[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]
[[Page 25387]]
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Semiannual Regulatory Agenda
[[Page 25388]]
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, Chs. II, III, and XIII
Unified Agenda of Federal Regulatory and Deregulatory Actions
AGENCY: Office of the Secretary, HHS.
ACTION: Semiannual regulatory agenda.
_______________________________________________________________________
SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order
12866 require the semiannual publication of an agenda outlining all
current and projected rulemakings. The purpose of this exercise is to
inform the public about regulatory actions under development within the
Department, and to provide an opportunity for all concerned with the
impact of these regulations to participate in their development at an
early stage. The last such agenda was published on November 30, 2000.
FOR FURTHER INFORMATION CONTACT: Ann Stallion, Department of Health
and Human Services, Washington, DC 20201, (202) 690-6824, or the
contact person for a specific component of the Department as listed
below.
SUPPLEMENTARY INFORMATION: The regulatory actions capsulized below do
not necessarily reflect the new policy perspectives of the Bush
administration and HHS Secretary Thompson. The statutorily dictated
timing of the regulatory agenda caused the Department to begin its
efforts to put together information required for the agenda well before
the new Administration came into place. The following agenda thus
simply reflects ongoing efforts by HHS to comply with many longstanding
statutory obligations, and/or to effect improvements at the program-
implementation level based on the Department's experience in
administering existing programs. The timing of the October 2001 agenda
will, obviously, provide the Department with an opportunity to set out
a regulatory agenda that does reflect the policy directions that
Secretary Thompson desires to take.
Public commentary is invited. Comments should be sent to the
addresses listed below, depending on the specific agenda entry that
is of interest. Comments may be sent to the Office of the Secretary
if the responsible component of the Department is not apparent, or
if a comment covers subjects crossing agency lines.
Administration on Children and Families: Madeline Mocko,
Director, Division of Policy and Legislation, 7th Floor, 370 L'
Enfant Promenade SW., Washington, DC 20447; Phone 202-401-9223.
Administration on Aging: Harry Posman, Executive Secretariat,
Room 4753, 330 Independence Avenue SW., Washington, DC 20201; Phone
202-260-0669.
Agency for Health Care Policy and Research: Nancy Werbel, 2101
East Jefferson Street, Suite 603, Rockville, Maryland 20852; Phone
301-594-1455.
Centers for Disease Control: Thena Durham, Executive
Secretariat, 1600 Clifton Road, Building 16, Atlanta, Georgia
30333; Phone 404-639-7120.
Food and Drug Administration: Ed Dutra, Director, Regulatory
Policy and Management Staff, 5600 Fishers Lane, Rockville, Maryland
20857; Phone 301-443-3480.
Health Care Financing Administration: Anthony Mazzarella,
Deputy Director, Operation Support Group, 7500 Security Boulevard,
C4-26-05, Baltimore, Maryland 21244; Phone 410-786-7501.
Health Resource Services Administration: Dolores R. Etherith,
5600 Fishers Lane, Room 14-A-08, Rockville, Maryland 20857; Phone
301-443-1786.
Indian Health Service: Betty Gould, 12300 Twinbrook Parkway,
Suite 450, Rockville, Maryland 20857; Phone 301-443-1116.
National Institutes of Health: Jerry Moore, 9000 Rockville
Pike, Building 31, Room 1B25, Bethesda, Maryland 20205; Phone 301-
496-4606.
Substance Abuse and Mental Health Services Administration: Joe
Faha, 5600 Fishers Lane, Room 12-A-17, Rockville, Maryland 20857;
Phone 301-443-4640.
Office of the Secretary: Ann C. Agnew, Executive Secretary to
the Department, Room 603H, Hubert H. Humphrey Building, 200
Independence Avenue SW., Washington, DC 20201.
Dated: March 14, 2001.
Ann C. Agnew,
Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
813 Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide 0991-AB12
Requirements for Drug-Free Workplace (Grants).......................................
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
814 Reproduction and Sale of Official Forms and Publications............................ 0991-AA83
815 Shared Risk Exception to the Safe Harbor Provisions................................. 0991-AA91
816 Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums 0991-AB04
for ESRD Beneficiaries..............................................................
817 Safe Harbor for Ambulance Restocking................................................ 0991-AB05
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818 Revisions and Technical Corrections to 42 CFR Chapter V............................. 0991-AB09
819 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.........................................................................
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
820 Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care 0991-AB03
Organizations.......................................................................
821 Safe Harbor for Arrangements Involving Federally Qualified Health Centers........... 0991-AB06
822 Definition of Terms; Substantially in Excess and Usual Charges and Clarification of 0991-AB13
the Good Cause Exception............................................................
----------------------------------------------------------------------------------------------------------------
Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
823 Standards for Privacy of Individually Indentifiable Health Information.............. 0991-AB08
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
824 Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change 0930-AA04
from March 31 to October 1 for FY 2001 and Beyond...................................
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
825 Final and Delegation of Authority To Implement SAMHSA's Accreditation Based System 0930-AA06
for Opiod Treatment Program Monitoring..............................................
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
826 Amendments to Quality Assurance and Administrative Provision for Approval of 0920-AA04
Respiratory Protective Devices......................................................
827 Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of 0920-AA05
Cancer for Energy Employees Occupational Illness Compensation Program...............
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
828 Packaging and Handling of Infectious Substances and Select Agents................... 0920-AA02
829 Control of Communicable Diseases.................................................... 0920-AA03
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Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
830 Implementation of the Equal Access to Justice Act in Agency Proceedings............. 0990-AA02
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
831 Natural Rubber-Containing Drugs; User Labeling...................................... 0910-AB56
832 Implementation of the Import Tolerance Provisions of the Animal Drug Availability 0910-AB71
Act of 1996.........................................................................
833 Part 600-Biological Products: General (Section 610 Review).......................... 0910-AC06
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
834 Over-the-Counter (OTC) Drug Review.................................................. 0910-AA01
835 Hearing Aids; Professional and Patient Labeling; Conditions for Sale................ 0910-AA39
836 Establishment Registration and Product Listing for Drugs and Biologics.............. 0910-AA49
837 Investigational New Drugs: Export Requirements for Unapproved New Drug Products..... 0910-AA61
838 Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs.............. 0910-AA86
839 Safety Reporting Requirements for Human Drug and Biological Products................ 0910-AA97
840 Radioactive Drugs for Basic Research................................................ 0910-AB00
841 Administrative Practices and Procedures; Advisory Opinions and Guidelines........... 0910-AB14
842 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based 0910-AB28
Products............................................................................
843 Applications for FDA Approval to Market a New Drug; Complete Response Letter; 0910-AB34
Amendments to Unapproved Applications...............................................
844 Expanded Access to Investigational Therapies........................................ 0910-AB37
845 Electronic Submission of Adverse Drug Reaction Reports.............................. 0910-AB42
846 Distinguishing Marks for Drug Products Containing Insulin........................... 0910-AB43
847 Pregnancy Labeling.................................................................. 0910-AB44
848 Positron Emission Tomography Drugs; Current Good Manufacturing Practices............ 0910-AB63
849 Current Good Manufacturing Practice for Medicated Feeds............................. 0910-AB70
850 Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use............. 0910-AB79
851 Repackaging Approval Requirements................................................... 0910-AB81
852 Stability Testing of Drugs.......................................................... 0910-AB82
853 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary 0910-AB88
Supplements.........................................................................
854 Submission in Electronic Format of Certain Labeling Information..................... 0910-AB91
855 Fees Relating to Drugs; Waiver and Reduction of Fees................................ 0910-AB92
856 Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product 0910-AB93
Final Specifications................................................................
857 Requirements Pertaining to Sampling Services and Private Laboratories Used in 0910-AB96
Connection with Imported Food.......................................................
858 Medical Devices, Medical Device Establishment Registration and Listing Requirements; 0910-AB99
Amendment...........................................................................
859 Availability for Public Disclosure and Submission to FDA for Public Disclosure of 0910-AC00
Certain Data and Information Related to Gene Therapy or Xenotransplantation.........
860 Reporting Information Regarding Potential Fabrication or Falsification of Data...... 0910-AC02
861 Status Reports for Quantity Marketed Information for Animal Drug Products Used in 0910-AC04
Food-Producing Animals..............................................................
862 Labeling Dietary Supplements for Women Who Are or May Become Pregnant............... 0910-AC09
863 Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) 0910-AC10
Containers..........................................................................
864 Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of 0910-AC13
``No Residue''......................................................................
865 Control of Salmonella Enteritidis in Shell Eggs During Production and Retail........ 0910-AC14
866 Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition... 0910-AC18
867 Use of Materials Derived from Ruminant Animals in FDA Regulated Products............ 0910-AC19
868 Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk 0910-AC20
Ingredients from Unapproved Sources.................................................
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Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
869 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal 0910-AA02
Drug and Patent Term Restoration Act (GADPTRA)......................................
870 Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished 0910-AA45
Pharmaceuticals.....................................................................
871 Bioavailability and Bioequivalence Requirements..................................... 0910-AA51
872 Labeling for Human Prescription Drugs; Revised Format............................... 0910-AA94
873 Current Good Manufacturing Practice; Revision of Certain Labeling Controls.......... 0910-AA98
874 Use of Ozone-Depleting Substances................................................... 0910-AA99
875 Exports; Notification and Recordkeeping Requirements................................ 0910-AB16
876 Foreign Establishment Registration and Listing...................................... 0910-AB21
877 FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping 0910-AB24
Requirements for Unapproved or Violative Products Imported for Further Processing or
Incorporation and Later Export......................................................
878 Blood Initiative.................................................................... 0910-AB26
879 Antibiotic Drug Approval and Exclusivity............................................ 0910-AB33
880 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs... 0910-AB39
881 Supplements and Other Changes to Approved New Animal Drug Applications.............. 0910-AB49
882 Revisions to the General Safety Requirements for Biological Products; Direct Final 0910-AB51
Rule................................................................................
883 Discontinuation of a Lifesaving Product............................................. 0910-AB60
884 Supplements and Other Changes to an Approved Application............................ 0910-AB61
885 Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and 0910-AB66
Health Claims.......................................................................
886 Presubmission Conferences........................................................... 0910-AB68
887 Surgeon's and Patient Examination Gloves; Reclassification.......................... 0910-AB74
888 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion 0910-AB76
Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting
HCV (Lookback)......................................................................
889 Antibiotic Resistance Labeling...................................................... 0910-AB78
890 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications.............. 0910-AB80
891 Food Additives: Food Contact Substances Notification System......................... 0910-AB94
892 State Certification of Mammography Facilities....................................... 0910-AB98
893 Examination of Administrative Record and Other Advisory Committee Records........... 0910-AC03
894 Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human 0910-AC05
Studies Are Unethical...............................................................
895 Additional Safeguards for Children in Clinical Investigations of FDA Regulated 0910-AC07
Products............................................................................
896 Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity............... 0910-AC11
897 Revocation of Conditions for Marketing Digoxin Products for Oral Use................ 0910-AC12
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
898 Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality 0910-AA04
Factors, Notification Requirements, and Records and Reports.........................
899 Food Labeling Review................................................................ 0910-AA19
900 Medical Foods....................................................................... 0910-AA20
901 Classification of Computer Software Programs That Are Medical Devices............... 0910-AA41
902 Reinventing FDA Food Regulations.................................................... 0910-AA58
903 Determination That Informed Consent Is Infeasible or Is Contrary to the Best 0910-AA89
Interest of Recipients..............................................................
904 Direct-to-Consumer Promotion Regulations............................................ 0910-AA90
905 Investigational Use New Animal Drug Regulations (Section 610 Review)................ 0910-AB02
906 Suitability Determination for Donors of Human Cellular and Tissue-Based Products.... 0910-AB27
907 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed............... 0910-AB50
908 Bulk Drug Substances for Use in Pharmacy Compounding................................ 0910-AB57
909 Pharmacy and Physician Compounding of Drug Products................................. 0910-AB58
910 Drug Products That Present Demonstrable Difficulties for Compounding Because of 0910-AB59
Reasons of Safety or Effectiveness..................................................
911 Mandatory HACCP Regulations for Manufacturers of Rendered Products.................. 0910-AB72
912 Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, 0910-AB73
and Referrals for Other Administrative Action.......................................
913 Substances Prohibited From Use in Animal Food or Feed............................... 0910-AB90
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914 Marking Requirements for and Prohibitions on the Reimportation of Imported Food 0910-AB95
Products That Have Been Refused Admission into the United States....................
915 Addition to the List of Drug Products That Have Been Withdrawn From the Market for 0910-AC01
Reasons of Safety or Effectiveness..................................................
916 Addition to the List of Drug Products That Have Been Withdrawn or Removed From the 0910-AC08
Market for Reasons of Safety or Effectiveness.......................................
917 Premarket Notice Concerning Bioengineered Foods..................................... 0910-AC15
918 Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures... 0910-AC16
919 Institutional Review Boards: Registration Requirements.............................. 0910-AC17
920 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed 0910-AC21
Animal Populations..................................................................
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
921 Biological Products: Reporting of Biological Product Deviations in Manufacturing.... 0910-AA12
922 Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for 0910-AA43
Juices..............................................................................
923 Drugs Used for Treatment of Narcotic Addicts........................................ 0910-AA52
924 Establishment Registration and Listing of Human Cells, Tissues, and Cellular and 0910-AB05
Tissue-Based Products...............................................................
925 Veterinary Feed Directives.......................................................... 0910-AB09
926 Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration 0910-AB30
Requirements........................................................................
927 Postmarketing Studies for Human Drugs and Licensed Biological Products: Status 0910-AB83
Reports.............................................................................
928 Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling 0910-AB89
Standards...........................................................................
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
929 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44
Areas...............................................................................
930 National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine 0906-AA55
Injury Table........................................................................
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
931 National Practitioner Data Bank for Adverse Information on Physicians and Other 0906-AA41
Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
932 Compliance Alternatives for Provision of Uncompensated Services..................... 0906-AA52
933 Final Rule for the Health Professions, Nursing, Public Health, and Allied Health 0906-AA53
Training Grant Programs Under 42 CFR Parts 57 and 58................................
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
934 Ricky Ray Hemophilia Relief Fund Program............................................ 0906-AA56
----------------------------------------------------------------------------------------------------------------
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Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
935 Tribal Self-Governance Amendments................................................... 0917-AA05
----------------------------------------------------------------------------------------------------------------
Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
936 Indian Child Protection and Family Violence Prevention Act Minimum Standards of 0917-AA02
Character...........................................................................
----------------------------------------------------------------------------------------------------------------
Indian Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
937 Contracts Under the Indian Self-Determination Act................................... 0917-AA04
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
938 National Institutes of Health AIDS Research Loan Repayment Program.................. 0925-AA02
939 Undergraduate Scholarship Program Regarding Professions Needed by the NIH........... 0925-AA10
940 National Cancer Institute Clinical Cancer Education Program......................... 0925-AA17
941 National Institutes of Health Loan Repayment Program for Research................... 0925-AA18
942 NIH Center Grants................................................................... 0925-AA24
943 National Institutes of Health Clinics Research Loan Repayment Program for 0925-AA25
Individuals from Disadvantaged Backgrounds..........................................
944 NIH Loan Repayment Program for Minority Health Disparties Research.................. 0925-AA26
945 Pediatric Research Loan Repayment Program........................................... 0925-AA27
946 NIH Training Grants................................................................. 0925-AA28
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
947 National Research Service Awards.................................................... 0925-AA16
948 National Institute of Child Health and Human Development Contraception and 0925-AA19
Infertility Research Loan Repayment Program.........................................
949 Scientific Peer Review of Research Grant Applications and Research and Development 0925-AA20
Contract Projects...................................................................
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
950 Traineeships........................................................................ 0925-AA11
951 Additional Protections for Pregnant Women and Human Fetuses Involved in Research, 0925-AA14
and Pertaining to Human In Vitro Fertilization......................................
952 Federal Policy (Common Rule) for the Protection of Human Subjects................... 0925-AA21
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Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
953 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01
Whistleblowers......................................................................
954 Federal Policy (Common Rule) for the Protection of Human Subjects................... 0940-AA03
----------------------------------------------------------------------------------------------------------------
Office of Public Health and Science--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
955 Additional Protections for Pregnant Women and Human Fetuses Involved in Research, 0940-AA02
and Pertaining to Human In Vitro Fertilization......................................
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
956 End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P) (Section 610 0938-AG82
Review).............................................................................
957 Recognition of the American Osteopathic Association for Critical Access Hospitals 0938-AK84
(HCFA-2099-PN)......................................................................
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
958 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities- 0938-AK47
Update (HCFA-1163-P)................................................................
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
959 ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare 0938-AD95
Overpayment Liability (HCFA-6007-F).................................................
960 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC) 0938-AF42
961 Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F).... 0938-AG79
962 Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F).................. 0938-AG81
963 Liability for Third Parties To Pay for Services (HCFA-2080-P)....................... 0938-AH01
964 Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas 0938-AH17
and Intestinal Transplants (HCFA-3835-P)............................................
965 Hospice Care-Conditions of Participation (HCFA-3844-P).............................. 0938-AH27
966 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer- 0938-AH48
Based Group Health Plans (HCFA-2047-F)..............................................
967 Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC).............. 0938-AH53
968 Requirements for Establishing and Maintaining Medicare Billing Privileges (HCFA-6002- 0938-AH73
P)..................................................................................
969 Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical 0938-AH81
Procedures for Ambulatory Surgical Centers (HCFA-1885-FC)...........................
970 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P).. 0938-AH83
971 National Standard for Identifiers of Health Plans (HCFA-4145-P)..................... 0938-AH87
972 Standard Unique Health Care Provider Identifier (HCFA-0045-F)....................... 0938-AH99
973 Medicaid: Medical Child Support (HCFA-2081-P)....................................... 0938-AI21
974 Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities, 0938-AI48
Rehabilitation Agencies (HCFA-6005-P)...............................................
975 Appeals of Carrier Determination That a Physician or Other Supplier Fails To Meet 0938-AI49
the Requirements for Medicare Billing Privileges (HCFA-6003-F)......................
976 Security Standards (HCFA-0049-F).................................................... 0938-AI57
[[Page 25395]]
977 National Standard Employer Identifier (HCFA-0047-F)................................. 0938-AI59
978 Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan 0938-AI75
(HCFA-1777-P).......................................................................
979 Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA- 0938-AI89
3004-F).............................................................................
980 Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic 0938-AI92
Laboratory Tests (HCFA-3250-F)......................................................
981 Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-F)............ 0938-AI93
982 External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-F)........ 0938-AJ06
983 Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the 0938-AJ10
Conditions of Participation for Home Health Agencies (HCFA-3006-F)..................
984 Rural Health Clinics: Amendments to Participation Requirements and Payment 0938-AJ17
Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
1910-F).............................................................................
985 Hospital Conditions of Participation: Laboratory Services (HCFA-3014-F)............. 0938-AJ29
986 Medicare Hospice Care Amendments (HCFA-1022-P)...................................... 0938-AJ36
987 Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-P).................... 0938-AJ39
988 Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC).... 0938-AJ44
989 Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital 0938-AJ55
Services (HCFA-1069-F)..............................................................
990 DME Surety Bonds (HCFA-6006-P)...................................................... 0938-AJ64
991 State Health Insurance Assistance Program (SHIP) (HCFA-4005-F)...................... 0938-AJ67
992 HHA Surety Bond (HCFA-6001-P)....................................................... 0938-AJ81
993 Application of Inherent Reasonableness to All Part B Services Other Than Physician 0938-AJ97
Services (HCFA-1908-F)..............................................................
994 Supplier Standards Related to Training Requirements for Oxygen, Therapeutic Shoes 0938-AJ98
(HCFA-6010-NPRM)....................................................................
995 Non-Federal Governmental Plans Exempt From HIPAA (HCFA-2033-IFC).................... 0938-AK00
996 End Stage Renal Disease Bad Debt Payment (HCFA-1126-P).............................. 0938-AK02
997 Practice Expense Data Collection (HCFA-1111-IFC).................................... 0938-AK14
998 Payment for Clinical Psychology Training Programs (HCFA-1089-F)..................... 0938-AK15
999 Provisions of the Balanced Budget and Refinement Act of 1999; Hospital Inpatient 0938-AK20
Payments and Rates and Costs of Graduate Medical Education (HCFA-1131-IFC)..........
1000 Conditions of Participation of Intermediate Care Facilities for Persons With Mental 0938-AK23
Retardation (HCFA-3046-P)...........................................................
1001 Clinical Lab Requirements-Revisions to Regulations Implementing CLIA (HCFA-2226-F).. 0938-AK24
1002 Prospective Fee Schedule for Ambulance Services (HCFA-1002-F)....................... 0938-AK30
1003 Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term 0938-AK35
Care Facilities (HCFA-3047-P).......................................................
1004 Medicare Provider and Supplier Hearing Procedures (HCFA-2093-P)..................... 0938-AK39
1005 Hospital Conditions of Participation: Quality Assessment and Performance 0938-AK40
Improvements (HCFA-3050-F)..........................................................
1006 Requirements for the Recredentialing of Medicare+Choice Organizations Providers 0938-AK41
(HCFA-1160-F).......................................................................
1007 Supplementary Medical Insurance Premium Surcharge Agreements (HCFA-4007-P).......... 0938-AK42
1008 Medical Devices Coverage Decisions Related to Health Care Technology (HCFA-3059-P).. 0938-AK43
1009 Medicaid Management Information System Revised Definition of ``Mechanized Claims 0938-AK44
Processing and Information Retrieval System'' (HCFA-2123-IFC).......................
1010 Medicare Program; Reporting and Repayment of Overpayments (HCFA-6011-P)............. 0938-AK45
1011 Improvements to the Medicare+Choice Appeals and Grievance Procedures (HCFA-4024-F).. 0938-AK48
1012 Civil Money Penalties, Assessments, and Revised Sanction Authorities (HCFA-6145-FC). 0938-AK49
1013 Payment for Upgraded Durable Medical Equipment (HCFA-1084-F)........................ 0938-AK50
1014 Update to the Prospective Payment System for Home Health Agencies for FY 2002 (HCFA- 0938-AK51
1147-NC)............................................................................
1015 Recognition of the American Osteopathic Association for Ambulatory Surgical Center 0938-AK53
Programs (HCFA-2079-FN).............................................................
1016 Prospective Payment System for Hospital Outpatient Services (HCFA-1159-P)........... 0938-AK54
1017 Medicare as Secondary Payer-Recovery of Conditional Payments (HCFA-6009-P).......... 0938-AK55
1018 Five Year Review of Work Relative Value Units Under the Physician Fee Schedule 0938-AK56
Proposed Notice (HCFA-1170-PN)......................................................
1019 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 0938-AK57
2002 (HCFA-1169-P)..................................................................
1020 Changes to National Coverage Determinations and Local Coverage Determinations (HCFA- 0938-AK58
4019-FC)............................................................................
1021 Revisions to the Prospective Payment System for Hospital Outpatient Services 0938-AK59
Mandated by BIPA (HCFA-1179-IFC)....................................................
1022 Challenges to National Coverage Determinations and Local Coverage Determinations 0938-AK60
(HCFA-3063-P).......................................................................
1023 Revised Process for Making Medicare Coverage Decisions (HCFA-3062-N)................ 0938-AK61
1024 Claims Attachment Standard (HCFA-0050-P)............................................ 0938-AK62
1025 Standards for Electronic Signatures (HCFA-0051-F)................................... 0938-AK63
1026 Health Insurance Reform: Modifications to Standards for Electronic Transaction (HCFA- 0938-AK64
0003-IFC)...........................................................................
1027 Replacement of Reasonable Charge Methodology by Fee Schedule (HCFA-1010-F).......... 0938-AK66
[[Page 25396]]
1028 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK67
Relationships-Phase II (HCFA-1810-FC)...............................................
1029 Increase in the Rate of Reimbursement of Photocopy Expenses for Prospective Payment 0938-AK68
System Providers (HCFA-3055-P)......................................................
1030 Long Term Care Prospective Payment System for FY 2003 (HCFA-1177-P)................. 0938-AK69
1031 Modifications to Managed Care Rules Based on Provisions of BIPA and Technical 0938-AK71
Corrections (HCFA-1180-P)...........................................................
1032 Changes to the Hospital Inpatients Prospective Payment System for Fiscal Year 2002 0938-AK73
Rates (HCFA-1158-P).................................................................
1033 Changes to Inpatient BIPA for Fiscal Year 2001 (HCFA-1178-IFC)...................... 0938-AK74
1034 Medicare+Choice ESRD Rates (HCFA-1182-PN)........................................... 0938-AK75
1035 Revisions to Transaction and Code Set Standards for Electronic Transactions (HCFA- 0938-AK76
0005-IFC)...........................................................................
1036 Medicare Inpatient Disproportionate Share Hospital Adjustment Calculation (HCFA-1171- 0938-AK77
IFC)................................................................................
1037 Statement of Intent (HCFA-1185-P)................................................... 0938-AK79
1038 Procedures for Public Consultations for Coding and Payment Determinations for New 0938-AK80
Laboratory Tests (HCFA-1186-N)......................................................
1039 Organ Procurement Organization Condition for Coverage (HCFA-3064-P)................. 0938-AK81
1040 Qualification Requirements for Directors of Laboratories Performing High Complexity 0938-AK83
Testing (HCFA-2094-NPRM)............................................................
1041 Protection and Promotion of Resident Rights (HCFA-3065-P)........................... 0938-AK85
1042 Standards for Electronic Transactions-Elimination of NDC Coding Standards (HCFA-0006- 0938-AK86
P)..................................................................................
1043 Hospital Reference Laboratory and Medicare Secondary Payer (HCFA-1187-P)............ 0938-AK87
1044 Portability in the Group Health Insurance Market (HCFA-2048-F)...................... 0938-AK88
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
1045 Changes to Peer Review Organization Regulations (HCFA-3135-F)....................... 0938-AD38
1046 Protection of Income and Resources for Community Spouses of Institutionalized 0938-AE12
Individuals (HCFA-2023-P)...........................................................
1047 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028- 0938-AE72
F)..................................................................................
1048 Payment for Nursing and Allied Health Science Education (HCFA-1685-F)............... 0938-AE79
1049 Coverage of Screening Pap Smears (HCFA-3705-F)...................................... 0938-AE98
1050 Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)... 0938-AF68
1051 Disclosure of Confidential PRO and ESRD Network Organization Information for 0938-AG33
Research Purposes (HCFA-3208-P).....................................................
1052 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, 0938-AG59
Underpayments and Overpayments (HCFA-2215-P)........................................
1053 Optional Coverage of Certain Tuberculosis to TB-Related Services, TB-Infected 0938-AG72
Individuals (HCFA-2082-P)...........................................................
1054 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AG80
Relationships-Expanded to Designated Health Services (HCFA-1809-FC).................
1055 Distinct Part Requirements for Nursing Homes and Prohibition on Financial Screening 0938-AG84
of Applicants for Nursing Home Admission (HCFA-3815-P)..............................
1056 CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)......................... 0938-AG99
1057 Additional Supplier Standards (HCFA-6004-FC)........................................ 0938-AH19
1058 State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P).................... 0938-AH24
1059 Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA- 0938-AH37
1843-P).............................................................................
1060 Medicaid; Estate Recoveries (HCFA-2083-P)........................................... 0938-AH63
1061 Individual Market Health Insurance Reform: Portability From Group to Individual 0938-AH75
Coverage; Federal Rules for Access in the Individual Market; State Alternative
Mechanisms to Federal Rules (HCFA-2882-F)...........................................
1062 Disclosure of Peer Review Organization Information in Response to Beneficiary 0938-AH85
Complaints (HCFA-3241-P)............................................................
1063 Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review 0938-AH89
Program (HCFA-2107-P)...............................................................
1064 Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)................. 0938-AH92
1065 Medicaid Program; Coverage and Payment for Federally Qualified Health Center 0938-AH95
Services (HCFA-2043-P)..............................................................
1066 Nondiscrimination in Health Coverage in the Group Market (HCFA-2022-F).............. 0938-AI08
1067 Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries 0938-AI11
Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).....................................
1068 Medicare Program; Adjustments to Cost Limits for Skilled Nursing Facility Inpatient 0938-AI14
Routine Service Costs (HCFA-1896-FN)................................................
[[Page 25397]]
1069 Medicare/Medicaid Program; User Fees for Information, Products, and Services (HCFA- 0938-AI46
6021-P).............................................................................
1070 Prospective Payment System for Hospital Outpatient Services (HCFA-1005-F)........... 0938-AI56
1071 State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)....... 0938-AI63
1072 Medicaid Program; Home and Community-Based Services (HCFA-2010-FC).................. 0938-AI67
1073 Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions 0938-AI70
of the Balanced Budget Act of 1997 (HCFA-2001-F)....................................
1074 Prospective Fee Schedule for Ambulance Services (HCFA-1002-P)....................... 0938-AI72
1075 Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and 0938-AI80
Elimination of Reclassifications (HCFA-1883-F)......................................
1076 Expanded Coverage for Diabetes Outpatient Self-Management Training Services (HCFA- 0938-AI96
3002-F).............................................................................
1077 Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier 0938-AJ15
Performance: Millennium Compliance (HCFA-4002-GNC)..................................
1078 Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of 0938-AJ47
1988 Exemption of Laboratories in the State of California (HCFA-2245-N).............
1079 Medicare Program: Criteria for Making National Coverage Decision (HCFA-3432-P)...... 0938-AJ54
1080 Medicare Program; Sustainable Growth Rate for Fiscal Year 2000 (HCFA-1110-N)........ 0938-AJ60
1081 Medicare and Medicaid Programs; Programs for All-Inclusive Care for the Elderly 0938-AJ63
(PACE) (HCFA-1903-P)................................................................
1082 Clinical Social Worker Services (HCFA-1088-F)....................................... 0938-AJ71
1083 Medicaid Disproportionate Share Hospital Payments-Institutions for Mental Disease 0938-AJ74
(HCFA-2062-N).......................................................................
1084 The Children's Health Insurance Program: Implementing the Balanced Budget Act of 0938-AJ75
1997 (HCFA-2006-F)..................................................................
1085 Medicare Program Update of Ambulatory Surgical Center Payment Rates Effective for 0938-AJ86
Services On or After October 1, 1999 (HCFA-1085-N)..................................
1086 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities- 0938-AJ93
Update (HCFA-1112-F)................................................................
1087 Use of Restraint and Seclusion in Residential Treatment Facilities Providing 0938-AJ96
Inpatient Psychiatric Services to Individuals Under Age 21 (HCFA-2065-F)............
1088 Conditions of Participation for Intermediate Care Facilities for the Mentally 0938-AJ99
Retarded............................................................................
1089 Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and 0938-AK04
Intermediate Care Facilities for the Mentally Retarded (HCFA-2004-F)................
1090 Hospital Conditions of Participation; Anesthesia Services (HCFA-3049-F)............. 0938-AK08
1091 Changes to the Appeals Process for Beneficiaries Receiving Home Health Services in 0938-AK10
the Fee For Service Program (HCFA-4006-P)...........................................
1092 Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 0938-AK11
2001 (HCFA-1120-F)..................................................................
1093 Revisions to Medicaid Upper Payment Limit Requirements for Hospital, Nursing 0938-AK12
Facility, Intermediate Care Facility Services for the Mentally Retarded and Clinic
Services (HCFA-2071-F)..............................................................
1094 Hospice Wage Index (HCFA-1135-N).................................................... 0938-AK13
1095 HIPAA Program; Bona Fide Wellness Programs (HCFA-2078-F)............................ 0938-AK19
1096 Application of Federal Financial Participation Limits (HCFA-2086-F)................. 0938-AK22
1097 Prospective Payment System for Hospital Outpatient Services: Exception to the 0938-AK25
Provider-Based Location Criteria for PPS-Exempt Facilities (HCFA-1143-F)............
1098 Criteria and Standards for Evaluating Intermediary and Carrier Performance During FY 0938-AK26
2001 (HCFA-4010-GNC)................................................................
1099 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AK27
Amounts for Calendar Year 2001 (HCFA-8007-N)........................................
1100 Mandatory Transmission of OASIS for Non-Medicare/Medicaid Patients in Home Health 0938-AK28
Agencies and Continued Delay of Requirements for Patients Receiving Personal Care
Services (HCFA-2070-N)..............................................................
1101 Removal of the Requirements for the Cardiac Pacemaker Registry (HCFA-3045-F)........ 0938-AK29
1102 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AK31
Relationships-Phase II (HCFA-1810-FC)...............................................
1103 Elimination of Application of Federal Financial Participation Limits (HCFA-2086-P).. 0938-AK32
1104 Conforming Regulations Changes and Statutory Revisions for Approval and Oversight of 0938-AK36
Accreditation Organizations (HCFA-2088-P)...........................................
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
1105 Program Performance Standards for the Operation of Head Start Programs.............. 0970-AB99
1106 Safeguarding Child Support and Expanded FPLS Information............................ 0970-AC01
[[Page 25398]]
1107 Developmental Disabilities and Bill of Rights Act................................... 0970-AC07
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
1108 Construction and Major Renovation of Head Start and Early Head Start Facilities..... 0970-AB54
1109 Child Support Enforcement for Indian Tribes......................................... 0970-AB73
1110 Child Support Enforcement Program Omnibus Conforming Regulation..................... 0970-AB81
1111 Family Child Care Program Option for Head Start Programs............................ 0970-AB90
1112 Technical Revision of Head Start Regulations To Make Them Conform to Recent 0970-AC00
Statutory Revisions.................................................................
1113 High Performance Bonus Awards Under the TANF Program................................ 0970-AC06
1114 Individual Development Accounts..................................................... 0970-AC08
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
1115 Standards for Safe Transportation................................................... 0970-AB24
1116 Incentive Payments and Audit Penalties to States and Political Subdivisions......... 0970-AB85
1117 State Self-Assessments To Determine Compliance With Federal Regulations............. 0970-AB96
1118 National Medical Support Notice..................................................... 0970-AB97
----------------------------------------------------------------------------------------------------------------
Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identification
Number Number
----------------------------------------------------------------------------------------------------------------
1119 Grants for State and Community Programs on Aging, Intrastate Funding Formulas; 0985-AA00
Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants
to Indians and Native Hawaiians.....................................................
1120 Grants for State and Community Programs on Aging, Family Caregivers, American 0985-AA01
Indians, and Native Hawaiians (Section 610 Review)..................................
----------------------------------------------------------------------------------------------------------------
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
813. GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
AND GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS)
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 5 USC 301; 41 USC 701 et seq, sec 2455; PL 103-355; 31
USC 6101 note; EO 12859
CFR Citation: 45 CFR 76; 45 CFR 82
Legal Deadline: None
Abstract: This proposed common rule is revised to simplify and
streamline nonprocurement debarment and suspension requirements, as
well as correspond to procurement regulations where possible. The
revision will separate the debarment and suspension and Drug-Free
Workplace regulations, and will be written in the plain language
format.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Diane Osterhus, Federal Assistance Policy Specialist,
Department of Health and Human Services, Office of the Secretary, Room
517D, Office of Grants and Acquisition Management, 200 Independence
Avenue SW., Washington, DC 20201
Phone: 202 690-6901
Fax: 202 690-5729
[[Page 25399]]
Email: [email protected]
RIN: 0991-AB12
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
814. REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS
Priority: Info./Admin./Other
Legal Authority: 42 USC 1320b-10
CFR Citation: 45 CFR 101
Legal Deadline: None
Abstract: This interim final rule with comment period will establish
procedures for implementation of section 312 of the Social Security
Independence Act. It amends existing prohibitions against ``misuse of
symbols, emblems, or names in reference to Social Security or
Medicare.'' Section 312 also prohibits the ``unauthorized reproduction,
reprinting, or distribution for fee'' of a ``form, application, or
other publication of the Social Security Administration or of the
Department of Health and Human Services.'' It requires prior written
authorization for any such activity in accordance with the Secretary's
regulations. The Department plans to distinguish between forms and
publications that potentially involve misuse in contrast to benign or
desirable reproductions and distributions, and to provide pre-
authorization for the latter. The rule will be developed in
consultation with the Social Security Administration.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 11/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Michael Herrell, Office of the Assistant Secretary for
Planning and Evaluation, Department of Health and Human Services,
Office of the Secretary, 200 Independence Avenue SW., Washington, DC
20201
Phone: 202 690-5739
RIN: 0991-AA83
_______________________________________________________________________
815. 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 08/00/01
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-AA91
_______________________________________________________________________
816. CIVIL MONEY PENALTY SAFE HARBOR TO PROTECT PAYMENT OF MEDICARE AND
MEDIGAP PREMIUMS FOR ESRD BENEFICIARIES
Priority: Substantive, Nonsignificant
Legal Authority: Social Security Act, sec 1128A(a)(5)
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This final rule will set forth in the OIG's civil money
penalty provisions in 42 CFR part 1003 a new safe harbor for unlawful
inducements to beneficiaries to provide protection for independent
dialysis facilities that pay, in whole or in part, premiums for
Supplementary Medical Insurance (Medicare part B) or Medicare
Supplemental Health Insurance policies (Medigap) for financially needy
Medicare beneficiaries with end-stage renal disease (ESRD). This safe
harbor specifically establishes various standards that, if met, would
result in the particular arrangement being protected from civil
penalties under section 1128A(a)(5) of the Social Security Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/02/00 65 FR 25460
NPRM Comment Period End 07/03/00
Final Action 10/00/01
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-AB04
_______________________________________________________________________
817. SAFE HARBOR FOR AMBULANCE RESTOCKING
Priority: Substantive, Nonsignificant
Legal Authority: PL 100-93, sec 14(a)
[[Page 25400]]
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This rule will set forth acceptable restocking arrangements
between municipal and nonprofit ambulance companies and hospitals.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/22/00 65 FR 32060
NPRM Comment Period End 07/21/00
Final Action 10/00/01
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-AB05
_______________________________________________________________________
818. REVISIONS AND TECHNICAL CORRECTIONS TO 42 CFR CHAPTER V
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1320a-7; 42 USC 1320a-7a; 42 USC
1320a-7b; 42 USC 1320a-7d(b); 42 USC 1395u
CFR Citation: 42 CFR 1001; 42 CFR 1003; 42 CFR 1008
Legal Deadline: None
Abstract: This final rule sets forth several miscellaneous revisions
and technical corrections to the OIG regulations codified in 42 CFR
chapter V. Among other revisions, this rule makes revisions or
clarifications to the term ``item or service'' contained in part 1003
of this chapter, to the reinstatement procedures relating to exclusions
resulting from the default on health education or scholarship
obligations set forth in part 1001, and to the statute of limitations
for the OIG to impose an exclusion under part 1001.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/20/00 65 FR 63035
NPRM Comment Period End 12/20/00
Final Action 09/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
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-AB09
_______________________________________________________________________
819. AMENDING THE REGULATIONS GOVERNING NONDISCRIMINATION ON THE BASIS
OF RACE, COLOR, NATIONAL ORIGIN, HANDICAP, SEX, AND AGE TO CONFORM TO
THE CIVIL RIGHTS RESTORATION ACT OF 1987
Priority: Other Significant
Legal Authority: PL 100-259, Civil Rights Restoration Act of 1987
CFR Citation: 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91
Legal Deadline: None
Abstract: The Secretary proposes to amend the Department's regulations
implementing title VI of the Civil Rights Act of 1964, as amended,
section 504 of the Rehabilitation Act of 1973, as amended, title IX of
the Education Amendments of 1972, and the Age Discrimination Act of
1975, as amended. The principal proposed conforming change is to amend
the regulations to add the definitions of ``program or activity'' or
``program'' that correspond to the statutory definitions enacted under
the Civil Rights Restoration Act of 1987.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/26/00 65 FR 64194
NPRM Comment Period End 11/27/00
Final Action 11/00/01
Final Action Effective 01/00/02
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Federal
Agency Contact: Roinsue Frohboese, Department of Health and Human
Services, Office of the Secretary
Phone: 202 619-0403
RIN: 0991-AB10
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Office of the Secretary (OS)
_______________________________________________________________________
820. CIVIL MONEY PENALTIES FOR MEDICARE+CHOICE ORGANIZATIONS AND
MEDICAID MANAGED CARE ORGANIZATIONS
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 reflect OIG's authority to impose
civil money penalties against Medicare+Choice organizations that engage
in certain abusive practices, including failure to provide medically
necessary care and discriminatory enrollment procedures. This rule
would specifically address the Medicare+Choice provisions set forth in
Public Law 105-33, the Balanced Budget Act of 1997, and the Medicaid
managed care provisions.
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
[[Page 25401]]
General (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AB03
_______________________________________________________________________
821. 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 Federal Qualified Health Centers and
certain service providers where a significant community benefit exists.
Timetable: Next Action Undetermined
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-AB06
_______________________________________________________________________
822. DEFINITION OF TERMS; SUBSTANTIALLY IN EXCESS AND USUAL
CHARGES AND CLARIFICATION OF THE GOOD CAUSE EXCEPTION
Priority: Substantive, Nonsignificant
Legal Authority: Sec. 1128(b)(A) of the Social Security Act
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This proposed rule would amend the OIG exclusion regulations
at 42 CFR 1001.701, addressing excessive claims, by including
definitions for the terms ``substantially in excess'' and ``usual
charges'', and by clarifying the ``good cause'' exception set forth in
this section.
Timetable: Next Action Undetermined
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-AB13
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
823. STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE HEALTH
INFORMATION
Priority: Economically Significant. Major under 5 USC 801.
CFR Citation: 45 CFR 160; 45 CFR 164
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 12/28/00 65 FR 82462
Delay of Effective Date To 04/
14/2001 02/26/01 66 FR 12434
Comment Period Extended 03/30/01 66 FR 12738
Regulatory Flexibility Analysis Required: Yes
Government Levels Affected: State, Local, Tribal, Federal
Federalism: This action may have federalism implications as defined in
EO 13132.
Agency Contact: Roxanne Gibson
Phone: 202 260-5083
RIN: 0991-AB08
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
824. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT APPLICATIONS
DUE DATE CHANGE FROM MARCH 31 TO OCTOBER 1 FOR FY 2001 AND BEYOND
Priority: Routine and Frequent
Legal Authority: Not Yet Determined
CFR Citation: 45 CFR 96; 45 CFR 96.122(d); 45 CFR 96.130(e); 45 CFR
96.134(d)
Legal Deadline: None
Abstract: The Substance Abuse and Mental Health Services Administration
(SAMHSA) (formerly, the Alcohol, Drug Abuse and Mental Health
Administration (ADAMHA)) has permitted applicants for its Substance
Abuse Prevention and Treatment (SAPT) Block Grant program to submit an
application for a grant as late as March 31 of the fiscal year for
which it is applying. Starting with the fiscal year 2001 applications,
SAMHSA is proposing a new date for receipt of the applications for SAPT
Block Grants of October 1 of the fiscal year for which Block Grant
funding is being requested. However, the deadline for two application
components required to be submitted by that due date may be extended
for a limited period, not to extend beyond December 31 of the same
fiscal year when good cause is demonstrated.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/04/00 65 FR 5474
NPRM Comment Period End 03/20/00
Next Action Undetermined
Regulatory Flexibility Analysis Required: No
Government Levels Affected: State
Federalism: This action may have federalism implications as defined in
EO 13132.
[[Page 25402]]
Agency Contact: Thomas Reynolds, Department of Health and Human
Services, Substance Abuse and Mental Health Services Administration,
5600 Fishers Lane, Room 13C-20, Parklawn, Rockville, MD 20857
Phone: 301 443-0179
RIN: 0930-AA04
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
825. FINAL AND DELEGATION OF AUTHORITY TO IMPLEMENT SAMHSA'S
ACCREDITATION BASED SYSTEM FOR OPIOD TREATMENT PROGRAM MONITORING
Priority: Other Significant
CFR Citation: 42 CFR 8
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Rule 01/17/01 66 FR 4075
60-Day Delay of Effective Date
To 05/18/2001 03/19/01 66 FR 15347
Regulatory Flexibility Analysis Required: Yes
Government Levels Affected: None
Agency Contact: Joseph D. Faha
Phone: 301 443-4640
RIN: 0930-AA06
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
826. AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE
PROVISION FOR APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
Priority: Other Significant
Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30
USC 811; 30 USC 842(h); 30 USC 844
CFR Citation: 42 CFR 84
Legal Deadline: None
Abstract: NIOSH plans to propose 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 06/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Larry Elliott, Acting Director, Office of Compensation
Analysis and Support, Department of Health and Human Services, Centers
for Disease Control and Prevention, NIOSH, R44, 5555 Ridge Avenue,
Cincinnati, OH 45213
Phone: 513 841-4400
RIN: 0920-AA04
_______________________________________________________________________
827. METHODS FOR ESTIMATING RADIATION DOSE AND GUIDELINES FOR
ASSESSING PROBABILITY OF CANCER FOR ENERGY EMPLOYEES OCCUPATIONAL
ILLNESS COMPENSATION PROGRAM
Priority: Other Significant
Legal Authority: PL 106-398, sec 3623
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: Pursant to Executive Order 13179, which implements section
3623 of the Energy Employees Occupational Illness Compensation Program
Act, Public Law 106-398, NIOSH plans to propose and finalize
regulations, to establish:
1) Guidelines to assess the likelihood that an individual with cancer
sustained that cancer in the performance of duty at a Department of
Energy facility or an atomic weapons employer facility, as defined in
that Act; and
2) Methods for arriving at and providing reasonable estimates of the
radiation doses received by individuals applying for assistance under
this program for whom there are inadequate records of radiation
exposure.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: Undetermined
Agency Contact: Roland Berry Ann, Team Leader, Policy Development,
Respirator Branch, Department of Health and Human Services, Centers for
Disease Control and Prevention, NIOSH, P04, 1095 Willowdale Road,
Morgantown, WV 26505
Phone: 304 285-5907
RIN: 0920-AA05
[[Page 25403]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
828. PACKAGING AND HANDLING OF INFECTIOUS SUBSTANCES AND SELECT AGENTS
Priority: Other Significant
Legal Authority: 42 USC 264; 42 USC 271; 42 USC 262 note; 31 USC 9701;
18 USC 3559; 18 USC 3571
CFR Citation: 42 CFR 72.6 (Renumbered); 42 CFR 72.7 (Renumbered); 42
CFR 72.1-5 (Revision)
Legal Deadline: None
Abstract: The purpose of this NPRM is to update regulations governing
the packaging, labeling, and shipment of infectious agents. Materials
must be packaged in such a way as to prevent damage and leakage during
transport in order to protect workers and the public from exposure.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/28/99 64 FR 58022
Next Action Undetermined
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Dr. Jonathan Y. Richmond, Director, Office on Health
and Safety, Department of Health and Human Services, Centers for
Disease Control and Prevention, MS F05, 1600 Clifton Road NE, Atlanta,
GA 30333
Phone: 404 639-2453
RIN: 0920-AA02
_______________________________________________________________________
829. CONTROL OF COMMUNICABLE DISEASES
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 264; 42 USC 271
CFR Citation: 42 CFR 70; 42 CFR 71
Legal Deadline: None
Abstract: CDC proposes to modify certain regulatory responsibilities of
42 CFR 70 and 42 CFR 71 that relate to quarantine in order to bring the
regulations up to date regarding modern communicable disease concerns.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Rule To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: State
Federalism: Undetermined
Agency Contact: Chuck Gollmar, Deputy Director, Department of Health
and Human Services, Centers for Disease Control and Prevention, MS D23,
1600 Clifton Road NE., Atlanta, GA 30333
Phone: 404 639-7070
Email: [email protected]
RIN: 0920-AA03
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________
830. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY
PROCEEDINGS
Priority: Substantive, Nonsignificant
Legal Authority: 5 USC 504(c)(1)
CFR Citation: 45 CFR 13
Legal Deadline: None
Abstract: The Equal Access to Justice Act requires agencies to pay fees
to parties prevailing against the Government in certain administrative
proceedings. The Act has been amended several times since its 1980
enactment, most recently by the Contract with America Advancement Act
of 1996, which increased the amount of the hourly fees payable. The
proposed rule revises 45 CFR part 13 (HHS' regulation implementing the
Equal Access to Justice Act) to conform with statutory changes.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/19/87 52 FR 23311
NPRM Comment Period End 08/17/87
Second NPRM 08/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Timothy M. White, Associate General Counsel, Business
and Administrative Law Division, Department of Health and Human
Services, Room 5362, HHS Cohen Building, 330 Independence Avenue SW.,
Washington, DC 20201
Phone: 202 619-0150
RIN: 0990-AA02
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
831. NATURAL RUBBER-CONTAINING DRUGS; USER LABELING
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 374; 21 USC 379; 42 USC 216; 42 USC
241; 42 USC 262; 42 USC 264; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The advance notice of proposed rulemaking requests comments
on requirements under consideration for labeling statements on products
regulated as drugs (including combination products regulated under drug
labeling provisions) that contain natural rubber that contacts humans.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
[[Page 25404]]
Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB56
_______________________________________________________________________
832. IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE ANIMAL
DRUG AVAILABILITY ACT OF 1996
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 556
Legal Deadline: None
Abstract: Section 4 of the Animal Drug Availability Act of 1996 (ADAA)
(Pub. L. 104-250) permits the Secretary of HHS to establish tolerances
for animal drugs used or intended for use in animals grown in an
exporting nation from which an edible portion is imported into the
United States. The standards used to establish tolerances are to be
similar to the food safety criteria used by the Secretary to establish
tolerances for drugs administered to animals grown in the United
States. The data used for establishing the tolerances may be from the
manufacturer and include data upon which a foreign approval is based or
data available to an international organization such as the Codex
Alimentarius Commission. This rule would implement the provisions in
ADAA.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 07/00/01
NPRM 02/00/02
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: George A. (``Bert'') Mitchell, Associate Director for
Policy and Regulations, Office of the Director, Department of Health
and Human Services, Food and Drug Administration, HFV-1, Center for
Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-2957
RIN: 0910-AB71
_______________________________________________________________________
833. PART 600-BIOLOGICAL PRODUCTS: GENERAL (SECTION 610 REVIEW)
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC
355; 21 USC 360; 21 USC 360(i); 21 USC 371; 21 USC 374; 42 USC 216; 42
USC 262; 42 USC 263(a); 42 USC 264; 42 USC 300aa-25
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: 21 CFR parts 600 through 680 describe regulations applicable
to biological products. Part 600 describes regulations for general
establishment standards, establishment inspections, and the reporting
of adverse experiences applicable to manufacturers of licensed
biological products. FDA is initiating a review under section 610 of
the Regulatory Flexibility Act for the regulations in part 600. The
purpose of this review is to determine if any of the regulations in
part 600 should be continued without change, or should be amended or
rescinded, to minimize adverse economic impacts on small entities. FDA
will consider, and solicit comments on the following: (1) the continued
need for a regulation in part 600; (2) the nature of complaints or
comments received concerning a regulation in part 600; (3) the
complexity of a regulation in part 600; (4) the extent to which a
regulation in part 600 overlaps, duplicates, or conflicts with other
Federal, State, or government rules; and (5) the degree to which
technology, economic conditions or other factors have changed in the
area affected by a regulation in part 600.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Begin Review of Current
Regulation 04/03/00
End Review 04/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Steven F. Falter, Director, Regulations and Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 200N (HFM-17), Center for Biologics Evaluation
and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Email: [email protected]
RIN: 0910-AC06
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
834. OVER-THE-COUNTER (OTC) DRUG REVIEW
Priority: Routine and Frequent
Legal Authority: 21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 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 310; 21 CFR 340; 21 CFR 341; 21 CFR 342; 21 CFR
343; 21 CFR 344; 21 CFR 345; 21 CFR 330; 21 CFR 333; 21 CFR 334; 21 CFR
335; 21 CFR 336; 21 CFR 337; 21 CFR 338; 21 CFR 339; ...
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. NOTE: NPRM for
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for
``Emetic
[[Page 25405]]
Products'' and reproposed as ``Poison Treatment Products.'' NPRM for
``Astringent (Wet Dressings) Products'' was included in the NPRM for
``Skin Protectant Products.'' NPRM for ``Diaper Rash Products'' was
included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' ``External
Analgesic'' and ``Skin Protectant Products.'' NPRM for ``Fever Blister/
Cold Sore Products (External)'' was included in NPRMs for ``External
Analgesic'' and ``Skin Protectant Products.'' NPRM for ``Insect Bites
and Stings (Relief) Products'' was included in NPRMs for ``External
Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/Oak/Sumac
Prevention'' was included in NPRMs for ``External Analgesic'' and
``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) Products''
was included in revised NPRM for ``Antimicrobial Products.'' NPRM for
``Alcohol (Topical) Products'' was included in revised NPRM for
``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' was
updated and split into two sections: First Aid Products and Health Care
Antiseptic Products.
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:
________________________________________________________________________
Acne (Topical) Products ANPRM 03/23/82 (47 FR 12430) NPRM 01/15/85
(50 FR 2172) NPRM (Amendment) 08/07/91 (56 FR 37622) Final Action 08/
16/91 (56 FR 41008)
Alcohol (Oral) in OTC Drug Products NPRM 10/21/93 (58 FR 54466) Final
Action 03/13/95 (60 FR 13590) NPRM (Amendment) 05/10/96 (61 FR
21392) Final Action (Amendment) 11/18/96 (61 FR 58629)
Anorectal Products ANPRM 05/27/80 (45 FR 35576) NPRM 08/15/88 (53 FR
30756) Final Action 08/03/90 (55 FR 31776) Final Action (LYCD) 09/02/
93 (58 FR 46746) Final Action (Witch Hazel) 06/03/94 (59 FR 28766)
Antacid Drug Products ANPRM 04/05/73 (38 FR 8714) NPRM 11/12/73 (38
FR 31260) Final Action 06/04/74 (39 FR 9862) NPRM (Amendment)
(Overindulgence) 12/24/91 (56 FR 66754) Final Action (Amendment)
(Warning) 08/26/93 (58 FR 45204) NPRM (Amendment) (Testing) 09/23/93
(58 FR 49826) NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR
5060) Final Action (Technical Amendment) 11/25/94 (59 FR 60555) Final
Action (Amendment) (Testing) 02/08/96 (61 FR 4822) Final Action
(Amendment) (Overindulgence) 12/00/01 Final Action (Amendment)(Sodium
B.) 06/00/02
Anthelmintic Products ANPRM 09/09/80 (45 FR 59541) NPRM 08/24/82 (47
FR 37062) Final Action 08/01/86 (51 FR 27756)
Antibiotic First Aid Products ANPRM 04/01/77 (42 FR 17642) NPRM 07/
09/82 (47 FR 29986) Final Action 12/11/87 (52 FR 47312) NPRM
(Amendment) 08/18/89 (54 FR 34188) Final Action 03/15/90 (55 FR
9721) NPRM (Amendment) 05/11/90 (55 FR 19868) NPRM (Amendment) 06/08/
90 (55 FR 23450) Final Action (Amendment) 10/03/90 (55 FR
40379) Final Action (Amendment) 12/05/90 (55 FR 50171) NPRM
(Amendment) (Warning) 02/14/96 (61 FR 5918) Final Action
(Amendment)(Warning) 11/15/96 (61 FR 58471)
Anticaries Products ANPRM 03/28/80 (45 FR 20666) NPRM 09/30/85 (50 FR
39854) NPRM 06/15/88 (53 FR 22430) Final Action 10/06/95 (60 FR
52474) Final Action (Technical Amendment) 10/07/96 (61 FR 52285)
Antidiarrheal Products ANPRM 03/21/75 (40 FR 12924) NPRM 04/30/86 (51
FR 16138) NPRM (Amendment)(Trav. Diar.) 12/00/01 Final Action 12/00/
01
Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts) ANPRM
01/05/82 (47 FR 444)
Antiemetic Products ANPRM 03/21/75 (40 FR 12934) NPRM 07/13/79 (44 FR
41064) Final Action 04/30/87 (52 FR 15886) NPRM (Amendment) 08/26/93
(58 FR 45216) Final Action 04/11/94 (59 FR 16981) NPRM
(Amendment)(Warning) 08/29/97 (62 FR 45767) Final Action (Amendment)
(Warning) 12/00/01
Antiflatulent Drug Products NPRM 11/12/73 (38 FR 31260) Final Action
06/04/74 (39 FR 19877) NPRM (Amendment) 01/29/88 (53 FR 2716) Final
Action (Amendment) 03/05/96 (61 FR 8836)
Antifungal (Topical) Products ANPRM 03/23/82 (47 FR 12480) NPRM 12/
12/89 (54 FR 51136) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25240) Final Action (Amdt.)(Diaper Rash) 12/18/92 (57 FR 60430) Final
Action (Partial) 09/02/93 (58 FR 46744) Final Action 09/23/93 (58 FR
49890) NPRM (Amendment) (Indications) 07/22/99 (64 FR 39452) Final
Action 08/29/00 (65 FR 52302) NPRM (Amendment) Clotrimazole 05/00/01
Antimicrobial Products ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25246) Final
Action (Diaper Rash) 03/00/04
Antiperspirant Products ANPRM 10/10/78 (43 FR 46694) NPRM 08/20/82
(47 FR 36492) Final Action 04/00/02
Aphrodisiac Products ANPRM 10/01/82 (47 FR 43572) NPRM 01/15/85 (50
FR 2168) Final Action 07/07/89 (54 FR 28780)
Astringent (Wet Dressings) Prdts (Merged w/other rulemkg) ANPRM 09/07/
82 (47 FR 39436)
Benign Prostatic Hypertrophy Products ANPRM 10/01/82 (47 FR
43566) NPRM 02/20/87 (52 FR 5406) Final Action 02/27/90 (55 FR 6926)
Boil Ointments ANPRM 06/29/82 (47 FR 28306) NPRM 01/26/88 (53 FR
2198) Final Action 11/15/93 (58 FR 60332)
Camphorated Oil Drug Products ANPRM 09/26/80 (45 FR 63869) Final
Action 09/21/82 (47 FR 41716)
Cholecystokinetic Products ANPRM 02/12/80 (45 FR 9286) NPRM 08/24/82
(47 FR 37068) Final Action 06/10/83 (48 FR 27004) NPRM (Amendment)
08/15/88 (53 FR 30786) Final Action (Amendment) 02/28/89 (54 FR 8320)
Corn and Callus Remover Products ANPRM 01/05/82 (47 FR 522) NPRM 02/
20/87 (52 FR 5412) Final Action 08/14/90 (55 FR 33258)
Cough/Cold (Anticholinergic) Products ANPRM 09/09/76 (41 FR
38312) NPRM 07/09/82 (47 FR 30002) Final Action 11/08/85 (50 FR
46582)
[[Page 25406]]
Cough/Cold (Antihistamine) Products ANPRM 09/09/76 (41 FR 38312) NPRM
01/15/85 (50 FR 2200) NPRM (Amendment) 08/24/87 (52 FR 31892) Final
Action 12/09/92 (57 FR 58356) Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216) NPRM (Amendment)(Warning) 08/29/97 (62 FR
45767) Reopen Record (Common Cold) 08/25/00 (65 FR 51780) Final
Action (Amendment)(Warning) 12/00/01 Final Action 12/00/02
Cough/Cold (Antitussive) Products ANPRM 09/09/76 (41 FR 38312) NPRM
10/19/83 (48 FR 48576) Final Action 08/12/87 (52 FR 30042) NPRM
(Amendment) (Warning) 07/06/89 (54 FR 28442) NPRM (Amendment) 10/02/89
(54 FR 40412) Final Action (Amendment) (Warning) 07/06/90 (55 FR
27806) Final Action (Amendment) 10/03/90 (55 FR 40381) NPRM
(Amendment)(Warning) 06/19/92 (57 FR 27666) NPRM
(Amendment)(Ingredients) 12/09/92 (57 FR 58378) Final Action
(Amendment)(Warning) 10/20/93 (58 FR 54232) Final Action
(Amdt.)(Ingredients) 06/03/94 (59 FR 29172) NPRM (Amendment)(Warning)
08/29/97 (62 FR 45767) NPRM (Amendment)(Flammability) 07/20/98 (63 FR
38762) Final Action (Amendment)(Flammability) 08/01/00 (65 FR
46864) Final Action (Amendment)(Warning) 12/00/01
Cough/Cold (Bronchodilator) Products ANPRM 09/09/76 (41 FR
38312) NPRM 10/26/82 (47 FR 47520) Final Action 10/02/86 (51 FR
35326) NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662) Final Action
(Amendment)(Warning) 10/20/93 (58 FR 54238) NPRM (Amendment)(MDI) 03/
09/95 (60 FR 13014) NPRM (Amendment)(Ephedrine) 07/27/95 (60 FR
38643) Final Action (Amendment) (MDI) 05/20/96 (61 FR 25142) Final
Action (Amendment) (Ephedrine) 12/00/01
Cough/Cold (Combination) Products ANPRM 09/09/76 (41 FR 38312) NPRM
08/12/88 (53 FR 30522) NPRM (Amendment)(DPH Combinations) 02/23/95 (60
FR 10286) Final Action (Theophylline) 07/27/95 (60 FR 38636) NPRM
(Amendment) (Ephedrine Combo) 12/00/01 Final Action 12/00/01
Cough/Cold (Diphenhydramine) Products Final Action/Enforcement Policy
04/09/96 (61 FR 15700)
Cough/Cold (Expectorant) Products ANPRM 09/09/76 (41 FR 38312) NPRM
07/09/82 (47 FR 30002) Final Action 02/28/89 (54 FR 8494) Final
Action (Technical Changes) 06/30/92 (57 FR 29176)
Cough/Cold (Expectorant/Ipecac) Products ANPRM 09/09/76 (41 FR
38312) NPRM 07/09/82 (47 FR 30002) Final Action 09/14/92 (57 FR
41857)
Cough/Cold (Nasal Decongestant) Products ANPRM 09/09/76 (41 FR
38312) NPRM 01/15/85 (50 FR 2220) NPRM (Amendment) 06/19/92 (57 FR
27658) Final Action 08/23/94 (59 FR 43386) Final Action; Partial Stay
03/08/96 (61 FR 9570) Final Action (Amendment)(Levmetamfetamine) 07/
30/98 (63 FR 40647) NPRM (Phenylpropanolamine) 06/00/01
Dandruff, Seborrheic Dermatitis and Psoriasis Control Products ANPRM
12/03/82 (47 FR 54646) NPRM 07/30/86 (51 FR 27346) Final Action 12/
04/91 (56 FR 63554) NPRM (Amendment) 04/05/93 (58 FR 17554) Final
Action 01/28/94 (59 FR 4000)
Daytime Sedatives ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/78 (43 FR
25544) Final Action 06/22/79 (44 FR 36378)
Diaper Rash Products (Merged w/other rulemkg) ANPRM 09/07/82 (47 FR
39406)
Digestive Aid Products ANPRM 01/05/82 (47 FR 454) NPRM 01/29/88 (53
FR 2706) Final Action 10/21/93 (58 FR 54450)
Eligibility Criteria for Additional Conditions ANPRM 10/03/96 (61 FR
51625) NPRM 12/20/99 (64 FR 71062) Final Action 06/00/01
Emetic Products ANPRM 03/21/75 (40 FR 12939) NPRM 09/05/78 (43 FR
39544)
Exocrine Pancreatic Insufficiency Products ANPRM 12/21/79 (44 FR
75666) NPRM 11/08/85 (50 FR 46594) NPRM (Reproposed) 07/15/91 (56 FR
32282) Final Action 04/24/95 (60 FR 20162)
External Analgesic Products ANPRM 12/04/79 (44 FR 69768) NPRM 02/08/
83 (48 FR 5852) NPRM (Amendment) (Dandruff) 07/30/86 (51 FR
27360) NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592) NPRM
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818) NPRM (Amendment) (Fvr
Blister/Ext) 01/31/90 (55 FR 3370) NPRM (Amendment) (1%Hydrocortisone)
02/27/90 (55 FR 6932) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25234) Final Action (Diaper Rash) 12/18/92 (57 FR 60426) NPRM
(Amendment)(Warning) 08/29/97 (62 FR 45767) Final Action
(Amendment)(Warning) 12/00/01
Fever Blister Products (Internal) ANPRM 01/05/82 (47 FR 502) NPRM 06/
17/85 (50 FR 25156) Final Action 06/30/92 (57 FR 29166)
First Aid Antiseptic ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Revised) 07/22/91 (56 FR 33644) Final Action 12/00/02
Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other
rulemkg) ANPRM 09/07/82 (47 FR 39436)
Hair Grower and Hair Loss Prevention Products ANPRM 11/07/80 (45 FR
73955) NPRM 01/15/85 (50 FR 2190) Final Action 07/07/89 (54 FR 28772)
Healthcare Antiseptic Products ANPRM 09/13/74 (39 FR 33103) NPRM 01/
06/78 (43 FR 1210) NPRM (Revised) 06/17/94 (59 FR 31402) Final Action
12/00/01
Hormone (Topical) Products ANPRM 01/05/82 (47 FR 430) NPRM 10/02/89
(54 FR 40618) Final Action 09/09/93 (58 FR 57608)
Hypo/Hyperphosphatemia Products ANPRM 12/09/80 (45 FR 81154) NPRM 01/
15/85 (50 FR 2160) Final Action 05/11/90 (55 FR 19852)
Ingrown Toenail Relief Products ANPRM 10/17/80 (45 FR 69128) NPRM 09/
03/82 (47 FR 39120) Final Action 09/09/93 (58 FR 47602) NPRM 12/00/01
Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg) ANPRM 09/
07/82 (47 FR 39412)
Insect Repellent Drug Products (Internal) ANPRM 01/05/82 (47 FR
424) NPRM 06/10/83 (48 FR 26986) Final Action 06/17/85 (50 FR 25170)
[[Page 25407]]
Internal Analgesic Products ANPRM 07/08/77 (42 FR 35346) NPRM 11/16/
88 (53 FR 46204) NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR
66762) NPRM 10/20/93 (58 FR 54224) NPRM (Amendment)(Sodium
Bicarbonate) 02/02/94 (59 FR 5068) NPRM (Prof. Labeling)(Acute MI) 06/
13/96 (61 FR 30002) NPRM (Amendment)(Alcohol Warning) 11/14/97 (62 FR
61041) Final Action (Alcohol Warning) 10/23/98 (63 FR 56789) Final
Action (Aspirin Prof. Label) 10/23/98 (63 FR 56802) NPRM
(Amendment)(Ibuprofen) 10/00/01 Final Action 12/00/01 Final Action
(Amendment)(Overindulgence) 12/00/01 Final Action (Sodium Bicarbonate)
06/00/02
Internal Deodorant Products ANPRM 01/05/82 (47 FR 512) NPRM 06/17/85
(50 FR 25162) Final Action 05/11/90 (55 FR 19862)
Labeling of Drug Products for OTC Human Use NPRM (Sodium Labeling) 04/
25/91 (56 FR 19222) NPRM 04/05/93 (58 FR 17553) Final Action 01/28/94
(59 FR 3998) NPRM (Do not mix drugs) 08/03/94 (59 FR 39499) NPRM
(Amendment) (Do not mix drugs) 10/04/95 (60 FR 52058) NPRM (Unless a
doctor tells you) 03/04/96 (61 FR 8450) Final Action (Sodium Labeling)
04/22/96 (61 FR 17798) NPRM (Calcium/Magnesium/Potassium) 04/22/96 (61
FR 17807) Withdrawal (Unless a doctor tells you) 02/27/97 (62 FR
9024) Final Action (Format/Examples) 03/17/99 (64 FR 13254) Final
Action (Technical Amendment) 01/03/00 (65 FR 7) Final Action (Ca/Mg/K/
Na) 07/00/01
Laxative Products ANPRM 03/21/75 (40 FR 12902) NPRM 01/15/85 (50 FR
2124) NPRM (Amendment) (Directions/Bulk) 10/01/86 (51 FR 35136) NPRM
(Amendment) (Docusate Salts) 09/02/93 (58 FR 46589) NPRM
(Amendment)(Sodium Phosphates) 03/31/94 (59 FR 15139) NPRM
(Phenolphthalein) 09/02/97 (62 FR 46223) Final Action (Sodium
Phosphates) 05/21/98 (63 FR 27836) NPRM (Amendment)(Phosphates Label)
05/21/98 (63 FR 27886) NPRM (Amendment)(Stim. Laxative) 06/19/98 (63
FR 33592) Final Action; stay (Na Phos. Enema) 12/07/98 (63 FR
67399) Part. With. (Na Phos. Prof. Lab.) 12/09/98 (63 FR 67817) Final
Action (Phenolphthalein) 01/29/99 (64 FR 4535) Final Action 01/00/
02 Final Action (Stim. Laxative) 12/00/03
Leg Muscle Cramps (Nocturnal Relief) Products ANPRM 10/01/82 (47 FR
43562) NPRM 11/08/85 (50 FR 46588) Final Action 08/22/94 (59 FR
43234)
Male Genital Desensitizer Products ANPRM 09/07/82 (47 FR 39412) NPRM
10/02/85 (50 FR 40260) Final Action 06/19/92 (57 FR 27654)
Menstrual Products ANPRM 12/07/82 (47 FR 55075) NPRM 11/16/88 (53 FR
46194) Final Action 12/00/01
Mercurial (Topical) Products (To be merged w/other rulemkg) ANPRM 01/
05/82 (47 FR 436)
NDA Labeling Exclusivity (Merged with other rulemaking) NPRM 11/09/93
(58 FR 59622)
Nailbiting/Thumbsucking Deterrent Products ANPRM 10/17/80 (45 FR
69122) NPRM 09/03/82 (47 FR 39096) Final Action 09/02/93 (58 FR
46749)
Nighttime Sleep Aid Products ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/
78 (43 FR 25544) Final Action 02/14/89 (54 FR 6814) NPRM (Amendment)
08/26/93 (58 FR 45217) Final Action (Amendment) 04/11/94 (59 FR
16982) NPRM (Amendment)(Warning) 08/29/97 (62 FR 45767) Final Action
(Amendment)(Warning) 12/00/01
Ophthalmic Products ANPRM 05/06/80 (45 FR 30002) NPRM 06/28/83 (48 FR
29788) Final Action 03/04/88 (53 FR 7076) Final Action (Anti-
infective) 12/18/92 (57 FR 60416) NPRM (Amendment) (Warning) 02/23/98
(63 FR 8888) Final Action 06/21/00 (65 FR 38426)
Oral Discomfort (Relief) Products ANPRM 05/25/82 (47 FR 22712) NPRM
09/24/91 (56 FR 48302) Final Action 06/00/02
Oral Health Care Products ANPRM 05/25/82 (47 FR 22760) NPRM 01/27/88
(53 FR 2436) NPRM (Amendment) (Antimicrobials) 02/09/94 (59 FR
6084) NPRM 04/00/01 ANPRM (Plaque/Gingivitis) 12/00/01
Oral Wound Healing Products ANPRM 11/02/79 (44 FR 63270) NPRM 07/26/
83 (48 FR 33984) Final Action 07/18/86 (51 FR 26112)
Otic Products (Dry Water-Clogged Ears) NPRM (Amendment) 08/17/99 (64
FR 44671) Final Action 08/10/00 (65 FR 48902)
Otic Products (Earwax) NPRM 07/09/82 (47 FR 30012) Final Action 08/
08/86 (51 FR 28656)
Otic Products (Swimmers Ear) NPRM 07/30/86 (51 FR 27366) Final Action
02/15/95 (60 FR 8916) Final Action Partial Stay 08/16/95 (60 FR 42435)
Overindulgence Remedies ANPRM 10/01/82 (47 FR 43540) NPRM 12/24/91
(56 FR 66742) Final Action 12/00/01
Overindulgence Remedies/Prevention of Inebriation ANPRM 10/01/82 (47
FR 43540) Final Action 07/19/83 (48 FR 32872)
Pediculicide Products ANPRM 06/29/82 (47 FR 28312) NPRM 04/03/89 (54
FR 13480) Final Action 12/14/93 (58 FR 65452) NPRM (Labeling
Amendment) 12/00/01
Phenylpropanolamine Products (Labeling) NPRM 02/14/96 (61 FR 3912)
Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg) ANPRM 09/07/
82 (47 FR 39412)
Poison Treatment Products NPRM 01/15/85 (50 FR 2244) Final Action 12/
00/01 NPRM (Amendment) 12/00/01
Quinine for Malaria NPRM 04/19/95 (60 FR 19650) Final Action 03/20/98
(63 FR 13526)
Salicylate (Reye Syndrome) NPRM (Amendment)(Warning) 05/05/93 (58 FR
26886) ANPRM 10/20/93 (58 FR 54228) Final Action (Warning) 12/00/01
Skin Bleaching Products ANPRM 11/03/78 (43 FR 51546) NPRM 09/03/82
(47 FR 39108) NPRM (Reproposed) 01/00/03
[[Page 25408]]
Skin Protectant Products ANPRM 08/04/78 (43 FR 34628) NPRM 02/15/83
(48 FR 6820) NPRM (Amendment) (Astringent) 04/03/89 (54 FR
13490) NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808) NPRM
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362) NPRM (Amendment)
(Diaper Rash) 06/20/90 (55 FR 25204) Final Action (Astringent) 10/21/
93 (58 FR 54466) Final Action (Witch Hazel) 06/03/94 (59 FR
28767) Final Action (Astringent) 07/00/01 Final Action (Poison Ivy)
07/00/01 Final Action 07/00/01
Smoking Deterrent Products ANPRM 01/05/82 (47 FR 490) NPRM 07/03/85
(50 FR 27552) Final Action 06/01/93 (58 FR 31236)
Status of Certain Category II and III Ingredients NPRM 05/16/90 (55 FR
20434) Final Action 11/07/90 (55 FR 46914) NPRM 08/25/92 (57 FR
38568) Final Action 05/10/93 (58 FR 27636) Final Action 04/22/98 (63
FR 19799) Final Action 08/24/98 (63 FR 44996) Final Action 12/00/01
Stimulant (Overindulgence) Products NPRM (Amendment) 12/24/91 (56 FR
66758) Final Action 12/00/01
Stimulant Products ANPRM 12/08/75 (40 FR 57292) NPRM 06/13/78 (43 FR
25544) Final Action 02/29/88 (53 FR 6100)
Stomach Acidifier Products ANPRM 10/19/79 (44 FR 60316) NPRM 01/15/85
(50 FR 2184) Final Action 08/17/88 (53 FR 31270)
Sunscreen Products ANPRM 08/25/78 (43 FR 38206) NPRM 05/12/93 (58 FR
28194) NPRM (Amendment) 06/08/94 (59 FR 29706) NPRM
(Amendment)(Avobenzone) 09/16/96 (61 FR 48645) Final Action
(Avobenzone Enf. Pol.) 04/30/97 (62 FR 23350) Final Action 05/21/99
(64 FR 27666) ANPRM (and Insect Repellant) 08/00/01 NPRM (UVA/UVB)
09/00/01
Sweet Spirits of Nitre ANPRM 02/22/80 (45 FR 11846) Final Action 06/
27/80 (45 FR 43400)
Topical Drug Products Containing Benzoyl Peroxide (Labeling) NPRM 02/
17/95 (60 FR 9554) Final Action 07/00/02
Vaginal Contraceptive Products ANPRM 12/12/80 (45 FR 82014) NPRM 02/
03/95 (60 FR 6892) NPRM (Amendment) 12/00/01
Vaginal Drug Products ANPRM 10/13/83 (48 FR 46694) Withdrawal 02/03/
95 (60 FR 5226) NPRM (Douches) 12/00/01
Vitamin/Mineral Products ANPRM 03/16/79 (44 FR 16126) Withdrawal 11/
27/81 (46 FR 57914)
Wart Remover Products ANPRM 10/03/80 (45 FR 65609) NPRM 09/03/82 (47
FR 39102) NPRM (Amendment) 03/27/87 (52 FR 9992) Final Action 08/14/
90 (55 FR 33246) NPRM (Amendment)(Directions) 01/28/94 (59 FR
4015) Final Action (Amdt.)(Directions) 11/23/94 (59 FR 60315)
Water Soluble Gums NPRM 10/30/90 (55 FR 45782) Final Action 08/26/93
(58 FR 45194) NPRM 01/00/02
Weight Control Products ANPRM 02/26/82 (47 FR 8466) NPRM 10/30/90 (55
FR 45788) Final Action 08/08/91 (56 FR 37792) NPRM
(Phenylpropanolamine) 06/00/01
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: 301 827-2222
RIN: 0910-AA01
_______________________________________________________________________
835. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR
SALE
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: This action may affect State, local or tribal
governments and the private sector.
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360d; 21 USC 371; 21
USC 360j(e)
CFR Citation: 21 CFR 801.420; 21 CFR 801.421
Legal Deadline: None
Abstract: FDA is considering revising its present regulation governing
the labeling and conditions for sale of hearing aids. The present rule
requires an examination by a physician before purchase of a hearing
aid, but permits an informed adult to waive that requirement. There is
some evidence that this waiver provision is being misused.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/10/93 58 FR 59695
ANPRM Comment Period End 01/10/94
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State
Federalism: This action may have federalism implications as defined in
EO 13132.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, HFZ-215,
Center for Devices and Radiological Health, 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 827-2974
RIN: 0910-AA39
_______________________________________________________________________
836. ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR DRUGS AND
BIOLOGICS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262
CFR Citation: 21 CFR 207
Legal Deadline: None
Abstract: The proposed rule would revise the regulations under part 207
to clarify the requirements for registration and listing and to
consolidate and reorganize the regulations. The proposal would also
require the electronic submission of establishment registration and
product listing information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department
of Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-
[[Page 25409]]
7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA49
_______________________________________________________________________
837. 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; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 371
CFR Citation: 21 CFR 312.110
Legal Deadline: None
Abstract: The proposed rule would amend the regulations on the
exportation of unapproved new drug products, including biological
products, for investigational use. In general, the proposed 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 recent changes in FDA's
export authority resulting from the FDA Export Reform and Enhancement
Act of 1996.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AA61
_______________________________________________________________________
838. SAFETY REPORTING AND RECORDKEEPING REQUIREMENTS FOR MARKETED OTC
DRUGS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 374; 21 USC 375; 21 USC 379; 42 USC
216; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC
358; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 201; 21 CFR 211; 21 CFR 327; 21 CFR 330
Legal Deadline: None
Abstract: The proposed rule would require manufacturers of marketed
nonprescription human drug products to report to FDA information they
receive about adverse drug reactions, maintain records of adverse drug
reactions, and permit access by FDA to adverse drug reaction records.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA86
_______________________________________________________________________
839. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL
PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42
USC 263; 42 USC 263a-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC
331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b-j; 21 USC
361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381
CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 600; 21 CFR
320; 21 CFR 601; 21 CFR 606
Legal Deadline: None
Abstract: 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 Harmonization and to define new terms; to
add to or revise current reporting requirements; to revise certain
reporting time frames; and to make other revisions to these regulations
to enhance the quality of safety reports received by FDA.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
[[Page 25410]]
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
840. RADIOACTIVE DRUGS FOR BASIC RESEARCH
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC
355; 21 USC 371; 42 USC 262
CFR Citation: 21 CFR 361
Legal Deadline: None
Abstract: The proposed rule would update FDA's regulations on the use
of radioactive drugs for basic research to reflect technological
changes in the field of radiopharmaceuticals. The proposed rule would
also clarify and correct certain provisions.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB00
_______________________________________________________________________
841. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND
GUIDELINES
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 15 USC 1451 to 1461; 42 USC 262; 42 USC 263b; 42 USC
264; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 321 to 394; 21 USC
467f; 21 USC 679; 21 USC 821; 21 USC 1034; 42 USC 201
CFR Citation: 21 CFR 10; 21 CFR 808
Legal Deadline: None
Abstract: This proposed rule would amend FDA regulations in 21 CFR part
10 concerning advisory opinions.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB14
_______________________________________________________________________
842. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLULAR
AND TISSUE-BASED PRODUCTS
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 263a; 42 USC 264; 42
USC 271
CFR Citation: 21 CFR 1271
Legal Deadline: None
Abstract: As part of implementing the proposed regulatory approach to
human cellular and tissue-based products, the Food and Drug
Administration (FDA) is proposing to require manufacturers of human
cells and tissue to follow current good tissue practice (GTP), which
includes proper handling, processing, and storage of human cells and
tissue, recordkeeping, and the maintenance of a quality program. FDA is
also proposing to amend the current good manufacturing practice
regulations that apply to medical device products and biological
products containing human cells or tissues in order to incorporate the
new GTP requirements into existing good manufacturing practice
regulations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/08/01 66 FR 1508
NPRM Comment Period End 05/08/01
Final Action 01/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
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
RIN: 0910-AB28
_______________________________________________________________________
843. 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; 21 USC 352; 21 USC
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 06/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy
[[Page 25411]]
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB34
_______________________________________________________________________
844. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 360bbb
CFR Citation: 21 CFR 312
Legal Deadline: None
Abstract: The proposed rule would revise the investigational new drug
regulations to clarify the conditions under which individual patients
may receive investigational drugs for treatment use; to clarify the
conditions under which a small group of patients may receive
investigational drugs for treatment use under an expanded access
protocol; and to clarify the criteria under which sponsors can recover
costs for providing investigational drugs to patients for certain
treatment uses.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Joseph Griffin, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, (HFD-40),
Center for Drug Evaluation and Research, 1451 Rockville Pike, Suite
6021, Rockville, MD 20852
Phone: 301 594-6758
Fax: 301 594-5298
RIN: 0910-AB37
_______________________________________________________________________
845. ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION REPORTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 216; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC
262; 21 USC 263; 21 USC 263a; 21 USC 264; 21 USC 300aa; 21 USC 321; 21
USC 331; 21 USC 251 to 353
CFR Citation: 21 CFR 20; 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 600
Legal Deadline: None
Abstract: The proposed rule would set forth requirements on the
electronic submission of adverse drug reaction reports using
international medical terminology, electronic data format, and
electronic transmission standards.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/05/98 63 FR 59746
ANPRM Comment Period End 02/03/99
NPRM 11/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB42
_______________________________________________________________________
846. DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING INSULIN
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC
374; 21 USC 379e; 42 USC 216; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The proposed rule would set forth a new system of distinctive
colors and marks to identify different types of insulin-containing drug
products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department
of Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB43
_______________________________________________________________________
847. PREGNANCY LABELING
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC
374; 21 USC 379e; 42 USC 216; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The proposed rule would revise the regulatory requirements
for the pregnancy labeling subsection of the labeling requirements for
human drugs and biologics.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
[[Page 25412]]
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB44
_______________________________________________________________________
848. 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: Positron emission tomography (PET) is a medical imaging
modality involving the use of a unique type of radiopharmaceutical
drug. PET drugs are usually injected intravenously into patients for
diagnostic purposes. Most PET drugs are produced using cyclotrons at
locations that are in close proximity to the patients to whom the drugs
are administered (e.g., in hospitals or academic institutions). Each
PET drug is compounded under a physician's prescription and, due to the
short half-lives of PET drugs, is administered to the patient within a
few minutes or hours.
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(the Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the
methods used in, or the facilities or controls used for, its
manufacture, processing, packing, or holding do not conform to or are
not operated or administered in conformity with current good
manufacturing practice (CGMP) to assure that the drug meets the
requirements of the Act as to safety and has the identity and strength,
and meets the quality and purity characteristics, that it purports or
is represented to possess. FDA's CGMP requirements for drug products
are set forth in 21 CFR parts 210 and 211.
On November 21, 1997, the President signed into law the Food and Drug
Administration Modernization Act (Modernization Act) (Pub. L. 105-115).
Section 121 of the Modernization Act contains several provisions
affecting the regulation of PET drugs. Section 121(c)(1)(A) of the
Modernization Act directs FDA to establish, within two years after
enactment, appropriate approval procedures and CGMP requirements for
PET drugs. Section 121(c)(1)(B) requires FDA to consult with patient
advocacy groups, professional associations, manufacturers, and other
interested persons as the agency develops PET drug CGMP requirements
and approval procedures. FDA's proposed rule on PET drug CGMP's will be
designed to reflect the unique nature of PET drug products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB63
_______________________________________________________________________
849. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360b; 21 USC 371; 21
USC 374
CFR Citation: 21 CFR 225
Legal Deadline: None
Abstract: This proposal is in response to a citizen petition request to
merge the separate requirements of the current good manufacturing
practice (CGMP) regulations, 21 CFR part 225 applicable to licensed and
unlicensed feed manufacturing facilities, respectively. The merger
would produce a single set of updated, streamlined CGMPs that apply to
all medicated feed manufacturers. This consolidation of existing CGMPs
would preserve and strengthen food safety, be more appropriate given
the changing structure of the medicated feed industry, and enhance
uniformity and enforcement.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: George Graber, Director, Division of Animal Feeds,
Department of Health and Human Services, Food and Drug Administration,
HFV-220, Center for Veterinary Medicine, 7500 Standish Place,
Rockville, MD 20855
Phone: 301 827-6651
Email: [email protected]
RIN: 0910-AB70
_______________________________________________________________________
850. FIXED-COMBINATION PRESCRIPTION AND OVER-THE-COUNTER DRUGS FOR HUMAN
USE
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC
360b; 21 USC 361; 21 USC 371
CFR Citation: 21 CFR 300.50; 21 CFR 330.10
Legal Deadline: None
Abstract: The proposed rule would amend 21 CFR 300.50 and 21 CFR
330.10(a)(4)(iv), which state the conditions under which two or more
drugs (for a prescription drug) or active ingredients (for an over-the-
counter drug) may be combined in a single dosage form. The proposed
rule would state how this provision will apply to products derived from
natural sources, including animal and botanical raw materials.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
[[Page 25413]]
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB79
_______________________________________________________________________
851. REPACKAGING APPROVAL REQUIREMENTS
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; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: The proposed rule would set forth requirements for FDA prior
approval of certain types of repackaging of approved drug products by
persons who are not holders of approved applications for the products.
The proposed rule would ensure that FDA approves changes to drug
product containers and closure systems by both application holders and
repackagers.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/00/02
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB81
_______________________________________________________________________
852. STABILITY TESTING OF DRUGS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: The proposed rule would specify required stability data that
must be submitted with new drug applications.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB82
_______________________________________________________________________
853. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING DIETARY SUPPLEMENTS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264
CFR Citation: 21 CFR 111
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) announced in an
advance notice of proposed rulemaking (ANPRM) of February 6, 1997 (62
FR 5700), its plans to consider developing regulations establishing
current good manufacturing practices (CGMP) for dietary supplements and
dietary ingredients. The ANPRM was published in order for FDA to
solicit comments on whether it should initiate action to establish CGMP
regulations and if so, what constitutes CGMP for these products. FDA
announced that this effort was in response to the section of the
Federal Food, Drug, and Cosmetic Act (the Act) that provides authority
to the Secretary of Health and Human Services to promulgate CGMP
regulations and to a submission from the dietary supplement industry
asking that FDA consider an industry-proposed CGMP framework as a basis
for CGMP regulations. The ANPRM also responds to concerns that such
regulations are necessary to ensure that consumers are provided with
dietary supplement products which have not been adulterated as a result
of manufacturing, packing, or holding; which have the identity and
provide the quantity of dietary ingredients declared in labeling; and
which meet the quality specifications that the supplements are
represented to meet.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 02/06/97 62 FR 5700
ANPRM Comment Period End 06/06/97
NPRM 06/00/01
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Karen Strauss, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, (HFS-820), 200
C Street SW, Washington, DC 20204
Phone: 202 205-4168
Fax: 202 205-5295
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
854. SUBMISSION IN ELECTRONIC FORMAT OF CERTAIN LABELING INFORMATION
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 350; 21 USC 351; 21 USC
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e; ...
[[Page 25414]]
CFR Citation: 21 CFR 314.50; 21 CFR 314.81; 21 CFR 314.94
Legal Deadline: None
Abstract: The Food and Drug Administration is proposing to amend its
regulations governing the format in which certain labeling in new drug
applications, abbreviated new drug applications, supplements, and
annual reports is required to be submitted. The proposal would require
that certain labeing content described under sections 201.56 and 201.57
be submitted to FDA in electronic format.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB91
_______________________________________________________________________
855. FEES RELATING TO DRUGS; WAIVER AND REDUCTION OF FEES
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 379g; 21 USC 379h
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: Sections 735 and 736 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. sections 379g and 379h) require FDA to assess and
collect fees related to human drug applications. Section 736(d) of the
Act (21 U.S.C. 379h(d)) authorizes the agency to grant a waiver or
reduction of such fees in certain circumstances. This proposed rule
would establish FDA's criteria for determining whether to grant a
waiver or reduction of fees.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB92
_______________________________________________________________________
856. PERIODIC TESTING FOR CERTAIN HUMAN DRUG, VETERINARY DRUG, AND
BIOLOGICAL PRODUCT FINAL SPECIFICATIONS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC
360(b); 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 211.165; 21 CFR 314; 21 CFR 514; 21 CFR 601; 21
CFR 610
Legal Deadline: None
Abstract: The proposed rule requests comments on when certain finished
product laboratory tests to determine satisfactory conformance to final
specifications for new human drug, animal drug, animal drugs and
biological products may be performed on a periodic basis.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB93
_______________________________________________________________________
857. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD
Priority: Routine and Frequent
Legal Authority: 21 USC 331; 21 USC 333; 21 USC 334; 21 USC 335b; 21
USC 335c; 21 USC 342; 21 USC 343; 21 USC 351; 21 USC 352; 21 USC 361;
21 USC 362; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381
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
might include recordkeeping requirements to ensure that the correct
sample is collected and analyzed, and a notification requirement if a
person intends to use a private laboratory in connection with imported
food. The proposed rule is intended to help insure the integrity and
scientific validity of data and results submitted to FDA.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: Undetermined
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
[[Page 25415]]
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB96
_______________________________________________________________________
858. MEDICAL DEVICES, MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND
LISTING REQUIREMENTS; AMENDMENT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC
360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: FDA is considering revising its present establishment
registration and device listing regulations. More particularly, FDA is
considering whether to: (1) merge establishment registration and device
listing into a single system and single reporting form; (2) encourage
the electronic submission of the establishment registration and device
listing information; (3) require premarket submission application
numbers; (4) amend time frames for providing and updating registration
and listing data; and (5) require notification of transfer of ownership
for all premarket applications.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Bryan H. Benesch, Special Assistant to the Director,
Office of Compliance, Department of Health and Human Services, Food and
Drug Administration, HFZ-300, Center for Devices and Radiological
Health, 2094 Gaither Road, Rockville, MD 20850
Phone: 301 549-4699
Fax: 301 594-4715
Email: [email protected]
RIN: 0910-AB99
_______________________________________________________________________
859. AVAILABILITY FOR PUBLIC DISCLOSURE AND SUBMISSION TO FDA FOR PUBLIC
DISCLOSURE OF CERTAIN DATA AND INFORMATION RELATED TO GENE THERAPY OR
XENOTRANSPLANTATION
Priority: Other Significant
Legal Authority: 5 USC 552; 21 USC 331(j); 18 USC 1905; 21 USC 355(i);
21 USC 371(a); 42 USC 264
CFR Citation: 21 CFR 20.100; 21 CFR 312.42; 21 CFR 312.130; 21 CFR
601.50; 21 CFR 601.51; 21 CFR 601.52; 21 CFR 601.53
Legal Deadline: None
Abstract: The proposed regulation would require sponsors of human
trials involving human gene therapy or xenotransplantation to submit a
redacted version for public disclosure of an investigational new drug
application (IND), an amendment to an IND, or other related documents.
The submission would be redacted to exclude trade secret information
and personal information, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy. FDA would then make
the redacted documents available to the general public and the
information would be able to be discussed in open session at scientific
advisory committee meetings and at other suitable fora.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/18/01 66 FR 4688
NPRM Comment Period End 04/18/01
Final Action 02/00/02
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Steven F. Falter, Director, Regulations and Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 200N (HFM-17), Center for Biologics Evaluation
and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Email: [email protected]
RIN: 0910-AC00
_______________________________________________________________________
860. REPORTING INFORMATION REGARDING POTENTIAL FABRICATION OR
FALSIFICATION OF DATA
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 349; 21 USC
352; 21 USC 355i; 21 USC 360b; 21 USC 360c; 21 USC 360e; 21 USC 360i;
21 USC 360j; 21 USC 360k; 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 06/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC02
_______________________________________________________________________
861. STATUS REPORTS FOR QUANTITY MARKETED INFORMATION FOR ANIMAL DRUG
PRODUCTS USED IN FOOD-PRODUCING ANIMALS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 524
Legal Deadline: None
Abstract: After approving a new animal drug application, the Food and
Drug Administration (FDA) requires the
[[Page 25416]]
sponsor to submit adverse experience and use information on the
product. The currently submitted distribution data are insufficient to
provide the use information needed by FDA. Because of concern about the
effect of the use of antimicrobial drugs in food-producing animals on
the development rate and extent of resistance in human pathogens, FDA
published a document describing a proposed framework for evaluating and
protecting human health. The Framework Document describes the need for
more detailed drug distribution information to permit the evaluation of
a correlation between changes in resistance and the use of
antimicrobial drugs in food-producing animals. The regulatory proposal
would require the reporting of the total number of distributed units of
each size, strength, or potency (distribution data or quantity marketed
data) and provide FDA with the more detailed information needed to
assess the correlation between resistance in human pathogens and the
use of antimicrobial drugs in food-producing animals.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/00/02
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: William Keller, Division Director, Division of
Surveillance, Department of Health and Human Services, Food and Drug
Administration, (HFV-210), Center for Veterinary Medicine, 7500
Standish Place, Rockville, MD 20855
Phone: 301 827-6642
RIN: 0910-AC04
_______________________________________________________________________
862. LABELING DIETARY SUPPLEMENTS FOR WOMEN WHO ARE OR MAY BECOME
PREGNANT
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321(n); 21 USC 342(f); 21 USC 343(a)(1); 21 USC
343(r)(6); 21 USC 371(a)
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to
require manufacturers to label their dietary supplements with a caution
statement for women who are or may become pregnant unless there is
evidence demonstrating that use in pregnancy is safe. FDA is including
in this proposal a list of products that would not require this caution
statement, as well as a petition process by which a product may be
exempted from bearing the caution statement. FDA is also proposing to
regulate manufacturers of dietary supplements that bear a claim about
an effect on a condition associated with pregnancy to maintain and
permit FDA inspection of certain records. FDA is proposing this rule
because of the special safety concerns associated with use of any
product during pregnancy.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AC09
_______________________________________________________________________
863. OVERWRAP FOR INHALATION PRODUCTS PACKAGED IN LOW DENSITY
POLYETHYLENE (LDPE) CONTAINERS
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; 21 USC 352; 21 USC
353; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 375
CFR Citation: 21 CFR 200
Legal Deadline: None
Abstract: The proposed rule would require overwrap on all inhalation
products packaged in low density polyethylene (LDPE) containers to
prevent ingress of contaminates.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC10
_______________________________________________________________________
864. REGULATION OF CARCINOGENIC COMPOUNDS USED IN FOOD-PRODUCING
ANIMALS; DEFINITION OF ``NO RESIDUE''
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC
348; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360b; 21 USC 371
CFR Citation: 21 CFR 500.82; 21 CFR 500.84; 21 CFR 500.88
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) is proposing to amend
its regulations relating to the operational definition of the term ``no
residue.'' The definition is used in determining whether any residue of
carcinogenic compounds used in food-producing animals would ``be found
in food produced from those animals under conditions of use reasonably
certain to be followed in practice'' (21 CFR 500.80(a)). Under the
current operational definition of no residue, it is possible for a
residue detected by a method approved by FDA to be considered ``no
residue.'' FDA is revising its regulations to make them consistent with
a 1995 Department of Justice opinion regarding this definition. The
proposed changes would revise the definition of ``no residue'' to mean
that no residue is detected with an approved regulatory method. FDA
would propose several conditions that sponsors of
[[Page 25417]]
carcinogenic compounds must satisfy with respect to the sponsors'
proposed regulatory methods.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Steven Brynes, Regulatory Scientist, Department of
Health and Human Services, Food and Drug Administration, HFV-151,
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD
20855
Phone: 301 827-6975
Email: [email protected]
RIN: 0910-AC13
_______________________________________________________________________
865. CONTROL OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION
AND RETAIL
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 264; 42 USC 343; 42 USC 264; 42 USC 271
CFR Citation: 21 CFR 116; 21 CFR 118
Legal Deadline: None
Abstract: The President's Council on Food Safety was established in
August 1998 to improve the safety of the food supply through science-
based regulations and well-coordinated inspection, enforcement,
research, and education programs. The Council has identified egg safety
as one component of the public health issue of food safety that
warrants immediate Federal, interagency action.
In July 1999, FDA and 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 by the
President 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), and April 6, 2000 (Sacramento, CA),
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 an
SE risk reduction plan that is designed to prevent transovarian SE from
contaminating eggs at the farm during production.
Because egg safety is a farm-to-table effort, FDA intends to include in
its proposal certain provisions of the 1999 Food Code that are relevant
to how eggs are handled, prepared, and served at retail establishments.
In addition, the agency intends to propose specific requirements for
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 06/00/01
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, 200 C Street SW.,
Washington, DC 20204
Phone: 202 205-4081
Fax: 202 205-4422
Email: [email protected]
Nancy Bufano, Consumer Safety Officer, Department of Health and Human
Services, Food and Drug Administration, HFS-306, Center for Food Safety
and Applied Nutrition, 200 C Street SW., Washington, DC 20204
Phone: 202 401-2022
Fax: 202 205-4422
Email: [email protected]
RIN: 0910-AC14
_______________________________________________________________________
866. ALUMINUM IN LARGE AND SMALL VOLUME PARENTERALS USED IN
TOTAL PARENTERAL NUTRITION
Priority: Other Significant
Legal Authority: 21 USC 352; 21 USC 321(n); 21 USC 371(a); 21 CFR
201.51; 21 CFR 201.100; 21 CFR 314.125
CFR Citation: 21 CFR 201.323(c)
Legal Deadline: None
Abstract: The proposed rule would revise 21 CFR 323(c) to permit small
volume parenterals and pharmacy bulk packages that contain less than 25
ug/L of aluminum to state ``contains less than 25ug/L'' rather than the
exact amount of aluminum.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC18
_______________________________________________________________________
867. USE OF MATERIALS DERIVED FROM RUMINANT ANIMALS IN FDA
REGULATED PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: Not Yet Determined
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The U.S. Department of Agriculture's Animal and Plant Health
Inspection Service maintains, by regulation in 9 CFR 94.18(a), a list
of countries: (1) where bovine spongiform encephalopathy (BSE) exists;
and (2) that present an undue risk of introducing BSE into the United
States. This proposed rule would restrict, in FDA regulated products,
the use of
[[Page 25418]]
most materials derived from ruminant animals born, raised, or
slaughtered in a country listed in 9 CFR 94.18(a). In addition, there
would be a waiver provision that could be used under appropriate
criteria.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC19
_______________________________________________________________________
868. POSTMARKETING REPORTS OF SUBSTANDARD OR INEFFECTIVE BULK
INGREDIENTS AND BULK INGREDIENTS FROM UNAPPROVED SOURCES
Priority: Info./Admin./Other
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The proposed rule would address reporting and other issues
relating to the importation or receipt of bulk ingredients that are
substandard, ineffective, or come from unapproved sources. The proposal
is intended to enhance FDA's ability to help ensure that human drug
products have the strength, quality, and purity appropriate for an
approved human drug product.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AC20
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
869. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT (GADPTRA)
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 360b; 21
USC 371; 21 USC 379e; 21 USC 381
CFR Citation: 21 CFR 514
Legal Deadline: Final, Statutory, November 16, 1989, The deadline
applies to the GADPTRA sections. There is no deadline relating to the
other sections.
Abstract: On December 17, 1991, the Agency published a proposed
revision of the existing regulations that is consistent with the
current procedural regulations for human drugs, where appropriate. The
New Animal Drug Application (NADA) revisions articulate general
requirements in regulations containing performance standards and would
complement these regulations through detailed guidance on, among other
matters, appropriate ways of meeting requirements for submission of
chemistry, pharmacology, and statistical data that would better address
the intricate scientific issues involved. A separate proposed rule for
reporting requirements for marketed animal drugs also was published on
that date. The agency intends to repropose the NADA proposed rule to
incorporate some recent changes in procedure. The NADA revisions are
expected to include regulations to implement the provisions of the
Animal Drug Availability Act of 1996, specifically the definition of
flexible labeling, and implement parts of the President's National
Performance Report ``Reinventing the Regulation of Animal Drugs,'' May
1996. In the reinventing regulations report, FDA proposed to revise its
regulations to reflect numerous new process changes and programs that
will maintain the safety and effectiveness of new animal drugs and
enable a more streamlined animal drug application review and approval
process which will result in less regulatory burden upon industry and
FDA. The Agency also proposes to amend its regulations to implement
title I of the Generic Animal Drug and Patent Term Restoration Act,
which established new standards for marketing approval of generic
copies of animal drugs approved after 1962.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/21/96 61 FR 59209
ANPRM Comment Period End 01/21/97
New Animal Drug Approval Process NPRM 12/17/91 (56 FR 65544) NPRM To
Be Determined
Records and Reports Concerning Experience with Approved New Animal
Drugs NPRM 12/17/91 (56 FR 65581) Final Action 05/00/01
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: For information concerning reporting
requirements for marketed animal drugs, contact William C. Keller,
Director, Division of Surveillance, Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855,
301 827-6642.
For further information concerning generic animal drugs, contact Lonnie
W. Luther, Chief, Quality Assurance
[[Page 25419]]
Support Team, Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, 301 827-0209.
Agency Contact: Claire Lathers, Director, Office of New Animal Drug
Evaluation, Department of Health and Human Services, Food and Drug
Administration, HFV-100, Center for Veterinary Medicine, 7500 Standish
Place, Rockville, MD 20855
Phone: 301 594-1620
RIN: 0910-AA02
_______________________________________________________________________
870. CURRENT GOOD MANUFACTURING PRACTICE; AMENDMENT OF CERTAIN
REQUIREMENTS FOR FINISHED PHARMACEUTICALS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 351 to 352; 21 USC 355; 21 USC
360b; 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 210.3; 21 CFR 211.113; 21 CFR 211.160; 21 CFR
211.165; 21 CFR 211.166; 21 CFR 211.180; 21 CFR 211.192; 21 CFR
211.220; 21 CFR 211.222; 21 CFR 211.240; 21 CFR 211.22; 21 CFR 211.68;
21 CFR 211.82; 21 CFR 211.84; 21 CFR 211.101; 21 CFR 211.103; 21 CFR
211.110; 21 CFR 211.111; ...
Legal Deadline: None
Abstract: FDA is finalizing revisions to the current good manufacturing
practice (CGMP) regulations at 21 CFR parts 210 and 211 regarding
finished pharmaceuticals. The new regulations codify certain current
agency policies or current industry practices. In addition, among other
things, the rule will create or clarify requirements for process and
methods validation, appropriate laboratory testing procedures, and
protection against contamination. The rule is designed to update the
CGMP regulations in response to technological changes and the agency's
experience with the regulations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/03/96 61 FR 20104
NPRM Comment Period End 09/30/96
Final Action 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department
of Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA45
_______________________________________________________________________
871. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC
371
CFR Citation: 21 CFR 320
Legal Deadline: None
Abstract: The final rule revises and clarifies certain sections of
parts 314 and 320 and eliminates duplication and inconsistencies.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/19/98 63 FR 64222
NPRM Comment Period End 02/02/99
Final Action 07/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA51
_______________________________________________________________________
872. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC
374; 21 USC 379e; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 42 USC 216; 42 USC 241;
42 USC 262; 42 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The proposed regulation would amend the regulations governing
the format and content of professional labeling for human prescription
drug and biologic products, 21 CFR 201.56 and 201.57. The proposal
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. The proposal
would also eliminate certain unnecessary statements that are currently
required to appear on prescription drug labels and move certain
information to professional labeling.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/22/00 65 FR 81082
Final Action 02/00/02
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Nancy M. Ostrove, Division of Drug Marketing, Advertising, and
Communications, Department of Health and Human Services, Food and Drug
Administration, (HFD-42), Center for Drug Evaluation and Research, 5600
Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
RIN: 0910-AA94
[[Page 25420]]
_______________________________________________________________________
873. CURRENT GOOD MANUFACTURING PRACTICE; REVISION OF CERTAIN LABELING
CONTROLS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC
360b; 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 210; 21 CFR 211
Legal Deadline: None
Abstract: The final rule amends the labeling control provisions in the
current good manufacturing practice regulations to make the provisions
less burdensome while still reducing the frequency of drug product
mislabeling and drug product recalls associated with cut labeling.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/29/97 62 FR 40489
NPRM Comment Period End 10/27/97
Final Action 10/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department
of Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA98
_______________________________________________________________________
874. USE OF OZONE-DEPLETING SUBSTANCES
Priority: Other Significant
Legal Authority: 15 USC 402; 21 USC 352; 21 USC 355; 21 USC 360b; 21
USC 361; 21 USC 371; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 335; 21
USC 342; 21 USC 346a; 21 USC 348; 21 USC 351
CFR Citation: 21 CFR 2
Legal Deadline: None
Abstract: FDA is amending the regulation that permits the use of ozone-
depleting substances in particular circumstances to set the standard
FDA will use to determine when the use of ozone-depleting substances
(ODS) is no longer essential under the Clean Air Act (CAA) and set a
new standard to determine when a new essential-use designation should
be granted after the effective date of the rule. FDA is also amending
the regulations to better conform to other statutes and regulations
relating to ozone-depleting substances to eliminate potential confusion
and conflicts. FDA is eliminating out-of-date transitional provisions
and making other nonsubstantive housekeeping changes to its regulations
on ozone-depleting substances. The intended effect of the rule is to
protect the health and safety of medical product users while complying
with the CAA and the Montreal Protocol.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 03/06/97 62 FR 10242
ANPRM Comment Period End 05/05/97
NPRM 09/01/99 64 FR 47719
NPRM Comment Period End 11/30/99
Final Action 05/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AA99
_______________________________________________________________________
875. EXPORTS; NOTIFICATION AND RECORDKEEPING REQUIREMENTS
Priority: Routine and Frequent
Legal Authority: 15 USC 1453 to 1455; 21 USC 382; 21 USC 393; 42 USC
216; 42 USC 241; 42 USC 243; 42 USC 262; 21 USC 321; 21 USC 343; 21 USC
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 381
CFR Citation: 21 CFR 1.101
Legal Deadline: None
Abstract: The final rule would establish the notification recordkeeping
requirements for persons exporting human drugs, animal drugs,
biological products, and devices under the FDA Export Reform and
Enhancement Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/02/99 64 FR 15944
Extension 06/17/99 64 FR 32442
NPRM Comment Period End 07/16/99
Final Action 06/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB16
_______________________________________________________________________
876. FOREIGN ESTABLISHMENT REGISTRATION AND LISTING
Priority: Routine and Frequent
Legal Authority: 21 USC 321; 21 USC 374; 42 USC 216; 42 USC 262; 21 USC
331; 21 USC 352; 21 USC 355; 21 USC 360; 21 USC 360b to 360c; 21 USC
360e; 21 USC 360i to 360j; 21 USC 371
CFR Citation: 21 CFR 207; 21 CFR 607; 21 CFR 807
Legal Deadline: None
Abstract: The final rule would amend the establishment registration and
product listing regulations for human drugs, biological products,
animal drugs, and devices to require foreign establishments engaged in
the manufacture, preparation, propagation, compounding, or processing
of such products that are imported or offered for import into the
United States to register and to register the name of a United States
agent for the foreign establishment.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/14/99 64 FR 26330
NPRM Comment Period Reopen 08/09/99
NPRM Comment Period End 10/08/99
Final Action 06/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
[[Page 25421]]
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB21
_______________________________________________________________________
877. FDA EXPORT REFORM AND ENHANCEMENT ACT OF 1996; REPORTING AND
RECORDKEEPING REQUIREMENTS FOR UNAPPROVED OR VIOLATIVE PRODUCTS IMPORTED
FOR FURTHER PROCESSING OR INCORPORATION AND LATER EXPORT
Priority: Substantive, Nonsignificant
Legal Authority: 15 USC 1453 to 1455; 21 USC 381; 21 USC 382; 21 USC
393; 42 USC 216; 21 USC 321; 21 USC 343; 21 USC 352; 21 USC 355; 21 USC
360b; 21 USC 362; 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 1.84
Legal Deadline: None
Abstract: The final rule would establish reporting and recordkeeping
requirements to implement sections 801(d)(3) and 801(d)(4) of the
Federal Food, Drug, and Cosmetic Act (the Act) as amended by the Food
and Drug Administration (FDA) Export Reform and Enhancement Act of
1996. Section 801(d)(3) of the Act provides that, under prescribed
conditions, drug and device components, food and color additives, and
dietary supplements may be imported if they are to be further processed
or incorporated into products that are to be exported from the United
States in accordance with sections 801(e) or 802 of the Act or section
351(h) of the Public Health Service (PHS) Act. Section 801(d)(4) of the
Act provides that blood, blood components, source plasma, or source
leukocytes, or a component, accessory, or part thereof, may not be
imported under section 801(d)(3) of the Act unless the importation
complies with section 351(a) of the PHS Act or FDA permits the
importation under FDA-determined appropriate circumstances and
conditions. Additionally, section 801(d)(4) of the Act prohibits the
importation of tissue or a component or part of tissue under section
801(d)(3) of the Act unless the importation complies with section 361
of the PHS Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/24/98 63 FR 64930
NPRM Comment Period End 02/08/99
Final Action 09/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB24
_______________________________________________________________________
878. BLOOD INITIATIVE
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
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 640; 21 CFR 660; 21 CFR 680
Legal Deadline: None
Abstract: In multiple rulemakings, the Food and Drug Administration is
amending the biologics regulations by removing, revising, or updating
specific regulations applicable to blood, blood components, Source
Plasma and blood derivative products to be more consistent with current
practices and to remove unnecessary or outdated requirements. This
action is based on a comprehensive review of the regulations that has
been performed by FDA. 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; the Institute of Medicine, as well as public
comments. Some of the subjects intended to be addressed in the
rulemakings include: 1) labeling; 2) notification of consignees and end
users of product safety information for plasma derivative products; 3)
notification of deferred donors; 4) requirements for donor suitability
and testing; and 5) infectious agent clearance. These actions are
intended to help ensure the continued safety of the Nation's blood
supply.
Timetable:
________________________________________________________________________
Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin
(Human); Rev. of Reqs. Direct Final Rule 05/14/99 (64 FR 26282) NPRM
05/14/99 (64 FR 26344) DFR: Confirmation in Part and Tech. Amendment
03/14/00 (65 FR 13678) Final Action 08/28/00 (65 FR 52016)
Current Good Manufacturing Practice for Blood and Blood Components;
Blood Labeling Standards NPRM 12/00/01
Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives;
Notification of Deferred Donors NPRM 08/19/99 (64 FR 45355) Final
Action 05/00/01
Infectious Agent Clearance NPRM 06/00/02
Plasma Derivatives and Other Blood-Derived Products; Reqs. for Tracking
and Notification ANPRM 08/19/99 (64 FR 45383) NPRM 06/00/02
Reqs. for Testing Human Blood Donors for Evid. of Infection Due to
Communicable Disease Agents NPRM 08/19/99 (64 FR 45340) Final Action
05/00/01
Rev. to the Requirements Applicable to Blood, Blood Components, and
Source Plasma Direct Final Rule 08/19/99 (64 FR 45366) NPRM 08/19/99
(64 FR 45375) Final Action 05/00/01
Suitability Reqs. for Whole Blood and Source Plasma Donors NPRM 12/00/
01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: See RIN 0910-AB76. CGMP for Blood and Blood
Components; Blood Labeling Standards formerly listed under 0910-AB89
Agency Contact: Steven F. Falter, Director, Regulations and Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 200N (HFM-17), Center for Biologics Evaluation
and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
[[Page 25422]]
Email: [email protected]
RIN: 0910-AB26
_______________________________________________________________________
879. ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 125
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: The final rule would implement the incorporation of
antibiotics, which were formerly regulated under authority of section
507 of the Federal Food, Drug, and Cosmetic Act, into the new drug
regulatory scheme under section 505 of the Act. The regulation will
describe which antibiotics are excepted under section 125(d) of the
Food and Drug Administration Modernization Act of 1997 from certain
provisions in section 505, including the exclusivity provisions under
sections 505(c) and 505(j) of the Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/24/00 65 FR 3623
NPRM Comment Period End 04/24/00
Final Action 10/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Paul C. Varki, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037, (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Email: [email protected]
RIN: 0910-AB33
_______________________________________________________________________
880. AMENDMENT OF REGULATIONS REGARDING CERTAIN LABEL STATEMENTS ON
PRESCRIPTION DRUGS
Priority: Substantive, Nonsignificant
Legal Authority: PL 105-115, sec 126
CFR Citation: 21 CFR 201; 21 CFR 250; 21 CFR 310; 21 CFR 329; 21 CFR
361; 21 CFR 369; 21 CFR 290
Legal Deadline: None
Abstract: This final rule revises 21 CFR parts 10, 201, 250, 310, 329,
361, 606, and 610 by removing the requirement that prescription drugs
be labeled ``Caution: Federal law prohibits dispensing without
prescription'' and substituting a requirement that prescription drugs
be labeled ``Rx only.'' The rule also revises 21 CFR parts 201, 329,
and 369 by removing the requirement that certain habit-forming drugs
bear the statement ``Warning--May be habit forming.'' The rule also
revises 21 CFR part 290 to clarify that drugs that are controlled
substances under the Federal Controlled Substances Act are prescription
drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/21/00 65 FR 21378
Final Action 08/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB39
_______________________________________________________________________
881. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG
APPLICATIONS
Priority: Other Significant
Legal Authority: 21 USC 356a
CFR Citation: 21 CFR 514.8
Legal Deadline: None
Abstract: Section 116 of the Food and Drug Administration Modernization
Act of 1997 added a new section to the Federal Food, Drug, and Cosmetic
Act that sets forth categories for the reporting of manufacturing
changes to a drug product (21 U.S.C. 356a). These categories are based
on the potential of the change to adversely affect the identity,
strength, quality, purity, and potency of the drug as they may relate
to the safety and effectiveness of the drug. The rulemaking will
establish the procedures for determining what information the agency
would require before drugs manufactured subject to these changes may be
distributed. The Center for Veterinary Medicine is amending the
regulations regarding supplementary new animal drug regulations to
incorporate the requirements of section 116.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/01/99 64 FR 53281
Final Rule 12/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: William Marnane, Director, Division of Manufacturing
Technologies, Department of Health and Human Services, Food and Drug
Administration, HFV-140, Center for Veterinary Medicine, 7500 Standish
Place, Rockville, MD 20855
Phone: 301 827-6966
RIN: 0910-AB49
_______________________________________________________________________
882. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL
PRODUCTS; DIRECT FINAL RULE
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 351
CFR Citation: 21 CFR 610.11(g)
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) issued a direct final
rule and companion proposed rule to amend the biologics regulations by
adding ``cellular therapy products'' to the list of products excepted
from the general safety test (GST) and by adding an administrative
procedure for obtaining an exemption from the GST requirements for
other biological products. Because the agency received significant
adverse comment on the administrative procedure portion of the direct
final rule, FDA withdrew that portion of the rule and confirmed the
remaining portion. FDA intends to finalize the companion proposed rule
to respond to the significant adverse comment on the administrative
procedure portion of the rule. FDA is taking this action because the
GST may not be relevant or necessary for all biological products,
including cellular therapy products, currently in various
[[Page 25423]]
stages of development. This action is part of FDA's continuing effort
to achieve the objectives of the ``Reinventing Government'' initiative,
and is intended to reduce the burden of unnecessary regulations on
biological products without diminishing the protection of the public
health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 04/20/98 63 FR 19399
Proposed Rule - Companion
Document to Direct Final Rule 04/20/98 63 FR 19431
Direct Final Rule Confirmation
in Part 08/05/98 63 FR 41718
Direct Final Rule Withdrawn in
Part 08/05/98 63 FR 41718
Final Action 10/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Stephen M. Ripley, Team Leader, 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
RIN: 0910-AB51
_______________________________________________________________________
883. DISCONTINUATION OF A LIFESAVING PRODUCT
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 356(c)
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: Section 131 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 506C to the Food, Drug, and
Cosmetic Act (21 U.S.C. 356c). This proposed rule would set forth
requirements on issues related to the implementation of section 131,
which requires that the sole manufacturer of certain drug products
notify the Secretary of the discontinuance of the manufacture of the
product at least six months prior to the discontinuance of the drug.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/07/00 65 FR 66665
Final Action 06/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB60
_______________________________________________________________________
884. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION
Priority: Other Significant
Legal Authority: 21 USC 356a
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: Section 116 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 506A to the Food, Drug, and
Cosmetic Act (21 U.S.C. 356a). Pursuant to section 116, the rulemaking
will revise current procedures for approving manufacturing changes and
generally classify such changes into four categories. Major
manufacturing changes, which are of a type determined by the Secretary
to have a substantial potential to adversely affect the identity,
strength, quality, purity, and potency of the drug as they may relate
to the safety and effectiveness of a drug, require prior approval of a
supplemental application. A second category of changes may be made if
FDA has not notified the company within 30 days after the submission of
a supplement that prior approval is required. A third category of
changes may be made upon submission of a supplement to the agency. The
rule will also identify another category of changes that may be made
without the submission of a supplement but which must be reported in an
annual report.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/28/99 64 FR 34608
Final Action 10/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department
of Health and Human Services, Food and Drug Administration, Suite 3037
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB61
_______________________________________________________________________
885. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT
CONTENT CLAIMS, AND HEALTH CLAIMS
Priority: Economically Significant. Major under 5 USC 801.
Unfunded Mandates: This action may affect the private sector under PL
104-4.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC
348; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act,
which was added by the Nutrition Labeling and Education Act of 1990,
requires that the label or labeling of food products bear nutrition
information. Among other things, section 403(q) authorizes the Food and
Drug Administration (FDA) to add or delete nutrients that are to be
declared on the labels or labeling of food products by regulation if it
finds such action necessary to assist consumers in maintaining healthy
dietary practices. FDA issued final regulations implementing these
provisions in 1993. FDA subsequently received a citizen petition
requesting that FDA amend its regulations on food labeling to require
that the amount of trans fatty acids be listed in the nutrition label
and be limited wherever saturated fat limits are placed on nutrient
content claims, health claims, or disqualifying levels and disclosure
levels. In response to this petition and based on new evidence, FDA
proposed the actions requested in the petition on November 17, 1999 (64
FR 62746). In addition, FDA proposed to define the claim ``trans fat
free.''
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/17/99 64 FR 62746
[[Page 25424]]
NPRM Comment Period Reopened 12/05/00 65 FR 75887
Final Rule 09/00/01
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Susan Thompson, Chemist, Department of Health and Human
Services, Food and Drug Administration, (HFS-832), Center for Food
Safety and Applied, Nutrition, 200 C Street SW, Washington, DC 20204
Phone: 202 205-5587
Email: [email protected]
RIN: 0910-AB66
_______________________________________________________________________
886. PRESUBMISSION CONFERENCES
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 514
Legal Deadline: None
Abstract: This rule will implement section 512(b)(3) of the Federal
Food, Drug, and Cosmetic Act (the Act). This section of the Act states
that any person intending to file a new animal drug application or
supplemental new animal drug application, or to investigate a new
animal drug is entitled to one or more conferences with the agency
prior to submission to reach an agreement establishing a submission or
investigational requirement. This rule would describe how to request a
presubmission conference and describe the procedures for the conduct of
presubmission conferences.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/25/00 65 FR 51782
Final Rule 09/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Gail Schmerfeld, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, HFV-100,
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD
20855
Phone: 301 594-1620
RIN: 0910-AB68
_______________________________________________________________________
887. SURGEON'S AND PATIENT EXAMINATION GLOVES; RECLASSIFICATION
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 360l; 21 USC 371; 21 USC 374; 21
USC 331; 21 USC 351 to 352; 21 USC 360; 21 USC 360c; 21 USC 360e; 21
USC 360i; 21 USC 360j
CFR Citation: 21 CFR 801.437; 21 CFR 878.4460; 21 CFR 878.4461; 21 CFR
880.6250; 21 CFR 880.6251; 21 CFR 801.440
Legal Deadline: None
Abstract: FDA is revising its present regulations governing the
classification of surgeon's and patient examination gloves. The present
rule classifies surgeon's and patient examination gloves as class I
devices. FDA is reclassifying surgeon's and patient examination gloves
as class II devices subject to special controls. FDA is also requiring
additional labeling concerning powder and protein levels for these
devices.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/30/99 64 FR 41710
Final Action 10/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, HFZ-215,
Center for Devices and Radiological Health, 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 827-2974
RIN: 0910-AB74
_______________________________________________________________________
888. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT
INCREASED RISK OF TRANSMITTING HCV (LOOKBACK)
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 21 USC 321; 42 USC 216; 42 USC 262; 42 USC 263; 42 USC
263a; 42 USC 264; 42 USC 300aa-25; 21 USC 331; 21 USC 351; 21 USC 352;
21 USC 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374
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 a comprehensive review of the
regulations performed by FDA, and are 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
public comments. In this rulemaking, FDA will propose to 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 repeatedly reactive for evidence
of HCV.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/16/00 65 FR 69377
NPRM Comment Period End 02/14/01
Final Action 03/00/02
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: See RIN 0910-AB26.
Agency Contact: Steven F. Falter, Director, Regulations and Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 200N (HFM-17), Center for Biologics Evaluation
and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Email: [email protected]
RIN: 0910-AB76
[[Page 25425]]
_______________________________________________________________________
889. ANTIBIOTIC RESISTANCE LABELING
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 371; 21 USC 374; 21 USC 379e; 42
USC 216; 42 USC 241; 42 USC 262; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; ...
CFR Citation: 21 CFR 201.24
Legal Deadline: None
Abstract: The final rule would require the inclusion of statements on
antibiotic prescription drug labeling concerning inappropriate
antibiotic use and the prevalence of drug resistant microorganisms.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/19/00 65 FR 5611
Final Rule 11/00/01
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Suite 3059
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB78
_______________________________________________________________________
890. 180-DAY GENERIC DRUG EXCLUSIVITY FOR ABBREVIATED NEW DRUG
APPLICATIONS
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 314.107
Legal Deadline: None
Abstract: The final rule will amend regulations governing 180-day
generic drug exclusivity to clarify existing eligibility requirements
and conditions for abbreviated new drug application sponsors, to modify
current eligibility requirements, and to impose new eligibility
conditions. These revisions are the result of recent court decisions,
including Mova Pharmaceutical v. Shalala, 140 F. 3d 1060 (D.C. Cir.
1998), invalidating an eligibility requirement for exclusivity.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/06/99 64 FR 42873
NPRM Comment Period End 10/04/99
Final Action 11/00/01
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB80
_______________________________________________________________________
891. FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION SYSTEM
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321 et seq
CFR Citation: 21 CFR 25.20; 21 CFR 25.32; 21 CFR 20.100; 21 CFR 58.3;
21 CFR 170.3; 21 CFR 170.100; 21 CFR 170.101; 21 CFR 170.102; 21 CFR
170.103; 21 CFR 170.104; 21 CFR 170.105; 21 CFR 171.1; 21 CFR 171.4; 21
CFR 174.5; 21 CFR 179.25; 21 CFR 170.106; ...
Legal Deadline: None
Abstract: In November 1997, Congress amended the Federal Food, Drug,
and Cosmetic Act (FFD&C) to establish a notification process whereby
manufacturers and suppliers of components of food contact materials may
notify FDA 120 days prior to marketing a new food contact substance. If
FDA does not object to the notification within 120 days, the substance
may be marketed with the same status as a regulated food additive. FDA
is authorized to publish regulations outlining the information required
to be submitted in premarket notifications for food-contact substances
submitted to the agency. FDA is also authorized to publish regulations
that identify when a food additive petition is required in lieu of a
premarket notification. FDA is not required to accept a premarket
notification in any fiscal year for which an appropriation is not
specifically made for this program. FDA expects that the majority of
food-contact substances that are currently the subject of food additive
petitions will be the subject of premarket notifications. FDA also
expects that substances currently reviewed under the agency's threshold
of regulation process will be reviewed as premarket notifications under
the new process. Unlike food additive regulations, premarket
notifications will be specific to the notifier. The proposed use of a
similar or identical substance produced by another manufacturer will
require a separate premarket notification submission. Also unlike food
additive petitions, the existence of the notification and any otherwise
releasable data within the notification is not publicly available until
the 120-day period has expired. FDA expects to keep a publicly
available list of effective premarket notifications to assist
manufacturers, distributors, and users of food packaging and other
food-contact materials. FDA published a proposed rule on the
notification process for food contact substances on July 13, 2000. The
comment period on the proposed rule ended on September 26, 2000.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/13/00 65 FR 43269
Final Rule 09/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Mitchell Alan Cheeseman, Team Leader, Department of
Health and Human Services, Food and Drug Administration, HFS-215,
Center for Food Safety and Applied Nutrition, 200 C Street SW,
Washington, DC 20204
Phone: 202 418-3083
Fax: 202 418-3131
Email: [email protected]
RIN: 0910-AB94
[[Page 25426]]
_______________________________________________________________________
892. STATE CERTIFICATION OF MAMMOGRAPHY FACILITIES
Priority: Other Significant
Legal Authority: 21 USC 360i; 21 USC 360nn; 21 USC 374; 42 USC 263b
CFR Citation: 21 CFR 900.2; 21 CFR 900.20; 21 CFR 900.21; 21 CFR
900.22; 21 CFR 900.23; 21 CFR 900.24; 21 CFR 900.25
Legal Deadline: None
Abstract: FDA is considering regulations to implement section (q) of
the Mammography Quality Standards Act of 1992 (the MQSA). This section
permits FDA to authorize individual States to certify mammography
facilities, to conduct the inspection of the facilities, to implement
the MQSA quality standards, and to administer other related functions.
FDA retains oversight responsibility for the activities of the States
authorized to carry out certification requirements and mammography
facilities certified by those States must continue to meet the quality
standards established by FDA for mammography facilities nationwide. The
rule would include procedures for application, approval, evaluation,
and withdrawal of approval of States as Certification Agencies. It also
would include standards to be met by States receiving this authority.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/30/00 65 FR 16847
NPRM Comment Period End 06/28/00
Final Rule 06/00/01
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: Ruth Fischer, Office of Health and Industry Programs,
Department of Health and Human Services, Food and Drug Administration,
HFZ-240, Center for Devices and Radiological Health, 1350 Piccard
Drive, Rockville, MD 20850
Phone: 301 594-3332
RIN: 0910-AB98
_______________________________________________________________________
893. EXAMINATION OF ADMINISTRATIVE RECORD AND OTHER ADVISORY COMMITTEE
RECORDS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321
CFR Citation: 21 CFR 14.75
Legal Deadline: None
Abstract: FDA is amending its administrative regulations in 21 CFR
14.75(a) to state that written information for consideration by an
advisory committee at an advisory committee meeting is available for
public disclosure, whenever practicable, before or at the time of the
meeting.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/08/01 66 FR 1275
Direct Final Rule 01/08/01 66 FR 1257
Direct Final Rule Withdrawn 05/00/01
Final Rule 09/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC03
_______________________________________________________________________
894. EFFICACY EVIDENCE NEEDED FOR PRODUCTS TO BE USED AGAINST TOXIC
SUBSTANCES WHEN HUMAN STUDIES ARE UNETHICAL
Priority: Other Significant
Legal Authority: 15 USC 1451 to 1561; 21 USC 331; 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 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42
USC 262; 42 USC 263b; 21 USC 321; PL 105-115, sec 122, 111 stat 2322
(21 USC 355 note)
CFR Citation: 21 CFR 601; 21 CFR 314
Legal Deadline: None
Abstract: The agency plans to publish a final rule that would amend its
new drug and biological product regulations to identify the information
needed to provide substantial evidence of the efficacy of new drug and
biological products used to reduce or prevent the toxicity of chemical,
biological, or radiological, substances when adequate and well-
controlled efficacy studies in humans cannot be conducted ethically.
Efficacy studies in humans cannot be conducted ethically if: 1) the
studies would involve administering a potentially lethal or permanently
disabling toxic substance or organism to healthy human volunteers
without a proven treatment; and 2) field trials (assessment of the
product after natural accidental, or malicious exposure to the
substance) are not feasible. FDA is taking this action because it
recognizes the importance of improving medical responses to the use of
lethal or permanently disabling chemical, biological, radiological, and
nuclear substances in order to protect individuals exposed to these
substances.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/05/99 64 FR 53960
Final Action 08/00/01
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AC05
_______________________________________________________________________
895. 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; 21 USC 352; 21 USC 353;
21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21
USC
[[Page 25427]]
371; 21 USC 379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41
USC 263b to 263n
CFR Citation: 21 CFR 50; 21 CFR 56
Legal Deadline: Other, Statutory, April 17, 2001, The Children's Health
Act of 2000 requires FDA to adopt existing HHS regulations within 6
months of the date of its enactment on 10/17/2000. Thus FDA is required
to adopt HHS Subpart D by 4/17/2001.
Abstract: The interim rule would provide 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 04/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC07
_______________________________________________________________________
896. IMPLEMENTING COURT DECISIONS, ANDA APPROVALS, AND 180-DAY
EXCLUSIVITY
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 314.107(e)
Legal Deadline: None
Abstract: The interim rule will amend regulations governing 180-day
generic drug exclusivity to redefine the term court decision. The
definition of court decision will be changed to the decision of a
District Court deciding the relevant patent litigation case. The
regulations will then correctly define court decision in accordance
with recent court holdings addressing the definition.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 07/13/00 65 FR 43233
Final Rule 11/00/01
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AC11
_______________________________________________________________________
897. REVOCATION OF CONDITIONS FOR MARKETING DIGOXIN PRODUCTS FOR ORAL
USE
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 360b-f; 21 USC 360j; 21 USC 361a; 21 USC 371;
21 USC 374; 21 USC 375; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC
242a; 42 USC 262; 42 USC 263b-n
CFR Citation: 21 CFR 310.500
Legal Deadline: None
Abstract: The final rule will revoke the regulation (21 CFR 310.500)
that established conditions for marketing digoxin products for oral
use.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/24/00 65 FR 70538
Final Rule 12/00/01
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Mary E. Catchings, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, HFD-7, Center for Drug Evaluation and Research, 1451
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-0951
RIN: 0910-AC12
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
898. INFANT FORMULA: 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. Two final rules will be published: one, on Quality
Factors and the second, on Good Manufacturing Practice, Quality Control
Procedures Notification Requirements, and Records and Reports.
Timetable:
________________________________________________________________________
Current Good Mfg. Practices; Qual. Control Proc. NPRM 07/09/96 (61 FR
36154) NPRM Comment Period End 12/06/96 Final Action To Be Determined
Infant Form Cons Comp, Micro Test & Recd Retention Req NPRM 01/26/89
(54 FR 3783) NPRM Comment Period End 03/27/89 Final Rule 12/24/91 (56
FR 66566)
[[Page 25428]]
Infant Formula Quality Factors NPRM 07/09/96 (61 FR 36154) NPRM
Comment Period End 12/06/96 Final Action To Be Determined
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Darla Danford, Supervisory Nutritionist, Department of
Health and Human Services, Food and Drug Administration, (HFS-800),
Center for Food Safety and Applied Nutrition, 200 C Street SW,
Washington, DC 20204
Phone: 202 205-5365
RIN: 0910-AA04
_______________________________________________________________________
899. FOOD LABELING REVIEW
Priority: Routine and Frequent
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371
CFR Citation: 21 CFR 100; 21 CFR 101; 21 CFR 102; 21 CFR 161
Legal Deadline: None
Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA)
requires that most foods bear nutrition labeling. The agency issued
final rules implementing most of the provisions contained in the NLEA
on January 6, 1993. Subsequently, however, the agency has identified
additional areas that should be the subject of rulemaking. FDA issued a
proposal on January 6, 1993, to establish requirements for the
identification of certain ingredients on food labels. FDA proposed on
June 15, 1993, to amend its January 6, 1993, final rules on nutrient
content and health claims to remove the provisions that exempted
restaurant menus from the requirements for how nutrient content claims
and health claims are to be made. The agency proposed on January 4,
1994, to establish reference daily intakes based on the 9th and 10th
editions of the National Research Council's Recommended Dietary
Allowances. On March 14, 1994, FDA published a proposal implementing
the provisions for exemptions from nutrition labeling for low-volume
food products of small businesses that were established by the
Nutrition Labeling and Education Act Amendments of 1993. On August 18,
1993, FDA published a proposal concerning the placement of the
nutrition facts panel on food labels. Finally, on July 18, 1994, FDA
published proposed revised guidelines for the voluntary declaration of
nutrition labeling for raw produce and fish. A final rule concerning
the placement of the nutrition facts panel was published on April 5,
1995. A final rule establishing reference daily intakes based on the
9th and 10th editions of Recommended Dietary Allowances was published
on December 28, 1995.
FDA published a final rule on August 2, 1996, on nutrient content
claims and health claims to remove the provisions that exempted
restaurant menus from the requirements for how nutrient content claims
and health claims are to be made. FDA published a final rule on August
7, 1996, implementing the exemption for small businesses from the
requirements for nutrition labeling and providing instructions on how
to file a notice claiming the exemption. FDA published on August 16,
1996, final guidelines on the voluntary declaration of nutrition
labeling for raw produce and fish.
Timetable:
________________________________________________________________________
Amend Standard of Identity for Grain Products (Folic Acid) NPRM 10/14/
93 (58 FR 53305) Final Action 03/05/96 (61 FR 8781)
Health Claims and Label Statements NPRM Folic Acid and Neural Tube Def
10/14/93 (58 FR 53254) Final Action 03/05/96 (61 FR 8752)
Misleading Containers; Nonfunctional Slack Fill NPRM 01/06/93 (58 FR
2957) Final Action 12/06/93 (58 FR 64123)
Nutrient Content Claims and Health Claims; Restaurant Foods NPRM 06/
15/93 (58 FR 33055) Final Action 08/02/96 (61 FR 40320)
Nutrient Content, Definition of the Term, Healthy NPRM 01/06/93 (58 FR
2944) Final Action 05/10/94 (59 FR 24232)
Placement of Nutrition Facts Panel NPRM 08/18/93 (58 FR 44091) Final
Action 04/05/95 (60 FR 17202) Final Action Effective 05/05/95 Final
Action Correction 06/12/95 (60 FR 30788)
Protein Hydrolysates; Broth in Tuna; and/or Labeling NPRM (Declaration
of Ingredients) 01/06/93 (58 FR 2950) Final Action (Dec. of
Ingredients) To Be Determined
Reference Daily Intakes NPRM 01/04/94 (59 FR 427) Final Action 12/28/
95 (60 FR 67164)
Small Business Exemption, Nutrition Labeling NPRM 03/14/94 (59 FR
11872) Final Action 08/07/96 (61 FR 40963)
Voluntary Guidelines for Nutrition Labeling Produce NPRM 07/18/94 (59
FR 36379) Final Action 08/16/96 (61 FR 42742)
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Federalism: This action may have federalism implications as defined in
EO 13132.
Additional Information: Federalism: Yes for Protein Hydrolysates; Broth
in Tuna; and/or Labeling
Agency Contact: Christine L. Lewis, Director, Office of Nutritional
Products, Labeling and Dietary Supplements, Department of Health and
Human Services, Food and Drug Administration, (HFS-800), Center for
Food Safety and Applied Nutrition, 200 C Street SW, Washington, DC
20204
Phone: 202 205-4561
RIN: 0910-AA19
_______________________________________________________________________
900. MEDICAL FOODS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 360ee; 21 USC 371; 21 USC 342; 21
USC 343; 21 USC 348; 21 USC 350; 21 USC 350a; 21 USC 351; 21 USC 352;
21 USC 355
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: The Food and Drug Administration is considering development
of regulations for medical foods, as defined by the Orphan Drug Act
Amendments of 1988 (21 U.S.C. 360ee(b)(3)) to assure, among other
things, the safety and effectiveness of these products, proper labeling
of the nutrient content and purported uses, including adequate and
appropriate directions for use, and quality control and good
manufacturing practices.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/29/96 61 FR 60661
ANPRM Comment Period End 04/28/97
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Yes
[[Page 25429]]
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Federalism: Undetermined
Agency Contact: Sue A. Anderson, Department of Health and Human
Services, Food and Drug Administration, (HFS-831), Center for Food
Safety and Applied, Nutrition, 200 C Street SW, Washington, DC 20204
Phone: 202 205-4240
RIN: 0910-AA20
_______________________________________________________________________
901. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL
DEVICES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321(h); 21 USC 351; 21 USC 352; 21 USC 360; 21
USC 360c to 360l; 21 USC 371 to 374
CFR Citation: Not Yet Determined
Legal Deadline: None
Abstract: FDA is considering whether to classify stand-alone computer
software products that fit the definition of a medical device under the
Federal Food, Drug, and Cosmetic Act. Although the Secretary has not
made a final decision to initiate such a program, the agency is
considering classifying these devices by using a risk-based approach as
required under the Medical Device Amendments to the Act. In addition,
the agency would use existing exemptions from regulation where
appropriate. Under this approach, low risk medical software devices
would be subject only to the adulteration and misbranding provisions of
the Act. Moderate risk devices would additionally be subject to the
registration, listing, good manufacturing practice requirements, and
reporting and recordkeeping requirements. High risk devices would be
the only products to require premarket submissions. FDA would seek
comment on potential criteria related to the intended uses of medical
software devices that might be used in determining the level of risk.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Charles S. Furfine, Regulatory Review Scientist/
Software Expert, Department of Health and Human Services, Food and Drug
Administration, HFZ-143, Center for Devices and Radiological, Health,
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2536
RIN: 0910-AA41
_______________________________________________________________________
902. REINVENTING FDA FOOD REGULATIONS
Priority: Substantive, Nonsignificant
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321 et
seq
CFR Citation: 21 CFR 101; 21 CFR 145; 21 CFR 146; 21 CFR 150; 21 CFR
152; 21 CFR 155; 21 CFR 156; 21 CFR 102; 21 CFR 103; 21 CFR 131; 21 CFR
133; 21 CFR 135; 21 CFR 136; 21 CFR 137; 21 CFR 139; ...
Legal Deadline: None
Abstract: In response to President Clinton's memorandum to heads of
departments and agencies entitled ``Regulatory Reinvention
Initiative,'' FDA has initiated rulemaking to retain, revise, or revoke
certain of its regulations for food. FDA published an advance notice of
proposed rulemaking (ANPRM) on December 29, 1995, requesting
information on the need to retain, revise, or revoke its food standards
of identity regulations and its common or usual name regulations. In
the same issue of the Federal Register, FDA proposed to improve the
coordination of the food additive, GRAS, and color additive approval
process with USDA for substances used in meat and poultry products. FDA
proposed to revoke several lower fat milk standards on November 9,
1995. On June 12, 1996, FDA published an ANPRM announcing its intention
to review: 1) its human food labeling regulations pertaining to the
exemption for soft drinks from requirements for the type size and
placement of certain information on the information panel, requirements
for listing ``statements of identity,'' and requirements for flavor
labeling; 2) its infant formula regulations to ensure that they fully
reflect the Federal Food, Drug, and Cosmetic Act; 3) its regulations
pertaining to the discharge of waste aboard casino ships, passenger
ships, and ferries; and 4) its food additive regulations to consolidate
certain existing regulations. In the same June 12 issue of the Federal
Register, FDA published a second ANPRM seeking public comment on
possible ways to streamline various food additive regulations. FDA also
proposed on June 12, 1996, to revoke certain food labeling regulations
pertaining to labeling of food with number of servings and labeling
Kosher and Kosher-style foods and to revoke the agency's voluntary
filing of cosmetic product experiences. The latter was published August
12, 1997.
On October 13, 1995, FDA proposed to revoke certain agency regulations
that were obsolete or no longer necessary to achieve public health
goals. The final rule (pertaining to food regulations only) was
published on June 3, 1996. A confirmation of effective date on those
regulations, promulgated under the formal rulemaking procedures of
section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 USC
371(e)), pertaining to diabetic labeling (21 CFR 105.67) and sodium
intake labeling (21 CFR 105.69), was published on August 27, 1996.
In the Federal Register of April 17, 1997 (62 FR 18938), FDA proposed
to establish a notification procedure for companies to use to inform
FDA of a company's determination that use of a substance in food is
generally recognized as safe (GRAS).
Timetable:
________________________________________________________________________
Exempt Infant Formula; Plan for Revisions ANPRM 06/12/96 (61 FR
29701) Comment Period Ended 10/10/96 NPRM To Be Determined
Food Standards of Identity, Quality, and Fill of Container ANPRM 12/
29/95 (60 FR 67492) Comment Period Ended 06/28/96 NPRM To Be
Determined
Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry) NPRM
12/29/95 (60 FR 67490) Comment Period Ended 03/14/96 Extension of
Comment Period 06/03/96 Final Action 08/25/00 (65 FR 51758)
Notification Procedures for GRAS Determinations NPRM 04/17/97 (62 FR
18938) NPRM Comment Period Ended 07/16/97 Final Action To Be
Determined
Revocation of Certain Food Labeling and Cosmetic Regulations NPRM 06/
12/96 (61 FR 29708) Comment Period Ended 08/26/96 Final Rule 08/12/97
(62 FR 43071)
[[Page 25430]]
Revocation of Lower Fat Milk Standards NPRM 11/09/95 (60 FR
56541) Comment Period Ended 01/23/96 Partial Final 11/20/96 (61 FR
58991) Confirmation of Effective Date 02/24/97 (62 FR 8163)
Revocation of Lower Fat Yogurt Standards NPRM 11/09/95 (60 FR
56541) Confirmation of Effective Date To Be Determined Final Action
(Yogurt) To Be Determined
Revocation of Obsolete Regulations NPRM 10/13/95 (60 FR
53480) Comment Period Ended 01/11/96 Final Rule 06/03/96 (61 FR
27771) Confirmation of Effective Date 08/27/96 (61 FR 43963)
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.
Additional Information: Federalism: Yes for Food Standards of Identity,
Quality, and Fill of Container
Agency Contact: L. Robert Lake, Director, Office of Regulations and
Policy, Department of Health and Human Services, Food and Drug
Administration, (HFS-4), Center for Food Safety and Applied, Nutrition,
200 C Street SW, Washington, DC 20204
Phone: 202 205-4561
RIN: 0910-AA58
_______________________________________________________________________
903. DETERMINATION THAT INFORMED CONSENT IS INFEASIBLE OR IS CONTRARY TO
THE BEST INTEREST OF RECIPIENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 42 USC 241; 42 USC 262; 21 USC 352; 21 USC
353; 21 USC 355; 21 USC 360; 21 USC 371; 42 USC 216; 21 USC 346; 21 USC
346a; 21 USC 348; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f;
21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 379e; 21 USC 381; 42 USC
263b; 42 USC 263e; 42 USC 263f; 42 USC 263g; 42 USC 263h; 42 USC 263i;
42 USC 263j; 42 USC 263k; 42 USC 263l; 42 USC 263m; 42 USC 263n; 42 USC
263c; 42 USC 263d
CFR Citation: 21 CFR 50; 21 CFR 312
Legal Deadline: None
Abstract: The Food and Drug Administration is planning to publish a
final rule that would finalize its 1999 interim final rule (64 FR
54180) that: (1) revoked its December 21, 1990, interim final
regulations that permitted the Commissioner to determine that obtaining
informed consent from military personnel for the use of investigational
products is not feasible in certain military combat situations; and (2)
established strengthened criteria and standards for the President to
apply in making a determination that informed consent is not feasible
or is contrary to the best interest of military personnel engaged in
specific military operations. The agency is taking this final action
after reviewing comments it received in response to a July 1997 Request
for Comment as to whether the agency should revise or revoke the rule
and its 1999 interim final regulation soliciting comments on this
action, and in light of the enactment of the Strom Thurmond National
Defense Authorization Act for Fiscal Year 1999 under which the
President is authorized to waive the Federal Food, Drug, and Cosmetic
Act's informed consent requirements in military operations, if the
President finds that obtaining consent is infeasible or contrary to the
best interests of recipients and on an additional ground that obtaining
consent is contrary to national security interests.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 10/05/99 64 FR 54180
Final Action 04/00/02
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Federal
Agency Contact: Bonnie M. Lee, Health Issues Analyst, Division of
Compliance Policy, Office of Enforcement, Department of Health and
Human Services, Food and Drug Administration, HFC-230, Office of
Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-0415
RIN: 0910-AA89
_______________________________________________________________________
904. DIRECT-TO-CONSUMER PROMOTION REGULATIONS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 360k; 21 USC 361; 21 USC 362; 21
USC 371; 21 USC 331; 21 USC 334; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 358; 21 USC 360e to 360i
CFR Citation: 21 CFR 200; 21 CFR 800
Legal Deadline: None
Abstract: The Food and Drug Administration will issue proposed
regulations for direct-to-consumer promotion of human and animal
prescription drugs, biologics, and restricted devices. The regulations
will set forth the requirements for what type of information shall be
contained in the consumer directed advertisements for these products
and how the information shall be presented.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/00/02
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Federalism: Undetermined
Agency Contact: Nancy M. Ostrove, Division of Drug Marketing,
Advertising, and Communications, Department of Health and Human
Services, Food and Drug Administration, (HFD-42), Center for Drug
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
RIN: 0910-AA90
_______________________________________________________________________
905. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS (SECTION 610
REVIEW)
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 5 USC 610; 21 USC 351; 21 USC 353; 21 USC 360b; 21 USC
371; 21 USC 321; 21 USC 352
CFR Citation: 21 CFR 511; 21 CFR 512
Legal Deadline: None
Abstract: FDA is proposing to revise its regulations governing
investigational use of new animal drugs by proposing to delete 21 CFR
511 and establish in 21 CFR part 512 revised investigational use of new
animal drug regulations. The investigational use new animal drug
regulations are expected to include regulations to implement provisions
of the Animal Drug Availability Act of 1996, specifically
[[Page 25431]]
presubmission conferences, and implement parts of the President's
National Performance Report, ``Reinventing the Regulation of Animal
Drugs,'' May 1996. In the reinventing regulations report, FDA proposed
to revise its regulations to reflect numerous new process changes and
programs that will enable a more streamlined animal drug application
review and approval process, and that would result in less regulatory
burden upon industry and FDA while maintaining the safety and
effectiveness of new animal drugs. In addition, FDA is initiating a
review of this rule under section 610 of the Regulatory Flexibility
Act. The purpose of the section 610 review is to determine if the rule
should be amended to minimize adverse economic impacts on small
entities. FDA will consider and solicit comments on the following: 1)
the continued need for the rule; 2) the nature of complaints or
comments received concerning the rule; 3) the complexity of the rule;
4) the extent to which the rule overlaps, duplicates, or conflicts with
other Federal, State or local government rules; and 5) the degree to
which technology, economic conditions or other factors have changed in
the area affected by the rule.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/21/96 61 FR 59209
ANPRM Comment Period End 01/21/97
Begin Review 04/03/00
Proposed Rule 02/00/03
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Marty Schoenemann, Department of Health and Human
Services, Food and Drug Administration, HFV-126, Center for Veterinary
Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220
RIN: 0910-AB02
_______________________________________________________________________
906. SUITABILITY DETERMINATION FOR DONORS OF HUMAN CELLULAR AND TISSUE-
BASED PRODUCTS
Priority: Other Significant
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42
USC 264; 42 USC 271
CFR Citation: 21 CFR 210.1(c); 21 CFR 210.2(a); 21 CFR 210.2(b); 21 CFR
211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271
Legal Deadline: None
Abstract: As part of implementing the proposed regulatory approach to
human cellular and tissue-based products, the Food and Drug
Administration is requiring manufacturers of human cellular and tissue-
based products to screen and test the donors of cells and tissues used
in those products for evidence of or risk factors for relevant
communicable disease. As part of this action, the agency is amending
the current good manufacturing practice regulations that apply to human
cellular and tissue-based products regulated as drugs, medical devices,
and/or biological products in order to incorporate the new donor
suitability requirements into existing good manufacturing practice
regulations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/30/99 64 FR 52696
NPRM Comment Period Reopened 04/18/00 65 FR 20774
NPRM Comment Period End 07/17/00
Final Action 01/00/03
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: State
Federalism: This action may have federalism implications as defined in
EO 13132.
Agency Contact: Astrid L. Szeto, Senior Regulatory Review Officer,
Department of Health and Human Services, Food and Drug Administration,
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB27
_______________________________________________________________________
907. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED
FEED
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-250; 21 USC 360b
CFR Citation: 21 CFR 558.5; 21 CFR 510.455
Legal Deadline: None
Abstract: In response to a citizen petition filed by the American Feed
Industry Association, the Food and Drug Administration (FDA) is
proposing to amend the requirements for liquid medicated animal feed to
clarify what information and data are required to demonstrate chemical
and positional stability. The amended regulations would also clarify
the provisions for the submission of such data through a master file
and the reference to master files by subsequent applicants.
Additionally, FDA is proposing to amend the regulations for free-choice
medicated feed in order to ensure consistency with the requirements for
liquid medicated feed. Finally, FDA is proposing to amend the
regulations for free-choice medicated feed and liquid medicated feed so
that these provisions comply with the terms of the Animal Drug
Availability Act of 1996.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: William D. Price, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, HFV-200,
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD
20855
Phone: 301 827-6652
Fax: 301 594-4512
RIN: 0910-AB50
_______________________________________________________________________
908. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING
Priority: Other Significant
Legal Authority: PL 105-115, sec 127; 21 USC 351; 21 USC 352; 21 USC
353a; 21 USC 355; 21 USC 371
CFR Citation: 21 CFR 216
[[Page 25432]]
Legal Deadline: None
Abstract: Section 127 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and
Cosmetic Act (21 U.S.C. 353a). Section 503A governs the application of
Federal law to the practice of pharmacy compounding. Under section
503A(b)(1)(A), FDA may issue by regulation a list of bulk drug
substances that may be used in compounding that are not covered by a
United States Pharmacopeia (USP) or National Formulary (NF) monograph
and are not components of FDA-approved drugs. Bulk drug substances that
do not appear on the list may not be used in compunding under section
127 unless such substances are covered by USP or NF monograph or are
components of approved drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/07/99 64 FR 996
NPRM Comment Period End 03/23/99
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB57
_______________________________________________________________________
909. PHARMACY AND PHYSICIAN COMPOUNDING OF DRUG PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353a; 21
USC 355; 21 USC 360; 21 USC 371
CFR Citation: 21 CFR 216
Legal Deadline: None
Abstract: Section 503A of the Federal Food, Drug, and Cosmetic Act (the
Act) (21 U.S.C. 353a) describes the circumstances under which
compounded drugs may qualify for exemption from three requirements of
the Act: (1) that a drug be manufactured according to current good
manufacturing practice; (2) that a drug have adequate directions for
use; and (3) that a marketing application be approved by FDA before a
new drug product is introduced for sale (i.e., sections 501(a)(2)(B),
502(f)(1), and 505 of the Act (21 U.S.C. 351(a)(2)(B), 352(f)(1), and
355)). To qualify for the exemption, a pharmacist or physician must
meet statutory conditions for compounding, including the following: (1)
there generally must be a prescription for an identified individual
patient before compounding; (2) compounding before receiving a
prescription is allowed only under limited circumstances; (3) the
quantity of drugs that may be shipped out of state is limited and may
vary depending on whether the compounder is located in a state that has
entered into a memorandum of understanding (MOU) with FDA; (4) drug
products may only be compounded using a bulk drug substance (which is
essentially the active ingredient) that is listed in the United States
Pharmacopoeia (USP) or National Formulary (NF), or a bulk drug
substance that is a component of an FDA-approved drug product, or a
bulk drug substance that is listed in the regulation as one that FDA
has found to be suitable for compounding; (5) the bulk drug substance
must be made in a facility registered with FDA and the bulk drug
substance must be accompanied by a certificate of analysis; (6) they
cannot compound regularly or in inordinate amounts of any drug products
that are essentially copies of commercially available products; (7)
drug products may not be compounded if they are listed in a regulation
as having been removed from the market or had their FDA-approval
withdrawn because they were found to be not safe or not effective; (8)
drug products that are listed in the regulations as ``demonstrably
difficult to compound'' may not be compounded. The regulations will
amplify and explain the statutory requirements as well as execute tasks
Congress assigned FDA in section 503A. This proposed rule will be one
of several rulemakings implementing section 503A. Related regulatory
initiatives are described below: (1) FDA has issued a final rule
listing drug products that may not be compounded because they were
found to be not safe or not effective and were removed from the market
or had their FDA approval withdrawn; (2) FDA has also issued a proposed
rule and is preparing a final rule listing drugs that are not the
subject of a USP or NF monograph, and are not components of an FDA-
approved drug product but are suitable for compounding; (3) FDA is
currently preparing a proposed rule listing those drugs that are
demonstrably difficult to compound and are not allowed to be
compounded; and (4) FDA has published a Federal Register notice
announcing the availability of a draft MOU between FDA and State boards
of pharmacy.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Federalism: Undetermined
Additional Information: See RINs 0910-AB57, 0910-AB59
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AB58
_______________________________________________________________________
910. DRUG PRODUCTS THAT PRESENT DEMONSTRABLE DIFFICULTIES FOR
COMPOUNDING BECAUSE OF REASONS OF SAFETY OR EFFECTIVENESS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 127
CFR Citation: 21 CFR 216
Legal Deadline: None
Abstract: Section 127 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and
Cosmetic Act (21 U.S.C. 353a). Section 503A governs the application of
Federal law
[[Page 25433]]
to the practice of pharmacy compounding, and exempts compounded drug
products, under certain circumstances, from several key provisions of
the Food, Drug, and Cosmetic Act. Section 503A(b)(3)(A) directs FDA to
issue by regulation a list of drug products that, if compounded, will
not qualify for these exemptions because their compounding would be
demonstrably difficult in terms of assuring the safety or effectiveness
of the compounded product.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB59
_______________________________________________________________________
911. MANDATORY HACCP REGULATIONS FOR MANUFACTURERS OF RENDERED PRODUCTS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC
371
CFR Citation: 21 CFR 589
Legal Deadline: None
Abstract: During the notice and comment rulemaking for 21 CFR part 589,
``Listing of Specific Substances Prohibited from Use in Animal Food or
Feed; Animal Proteins Prohibited in Ruminant Feed,'' FDA received
several comments supporting the application of mandatory Hazard
Analysis Critical Control Point (HACCP) regulations for renderers. Some
of these comments were from renderers. Because of the need to expedite
the rulemaking for 21 CFR part 589, FDA stated that it would take up
the HACCP regulations for renderers as a separate initiative. This
rulemaking is to address the need expressed in the comments to 21 CFR
part 589 by promulgating mandatory HACCP regulations for renderers.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Federalism: Undetermined
Agency Contact: Daniel G. McChesney, Deputy Director, Office of
Surveillance and Compliance, Department of Health and Human Services,
Food and Drug Administration, HFV-200, Center for Veterinary Medicine,
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6648
RIN: 0910-AB72
_______________________________________________________________________
912. CITIZEN PETITIONS; ACTIONS THAT CAN BE REQUESTED BY PETITION;
DENIALS, WITHDRAWALS, AND REFERRALS FOR OTHER ADMINISTRATIVE ACTION
Priority: Info./Admin./Other
Legal Authority: 5 USC 551 to 558; 21 USC 1034; 28 USC 2112; 42 USC
201; 42 USC 262; 42 USC 263b to 263n; 42 USC 264; 5 USC 701 to 706; 15
USC 1451 to 1461; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 321 to
393; 21 USC 467f; 21 USC 679; 21 USC 821
CFR Citation: 21 CFR 10
Legal Deadline: None
Abstract: The final rule would amend the agency's regulations
pertaining to citizen petitions by specifying the types of actions that
could be requested through a petition. The final rule would also revise
the content requirements for citizen petitions and would allow the
agency to take various administrative actions in response to citizen
petitions. These changes are intended to improve the citizen petition
mechanism by focusing FDA's resources on important public health
issues.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/30/99 64 FR 66822
NPRM Comment Period End 02/28/00
Final Action To Be Determined
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Room 15-61
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane,
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AB73
_______________________________________________________________________
913. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 342; 21 USC 348; 21 USC 371; 21 USC
343
CFR Citation: 21 CFR 589
Legal Deadline: None
Abstract: After determining that dioxins were present in some clays
used as anti-caking agents in animal feeds, the agency is considering
proposing a rule that would prohibit the use of these clays unless they
meet certain conditions under the Federal Food, Drug, and Cosmetic Act.
At this time, it is not clear whether there are other types of mined
clay products that contain dioxins or whether the relatively low
concentrations found in recent samples of mined clay products would
have a significant impact on the public health. Thus, the advance
notice of proposed rulemaking will request further information
regarding the presence of dioxins in mined clay products used in animal
feeds or feed ingredients and the significance of these dioxins to the
public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No
Government Levels Affected: State
Federalism: Undetermined
[[Page 25434]]
Agency Contact: Randall A. Lovell, Veterinary Medical Officer,
Department of Health and Human Services, Food and Drug Administration,
HFV-222, Center for Veterinary Medicine, 7500 Standish Place,
Rockville, MD 20855
Phone: 301 827-0176
Fax: 301 827-1484
Email: