[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 21195]]
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Part VIII
Department of Health and Human Services
_______________________________________________________________________
Semiannual Regulatory Agenda
[[Page 21196]]
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 President's Executive Order 12866 and the Regulatory
Flexibility Act of 1980 require the semiannual publication of an agenda
which summarizes all current, projected, and recently completed
rulemakings. The agenda thus informs the public about regulatory
actions under development within the Department, and it provides an
opportunity for all concerned with the impact of the regulations to
participate at an early stage. The last such agenda was published on
November 9, 1998.
FOR FURTHER INFORMATION CONTACT: Ann White, 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 described below
continue to reflect the Department's efforts to exemplify in its
rulemaking practices the President's initiative to streamline the
Federal regulatory system so that it helps bring important benefits to
the American people while creating fewer burdens. These regulatory
actions also are an indication of emerging policy mandates for HHS
involving such national priorities as: Strengthening and modernizing
the Medicare program; assuring the safety of the American food supply;
establishing improved access to health services for children; shoring
up recent advances in welfare reform and health-insurance reform; and
eliminating waste, fraud, and abuse from the health care system.
Underlying the Department's pursuit of its regulatory responsibilities
in all of the above-mentioned programmatic areas, there endures the
focus and discipline with which the principles of Executive Order 12866
and the many subsequent regulatory reform initiatives of the Clinton
Administration have energized the Department's regulatory functions.
Public comments are invited to assist the Department in continuing
these efforts.
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.
Health Care Financing Administration: Sue Brown, Director,
Division of Regulations and Issuances, 7500 Security Boulevard, C5-
09-27, Baltimore, Maryland 21244; phone 410-786-4473.
Food and Drug Administration: Ed Dutra, Director, Regulatory
Policy and Management Staff, 5600 Fishers Lane, Rockville, Maryland
20857; phone 301-443-3480.
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: David Bunoski, 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.
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 Penn, 12300 Twinbrook Parkway,
Suite 450, Rockville, Maryland 20857; phone 301-443-1116.
National Institutes of Health: Jerry Moore, 6011 Executive
Boulevard, Room 601, MSC 7669, Rockville, Maryland 20852; 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: Jacquelyn Y. White, Deputy Executive
Secretary to the Department, Office of the Executive Secretariat,
Room 603H, Hubert H. Humphrey Building, 200 Independence Avenue
SW., Washington, DC 20201.
Dated: March 22, 1999.
LaVarne Burton,
Executive Secretary to the Department.
Office of the Secretary--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
905 Privacy Act Exempt Record System from the Healthcare Integrity and Protection Data 0991-AA99
Bank..................................................................................
906 Revision of HHS Freedom of Information Act Regulations............................... 0991-AB01
907 Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care 0991-AB03
Organizations.........................................................................
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Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
908 Clarification of the Initial OIG Safe Harbor Provisions and Establishment of 0991-AA66
Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................
909 Reproduction and Sale of Official Forms and Publications............................. 0991-AA83
910 Revised OIG Civil Money Penalties Resulting From Public Law 104-191.................. 0991-AA90
911 Shared Risk Exception to the Safe Harbor Provisions.................................. 0991-AA91
912 Revised OIG Sanction Authorities Resulting From Public Law 105-33.................... 0991-AA95
913 Block Grant Programs................................................................. 0991-AA97
914 Health Care Fraud and Abuse Data Collection Program.................................. 0991-AA98
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Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
915 Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans.......... 0991-AA45
916 Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental 0991-AA53
Policies..............................................................................
917 Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community- 0991-AA79
Based Health Care Center or Provider, of a Standard Survey............................
918 Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and 0991-AA80
Rebate Agreements.....................................................................
919 Senior Biomedical Research Service................................................... 0991-AA82
----------------------------------------------------------------------------------------------------------------
Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
920 Block Grants for Prevention and Treatment of Substance Abuse......................... 0930-AA01
----------------------------------------------------------------------------------------------------------------
Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
921 Interstate Shipment of Biological Materials That Contain or May Contain Infectious 0920-AA02
Substances............................................................................
----------------------------------------------------------------------------------------------------------------
Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
922 Implementation of the Equal Access to Justice Act in Agency Proceedings.............. 0990-AA02
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
923 Blood Initiative..................................................................... 0910-AB26
924 Pregnancy Labeling Revision.......................................................... 0910-AB44
925 Natural Rubber-Containing Drugs; User Labeling....................................... 0910-AB56
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Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
926 Over-the-Counter (OTC) Drug Review................................................... 0910-AA01
927 Hearing Aids; Professional and Patient Labeling; Conditions for Sale................. 0910-AA39
928 Drugs Used for Treatment of Narcotic Addicts......................................... 0910-AA52
929 Investigational New Drugs: Export Requirements for Unapproved New Drug Products...... 0910-AA61
930 Adverse Drug Reaction Reporting and Recordkeeping Requirements for Marketed OTC Drugs 0910-AA86
931 Informed Consent for Human Drugs and Biologics; Determination That Informed Consent 0910-AA89
Is Not Feasible.......................................................................
932 Direct-to-Consumer Promotion Regulations............................................. 0910-AA90
933 Labeling for Human Prescription Drugs; Revised Format................................ 0910-AA94
934 Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products.. 0910-AA97
935 Use of Ozone-Depleting Substances.................................................... 0910-AA99
936 Radioactive Drugs for Basic Research................................................. 0910-AB00
937 Veterinary Feed Directives........................................................... 0910-AB09
938 Administrative Practices and Procedures; Advisory Opinions and Guidelines............ 0910-AB14
939 Exports; Reporting and Recordkeeping Requirements.................................... 0910-AB16
940 Registration of Foreign Establishments and Product Listing........................... 0910-AB21
941 Suitability Determination for Donors of Human Cellular and Tissue-Based Products..... 0910-AB27
942 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based 0910-AB28
Products..............................................................................
943 Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration 0910-AB30
Requirements..........................................................................
944 Antibiotic Drug Approval and Exclusivity............................................. 0910-AB33
945 Applications for FDA Approval To Market a New Drug or Antibiotic Drug; Complete 0910-AB34
Response Letter; Amendments to Unapproved Applications................................
946 Expanded Access to Investigational Therapies......................................... 0910-AB37
947 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs.... 0910-AB39
948 Electronic Submission of Adverse Drug Reaction Reports............................... 0910-AB42
949 Distinguishing Marks for Drug Products Containing Insulin............................ 0910-AB43
950 Progestational Drug Products for Human Use; Requirements for Labeling Directed to the 0910-AB45
Patient...............................................................................
951 Supplemental Manufacturing Changes for New Animal Drugs.............................. 0910-AB49
952 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed................ 0910-AB50
953 Pharmacy Compounding; General Regulations............................................ 0910-AB58
954 Drug Products That Present Demonstrable Difficulties for Compounding Because of 0910-AB59
Reasons of Safety or Effectiveness....................................................
955 Discontinuation of a Life-Saving Product............................................. 0910-AB60
956 Manufacturing Changes for Drugs...................................................... 0910-AB61
957 Pediatric Studies of Drugs........................................................... 0910-AB62
958 Positron Emission Tomography Drugs; Current Good Manufacturing Practices............. 0910-AB63
959 Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims... 0910-AB66
960 Designated Journals.................................................................. 0910-AB67
961 Presubmission Conferences............................................................ 0910-AB68
962 Classification of Sheep as a Minor Species for All Data Collection Purposes.......... 0910-AB69
963 Current Good Manufacturing Practice for Medicated Feeds.............................. 0910-AB70
964 Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act 0910-AB71
of 1996 and the Safe Level Provisions of the Animal Medicinal Drug Clarification Act
of 1994...............................................................................
965 Mandatory HACCP Regulations for Manufacturers of Rendered Products................... 0910-AB72
966 Surgeon's and Patient Examination Gloves; Reclassification........................... 0910-AB74
967 Current Good Manufacturing Practices for Blood and Blood Components: Notification of 0910-AB76
Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HCV
Infection.............................................................................
968 Antibiotic Resistance Labeling....................................................... 0910-AB78
969 Fixed-Combination Dosage Form Prescription Drugs for Human Use....................... 0910-AB79
970 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications............... 0910-AB80
971 Repackaging Approval Requirements.................................................... 0910-AB81
972 Stability Testing of Drug Substances and Drug Products............................... 0910-AB82
973 Postmarketing Studies for Human Drugs and Licensed Biological Products: Status 0910-AB83
Reports...............................................................................
974 Amendment of Various Food Additive and Device Regulations to Reflect Current American 0910-AB84
Society for Testing and Materials Citations...........................................
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Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
975 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal 0910-AA02
Drug and Patent Term Restoration Act (GADPTRA)........................................
976 Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and 0910-AA08
Clarifications........................................................................
977 Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for 0910-AA43
Juices................................................................................
978 Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished 0910-AA45
Pharmaceuticals.......................................................................
979 Bioavailability and Bioequivalence Requirements...................................... 0910-AA51
980 Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant; 0910-AA74
Labeling Requirements; Warning Statement..............................................
981 New Drug Applications; Drug Master File.............................................. 0910-AA78
982 Over-the-Counter Human Drugs; Labeling Requirements.................................. 0910-AA79
983 Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening 0910-AA84
Illnesses.............................................................................
984 Sterility Requirements for Inhalation Solution Products.............................. 0910-AA88
985 Current Good Manufacturing Practice; Revision of Certain Labeling Controls........... 0910-AA98
986 Definition of Substantial Evidence................................................... 0910-AB08
987 New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification 0910-AB12
988 Medicated Feed Mill Licenses......................................................... 0910-AB18
989 Public Information; Communications With State and Foreign Government Officials....... 0910-AB22
990 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........................................................
991 Biological Products Regulated Under Section 351 of the Public Health Service Act; 0910-AB29
Implementation of Biologics License; Elimination of Establishment License and Product
License...............................................................................
992 Revisions to the General Safety Requirements for Biological Products; Direct Final 0910-AB51
Rule..................................................................................
993 Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring....................... 0910-AB52
994 Bulk Drug Substances for Use in Pharmacy Compounding................................. 0910-AB57
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
995 Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality 0910-AA04
Factors, Notification Requirements, and Records and Reports...........................
996 Biological Products: Reporting of Errors and Accidents in Manufacturing.............. 0910-AA12
997 Food Labeling Review................................................................. 0910-AA19
998 Medical Foods........................................................................ 0910-AA20
999 Classification of Computer Software Programs That Are Medical Devices................ 0910-AA41
1000 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution... 0910-AA49
1001 Reinventing FDA Food Regulations..................................................... 0910-AA58
1002 Dietary Supplement Regulations in Response to DSHEA.................................. 0910-AA59
1003 Debarment Certification Regulations for Drug Applications............................ 0910-AA76
1004 Investigational New Drug Applications; Request for Information and Comments.......... 0910-AA83
1005 Investigational Use New Animal Drug Regulations...................................... 0910-AB02
1006 Establishment Registration and Listing of Human Cellular and Tissue-Based Products... 0910-AB05
1007 Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless 0910-AB17
Tobacco To Protect Children and Adolescents; Use of Nontobacco Trade or Brand Names...
1008 Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco 0910-AB19
Requirements; Applications for Exemption Submitted by Various State Governments; Group
1; Group 2............................................................................
1009 Citizen Petitions; Actions That Can Be Requested by Petition; Summary Denial; and 0910-AB73
Referral for Other Administrative Action..............................................
----------------------------------------------------------------------------------------------------------------
Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1010 Review of Warnings, Use Instructions, and Precautionary Information Under Section 314 0910-AA14
of the National Childhood Vaccine Injury Act of 1986..................................
[[Page 21200]]
1011 Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products....... 0910-AA26
1012 Amalgam Ingredient Labeling.......................................................... 0910-AA33
1013 Prescription Drug Product Labeling; Medication Guide................................. 0910-AA37
1014 Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent 0910-AA75
Requirements..........................................................................
1015 Animal Drug Approvals for Minor Species and Minor Usage.............................. 0910-AB07
1016 Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New 0910-AB20
Drugs and Biological Products in Pediatric Patients...................................
1017 Dissemination of Treatment Information on Unapproved Uses for Marketed Drugs and 0910-AB23
Devices...............................................................................
1018 Revocation of Antibiotic Certification Requirements; Conforming Revisions to 0910-AB32
Regulations...........................................................................
1019 List of Drugs That Have Been Withdrawn or Removed From the Market for Reasons of 0910-AB40
Safety and Effectiveness..............................................................
1020 Clinical Hold; Streamlining Clinical Research........................................ 0910-AB41
1021 Medical Devices; IDE Modifications................................................... 0910-AB53
1022 Dispute Resolution................................................................... 0910-AB54
1023 Effective Date of Approval of an Abbreviated New Drug Application.................... 0910-AB64
1024 Mutual Recog. of Pharmaceutical Good Manufacturing Inspection Rpts., Med. Device 0910-AB75
Quality Sys. Audit Rpts., and Certain Medical Device Product Eval. Rpts.; the U.S. and
the European Community................................................................
1025 Financial Disclosure by Clinical Investigators....................................... 0910-AB77
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1026 National Practitioner Data Bank for Adverse Information on Physicians and Other 0906-AA41
Health Care Practitioners: Corporate Shield...........................................
1027 Designation of Medically Underserved Populations and Health Professional Shortage 0906-AA44
Areas.................................................................................
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1028 National Practitioner Data Bank for Adverse Information on Physicians and Other 0906-AA42
Health Care Practitioners: Charge for Self-Queries....................................
1029 National Practitioner Data Bank for Adverse Information on Physicians and Other 0906-AA43
Health Care Practitioners: Reporting Adverse and Negative Actions.....................
1030 National Practitioner Data Bank for Adverse Information on Physicians and Other 0906-AA48
Health Care Providers: Clarification and Modernization of Regulatory Terms............
----------------------------------------------------------------------------------------------------------------
Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1031 Indian Child Protection and Family Violence Prevention Act Minimum Standards of 0917-AA02
Character.............................................................................
----------------------------------------------------------------------------------------------------------------
Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1032 Currently Effective Indian Health Service Eligibility Regulations.................... 0917-AA03
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[[Page 21201]]
National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1033 National Institutes of Health AIDS Research Loan Repayment Program................... 0925-AA02
1034 Undergraduate Scholarship Program Regarding Professions Needed by the NIH............ 0925-AA10
1035 National Research Service Awards..................................................... 0925-AA16
1036 Removal of National Cancer Institute Clinical Cancer Education Program............... 0925-AA17
1037 National Institutes of Health Loan Repayment Program for Research.................... 0925-AA18
1038 National Institute of Child Health and Human Development Contraception and 0925-AA19
Infertility Research Loan Repayment Program...........................................
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National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1039 National Institutes of Health Construction Grants.................................... 0925-AA04
1040 Traineeships......................................................................... 0925-AA11
1041 Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects 0925-AA14
in Research, and Pertaining to Human In Vitro Fertilization...........................
1042 Scientific Peer Review of Research Grant Applications and Research and Development 0925-AA20
Contract Projects.....................................................................
1043 Federal Policy (Common Rule) for the Protection of Human Subjects.................... 0925-AA21
1044 Service Fellowships.................................................................. 0925-AA22
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1045 National Institutes of Health Clinical Research Loan Repayment Program for 0925-AA09
Individuals From Disadvantaged Backgrounds............................................
----------------------------------------------------------------------------------------------------------------
Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1046 Public Health Service Standards for the Protection of Research Misconduct 0940-AA01
Whistleblowers........................................................................
----------------------------------------------------------------------------------------------------------------
Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1047 Standards of Compliance for Abortion-Related Services in Family Planning Service 0940-AA00
Projects..............................................................................
----------------------------------------------------------------------------------------------------------------
Office of Assistant Secretary for Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1048 Standards of Compliance for Abortion-Related Services in Family Planning Service 0937-AA00
Projects..............................................................................
----------------------------------------------------------------------------------------------------------------
[[Page 21202]]
Public Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1049 Public Health Service Standards for the Protection of Research Misconduct 0905-AE71
Whistleblowers........................................................................
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1050 Medicare Coverage of Heart, Liver, and Lung Transplantation (HCFA-3835-PN)........... 0938-AH17
1051 Children's Health Insurance: Program Implementation; State Plan Approval; State 0938-AI28
Payment; Coordination With State Medicaid Program (HCFA-2006-P).......................
1052 Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for 0938-AI49
Medicare Billing Privileges (HCFA-6003-P).............................................
1053 Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR)....................... 0938-AI72
1054 Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests; Intent 0938-AI92
To Form Negotiated Rulemaking Committee (HCFA-3250-NOI)...............................
1055 Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--Third 0938-AJ37
Quarter, 1998 (HCFA-9000-N)...........................................................
1056 Recognition of the Community Health Accreditation Program, Inc., (CHAP), (HCFA-2029- 0938-AJ42
FN)...................................................................................
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Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1057 Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure 0938-AG44
Breathing Machine Therapy (HCFA-3781-FN)..............................................
1058 Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F)... 0938-AG48
1059 CLIA Program: Categorization of Waived Tests (HCFA-2225-FC).......................... 0938-AG99
1060 Additional Supplier Standards (HCFA-6004-F).......................................... 0938-AH19
1061 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer- 0938-AH48
Based Group Health Plans (HCFA-2047-FC)...............................................
1062 Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)............... 0938-AH53
1063 Utilization Control and Discontinued Review Activities; Medicaid (HCFA-2101-FC)...... 0938-AH64
1064 Individual Market Health Ins. Reform Portability From Group to Indiv. Coverage; 0938-AH75
Federal Rules for Access in the Indiv. Market; State Alternative Mechanisms to Federal
Rules (HCFA-2882-F)...................................................................
1065 Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical 0938-AH81
Procedures for Ambulatory Surgical Centers Effective for Calendar Year 1998 (HCFA-1885-
F)....................................................................................
1066 Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC).................. 0938-AH92
1067 Medicare+Choice Program (HCFA-1030-F)................................................ 0938-AI29
1068 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled 0938-AI47
Nursing Facilities. (HCFA-1913-IFC)...................................................
1069 Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab. 0938-AI48
Agencies, Community Mental Health Centers, and Independent Diagnostic Testing
Facilities (HCFA-6005-P)..............................................................
1070 Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)................... 0938-AI67
1071 Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-F)................ 0938-AI83
1072 Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-IFC)........... 0938-AI93
1073 Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the 0938-AJ10
Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)..................
1074 Establishment of a Program To Collect Suggestions for Improving Medicare Program 0938-AJ30
Efficiency and To Reward Suggestors (HCFA-4000-FC)....................................
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1075 Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F)....................... 0938-AB50
[[Page 21203]]
1076 Changes to Peer Review Organization Regulations (HCFA-3135-F)........................ 0938-AD38
1077 Omnibus Nursing Home Reform Requirements (HCFA-3488-F)............................... 0938-AD81
1078 ``Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare 0938-AD95
Overpayment Liability (HCFA-1719-P)...................................................
1079 Protection of Income and Resources for Community Spouses of Institutionalized 0938-AE12
Individuals (HCFA-2023-P).............................................................
1080 Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F). 0938-AE39
1081 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028- 0938-AE72
F)....................................................................................
1082 Payment for Nursing and Allied Health Science Education (HCFA-1685-F)................ 0938-AE79
1083 Coverage of Screening Pap Smears (HCFA-3705-F)....................................... 0938-AE98
1084 Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC)................. 0938-AF02
1085 Case Management (HCFA-2027-F)........................................................ 0938-AF07
1086 Requirements for Certain Health Insuring Organizations and OBRA '90 Technical 0938-AF15
Amendments (HCFA-1018-F)..............................................................
1087 Provider Reimbursement Determinations and Appeals (HCFA-1727-P)...................... 0938-AF28
1088 Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)........................ 0938-AF32
1089 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC). 0938-AF42
1090 Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F).... 0938-AF68
1091 Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, 0938-AF69
Infants, and Children Under Age 19 (HCFA-2052-F)......................................
1092 Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)........ 0938-AF87
1093 Revised Medicaid Management Information Systems (HCFA-2038-FN)....................... 0938-AG10
1094 Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P).................... 0938-AG31
1095 Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth 0938-AG32
Scope of Work Contracts (HCFA-3207-N).................................................
1096 Disclosure of Confidential PRO and ESRD Network Organization Information for Research 0938-AG33
Purposes (HCFA-3208-P)................................................................
1097 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, 0938-AG59
Underpayments and Overpayments (HCFA-2215-P)..........................................
1098 Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With 0938-AG72
Tuberculosis (HCFA-2082-P)............................................................
1099 Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F)..... 0938-AG79
1100 Physicians' Referrals to Health Care Entities With Which They Have Financial 0938-AG80
Relationships--Expanded to Designated Health Services (HCFA-1809-F)...................
1101 Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)................... 0938-AG81
1102 End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P)................. 0938-AG82
1103 Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening 0938-AG84
of Applicants for Nursing Home Admission (HCFA-3815-P)................................
1104 Liability for Third Parties To Pay for Care and Services (HCFA-2080-P)............... 0938-AH01
1105 Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F).... 0938-AH15
1106 Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical 0938-AH16
Equipment (DME) and Home Health (HCFA-1834-P).........................................
1107 State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)..................... 0938-AH24
1108 Hospice Care--Conditions of Participation (HCFA-3844-P).............................. 0938-AH27
1109 CLIA Program; Cytology Proficiency Testing (HCFA-2233-N)............................. 0938-AH35
1110 Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA- 0938-AH37
1843-P)...............................................................................
1111 Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC).... 0938-AH49
1112 Limitations on Liability (HCFA-4859-FC).............................................. 0938-AH51
1113 Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P)................. 0938-AH52
1114 Revision to Accrual Basis of Accounting Policy (HCFA-1876-F)......................... 0938-AH61
1115 Medicaid; Estate Recoveries (HCFA-2083-P)............................................ 0938-AH63
1116 Medicaid Hospice Care (HCFA-2016-P).................................................. 0938-AH65
1117 Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance 0938-AH66
(HCFA-1848-P).........................................................................
1118 Medicare Technical Conforming Amendments (HCFA-1858-FC).............................. 0938-AH67
1119 Elimination of Certain Requirements for Peer Review Organizations in the Utilization 0938-AH68
and Quality Review Process and a Change in the Length of Peer Review Organization
Contracts (HCFA-3235-FC)..............................................................
1120 Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)...................... 0938-AH69
1121 Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities 0938-AH72
Participating in an Experiment (HCFA-2236-GNC)........................................
1122 Provider and Supplier Enrollment Periodic Renewal of Eligibility Requirements (HCFA- 0938-AH73
6002-P)...............................................................................
1123 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)... 0938-AH83
1124 Disclosure of Peer Review Organization Information in Response to Beneficiary 0938-AH85
Complaints (HCFA-3241-P)..............................................................
[[Page 21204]]
1125 National Standard for Identifiers of Health Plans (HCFA-4145-P)...................... 0938-AH87
1126 Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review 0938-AH89
Program (HCFA-2107-P).................................................................
1127 Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services 0938-AH95
(HCFA-2043-P).........................................................................
1128 Revision to the Definition of an Unemployed Parent (HCFA-2106-FC).................... 0938-AH98
1129 National Standard Health Care Provider Identifier (HCFA-0045-F)...................... 0938-AH99
1130 Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F). 0938-AI08
1131 Medicare Program; Medicare Integrity Program (HCFA-7020-F)........................... 0938-AI09
1132 Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries 0938-AI11
Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).......................................
1133 Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage 0938-AI13
Decisions--Second Quarter, 1998 (HCFA-9002-N).........................................
1134 Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and 0938-AI16
Sustainable Growth Rate for Fiscal Year 1998 (HCFA-1893-FN)...........................
1135 Medicaid: Medical Child Support (HCFA-2081-P)........................................ 0938-AI21
1136 GME: Incentive Payments Under Plans for Voluntary Reduction in Number of Residents 0938-AI27
(HCFA-1001-IFC).......................................................................
1137 Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F). 0938-AI38
1138 Medicare/Medicaid Program; User Fees (HCFA-6021-P)................................... 0938-AI46
1139 Security and Electronic Signature Standards (HCFA-0049-F)............................ 0938-AI57
1140 Standards for Electronic Transactions (HCFA-0149-F).................................. 0938-AI58
1141 National Standard Employer Identifier (HCFA-0047-F).................................. 0938-AI59
1142 State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)........ 0938-AI63
1143 Recognition of the Community Health Accreditation Program, Inc. (CHAP) and Joint 0938-AI69
Commission for Accreditation of Healthcare Organizations (JCAHO) for Hospices (HCFA-
2029-PN)..............................................................................
1144 Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions of 0938-AI70
the Balanced Budget Act of 1997 (HCFA-2001-P).........................................
1145 Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC). 0938-AI73
1146 Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P).......... 0938-AI74
1147 Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan 0938-AI75
(HCFA-1777-P).........................................................................
1148 Medicare Hospice Care (HCFA-1022-P).................................................. 0938-AI77
1149 Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and 0938-AI80
Elimination of Reclassifications (HCFA-1883-P)........................................
1150 Medicare Program; Standardization of Medicare Coverage for Bone Mass Measurements 0938-AI89
(HCFA-3004-IFC).......................................................................
1151 Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI)............. 0938-AI91
1152 Peer Review Organization Contracts: Solicitation of Statements of Interest From In- 0938-AI99
State Organizations (HCFA-3009-N).....................................................
1153 Replacement of Reasonable Charge Methodology by Fee Schedules (HCFA-1010-P).......... 0938-AJ00
1154 External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-P)......... 0938-AJ06
1155 HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-2025- 0938-AJ07
N)....................................................................................
1156 Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--First Quarter 0938-AJ12
1998 (HCFA-9879-N)....................................................................
1157 Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier 0938-AJ15
Performance: Millennium Compliance (HCFA-4002-GNC)....................................
1158 Rural Health Clinics: Amendments to Participation Requirements and Payment 0938-AJ17
Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
1910-P)...............................................................................
1159 Home Health Prospective Payment System (HCFA-1102-FC)................................ 0938-AJ24
1160 Medicare Program State Allotments for Payments of Medicare Part B Premium for 0938-AJ28
Qualifying Individuals: Federal Fiscal Year for 1999 (HCFA-2032-N)....................
1161 Hospital Conditions of Participation: Laboratory Services (HCFA-3 014-P)............. 0938-AJ29
1162 Medicare Program; Procedures for Making Medical Services National Coverage Decisions 0938-AJ31
(HCFA-3432-FNC).......................................................................
1163 Medicare Program; Special Payment Limits for Certain Durable Medical Equipment and 0938-AJ34
Prosthetic Devices (HCFA-1050-PN).....................................................
1164 Medicaid Program; Civil Money Penalties for Nursing Homes (SNF/NF), Change in Notice 0938-AJ35
Requirements, and Expansion of Discretionary Remedy (HCFA-2035-FC)....................
1165 Medicare Hospice Care (HCFA-1022-P).................................................. 0938-AJ36
1166 Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-FC).................... 0938-AJ39
1167 Recognition of the Joint Commission for Accreditation of Healthcare Organizations 0938-AJ41
(JCAHO for Hospices) (HCFA-2039-FN)...................................................
1168 Decision on the Funding for the AIDS Healthcare Foundation START Program, (HCFA-2041- 0938-AJ43
N)....................................................................................
1169 Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC)..... 0938-AJ44
[[Page 21205]]
1170 Accelerated Payments to Providers Furnishing Services Under Medicare Part A and Part 0938-AJ45
B and Advance Payments to Suppliers Furnishing Items or Services Under Medicare Part B
(HCFA-1066-FC)........................................................................
1171 Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of 0938-AJ47
1988 Exemption of Laboratories in the State of California (HCFA-2245-N)...............
1172 Federal Enforcement in Group and Individual Health Insurance Markets (HCFA-2019-FC).. 0938-AJ48
1173 Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2000 0938-AJ50
Rates (HCFA-1053-P)...................................................................
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1174 Deduction of Incurred Medical Expenses (Spenddown) (HCFA-2020-F)..................... 0938-AB07
1175 Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge 0938-AC58
Rights Notice, and Hospital Responsibility for Emergency Care (HCFA-1393-IFC).........
1176 Criteria and Procedures for Developing Medical Services Coverage Policy (HCFA-3546-F) 0938-AD07
1177 Medicare Secondary Payer for Disabled Individuals (HCFA-1482-F)...................... 0938-AD73
1178 Revisions to Regulations Implementing CLIA (HCFA-2226-F)............................. 0938-AE47
1179 Medicare Coverage of, and Application of the Outpatient Mental Health Treatment 0938-AE99
Limitation to, Clinical Psychologist and Clinical Social Worker Services (HCFA-3706-F)
1180 Revisions to Rules on Health Care Prepayment Plans (HCFA-1016-P)..................... 0938-AF97
1181 Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and 0938-AF98
Competitive Medical Plans (HCFA-1015-F)...............................................
1182 Payment for Preadmission Services (HCFA-1731-F)...................................... 0938-AG00
1183 Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions 0938-AG05
and Establishment of a Quality Assessment and Performance Improvement Program (HCFA-
1910-P)...............................................................................
1184 Request for Assessment on the Salitron System for the Treatment of Xerostomia 0938-AG45
Secondary to Sjogren's Syndrome (HCFA-3782-NC)........................................
1185 Clinical Laboratory Improvement Amendment (CLIA) Fee Schedule Revision (HCFA-3219- 0938-AG87
GNC)..................................................................................
1186 Categorization and Certification Requirements for a New Subcategory of Moderate 0938-AG98
Complexity Testing (HCFA-2222-F)......................................................
1187 Ambulance Services (HCFA-1813-F)..................................................... 0938-AH13
1188 Criteria and Procedures for Extending Coverage to Certain Devices and Related 0938-AH21
Services (HCFA-3841-F)................................................................
1189 Delegation of Civil Money Penalties (HCFA-6135-FC)................................... 0938-AH22
1190 Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating 0938-AH50
Physicians (HCFA-1862-P)..............................................................
1191 Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998 0938-AH55
Rates (HCFA-1878-F)...................................................................
1192 Conditions for Certification of Community Mental Health Centers and Coverage 0938-AH58
Requirements for Partial Hospitalization Services (HCFA-1871-P).......................
1193 Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform 0938-AH76
(HCFA-2105-IFC).......................................................................
1194 Medicare Program; Beneficiary Incentive Programs (HCFA-6144-FC)...................... 0938-AH86
1195 Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB- 0938-AH90
103-N)................................................................................
1196 Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal 0938-AH93
Fiscal Year 1998 (HCFA-2110-N)........................................................
1197 Medicare Coverage of Certified Nurse-Midwife Services (HCFA-1496-P).................. 0938-AH96
1198 Health Insurance Reform: Parity in the Application of Certain Limits to Mental Health 0938-AI05
Benefits (HCFA-2891-IFC)..............................................................
1199 Part A Premium for 1998 for the Uninsured Aged and for Certain Disabled Individuals 0938-AI10
Who Have Exhausted Other Entitlement (HCFA-5056-N)....................................
1200 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance 0938-AI12
Amounts for 1998 (HCFA-5057-N)........................................................
1201 Health Insurance Portability: Newborns' and Mothers' Health Protection (HCFA-2892- 0938-AI17
IFC)..................................................................................
1202 Medicaid Program: Charges for Vaccine Administration Under the Vaccines for Children 0938-AI20
(VCF) Program (HCFA-2084-FNC).........................................................
1203 Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999 0938-AI22
Rates (HCFA-1003-P)...................................................................
1204 Medicare Program; Notice for the Solicitation for Proposals for a Case Management 0938-AI26
Demonstration Project Focused on Congestive Heart Failure or Diabetes Mellitus (HCFA-
1104-N)...............................................................................
1205 Collection of User Fees From Medicare+Choice Plans and Risk-Sharing Contractors (HCFA- 0938-AI35
1911-IFC).............................................................................
1206 Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for 0938-AI39
Qualified Individuals: Federal Fiscal Year 1998 (HCFA-2005-NC)........................
[[Page 21206]]
1207 Medicare Program: Payments for Teleconsultations in Rural Health Professional 0938-AI44
Shortage Areas (HCFA-1906-F)..........................................................
1208 Review and Payment for Claims Filed on Behalf of Medicare/Medicaid Dually Eligible 0938-AI50
Beneficiaries (HCFA-2097-3)...........................................................
1209 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for 0938-AI52
Calendar Year 1999 (HCFA-1006-FC) (HCFA-1006-P).......................................
1210 Medicare Program; Prospective Payment System for Hospital Outpatient Services (HCFA- 0938-AI56
1005-P)...............................................................................
1211 Medicare Program; Definition of Provider-Sponsored Organization and Related 0938-AI60
Requirements (HCFA-1027-IFC)..........................................................
1212 Child Health Insurance Allotments FY 1999 (HCFA-2014-N).............................. 0938-AI64
1213 State Children's Health Insurance Program Allotments and Payments to States (HCFA- 0938-AI65
2114-P)...............................................................................
1214 DSH Payments - Institution for Mental Disease (HCFA-2012-N).......................... 0938-AI66
1215 New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a) 0938-AI71
of the Social Security Act July, August, September, October, and November 1997........
1216 Medicare Program; Advertising Costs (HCFA-1880-P).................................... 0938-AI76
1217 State Allotments for Additional Federal Funding of Emergency Health Services 0938-AI78
Furnished to Undocumented Aliens: Federal Fiscal Years 1998 Through (HCFA-2000-N).....
1218 Medicaid Program; Extension of Waiver To Extend Medicaid Eligibility Timeframes (HCFA- 0938-AI79
2009-N)...............................................................................
1219 Medicare and Medicaid Programs; Surety Bond Requirements for Home Health Agencies 0938-AI82
(HCFA-1038-NC)........................................................................
1220 Schedule of Per-Beneficiary Limitations on Home Health Agency Costs for Cost 0938-AI84
Reporting Periods Beginning On or After October 1, 1997 (HCFA-1905-FC)................
1221 Expanded Coverage of Blood Glucose Monitors and Test Strips (HCFA-3003-IFC).......... 0938-AI85
1222 Medicare Program; Hospice Wage Index (HCFA-1039-N)................................... 0938-AI87
1223 Recognition of the American Association for Accreditation of Ambulatory Surgery 0938-AI90
Facilities, Inc. for Ambulatory Surgical Centers Program (HCFA-2008-PN)...............
1224 Medicaid, Medicare CLIA Program; Extension of Certain Effective Dates for Clinical 0938-AI94
Laboratory Requirements Under CLIA (HCFA 2024-IFC)....................................
1225 Hospital Conditions of Participation, Identification of Potential Organ, Tissue, and 0938-AI95
Eye Donor and Transplant Hospitals Provisions of Transplant Related Data (HCFA-3005-F)
1226 Expanded Coverage for Diabetes Outpatient Self-Management Training Services (HCFA- 0938-AI96
3002-P)...............................................................................
1227 Medicare Program; Monthly Actuarial Rates and Monthly Supplementary Medical Insurance 0938-AI98
Premium Rate Beginning January 1, 1999 (HCFA-8003-N)..................................
1228 Notice Announcing Revised Positron Emission Tomography (PET) Policy (HCFA-3008-NC)... 0938-AJ01
1229 Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care 0938-AJ02
Services Coinsurance Amounts for 1999 (HCFA-8001-N)...................................
1230 Medicare Program; Part A Premium for 1999 for the Uninsured Aged and for Certain 0938-AJ03
Disabled Individuals Who Have Exhausted Other Entitlement (HCFA-8000-N)...............
1231 Inpatient Psychiatric Services Benefit for Individuals Under Age 21 (HCFA-2060-F).... 0938-AJ05
1232 Physician Sustainable Growth Rate of Increase for FY 1999 (HCFA-1021-FN)............. 0938-AJ09
1233 Comprehensive Assessment and Use of OASIS as Part of Conditions of Participation for 0938-AJ11
Home Health Agencies (HCFA-3007-F)....................................................
1234 Request for Public Comments on Implementation of Risk Adjusted Payment for the 0938-AJ16
Medicare+Choice Program and Notice of Public Meeting..................................
1235 Adjustments to Payment Amount for Erythropoietin/Epoietin for End-Stage Renal Disease 0938-AJ18
Patients (HCFA-1098-PN)...............................................................
1236 Recognition of the Commission for Accreditation of Rehabilitation Facilities (HCFA- 0938-AJ25
2036-NC)..............................................................................
1237 Medicare Program; Limited Additional Opportunity to Request Certain Hospital Wage 0938-AJ26
Data Revisions for FY 1999 (HCFA-1049-FC).............................................
1238 Request for Nominations for Members for Practicing Physicians Advisory Council (HCFA- 0938-AJ27
1048-N)...............................................................................
1239 Medicare and Medicaid Programs; Announcement of Additional Application From Hospitals 0938-AJ32
Requesting Waivers for Organ Procurement Service Area (HCFA-1062-N)...................
1240 Medicare Program; January 6, 1999, Meeting of the Competitive Pricing Advisory 0938-AJ33
Committee (HCFA-1061-N)...............................................................
1241 Medicare Program; March 15, 1999, Meeting of the Practicing Physician Advisory 0938-AJ38
Council (HCFA-1064-N).................................................................
1242 March 9, April 8, and May 12, 1999 Meetings of the Kansas City Metropolitan Area, 0938-AJ46
Competitive Pricing Demonstration Area Advisory Committee (HCFA-1068-N)...............
1243 Medicare Coordinated Care Demonstration Project and Request for Comments on Potential 0938-AJ49
Best Practices of Coordinated Care (HCFA-1100-N)......................................
----------------------------------------------------------------------------------------------------------------
[[Page 21207]]
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1244 Construction of Head Start Facilities................................................ 0970-AB54
1245 Bonus To Reward High Performance States Under the Temporary Assistance for Needy 0970-AB66
Families Block Grant..................................................................
1246 Child Support Enforcement for Indian Tribes.......................................... 0970-AB73
1247 Incentive Payments and Audit Penalties to States and Political Subdivisions.......... 0970-AB85
1248 Family Child Care Program Option for Head Start Programs............................. 0970-AB90
1249 Implementation of AFCARS Corrective Action and Penalties and CAPTA Amendments........ 0970-AB94
1250 State Self Assessments To Determine Compliance With Federal Regulations.............. 0970-AB96
1251 Priority for Previously Selected Headstart Agencies.................................. 0970-AB98
1252 Program Performance Standards for the Operation of Head Start Programs............... 0970-AB99
1253 Safeguarding Child Support and Expanded FPLS Information............................. 0970-AC01
1254 Assets for Independence Reserve Account.............................................. 0970-AC02
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1255 Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan 0970-AA97
Reviews, MEPA Implementation, and ASFA Implementation.................................
1256 Standards for Safe Transportation.................................................... 0970-AB24
1257 Methodology for Determining Whether an Increase in a State's Child Poverty Rate Is 0970-AB65
the Result of the TANF Program........................................................
1258 Temporary Assistance for Needy Families (TANF)....................................... 0970-AB77
1259 Requirements for the Tribal Programs................................................. 0970-AB78
1260 Bonus to Reward Decrease in Illegitimacy Ratio....................................... 0970-AB79
1261 Child Support Enforcement Program Omnibus Conforming Regulation...................... 0970-AB81
1262 Refugee Resettlement Program: Public/Private Partnership............................. 0970-AB83
1263 Head Start Appeal Timelines.......................................................... 0970-AB87
1264 Welfare-to-Work Data Collection...................................................... 0970-AB92
1265 National Medical Support Notice...................................................... 0970-AB97
1266 Technical Revision of Head Start Regulations to Make Them Conform to Recent Statutory 0970-AC00
Revisions.............................................................................
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1267 Standards for Purchase of Facilities................................................. 0970-AB31
1268 State Law Concerning Paternity Establishment......................................... 0970-AB69
1269 Grants to States for Access and Visitation Programs.................................. 0970-AB72
1270 Case Closure......................................................................... 0970-AB82
----------------------------------------------------------------------------------------------------------------
Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1271 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 & Native Hawaiians............................................................
----------------------------------------------------------------------------------------------------------------
[[Page 21208]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
905. PRIVACY ACT EXEMPT RECORD SYSTEM FROM THE HEALTHCARE
INTEGRITY AND PROTECTION DATA BANK
Priority: Substantive, Nonsignificant
Legal Authority: 5 USC 552a
CFR Citation: 45 CFR 56
Legal Deadline: None
Abstract: This proposed rule would exempt the new system of records for
the Healthcare Integrity and Protection Data Bank (HIPDB) from certain
provisions of the Privacy Act (5 U.S.C. 552a). The proposed exemption
being set forth would apply to investigative materials compiled for law
enforcement purposes in anticipation of civil, criminal or
administrative proceedings.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
NPRM Comment Period End 08/00/99
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 the
Inspector General, OIG, 330 Independence Avenue SW., Washington, DC
20201
Phone: 202 619-0089
RIN: 0991-AA99
_______________________________________________________________________
906. REVISION OF HHS FREEDOM OF INFORMATION ACT REGULATIONS
Priority: Other Significant
Legal Authority: 5 USC 552; 18 USC 1905; 42 USC 1306(C)
CFR Citation: 45 CFR 5
Legal Deadline: None
Abstract: This proposal responds to 1996 statutory amendments and it
reflects organizational changes within HHS. Under the proposal, we will
make records available in the form and format identified by the
requester regardless of how the record already exists, when the
requested record is ``readily reproducible'' in the requested form or
format.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/26/99 64 FR 14668
NPRM Comment Period End 05/26/99
Final Action 09/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Rosario Cirrincione, Director, Freedom of Information
and Privacy, Acts Division, OASPA, Department of Health and Human
Services, Office of the Secretary, 200 Independence Avenue SW.,
Washington, DC 20201
Phone: 202 690-7453
Fax: 202 690-8320
RIN: 0991-AB01
_______________________________________________________________________
907. 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 health maintenance organizations and
competitive medical plans 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 09/00/99
NPRM Comment Period End 11/00/99
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer, Regulatory Officer, Department of
Health and Human Services, Office of the Secretary, Office of the
Inspector General, OIG, 330 Independence Avenue SW., Washington, DC
20201
Phone: 202 619-0089
RIN: 0991-AB03
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
908. CLARIFICATION OF THE INITIAL OIG SAFE HARBOR PROVISIONS AND
ESTABLISHMENT OF ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-
KICKBACK STATUTE
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: PL 100-93, sec 2; PL 100-93, sec 14
CFR Citation: 42 CFR 1001
Legal Deadline: None
Abstract: This final rule serves both to clarify various aspects of the
original safe harbor provisions and to add new safe harbors as
authorized under section 14 of PL 100-93. Specifically, this rule
modifies the original set of final safe harbor provisions (56 FR 35952,
7/29/91) to give greater clarity to the rulemaking's original intent.
In addition, this rule sets forth an expanded listing of safe harbor
provisions designed to protect additional payment and business
practices from criminal prosecution and civil sanctions under the anti-
kickback statute.
[[Page 21209]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/21/93 58 FR 49008
NPRM Comment Period End 11/22/93
Final Action 09/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Additional Information: This final rule incorporates the safe harbor
clarification provisions previously addressed in RIN 0991-AA74 and set
forth in proposed rulemaking (59 FR 37202, July 21, 1994).
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-AA66
_______________________________________________________________________
909. REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS
Priority: Info./Admin./Other
Legal Authority: PL 103-296, sec 312 (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. That section amends existing prohibitions against
``misuse of symbols, emblems, or names in reference to Social Security
or Medicare.'' Section 312 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 12/00/99
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: 202 690-8291
RIN: 0991-AA83
_______________________________________________________________________
910. REVISED OIG CIVIL MONEY PENALTIES RESULTING FROM PUBLIC LAW 104-191
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-191, sec 231(a); PL 104-191, sec 231(b); PL
104-191, sec 231(c); PL 104-191, sec 231(d); PL 104-191, sec 231(e); PL
104-191, sec 231(h); PL 104-191, sec 232
CFR Citation: 42 CFR 1003; 42 CFR 1005; 42 CFR 1006
Legal Deadline: None
Abstract: This final rule will revise the OIG's civil money penalty
provisions in conjunction with new and revised authorities set forth in
the Health Insurance Portability and Accountability Act of 1996. Among
other provisions, this final rulemaking would codify new civil money
penalties for (1) excluded individuals retaining ownership or control
interest in an entity; (2) upcoding and claims for medically
unnecessary services; (3) offering inducements to beneficiaries; and
(4) false certification of eligibility for home health services.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/25/98 63 FR 14393
NPRM Comment Period End 05/26/98
Final Action 09/00/99
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-AA90
_______________________________________________________________________
911. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 1302, sec 216; 42 USC 1320a-7b; 42 USC 1395hh
CFR Citation: 41 CFR 1001
Legal Deadline: Final, Statutory, January 1, 1997.
Abstract: This interim final rule will establish 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 would allow
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
which 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 07/00/99
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
_______________________________________________________________________
[[Page 21210]]
912. REVISED OIG SANCTION AUTHORITIES RESULTING FROM PUBLIC LAW 105-33
Priority: Substantive, Nonsignificant
Legal Authority: PL 105-33, sec 4301; PL 105-33, sec 4303; PL 105-33,
sec 4304; PL 105-33, sec 4331(c); PL 105-33, sec 4331(d)
CFR Citation: 42 CFR 1001; 42 CFR 1002; 42 CFR 1003
Legal Deadline: None
Abstract: This final rule will revise the OIG's exclusion and civil
money penalty (CMP) authorities resulting from the Balanced Budget Act
of 1997, Public Law 105-33. This rule will protect and strengthen
Medicare and other Federal health care programs by increasing the OIG's
anti-fraud and abuse authorities through new or revised exclusion and
CMP provisions, including new CMPs (1) against institutional health
care providers that employ, or enter into contracts for medical
services with, excluded individuals; (2) for failure to report
information to the Healthcare Integrity and Protection Data Bank; and
(3) for health care providers who violate the anti-kickback statute.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/02/98 63 FR 46736
NPRM Comment Period End 11/02/98
Final Action 08/00/99
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, 330 Independence
Avenue, OCIG, Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA95
_______________________________________________________________________
913. BLOCK GRANT PROGRAMS
Priority: Info./Admin./Other
Legal Authority: 42 USC 300w et seq; 42 USC 300x et seq; 42 USC 300y
et seq; 42 USC 701 et seq; 42 USC 1243 et seq; 42 USC 1397 et seq; 42
USC 8621 et seq; 42 USC 9901 et seq
CFR Citation: 45 CFR 96
Legal Deadline: None
Abstract: The rule amends the regulations governing the administration
on block grants. It updates current regulations to reflect current name
and statutory petitions. It establishes submission and completion dates
for funding applications from LIHEAP, CSBG and SSSBG. It clarifies that
the department may specify the form of an application where this is
authorized by statute. It requires to submit a obligation and
expenditure for all block grants.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action 04/00/99
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Agency Contact: Mike Herrell, Director, Division of Decision Systems,
Department of Health and Human Services, Office of the Secretary, 200
Independence Avenue SW., Room 447D, Washington, DC 20201
Phone: 202 690-8774
Fax: 202 690-8252
RIN: 0991-AA97
_______________________________________________________________________
914. HEALTH CARE FRAUD AND ABUSE DATA COLLECTION PROGRAM
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1320a-7e
CFR Citation: 42 CFR 61 (New)
Legal Deadline: Final, Statutory, January 1, 1997.
Abstract: This final rule would implement the requirements of section
1128E of the Social Security Act, as added by section 221(a) of the
Health Insurance Portability and Accountability Act of 1996. Section
1128E of the Act directs the Department to establish a national health
care fraud and abuse data collection program for the reporting and
disclosure of certain final adverse actions taken against health care
providers, suppliers and practitioners. The statute also requires the
Department to implement the national health care fraud and abuse data
collection program in such a manner as to avoid with reporting
requirements established for the National Practitioner Data Bank under
the Health Care Quality Improvement Act of 1986.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/30/98 63 FR 58341
NPRM Comment Period End 01/11/99
Final Action 09/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Undetermined
Additional Information: Was previously 0906-AA46.
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-AA98
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
915. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN
INCENTIVE PLANS
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 1001; 42 CFR 1003
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 02/18/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Joel Jay Schaer
Phone: 202 619-0089
RIN: 0991-AA45
_______________________________________________________________________
[[Page 21211]]
916. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO
MEDICARE SUPPLEMENTAL POLICIES
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 1003
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 02/18/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer
Phone: 202 619-0089
RIN: 0991-AA53
_______________________________________________________________________
917. CIVIL MONEY PENALTIES FOR NOTIFYING A HOME HEALTH AGENCY, OR A HOME
OR COMMUNITY-BASED HEALTH CARE CENTER OR PROVIDER, OF A STANDARD SURVEY
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 1003
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 02/18/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer
Phone: 202 619-0089
RIN: 0991-AA79
_______________________________________________________________________
918. CIVIL MONEY PENALTIES FOR FALSE INFORMATION ON DRUG MANUFACTURER
PRICE SURVEYS AND REBATE AGREEMENTS
Priority: Substantive, Nonsignificant
CFR Citation: 42 CFR 1003
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 02/18/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer
Phone: 202 619-0089
RIN: 0991-AA80
_______________________________________________________________________
919. SENIOR BIOMEDICAL RESEARCH SERVICE
Priority: Info./Admin./Other
CFR Citation: 42 CFR 24
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 03/12/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: Federal
Agency Contact: Rosemary Taylor
Phone: 202 690-7358
Fax: 202 690-6758
RIN: 0991-AA82
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
920. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
Priority: Other Significant
CFR Citation: 45 CFR 96
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Withdrawn 02/18/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Agency Contact: Joseph D. Faha
Phone: 301 443-4640
Jim Sayers
Phone: 301 443-3820
RIN: 0930-AA01
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Centers for Disease Control and Prevention (CDC)
_______________________________________________________________________
921. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIALS THAT CONTAIN
OR MAY CONTAIN INFECTIOUS SUBSTANCES
Priority: Other Significant
Legal Authority: 42 USC 216; 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); 42 CFR 72.1; 42 CFR 72.2
Legal Deadline: None
Abstract: The Centers for Disease Control and Prevention proposes to
amend existing regulations located at 42 CFR Part 72 concerning the
interstate shipment of infectious substances in order to clarify and
expand the existing requirements for proper packaging and handling of
these agents. One purpose of the proposed rule is to ensure that all
biological materials that are known or suspected of containing an
infectious substance are packaged for interstate shipment to minimize
the potential for leakage of contents that could contaminate the
environment or come into direct physical contact with persons handling
such packages during transit. A second purpose is to insure receipt of
certain infectious substances. This new regulation will harmonize CDC
regulations with other Federal agencies' regulations and with
international regulations. See ``A'' for additional information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
[[Page 21212]]
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Additional Information: The purpose of this NPRM is to update
regulations governing the packaging, labeling, and shipment of
infectious agents. It is critical that infectious agents be transferred
between labs for high priority diagnostic and research activities.
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. This NPRM is also a critical element of CDC's
bioterrorism plan.
Agency Contact: Dr. Jonathan 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
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________
922. 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 05/00/99
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)
_______________________________________________________________________
923. BLOOD INITIATIVE
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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; 42 USC 300aa-25
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
proposing to amend the biologics regulations by removing, revising, or
updating specific regulations applicable to 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: ``Lookback''
requirements for hepatitis C virus; notification of consignees and end
users of product safety information for plasma derivative products; and
notification of permanently deferred donors; requirements for donor
suitability and testing; viral inactivation. These actions are intended
to help ensure the continued safety of the nation's blood supply.
Timetable:
Minor Changes to Reqs. for CGMP for Blood and Blood Components Direct
Final Rule 06/00/99
Notification of End Users of Plasma Derivative Products ANPRM 06/00/99
Notification of Permanently Deferred Donors NPRM 06/00/99
Reqs. Applicable to Albumin (Human), Plasma Protein Fraction Direct
Final Rule 06/00/99
Requirements for Donor Testing NPRM 06/00/99
Suitability Reqs. for Whole Blood and Source Plasma Donors NPRM To Be
Determined
Viral Inactivation NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Additional Information: See RIN 0910-AB76.
Agency Contact: Steven F. Falter, Director, Regulations and Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Biologics Evaluation and Research (HFM-17),
1401 Rockville Pike, Suite 200N, Rockville, MD 20852
[[Page 21213]]
Phone: 301 827-6210
RIN: 0910-AB26
_______________________________________________________________________
924. PREGNANCY LABELING REVISION
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 358; 21 USC 360; 21 USC 360b; 21 USC 360gg
to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The advance notice of proposed rulemaking will announce that
the Food and Drug Administration is considering ways to revise the
regulatory requirements for the pregnancy labeling subsection of the
labeling requirements for human drugs and biologics. The notice will
make available preliminary proposals for changing the current
requirements and will invite comments on all aspects of the notice.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 05/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB44
_______________________________________________________________________
925. NATURAL RUBBER-CONTAINING DRUGS; USER LABELING
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 358; 21 USC 360; 21 USC 371; 21 USC 374; 21
USC 379; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
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 11/00/99
ANPRM Comment Period End 02/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB56
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
926. OVER-THE-COUNTER (OTC) DRUG REVIEW
Priority: Routine and Frequent
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: 21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 353; 21
USC 355; 21 USC 360a; 21 USC 371a
CFR Citation: 21 CFR 310; 21 CFR 330; 21 CFR 333; 21 CFR 334; 21 CFR
335; 21 CFR 336; 21 CFR 337; 21 CFR 338; 21 CFR 339; 21 CFR 340; 21 CFR
341; 21 CFR 342; 21 CFR 343; 21 CFR 344; 21 CFR 345; ...
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 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.
[[Page 21214]]
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)(Sodium B.) 09/00/99
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.) 10/00/99 Final Action 10/00/
99
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)
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)
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 12/00/99
Aphrodisiac Products ANPRM 10/01/82 (47 FR 43572) NPRM 01/15/85 (50
FR 2168) Final Action 07/07/89 (54 FR 28780)
Aspirin (Heart Labeling Warning) NPRM 10/20/93 (58 FR 54224) Final
Action 06/00/00
Aspirin (Heart Labeling) Final Action 10/23/98 (63 FR 56802)
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)
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)(Diphenhydramine) 08/29/97 (62 FR
45767) Final Action 06/00/99
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) 07/06/89 (54 FR 28442) NPRM (Amendment) 10/02/89 (54 FR
40412) Final Action (Amendment) 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)(Diphenhydramine) 08/29/97 (62 FR 45767) NPRM
(Amendment)(Flammability) 07/20/98 (63 FR 38762) Final Action 09/00/99
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) NPRM
(Amendment)(Ephedrine) 06/00/99
[[Page 21215]]
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) Final
Action (Ephedrine Combo) 06/00/99 Final Action 06/00/99
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 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) NPRM (Phenylpropanolamine) To Be Determined
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 05/00/99
Emetic Products ANPRM 03/21/75 (40 FR 12939) NPRM 09/05/78 (43 FR
39544) Final Action To Be Determined
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 To Be
Determined
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 To Be
Determined
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)
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)
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)
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 (Amdt.)(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) Final Action (Sodium Bicarbonate) 09/00/
99 NPRM (Labeling-revised indications) 12/00/99 Final Action
(Labeling-rev. ind.) 12/00/01
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) NPRM (Unless a doc. tells you)(Wi.) 02/27/97 (62 FR
9024) Final Action (Format/Examples) 03/17/99 (64 FR 13254) Final
Action (Ca/Mg/K/Na) 08/00/99
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 10/00/
99 Final Action (Stim. Laxative) 06/00/00
[[Page 21216]]
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 (Active/Inactive) NPRM To Be Determined
Mercurial (Topical) Products (To be merged w/other rulemkg) ANPRM 01/
05/82 (47 FR 436)
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
To Be Determined
NDA Labeling Exclusivity NPRM 11/09/93 (58 FR 59622) Final Action To
Be Determined
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)
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) ANPRM (Plaque/Gingivitis) 08/00/99 Final Action 12/00/00
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) To Be
Determined
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)
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) 12/00/99
Phenylpropanolamine Products (Labeling) NPRM 02/14/96 (61 FR
3912) Final Action To Be Determined
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) NPRM (Amendment)
04/00/99 Final Action 06/00/99
Quinine for Malaria NPRM 04/19/95 (60 FR 19650) Final Action 03/20/98
(63 FR 13526)
Reporting of Adverse Reactions NPRM 06/00/99
Salicylate (Reye Syndrome) NPRM (Amendment)(Warning) 05/05/93 (58 FR
26886) ANPRM 10/20/93 (58 FR 54228) Final Action (Warning) 10/00/99
Skin Bleaching Products ANPRM 11/03/78 (43 FR 51546) NPRM 09/03/82
(47 FR 39108) NPRM (Reproposed) 12/00/99
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 (Poison Ivy) 06/00/99 Final Action 06/00/99
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) NPRM 04/22/98 (63 FR
19799)
Stimulant (Overindulgence) Products NPRM (Amendment) 12/24/91 (56 FR
66758)
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 05/00/99
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)
Vaginal Contraceptive Products ANPRM 12/12/80 (45 FR 82014) NPRM 02/
03/95 (60 FR 6892) NPRM (Amendment) 12/00/99
Vaginal Drug Products ANPRM 10/13/83 (48 FR 46694) Withdrawal 02/03/
95 (60 FR 5226) NPRM (Douches) 06/00/00
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)
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 (Amendment) To Be
Determined
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AA06.
NOTE: Reinventing government applies only to the Antacid Drug Products
final action.
Agency Contact: Rosemary Cook, Supervisor, Project Management Staff,
Office of Drug Evaluation V, Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research
(HFD-105), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2222
RIN: 0910-AA01
_______________________________________________________________________
[[Page 21217]]
927. 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.
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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 10/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State
Additional Information: Previously reported under RIN 0905-AE46.
Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health (HFZ-215), 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 594-4765
RIN: 0910-AA39
_______________________________________________________________________
928. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 355; 21 USC 371; 21 USC 823; 42 USC 241; 42
USC 257a; 42 USC 290; 42 USC 300
CFR Citation: 21 CFR 291
Legal Deadline: None
Abstract: The proposed rule will revise the regulations under part 291
and title 42 to provide for the certification of narcotic treatment
programs as a basis for fulfilling the Department's requirements of the
Narcotic Addict Treatment Act of 1974. Certification will be based on
accreditation by non-profit accrediting bodies. This new system will
replace the current system which relies solely on direct FDA approval
and inspection for determining whether narcotic treatment programs
comply with Federal treatment standards. The proposed rule will provide
for a transition period for programs operating under the existing
regulatory system.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Nicholas Reuter, Associate Director for International
and Domestic Drug Control, Department of Health and Human Services,
Food and Drug Administration, Office of Health Affairs (HFY-20), 5600
Fishers Lane, Rockville, MD 20857
Phone: 301 827-1696
Fax: 301 443-0232
Email: [email protected]
RIN: 0910-AA52
_______________________________________________________________________
929. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW
DRUG PRODUCTS
Priority: Routine and Frequent
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 21 USC 381; 21
USC 382; 21 USC 393; 42 USC 241; 42 USC 243; 42 USC 262
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 05/00/99
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, Office of
Policy (HF-
[[Page 21218]]
23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]
RIN: 0910-AA61
_______________________________________________________________________
930. ADVERSE DRUG REACTION REPORTING AND RECORDKEEPING REQUIREMENTS FOR
MARKETED OTC 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 358; 21 USC 360; 21 USC 371; 21 USC 374; 21
USC 375; 21 USC 379; 42 USC 216
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 02/00/00
NPRM Comment Period End 05/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA86
_______________________________________________________________________
931. INFORMED CONSENT FOR HUMAN DRUGS AND BIOLOGICS; DETERMINATION THAT
INFORMED CONSENT IS NOT FEASIBLE
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 352; 21 USC 353; 21 USC 355; 21
USC 357; 21 USC 360; 21 USC 371; 21 USC 381; 42 USC 216; 42 USC 241; 42
USC 262
CFR Citation: 21 CFR 50; 21 CFR 314; 21 CFR 601
Legal Deadline: None
Abstract: The Food and Drug Administration is proposing to revoke the
interim final rule which permitted the Commissioner to determine, based
on a request by the Department of Defense, that obtaining informed
consent from military personnel for the use of investigational products
is not feasible in certain military combat situations. The rule was
used to permit a waiver from the informed consent requirements for
pyridostigmine bromide and the botulinum toxoid vaccine during the Gulf
War. The agency is proposing this 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.
At the same time, it will propose to amend its new drug and biological
product regulations to identify the kind of evidence needed to
demonstrate the efficacy of drug and biological products used to treat
or prevent the toxicity of potentially devastating chemical or
biological substances when efficacy studies in humans ethically cannot
be conducted because they would involve administering a lethal or
permanently disabling toxic substance to healthy human volunteers
without a proven treatment.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Bonnie M. Lee, Senior Policy Analyst, Office of the
Executive Secretariat (HF-40), Department of Health and Human Services,
Food and Drug Administration, Office of the Commissioner, 5600 Fishers
Lane, Rockville, MD 20857
Phone: 301 827-4450
Fax: 301 443-1863
RIN: 0910-AA89
_______________________________________________________________________
932. 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 331; 21 USC 334; 21 USC 351; 21
USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360e to 360i; 21
USC 360k; 21 USC 361; 21 USC 362; 21 USC 371
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 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 12/00/99
NPRM Comment Period End 03/00/00
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising,
and Communications, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-40),
Room 17B-04, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
RIN: 0910-AA90
_______________________________________________________________________
933. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
[[Page 21219]]
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg
to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e
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, 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
patient labeling.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
NPRM Comment Period End 10/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: Legal Authority continued: 42 USC 216; 42 USC
241; 42 USC 262; 42 USC 264
Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising,
and Communications, Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and Research (HFD-40),
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
Fax: 301 594-6759
Lee Korb, Regulatory Counsel, Department of Health and Human Services,
Food and Drug Administration, Center for Drug Evaluation and Research
(HFD-7), 1451 Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-5626
Fax: 301 827-5562
RIN: 0910-AA94
_______________________________________________________________________
934. ADVERSE DRUG REACTION REPORTING REQUIREMENTS FOR HUMAN DRUG AND
BIOLOGICAL PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 216; 21 USC 262; 21 USC 263; 21 USC 263a; 21
USC 264; 21 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21
USC 355; 21 USC 371; 21 USC 374
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 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 adverse drug reaction reports received by
FDA.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/99
NPRM Comment Period End 01/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
935. USE OF OZONE-DEPLETING SUBSTANCES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21
USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352;
21 USC 355; 21 USC 360b; 21 USC 361; 21 USC 371
CFR Citation: 21 CFR 2
Legal Deadline: None
Abstract: FDA is proposing to amend 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 proposing to amend the regulations to better conform to other
statutes and regulations relating to ozone-depleting substances to
eliminate potential confusion and conflicts. FDA is proposing to
eliminate out-of-date transitional provisions and make other
nonsubstantive housekeeping changes to its regulations on ozone-
depleting substances. The intended effect of the proposed rule is to
protect the health and safety of medical device 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 09/00/99
NPRM Comment Period End 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
[[Page 21220]]
Fax: 301 827-5562
RIN: 0910-AA99
_______________________________________________________________________
936. RADIOACTIVE DRUGS FOR BASIC RESEARCH
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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 09/00/99
NPRM Comment Period End 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB00
_______________________________________________________________________
937. VETERINARY FEED DIRECTIVES
Priority: Other Significant
Legal Authority: PL 104-250
CFR Citation: 21 CFR 510; 21 CFR 514; 21 CFR 558
Legal Deadline: None
Abstract: The Animal Drug Availability Act (ADAA) amended the Federal
Food, Drug, and Cosmetic Act (the act) to create a new section 504,
Veterinary Feed Directive Drugs (VFD drugs). VFD drugs are animal drugs
intended for use in or on animal feed which are limited by an approved
application filed pursuant to section 512(b) of the act for use under
the professional supervision of a licensed veterinarian in the course
of the veterinarian's professional practice. This section requires,
among other things, that the labeling, distribution and use of a VFD
drug be consistent with its approval; that persons involved in the
distribution and use of a VFD drug maintain copies of the VFD; and that
persons distributing animal feed provide a one time notice upon first
engaging in the distribution of VFD drugs. The proposed rule will
provide guidance to the industry about how to comply with section 504
of the act and will serve as a basis for enforcement action.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: George Graber, Department of Health and Human Services,
Food and Drug Administration, Center for Veterinary Medicine (HFV-220),
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6651
Fax: 301 594-1812
RIN: 0910-AB09
_______________________________________________________________________
938. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND
GUIDELINES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 15 USC 1451 to 1461; 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; 42 USC 262; 42 USC 263b; 42 USC 264
CFR Citation: 21 CFR 10; 21 CFR 808
Legal Deadline: NPRM, Statutory, July 1, 2000.
Abstract: This proposed rule would amend FDA regulations in 21 CFR part
10 concerning advisory opinions and guidelines to implement the Food
and Drug Administration Modernization Act of 1997 requirement in 21
U.S.C. 371(h) to issue regulations on good guidance practices.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Andrea Masciale, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB14
_______________________________________________________________________
939. EXPORTS; REPORTING AND RECORDKEEPING REQUIREMENTS
Priority: Routine and Frequent
Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 343; 21 USC
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 381; 21
USC 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 243; 42 USC 262
CFR Citation: 21 CFR 1
Legal Deadline: None
Abstract: The proposed rule would establish the recordkeeping and
notification requirements for persons exporting human drugs, animal
drugs, biologics, and devices under the FDA Export Reform and
Enhancement Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/99
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, Office of
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]
RIN: 0910-AB16
_______________________________________________________________________
[[Page 21221]]
940. REGISTRATION OF FOREIGN ESTABLISHMENTS AND PRODUCT LISTING
Priority: Routine and Frequent
Legal Authority: 21 USC 321; 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; 21 USC 374; 42 USC 216; 42 USC 262
CFR Citation: 21 CFR 207; 21 CFR 607; 21 CFR 807
Legal Deadline: None
Abstract: The proposal would amend the establishment registration and
product listing regulations for human drugs, biologics, 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 04/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Office of
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]
RIN: 0910-AB21
_______________________________________________________________________
941. SUITABILITY DETERMINATION FOR DONORS OF HUMAN CELLULAR AND TISSUE-
BASED PRODUCTS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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 proposing to require 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
proposing to amend 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 06/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210
RIN: 0910-AB27
_______________________________________________________________________
942. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLULAR
AND TISSUE-BASED PRODUCTS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 262; 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
cellular and tissue-based products to follow current good tissue
practice (GTP), which includes proper handling, processing, and storage
of human cellular and tissue-based products, recordkeeping, and the
maintenance of a quality program. FDA is also proposing to amend 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 GTP
requirements into existing good manufacturing practice regulations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210
RIN: 0910-AB28
_______________________________________________________________________
943. SHELL EGGS: WARNING, NOTICE AND SAFE HANDLING LABELING STATEMENTS
AND REFRIGERATION REQUIREMENTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: 21 USC 321; 42 USC 264
CFR Citation: 21 CFR 101.17(g); 21 CFR 115.50; 21 CFR 16.5
Legal Deadline: None
Abstract: There have been numerous foodborne outbreaks of
salmonellosis, principally due to Salmonella Enteritidis (SE), that
have been traced to the consumption of temperature abused and/or
undercooked shell eggs. The Food and Drug Administration has received
petitions from Rose Acres Farm, Inc., and the Center for Science in the
Public Interest that request, in part, that FDA establish safe handling
statements for shell eggs. FDA intends
[[Page 21222]]
to propose to require safe handling statements on labeling of shell
eggs that have not been treated to destroy Salmonella microorganisms
that may be present. In accordance with amendments to the Egg Products
Inspection Act, USDA published on August 27, 1998, a final rule to
require that shell eggs be stored at an ambient temperature of 7
degrees Celsius (45 degrees Fahrenheit). However, the USDA rulemaking
does not include refrigeration at retail. FDA intends to propose
regulations to mandate that shell eggs be stored for retail sale at 7
degrees celsius (45 degrees Fahrenheit) or less. FDA is proposing this
measure to ensure that shell eggs are handled in a manner to decrease
the possible growth of any SE that may be present in shell eggs. All of
these actions are intended to reduce the occurrence of illnesses and
deaths associated with the consumption of improperly cooked shell eggs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Geraldine A. June, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, (HFS-158), 200 C Street SW.,
Washington, DC 20204
Phone: 202 205-5099
Fax: 202 205-4594
Email: [email protected]
RIN: 0910-AB30
_______________________________________________________________________
944. ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
Legal Authority: PL 105-115, sec 125
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: The proposed 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 08/00/99
NPRM Comment Period End 11/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Wayne Mitchell, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB33
_______________________________________________________________________
945. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR ANTIBIOTIC
DRUG; COMPLETE RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/99
NPRM Comment Period End 11/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB34
_______________________________________________________________________
946. 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 11/00/99
NPRM Comment Period End 02/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joseph Griffin, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-7), 1451
[[Page 21223]]
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB37
_______________________________________________________________________
947. AMENDMENT OF REGULATIONS REGARDING CERTAIN LABEL STATEMENTS ON
PRESCRIPTION DRUGS
Priority: Other Significant
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
Legal Deadline: None
Abstract: This proposed rule would revise 21 CFR parts 201, 250, 310,
and 361 by removing the requirement that prescription drugs be labeled
``Caution: Federal law prohibits the dispensing without prescription''
and substituting a requirement that prescription drugs be labeled ``Rx
only''. The rule would also revise parts 201, 329, and 369 by removing
the requirement that certain habit-forming narcotics or hypnotics bear
the statement ``Warning--May be habit forming.''
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/99
NPRM Comment Period End 08/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB39
_______________________________________________________________________
948. 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 262; 21 USC 263; 21 USC 263a; 21
USC 264; 21 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 251 to 353; 21
USC 355; 21 USC 371; 21 USC 374
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 01/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB42
_______________________________________________________________________
949. DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING INSULIN
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 358; 21 USC 360; 21 USC 360b; 21 USC 360gg
to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216
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 11/00/99
NPRM Comment Period End 02/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB43
_______________________________________________________________________
950. PROGESTATIONAL DRUG PRODUCTS FOR HUMAN USE; REQUIREMENTS FOR
LABELING DIRECTED TO THE PATIENT
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 360b to 360f; 21 USC 360j; 21 USC 361(a);
21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e
CFR Citation: 21 CFR 310
Legal Deadline: None
Abstract: The proposed rule would revoke 21 CFR 310.516 which requires
that progestational drug products be dispensed with a patient package
insert containing a discussion of the risks of birth defects resulting
from the use of these drugs during the first four months of pregnancy.
The Food and Drug Administration is proposing to revoke this labeling
requirement because of changes in the currently available scientific
information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/99
NPRM Comment Period End 07/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
[[Page 21224]]
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB45
_______________________________________________________________________
951. SUPPLEMENTAL MANUFACTURING CHANGES FOR NEW ANIMAL DRUGS
Priority: Other Significant
Legal Authority: PL 105-115, sec 116
CFR Citation: 21 CFR 514.8
Legal Deadline: Final, Statutory, November 21, 1999.
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. 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 propose 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 proposing to amend the regulations regarding
supplementary new animal drug regulations to incorporate the
requirements of section 116.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: William Marnane, Department of Health and Human
Services, Food and Drug Administration, Center for Veterinary Medicine
(HFV-140), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6966
Fax: 301 594-2297
RIN: 0910-AB49
_______________________________________________________________________
952. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED
FEED
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-25; 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 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: William Price, Department of Health and Human Services,
Food and Drug Administration, Center for Veterinary Medicine (HFV-200),
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6652
RIN: 0910-AB50
_______________________________________________________________________
953. PHARMACY COMPOUNDING; GENERAL REGULATIONS
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 USC 353A). Section 503A governs the application of
Federal law to the practice of pharmacy compounding. This rule will
propose regulations for the interpretation and enforcement of section
503A. The proposed regulations will delineate the conditions under
which compounding is exempt from the manufacturing, misbranding, and
new drug provisions of the Food, Drug, and Cosmetic Act. The proposed
regulations will also set forth other definitions and conditions for
distinguishing legitimate pharmacy compounding from pharmaceutical drug
manufacturing performed under the guise of compounding.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB58
_______________________________________________________________________
954. 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 USC 353a). Section 503A governs the application of
Federal law to the practice of pharmacy compounding, and exempts
[[Page 21225]]
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 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB59
_______________________________________________________________________
955. DISCONTINUATION OF A LIFE-SAVING PRODUCT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 131
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 USC 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 life-saving 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 08/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Andrea Masciale, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB60
_______________________________________________________________________
956. MANUFACTURING CHANGES FOR DRUGS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 116
CFR Citation: 21 CFR 314
Legal Deadline: Final, Statutory, November 21, 1999.
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 USC 356A). Pursuant to section 116, the rulemaking
will propose to revise current procedures for approving manufacturing
changes and generally classify such changes into three 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. Other changes may be made
pending review of a supplemental application if FDA has not notified
the company within 30 days after the submission of a supplement that
prior approval is required. The proposed rule would 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 04/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department
of Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB61
_______________________________________________________________________
957. PEDIATRIC STUDIES OF DRUGS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 111
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: Section 111 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 505A to the Food, Drug, and
Cosmetic Act (21 USC 355A). Section 505A permits certain applications
to obtain an additional six months of marketing exclusivity if, in
accordance with the requirements of the statute, the sponsor submits
information relating to the use of the drug in the pediatric
population. The proposed regulations would implement the pediatric
exclusivity provisions of section 111. FDA is proposing to amend 21 CFR
part 314 to add pediatric exclusivity to FDA's new drug product
exclusivity regulations. FDA is also proposing to add new regulations
describing the requirements an applicant must fulfill in order to
qualify for pediatric exclusivity.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/00/99
NPRM Comment Period End 02/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
[[Page 21226]]
Fax: 301 827-5562
RIN: 0910-AB62
_______________________________________________________________________
958. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING
PRACTICES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 121
CFR Citation: 21 CFR 220
Legal Deadline: Final, Statutory, November 21, 1999.
Abstract: Section 121 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for
current good manufacturing practices (CGMPs) for positron emission
tomography (PET) drugs, a type of radiopharmaceutical. The proposed
rule would adopt CGMPs that reflect the unique characteristics of PET
drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB63
_______________________________________________________________________
959. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING AND NUTRIENT
CONTENT CLAIMS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 343; 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. In response to this section, FDA published a
proposal on November 27, 1991 (56 FR 60366). Among other things, FDA
discussed including trans fatty acids among the nutrients that could
voluntarily be listed on the nutrition label but concluded that there
was no basis for doing so. On January 6, 1993, FDA issued a final rule
entitled ``Food Labeling: Mandatory Status of Nutrition Labeling and
Nutrient Content Revision, Format for Nutrition Label'' (58 FR 2079)
prescribing how nutrition labeling is to be provided on the food. Based
on its review of the comments to the proposal, the agency stated that
it was premature to consider the listing of trans fatty acids on the
nutrition label because of a lack of consensus on the dietary
implications of trans fatty acids intake. However, the agency
acknowledged that it might be necessary to readdress the labeling of
trans fatty acids in the future. FDA subsequently received a citizen
petition requesting that FDA amend the definition of saturated fatty
acid in section 101.9(c)(2)(i) to include trans fatty acid. In response
to this petition and based on new evidence, FDA is proposing to amend
its regulations to provide for the declaration of trans fatty acids in
nutrition labeling, to add a requirement that prevents foods from
bearing nutrient content claims for saturated fat (i.e., saturated
fatty acids) and cholesterol if they contain trans fatty acids above a
specified level, and to define a ``trans fatty acids free'' nutrient
content claim.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Agency Contact: Susan Thompson, Chemist, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition, (HFS-165), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5587
Fax: 202 205-5532
Email: [email protected]
RIN: 0910-AB66
_______________________________________________________________________
960. DESIGNATED JOURNALS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 510.95
Legal Deadline: None
Abstract: FDA intends to remove this rule. The current rule lists the
veterinary and scientific journals available in FDA's library and
allows sponsors to reference an article from a listed journal in
applications rather than submitting a copy of the article. FDA is
taking this action because the list of journals is outdated and is no
longer being used by sponsors except on an extremely limited basis.
Also, the application of this rule is not an efficient use of agency
resources.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: None
Agency Contact: Margaret Miller, Deputy Director, Office of New Animal
Drug Evaluation, Department of Health and Human Services, Food and Drug
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish
Place, Rockville, MD 20855
Phone: 301 594-1620
RIN: 0910-AB67
_______________________________________________________________________
961. 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
[[Page 21227]]
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 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Gail Schmerfeld, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine (HFV-100), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0205
Fax: 301 594-2297
RIN: 0910-AB68
_______________________________________________________________________
962. CLASSIFICATION OF SHEEP AS A MINOR SPECIES FOR ALL DATA COLLECTION
PURPOSES
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360b
CFR Citation: 21 CFR 514.1
Legal Deadline: None
Abstract: This rule would amend 21 CFR 514.1(d) to state that sheep are
minor species for all data collection purposes, thereby allowing
extrapolation from major species data and limited studies to fulfill
the human food safety data requirements for New Animal Drug
Applications. Sheep were originally classified as major species for
human food safety requirements based upon certain expectations of
consumption levels. However, over the years, domestic production of
sheep for food has declined drastically.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 04/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Margaret Oeller, Veterinary Medical Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine (HFV-130), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-7581
RIN: 0910-AB69
_______________________________________________________________________
963. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will eliminate existing text in the CFR.
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: 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 11/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Procurement: This is a procurement-related action for which there is no
statutory requirement. There is a paperwork burden associated with this
action.
Agency Contact: George Graber, Director, Division of Animal Feeds,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine (HFV-220), 7500 Standish Place,
Rockville, MD 20855
Phone: 301 827-6651
Fax: 301 594-1812
Email: [email protected]
RIN: 0910-AB70
_______________________________________________________________________
964. IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE ANIMAL
DRUG AVAILABILITY ACT OF 1996 AND THE SAFE LEVEL PROVISIONS OF THE
ANIMAL MEDICINAL DRUG CLARIFICATION ACT OF 1994
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 (Pub.
L. 104-250) permits the Secretary of HHS 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. The Animal Medicinal Drug Clarification Act of 1994 (Pub.
L. 103-396) allows the Secretary to establish a safe level for a
residue of an animal drug when the drug is used in an extralabel
manner, if the Secretary finds that there is a reasonable probability
that an extralabel use may present a risk to the public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Margaret Miller, Deputy Director, Office of New Animal
Drug Evaluation, Department of Health and Human Services, Food and Drug
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish
Place, Rockville, MD 20855
Phone: 301 594-1620
RIN: 0910-AB71
_______________________________________________________________________
[[Page 21228]]
965. 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 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Daniel G. McChesney, Team Leader, Feed Safety Team,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine (HFV-222), 7500 Standish Place,
Rockville, MD 20855
Phone: 301 827-6653
RIN: 0910-AB72
_______________________________________________________________________
966. 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 331; 21 USC 351 to 352; 21 USC
357; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21
USC 360l; 21 USC 371; 21 USC 374
CFR Citation: 21 CFR 801.440; 21 CFR 878.4460; 21 CFR 878.4461; 21 CFR
880.6250; 21 CFR 880.6251
Legal Deadline: None
Abstract: FDA is considering 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 considering reclassifying surgeon's and patient
examination gloves as class II devices subject to special controls. FDA
is also considering requiring additional labeling concerning powder and
protein levels for these devices.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
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, Center for
Devices and Radiological Health (HFZ-215), 1350 Piccard Drive,
Rockville, MD 20850
Phone: 301 594-4765
RIN: 0910-AB74
_______________________________________________________________________
967. CURRENT GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD
COMPONENTS: NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD
COMPONENTS AT INCREASED RISK FOR TRANSMITTING HCV INFECTION
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 360; 21 USC 371; 21 USC 374; 42 USC 216; 42
USC 262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25
CFR Citation: 21 CFR 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; 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 at increased risk for transmitting hepatitis
C virus (HCV) infection have been collected from a donor who, at a
later date, tested repeatedly reactive for evidence of HCV.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
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, Center for Biologics Evaluation and Research (HFM-17),
1401 Rockville Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210
RIN: 0910-AB76
_______________________________________________________________________
968. ANTIBIOTIC RESISTANCE LABELING
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 358; 21 USC 360; 21 USC 360b; 21 USC 371;
21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; ...
CFR Citation: 21 CFR 201.57
Legal Deadline: None
Abstract: The proposed rule would require the inclusion of statements
on
[[Page 21229]]
antibiotic prescription drug labeling concerning inappropriate
antibiotic use and the prevalence of drug resistant microorganisms.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/00/99
NPRM Comment Period End 11/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB78
_______________________________________________________________________
969. FIXED-COMBINATION DOSAGE FORM PRESCRIPTION DRUGS FOR HUMAN
USE
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 355; 21
USC 360b; 21 USC 361; 21 USC 371
CFR Citation: 21 CFR 300.50
Legal Deadline: None
Abstract: The proposed rule would amend 21 CFR 300.50 which states that
two or more drugs may be combined in a single dosage form when each
component makes a contribution to the claimed effects and the dosage of
each component is such that the combination is safe and effective for a
significant patient population requiring such concurrent therapy as
defined in the labeling for the drug. The proposed rule would state how
this provision will apply to fixed combination prescription drugs
derived from two or more botanical raw materials.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/99
NPRM Comment Period End 01/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB79
_______________________________________________________________________
970. 180-DAY GENERIC DRUG EXCLUSIVITY FOR ABBREVIATED NEW DRUG
APPLICATIONS
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 314.107
Legal Deadline: None
Abstract: The proposed rule would 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 a court decision in Mova
Pharmaceutical v. Shalala, 140 F. 3d 1060 (D.C. Cir. 1998),
invalidating an eligibility requirement for exclusivity.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
NPRM Comment Period End 10/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB80
_______________________________________________________________________
971. REPACKAGING APPROVAL REQUIREMENTS
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 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 11/00/99
NPRM Comment Period End 02/00/00
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB81
_______________________________________________________________________
972. STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS
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.
[[Page 21230]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/99
NPRM Comment Period End 12/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB82
_______________________________________________________________________
973. POSTMARKETING STUDIES FOR HUMAN DRUGS AND LICENSED
BIOLOGICAL PRODUCTS: STATUS REPORTS
Priority: Other Significant
Legal Authority: PL 105-115
CFR Citation: 21 CFR 314.81; 21 CFR 601.70
Legal Deadline: Other, Statutory, October 1, 2001.
Section 130(b) requires the FDA to report by 10/01/01 to the House and
Senate committees summarizing submitted postmarketing study reports
evaluating sponsor performance and the timeliness
Abstract: Section 130(a) of the Food and Drug Administration
Modernization Act of 1997 adds a new section 506B to the Federal Food,
Drug, and Cosmetic Act requiring a drug sponsor that has agreed to
conduct a postmarketing study to submit within one year after the
drug's approval and annually thereafter until the study's conclusion,
(1) A progress report or, (2) an explanation of why no study has been
conducted.
Any information pertaining to postmarketing study reports will be
considered public to identify the sponsor or explain the status of the
study or why it has not been carried out. FDA is required to publish
annually in the Federal Register the status of postmarketing studies
that sponsors have agreements to conduct and those with filed reports.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/99
NPRM Comment Period End 09/00/99
Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: Description of Legal Deadline continued... of
FDA review.
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB83
_______________________________________________________________________
974. AMENDMENT OF VARIOUS FOOD ADDITIVE AND DEVICE REGULATIONS
TO REFLECT CURRENT AMERICAN SOCIETY FOR TESTING AND MATERIALS CITATIONS
Priority: Routine and Frequent
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 341; 21 USC 342; 21
USC 343; 21 USC 346; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 360i;
21 USC 360j; 21 USC 371; 21 USC 373; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 172.210; 21 CFR 172.250; 21 CFR 172.615; 21 CFR
172.862; 21 CFR 172.864; 21 CFR 172.882; 21 CFR 173.25; 21 CFR 175.250;
21 CFR 175.270; 21 CFR 175.300; 21 CFR 176.170; 21 CFR 176.180; 21 CFR
177.1040; 21 CFR 177.1200; 21 CFR 177.1210; ...
Legal Deadline: None
Abstract: The proposed rule would amend various food additive and
medical device regulations. The amendments would update the references
in those regulations to various standards of the American Society for
Testing and Materials (ASTM) to reflect the current standards
designations.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/99
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, Office of
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]
RIN: 0910-AB84
[[Page 21231]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
975. 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.
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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 guidances 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 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
Reporting Requirements for Marketed Animal Drugs NPRM 12/17/91 (56 FR
65581) Final Action 12/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AA96.
For information concerning reporting requirements for marketed animal
drugs, contact William C. Keller, Director, Division of Epidemiology
and Surveillance, Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-
6642. For further information concerning generic animal drugs, contact
Lonnie W. Luther, Chief, Quality Assurance Support Team, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855, (301) 827-0209.
Agency Contact: Margaret Miller, Deputy Director, Office of New Animal
Drug Evaluation, Department of Health and Human Services, Food and Drug
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish
Place, Rockville, MD 20855
Phone: 301 594-1620
RIN: 0910-AA02
_______________________________________________________________________
976. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION,
GUIDANCE, AND CLARIFICATIONS
Priority: Other Significant
Legal Authority: PL 100-293 Prescription Drug Marketing Act of 1987
CFR Citation: 21 CFR 203
Legal Deadline: None
Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended
the Federal Food, Drug, and Cosmetic Act to: (1) require State
licensing of wholesale distributors of prescription human drugs under
Federal guidelines including minimum standards for storage, handling,
and recordkeeping; (2) ban the reimportation of prescription human
drugs produced in the United States, except when reimported by the
manufacturer or for emergency use; (3) ban the sale, trade, or purchase
of drug samples; (4) ban trafficking in or counterfeiting of drug
coupons; (5) mandate storage, handling, and recordkeeping requirements
for drug samples; (6) require licensed practitioners to request drug
samples in writing; (7) prohibit, with certain exceptions, the resale
of prescription human drugs purchased by hospitals or health care
facilities; and (8) set forth criminal and civil penalties for
violations of these provisions. In the Federal Register of September
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal
guidelines for State licensing of wholesale drug distributors. This
final rule would provide information, guidance, and clarification of
those sections of PDMA that are not related to State licensing of
wholesale distributors.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/14/94 59 FR 11842
NPRM Comment Period End 08/01/94
Final Action 06/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD44.
Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
[[Page 21232]]
Fax: 301 827-5562
RIN: 0910-AA08
_______________________________________________________________________
977. FRUIT AND VEGETABLE JUICES: DEVELOPMENT OF HACCP AND LABEL WARNING
STATEMENTS FOR JUICES
Priority: Economically Significant. Major under 5 USC 801.
Legal Authority: 21 USC 321 et seq; 42 USC 264
CFR Citation: 21 CFR 120
Legal Deadline: None
Abstract: The Food and Drug Administration (FDA) announced in an
advance notice of proposed rulemaking of August 4, 1994, its plans to
consider the development of regulations establishing requirements for a
new comprehensive food safety assurance program that would be based on
the principles of Hazard Analysis Critical Control Points (HACCP). The
new food safety program would respond to new challenges, such as new
food processing and packaging technologies, new food distribution and
consumption patterns, exposure to industrial chemicals and chemical
waste, the increasing importation of foods, new microbial pathogens,
and resource constraints. Current information shows that the most
serious of these challenges is presented by food-borne pathogens. The
number of recognized food-borne pathogens has broadened considerably,
as has the awareness of long-term complications from certain food-borne
illnesses--such as arthritis, heart disease, and kidney and
neurological damage. To meet such challenges, FDA intends to shift the
focus of its food safety assurance program away from periodic visual
inspection and end-product testing and toward prevention of food safety
risks and problems, utilizing the state-of-the-art HACCP preventive
approach. A first step was taken when FDA published a HACCP regulation
for fish and fishery products on December 18, 1995. Consistent with
FDA's HACCP efforts, USDA published a HACCP regulation for meat and
poultry on July 25, 1996. FDA proposed on April 24, 1998 to adopt a
HACCP regulation for the processing of juice. The agency simultaneously
proposed to require a warning statement on the labels or in labeling
for juice products that have not been processed to reduce, control, or
eliminate the presence of harmful bacteria. Such labeling would serve
to reduce the risk of food-borne illness, pending development of a
final HACCP rule for juice. As part of the development of the HACCP
proposal, FDA considered information obtained during agency HACCP pilot
activities, and comments and scientific and technological information
relating to fresh juices provided during and after an agency public
meeting on juice held on December 16 and 17, 1996. On July 8, 1998, the
agency finalized the warning statement requirement. FDA held two
technical scientific workshops, one November 12, 1998, in Lake Alfred,
Florida and the other November 29, 1998, in Irvine, California, to
discuss and clarify issues related to the implementation of the
agency's rule requiring a warning statement for certain juice products.
The workshops addressed citrus juice production and the methods for
measuring and validating such systems.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 08/04/94 59 FR 39888
ANPRM Comment Period End 12/02/94
Economic Analysis for Juice HACCP and Labeling PRIA 05/01/98 (63 FR
24254) PRIA Comment Period End 06/22/98
HACCP for Juice NPRM 04/24/98 (63 FR 20450) NPRM Comment Period End
08/07/98 NPRM Comment Period Reopened 12/17/98 (63 FR 69579) NPRM
Reopened Comment Period End 01/19/99 Final Action 01/00/00
Label Warning Statements for Juice Notice of Intent 08/28/97 (62 FR
45593) NPRM 04/24/98 (63 FR 20496) NPRM Comment Period End 06/21/
98 Final Action 07/08/98 (63 FR 37029)
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
Additional Information: Previously reported under RIN 0905-AE60.
Agency Contact: John E. Kvenberg, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-10), 200 C Street SW., Washington, DC 20204
Phone: 202 205-4020
Fax: 202 205-4018
Email: [email protected]
RIN: 0910-AA43
_______________________________________________________________________
978. CURRENT GOOD MANUFACTURING PRACTICE; AMENDMENT OF CERTAIN
REQUIREMENTS FOR FINISHED PHARMACEUTICALS
Priority: Other Significant
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 211.22; 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; 21 CFR 211.113; 21 CFR 211.115; 21 CFR 211.160; 21 CFR
211.166; 21 CFR 211.192; 21 CFR 211.220; ...
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 current agency
policies or current industry practices. 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 12/00/99
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: Federal
Additional Information: Previously reported under RIN 0905-AE63.
Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA45
_______________________________________________________________________
[[Page 21233]]
979. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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 part
320 and eliminate duplication and inconsistencies.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 11/19/98 63 FR 64222
NPRM Comment Period End 02/02/99
Final Action 09/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Christine Rogers, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA51
_______________________________________________________________________
980. PARENTERAL DRUG PRODUCTS CONTAINING ALUMINUM AS AN INGREDIENT OR
CONTAMINANT; LABELING REQUIREMENTS; WARNING STATEMENT
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379; 42 USC
216; 42 USC 241; 21 USC 262; 21 USC 264
CFR Citation: 21 CFR 201
Legal Deadline: None
Abstract: The rule will establish a maximum level of aluminum permitted
in large volume parenterals used in total parenteral nutrition therapy;
require that the maximum aluminum content present at the time of
release be stated on the immediate container label of certain small
volume parenterals and pharmacy bulk packages; require that the package
insert of all parenterals include a warning statement on the effects of
aluminum toxicity in patients with impaired kidneys receiving total
parenteral nutrition therapy; and require manufacturers to develop
validated assay methods for determining the aluminum content.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/05/98 63 FR 176
NPRM Comment Period End 04/06/98
Final Action 09/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA74
_______________________________________________________________________
981. NEW DRUG APPLICATIONS; DRUG MASTER FILE
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 371; 21 USC 374; 21 USC 379
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: The final rule eliminates Type I Drug Master Files, which
contain information about manufacturing sites, facilities, operating
procedures, and personnel, because these files contain outdated
information, duplicate information contained in marketing applications,
and are not used by application review divisions or field inspectors.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/03/95 60 FR 34486
NPRM Comment Period End 10/02/95
Final Action 05/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Lee D. Korb, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research, (HFD-7), 1451 Rockville Pike, Suite 3047,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA78
_______________________________________________________________________
982. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS
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 371
CFR Citation: 21 CFR 201; 21 CFR 330
Legal Deadline: None
Abstract: The final rule will provide standardized format and content
requirements for over-the-counter (OTC) drug product labeling,
including legibility and design features for the presentation of such
information as the uses for the drug, directions for use, warnings,
drug interactions, active ingredients, and other information that the
consumer would need to know to use the product safely and effectively.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/27/97 62 FR 9024
NPRM Comment Period End 10/06/97 62 FR 33379
Reopening of Comment Period
(Study B) 12/30/97 62 FR 67770
Reopening of Comment Period
(Study A) 02/13/98 63 FR 7331
Final Action 04/00/99
[[Page 21234]]
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Debra Bowen, M.D., Division of OTC Drug Evaluation,
Department of Health and Human Services, Food and Drug Administration,
Center for Drug Evaluation and Research (HFD-560), 9201 Corporate
Blvd., Rockville, MD 20850
Phone: 301 827-2222
RIN: 0910-AA79
_______________________________________________________________________
983. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS FOR DRUGS FOR
LIFE-THREATENING ILLNESSES
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 371; 42 USC 262
CFR Citation: 21 CFR 312
Legal Deadline: None
Abstract: The final rule amends the provisions governing
investigational new drug applications to permit FDA to place a clinical
hold on one or more studies under an IND involving a drug that is
intended to treat a life-threatening disease affecting both genders if
men or women with reproductive potential who have the disease are
excluded from eligibility in any phase of the investigation because of
a risk or potential risk of reproductive or developmental toxicity from
use of the investigational drug.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/24/97 62 FR 49946
NPRM Comment Period End 12/23/97
Final Action 07/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Andrea Masciale, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-5), 1451 Rockville Pike, Suite 6027,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA84
_______________________________________________________________________
984. STERILITY REQUIREMENTS FOR INHALATION SOLUTION PRODUCTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374 to 375
CFR Citation: 21 CFR 200
Legal Deadline: None
Abstract: The final rule requires that all inhalation solution products
be manufactured to be sterile. Based on reports of adverse drug
experiences from contaminated nonsterile inhalation solution products
and recalls of these products, FDA is taking this action to prevent
future additional adverse health consequences.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/23/97 62 FR 49638
NPRM Comment Period End 12/22/97
Final Action 07/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA88
_______________________________________________________________________
985. CURRENT GOOD MANUFACTURING PRACTICE; REVISION OF CERTAIN LABELING
CONTROLS
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 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 associated 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 09/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA98
_______________________________________________________________________
986. DEFINITION OF SUBSTANTIAL EVIDENCE
Priority: Other Significant
Legal Authority: 21 USC 360b; PL 104-250
CFR Citation: 21 CFR 514.4
Legal Deadline: NPRM, Statutory, October 9, 1997. Final, Statutory,
October 9, 1998.
Abstract: The Animal Drug Availability Act (ADAA) requires FDA to issue
within 24 months after the date of its enactment final regulations to
encourage dose range labeling and to further define the term
``substantial evidence,'' as the term is defined in section 512(d)(3)
of the Federal Food, Drug, and Cosmetic Act, as amended by the ADAA, in
a manner that encourages the submission of applications and
supplemental applications.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/21/96 61 FR 59209
NPRM 11/05/97 62 FR 59830
Final Action 07/00/99
[[Page 21235]]
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Gail Schmerfeld, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine (HFV-100), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0205
Fax: 301 594-2297
RIN: 0910-AB08
_______________________________________________________________________
987. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR PATENT
HOLDER NOTIFICATION
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 371; 21 USC 374; 21 USC 379e
CFR Citation: 21 CFR 314
Legal Deadline: None
Abstract: This final rule will clarify the methods by which application
holders may provide notice to patent holders.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/06/98 63 FR 11174
NPRM Comment Period End 06/04/98
Final Action 11/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB12
_______________________________________________________________________
988. MEDICATED FEED MILL LICENSES
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-250
CFR Citation: 21 CFR 5; 21 CFR 207; 21 CFR 225; 21 CFR 510; 21 CFR
514; 21 CFR 515; 21 CFR 558
Legal Deadline: None
Abstract: The Animal Drug Availability Act of 1996 (ADAA) amends
sections 512(a) and 512(m) of the Federal Food, Drug, and Cosmetic Act
(the act) to require a single facility license for the manufacture of
feeds containing approved new animal drugs, rather than multiple
medicated feed applications (MFAs) for each feed mill, as previously
required by the act. Prior to the passage of the ADAA, an approved
medicated feed application was required by the act for the manufacture
of medicated feed. The ADAA eliminates the requirement that a feed mill
submit a separate medicated feed application for the manufacture of
each type of medicated feed and instead provides for feed mills to be
licensed and allows a licensed facility to manufacture any feed
containing an approved new animal drug. Additionally, the act, as
amended by the ADAA, provides the agency with the authority to exempt
facilities that manufacture certain types of medicated feed from the
requirement of a medicated feed mill license.
The Food and Drug Administration published on July 30, 1997, a proposed
rule to amend the animal drug regulations and add a new part (21 CFR
515) to provide for feed mill licensing in accordance with the ADAA.
The proposed regulation implements the requirements for feed mill
licensing set forth in the ADAA. Under this proposal, those medicated
feeds exempted from the MFA requirement under 21 CFR 558.4 will also be
exempt from the requirement of a medicated feed mill license.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/30/97 62 FR 40765
NPRM Comment Period End 10/28/97
Final Action 07/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: William D. Price, Special Assistant, Department of
Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6652
Fax: 301 594-4512
RIN: 0910-AB18
_______________________________________________________________________
989. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN
GOVERNMENT OFFICIALS
Priority: Info./Admin./Other
Legal Authority: 5 USC 552; 18 USC 1905; 19 USC 2531 to 2582; 21 USC
321 to 393; 21 USC 1401 to 1403; 42 USC 241; 42 USC 242; 42 USC 242a;
42 USC 242e; 42 USC 242l; 42 USC 242n; 42 USC 243; 42 USC 262; 42 USC
263; 42 USC 263b to 263n
CFR Citation: 21 CFR 20.88; 21 CFR 20.89
Legal Deadline: None
Abstract: The final rule would amend the regulations governing
communications with State and foreign government officials. The
proposed rule would permit the Food and Drug Administration (FDA) to
disclose confidential commercial information to international
organizations having responsibility to facilitate global or regional
harmonization of standards and requirements. These disclosures would,
in almost all instances, occur only with the consent of the person
providing the confidential commercial information to FDA. The proposed
rule would also eliminate the need for a written statement by a State
or foreign government official establishing that government's ability
to protect from public disclosure nonpublic, predecisional documents
(such as draft rules and guidance documents) provided by FDA that do
not include confidential commercial information. These changes are
intended to facilitate information exchanges with State and foreign
governments.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/27/98 63 FR 40069
NPRM Comment Period End 10/13/98
Final Rule 04/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Additional Information: 5 USC 552
Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of
Health and Human Services, Food and Drug Administration, Office of
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
[[Page 21236]]
Email: [email protected]
RIN: 0910-AB22
_______________________________________________________________________
990. 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 321; 21 USC 343; 21 USC
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21
USC 381; 21 USC 382; 21 USC 393; 42 USC 216
CFR Citation: 21 CFR 1.84
Legal Deadline: None
Abstract: The proposed 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 10/00/99
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, Office of
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]
RIN: 0910-AB24
_______________________________________________________________________
991. BIOLOGICAL PRODUCTS REGULATED UNDER SECTION 351 OF THE PUBLIC
HEALTH SERVICE ACT; IMPLEMENTATION OF BIOLOGICS LICENSE; ELIMINATION OF
ESTABLISHMENT LICENSE AND PRODUCT LICENSE
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 262; PL 105-115
CFR Citation: 21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 20; 21 CFR 207; 21
CFR 310; 21 CFR 312; 21 CFR 316; 21 CFR 600; 21 CFR 601; 21 CFR 607; 21
CFR 610; 21 CFR 640; 21 CFR 660
Legal Deadline: None
Abstract: As a ``Reinventing Government'' initiative and to amend
regulations to implement section 123 of the Food and Drug
Administration Modernization Act of 1997, FDA is eliminating the
requirement and use of establishment licenses and product licenses for
biological products regulated under section 351 of the Public Health
Service Act. In lieu of product licenses and establishment licenses,
FDA will require submission and approval of a biologics license
application in order to market these biologic products in interstate
commerce.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/31/98 63 FR 40858
Public Workshop 08/11/98 63 FR 42773
Final Action 04/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Robert A. Yetter, Department of Health and Human
Services, Food and Drug Administration, Center for Biologics Evaluation
and Research (HFM-10), 1401 Rockville Pike, Suite 200N, Rockville, MD
20852
Phone: 301 827-0373
RIN: 0910-AB29
_______________________________________________________________________
992. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL
PRODUCTS; DIRECT FINAL RULE
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
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 stages of
development. This action is part of FDA's continuing effort to achieve
the objectives of the President's ``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
[[Page 21237]]
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 Withdrawal in
Part 08/05/98 63 FR 41718
Final Action 10/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Stephen M. Ripley, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB51
_______________________________________________________________________
993. RADIOPHARMACEUTICALS USED FOR IN VIVO DIAGNOSIS AND MONITORING
Priority: Other Significant
Legal Authority: PL 105-115, sec 122
CFR Citation: 21 CFR 315; 21 CFR 601
Legal Deadline: NPRM, Statutory, May 20, 1998. Final, Statutory, May
20, 1999.
Abstract: Section 122 of FDAMA, Requirements for Radiopharmaceuticals,
requires the Secretary, HHS, after consultation with patient advisory
groups, associations, physicians licensed to use radiopharmaceuticals,
and the regulated industry, to issue proposed regulations governing the
approval of radiopharmaceuticals. The regulations shall provide that
the determination of safety and effectiveness of a radiopharmaceutical
under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C.
262) shall include consideration of the proposed use of the
radiopharmaceutical in the practice of medicine, the pharmacological
and toxicological activity of the radiopharmaceutical (including any
carrier or ligand component of the radiopharmaceutical), and the
estimated radiation dose of the radiopharmaceutical. In addition, the
indication for which a radiopharmaceutical is approved for marketing
may, in appropriate cases, refer to manifestations of disease (such as
biochemical, physiological, anatomical, or pathological processes)
common to, or present in, one or more disease states.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/22/98 63 FR 28301
Final Action 05/00/99
Regulatory Flexibility Analysis Required: No
Government Levels Affected: None
Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Steven F. Falter, Director, Regulations and Policy Staff, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB52
_______________________________________________________________________
994. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING
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 USC 353a). Section 503A governs the application of
Federal law to the practice of pharmacy compounding. Section
503A(b)(1)(A) directs FDA to 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 compounding under section
127 unless such substances are covered by a 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 08/00/99
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Richard Schwartzbard, Regulatory Counsel, Regulatory
Policy Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AB57
[[Page 21238]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
995. 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 343; 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
will establish current good manufacturing practice regulations, quality
control procedures, quality factors, notification requirements, and
records and reports for the production of infant formulas. This
proposal was issued in response to the Infant Formula Act of 1986.
Timetable:
Current Good Mfg. Practices; Qual Control Proc NPRM 07/09/96 (61 FR
36154) NPRM Comment Period End 12/06/96 Final Rule 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)
Regulatory Flexibility Analysis Required: No
Small Entities Affected: No
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AC46.
Agency Contact: Nicholas Duy, Consumer Safety Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-456), 200 C Street SW.,
Washington, DC 20204
Phone: 202 205-5374
RIN: 0910-AA04
_______________________________________________________________________
996. BIOLOGICAL PRODUCTS: REPORTING OF ERRORS AND ACCIDENTS IN
MANUFACTURING
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374; 42
USC 216; 42 USC 262 to 264; 42 USC 300aa-25
CFR Citation: 21 CFR 600; 21 CFR 606
Legal Deadline: None
Abstract: FDA is amending the regulations that require licensed
manufacturers of biological products to report errors and accidents in
manufacturing that may affect the safety, purity, or potency of a
product. FDA defines terms used; establishes a reporting period for all
licensed biological products; and amends the current good manufacturing
practice (CGMP) regulations for blood and blood components to require
error and accident reporting by unlicensed registered blood
establishments and transfusion services currently reporting on a
voluntary basis. The reporting requirements will expedite reporting of
errors and accidents in manufacturing of biological products; provide
FDA with a more accurate surveillance of the Nation's blood supply
enabling FDA to monitor actions taken in response to the errors and
accidents detected for all establishments involved in the manufacture
of blood and blood components; and facilitate a rapid response where
public health may be at risk. The cost to licensed establishments would
be minimal, since they already are required to report. Unlicensed
establishments would only have to make some changes in standard
operating procedures. Unlicensed establishments are already required to
keep records and conduct investigations. Under the final rule they
would have to establish reporting procedures and report to FDA. The
transfusion services would have to assure that their recordkeeping and
investigation procedures are sufficient, and establish reporting
procedures.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/23/97 62 FR 49642
NPRM Comment Period End 12/22/97
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD67.
Agency Contact: Valerie A. Butler, Consumer Safety Officer, Department
of Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AA12
_______________________________________________________________________
997. 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
[[Page 21239]]
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
Additional Information: Previously reported under RIN 0905-AD89.
Agency Contact: Gerard L. McCowin, Acting Deputy Director, Office of
Food Labeling, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-150),
200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
Fax: 202 205-4594
RIN: 0910-AA19
_______________________________________________________________________
998. MEDICAL FOODS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 341; 21 USC 342; 21 USC 343; 21
USC 348; 21 USC 350; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360ee;
21 USC 371
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 USC 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
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD91.
Agency Contact: Robert Moore, Senior Regulatory Scientist, Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFS-456), 200 C Street SW.,
Washington, DC 20204
Phone: 202 205-4605
Fax: 202 260-8957
RIN: 0910-AA20
_______________________________________________________________________
999. 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 is also seeking
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
Additional Information: Previously reported under RIN 0905-AE58.
Agency Contact: Chuck Furfine, Regulatory Review Scientist/Software
Expert, Department of Health and Human Services, Food and Drug
Administration, Center for Devices and Radiological Health (HFZ-84),
2098 Gaither Road, Rockville, MD 20850
Phone: 301 443-2536
RIN: 0910-AA41
_______________________________________________________________________
[[Page 21240]]
1000. REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN
COMMERCIAL DISTRIBUTION
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21
USC 360; 21 USC 371
CFR Citation: 21 CFR 207
Legal Deadline: None
Abstract: The proposed rule would revise the regulations under part 207
to clarify the burden on manufacturers, packers, and distributors and
to consolidate, reorganize, and streamline the requirements.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Lee D. Korb, Regulatory Counsel, Department of Health
and Human Services, Food and Drug Administration, Center for Drug
Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA49
_______________________________________________________________________
1001. REINVENTING FDA FOOD REGULATIONS
Priority: Substantive, Nonsignificant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321 et
seq
CFR Citation: 21 CFR 101; 21 CFR 102; 21 CFR 103; 21 CFR 131; 21 CFR
133; 21 CFR 135; 21 CFR 136; 21 CFR 137; 21 CFR 139; 21 CFR 145; 21 CFR
146; 21 CFR 150; 21 CFR 152; 21 CFR 155; 21 CFR 156; ...
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 (CED) 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 Additive, GRAS Regulations ANPRM 06/12/96 (61 FR
29701) Comment Period Ended 09/10/96 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 To Be Determined
Notification Procedures for Independent 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 Action 08/12/
97 (62 FR 43071)
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 Action 06/03/96 (61 FR
27771) Confirmation of Eff. Date 08/27/96 (61 FR 43963)
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State
[[Page 21241]]
Additional Information: ABSTRACT CONT: 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).
Agency Contact: L. Robert Lake, Director, Office of Policy Planning and
Strategic Initiatives, Department of Health and Human Services, Food
and Drug Administration, Center for Food Safety and Applied Nutrition
(HFS-150), 200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
Fax: 202 401-7739
RIN: 0910-AA58
_______________________________________________________________________
1002. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA
Priority: Other Significant
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 351; 21 USC 352; 21
USC 355; 21 USC 371
CFR Citation: 21 CFR 101
Legal Deadline: None
Abstract: On January 4, 1994, FDA published final rules relative to
nutrition labeling, nutrient content claims and health claims for
dietary supplements. The Dietary Supplement Health and Education Act
(DSHEA) was enacted on October 25, 1994, modifying the statutory
provisions governing labeling of dietary supplements. FDA has initiated
rulemaking to modify its regulations for dietary supplements
accordingly. One proposal would modify the nutrition labeling and
ingredient declaration requirements. A second proposal would provide
for the use of nutrient content claims and health claims on dietary
supplements and establish procedures for the use of a disclaimer to
accompany statements of nutritional support. A third proposal would
define the terms ``high potency'' and ``antioxidant.'' These three
proposals were published in the Federal Register on December 28, 1995.
An ANPRM was published in February 1997 seeking public comments on
issues related to the establishment of current good manufacturing
practices for dietary supplements. FDA published three final rules on
September 23, 1997, responding to the proposals of December 28, 1995,
and entitled: (1) ``Food Labeling; Statement of Identity, Nutrition
Labeling and Ingredient Labeling of Dietary Supplements; Compliance
Policy Guide, Revocation;'' (2) ``Food Labeling; Requirements for
Nutrient Content Claims, Health Claims, and Statements of Nutritional
Support for Dietary Supplements;'' and (3) ``Food Labeling; Nutrient
Content Claims: Definition for ``High Potency'' and Definition for
``Antioxidant'' for Use in Nutrient Content Claims for Dietary
Supplements and Conventional Foods.'' The agency received several
petitions for reconsideration of aspects of the final rule on nutrition
labeling and ingredient declaration for dietary supplements. In
response to these petitions, FDA published a final rule revising the
nutrition labeling requirements for dietary supplements that contain
liquid or dried extracts.
DSHEA provides that FDA may, by regulation, prescribe current good
manufacturing practices (CGMPs) for dietary supplements. On February 6,
1997, FDA announced in an advance notice of proposed rulemaking that it
was considering whether it should develop CGMPs for dietary
supplements, and if so, what constitutes CGMPs for these products. The
ANPR included an industry-sponsored outline for the development of CGMP
regulations and requested public comment on the outline and other
issues raised by the agency.
DHSEA also established an independent agency within the Executive
Branch known as the Commission on Dietary Supplement Labels. The
Commission was charged with conducting a study on, and providing
recommendations for, regulating label claims and statements for dietary
supplements, including the use of literature in connection with the
sale of dietary supplements and procedures for evaluating such claims.
On November 24, 1997, the Commission's final report was released. On
April 29, 1998, FDA issued a notice on its views on the Commission's
report and a proposed rule that responds to guidance in the report
concerning statements about the effect of dietary supplements on the
structure or function of the body.
Timetable:
Comments on Report of the Commission on Dietary Supp. Labels Notice
04/29/98 (63 FR 23633)
CGMPs in the Manufacturing, Packing, or Holding of Dietary
Supps. ANPRM 02/06/97 (62 FR 5700) Comment Period End 06/06/97 NPRM
To Be Determined
High Potency and Antioxidant Terms; Dietary Supplements NPRM 12/28/95
(60 FR 67184) Comment Period End 06/10/96 Final Action 09/23/97 (62
FR 49808)
Nutrient Content and Health Claims; Dietary Supplements NPRM 12/28/95
(60 FR 67176) Comment Period End 06/10/96 Final Action 09/23/97 (62
FR 49859)
Nutrient Labeling and Ingredient Labeling; Dietary Supplements NPRM
12/28/95 (60 FR 67194) Comment Period End 06/10/96 Final Action 09/
23/97 (62 FR 49826) Final Action 06/05/98 (63 FR 30615)
Regs on Statements Made for Diet. Supps re Effect of Product NPRM 04/
29/98 (63 FR 23624)
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Agency Contact: Elizabeth A. Yetley, Director, Office of Special
Nutritionals, Department of Health and Human Services, Food and Drug
Administration, Center for Food Safety and Applied Nutrition (HFS-450),
200 C Street SW. Washington, DC 20204
Phone: 202 205-4168
Fax: 202 205-5295
RIN: 0910-AA59
_______________________________________________________________________
1003. DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 15 USC 1451 to 1461; 21 USC 321; 21 USC 331; 21 USC
335; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374;
21 USC 379; 21 USC 381 to 382; 42 USC 216; 42 USC 241; 42 USC 262 to
263
CFR Citation: 21 CFR 314; 21 CFR 514; 21 CFR 601
Legal Deadline: None
[[Page 21242]]
Abstract: The proposed rule would amend the regulations to require
applicants to submit a debarment certification statement in accordance
with 21 U.S.C. 335a(k).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy
Staff, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-7), 1451
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA76
_______________________________________________________________________
1004. INVESTIGATIONAL NEW DRUG APPLICATIONS; REQUEST FOR INFORMATION AND
COMMENTS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC
355; 21 USC 371; 42 USC 262
CFR Citation: 21 CFR 56; 21 CFR 312
Legal Deadline: None
Abstract: The rulemaking would permit certain uses of investigational
new drugs by individual investigators who are not included in a
commercial sponsor's application provided that, among other things, the
drugs are in Phase 2 of commercial development.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joseph Griffin, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047,
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-5562
RIN: 0910-AA83
_______________________________________________________________________
1005. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 353; 21 USC 360b; 21
USC 371; 21 USC 381
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 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 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 which would result in less regulatory burden upon
industry and FDA while maintaining safety and effectiveness of new
animal drugs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/21/96 61 FR 59209
ANPRM Comment Period End 01/21/97
NPRM To Be Determined
Regulatory Flexibility Analysis Required: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Marty Schoenemann, Department of Health and Human
Services, Food and Drug Administration, Center for Veterinary Medicine
(HFV-126), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220
RIN: 0910-AB02
_______________________________________________________________________
1006. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLULAR AND
TISSUE-BASED PRODUCTS
Priority: Other Significant
Reinventing Government: This rulemaking is part of the Reinventing
Government effort. It will revise text in the CFR to reduce burden or
duplication, or streamline requirements.
Legal Authority: 42 USC 264
CFR Citation: 21 CFR 207; 21 CFR 807; 21 CFR 1271
Legal Deadline: None
Abstract: This action is a continuation of FDA's approach for the
regulation of human tissues and is part of FDA's reinventing government
initiative. The final rule requires manufacturers of human cellular and
tissue-based products to register with the agency and submit a list of
all such products produced. Future regulations would include the
promulgation of good tissue practices (GTP) that will provide good
manufacturing standards and regulations for donor screening and
testing, and compliance and procedural issues. The proposed approach
would provide a rational, comprehensive, and clear framework under
which tissue processors can develop and market their products without
being subjected to unnecessary regulation and without sacrificing the
protection of the public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/14/98 63 FR 26744
NPRM Comment Period End 08/12/98
Final Action To Be Determined
Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses
Government Levels Affected: None
[[Page 21243]]
Agency Contact: Paula S. McKeever, Regulatory Policy Analyst,
Department of Health and Human Services, Food and Drug Administration,
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville
Pike, Suite 200N, Rockville MD 20852
Phone: 301 827-6210
RIN: 0910-AB05
_______________________________________________________________________