Testing Programs; Specimen Validity 0930-AA13
Testing...............................................................................
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
831 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04
Respiratory Protective Devices........................................................
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
832 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........
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Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
833 Safety Reporting Requirements for Human Drug and Biological Products.................. 0910-AA97
834 Food Labeling; Prominence of Calories................................................. 0910-AF22
835 Food Labeling; Serving Sizes.......................................................... 0910-AF23
836 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43
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[[Page 37430]]
Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
837 Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and 0910-AA49
Biologics.............................................................................
838 Applications for FDA Approval To Market a New Drug; Complete Response Letter; 0910-AB34
Amendments To Unapproved Applications.................................................
839 Prevention of Salmonella Enteritidis in Shell Eggs.................................... 0910-AC14
840 Exception From General Requirements for Informed Consent; Request for Comments and 0910-AC25
Information...........................................................................
841 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure 0910-AC30
Regulators for Use With Medical Oxygen................................................
842 Food Standards: General Principles and Food Standards Modernization................... 0910-AC54
843 Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............. 0910-AC55
844 Reporting Information Regarding Falsification of Data................................. 0910-AC59
845 Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security 0910-AF06
and Bioterrorism Preparedness and Response Act of 2002................................
846 Health Claims......................................................................... 0910-AF09
847 Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water. 0910-AF10
848 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11
Requirements for Pregnancy and Lactation..............................................
849 Cochineal Extract and Carmine Label Declaration....................................... 0910-AF12
850 Charging for Investigational Drugs.................................................... 0910-AF13
851 Treatment Use of Investigational Drugs................................................ 0910-AF14
852 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AF16
Policies, Requirements, and Administrative Procedures; Derivatives of Blood...........
853 Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol.... 0910-AF18
854 Revocation of the Status of Specific Products; Group A Streptococcus.................. 0910-AF20
855 Latex Condoms: Special Controls....................................................... 0910-AF21
856 Blood Initiative--Regulations for Human Blood and Blood Components Intended for 0910-AF25
Transfusion or for Further Manufacturing Use..........................................
857 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32
858 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33
859 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34
860 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36
861 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37
862 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45
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Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
863 Investigational New Drugs: Export Requirements for Unapproved New Drug Products....... 0910-AA61
864 Labeling for Human Prescription Drugs; Revised Format................................. 0910-AA94
865 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based 0910-AB28
Product Establishments; Inspection and Enforcement....................................
866 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)..................................................................
867 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88
Ingredients and Dietary Supplements...................................................
868 Additional Safeguards for Children in Clinical Investigations of FDA-Regulated 0910-AC07
Products..............................................................................
869 Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration............... 0910-AC32
870 Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major 0910-AC34
Components............................................................................
871 Establishment and Maintenance of Records Pursuant to the Public Health Security and 0910-AC39
Bioterrorism Preparedness and Response Act of 2002....................................
872 Registration of Food and Animal Feed Facilities....................................... 0910-AC40
873 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism 0910-AC41
Preparedness and Response Act of 2002.................................................
874 Presubmission Conferences............................................................. 0910-AC44
875 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an 0910-AF15
Investigational New Drug Application..................................................
876 Blood Initiative--Revisions to Labeling and Storage Requirements for Blood and Blood 0910-AF26
Components, Including Source Plasma...................................................
[[Page 37431]]
877 Over-the-Counter (OTC) Drug Review--Antiperspirant Products........................... 0910-AF30
878 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31
879 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39
880 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42
881 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44
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Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
882 Requirements Pertaining to Sampling Services and Private Laboratories Used in 0910-AB96
Connection With Imported Food.........................................................
883 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed 0910-AC21
Animal Populations....................................................................
884 Requirements for Submission of In Vivo Bioequivalence Data............................ 0910-AC23
885 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs............. 0910-AC35
886 Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider 0910-AC50
Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements.....
887 Submission of Standardized Electronic Study Data From Clinical Studies Evaluating 0910-AC52
Human Drugs and Biologics.............................................................
888 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53
889 Food Labeling: Food Allergen Ingredient Labeling...................................... 0910-AF07
890 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding 0910-AF08
of Drugs; Revision of Certain Labeling Controls.......................................
891 Current Good Manufacutring Practices; Quality Control Procedures; Notification 0910-AF27
Requirements; Records and Reports.....................................................
892 Infant Formula Quality Factors........................................................ 0910-AF28
893 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35
894 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38
895 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40
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Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
896 Over-the-Counter (OTC) Drug Review.................................................... 0910-AA01
897 Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality 0910-AA04
Control Procedures, Quality Factors, Notification Requirements, and Records and
Reports...............................................................................
898 Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest 0910-AA89
of Recipients.........................................................................
899 Blood Initiative...................................................................... 0910-AB26
900 Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue- 0910-AB27
Based Products........................................................................
901 Supplements and Other Changes to an Approved Application.............................. 0910-AB61
902 Current Good Manufacturing Practice for Medicated Feeds............................... 0910-AB70
903 Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in 0910-AB91
Electronic Format.....................................................................
904 Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products...... 0910-AC19
905 Bar Code Label Requirements for Human Drug Products and Blood......................... 0910-AC26
906 Administrative Detention of Food for Human or Animal Consumption Under the Public 0910-AC38
Health Security and Bioterrorism Preparedness and Response Act of 2002................
907 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed................. 0910-AC43
908 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review 0910-AC56
909 Revision of the Requirements for Spore-Forming Microorganisms......................... 0910-AC57
910 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food 0910-AC58
(Part 110) (Completion of a Section 610 Review).......................................
911 Over-the-Counter (OTC) Drug Review--Antidiarrheal Products............................ 0910-AF29
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[[Page 37432]]
Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
912 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA41
Care Practitioners: Medical Malpractice Payments Reporting Requirements...............
913 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44
Areas.................................................................................
914 Intestines Added to the Definition of Organs Covered by the Rules Governing the 0906-AA62
Operation of the Organ Procurement and Transplantation Network (OPTN).................
915 Notice of Proposed Rulemaking to Amend the Final Rule Governing the Operation of the 0906-AA63
Organ Procurement and Transplantation Network (OPTN)..................................
916 National Vaccine Injury Compensation Program; Revisions and Additions to the Vaccine 0906-AA66
Injury Table..........................................................................
917 Liability Protection for Certain Free Clinic Health Professionals..................... 0906-AA67
918 National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health 0906-AA68
Insurance Policy......................................................................
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
919 Interim Final Rule for the Smallpox Emergency Personnel Protection Program: Smallpox 0906-AA60
(Vaccinia) Vaccine Injury Table.......................................................
920 Smallpox Vaccine Injury Compensation Program: Administrative Implementation........... 0906-AA61
921 Requirements Establishing a Limitation on Administrative Expenses; Ryan White CARE Act 0906-AA65
Title IV Grants for Coordinated Services and Access to Research.......................
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
922 National Practitioner Data Bank for Adverse Information on Physicians and Other Health 0906-AA57
Care Practitioners: Reporting Adverse and Negative Actions............................
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
923 Undergraduate Scholarship Program Regarding Professions Needed by the National 0925-AA10
Institutes of Health (NIH)............................................................
924 National Institutes of Health Training Grants......................................... 0925-AA28
925 Standards for a National Chimpanzee Sanctuary System.................................. 0925-AA31
926 National Institutes of Health AIDS Research Loan Repayment Program.................... 0925-AA32
927 National Institutes of Health Extramural Loan Repayment Program for Clinical 0925-AA33
Researchers...........................................................................
928 National Institutes of Health Pediatric Research Loan Repayment Program............... 0925-AA34
929 National Institutes of Health Loan Repayment Program for Health Disparities Research.. 0925-AA35
930 National Institutes of Health Clinical Research Loan Repayment Program for Individuals 0925-AA36
From Disadvantaged Backgrounds........................................................
931 National Institute of Child Health and Human Development Contraception and Infertility 0925-AA41
Research Loan Repayment Program.......................................................
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
932 National Institutes of Health Loan Repayment Program for Research Generally........... 0925-AA18
933 National Institutes of Health Center Grants........................................... 0925-AA24
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[[Page 37433]]
National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
934 Scientific Peer Review of Research Grant Applications and Research and Development 0925-AA20
Contract Projects.....................................................................
----------------------------------------------------------------------------------------------------------------
Office of Public Health and Science--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
935 Human Subjects Protection Regulations: Additional Protections for Adult Individuals 0940-AA11
with Impaired Decisionmaking Capacity.................................................
----------------------------------------------------------------------------------------------------------------
Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
936 Public Health Service Policies on Research Misconduct................................. 0940-AA04
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Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
937 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01
Whistleblowers........................................................................
938 Human Subjects Protection Regulations: Institutional Review Boards Registration 0940-AA06
Requirements..........................................................................
939 Federal Policy for the Protection of Human Subjects Technical Amendment............... 0940-AA10
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Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
940 Human Subjects Protection Regulations: Training and Education Requirements for 0940-AA08
Institutional Officials, Institutional Review Board Members and Staff, Human
Protections Administrators, and Investigator..........................................
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Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
941 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P).............. 0938-AG81
942 End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610 0938-AG82
Review)...............................................................................
943 Hospital Conditions of Participation: Requirements for Approval and Reapproval of 0938-AH17
Transplant Centers To Perform Organ Transplants (CMS-3835-P)..........................
944 Hospice Care--Conditions of Participation (CMS-3844-P)................................ 0938-AH27
945 Standard Unique National Health Plan Identifiers (CMS-6017-P)......................... 0938-AH87
946 Appeals of Carrier Determination that a Supplier Fails to Meet the Requirements for 0938-AI49
Medicare Billing Privileges (CMS-6003-P2).............................................
947 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AJ17
and Establishment of a Quality Assessment and Improvement Program (CMS-1910-P2).......
948 Supplier Standards for Home Oxygen, Therapeutic Shoes, and Home Nutrition Therapy (CMS- 0938-AJ98
6010-P)...............................................................................
949 Health Insurance Reform: Claims Attachments Standards (CMS-0050-P).................... 0938-AK62
950 Organ Procurement Organization Conditions for Coverage (CMS-3064-P)................... 0938-AK81
951 Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That 0938-AL26
Provide Inpatient or Residential Care (CMS-2130-P)....................................
[[Page 37434]]
952 Provider Reimbursement Determinations and Appeals (CMS-1727-P)........................ 0938-AL54
953 Health Coverage Portability's Request for Information on Benefit-Specific Waiting 0938-AL64
Periods (CMS-2150-NC).................................................................
954 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)..... 0938-AL80
955 Health Coverage Portability: Tolling Certain Time Periods and Interactions With Family 0938-AL88
and Medical Leave Act (CMS-2158-P)....................................................
956 Modifications to Electronic Transactions and Code Sets (CMS-0009-P)................... 0938-AM50
957 Changes to the Hospital Outpatient Prospective System and Calendar Year 2005 Payment 0938-AM75
Rates (CMS-1427-P)....................................................................
958 Ticket to Work: Defining Individuals with Potentially Severe Disabilities and 0938-AM79
Providing a Work Threshold (CMS-2172-P)...............................................
959 Payment Error Rate Measurement (PERM) Program (CMS-2186-P)............................ 0938-AM86
960 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-P)............. 0938-AM87
961 Hospital Conditions of Participation: Requirements For History and Physical 0938-AM88
Examinations; Authentication of Verbal Orders, Securing Medications and Post-
Anesthesia Evaluations (CMS-3122-P)...................................................
962 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2005 0938-AM90
(CMS-1429-P)..........................................................................
963 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM98
(CMS-6146-P)..........................................................................
964 Physician Referral for Nuclear Medicine Services and Supplies (CMS-1261-P)............ 0938-AN04
965 Medicare Advantage Program Title II (CMS-4069-P)...................................... 0938-AN06
966 Special Rules for Employer-Sponsored Drug Programs: Subsidies to Encourage Retention 0938-AN07
(Title I) (CMS-2199-P)................................................................
967 Medicare Drug Benefit Effective Calendar Year 2006 (Title I) (CMS-4068-P)............. 0938-AN08
968 Enhanced DSH Treatment for Certain Hospitals (CMS-2198-P)............................. 0938-AN09
969 Prior Determination Process (CMS-6024-P).............................................. 0938-AN10
970 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, 0938-AN14
Orthotics, and Supplies (CMS-1270-P)..................................................
971 Update of the List of Covered Procedures for Ambulatory Surgical Centers for 2005 (CMS- 0938-AN23
1478-PN)..............................................................................
972 Revisions to HIPAA Code Sets (CMS-0013-P)............................................. 0938-AN25
973 Payment for Clinical Laboratory Tests (CMS-1494-P).................................... 0938-AN26
974 Prospective Payment System for Long Term Care Hospitals: Annual Payment Rate Updates 0938-AN28
and Policy Changes for 2006 (CMS-1483-P)..............................................
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Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
975 Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient 0938-AJ96
Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).........................
976 Revisions to the Medicare Appeals Process (CMS-4004-FC)............................... 0938-AL67
977 Electronic Medicare Claims Submission (CMS-0008-F).................................... 0938-AM22
978 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-- 0938-AM46
Update for FY 2005 (CMS-1249-N).......................................................
979 Title I: Non-Federal Governmental Plans Exempt From HIPAA (CMS-2033-F)................ 0938-AM71
980 Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-FC)....... 0938-AM73
981 Conditions for Coverage of Power Mobility Devices, including Powered Wheelchairs and 0938-AM74
Power-Operated Vehicles Scooter(CMS-3017-IFC).........................................
982 Hospice Wage Index FY 2005 (CMS-1264-N)............................................... 0938-AM78
983 Changes to the Hospital Inpatient Prospective Payment System and FY 2005 Rates (CMS- 0938-AM80
1428-F)...............................................................................
984 Prospective Payment System for Inpatient Rehabilitation Facilities for FY 2005 (CMS- 0938-AM82
1360-N)...............................................................................
985 Home Health Prospective Payment System Rate Update FY 2005 (CMS-1265-P)............... 0938-AM93
986 Changes to Medicare Payment for Drugs and Physician Fee Schedule Payments for Calendar 0938-AM97
Year 2004--Correction Notice CMS-1372-IFC)............................................
987 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AM99
Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F5).............
988 Time Limitation on Record keeping Requirements Under the Drug Rebate Program (CMS-2188- 0938-AN01
P)....................................................................................
989 Extended Availability of Unexpended SCHIP Funds From the Appropriation for FYs 1998 0938-AN03
Through 2004; Authority To Use a Portion of SCHIP Funds for Medicaid Expenditures (CMS-
2187-N)...............................................................................
990 FY 2005 SCHIP Allotments (CMS-2201-N)................................................. 0938-AN11
991 Schedule for Publishing Medicare Final Regulations After a Proposed or Interim Final 0938-AN12
Regulation (CMS-9026-N)...............................................................
992 Evaluation Criteria and Standards for Quality Improvement Program Contracts (CMS-3142- 0938-AN13
NC)...................................................................................
[[Page 37435]]
993 Part A Premiums for Calendar Year 2005 for the Uninsured Aged and for Certain Disabled 0938-AN15
Individuals Who Have Exhausted Other Entitlement (CMS-8022-N).........................
994 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AN16
Amounts for Calendar Year 2005 (CMS-8021-N)...........................................
995 Medicare Part B Monthly Actuarial Rates and Premium Rate Beginning January 1, 2005 0938-AN18
(CMS-8020-N)..........................................................................
996 Fee Schedule for Payment of Ambulance Services-Update for Calendar Year 2005 (CMS-1267- 0938-AN20
N)....................................................................................
997 Procedure for Producing Guidance Documents Describing Medicare's Coverage Process (CMS- 0938-AN21
3141-N)...............................................................................
998 Amendment to the Interim Final Regulation for Mental Health Parity (CMS-2152-F2)...... 0938-AN22
999 Medicare Ambulance Fee Schedule Update (CMS-1492-IFC)................................. 0938-AN24
1000 Medicare Secondary Payer (MSP): Workmen's Compensation (CMS-1272-FC).................. 0938-AN27
1001 Random Prepayment Review (CMS-6022-IFC)............................................... 0938-AN31
1002 Additional Payments for Certain Medicare Part B Drugs (CMS-1280-FC)................... 0938-AN34
1003 Federal Enforcement in Group and Individual Health Insurance Markets (CMS-2019-F)..... 0938-AN35
1004 Fire Safety Requirements for Certain Health Care Facilities, Amendment (CMS-3047-F2).. 0938-AN36
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Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1005 Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-F) 0938-AH73
1006 Medicare Outcome and Assessment Information Set (OASIS) Data Reporting Requirements 0938-AJ10
(CMS-3006-F)..........................................................................
1007 Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)................ 0938-AJ29
1008 Medicare Hospice Care Amendments (CMS-1022-F)......................................... 0938-AJ36
1009 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67
Relationships--Phase II (CMS-1810-IFC)................................................
1010 Continuation of Medicare Entitlement When Disability Benefit Ends Because of 0938-AK94
Substantial Gainful Activity (CMS-4018-F).............................................
1011 Medicare Program; Interest Calculation (CMS-6014-F)................................... 0938-AL14
1012 Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers 0938-AL43
(CMS-2151-F)..........................................................................
1013 Prospective Payment System for Inpatient Psychiatric Facilities FY 2004 (CMS-1213-F).. 0938-AL50
1014 DMERC Service Areas and Related Matters (CMS-1219-F).................................. 0938-AL76
1015 Procedures for Maintaining Code Lists in the Negotiated National Coverage 0938-AM36
Determinations for Clinical Diagnostic Laboratory Services (CMS-3119-F)...............
1016 Hospital Patients' Rights CoP--Standard Safety Compliance Committees (CMS-3120-P)..... 0938-AM39
1017 Requirements for Nursing Homes To Identify the Number of Licensed and Unlicensed 0938-AM55
Nurses (CMS-3121-F)...................................................................
1018 Covered Outpatient Drugs Under the Medicaid Drug Rebate Program (CMS-2174-P).......... 0938-AM81
1019 Revisions to Cost Sharing Regulations (CMS-2144-P).................................... 0938-AM94
1020 Medicare Program; Hospital Outpatient Prospective Payment System Payment Reform for 0938-AM96
Calendar Year 2004 CMS-1371-IFC.......................................................
1021 Payment for Respiratory Assist Devices with Bi-level Capability and a Back-up Rate 0938-AN02
(CMS-1167-F)..........................................................................
1022 Manufacturers' Submission of Average Sales Price Data for Medicare Part B Drugs and 0938-AN05
Biologicals (CMS-1380-IFC)............................................................
1023 Nondiscrimination In Post-Hospital Referral to Home Health Agencies and Other Entities 0938-AN19
(CMS-1224-F)..........................................................................
1024 Nondiscrimination in Health Coverage and Bonafide Wellness Plans in the Group Market 0938-AN29
(CMS-2022-F)..........................................................................
1025 Hospital Conditions of Participation: Patients' Rights (CMS-3018-F)................... 0938-AN30
----------------------------------------------------------------------------------------------------------------
Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1026 Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F). 0938-AH99
1027 Coverage of Religious Nonmedical Health Care Institutions (CMS-1909-F)................ 0938-AI93
1028 All Provider Bad Debt Payment (CMS-1126-F)............................................ 0938-AK02
1029 Review of National Coverage Determinations and Local Coverage Determinations (CMS-3063- 0938-AK60
F)....................................................................................
1030 Rate of Reimbursement of Photocopy Expenses for Quality Improvement Organizations (CMS- 0938-AK68
3055-F)...............................................................................
[[Page 37436]]
1031 Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-F). 0938-AK79
1032 Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans (CMS- 0938-AL49
6016-F)...............................................................................
1033 Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004 0938-AL91
Payment Rates (CMS-1471-F)............................................................
1034 Criteria for Determining Whether a Drug is Considered Usually Self-Administered (CMS- 0938-AM13
1228-P)...............................................................................
1035 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AM31
Amounts for Calendar Year 2004 (CMS-8016-N)...........................................
1036 Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate 0938-AM32
Beginning January 1, 2004 (CMS-8017-N)................................................
1037 Part A Premiums for Calendar Year 2004 for the Uninsured Aged and for Certain Disabled 0938-AM33
Individuals Who Have Exhausted Other Entitlement (CMS-8018-N).........................
1038 Grants to States for Operation of Qualified High Risk Pools (CMS-2179-FC)............. 0938-AM42
1039 Fee Schedule for Payment of Ambulance Services Update for Calendar Year 2004 (CMS-1232- 0938-AM44
FCC)..................................................................................
1040 Exclusion of Medicare Benefits for Aliens Not Lawfully Present in the United States 0938-AM47
(CMS-1222-FC).........................................................................
1041 Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures 0938-AM54
(CMS-6146-P)..........................................................................
1042 Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility 0938-AM72
(CMS-1262-F)..........................................................................
1043 Prospective Payment System for Long-Term Care Hospitals: Annual Payment Rate Updates 0938-AM84
and Policy Changes (Effective 7/1/04) (CMS-1263-F)....................................
1044 Disproportionate Share Hospital (DSH) Payments Institutions for Mental Disease (IMDs) 0938-AM89
(CMS-2062-N)..........................................................................
1045 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AM95
Relationships: Extension of Partial Delay of Effective Date (CMS-1809-F4).............
1046 Notice of One-Time Appeal Process for Hospital Wage Index Classification (CMS-1373-N). 0938-AN00
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1047 Safeguarding Child Support and Expanded Federal Parent Locator Services (FPLS) 0970-AC01
Information...........................................................................
1048 Developmental Disabilities and Bill of Rights Act..................................... 0970-AC07
1049 Administrative Costs for Children in Title IV-E Foster Care........................... 0970-AC14
1050 Administrative Cost Sharing Under TANF................................................ 0970-AC15
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1051 Child Support Enforcement Program; Federal Tax Refund Offset.......................... 0970-AC09
1052 Head Start Transportation............................................................. 0970-AC16
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1053 Child Support Enforcement for Indian Tribes........................................... 0970-AB73
1054 Charitable Choice Provisions Applicable to the Temporary Assistance for Needy Families 0970-AC12
Program...............................................................................
1055 Community Services Block Grant Charitable Choice...................................... 0970-AC13
----------------------------------------------------------------------------------------------------------------
[[Page 37437]]
Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1056 Grants for State and Community Programs on Aging, Training, Research, and 0985-AA00
Discretionary Programs; Vulnerable Elder Rights; Grants to Indians and Native
Hawaiians.............................................................................
----------------------------------------------------------------------------------------------------------------
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
813. 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 12/00/04
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
_______________________________________________________________________
814. 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 07/00/04
NPRM Comment Period End 09/00/04
Final Rule 11/00/04
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-AB18
_______________________________________________________________________
815. 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 07/00/04
NPRM Comment Period End 09/00/04
Final Rule 11/00/04
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
_______________________________________________________________________
816. MEDICARE AND FEDERAL HEALTH CARE PROGRAMS: FRAUD
AND ABUSE; REVISIONS TO THE WAIVER PROVISIONS OF THE OIG'S EXCLUSION
AUTHORITIES
Priority: Substantive, Nonsignificant
Legal Authority: Sec 949, PL 108-173; Sec 4331, PL 105-33; Sec
1128(c)(3)(b), Social Security Act
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: In accordance with section 949 of the Medicare Prescription
Drug, Improvement, and Modernization Act
[[Page 37438]]
of 2003, this rule would revise the OIG's exclusion authority to permit
any Federal healhcare program to request a waiver of an OIG exclusion
imposed under sections 1128(a)(1), (a)(3), or (a)(4) of the Social
Security Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/04
NPRM Comment Period End 11/00/04
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
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-AB33
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
817. 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 12/00/04
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
_______________________________________________________________________
818. 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. Major status under 5 USC 801 is
undetermined.
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
Final Action 07/00/04
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: Federal, Local, State, Tribal
Agency Contact: Robinsue Frohboese, Principal Deputy Director, Office
for Civil Rights, Department of Health and Human Services, Office of
the Secretary, 200 Independence Avenue SW., Washington, DC 20202
Phone: 202 619-0403
RIN: 0991-AB10
_______________________________________________________________________
819. 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 04/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
[[Page 37439]]
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
_______________________________________________________________________
820. 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 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 09/15/03 68 FR 53939
NPRM Comment Period End 11/14/03
Final Action 01/00/05
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
_______________________________________________________________________
821. TECHNICAL REVISIONS TO HIPDB DATA COLLECTION
ACTIVITIES
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: Sec 221(a), PL 104-91; Sec 1128E(b)(2), Social
Security Act
CFR Citation: 45 CFR 61
Legal Deadline: None
Abstract: This rule makes technical changes to the Healthcare Integrity
and Protection Data Bank data collection reporting requirements by
clarifying the types of personal numeric identifiers that may be
reported to the data bank in connection with adverse actions. The rule
classifies that in lieu of a Social Security Number (SSN), an
individual taxpayer identification number (ITIN) may be reported to the
data bank when, in those limited situations, an individual does not
have a SSN.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 10/00/04
Interim Final Rule Comment
Period End 11/00/04
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-AB31
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Office of the Secretary (OS)
_______________________________________________________________________
822. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE
CIVIL MONEY PENALTIES AND ASSESSMENTS
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
_______________________________________________________________________
823. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--ENFORCEMENT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: Subtitle F of title II of PL 104-191; 42 USC 1320d-5
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: This rulemaking would seek to establish a framework for
enforcing compliance with the ``administrative simplification''
provisions of the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 -- subtitle F of title II of Public Law 104-191,
through the imposition of civil money penalties.
[[Page 37440]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Carol Conrad, Department of Health and Human Services,
Room 5347, Office of the General Counsel, 330 Independence Avenue SW.,
Washington, DC 20201
Phone: 202 690-1840
RIN: 0991-AB29
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
824. TAX REFUND OFFSET
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
CFR Citation: 45 CFR 31
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 12/18/03 68 FR 70444
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Katherine M. Drews
Phone: 202 619-0150
RIN: 0991-AB17
_______________________________________________________________________
825. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY
PROCEEDINGS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
CFR Citation: 45 CFR 13
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 01/21/04 69 FR 2843
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Katherine M. Drews
Phone: 202 619-0150
Related RIN: Previously reported as 0990-AA02
RIN: 0991-AB22
_______________________________________________________________________
826. OIG CIVIL MONEY PENALTIES UNDER THE MEDICARE
PRESCRIPTION DRUG DISCOUNT CARD PROGRAM
Priority: Substantive, Nonsignificant
Legal Authority: Sec 101, PL 108-173; Sec 1860D-31, Social Security Act
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This rule sets forth the OIG's new authority for imposing
civil money penalties against endorsed sponsors under the medicare
prescription drug discount card program that knowingly engage in false
or misleading marketing practicies; overcharge program enrollees; or
misuse transtional assistance funds.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 05/19/04 69 FR 28842
Interim Final Rule Comment
Period End 07/19/04
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-AB30
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
827. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN
CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
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 nonmedical, 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:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/04
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: Paolo Del Vecchio, Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration,
Room 13-103, Parklawn, Rockville, MD 20857
Phone: 301 443-2619
RIN: 0930-AA10
[[Page 37441]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
828. MANDATORY GUIDELINES FOR THE FEDERAL WORKPLACE DRUG TESTING PROGRAM
Priority: Other Significant
Legal Authority: PL 100-71; 5 USC 7301
CFR Citation: None
Legal Deadline: NPRM, Statutory, December 2003.
Abstract: HHS is proposing to establish scientific and technical
guidelines for the testing of hair, sweat, and oral fluid specimens in
addition to urine specimens; scientific and technical guidelines for
using on-site tests to test urine and oral fluids at the collection
site; requirements for the certification of instrumented initial test
facilities; and added standards for collectors, on-site testers, and
medical review officers.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Notice 04/13/04 69 FR 19673
Final Action 04/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Federal
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-AA12
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
829. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA)
CHARITABLE CHOICE
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
CFR Citation: 42 CFR 54, sec 54.1--13; 42 CFR 54a, sec 54a.1--14
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 09/30/03 68 FR 56429
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
Phone: 301 443-2324
Fax: 301 443-0247
RIN: 0930-AA11
_______________________________________________________________________
830. MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG
TESTING PROGRAMS; SPECIMEN VALIDITY TESTING
Priority: Other Significant
Legal Authority: PL 100-71, sec 503
CFR Citation: None
Legal Deadline: None
Abstract: HHS is establishing standards for determining the validity of
urine specimens collected under the Mandatory Guidelines for Federal
Workplace Drug Testing Programs. These standards ensure that specimen
validity testing (SVT) and reporting procedures are uniformly applied
to all Federal agency urine specimens when a validity test is
conducted.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Notice 04/13/04 69 FR 19644
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Local, State
Agency Contact: Walter F. Vogel, CSAP, Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration,
CSAP, Suite 815, Rockville II, Rockville, MD 20857
Phone: 301 443-6014
RIN: 0930-AA13
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
831. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE PROVISION FOR
APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
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 10/00/04
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
[[Page 37442]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
832. 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
CFR Citation: 42 CFR 83
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 05/28/04 69 FR 30763
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Larry Elliott
Phone: 513 841-4498
RIN: 0920-AA07
_______________________________________________________________________
Department of Health and Human Services (HHS) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
833. 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 to 263-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 to
360j; 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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/14/03 68 FR 12406
NPRM Comment Period Extended 06/18/03
NPRM Comment Period End 07/14/03
NPRM Comment Period Extension
End 10/14/03
Comment Review End 09/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Elizabeth J Sadove, Regulatory Counsel, Office of
Regulatory Policy, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and
ResearchAdministration, 5515 Security Lane, Suite 1101 (HFD-7),
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
834. FOOD LABELING; PROMINENCE OF CALORIES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101.9
Legal Deadline: None
Abstract: In response to the Report of the Working Group on Obesity
(OWG) that FDA issued on March 12, 2004, the agency will issue an
advance notice of proposed rulemaking (ANPRM) in its efforts to combat
the nation's obesity problem. The ANPRM will request comments on ways
to give more prominence to ``calories'' on the food label.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 10/00/04
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Shellee Anderson, Team Leader, Department of Health and
Human Services, Food and Drug Administration, HFS-830, 5100 Paint
Branch Parkway, College Park, MD 20740
Phone: 301 436-1450
Fax: 301-436-2636
Email: [email protected]
RIN: 0910-AF22
_______________________________________________________________________
835. FOOD LABELING; SERVING SIZES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101.9(b)
Legal Deadline: None
Abstract: In response to the Report of the Working Group on Obesity
(OWG) that FDA issued on March 12, 2004, the agency will issue an
advance notice of proposed rulemaking (ANPRM) in its efforts to combat
the nation's obesity problem. The ANPRM will request comments on
changes to the agency's nutrition labeling regulations on serving size
and comments on allowance of truthful, nonmisleading and useful
approaches for promoting consumption of smaller portion sizes.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 10/00/04
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
[[Page 37443]]
Federalism: Undetermined
Agency Contact: Lori LeGault, Nutritionist, Department of Health and
Human Services, Food and Drug Administration, HFS-840, 5100 Paint
Branch Parkway, College Park, MD 20740
Phone: 301 436-1791
Fax: 301-436-2635
Email: [email protected]
RIN: 0910-AF23
_______________________________________________________________________
836. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN
PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM (Sunscreen and Insect
Repellent) 11/00/04
NPRM (UVA/UVB) 11/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF43
_______________________________________________________________________
Department of Health and Human Services (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
837. 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; 42
USC 264; 42 USC 271
CFR Citation: 21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR
330; 21 CFR 514; 21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 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 drugs 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 National Drug Code number and would require the electronic
submission of most registration and listing information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
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, 5515
Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AA49
_______________________________________________________________________
838. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE
RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 312; 21 CFR 314
Legal Deadline: None
Abstract: The proposed rule would amend the regulations on marketing
approval of new drugs to discontinue the use of approvable and not
approvable letters when taking action on a marketing application and
instead use complete response letters. The proposed rule would also
amend the regulations on extension of the review clock because of
amendments to applications.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/04
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB34
[[Page 37444]]
_______________________________________________________________________
839. 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 09/00/04
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-AC14
_______________________________________________________________________
840. 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 agents in a
potential terrorist event or other public health emergency.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/04
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
_______________________________________________________________________
841. MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED RECLASSIFICATION
OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 351; 21 USC 352; 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 (FDA) 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 12/00/04
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, HFZ-215, 1350 Piccard
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]
RIN: 0910-AC30
[[Page 37445]]
_______________________________________________________________________
842. 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, which ones 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
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 09/00/04
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
_______________________________________________________________________
843. 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 01/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions
Government Levels Affected: Federal, State
URL For More Information:
www.fda.gov/cder/regulatory/pet
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, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
Related RIN: Previously reported as 0910-AB63
RIN: 0910-AC55
_______________________________________________________________________
844. 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 to 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 02/00/05
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
Related RIN: Previously reported as 0910-AC02
RIN: 0910-AC59
[[Page 37446]]
_______________________________________________________________________
845. DEFINITION OF ``SERIOUS ADVERSE HEALTH CONSEQUENCES'' UNDER THE
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF
2002
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 334(h)(1)(A); 21 USC 335a(b)(3); 21 USC 343(v);
21 USC 350c(a) and (b); 21 USC 371; 21 USC 374(a)(1); 21 USC 381(j)(1)
and (m)(2)(B)(ii); 21 USC 398(a)
CFR Citation: 21 CFR 1.3(c)
Legal Deadline: None
Abstract: The proposed rule would define the term ``serious adverse
health consequences'' for purposes of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act) and any implementing regulations. The term is used to describe
part of the standard that is the basis for FDA to exercise certain
authorities provided in sections 303, 304, 306, 307, 308, and 310 of
title III (Protecting Safety and Security of the Food and Drug Supply),
subtitle A (Protection of Food Supply), of the Bioterrorism Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/04
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Ms. Karen Carson, Deputy Director, Office of Plant and
Dairy Foods and Beverages, Department of Health and Human Services,
Food and Drug Administration, Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Parkway, Rm 3 A-001, College Park, MD
20740
Phone: 301 436-1664
Fax: 301 436-2632
Email: [email protected]
John E. Kvenberg, Deputy Director, Office of Compliance (HFS-600),
Department of Health and Human Services, Food and Drug Administration,
HFS-10, Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, Rm 3B064, College Park, MD 20740
Phone: 301 436-2359
Fax: 301 436-2717
Email: [email protected]
RIN: 0910-AF06
_______________________________________________________________________
846. HEALTH CLAIMS
Priority: Other Significant
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 343; 21 USC 371
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: On November 25, 2003 (68 FR 66040), FDA issued an advance
notice of proposed rulemaking (ANPRM) to request comments on
alternatives for regulating qualified health claims in the labeling of
conventional human foods and dietary supplements. FDA also solicited
comments on various other issues related to health claims and on the
appropriateness and nature of dietary guidance statements on
conventional food and dietary supplement labels. This ANPRM was
signaled in the July 11, 2003 (68 FR 41387)notice that announced the
availability of the final report of the FDA Task Force on the Consumer
Health Information for Better Nutrition Initiative.
Comments on the regulatory alternatives and additional topics
identified in the ANPRM will inform FDA decisions about regulation of
qualified health claims.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/25/03 68 FR 66040
ANPRM Comment Period Extended 01/27/04 69 FR 3868
ANPRM Comment Period End 02/25/04
NPRM 01/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Nancy Crane, Department of Health and Human Services,
Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway,
College Park, MD 20740
Phone: 301 436-1456
Fax: 301 436-2636
Email: [email protected]
RIN: 0910-AF09
_______________________________________________________________________
847. QUALITY STANDARD REGULATION ESTABLISHING ALLOWABLE LEVEL FOR
ARSENIC IN BOTTLED WATER
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 343; 21 USC 343-1; 21
USC 348; 21 USC 349; 21 USC 371; 21 USC 379e
CFR Citation: 21 CFR 165.110(b)
Legal Deadline: Final, Statutory, July 27, 2005.
Abstract: Under section 410 of the Federal Food, Drug, and Cosmetic Act
(the Act), not later than 180 days before the effective date of a
National Primary Drinking Water Regulation (NPDWR) issued by the
Environmental Protection Agency (EPA) for a contaminant under section
1412 of the Safe Drinking Water Act, the Food and Drug Administration
(FDA) is required to issue a standard of quality regulation for that
contaminant in bottled water or make a finding that such a regulation
is not necessary to protectthe public health because the contaminant is
contained in water in public water systems but not in water used for
bottled water. The effective date for any such standard of quality
regulation is to be the same as the effective date of the NPDWR. On
January 22, 2001, EPA published a final rule revising the existing 0.05
mg/L maximum contaminant level (MCL) for arsenic in public drinking
water to 0.01 mg/L (10 ppb). The effective date for this rule was
temporarily delayed for 60 days from March 23, 2001, to a new effective
date of May 22, 2001, in accordance with the memorandum of January 20,
2001, from the Assistant to the President and Chief of Staff, entitled
``Regulatory Review Plan'' (66 FR 7701; January 24, 2001). On May 22,
2001, EPA announced that it would further delay the effective date for
the rule until February 22, 2002, to allow time to complete a
reassessment of the information on which the revised arsenic standard
is based. On February 22, 2002, the arsenic MCL of 0.01 mg/L in public
drinking water rule became effective and water systems must comply with
the new standard for arsenic in public drinking water by January 23,
2006. In accordance with section 410 of the Act, FDA is required to
issue a standard of quality regulation for arsenic in bottled drinking
water by July 27, 2005, with an effective date of January 23, 2006, or
make a finding
[[Page 37447]]
that such a regulation is not necessary to protect the public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/04
NPRM Comment Period End 12/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Dr. Henry Kim, Supervisory Interdisciplinary Scientist,
Department of Health and Human Services, Food and Drug Administration,
HFS-306, 5100 Paint Branch Parkway, College Park, MD 20740
Phone: 301 436-2023
Fax: 301-436-2651
Email: [email protected]
RIN: 0910-AF10
_______________________________________________________________________
848. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 358; 21 USC 360; 21 USC 360(b); 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 201.57
Legal Deadline: None
Abstract: The proposed rule would amend FDA regulations concerning the
format and content of the ``Pregnancy,'' ``Labor and Delivery,'' and
``Nursing Mothers'' subsections of the ``Use in Specific Populations''
section of the labeling for human prescription drugs. The proposal
would require that labeling include a summary of the risks of using a
drug during pregnancy and lactation and a discussion of the data
supporting that summary.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/00/05
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AF11
_______________________________________________________________________
849. COCHINEAL EXTRACT AND CARMINE LABEL DECLARATION
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 379e(b)
CFR Citation: 21 CFR 73.100 (d); 21 CFR 73.1100 (c); 21 CFR 73.2087
(c); 21 CFR 101.22 (k); 21 CFR 701.3; 21 CFR 740.20
Legal Deadline: None
Abstract: The purpose of this proposed rule is to protect consumers who
have allergies to the color additives carmine and cochineal extract by
requiring label declaration on products under FDA jurisdiction. This
action responds to adverse event reports received by FDA and to a
citizen petition submitted to FDA.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Mical E Honigfort, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, HFS-265,
5100 Paint Branch Parkway, College Park, MD 20740
Phone: 202 418-0714
Fax: 202-418-3126
Email: [email protected]
RIN: 0910-AF12
_______________________________________________________________________
850. CHARGING FOR INVESTIGATIONAL DRUGS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355;
21 USC 371; 42 USC 262
CFR Citation: 21 CFR 312.7; 21 CFR 312.8
Legal Deadline: None
Abstract: The proposed rule would amend FDA's investigational new drug
exemption regulations concerning charging for investigational drugs.
The proposed rule describes the types of investigational uses for which
a sponsor may be able to charge, including uses for which charging was
not previously expressly permitted, and the criteria for allowing
charging for the identified investigational uses. The proposed rule
would also describe the types of costs that can be recovered when
charging for an investigational drug.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/04
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AF13
_______________________________________________________________________
851. TREATMENT USE OF INVESTIGATIONAL DRUGS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 353;
21 USC 355; 21 USC 371; 42 USC 262
CFR Citation: 21 CFR 312.42; 21 CFR 312.400; 21 CFR 312.405; 21 CFR
312.410; 21 CFR 312.415; 21 CFR
[[Page 37448]]
312.420; 21 CFR 312.425; 21 CFR 312.430; 21 CFR 312.435
Legal Deadline: None
Abstract: The proposed rule would amend FDA regulations governing
investigational new drug exemptions (INDs) to describe the way patients
may obtain investigational drugs for treatment use. Treatment use of
investigational drugs would be available to: 1) individual patients,
including in emergencies; 2) intermediate size patient; and 3) larger
populations under a treatment protocol or IND.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/04
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Christine F. Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaulation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AF14
_______________________________________________________________________
852. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE
PROCEDURES; DERIVATIVES OF BLOOD
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 351 to 353; 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 203.3(q); 21 CFR 203.22(h); 21 CFR 205.3(h)
Legal Deadline: Other, Statutory, April 1, 2004, Effective date of
final rule, 64 FR 67720, December 3, 1999.
Date final rule takes effect: ``Prescription Drug Marketing Act of
1987; Prescription Drug Amendments of 1992; Policies, Requirements, and
Administrative Procedures.''.
Abstract: FDA is proposing to amend the implementing regulation of the
Prescription Drug Marketing Act of 1987, as modified by the
Prescription Drug Amendments of 1992 and the FDA Modernization Act of
1997. Certain provisions of that final rule that published on December
3, 1999, (64 FR 67720), do not allow a registered blood establishment
that provides health care services related to its activities as a blood
establishment to concurrently distribute derivatives of blood. The
effective date of those provisions of that rule is December 1, 2006, as
published on February 3, 2004, (69 FR 8105). FDA is amending the final
rule to allow a registered blood establishment that concurrently
provides health care services to also distribute derivatives of blood.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/05
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Kathleen E. Swisher, Supervisory Regulatory Counsel,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research, 1401 Rockville Pike Suite
200N, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AF16
_______________________________________________________________________
853. USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE
DESIGNATION; ALBUTEROL
Priority: Economically Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC
335; 21 USC 342; 21 USC 343; 21 USC 346a; 21 USC 348; 21 USC 351; 21
USC 352; 21 USC 355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371;
21 USC 372; 21 USC 374; 42 USC 7671 et seq
CFR Citation: 21 CFR 2.125
Legal Deadline: None
Abstract: Under the Clean Air Act, the Food and Drug Administration
(FDA) within the U.S. Department of Health and Human Services, in
consultation with the Environmental Protection Agency, is required to
determine whether an FDA-regulated product that releases an ozone-
depleting substance (ODS) is essential. The two agencies have
tentatively determined that the two currently marketed non-ODS metered-
dose inhalers (MDIs) will be satisfactory alternatives to albuterol
MDIs that contain ODS, and are proposing to remove the essential use
designations for albuterol MDIs. If the essential use designation is
removed, albuterol MDIs that contain an ODS could not be marketed after
a suitable transition period. The proposed rule will specifically ask
for comments on which phase-out period length will best ensure a smooth
transition and minimize any adverse affects on the public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/16/04 69 FR 33602
NPRM Comment Period End 08/16/04
Final Action 03/00/05
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, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF18
_______________________________________________________________________
854. REVOCATION OF THE STATUS OF SPECIFIC PRODUCTS;
GROUP A STREPTOCOCCUS
Priority: Info./Admin./Other
Legal Authority: 42 USC 262
CFR Citation: 21 CFR 610.19
Legal Deadline: None
Abstract: FDA is issuing a direct final rule and companion proposed
rule to revoke 21 CFR 610.19, Status of specific products; Group A
streptococcus. The current regulation was based on the panel report for
bacterial vaccines with ``No U.S.
[[Page 37449]]
Standard of Potency.'' The vaccines had been licensed by the National
Institutes of Health prior to 1972, when regulatory authority over
these vaccines was transferred to FDA. The regulation prohibits the use
of Group A streptococcus organisms and derivatives of Group
Astreptococcus as ingredients in Bacterial Vaccines and Bacterial
Antigens with ``No U.S. Standard of Potency.'' The regulation was never
intended to refer to purified streptococcus vaccines, which were not
developed at that time. Therefore, the regulation is being revoked.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM - Companion to Direct Final
Rule 04/00/05
Direct Final Rule 04/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: 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), HFM-17, 1401 Rockville Pike, Rockville, MD 20852
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AF20
_______________________________________________________________________
855. LATEX CONDOMS: SPECIAL CONTROLS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360c
CFR Citation: 21 CFR 884.5300; 21 CFR 884.5310
Legal Deadline: None
Abstract: The classification regulations for male condoms would be
amended to specify a labeling guidance document as a special control
for condoms made from NR latex. The new special control guidance
document would provide detailed recommendations for labeling meeting
the requirements of 21 CFR 801, that together with the general
controls, provides a resaonable assurance of the safety and
effectiveness of these devices. The rule will demonstrate how the
agency is moving forward to meet the congressionaldirective of Public
Law 106-554 that FDA review condom labeling to assure that the
information regarding sexually transmitted disease transmission is
medically accurate.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/04
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
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, HFZ-215, 1350 Piccard
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]
RIN: 0910-AF21
_______________________________________________________________________
856. BLOOD INITIATIVE--REGULATIONS FOR HUMAN BLOOD
AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER
MANUFACTURING USE
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; . . .
CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR
610; . . .
Legal Deadline: None
Abstract: In multiple rulemakings, the Food and Drug Administration
(FDA) 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
Subcommittee on House Resources and Intergovernmental Relations, the
General Accounting Office, and the Institute of Medicine, as well as on
public comments. The other remaining subject intended to be addressed
in the rulemakings include: labeling of blood and blood components
(0910-AF26). These actions are intended to help ensure the continued
safety of the Nation's blood supply.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/05
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: 301 827-9434
Related RIN: Split from 0910-AB26
RIN: 0910-AF25
_______________________________________________________________________
857. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD
(BRONCHODILATOR) PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) 09/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of
[[Page 37450]]
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF32
_______________________________________________________________________
858. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD
(COMBINATION) PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) 09/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF33
_______________________________________________________________________
859. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD
(NASAL DECONGESTANT) PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Phenylephrine Bitartrate) 09/00/04
NPRM (Phenyl-propanolamine) 09/00/04
NPRM (Amendment) (Sinusitis
Claim) 10/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF34
_______________________________________________________________________
860. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL
ANALGESIC PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Amendment) (Labeling) 08/00/04
NPRM (Amendment) (Pediatric) 09/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF36
_______________________________________________________________________
861. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF
DRUG PRODUCTS FOR OTC HUMAN USE
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
[[Page 37451]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Convenience Sizes) 08/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF37
_______________________________________________________________________
862. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT
CONTROL PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM (Phenyl-propanolamine) 09/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF45
_______________________________________________________________________
Department of Health and Human Services (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
863. 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 09/00/04
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 and Planning, 5600 Fishers Lane, Rockville,
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AA61
_______________________________________________________________________
864. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT
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 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
[[Page 37452]]
prescription drug and biologic products, 21 C.F.R. 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 10/00/04
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, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA94
_______________________________________________________________________
865. CURRENT GOOD TISSUE PRACTICE FOR HUMAN CELL, TISSUE, AND CELLULAR
AND TISSUE-BASED PRODUCT ESTABLISHMENTS; INSPECTION AND ENFORCEMENT
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42
USC 271
CFR Citation: 21 CFR 1270; 21 CFR 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 12/00/04
Regulatory Flexibility Analysis Required: Yes
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: 301 827-9434
RIN: 0910-AB28
_______________________________________________________________________
866. 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 ofMedicine, 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
HIV lookback regulations will be amended for consistency.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/16/00 65 FR 69377
NPRM Comment Period End 02/14/01
Final Action 11/00/04
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: 301 827-9434
Related RIN: Related to 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________
867. 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 proposed in the Federal
Register of March 13, 2003 (68 FR
[[Page 37453]]
12158), current good manufacturing practice (CGMP) regulations for
dietary ingredients and dietary supplements. The proposed rule was
published to establish the minimum CGMPs necessary to ensure that, if
firms engage in activities related to manufacturing, packaging, or
holding dietary ingredients of dietary supplements, they do so in a
manner that will not adulterate and misbrand such dietary ingredientsor
dietary supplements. FDA also proposed to require manufacturers to
evaluate the identity, purity, quality, strength, and composition of
their dietary ingredients and dietary supplements. The proposed rule
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,
e.g., which have the identity and provide the quantity of dietary
ingredients declared in labeling.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 02/06/97 62 FR 5700
ANPRM Comment Period End 06/06/97
NPRM 03/13/03 68 FR 12157
NPRM Comment Period End 08/11/03
Final Action 11/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Linda Kahl, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, HFS-206,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 202 418-3101
Fax: 202 418-3131
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
868. 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: Final, Statutory, April 17, 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 Action 11/00/04
Regulatory Flexibility Analysis Required: No
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, 5515 Security Lane, Suite 1101
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC07
_______________________________________________________________________
869. 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, HFZ-215, 1350 Piccard
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]
RIN: 0910-AC32
_______________________________________________________________________
870. AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY SYSTEMS
AND THEIR MAJOR COMPONENTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360e to 360j; 21 USC
360hh to 360ss; 21 USC 371; 21 USC 381
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, 1020.32,
and 1020.33 to address the changes in technology and practice.
[[Page 37454]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/10/02 67 FR 76056
Final Action 06/00/04
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, HFZ-215, 1350 Piccard
Drive, Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4765
Email: [email protected]
RIN: 0910-AC34
_______________________________________________________________________
871. 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: 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
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 05/09/03 68 FR 25188
NPRM Comment Period End 07/08/03
Final Action 07/00/04
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
URL For More Information:
www.fda.gov/oc/bioterrorism/bioact.html
URL For Public Comments:
www.fda.gov/ohrms/dockets/02n0277/02n0277.htm
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
_______________________________________________________________________
872. 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 and other
foodborne illness emergencies. 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 facilities
engaged in manufacturing, processing, packing, or holding of food for
consumption in theUnited States to be registered with the Secretary.
Section 415 directs the Secretary, 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 the Secretary determines 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 information contained in the
registration in a timely manner. Under the interim final rule (IFR)
published on October 10, 2003 (68 FR 58894), upon receipt of the
completed registration form, FDA will notify the registrant of receipt
of the registration and assign a unique registration number to the
facility. Section 415 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
[[Page 37455]]
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 food
from an unregistered foreign facility is offered for import 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. On April 14, 2004, FDA issued a notice reopening for 30
days, on a limited range of issues, the comment period on the IFR. FDA
took this action consistent with its statement in the IFR that it would
reopen the comment period for 30 days in order to ensure that those
commenting on the IFRhave had the benefit of FDA's outreach and
educational efforts and have had experience with the systems,
timeframes, and data elements of the registration system.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/03/03 68 FR 5377
Interim Final Rule 10/10/03 68 FR 58894
Interim Final Rule Comment
Period Reopened 04/14/04 69 FR 19766
Interim Final Rule Comment
Period Reopened End 05/14/04
Final Rule 03/00/05
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
_______________________________________________________________________
873. 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 priornotice 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
Interim Final Rule 10/10/03 68 FR 58974
Interim Final Rule Comment
Period Reopened 04/14/04 69 FR 19763
Interim Final Rule Comment
Period Reopened End 06/14/04
Final Rule 03/00/05
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
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
_______________________________________________________________________
874. 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 anddescribe the procedures for the conduct of
presubmission conferences.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/25/00 65 FR 51782
Final Action 08/00/04
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Gail Schmerfeld, Special Assistant, Department of
Health
[[Page 37456]]
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
_______________________________________________________________________
875. HUMAN SUBJECT PROTECTION; FOREIGN CLINICAL STUDIES NOT CONDUCTED
UNDER AN INVESTIGATIONAL NEW DRUG APPLICATION
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 355(d)(5); 21 USC 355(i); 21 USC 371(a); 42 USC
262(a)(2)(A); 42 USC 262(a)(2)(B)(i)(l)
CFR Citation: 21 CFR 312.120
Legal Deadline: None
Abstract: The proposed rule would update the standards for the
acceptance of foreign clinical studies not conducted under an
investigational new drug application (IND) as support for an IND or
marketing application for a drug or biological product. We are
proposing to replace the requirement in 21 CFR 312.120 that non-IND
foreign clinical studies be conducted in accordance with ethical
principles stated in the Declaration of Helsinki. We would replace that
with a requirement that such studies be conducted in accordance with
good clinical practice (GCP), including review and approval by an
independent ethics committee. The proposed GCP standard is consistent
with the standard of the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use for GCP and is sufficiently flexible to accommodate differences in
how countries regulate the conduct of clinical research and obtain the
informed consent of patients.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/10/04 69 FR 32467
Final Action 06/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 5515 Security Lane,
Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF15
_______________________________________________________________________
876. BLOOD INITIATIVE--REVISIONS TO LABELING AND
STORAGE REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE
PLASMA
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; . . .
CFR Citation: 21 CFR 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR
610; . . .
Legal Deadline: None
Abstract: In multiple rulemakings, the Food and Drug Administration
(FDA) 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
Subcommittee on House Resources and Intergovernmental Relations, the
General Accounting Office, and the Institute of Medicine, as well as on
public comments. The other remaining subject intended to be addressed
in the rulemakings include: donor eligibility requirements (0910-AF25).
These actions are intended to help ensure the continued safety of the
Nation's blood supply.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action 06/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Suite 400S
(HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville
Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Related RIN: Split from 0910-AB26
RIN: 0910-AF26
_______________________________________________________________________
877. OVER-THE-COUNTER (OTC) DRUG REVIEW--
ANTIPERSPIRANT PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Partial Stay) 09/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF30
[[Page 37457]]
_______________________________________________________________________
878. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD
(ANTIHISTAMINE) PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Amendment) (Common
Cold) 10/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF31
_______________________________________________________________________
879. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC
PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Emergency First
Aid Eyewashes) 11/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF39
_______________________________________________________________________
880. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN
PROTECTANT PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Technical
Amendments) 12/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF42
_______________________________________________________________________
881. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL
CONTRACEPTIVE PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action (Warnings) 11/00/04
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF44
[[Page 37458]]
_______________________________________________________________________
Department of Health and Human Services (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
882. 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 to 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
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 collectedand analyzed, and a notification requirement if a
person intends to use a sampling service or 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 04/29/04 69 FR 23460
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
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 and Planning, 5600 Fishers Lane, Rockville,
MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB96
_______________________________________________________________________
883. CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND COSMETICS
DERIVED FROM EXPOSED ANIMAL POPULATIONS
Priority: Other Significant
Legal Authority: 42 USC 264; 21 USC 301 et seq
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to
prohibit the use of cervids (deer, elk) for food, including dietary
supplements, and cosmetics if the cervids have been exposed to chronic
wasting disease (CWD). FDA is proposing this regulation because of
potential risks to health.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group
of fatal, neurodegenerative diseases that include bovine spongiform
encephalopathy (BSE) in cattle, scrapie in sheep and 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 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 preclinical 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, DA 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 01/00/06
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
_______________________________________________________________________
884. 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 to 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 10/29/03 68 FR 61640
Next Action Undetermined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
[[Page 37459]]
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, 5515 Security Lane, Suite 1101 (HFD-7),
Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC23
_______________________________________________________________________
885. TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS ON LABELING FOR HUMAN
DRUGS
Priority: Other Significant
Legal Authority: 21 USC 355b
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 04/22/04 69 FR 21778
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
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, 5515 Security Lane, Suite 1101
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC35
_______________________________________________________________________
886. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING: CONSUMER
RESEARCH TO CONSIDER NUTRIENT CONTENT AND HEALTH CLAIMS AND POSSIBLE
FOOTNOTE OR DISCLOSURE STATEMENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 343; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: The Food and Drug Administration issued an advance noitce of
proposed rulemaking on July 11, 2003 (68 FR 41507), to solicit
information and data that potentially could be used to establish new
nutrient content claims about trans fatty acids; to establish
qualifying criteria for trans fat in current nutrient content claims
for saturated fat and cholesterol, lean and extra lean claims, and
health claims that contain a message about cholesterol-raising lipids;
and, in addition, to establish disclosure and disqualifying criteria to
help consumers make heart-healthy food choices. The agency also
requested comments on whether it should consider statements about trans
fat, either alone or in combination with saturated fat and cholesterol,
as a footnote in the Nutrition Facts panel or as a disclosure statement
in conjunction with claims to enhance consumers' understanding about
such cholesterol-raising lipids and how to use the information to make
healthy food choices. Information and data obtained from comments and
from consumer studies that will be conducted by FDA also may be used to
help draft a proposed rule that would establish criteria for certain
nutrient content or health claims or require the use of a footnote, or
other labeling approach, about one or more cholesterol-raising lipids
in the Nutrition Facts panel to assist consumers in maintaining healthy
dietary practices.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 07/11/03 68 FR 41507
ANPRM Comment Period End 10/09/03
NPRM To Be Determined
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Federal
Agency Contact: Julie Schrimpf, Department of Health and Human
Services, Food and Drug Administration, (HFS-832), HFS-800, Center for
Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College
Park, MD 20740
Phone: 301 436-2373
Fax: 301 436-2639
Email: [email protected]
Related RIN: Related to 0910-AB66
RIN: 0910-AC50
_______________________________________________________________________
887. 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 601.12; 21 CFR 314.94
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) 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 that 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
________________________________________________________________________
Next Action Undetermined
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
[[Page 37460]]
Drug Administration, Room 3037, (HFD-7), Center for Drug Evaluation and
Research, 5515 Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-6197
Email: [email protected]
RIN: 0910-AC52
_______________________________________________________________________
888. 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 is proposing to amend its
current good manufacturing practice 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 To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Elaine H. Tseng, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research, 5515 Security Lane, Suite 1101
(HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC53
_______________________________________________________________________
889. FOOD LABELING: FOOD ALLERGEN INGREDIENT LABELING
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321 ; 21 USC 331; 21 USC 342; 21 USC 343; 21
USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: The purpose of this rulemaking is to reduce mortality and
morbidity by providing sensitive individuals with additional food
allergen information to help them protect themselves from serious
allergic reactions, including life-threatening anaphylactic shock. The
eight most common food allergens are: 1) peanuts; 2) soybeans; 3) milk;
4) eggs; 5) fish; 6) crustacea (e.g., lobster, crab, shrimp); 7) tree
nuts (e.g., almonds, chestnuts, macadamia nuts, pecans, walnuts,
hazelnuts or filberts, cashews, brazil nuts, pistachios, pine nuts);
and 8) wheat. The rule would propose to require that foods that contain
ingredients derived from these eight allergens include information on
the label in plain English terms that clearly identifies the allergenic
source of these ingredients.
The agency is also proposing to require individual label declaration of
spices, flavors, noncertified colors and incidental additives.
Currently, section 403(i) of the Federal Food, Drug, and Cosmetic Act
allows spices, flavors and noncertified colors used as ingredients of
foods to be declared collectively on the label without naming each one.
Federal regulations at 21 C.F.R. 101.100(a)(3) exempt incidental
additives from ingredient declaration on the label if they are present
in the food at an insignificant level and do not have any technical or
functional effect in the finished food.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Rhonda Rhoda Kane M.S., R.D., 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: 301 436-2371
Fax: 301 436-2636
Email: [email protected]
RIN: 0910-AF07
_______________________________________________________________________
890. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING,
PACKING, OR HOLDING OF DRUGS; REVISION OF CERTAIN LABELING CONTROLS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 351
CFR Citation: 21 CFR 211.122
Legal Deadline: None
Abstract: The proposed rule would amend the packaging and labeling
control provisions of the current good manufacturing practice
regulations for human and veterinary drug products by limiting the
application of special control procedures for the use of cut labeling
to immediate container labels, individual unit cartons, or multiunit
cartons containing immediate containers that are not packaged in
individual unit cartons. The proposal would also permit the use of any
automated technique, including differentiation by labeling size and
shape, that physically prevents incorrect labeling from being processed
by labeling and packaging equipment when cut labeling is used.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/29/97 62 FR 40489
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
[[Page 37461]]
Federalism: Undetermined
Agency Contact: Howard P. Muller, Office of Regulatory Policy,
Department of Health and Human Services, Food and Drug Administration,
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5515
Security Lane, Suite 1101 (HFD-7), Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF08
_______________________________________________________________________
891. CURRENT GOOD MANUFACUTRING PRACTICES; QUALITY CONTROL PROCEDURES;
NOTIFICATION REQUIREMENTS; 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. On April 28, 2003, FDA reopened the comment period
to update comments on the proposal. The comment period was extended on
June 27, 2003, to end onAugust 26, 2003.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action 09/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Melissa Scales, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, HFS-800, HFS-
024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]
Related RIN: Split from 0910-AA04
RIN: 0910-AF27
_______________________________________________________________________
892. INFANT FORMULA QUALITY FACTORS
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. On April 28, 2003, FDA reopened the comment period
to update comments on the proposal. The comment period was extended on
June 27, 2003, to end onAugust 26, 2003.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action 09/00/05
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Melissa Scales, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, HFS-800, HFS-
024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]
Related RIN: Split from 0910-AA04
RIN: 0910-AF28
_______________________________________________________________________
893. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL
ANALGESIC PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable: Next Action Undetermined
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF35
_______________________________________________________________________
894. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE
DRUG PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable: Next Action Undetermined
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
[[Page 37462]]
Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]
Related RIN: Split from 0910-AA01
RIN: 0910-AF38
_______________________________________________________________________
895. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH
CARE PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC
360a; 21USC 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 358
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.
Timetable: Next Action Undetermined
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]
Related RIN: Split from 0910-AA01
RIN: 0910-AF40
_______________________________________________________________________
Department of Health and Human Services (HHS) Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
896. 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 358
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:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Actions Will Continue Under
Separate Rulemakings 06/08/04
Anorectal Products (0910-AC65) Final Action (Amendment) 08/26/03 (68
FR 51167)
Antidiarrheal Products (0910-AC82) NPRM (Amendment) (Trav. Diar) 04/
17/03 (68 FR 18915) Merged With 0910-AF29 06/08/04
Antiemetic Products (0910-AC71) Final Action (Amendment) (Warning) 12/
06/02 (67 FR 72555)
Antiperspirant Products (0910-AC89) Final Action 06/09/03 (68 FR
34273) Final Action (Partial Stay) Merged With 0910-AF30 06/08/04
Cough/Cold (Antihistamine) Products (0910-AD31) Merged With 0910-AF31
06/08/04
Cough/Cold (Antitussive) Products (0910-AD24) Final Action (Amendment)
(Warning) 12/06/02 (67 FR 72555)
Cough/Cold (Bronchodilator) Products (0910-AD33) Merged With 0910-AF32
06/08/04
Cough/Cold (Combination) Products (0910-AD25) Final Action 12/23/02
(67 FR 78158) NPRM (Amendment) Merged With 0910-AF33 06/08/04
Cough/Cold (Nasal Decongestant) Products (0910-AD43) Merged With 0910-
AF34 06/08/04
External Analgesic Products (0910-AD06) Final Action
(Amendment)(Warning) 12/06/02 (67 FR 72555) NPRM (Amendment)(Patches)
07/17/03 (68 FR 42324) Merged With 0910-AF35 06/08/04
Ingrown Toenail Relief Products (0910-AD21) NPRM 10/04/02 (67 FR
62218) Final Action 05/07/03 (68 FR 24347)
Internal Analgesic Products (0910-AD07) NPRM (Amendment)(Ibuprofen)
08/21/02 (67 FR 54139) Merged With 0910-AF36 06/08/04
Labeling of Drug Products for OTC Human Use (0910-AD47) NPRM (Sodium
Labeling) 03/24/04 (69 FR 13765) Final Action (Sodium Labeling) 03/24/
04 (69 FR 13717) Final Action (Ca/Mg/K/Na) 03/24/04 (69 FR 13725)
Laxative Drug Products (0910-AC85) NPRM (Amendment) (Psyllium Granular
Dosage Form) 08/05/03 (68 FR 46133) Merged With 0910-AF38 06/08/04
Nighttime Sleep Aid Products (0910-AD11) Final Action
(Amendment)(Warning) 12/06/02 (67 FR 72555)
Ophthalmic Products (0910-AC72) NPRM (Emergency First Aid Eyewashes)
02/19/03 (68 FR 7951) Final Action (Technical Amendment) 02/19/03 (68
FR 7919) Final Action (Name Change) 06/03/03 (68 FR 32981) Final
Action (Emerg. First Aid Eyewashes) Merged With 0910-AF39 06/08/04
Oral Health Care Products (0910-AC98) ANPRM (Plaque/Gingivitis) 05/29/
03 (68 FR 32232) Merged With 0910-AF40 06/08/04
Pediculicide Products (0910-AC79) NPRM (Labeling Amendment) 05/10/02
(67 FR 31739) Final Action (Labeling Amendment) 12/31/03 (68 FR 75414)
Salicylate (Reye's Syndrome) (0910-AD13) Final Action (Warning) 04/17/
03 (68 FR 18861)
[[Page 37463]]
Skin Protectant Products (0910-AC96) Final Action 06/04/03 (68 FR
33362) NPRM (Astringent) 06/13/03 (68 FR 35346) Final Action
(Astringent) 06/13/03 (68 FR 35290) Final Action (Astringent) (Confirm
Effective Date) 10/09/03 (68 FR 58273) Final Action (Technical
Amendment) 12/09/03 (68 FR 68509) Final Action (Technical Amendment)
Merged With 0910-AF42 06/08/04
Sunscreen Products (0910-AC68) Final Action (Names) 06/20/02 (67 FR
41821) ANPRM (Bug and Insect Repellent) and NPRM (UVA/UVB) Merged With
0910-AF43 06/08/04
Vaginal Contraceptive Products (0910-AD19) NPRM (Amendment) 01/16/03
(68 FR 2254) Merged With 0910-AF44 06/08/04
Weight Control Products (0910-AC93) Merged With 0910-AF45 06/08/04
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
_______________________________________________________________________
897. 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. On April 28, 2003, FDA reopened the comment period
to update comments on the proposal. The comment period was extended on
June 27, 2003, to end onAugust 26, 2003.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Actions Will Continue Under
Separate Rulemakings 06/04/04
Current Good Mfg. Practices; Qual. Control Proc.; Quality Factors
(0910-AD81) NPRM 07/09/96 (61 FR 36154) NPRM Comment Period End 12/
06/96 NPRM Comment Period Reopened 04/28/03 (68 FR 22341) NPRM
Comment Period Extended 06/27/03 (68 FR 38247) NPRM Comment Period End
08/26/03 Merged With 0910-AF27 06/04/04
Infant Form Cons Comp, Micro Test & Recd Retention Req (0910-
AD80) 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 (0910-AD77) NPRM Comment Period End 12/
06/96 NPRM Comment Period Reopened 04/28/03 (68 FR 22341) NPRM
Comment Period Extended 06/27/03 (68 FR 38247) NPRM Comment Period End
08/26/03 Merged With 0910-AF28 06/04/04
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Melissa Scales, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, HFS-800, HFS-
024, Center for Food Safety and Applied Nutrition, 5100 Paint Branch
Parkway, College Park, MD 20740
Phone: 301 436-1720
Email: [email protected]
RIN: 0910-AA04
_______________________________________________________________________
898. DETERMINATION THAT INFORMED CONSENT IS INFEASIBLE OR IS CONTRARY TO
THE BEST INTEREST OF RECIPIENTS
Priority: Other Significant
CFR Citation: 21 CFR 50; 21 CFR 312
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 06/10/04
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Federal
Agency Contact: Philip L. Chao
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AA89
_______________________________________________________________________
899. BLOOD INITIATIVE
Priority: Other Significant
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
(FDA) 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
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 of blood and blood components and donor
eligibility requirements. These actions are intended to help ensure the
continued safety of the Nation's blood supply.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Actions Will Continue Under
Separate Rulemakings 06/04/04
Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin
(Human); Revision of Requirements (0910-AE95) NPRM 05/14/99 (64 FR
26344) Direct Final Rule 05/14/99 (64 FR 26282) Direct Final Rule -
Confirmation in Part and Technical Amendment 03/14/00 (65 FR
13678) Final Action 08/28/00 (65 FR 52016)
[[Page 37464]]
General Requirements for Blood, Blood Components, and Plasma
Derivatives; Notification of Deferred Donors (0910-AE99) NPRM 08/19/99
(64 FR 45355) Final Action 06/11/01 (66 FR 31165)
Plasma Derivatives and Similar Recombinant-Based Products; Requirements
for Notification of Recalls and Withdrawals (0910-AF02) ANPRM 08/19/99
(64 FR 45383) Withdrawn 06/04/04
Regulations for Human Blood and Blood Components Intended for
Transfusion or for Further Manufacturing Use (0910-AF00) Merged With
0910-AF25 06/04/04
Requirements for Testing Human Blood Donors for Evidence of Infection
Due to Communicable Disease Agents (0910-AE98) 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 (0910-AE96) NPRM 07/30/03 (68 FR
44678) Correction Notice 10/27/03 (68 FR 61172) NPRM Comment Period
End 10/30/03 Merged With 0910-AF26 06/04/04
Revisions to the Requirements Applicable to Blood, Blood Components,
and Source Plasma (0910-AE89) NPRM 08/19/99 (64 FR 45375) Direct
Final Rule 08/19/99 (64 FR 45366) 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: 301 827-9434
Related RIN: Related to 0910-AB76
RIN: 0910-AB26
_______________________________________________________________________
900. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND
CELLULAR AND TISSUE-BASED PRODUCTS
Priority: Other Significant
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
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 05/24/04 69 FR 29786
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State
Agency Contact: Paula S. McKeever
Phone: 301 827-6210
Fax: 301 827-9434
RIN: 0910-AB27
_______________________________________________________________________
901. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION
Priority: Other Significant
CFR Citation: 21 CFR 314
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 04/08/04 69 FR 18728
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Howard P. Muller
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB61
_______________________________________________________________________
902. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
CFR Citation: 21 CFR 225
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 05/19/04
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: George Graber
Phone: 301 827-6651
Email: [email protected]
RIN: 0910-AB70
_______________________________________________________________________
903. REQUIREMENTS FOR SUBMISSION OF LABELING FOR HUMAN PRESCRIPTION
DRUGS AND BIOLOGICS IN ELECTRONIC FORMAT
Priority: Other Significant
CFR Citation: 21 CFR 314; 21 CFR 601
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 12/11/03 68 FR 69009
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Federal
Agency Contact: Nicole K. Mueller
Phone: 301 594-2041
Fax: 301 594-6197
Email: