[Unified Agenda of Federal Regulatory and Deregulatory Actions]
[Department of Health and Human Services Semiannual Regulatory Agenda]
[From the U.S. Government Printing Office, www.gpo.gov]
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Part VIII
Department of Health and Human Services
_______________________________________________________________________
Semiannual Regulatory Agenda
[[Page 21932]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
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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 of the Department. The agenda enables the public to know
about and to participate in the Department's regulations development
work. The last such agenda was published on October 29, 1997.
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 agenda of regulatory actions set out
below continues to reflect the Department's efforts to exemplify in its
rulemaking the President's initiative to streamline the Federal
regulatory system so that it affords important benefits to the American
people while creating fewer burdens. The agenda also reflects emerging
policy mandates for HHS, stemming from several major new pieces of
legislation, broadly ranging over child health; welfare reform; health
insurance reform; food safety; improved regulation of drugs and medical
products; the combating of waste, fraud, and abuse in the health care
system; and the restructuring of the Medicare and Medicaid financing
systems.
For example, the Balanced Budget Act of 1997 (BBA) includes
numerous provisions requiring regulatory actions substantially
affecting the characteristics and administration of the Medicare
Program. These actions will affect areas such as changes in
Medicare reimbursement rules for graduate medical education;
revisions to payment procedures for hospice and home health
services; and solvency standards for provider-sponsored
organizations.
Also, the Health Insurance Portability and Accountability Act
of 1996, along with its health insurance reforms, gives the
Department major new responsibilities concerning health data
standards and health record privacy. These provisions require the
Secretary to adopt a series of data standards to support electronic
data interchange for health insurance and related transactions,
such as claims processing and enrollment. The standards will apply
to the entire health industry, not just Federal programs.
And, the FDA Modernization Act put into law many of the
initiatives undertaken under the Vice President's Reinventing
Government program. In addition, the Act requires, among many other
things, regulations to codify FDA's existing practices of
increasing patient access to experimental drugs and of accelerating
review of important new medications. The Act also requires
regulations facilitating dissemination by manufacturers of peer-
reviewed journal articles about unapproved uses of drugs and
medical devices, in exchange for commitments by the manufacturers
to submit research data to FDA regarding safety and effectiveness
of these products.
Underlying these initiatives, there endures the focus and
discipline which the principles articulated in the President's
Executive Order 12866 and the many subsequent regulatory reform
initiatives of the Administration have brought to the Department's
regulatory program. Public comments are invited to assist the
Department in continuing to pursue the President's purposes.
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 Wilbur H. Cohen Building, 330 Independence Avenue SW.,
Washington, DC 20201; phone 202-260-0669.
Agency for Health Care Policy and Research: Peggy Washburn,
2101 East Jefferson Street, Suite 603, Rockville, Maryland 20852;
phone 301-594-1455.
Centers for Disease Control: Dana Weller, Policy Analyst,
Office of Program and Planning and Evaluation, Office of the
Director, 1600 Clifton Road, Building 16, Mail Stop D23, Atlanta,
Georgia 30333; phone 404-639-7077.
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, Mail Stop 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.
LaVarne Burton,
Executive Secretary to the Department.
[[Page 21933]]
Office of the Secretary--Proposed Rule Stage
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Regulation
Sequence Title Identifier
Number Number
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921 Revised OIG Sanction Authorities Resulting From Public Law 105-33.................... 0991-AA95
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Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
922 Clarification of the Initial OIG Safe Harbor Provisions and Establishment of
Additional Safe Harbor Provisions Under the Anti-Kickback Statute..................... 0991-AA66
923 Reproduction and Sale of Official Forms and Publications............................. 0991-AA83
924 Revised OIG Exclusion Authorities Resulting From Public Law 104-191.................. 0991-AA87
925 Revised OIG Civil Money Penalties Resulting From Public Law 104-191.................. 0991-AA90
926 Shared Risk Exception to the Safe Harbor Provisions.................................. 0991-AA91
927 Issuance of Advisory Opinions by the Inspector General............................... 0991-AA94
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Office of the Secretary--Long-Term Actions
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
928 Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans.......... 0991-AA45
929 Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental
Policies.............................................................................. 0991-AA53
930 Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community-
Based Health Care Center or Provider, of a Standard Survey............................ 0991-AA79
931 Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and
Rebate Agreements..................................................................... 0991-AA80
932 Senior Biomedical Research Services.................................................. 0991-AA82
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Office of the Secretary--Completed Actions
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
933 Civil Money Penalties for Referrals to Entities and for Prohibited Arrangements and
Schemes............................................................................... 0991-AA65
934 Administrative Requirements for Grantees To Reflect Single Audit Act Amendments...... 0991-AA92
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Substance Abuse and Mental Health Services Administration--Long-Term Actions
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Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
935 Block Grants for Prevention and Treatment of Substance Abuse......................... 0930-AA01
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Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
936 Protection and Advocacy for Individuals With Mental Illness.......................... 0930-AA02
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[[Page 21934]]
Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
937 Implementation of the Equal Access to Justice Act in Agency Proceedings.............. 0990-AA02
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Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
938 Animal Drug Approvals for Minor Species and Minor Usage.............................. 0910-AB07
939 Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration
Requirements.......................................................................... 0910-AB30
940 Electronic Submission of Adverse Drug Reaction Reports............................... 0910-AB42
941 Supplemental Manufacturing Changes for New Animal Drugs.............................. 0910-AB49
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Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
942 Over-the-Counter (OTC) Drug Review................................................... 0910-AA01
943 Fees for Certification Services; Insulin and Color Additive Certification Programs... 0910-AA07
944 Review of Warnings, Use Instructions, and Precautionary Information Under Section 314
of the National Childhood Vaccine Injury Act of 1986.................................. 0910-AA14
945 Hearing Aids; Professional and Patient Labeling; Conditions for Sale................. 0910-AA39
946 Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for
Juices................................................................................ 0910-AA43
947 Bioavailability and Bioequivalence Requirements...................................... 0910-AA51
948 Drugs Used for Treatment of Narcotic Addicts......................................... 0910-AA52
949 Dietary Supplement Regulations in Response to DSHEA.................................. 0910-AA59
950 Investigational New Drugs: Export Requirements for Unapproved New Drug Products...... 0910-AA61
951 Adverse Drug Reaction Reporting, Recordkeeping, and Records Access Requirements for
Marketed OTC Drugs.................................................................... 0910-AA86
952 Informed Consent for Human Drugs and Biologics; Determination That Informed Consent
Is Not Feasible....................................................................... 0910-AA89
953 Direct-to-Consumer Promotion Regulations............................................. 0910-AA90
954 Labeling for Human Prescription Drugs; Revised Format................................ 0910-AA94
955 Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products.. 0910-AA97
956 Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That
Uses Are No Longer Essential.......................................................... 0910-AA99
957 Radioactive Drugs for Basic Research................................................. 0910-AB00
958 Establishment Registration and Listing of Human Cellular and Tissue-Based Products... 0910-AB05
959 Veterinary Feed Directives: Distributor Notification................................. 0910-AB09
960 Use of Ozone-Depleting Substances in Aerosol Products or Other Pressurized Dispensers 0910-AB10
961 Exports; Reporting and Recordkeeping Requirements.................................... 0910-AB16
962 Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and Adolescents; Use of Nontobacco Trade or Brand Names... 0910-AB17
963 Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco
Requirements; Applications for Exemption Submitted by Various State Governments; Group
1; Group 2............................................................................ 0910-AB19
964 Registration of Foreign Establishments and Product Listing........................... 0910-AB21
965 Public Information; Communications with State and Foreign Government Officials....... 0910-AB22
966 Dissemination of Treatment Information on Unapproved Uses for Marketed Drugs and
Devices............................................................................... 0910-AB23
967 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........................................................ 0910-AB24
968 Blood Initiative..................................................................... 0910-AB26
969 Suitability Determination for Donors of Human Cellular and Tissue-Based Products..... 0910-AB27
970 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based
Products.............................................................................. 0910-AB28
971 Biological Products Regulated Under Section 351 of the Public Health Services Act;
Implementation of Biologics License; Elimination of Establishment License and Product
License............................................................................... 0910-AB29
972 Antibiotic Drug Approval and Exclusivity............................................. 0910-AB33
973 Applications for FDA Approval to Market a New Drug or Antibiotic Drug; Complete
Review Letter; Amendments to Unapproved Applications.................................. 0910-AB34
974 Expanded Access to Investigational Therapies......................................... 0910-AB37
975 Distinguishing Marks for Drug Products Containing Insulin............................ 0910-AB43
[[Page 21935]]
976 Progestational Drug Products for Human Use; Requirements for Labeling Directed to the
Patient............................................................................... 0910-AB45
977 Requirements for Liquid Medicated Feed and Free Choice Medicated Feed................ 0910-AB50
978 Revisions to the General Safety Requirements for Biological Products; Direct Final
Rule.................................................................................. 0910-AB51
979 Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring....................... 0910-AB52
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Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
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980 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal
Drug and Patent Term Restoration Act (GADPTRA)........................................ 0910-AA02
981 Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and
Clarifications........................................................................ 0910-AA08
982 Biological Products: Reporting of Errors and Accidents in Manufacturing.............. 0910-AA12
983 Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products....... 0910-AA26
984 Prescription Drug Product Labeling; Medication Guide................................. 0910-AA37
985 Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished
Pharmaceuticals....................................................................... 0910-AA45
986 Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant;
Labeling Requirements; Warning Statement.............................................. 0910-AA74
987 New Drug Applications; Drug Master File.............................................. 0910-AA78
988 Over-the-Counter Human Drugs; Labeling Requirements.................................. 0910-AA79
989 Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening
Illnesses............................................................................. 0910-AA84
990 Sterility Requirements for Inhalation Solution Products.............................. 0910-AA88
991 Current Good Manufacturing Practice; Revision of Certain Labeling Controls........... 0910-AA98
992 Definition of Substantial Evidence................................................... 0910-AB08
993 Medicated Feed Mill Licenses......................................................... 0910-AB18
994 Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New
Drugs and Biological Products in Pediatric Patients................................... 0910-AB20
995 Revocation of Lather Brushes Regulation.............................................. 0910-AB25
996 Removal of Regulations Regarding Certification of Antibiotic Drugs................... 0910-AB31
997 Revocation of Antibiotic Certification Requirements; Conforming Revisions to
Regulations........................................................................... 0910-AB32
998 Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of
Insulin............................................................................... 0910-AB38
999 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs.... 0910-AB39
1000 List of Drugs That Have Been Withdrawn or Removed from the Market for Reasons of
Safety and Effectiveness.............................................................. 0910-AB40
1001 Streamlining Clinical Research....................................................... 0910-AB41
1002 Medical Devices; IDE Modifications................................................... 0910-AB53
1003 Dispute Resolution................................................................... 0910-AB54
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Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1004 Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality
Factors, Notification Requirements, and Records and Reports........................... 0910-AA04
1005 Food Labeling Review................................................................. 0910-AA19
1006 Medical Foods........................................................................ 0910-AA20
1007 Amalgam Ingredient Labeling.......................................................... 0910-AA33
1008 Classification of Computer Software Programs That Are Medical Devices................ 0910-AA41
1009 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution... 0910-AA49
1010 Reinventing FDA Food Regulations..................................................... 0910-AA58
1011 Reinvention of Administrative Procedures Regulations................................. 0910-AA69
1012 Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent
Requirements.......................................................................... 0910-AA75
1013 Debarment Certification Regulations for Drug Applications............................ 0910-AA76
1014 Investigational New Drug Applications; Request for Information and Comments.......... 0910-AA83
1015 Investigational New Animal Drug Regulations.......................................... 0910-AB02
1016 New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification 0910-AB12
[[Page 21936]]
1017 Administrative Practices and Procedures; Advisory Opinions and Guidelines............ 0910-AB14
1018 Pregnancy Labeling Revision.......................................................... 0910-AB44
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Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1019 Implementation of the Safe Medical Devices Act of 1990............................... 0910-AA09
1020 Mammography Quality Standards Act of 1992............................................ 0910-AA24
1021 Financial Disclosure by Clinical Investigators....................................... 0910-AA30
1022 Habit-Forming Drugs.................................................................. 0910-AA50
1023 Revocation of Certain Regulations.................................................... 0910-AA54
1024 Investigational New Drug Applications; Clinical Holds................................ 0910-AA73
1025 Certification of Drugs Composed Wholly or Partly of Insulin.......................... 0910-AA77
1026 Investigational New Drug Applications and New Drug Applications...................... 0910-AA82
1027 Postmarketing Periodic Adverse Experience Reporting Requirements for Human Drug and
Licensed Biological Products.......................................................... 0910-AA85
1028 New Drugs for Human Use; Clarification of Requirements for Application Supplements... 0910-AA87
1029 Definition of Adequate and Well-Controlled Studies................................... 0910-AB01
1030 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........................................................ 0910-AB06
1031 Clarification of the Scope of Treatment Uses With Investigational New Drugs That Can
Be Authorized Under INDs and the Criteria for Charging for Investigational New Drugs
Under INDs............................................................................ 0910-AB11
1032 Prescription Drug Compounding........................................................ 0910-AB13
1033 Revocation of Regulation on Positron Emission Tomography Drug Products............... 0910-AB46
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Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1034 National Practitioner Data Bank for Adverse Information on Physicians and Other
Health Care Practitioners: Corporate Shield........................................... 0906-AA41
1035 National Practitioner Data Bank for Adverse Information on Physicians and Other
Health Care Practitioners: Reporting Adverse and Negative Actions..................... 0906-AA43
1036 Designation of Medically Underserved Populations and Health Professional Shortage
Areas................................................................................. 0906-AA44
1037 Health Care Fraud and Abuse Data Collection Program.................................. 0906-AA46
1038 National Practitioner Data Bank for Adverse Information on Physicians and Other
Health Care Providers: Clarification and Modernization of Regulatory Terms............ 0906-AA48
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Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1039 Organ Procurement and Transplantation Network Rules.................................. 0906-AA32
1040 National Vaccine Injury Compensation Program: Effective Date Provisions of Coverage
of Certain Vaccines to the Vaccine Injury Table....................................... 0906-AA49
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[[Page 21937]]
Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1041 Drug Pricing Program: Prime Vendor User Charge....................................... 0906-AA45
----------------------------------------------------------------------------------------------------------------
Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1042 National Practitioner Data Bank for Adverse Information on Physicians and Other
Health Care Practitioners: Charge for Self-Queries.................................... 0906-AA42
1043 Grants for Residency Training and Advanced Education in the General Practice of
Dentistry; Technical Amendments....................................................... 0906-AA47
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Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1044 Acquisition Under the Buy Indian Act................................................. 0917-AA00
1045 Indian Child Protection and Family Violence Prevention Act Minimum Standards of
Character............................................................................. 0917-AA02
----------------------------------------------------------------------------------------------------------------
National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1046 National Institutes of Health AIDS Research Loan Repayment Program................... 0925-AA02
1047 Undergraduate Scholarship Program Regarding Professions Needed by the NIH............ 0925-AA10
1048 Traineeships......................................................................... 0925-AA11
1049 Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects
in Research, and Pertaining to Human In Vitro Fertilization........................... 0925-AA14
1050 National Research Service Awards..................................................... 0925-AA16
1051 Removal of National Cancer Institute Clinical Cancer Education Program............... 0925-AA17
1052 National Institutes of Health Loan Repayment Program for Research.................... 0925-AA18
1053 National Institute of Child Health and Human Development Contraception and
Infertility Research Loan Repayment Program........................................... 0925-AA19
1054 Scientific Peer Review of Research Grant Applications and Research and Development
Contract Projects..................................................................... 0925-AA20
1055 Federal Policy (Common Rule) for the Protection of Human Subjects.................... 0925-AA21
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National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1056 National Institutes of Health Construction Grants.................................... 0925-AA04
1057 National Institutes of Health Clinical Research Loan Repayment Program for
Individuals From Disadvantaged Backgrounds............................................ 0925-AA09
1058 Service Fellowship................................................................... 0925-AA22
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[[Page 21938]]
Office of Assistant Secretary for Health--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1059 Standards of Compliance for Abortion-Related Services in Family Planning Service
Projects.............................................................................. 0937-AA00
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Public Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1060 Public Health Service Standards for the Protection of Research Misconduct
Whistleblowers........................................................................ 0905-AE71
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Health Care Financing Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1061 Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR)....................... 0938-AI72
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Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1062 ``Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare
Overpayment Liability (HCFA-1719-P)................................................... 0938-AD95
1063 Provider Reimbursement Determinations and Appeals (HCFA-1727-P)...................... 0938-AF28
1064 Revisions to Rules on Health Care Prepayment Plans (HCFA-1016-P)..................... 0938-AF97
1065 Conditions of Participation for Rural Health Clinics (HCFA-1764-P)................... 0938-AG05
1066 Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P).................... 0938-AG31
1067 Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,
Underpayments and Overpayments (HCFA-2215-P).......................................... 0938-AG59
1068 Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With
Tuberculosis (HCFA-2082-P)............................................................ 0938-AG72
1069 Physicians' Referrals to Health Care Entities With Which They Have Financial
Relationships--Expanded to Designated Health Services (HCFA-1809-F)................... 0938-AG80
1070 End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P)................. 0938-AG82
1071 Liability for Third Parties To Pay for Care and Services (MB-080-P).................. 0938-AH01
1072 Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical
Equipment (DME) (BPD-834-P)........................................................... 0938-AH16
1073 Medicare Coverage of Organ Transplantation (HCFA-3835-PN)............................ 0938-AH17
1074 State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)..................... 0938-AH24
1075 Hospice Care--Conditions of Participation (HCFA-3844-P).............................. 0938-AH27
1076 Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-
1843-P)............................................................................... 0938-AH37
1077 Payment Amount If Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC).... 0938-AH49
1078 Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating
Physicians (HCFA-1862-P).............................................................. 0938-AH50
1079 Revision to Accrual Basis of Accounting Policy (HCFA-1876-P)......................... 0938-AH61
1080 Medicaid; Estate Recoveries (HCFA-2083-P)............................................ 0938-AH63
1081 Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance
(HCFA-1848-P)......................................................................... 0938-AH66
1082 Medicare Technical Conforming Amendments (HCFA-1858-FC).............................. 0938-AH67
1083 Elimination of Certain Requirements for Peer Review Organizations in the Utilization
and Quality Review Process and a Change in the Length of Peer Review Organization
Contracts (HCFA-3235-FC).............................................................. 0938-AH68
1084 Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)...................... 0938-AH69
1085 Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical
Procedures for Ambulatory Surgical Centers Effective for Calendar Year 1998 (HCFA-1885-
P).................................................................................... 0938-AH81
1086 Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)... 0938-AH83
1087 Disclosure of Peer Review Organization Information in Response to Beneficiary
Complaints (HCFA-3241-P).............................................................. 0938-AH85
1088 Medicare Program; Beneficiary Incentives Programs (HCFA-6144-P)...................... 0938-AH86
1089 National Standard for Identifiers of Health Plans (HCFA-4145-P)...................... 0938-AH87
1090 Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review
Program (HCFA-2107-P)................................................................. 0938-AH89
[[Page 21939]]
1091 Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services
(HCFA-2043-P)......................................................................... 0938-AH95
1092 Medicare Coverage of Certified Nurse-Midwife Services (HCFA-1496-P).................. 0938-AH96
1093 National Standard Health Care Provider Identifier (HCFA-0045-P)...................... 0938-AH99
1094 Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries
Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P)....................................... 0938-AI11
1095 Newborns' and Mothers' Health Protection............................................. 0938-AI13
1096 Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999
Rates (HCFA-1003-P)................................................................... 0938-AI22
1097 Children's Health Insurance: Program Implementations; State Plan Approval; State
Payment; Coordination With State Medicaid Program (HCFA-2006-P)....................... 0938-AI28
1098 Standards for Electronic Transactions (HCFA-0149-P).................................. 0938-AI58
1099 National Standard Employer Identifier (HCFA-0047-P).................................. 0938-AI59
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Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1100 Deduction of Incurred Medical Expenses (Spenddown) (HCFA-2020-F)..................... 0938-AB07
1101 Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F)....................... 0938-AB50
1102 Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge
Rights Notice, and Hospital Responsibility for Emergency Care (HCFA-1393-IFC)......... 0938-AC58
1103 Medicare Secondary Payer for Disabled Individuals (HCFA-1482-F)...................... 0938-AD73
1104 Omnibus Nursing Home Reform Requirements (HCFA-3488-F)............................... 0938-AD81
1105 Coverage of Screening Pap Smears (BPD-705-F)......................................... 0938-AE98
1106 Case Management (HCFA-2027-F)........................................................ 0938-AF07
1107 Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC). 0938-AF42
1108 Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,
Infants, and Children Under Age 19 (HCFA-2052-F)...................................... 0938-AF69
1109 Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and
Competitive Medical Plans (HCFA-1015-F)............................................... 0938-AF98
1110 Payment for Preadmission Services (HCFA-1731-F)...................................... 0938-AG00
1111 Change in Provider Agreement Regulations Related to Federal Employee Health Benefits
(HCFA-1748-F)......................................................................... 0938-AG03
1112 Revised Medicaid Management Information Systems (MB-38-FN)........................... 0938-AG10
1113 Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia
(Dry Mouth) (HCFA-3782-FN)............................................................ 0938-AG45
1114 Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F)... 0938-AG48
1115 Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)................... 0938-AG81
1116 CLIA Program: Categorization of Waived Tests (HCFA-2225-FC).......................... 0938-AG99
1117 Ambulance Services (HCFA-1813-F)..................................................... 0938-AH13
1118 Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F).... 0938-AH15
1119 CLIA Program: Cytology Proficiency Testing (HCFA-2233-N)............................. 0938-AH35
1120 Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-
Based Group Health Plans (HCFA-2047-FC)............................................... 0938-AH48
1121 Limitations on Liability (HCFA-4859-FC).............................................. 0938-AH51
1122 Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)............... 0938-AH53
1123 Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998
Rates (HCFA-1878-F)................................................................... 0938-AH55
1124 Utilization Control and Discontinued Review Activities; Medicaid (MB-101-FC)......... 0938-AH64
1125 Individual Market Health Ins. Reform Portability from Group to Indiv. Coverage;
Federal Rules for Access in the Indiv. Market; State Alternative Mechanisms to Federal
Rules (HCFA-2882-F)................................................................... 0938-AH75
1126 Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform
(HCFA-2105-IFC)....................................................................... 0938-AH76
1127 CLIA Program; Simplifying CLIA Regulations to Accreditation Exemption of Laboratories
Under a State Licensure Program, and Proficiency Testing and Inspection (HCFA-2239-FC) 0938-AH82
1128 Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB-
103-N)................................................................................ 0938-AH90
1129 Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC).................. 0938-AH92
1130 Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal
Fiscal Year 1998 (HCFA-2110-N)........................................................ 0938-AH93
1131 Revision to the Definition of an Unemployed Parent (HCFA-2106-FC).................... 0938-AH98
1132 Health Insurance Reform: Parity in the Application of Certain Limits to Mental Health
Benefits (HCFA-2891-IFC).............................................................. 0938-AI05
[[Page 21940]]
1133 Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F). 0938-AI08
1134 Part A Premium for 1998 for the Uninsured Aged and for Certain Disabled Individuals
Who Have Exhausted Other Entitlement (HCFA-5056-N).................................... 0938-AI10
1135 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance
Amounts for 1998 (HCFA-5057-N)........................................................ 0938-AI12
1136 Health Insurance Portability: Newborns' and Mothers' Health Protection (HCFA-2892-
IFC).................................................................................. 0938-AI17
1137 Medicare Program: Update of Ambulatory Surgical Center Payment Rates Effective for
Services On or Before October 1, 1997 (HCFA-1897-N)................................... 0938-AI18
1138 Medicaid Program: Charges for Vaccine Administration Under the Vaccines for Children
(VCF) Program (HCFA-2084-FNC)......................................................... 0938-AI20
1139 Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC).............. 0938-AI25
1140 Medicare Program; Notice for the Solicitation for Proposals for a Demonstration
Project for Congestive Heart Failure Case Management HCFA-1104-N)..................... 0938-AI26
1141 GME: Incentive Payments under Plans for Voluntary Reduction in Number of Residents
(HCFA-1001-IFC)....................................................................... 0938-AI27
1142 Medicare + Choice Program; Regulatory Program to Implement Certain Medicare
Provisions of the Balanced Budget Act of 1997 (OMC-030-IFC)........................... 0938-AI29
1143 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled
Nursing Facilities. (HCFA-1913-IFC)................................................... 0938-AI47
1144 Resource Based Practice Expense Payments and Revisions to Payment Policies for CY
1999 (HCFA-1006-P).................................................................... 0938-AI52
1145 Medicare Program; Definition of Provider-Sponsored Organization and Related
Requirements (HCFA-1027-IFC).......................................................... 0938-AI60
----------------------------------------------------------------------------------------------------------------
Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1146 Criteria and Procedures for Developing Medical Services Coverage Policy (HCFA-3546-F) 0938-AD07
1147 Medicare Coverage of Outpatient Occupational Therapy Services (HCFA-1425-P).......... 0938-AD32
1148 Changes to Peer Review Organization Regulations (HCFA-3135-F)........................ 0938-AD38
1149 Protection of Income and Resources for Community Spouses of Institutionalized
Individuals (HCFA-2023-P)............................................................. 0938-AE12
1150 Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F). 0938-AE39
1151 Revisions to Regulations Implementing CLIA (HCFA-2226-F)............................. 0938-AE47
1152 Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)... 0938-AE72
1153 Payment for Nursing and Allied Health Science Education (HCFA-1685-F)................ 0938-AE79
1154 Medicare Coverage of, and Application of the Outpatient Mental Health Treatment
Limitation to, Clinical Psychologist and Clinical Social Worker Services (HCFA-3706-F) 0938-AE99
1155 Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC)................. 0938-AF02
1156 Requirements for Certain Health Insuring Organizations and OBRA'90 Technical
Amendments (HCFA-1018-F).............................................................. 0938-AF15
1157 Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)........................ 0938-AF32
1158 Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F).... 0938-AF68
1159 Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)........ 0938-AF87
1160 Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth
Scope of Work Contracts (HCFA-3207-N)................................................. 0938-AG32
1161 Disclosure of Confidential PRO and ESRD Network Organization Information for Research
Purposes (HCFA-3208-P)................................................................ 0938-AG33
1162 Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure
Breathing Machine Therapy (HCFA-3781-FN).............................................. 0938-AG44
1163 Revision of Medicare Hospital Conditions of Participation (HCFA-3745-F).............. 0938-AG79
1164 Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening
of Applicants for Nursing Home Admission (BPD-815-P).................................. 0938-AG84
1165 Clinical Laboratory Improvement Amendment (CLIA) Fee Schedule Revision (HCFA-3219-
GNC).................................................................................. 0938-AG87
1166 Categorization and Certification Requirements for a New Subcategory of Moderate
Complexity Testing (HCFA-2222-F)...................................................... 0938-AG98
1167 Additional Supplier Standards (HCFA-1864-P).......................................... 0938-AH19
1168 Criteria and Procedures for Extending Coverage to Certain Devices and Related
Services (HCFA-3841-F)................................................................ 0938-AH21
1169 Delegation of Civil Money Penalties (HCFA-6135-FC)................................... 0938-AH22
1170 Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P)................. 0938-AH52
[[Page 21941]]
1171 Conditions for Certification of Community Mental Health Centers and Coverage
Requirements for Partial Hospitalization Services (HCFA-1871-P)....................... 0938-AH58
1172 Medicaid Hospice Care (HCFA-2016-P).................................................. 0938-AH65
1173 Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities
Participating in an Experiment (HCFA-2236-GNC)........................................ 0938-AH72
1174 Provider and Supplier Enrollment and Re-enrollment Requirements (HCFA-1023-P)........ 0938-AH73
1175 Medicare Program; Medicare Integrity Program (HCFA-7020-P)........................... 0938-AI09
1176 Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and
Sustainable Growth Rate For Fiscal Year 1998 (HCFA-1893-FN)........................... 0938-AI16
1177 Medicaid: Medical Child Support (HCFA-2081-P)........................................ 0938-AI21
1178 Collection of User Fees From Medicare+Choice Plans and Risk-Sharing Contractors (HCFA-
1911-IFC)............................................................................. 0938-AI35
1179 Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F). 0938-AI38
1180 Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for
Qualified Individuals: Federal Fiscal Year 1998 (HCFA-2005-NC)........................ 0938-AI39
1181 Medicare Program: Payments for Teleconsultations in Rural Health Professional
Shortage Areas (HCFA-1906-P).......................................................... 0938-AI44
1182 Medicare Program: User Fees (HCFA-6021-P)............................................ 0938-AI46
1183 Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab.
Agencies, Community Mental Health Centers, and Independent Diagnostic Testing
Facilities (HCFA-1026-P).............................................................. 0938-AI48
1184 Administrative Appeals Process for Suppliers Seeking To Enroll in Medicare Program
(HCFA-1907-FC)........................................................................ 0938-AI49
1185 Medicare Program; Prospective Payment System for Hospital Outpatient (HCFA-1005-P)... 0938-AI56
1186 Security and Electronic Signature Standards (HCFA-0049-P)............................ 0938-AI57
1187 Surety Bond for Suppliers of Medical Equipment (HCFA-2007-P)......................... 0938-AI63
1188 Child Health Insurance Allotments FY 1999 (HCFA-2014-N).............................. 0938-AI64
1189 State Children Health Plan Allotments and Payments to States (HCFA-2114-FC).......... 0938-AI65
1190 DSH Payments - Institution for Mental Disease (HCFA-2007-P).......................... 0938-AI66
1191 Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)................... 0938-AI67
1192 Revisions to Payment Policies Under the Physician Fee Schedule and Other Part B
Payment Policies for Calendar Year 1999 and the Rebasing of the Medicare Economic
Index (HCFA-1006-P)................................................................... 0938-AI69
1193 Managed Care: Global Medicaid Managed Care Provisions in the Balanced Budget Act of
1997 (HCFA-2001-P).................................................................... 0938-AI70
1194 New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a)
of the Social Security Act July, August, September, October, and November 1997........ 0938-AI71
1195 Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC). 0938-AI73
1196 Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P).......... 0938-AI74
1197 Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan
(HCFA-1777-P)......................................................................... 0938-AI75
1198 Medicare Program; Advertising Costs (HCFA-1880-P).................................... 0938-AI76
1199 Medicare Hospice Care (HCFA-1022-P).................................................. 0938-AI77
1200 State Allotments for Additional Federal Funding of Emergency Health Services
Furnished to Undocumented Aliens: Federal Fiscal Years 1998 Through 2001.............. 0938-AI78
1201 Medicaid Program; Extension of Waiver To Extend Medicaid Eligibility Timeframes (HCFA-
2009-N)............................................................................... 0938-AI79
1202 Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and
Elimination of Reclassifications (HCFA-1883-P)........................................ 0938-AI80
1203 Medicare and Medicaid Programs; Surety Bond and Capitalization Requirements for Home
Health Agencies (HCFA-1038-NC)........................................................ 0938-AI82
1204 Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC).............. 0938-AI83
1205 Schedule of Per-Beneficiary Limitations on Home Health Agency Costs for Cost
Reporting Periods Begining On or After October 1, 1997 (HCFA-1905-FC)................. 0938-AI84
1206 Expanded Coverage of Blood Glucose Monitors and Test Strips (HCFA-3003-IFC).......... 0938-AI85
1207 Surety Bond Requirements for Home Health Agencies (HCFA-1152.1-F).................... 0938-AI86
1208 Hospice Wage Index Notice (HCFA-1039-N).............................................. 0938-AI87
1209 Medicare Program; Standardization of Medicare Coverage for Bone Mass Measurements
(HCFA-3004-IFC)....................................................................... 0938-AI89
1210 Recognition of the American Association for Accreditation of Ambulatory Surgery
Facilities Inc., for Ambulatory Surgical Centers Program (HCFA-2008-PN)............... 0938-AI90
----------------------------------------------------------------------------------------------------------------
[[Page 21942]]
Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1211 Effective Dates for Provider Agreements and Supplier Approvals (HCFA-3139-F)......... 0938-AC88
1212 Prohibition on Unbundling of Hospital Outpatient Services (HCFA-1426-F).............. 0938-AD33
1213 Resident Assessment in Long-Term Care Facilities (HCFA-2180-F)....................... 0938-AE61
1214 Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)............... 0938-AE63
1215 Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech
Pathology, and Occupational Therapy (HCFA-1808-F)..................................... 0938-AG70
1216 Home Health Agency Physician Certification Regulations (BPD-875-NC).................. 0938-AH59
1217 Medicare Program; Establishment of an Expedited Review Process for Medicare
Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (HCFA-1025-FC)........................ 0938-AH62
1218 Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies
(HCFA-3238-F)......................................................................... 0938-AH74
1219 Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value
Units Under the Physician Fee Schedule, Other Part B Payment Policies for Calendar YR
1998 (HCFA-1884-FC)................................................................... 0938-AH94
1220 Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medicare
Insurance Premium Rate Beginning January 1, 1998 (OACT-055-N)......................... 0938-AI03
1221 Schedule of Limits on Home Health Agency Cost Per Visit for Cost Reporting Periods
Beginning On or After October 1, 1997 (BPD-904-FC).................................... 0938-AI24
1222 Surety Bond and Capitalization Requirements for Home Health Agencies (HCFA-1152-FC).. 0938-AI31
1223 Health Insurance Portability and Accountability Act (HIPPA) of 1996: Administrative
Simplification........................................................................ 0938-AI32
1224 Medicare Program: Delay in Implementing Adjustments to Practice Expense Relative
Value Units Under the Physician Fee Schedule For Calendar Year 1998 (HCFA-1901-NC).... 0938-AI33
1225 Medicare Program; Limit on the Valuation of Depreciable Asset Recognized as an
Allowance for Depreciation and Interest on Capital Indebtedness After a Change of
Ownership (HCFA-1004-FC).............................................................. 0938-AI34
1226 Application of Inherent Reasonableness to All Medicare Part B Services (Other than
Physician Services) (HCFA-1908-IFC)................................................... 0938-AI37
1227 Medicare Program: Request for Public Comments on Implementation of the
Medicare+Choice Program and Notice of Timeframes for Submission of Applications for
Contracts (HCFA-1014-N)............................................................... 0938-AI45
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1228 Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan
Reviews, MEPA Implementation, and ASFA Implementation................................. 0970-AA97
1229 Construction of Head Start Facilities................................................ 0970-AB54
1230 Methodology for Determining Child Poverty Rates...................................... 0970-AB65
1231 Bonus to Reward High Performance States Under the Temporary Assistance for Needy
Families Block Grant.................................................................. 0970-AB66
1232 Child Support Enforcement for Indian Tribes.......................................... 0970-AB73
1233 Requirements for the Tribal Programs................................................. 0970-AB78
1234 Refugee Resettlement Program: Responding to TANF Replacing AFDC...................... 0970-AB83
1235 Child Support Non-Performance Penalty................................................ 0970-AB85
1236 Child Abuse and Neglect Prevention and Treatment..................................... 0970-AB86
1237 Head Start Appeal Timelines.......................................................... 0970-AB87
1238 Title IV-E Training.................................................................. 0970-AB89
1239 Family Child Care Program Option for Head Start Programs............................. 0970-AB90
1240 Implementation of Adoption & Safe Families Act of Remaining Provisions of the 1997
and Other Title IV-B/IV-E Regulatory Amendments....................................... 0970-AB94
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1241 Standards for Safe Transportation.................................................... 0970-AB24
1242 Standards for Purchase of Facilities................................................. 0970-AB31
1243 Designation of Alternative Agency To Serve Indian Tribal Children.................... 0970-AB52
1244 Quarterly Wage and Unemployment Compensation Claims Reporting to the National
Directory of New Hires................................................................ 0970-AB67
[[Page 21943]]
1245 State Law Concerning Paternity Establishment......................................... 0970-AB69
1246 Automated Data Processing Requirements/State Case Registry........................... 0970-AB70
1247 Automated Data Processing Funding Limitation......................................... 0970-AB71
1248 Grants to States for Access and Visitation Programs.................................. 0970-AB72
1249 Child Care and Development Fund...................................................... 0970-AB74
1250 Temporary Assistance for Needy Families (TANF)....................................... 0970-AB77
1251 Bonus to Reward Decrease in Illegitimacy............................................. 0970-AB79
1252 Child Support Enforcement Program Omnibus Conforming Regulation...................... 0970-AB81
1253 Case Closure......................................................................... 0970-AB82
1254 Data Collection and Elements for the Welfare to Work Program......................... 0970-AB92
----------------------------------------------------------------------------------------------------------------
Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1255 Income Eligibility Criteria for Indian Tribes........................................ 0970-AB53
1256 Income and Resource Disregards Related to Interests of Individual Indians in Trust or
Restricted Lands...................................................................... 0970-AB59
1257 State Case Registry and Expansion of the Federal Parent Locator Service (FPLS)....... 0970-AB68
1258 Personal Responsibility and Work Opportunity Reconciliation Act of 1996 Conforming
Regulation............................................................................ 0970-AB84
1259 Title IV-B Planning Requirements for Tribes.......................................... 0970-AB88
----------------------------------------------------------------------------------------------------------------
Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier
Number Number
----------------------------------------------------------------------------------------------------------------
1260 Grants for State and Community Programs on Aging, Intrastate Funding Formulas;
Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to
Indians & Native Hawaiians............................................................ 0985-AA00
----------------------------------------------------------------------------------------------------------------
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
921. 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 proposed rule would revise the OIG's exclusion and civil
money penalty (CMP) authorities resulting from the Balanced Budget Act
of 1997, Public Law 105-33. These proposed revisions would 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 provider 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 06/00/98
NPRM Comment Period End 08/00/98
Small Entities Affected: None
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
[[Page 21944]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________
922. 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.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/21/93 58 FR 49008
NPRM Comment Period End 11/22/93
Final Action 11/00/98
Small Entities Affected: None
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 (59FR37202, July 21, 1994).
Agency Contact: Joel Jay Schaer, Regulations Officer, Office of
Inspector General, OCIG, Department of Health and Human Services,
Office of the Secretary, 330 Independence Avenue SW., Washington, DC
20201
Phone: 202 619-0089
RIN: 0991-AA66
_______________________________________________________________________
923. 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 newly 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
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 06/00/98
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Suzanne Stoiber, Deputy 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
_______________________________________________________________________
924. REVISED OIG EXCLUSION AUTHORITIES RESULTING FROM PUBLIC LAW 104-191
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-191, sec 211; PL 104-191, sec 212; PL 104-191,
sec 213
CFR Citation: 42 CFR 1000; 42 CFR 1001; 42 CFR 1002; 42 CFR 1005
Legal Deadline: None
Abstract: This final rule addresses revisions to the OIG's sanction
authorities in conjunction with sections 211, 212, and 213 resulting
from the Health Insurance Portability and Accountability Act of 1996,
along with other technical and conforming changes to the OIG exclusion
authorities. The revisions are specifically designed to expand the
protection of certain basic fraud authorities and revise and strengthen
the current legal authorities pertaining to exclusions from Medicare
and and other Federal health care programs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/08/97 62 FR 47182
NPRM Comment Period End 11/07/97
Final Action 08/00/98
Small Entities Affected: None
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-AA87
_______________________________________________________________________
925. 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.
[[Page 21945]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/25/98 63 FR 14393
NPRM Comment Period End 05/26/98
Final Action 12/00/98
Small Entities Affected: None
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, OCIG, 330 Independence Avenue SW., Washington, DC
20201
Phone: 202 619-0089
RIN: 0991-AA90
_______________________________________________________________________
926. 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 would establish a new statutory
exception for risk-sharing arrangements under the Federal health care
programs anti-kickback provisions. The rule would set forth an
exception from liability for remuneration between an eligible
organization under section 1876 of the Social Security Act and an
individual or entity providing items or services in accordance with a
written agreement between these parties. The rule would also 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 10/00/98
Small Entities Affected: None
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
_______________________________________________________________________
927. ISSUANCE OF ADVISORY OPINIONS BY THE INSPECTOR GENERAL
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 1320a-7d(b)
CFR Citation: 42 CFR 1008
Legal Deadline: Final, Statutory, February 21, 1997.
Abstract: This final rule sets forth the specific procedures by which
the OIG, in consultation with the Department of Justice, will issue
advisory opinions to outside parties regarding the interpretation and
applicability of certain statutes relating to the Medicare and State
health care programs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 02/19/97 62 FR 7350
Final Action 07/00/98
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Schaer, Regulations Officer, Department of Health
and Human Services, Office of the Secretary, Office of Inspector
General, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA94
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Office of the Secretary (OS)
_______________________________________________________________________
928. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN
INCENTIVE PLANS
Priority: Substantive, Nonsignificant
Legal Authority: PL 99-509, Sec 9313(c); PL 101-239, Sec 6003(g)(3);
PL 101-508, Sec 4204(a)(3); PL 101-508, Sec 4731(b)(1)
CFR Citation: 42 CFR 1001; 42 CFR 1003
Legal Deadline: None
Abstract: This final rule will prohibit a hospital from knowingly
making incentive payments to a physician as an inducement to reduce or
limit services provided to Medicare or Medicaid beneficiaries who are
under the direct care of that physician. The rule would also set forth
standards governing the imposition of CMPs for each such individual for
whom payments are made.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 12/01/94 59 FR 61571
NPRM Comment Period End 01/30/95
Final Action 00/00/00
Small Entities Affected: None
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-AA45
_______________________________________________________________________
929. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO
MEDICARE SUPPLEMENTAL POLICIES
Priority: Substantive, Nonsignificant
Legal Authority: PL 100-360, Sec 428(b); PL 101-508, Sec 4204(g)(1);
PL
[[Page 21946]]
101-508, Sec 4351; PL 101-508, Sec 4354(a)(1)(E); PL 101-508, Sec
4354(a)(2); PL 101-508, Sec 4355(a); PL 101-508, Sec 4357
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This rule would authorize CMPs against any individual or
entity who knowingly and willfully uses misleading or fraudulent
practices in the advertisement, solicitation, offering for sale or
delivery of Medicare supplemental health insurance (Medigap) policies.
Penalties would also be established for failure to (1) meet Medigap
policy loss-ratio requirements, (2) comply with policy simplification
standards, or (3) obtain Secretarial certification of Medigap policies
in States with non-approved regulatory programs. In addition, this rule
would also set forth CMPs for the failure of sellers or issuers to
solicit information, and to provide notice, about Medicaid status and
eligibility before selling or issuing Medigap policies.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OCIG, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA53
_______________________________________________________________________
930. 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
Legal Authority: 42 USC 1395bbb; 42 USC 1396t
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would set forth civil money penalties
against any individual or entity that notifies, or causes to notify, a
home health agency, or a home or community-based health care center or
provider, of the time or date on which a standard survey is scheduled
to be conducted by a State or local agency.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OCIG, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA79
_______________________________________________________________________
931. CIVIL MONEY PENALTIES FOR FALSE INFORMATION ON DRUG MANUFACTURER
PRICE SURVEYS AND REBATE AGREEMENTS
Priority: Substantive, Nonsignificant
Legal Authority: 42 USC 1302; 42 USC 1396r-8
CFR Citation: 42 CFR 1003
Legal Deadline: None
Abstract: This proposed rule would set forth civil money penalties
against any manufacturer of covered outpatient drugs thatfails to
respond to a request for information about charges or prices, or
knowingly provide false information, in a survey by the Secretary to
verify manufacturers' reported prices under the Medicaid drug rebate
program. In addition, this rule would set forth civil money penalties
against any drug manufacturer that, in accordance with section
1927(b)(3)(A) of the Social Security Act, fails to provide rebate
agreement price information on a timely basis.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joel Jay Schaer, Regulations Officer, Department of
Health and Human Services, Office of the Secretary, Office of Inspector
General, OCIG, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089
RIN: 0991-AA80
_______________________________________________________________________
932. SENIOR BIOMEDICAL RESEARCH SERVICES
Priority: Info./Admin./Other
Legal Authority: 42 USC 228
CFR Citation: 42 CFR 24
Legal Deadline: None
Abstract: This regulation implements the Senior Biomedical Research
Service (SBRS), a personnel system established in the Public Health
Service by section 304 of Public Law 101-509. The SBRS will consist of
500 members appointed by the Secretary without regard to the provisions
of title 5, U.S. Code, regarding appointment, who are outstanding in
the field of biomedical research or clinical research evaluation.
Appointments to the SBRS will be only to individuals with doctoral-
level degrees in biomedicine or a related field. The regulation
describes basic eligibility criteria, pay rates, performance appraisal
system, optional retirement system, and procedure for removal from the
SBRS.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 02/21/96 61 FR 6557
Interim Final Rule Comment
Period End 03/31/96
Final Action 00/00/00
Small Entities Affected: None
Government Levels Affected: Federal
Agency Contact: Rosemary Taylor, Personnel Management Specialist,
Department of Health and Human Services, Office of the Secretary, 200
Independence Avenue SW., Room 522A, Washington, DC 20201
Phone: 202 690-7358
Fax: 202 690-6758
RIN: 0991-AA82
[[Page 21947]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________
933. CIVIL MONEY PENALTIES FOR REFERRALS TO ENTITIES AND FOR PROHIBITED
ARRANGEMENTS AND SCHEMES
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.
CFR Citation: 42 CFR 1001; 42 CFR 1003
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 10/20/93 58 FR 54096
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Joel Jay Schaer
Phone: 202 619-0089
RIN: 0991-AA65
_______________________________________________________________________
934. ADMINISTRATIVE REQUIREMENTS FOR GRANTEES TO REFLECT SINGLE AUDIT
ACT AMENDMENTS
Priority: Info./Admin./Other
Unfunded Mandates: This action may affect State, local or tribal
governments and the private sector.
CFR Citation: 45 CFR 74; 45 CFR 92; 45 CFR 96
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
No Further Action Required 10/28/97
Small Entities Affected: None
Government Levels Affected: State, Local, Tribal
Agency Contact: Charles Gale
Phone: 202 690-6377
TDD: 202 690-6902
Fax: 202 690-6415
RIN: 0991-AA92
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
935. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE
Priority: Other Significant
Legal Authority: 42 USC 300-x et seq, as amended by PL 102-321
CFR Citation: 45 CFR 96
Legal Deadline: Final, Statutory, August 25, 1992.
Awards to States after January 1, 1993 cannot be made until
implementing regulations are published.
Abstract: Sets requirements for block grants for prevention and
treatment of substance abuse. The requirements include criteria for
approval of State plans which must by statute be prescribed in
regulations. These provisions would replace the existing interim final
rule published March 31, 1993. Given the pending reauthorization of
SAMHSA and the current Administration's FY 1996 legislative proposal to
turn the block grant into a ``Performance Partnership,'' publication of
this regulation has been put on hold.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Interim Final Rule 03/31/93 58 FR 17062
Interim Final Rule Comment
Period End 06/01/93
Final Action 00/00/00
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Tribal
Additional Information: Previously reported under RIN 0905-AD98.
Alternate Contact: Jim Sayers, DSP, C SAT SAMHSA, 5515 Security Lane,
Suite 800, Rockville, MD 20852; 301-443-3820.
Agency Contact: Joseph D. Faha, Director, DLEA, SAMHSA, Department of
Health and Human Services, Substance Abuse and Mental Health Services
Administration, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20857
Phone: 301 443-4640
RIN: 0930-AA01
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________
936. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS
Priority: Substantive, Nonsignificant
CFR Citation: 45 CFR 51
Completed:
________________________________________________________________________
Reason Date FR Cite
________________________________________________________________________
Final Action 10/15/97 62 FR 53548
Small Entities Affected: Governmental Jurisdictions, Organizations
Government Levels Affected: State, Local
Agency Contact: Joseph D. Faha
Phone: 301 443-4640
RIN: 0930-AA02
[[Page 21948]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________
937. 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 06/00/98
Final Action 08/00/98
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Leslie L. Clune, 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)
_______________________________________________________________________
938. ANIMAL DRUG APPROVALS FOR MINOR SPECIES AND MINOR USAGE
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Legal Authority: PL 104-250
CFR Citation: Not yet determined
Legal Deadline: Other, Statutory, April 9, 1998.
Animal Drug Availability Act of 1996.
Abstract: The Animal Drug Availability Act of 1996 (ADAA) requires FDA
to consider legislative and regulatory options for facilitating
approval of new animal drugs intended for use in minor species and for
minor uses, and to announce no later than April 9, 1998, proposals for
legislative or regulatory change to the approval process for such
drugs. Because the markets are small for approved new animal drugs
intended for minor species or for minor uses, there are often
insufficient economic incentives to motivate sponsors to develop the
data necessary to support approvals. Manufacturers have not, in many
cases, been willing to fund research to obtain these data, so only
small numbers of new animal drugs intended for minor species or for
minor uses have been approved and are legally marketed. Facilitating
approvals for minor uses and minor species will bring about an increase
in approvals of new animal drugs intended for these uses, which would
be desirable to address the scarcity of approved, legally marketed new
animal drugs intended for minor species or minor uses.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 06/23/97 62 FR 33781
Notice of Availability 04/00/98
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Request for Comments 62 FR 33789, 6/23/97.
Agency Contact: Linda Wilmot, Veterinary Medical Officer, Department of
Health and Human Services, Food and Drug Administration, Center for
Veterinary Medicine (HFV-112), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-0614
RIN: 0910-AB07
_______________________________________________________________________
939. 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 1240.63
Legal Deadline: None
Abstract: There have been numerous foodborne outbreaks of
Salmonellosis, principally due to Salmonella Enteritidis, 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 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
proposed on October 27, 1992, to require that shell eggs be stored at
an ambient temperature of 7 degrees celcius (45 degrees farenheit).
USDA intends to finalize that requirement shortly. However, the USDA
rulemaking does not include refrigeration at retail. As part of
separate rulemaking, FDA intends to propose regulations, based on
recommended provisions of the Retail Food Code, to mandate that shell
eggs be stored for retail sale at 5 degrees celsius (41 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
________________________________________________________________________
ANPRM 09/00/98
Small Entities Affected: 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
[[Page 21949]]
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
_______________________________________________________________________
940. 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 to 357; 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: This advance notice of proposed rulemaking will discuss and
request comments 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 07/00/98
ANPRM Comment Period End 10/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Thomas Kuchenberg, 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
_______________________________________________________________________
941. SUPPLEMENTAL MANUFACTURING CHANGES FOR NEW ANIMAL DRUGS
Priority: Substantive, Nonsignificant
Legal Authority: PL 105-115, sec 116
CFR Citation: 21 CFR 514.8
Legal Deadline: None
Abstract: Section 116 of the Food and Drug Administration Modernization
Act of 1997 added a new section to the Federal Food, Drug, and Cosmetic
Act that requires the agency to distinguish between moderate and
minimal manufacturing changes and to establish systems 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
________________________________________________________________________
ANPRM 05/00/98
NPRM 12/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: William Marnane, Department of Health and Human
Services, Food and Drug Administration, Center for Veterinary Medicine
(HFV-200), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-0678
RIN: 0910-AB49
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
942. 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 21950]]
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)
Alcohol (Topical) Products (To be merged w/other rulemkg) ANPRM 05/21/
82 (47 FR 22324)
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.) 08/00/98
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.) 06/00/99 Final Action 06/00/
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)
Antiperspirant Products ANPRM 10/10/78 (43 FR 46694) NPRM 08/20/82
(47 FR 36492) Final Action 12/00/98
Antiseptic First Aid ANPRM 09/13/74 (39 FR 33103) NPRM 01/06/78 (43
FR 1210) NPRM (Revised) 07/22/91 (56 FR 33644) Final Action 00/00/00
Antiseptic Products (Professional Use) ANPRM 09/13/74 (39 FR
33103) NPRM 01/06/78 (43 FR 1210) NPRM (Revised) 06/17/94 (59 FR
31402)
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) NPRM 10/20/93 (58 FR 54224)
Aspirin (Reye Syndrome) NPRM 10/20/93 (58 FR 54228)
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)(Warning) 08/29/97 (62 FR 45767)
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)(Warning) 08/29/97 (62 FR 45767) NPRM (Amendment)(Warning)
08/00/98
[[Page 21951]]
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)
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 03/00/99
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) 00/00/00
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 10/00/98
Emetic Products ANPRM 03/21/75 (40 FR 12939) NPRM 09/05/78 (43 FR
39544)
Exocrine Pancreatic Insufficiency Products ANPRM 12/21/79 (44 FR
75666) NPRM 11/08/85 (50 FR 46594) NPRM (Reproposed) 07/15/91 (56 FR
32282) Final Action 04/24/95 (60 FR 20162)
External Analgesic Products ANPRM 12/04/79 (44 FR 69768) NPRM 02/08/
83 (48 FR 5852) NPRM (Amendment) (Dandruff) 07/30/86 (51 FR
27360) NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592) NPRM
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818) NPRM (Amendment) (Fvr
Blister/Ext) 01/31/90 (55 FR 3370) NPRM (Amendment) (1%Hydrocortisone)
02/27/90 (55 FR 6932) NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR
25234) Final Action (Diaper Rash) 12/18/92 (57 FR 60426) NPRM
(Amendment)(Warning) 08/29/97 (62 FR 45767) Final Action 00/00/00
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)
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)
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
(ProfessionalLabeling) 06/00/98 Final Action 06/00/98 NPRM (Labeling-
revised indications) 10/00/99
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 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) 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) 07/00/98 Final Action (Ca/Mg/K) 12/00/98
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) 04/00/98 NPRM (Amendment)(Phosphates Label) 04/00/
98 Final Action 09/00/98
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)
Mercurial (Active/Inactive) NPRM 00/00/00
Mercurial (Topical) Products (To be merged w/other rulemkg) ANPRM 01/
05/82 (47 FR 436)
[[Page 21952]]
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)
NDA Labeling Exclusivity NPRM 11/09/93 (58 FR 59622) Final Action 00/
00/00
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)
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) Final Action 00/00/00
Oral Mucosal Injury Products (Merged w/Oral Health Care) ANPRM 11/02/
79 (44 FR 63270) NPRM 07/26/83 (48 FR 33984)
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) 12/00/98
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) NPRM (Amendment) (Warning) 05/05/93 (58 FR 26886) Final
Action (Amendment) (Warning) 08/00/98
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)
Phenylpropanolamine Products (Labeling) NPRM 02/14/96 (61 FR
3912) Final Action 00/00/00
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)
12/00/98 Final Action 06/00/99
Quinine for Malaria NPRM 04/19/95 (60 FR 19650) Final Action 07/00/98
Reporting of Adverse Reactions NPRM 12/00/98
Skin Bleaching Products ANPRM 11/03/78 (43 FR 51546) NPRM 09/03/82
(47 FR 39108) NPRM (Reproposed) 12/00/98
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) 06/00/98 Final Action 06/00/98
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)
Sodium Labeling NPRM 04/25/91 (56 FR 19222) Final Action 04/22/96 (61
FR 17798) Final Action (Technical Amendment) 12/00/98
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 08/00/98
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 03/00/99
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)
Vaginal Drug Products ANPRM 10/13/83 (48 FR 46694) Withdrawal 02/03/
95 (60 FR 5226)
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) 00/00/
00
Small Entities Affected: None
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
_______________________________________________________________________
943. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE
CERTIFICATION PROGRAMS
Priority: Routine and Frequent
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 356; 21 USC 371; 21 USC 379e(e)
CFR Citation: 21 CFR 80; 21 CFR 429
[[Page 21953]]
Legal Deadline: None
Abstract: Insulin Certification Program:
Section 506 of the Federal Food, Drug, and Cosmetic Act, which
authorized the certification of drugs containing insulin, was repealed
by section 125 of the Food and Drug Administration Modernization Act of
1997. The repeal was effective on November 21, 1997.
Color Certification Program:
In the Federal Register of November 29, 1994, FDA issued an interim
rule effective December 29, 1994, which amended the color additive
regulations by increasing the fees for certification services. In the
Federal Register of February 1, 1996 (61 FR 3571), FDA issued a final
rule, effective March 4, 1996, which incorporated comments FDA received
from the International Association of Color Manufacturers (IACM) on the
interim rule. FDA received an objection from IACM to an annual
escalator provision which would have allowed FDA to increase the fees
for color certification services by a rate proportional with Federal
salary increases. After considering the objection, FDA decided not to
implement this provision. The FDA's Office of Financial Management
completed a fee study of the color certification program in May 1997
which supports the maintenance of the existing fee schedule.
Timetable:
Color Additives Interim Final Rule 11/29/94 (59 FR 60898) Final
Action 02/01/96 (61 FR 3571)
Insulin Interim Final Rule 10/04/91 (56 FR 50248) Interim Final Rule
11/09/95 (60 FR 56515) Removal of 21 CFR 429 04/00/98
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AD34 and RIN
0910-AA27.
Agency Contact: David R. Petak, Director, Division of Accounting,
Department of Health and Human Services, Food and Drug Administration,
Office of Financial Management (HFA-120), 5600 Fishers Lane, Rockville,
MD 20857
Phone: 301 827-5004
Fax: 301 443-6242
RIN: 0910-AA07
_______________________________________________________________________
944. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION
UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986
Priority: Other Significant
Legal Authority: PL 99-660, sec 314
CFR Citation: 21 CFR 601
Legal Deadline: Final, Statutory, February 1, 1991.
Abstract: Section 314 of the National Childhood Vaccine Injury Act of
1986 mandated that the warnings, use instructions, and precautionary
information of specified childhood vaccines be reviewed and that their
adequacy in warning health care professionals of the nature and extent
of dangers posed by such vaccines be determined. This precautionary
information is contained in the package insert of each vaccine licensed
by the agency. FDA held a public meeting to receive public comment on
the adequacy of these package inserts.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Notice of Public Meeting; Public
Comment on Package Inserts 07/31/92 57 FR 33915
NPRM 09/00/98
Small Entities Affected: None
Government Levels Affected: State
Additional Information: Previously reported under RIN 0905-AD72.
A public meeting was held on 9/18/92 on section 314 Labeling Review.
Presentations were made by FDA, CDC, manufacturers, parents groups, and
the public on the adequacy of the current labeling.
Agency Contact: Dano B. Murphy, Regulatory Counsel, 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-AA14
_______________________________________________________________________
945. 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. FDA is
considering eliminating the waiver provision and instead requiring a
medical evaluation when certain previously undiagnosed medical
conditions are found or when the prospective hearing aid user is under
18 years of age. In addition, FDA is considering restricting the
dispensing of a hearing aid to patients who have undergone a
comprehensive hearing assessment within the past 12 months and an
evaluation to select and fit a hearing aid, both of which would be
required to be conducted by hearing care professionals licensed by the
States as competent to conduct such assessments and evaluations. FDA is
also considering revisions to its professional and patient labeling
requirements to require updated information.
Statement of Need: FDA has become aware of changes in the nature of the
causes of hearing loss and the technology of hearing aids that
necessitate reconsideration of the regulations governing the types of
testing needed before a hearing aid purchase and the labeling for
health professionals and patients. In the past, hearing loss often was
caused by medically treatable conditions: because
[[Page 21954]]
of advances in health care, this is less common. Therefore, there may
be less need for medical evaluation. On the other hand, advances in
hearing aid technology necessitate proper testing in order for a
hearing aid to be effective.
Summary of the Legal Basis: Under 21 USC 360j(e), FDA has the authority
to restrict the sale, distribution, or use of a medical device, if FDA
determines that, without such restrictions, there cannot be reasonable
assurance of its safety and effectiveness. Under 21 USC 352, FDA has
the authority to require that the labeling of a medical device include
adequate directions for use.
Alternatives: FDA considered applying the rule only to first time
purchasers of hearing aids. FDA believes, however, that this would not
adequately protect present users of inappropriate or unneeded hearing
aids. FDA also considered requiring additional tests, but has
preliminarily determined to list these tests as recommended only in
order to provide additional flexibility.
Anticipated Costs and Benefits: FDA has estimated the costs of the
mandatory testing required by the rule would add an additional $24.8
million to $51.7 million depending upon the assumptions concerning
present practices. On the average, FDA estimates that this would add
about $24 to the cost of a hearing aid. FDA expects that the benefits
from the rule would include: (1) Improving the quality of life of
hearing aid users; (2) avoiding the cost of inappropriate hearing aid
purchase; (3) reducing doctor visits for hearing aid evaluations; (4)
lowering treatment costs due to early detection of serious conditions;
and (5) encouraging the dissemination of accurate information
concerning the benefits and limitations of hearing aids.
Risks: If the hearing aid purchaser inappropriately waives the medical
evaluation requirement under the existing rule, treatable causes of
hearing loss may go undetected. Many purchasers who have not had proper
testing before a hearing aid purchase will forego the use of a hearing
aid because the one purchased does not adequately improve their hearing
ability. At this time, FDA believes that many hearing impaired people
who may benefit from a hearing aid do not purchase one because they
fear that they will not benefit from one due to inaccurate information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 11/10/93 58 FR 59695
ANPRM Comment Period End 01/10/94
NPRM 06/00/98
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
_______________________________________________________________________
946. 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: 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 for both domestically produced and imported foods 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. As a next step in this food
safety program, FDA will propose a HACCP regulation for the processing
of juice. As part of the development of this document, FDA is
considering 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. As a separate rulemaking, the
agency intends to propose to require warning statements 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 will serve to reduce the risk of foodborne illness.
Statement of Need: In this proposed rule, the Food and Drug
Administration (FDA) is proposing to adopt regulations that would
establish requirements for a new comprehensive food safety assurance
program for both domestically produced and imported fruit and vegetable
juices that would be based on the principles of Hazard Analysis
Critical control Points (HACCP). FDA intends to propose a juice HACCP
regulation because there have been a number of outbreaks of illnesses
associated with juice products, including some directly affecting
children, and because the agency believes that a system of preventive
controls is the most effective and efficient way to ensure that these
products will be safe.
Summary of the Legal Basis: Failure of a processor to have and
implement a HACCP system will render the food products of that
processor adulterated under section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act. Whether a processor's actions are consistent
with ensuring the safety of food will be determined through an
evaluation of the overall implementation of the firm's HACCP system.
[[Page 21955]]
Alternatives: The two principal alternatives to HACCP are end-product
testing and comprehensive current good manufacturing practices (CGMPs).
FDA has concluded, based on information available at this time, that
these alternatives lack the distinct advantages of a HACCP-based
approach. End-product testing does not address the root causes of food
safety problems, is not preventive by design, and requires that a large
number of samples be analyzed to ensure product integrity. CGMPs are
not practical because they are plant-wide operating procedures and do
not concentrate on the identification and prevention of food hazards.
Anticipated Costs and Benefits: In general terms, HACCP focuses on
prevention and is designed to prevent the occurrence of hazards
affecting food; HACCP permits more effective and efficient oversight by
Federal, State, and local governments; and HACCP appropriately places
primary responsibility for ensuring food safety on the food
manufacturer/distributor to analyze, in a rational, scientific manner,
its production processes in order to identify critical control points
and establish critical limits and monitoring procedures. FDA
anticipates that costs to industry generated by implementation of HACCP
would be offset in four ways: (1) by reducing the amount of food-borne
illnesses (for example, total illness reduction benefits estimated to
result from FDA's HACCP-based requirements for seafood regulation are
between $15 and $75 million per year); (2) by increasing public
confidence in the Nation's food supply; (3) by enabling U.S. food
companies to compete more effectively in the world market (for example,
current recommendations of the Codex Alimentarius Commission's
Committee on Food Hygiene encourage the use of the HACCP system, and
the European Community (EC) has begun to require that foods produced
within the EC be processed under HACCP requirements); and (4) by
decreasing the number of future product recalls.
Risks: Any potential for contamination of the food supply with
industrial chemicals or microbial pathogens must be considered a very
serious risk because of the possibility that such contamination could
be widespread, affecting whole segments of the population, causing some
severe long-term effects and even loss of life. FDA made a decision to
adopt a HACCP-based approach to regulation of seafood, based on a
considerable body of literature and expertise in this area. Likewise,
FDA has reviewed current information on hazards associated with
unprocessed juice, and intends to propose that processors use HACCP in
the manufacture of certain juice products.
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 04/00/98
HACCP for Juice NPRM 04/00/98
Label Warning Statements for Juice NPRM 04/00/98
Small Entities Affected: Businesses
Government Levels Affected: Undetermined
Additional Information: Previously reported under RIN 0905-AE60.
Agency Contact: John E. Kvenberg, Strategic Manager, 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
_______________________________________________________________________
947. 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 357; 21 USC 371
CFR Citation: 21 CFR 320
Legal Deadline: None
Abstract: The proposed rule would revise and clarify certain sections
of part 320 and eliminate duplication and inconsistencies.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/98
NPRM Comment Period End 09/00/98
Small Entities Affected: 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
_______________________________________________________________________
948. 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 257; 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 09/00/98
Small Entities Affected: Undetermined
[[Page 21956]]
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
_______________________________________________________________________
949. 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 provisions for
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 ``Antioxident'' 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.
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
supplement, including using 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. FDA is
issuing 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 structure or function of the
body.
Timetable:
Comments on Report of the Commission on Dietary Supp. Labels Notice
04/00/98
CGMPs in the Manufacturing, Packing, or Holding of Dietary
Supps. ANPRM 02/06/97 (62 FR 5700) Comment Period End 06/06/97 NPRM
00/00/00
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)
Regs on Statements Made for Diet. Supps re Effect of Product NPRM 04/
00/98
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
_______________________________________________________________________
950. 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. The proposed rule would create 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). 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 developed countries specified in the rule. The
fourth route would permit exportation only if FDA authorized shipment
of the investigational drug; such authorization would be obtained
through submission of a written request to export the drug. 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 second or third routes would
be subject to additional
[[Page 21957]]
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 05/00/98
Small Entities Affected: None
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-AA61
_______________________________________________________________________
951. ADVERSE DRUG REACTION REPORTING, RECORDKEEPING, AND RECORDS ACCESS
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 356; 21 USC 357; 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 10/00/98
NPRM Comment Period End 01/00/99
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Audrey Thomas, Consumer Safety Officer, 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
_______________________________________________________________________
952. 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 permited 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 05/00/98
Small Entities Affected: None
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: 301 827-4433
Fax: 301 443-1863
RIN: 0910-AA89
_______________________________________________________________________
953. 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 356; 21 USC 357; 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 01/00/99
NPRM Comment Period End 03/00/99
Small Entities Affected: None
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
[[Page 21958]]
_______________________________________________________________________
954. 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.
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 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 rule would revise existing regulations governing
the format of prescription drug labeling directed toward prescribers
and other health care professionals to increase the usefulness of this
labeling. The revisions to part 201.57 would reorder the content areas
of the labeling; add an introductory section of highlights and an
index; and institute an identification system to enhance accessibility
to detailed information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/98
NPRM Comment Period End 12/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
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
RIN: 0910-AA94
_______________________________________________________________________
955. 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 to 357; 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 10/00/98
NPRM Comment Period End 01/00/99
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Audrey Thomas, Consumer Safety Officer, 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
_______________________________________________________________________
956. CHLOROFLUOROCARBON PROPELLANTS IN SELF-PRESSURIZED CONTAINERS;
DETERMINATIONS THAT USES ARE NO LONGER ESSENTIAL
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 357; 21 USC 360b; 21 USC 361; 21 USC 371; ...
CFR Citation: 21 CFR 2
Legal Deadline: None
Abstract: The proposed rule presents the policy FDA is proposing to
adopt on making and implementing determinations that uses of
chlorofluorocarbons (CFCs) currently designated essential will no
longer be deemed essential under section 610 of the Clean Air Act due
to the availability of safe and effective medical product technology
that does not use CFCs.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 03/06/97 62 FR 10242
ANPRM Comment Period End 05/05/97
NPRM 12/00/98
NPRM Comment Period End 03/00/99
Small Entities Affected: 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-AA99
_______________________________________________________________________
957. 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
[[Page 21959]]
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 10/00/98
NPRM Comment Period End 01/00/99
Small Entities Affected: 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
_______________________________________________________________________
958. 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 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 proposed rule would require 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, promotion and labeling, 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.
Statement of Need: Presently, FDA can only approximate the numbers of
manufacturers involved in the production of human cellular and tissue-
based products. Recent innovations in the methods of manipulating human
cells and tissues for therapeutic purposes has resulted in the rapid
growth of the industry producing human cellular and tissue-based
products. The growth has occurred in industry segments that normally
communicate with the agency as well as in segments that have not
previously had any contact with FDA. In order to characterize the
industry and establish a basis for communication with that industry,
FDA is proposing that all manufacturers of human cellular and tissue-
based products register with FDA and submit lists of all their products
to the agency.
Summary of the Legal Basis: The Public Health Service Act (42 USC 216
et seq.) and the Federal Food, Drug, and Cosmetic Act (21 USC 321 et
seq.) authorize FDA to regulate biological products and to ensure that
the products are safe, pure, potent, and effective. The Public Health
Service Act also contains the authority under which FDA can promulgate
regulations designed to prevent the spread of communicable diseases. In
order to meet these objectives, FDA must be able to identify those
manufacturers participating in activities that may be subject to
regulation. FDA proposes the registration and listing as a simple and
efficient means of acquiring the needed information.
Alternatives: FDA has considered two alternatives. The first
alternative would be an information collection undertaken by the agency
that would be entirely dependent on voluntary compliance. FDA considers
this alternative inefficient and lacking in any compliance inducements.
The second alternative is to compel the registration of manufacturers
and require registrants to list their products with the agency. Such a
system has been proposed to industry and gained general acceptance.
Manufacturers would simply fill out an electronically available,
registration and listing form and fax or mail the completed form to the
agency with periodic updates. No other paperwork should be required.
Anticipated Costs and Benefits: Registration and listing will enable
FDA to characterize the industry without imposing any significant
procedural or monetary burdens. Registration and listing would provide
effective means by which FDA can monitor the production of human
cellular and tissue-based products. The costs of registration and
listing are expected to be minimal because, as stated above, the
process would require only the information necessary for FDA to
identify the affected industry.
Risks: FDA believes that the risks posed by requiring registration and
listing of human cellular and tissue-based products are minimal. In
contrast, failure to identify manufacturers involved in the production
of human cellular and tissue-based products would subject the public to
the great and avoidable risk of contracting debilitating communicable
diseases. Without any mechanism to target regulations intended to
ensure the safety, purity and potency of human cellular and tissue-
based products, FDA's oversight of the industry would be severely
hindered and the protection of the public health jeopardized.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/98
NPRM Comment Period End 09/00/98
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Dano B. Murphy, Regulatory Counsel, 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-AB05
_______________________________________________________________________
959. VETERINARY FEED DIRECTIVES: DISTRIBUTOR NOTIFICATION
Priority: Other Significant
Legal Authority: PL 104-250
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: The Animal Drug Availability Act (ADAA) amended the Federal
Food, Drug, and Cosmetic Act (the act)
[[Page 21960]]
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 to 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 12/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: George Graber, Department of Health and Human Services,
Food and Drug Administration, Center for Veterinary Medicine (HFV-228),
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1733
Fax: 301 594-1512
RIN: 0910-AB09
_______________________________________________________________________
960. USE OF OZONE-DEPLETING SUBSTANCES IN AEROSOL PRODUCTS OR OTHER
PRESSURIZED DISPENSERS
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 357; 21 USC 360b; 21 USC 361; 21 USC 371; ...
CFR Citation: 21 CFR 2
Legal Deadline: None
Abstract: FDA is proposing to amend its essential-use regulations to
provide stricter scrutiny of proposed exemptions from the general ban
on the use of ozone-depleting substances for new uses of ozone-
depleting substances. 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 also proposing to eliminate out-of-date transitional provisions
and make other nonsubstantive housekeeping changes to its regulations
on ozone-depleting substances.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/98
NPRM Comment Period End 10/00/98
Small Entities Affected: 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-AB10
_______________________________________________________________________
961. 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 05/00/98
Small Entities Affected: None
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
_______________________________________________________________________
962. REQUIREMENTS PERTAINING TO THE SALE AND DISTRIBUTION OF CIGARETTES
AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS; USE OF
NONTOBACCO TRADE OR BRAND NAMES
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 352; 21 USC 360; 21 USC 360(j); 21 USC 371; 21
USC 372
CFR Citation: 21 CFR 897
Legal Deadline: None
Abstract: The proposed rule would clarify the restrictions on the use
of nontobacco product names and other identification on tobacco
products and would modify the list of established names for smokeless
tobacco products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 06/00/98
Small Entities Affected: None
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-AB17
_______________________________________________________________________
963. EXEMPTION FROM PREEMPTION OF STATE AND LOCAL CIGARETTE AND
SMOKELESS TOBACCO REQUIREMENTS; APPLICATIONS FOR EXEMPTION SUBMITTED BY
VARIOUS STATE GOVERNMENTS; GROUP 1; GROUP 2
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360k; 21 USC 371
CFR Citation: 21 CFR 808
Legal Deadline: None
[[Page 21961]]
Abstract: FDA published a notice of proposed rulemaking on November 7,
1996, announcing that the agency would be accepting applications for
exemption from Federal preemption for State and local cigarette and
smokeless tobacco requirements. The notice explained that FDA would
consider the applications in two groups and set deadlines for
submitting applications. Group 1 applications, due December 9, 1996,
pertain to State and local requirements governing the sale and
distribution of cigarettes and smokeless tobacco that are different
from, or in addition to, FDA requirements under section 897.14(a) and
section 897.14(b) of the final tobacco rule (the age and identification
requirements). Group 2 applications, due May 6, 1997, pertain to State
and local requirements governing the sale and distribution of
cigarettes and smokeless tobacco that are different from, or in
addition to, all other requirements under the final tobacco rule.
Timetable:
Group 1 NPRM 02/19/97 (62 FR 7390) NPRM Comment Period End 06/23/
97 Final Action 11/28/97 (62 FR 63271)
Group 2 NPRM 05/00/98
Groups 1 and 2 Notice 11/07/96 (61 FR 57685)
Small Entities Affected: None
Government Levels Affected: State, Local
Additional Information: Formerly listed under RIN 0910-AB03.
Agency Contact: Anne M. Kirchner, Policy Analyst, Department of Health
and Human Services, Food and Drug Administration, Office of Policy
(HFD-11), 5600 Fishers Lane, Room 14-72, Rockville, MD 20857
Phone: 301 827-5321
Fax: 301 443-5169
RIN: 0910-AB19
_______________________________________________________________________
964. 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 manufacturers importing such products
into the United States to register and to list their products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/00/98
Small Entities Affected: None
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
_______________________________________________________________________
965. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN
GOVERNMENT OFFICIALS
Priority: Info./Admin./Other
Legal Authority: 18 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 proposed 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 06/00/98
Small Entities Affected: None
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
Email: [email protected]
RIN: 0910-AB22
_______________________________________________________________________
966. DISSEMINATION OF TREATMENT INFORMATION ON UNAPPROVED USES
FOR MARKETED DRUGS AND DEVICES
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 355; 21 USC 360b; 21 USC 360c; 21 USC 360e; 21 USC 371; 21 USC 374;
PL 105-115 sec. 401
CFR Citation: 21 CFR 99
Legal Deadline: None
Abstract: The proposal would establish the procedures and requirements
for the dissemination of information on unapproved new uses of marketed
drugs, biologics, and devices. The proposal would include requirements
concerning submissions to the Food and Drug Administration, requests to
extend the time period for completing studies needed to submit a
supplemental application for a new use, applications for an exemption
from the requirement to conduct studies, recordkeeping, and reporting.
The proposal would also cover agency actions on such submissions,
requests, and applications, as well as orders to cease or to terminate
dissemination of information.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 05/00/98
[[Page 21962]]
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Peggy Dotzel, Senior Science Policy Advisor, Department
of Health and Human Services, Food and Drug Administration, Office of
Policy (HF-13), 5600 Fishers Lane, Room 14-72, Rockville, MD 20857
Phone: 301 827-5321
Fax: 301 443-5169
RIN: 0910-AB23
_______________________________________________________________________
967. 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 05/00/98
Small Entities Affected: None
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
_______________________________________________________________________
968. BLOOD INITIATIVE
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 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. 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 received in response
to the comprehensive review. Some of the subjects 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; notification of permanently
deferred donors; requirements for donor suitability and testing; viral
inactivation; and definitions for ``analogous products.'' These actions
are intended to help ensure the continued safety of the nation's blood
supply.
Timetable:
CGMPs for Blood and Blood Components NPRM 10/00/98
Definition for ``Analogous Products'' NPRM 01/00/99
Minor Changes to Reqs. for CGMP for Blood and Blood Components Direct
Final Rule 10/00/98
Notification of End Users of Plasma Derivative Products NPRM 10/00/98
Notification of Permanently Deferred Donors NPRM 01/00/99
Reqs. Applicable to Albumin (Human), Plasma Protein Fraction Direct
Final Rule 10/00/98
Requirements for Donor Testing NPRM 01/00/99
Suitability Reqs. for Whole Blood and Source Plasma Donors NPRM 01/00/
99
Viral Inactivation NPRM 01/00/99
Small Entities Affected: Undetermined
Government Levels Affected: None
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-AB26
_______________________________________________________________________
969. 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 311.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271
Legal Deadline: None
[[Page 21963]]
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 09/00/98
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula S. McKeever, 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
Phone: 301 827-6210
RIN: 0910-AB27
_______________________________________________________________________
970. 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 12/00/98
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula S. McKeever, 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
Phone: 301 827-6210
RIN: 0910-AB28
_______________________________________________________________________
971. BIOLOGICAL PRODUCTS REGULATED UNDER SECTION 351 OF THE
PUBLIC HEALTH SERVICES 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 proposing to eliminate
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 07/00/98
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Timothy W. Beth, 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
Phone: 301 827-6333
Email: [email protected]
RIN: 0910-AB29
_______________________________________________________________________
972. 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: Not yet determined
Legal Deadline: None
Abstract: This proposed rule will 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 will be eligible for exclusivity under
sections 505(c)(3)(D) and 505 (j)(4)(D) of the Act.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 09/00/98
NPRM Comment Period End 11/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Wayne Mitchell, Regulatory Counsel, Department of
[[Page 21964]]
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
_______________________________________________________________________
973. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR
ANTIBIOTIC DRUG; COMPLETE REVIEW 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 356; 21 USC 357; 21 USC 371; 21 USC 374; 21
USC 379e
CFR Citation: 21 CFR 312; 21 CFR 314
Legal Deadline: None
Abstract: This proposed rule will 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 review letters.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 07/00/98
NPRM Comment Period End 10/00/98
Small Entities Affected: 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
_______________________________________________________________________
974. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 402
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: This proposed rule will 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 08/00/98
NPRM Comment Period End 11/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Joseph Griffin, 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-AB37
_______________________________________________________________________
975. 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 357; 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: This proposed rule will 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 10/00/98
NPRM Comment Period End 01/00/99
Small Entities Affected: 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
_______________________________________________________________________
976. 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 356; 21 USC 357; 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: This proposed rule will 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 07/00/98
NPRM Comment Period End 10/00/98
Small Entities Affected: Undetermined
[[Page 21965]]
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-AB45
_______________________________________________________________________
977. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE CHOICE
MEDICATED FEED
Priority: Substantive, Nonsignificant
Legal Authority: PL 104-25; 21 USC 360(b)
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 01/00/99
Small Entities Affected: 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: 301 594-1725
RIN: 0910-AB50
_______________________________________________________________________
978. 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) is amending 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 exemptions from the
GST requirements for other biological products. 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 direct final rule 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. FDA is publishing a
companion proposed rule under FDA's usual procedures for notice and
comment to provide a procedural framework to finalize the rule in the
event the agency receives any significant adverse comment and withdraws
this direct final rule.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 04/00/98
Companion Document to Direct Final Rule Proposed Rule 04/00/98
Small Entities Affected: None
Government Levels Affected: None
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: Dano B. Murphy, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-617), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB51
_______________________________________________________________________
979. RADIOPHARMACEUTICALS USED FOR IN VIVO DIAGNOSIS AND
MONITORING
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
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 consideraton 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 05/00/98
Final Action 05/00/99
Small Entities Affected: Undetermined
Government Levels Affected: None
[[Page 21966]]
Agency Contact: Dano B. Murphy, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Biologics Evaluation and Research (HFM-617), 1401 Rockville Pike, Suite
200N, Rockville, MD 20852-1448
Phone: 301 827-6210
RIN: 0910-AB52
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________
980. 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 guidelines 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 00/
00/00
Reporting Requirements for Marketed Animal Drugs NPRM 12/17/91 (56 FR
65581) Final Action 12/00/98
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 Surveillance,
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, (301) 594-1722. For further
information concerning generic animal drugs, contact Lonnie W. Luther,
Chief, Generic Animal Drug and Quality Control Staff, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855, (301) 594-1623.
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
_______________________________________________________________________
981. 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.
[[Page 21967]]
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 03/14/94 59 FR 11842
NPRM Comment Period End 08/01/94
Final Action 07/00/98
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
Fax: 301 827-5562
RIN: 0910-AA08
_______________________________________________________________________
982. BIOLOGICAL PRODUCTS: REPORTING OF ERRORS AND ACCIDENTS IN
MANUFACTURING
Priority: Substantive, Nonsignificant
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; provides
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 12/00/98
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
_______________________________________________________________________
983. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER HUMAN
DRUG PRODUCTS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21
USC 371
CFR Citation: 21 CFR 211
Legal Deadline: None
Abstract: FDA has required tamper-resistant packaging features for OTC
drug products since 1982. The tamper-resistant packaging regulations
were revised in 1989 in response to continuing tampering incidents.
Despite the regulatory protection provided by the regulations, two-
piece, hard gelatin capsules remain vulnerable to malicious tampering
and were implicated in tampering incidents in 1991. This action is in
response to the 1991 tampering incidents and requires use of the term
``tamper-evident'' instead of ``tamper-resistant'', and that all OTC
human drug products marketed in two-piece, hard gelatin capsules be
sealed.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 01/18/94 59 FR 2542
NPRM Comment Period End 03/21/94
Final Action 06/00/98
Final Action Effective 06/00/99
Small Entities Affected: Businesses
Government Levels Affected: Federal
Additional Information: Previously reported under RIN 0905-AE27.
Agency Contact: Thomas Kuchenberg, 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-AA26
_______________________________________________________________________
984. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 352; 21 USC 371; 21 USC 355; 42
USC 262
CFR Citation: 21 CFR 201; 21 CFR 208; 21 CFR 314; 21 CFR 600
Legal Deadline: None
Abstract: In August, 1995 the Food and Drug Administration (FDA)
published a proposed rule that specified standards for the distribution
and quality of useful prescription medication information, designed for
patients, that voluntary, private-sector efforts should supply to
patients receiving new prescriptions. On August 6, 1996, section 601 of
the Agriculture Rural Development, Food and Drug Administration, and
Related Agencies Appropriations Act, 1997 was enacted which places the
proposed rule as it relates to a voluntary program in abeyance. The
legislation did not address the provisions that would have required
mandatory Medication Guides in relatively rare instances (approximately
5 products annually)
[[Page 21968]]
where a product poses a serious and significant public health concern
requiring immediate distribution of FDA-approved patient information.
FDA is in the process of finalizing the requirement for mandatory
Medication Guides for these rare products.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/24/95 60 FR 44182
Final Action 07/00/98
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AE43.
Agency Contact: Nancy M. 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-240), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-6828
RIN: 0910-AA37
_______________________________________________________________________
985. 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 to 357; 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 12/00/98
Final Action Effective 03/00/99
Small Entities Affected: Businesses
Government Levels Affected: Federal
Additional Information: Previously reported under RIN 0905-AE63.
Agency Contact: Thomas Kuchenberg, 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
_______________________________________________________________________
986. 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
to 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379; 42 USC 216; 42
USC 241; 42 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 11/00/98
Small Entities Affected: 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
_______________________________________________________________________
987. 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
to 357; 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 06/00/98
Final Action Effective 12/00/98
Small Entities Affected: None
Government Levels Affected: None
Agency Contact: Thomas Kuchenburg, Regulatory Counsel, Department of
[[Page 21969]]
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
_______________________________________________________________________
988. 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 OTC drug product labeling, including legibility and
design features of such information as the uses for the drug,
directions for use, warnings, drug interactions, precautions, active
ingredients, and other information that the consumer would need to know
to use the product safely and effectively.
Statement of Need: Currently, the design, format, and placement of
required labeling information varies considerably among OTC products.
As a result, consumers often have difficulty finding, reading, and
understanding this labeling information. Modifying and simplifying the
manner in which the information is presented can improve the legibility
and understandability of OTC drug product labeling. Therefore, this
final rule will establish a standardized format for the labeling of all
marketed OTC drug products. This action is intended to enable consumers
to better read and understand OTC drug product labeling and to apply
this information to the safe and effective use of OTC drug products.
Summary of the Legal Basis: FDA's legal authority to modify and
simplify the manner in which certain information is presented in OTC
drug product labeling derives from sections 201, 502, 505, and 701 of
the Federal Food, Drug, and Cosmetic Act (the act). Regulating the
order, appearance, and format of OTC drug product labeling is
consistent with the agency's authority to ensure that drug labeling
convey all material information to the consumer (21 USC 321(n) and
352(a)), and that the labeling communicates this information in a
manner that is ``likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.'' (21 USC
352(c)). Regulating the content of OTC drug product labeling is
consistent with FDA's authority to ensure that the products are safe
and effective for use (sections 201(n) and (p), 502, and 505 of the
act).
Alternatives: FDA considered several alternatives. First, the agency
considered but rejected a voluntary labeling scheme, as previous
industry efforts have been unsuccessful in achieving both a uniform
format and an acceptable minimum print size for a majority of the
products on the market. Second, the agency considered but rejected
revising all OTC monographs on an individual basis because this
approach would not achieve a standardized labeling format for a
majority of the marketed products in a timely manner. Third, the agency
considered alternative implementation periods but chose the option
proposed because it believed that the chosen approach provides
significant reduction in cost while meeting the agency objective of
achieving a standardized labeling format for a majority of the products
in a timely manner.
Anticipated Costs and Benefits: The final rule is expected to cost a
total of $14 million when implemented. This cost includes a 1-year
extension for implementation time of individual OTC drug products
having sales of less than $25,000 per year.
In general, the rule will benefit consumers by allowing them to make
more appropriate choices for self-treatment, and to reduce trial and
error approaches to self-medication. Consequently, this could lead to
decreased overall health care costs resulting from reduced visits to
the doctor or hospital for treatment. Additionally, the easy to read,
standardized format will directly benefit consumers by helping ensure
the safe and effective use of the product.
Risks: None.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 02/27/97 62 FR 9024
NPRM Comment Period End 10/06/97 62 FR 33379
Final Action 08/00/98
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Cazemiro Martin, 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
_______________________________________________________________________
989. 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 356; 21 USC 357; 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 10/00/98
Small Entities Affected: 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
[[Page 21970]]
Rockville Pike, Suite 6027, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA84
_______________________________________________________________________
990. 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
to 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 09/00/98
Small Entities Affected: 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
_______________________________________________________________________
991. 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 356; 21 USC 357; 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 11/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Thomas Kuchenberg, 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
_______________________________________________________________________
992. DEFINITION OF SUBSTANTIAL EVIDENCE
Priority: Other Significant
Legal Authority: 21 USC 360(b); PL 104-250
CFR Citation: 21 CFR 514.4
Legal Deadline: NPRM, Statutory, October 9, 1997. Final, Statutory,
October 9, 1998.
Abstract: The ADAA requires FDA to issue within 24 months after the
date of its enactment final proposed 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 10/00/98
Small Entities Affected: None
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
_______________________________________________________________________
993. 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
[[Page 21971]]
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 12/00/98
Small Entities Affected: None
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: 301 594-1724
RIN: 0910-AB18
_______________________________________________________________________
994. REGULATIONS REQUIRING MANUFACTURERS TO ASSESS THE SAFETY AND
EFFECTIVENESS OF NEW DRUGS AND BIOLOGICAL PRODUCTS IN PEDIATRIC PATIENTS
Priority: Other Significant
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 352; 21 USC 355; 21
USC 371; 21 USC 502; 42 USC 262
CFR Citation: 21 CFR 200; 21 CFR 312; 21 CFR 314; 21 CFR 601
Legal Deadline: None
Abstract: The final rule, if promulgated, would require pediatric
studies of a limited class of new drug and biological products so that
the products will have sufficient data and information to support
directions for pediatric use for the claimed indications.
Statement of Need: Many new drugs and biological products represent
treatments that are, at least at times, the best available treatment
for children, but most of them have not been adequately tested in the
pediatric population. As a result, product labeling frequently fails to
provide directions for safe and effective use in pediatric patients.
The absence of pediatric labeling information poses a number of
disadvantages to pediatric patients, including the potential for under-
or over-dosing leading to ineffective treatment or excessive or
unanticipated side effects. It may also result in the failure to
provide optimal treatment to children because of the lack of
appropriate scientific data.
Despite previous efforts to increase the amount of pediatric use
information in drug labeling, the majority of new drugs and biological
products are still insufficiently tested in the pediatric population
and their labeling carries little or no information on pediatric safety
and effectiveness. The final rule would help address this lack of
pediatric information.
Summary of the Legal Basis: Under 502(a), 502(f), 505(d)(7), and 201(n)
of the Federal Food, Drug, and Cosmetic Act (the act), FDA may require
a product to carry labeling that provides safety and effectiveness
information on use in subpopulations in which the product is
customarily or commonly used. Section 505(i) of the act authorizes the
issuance of regulations governing the use of investigational drugs, and
provision 505(k) of the act, which requires regulations issued under
505(i) to have ``due regard * * * for the interests of patients,''
together authorize FDA to impose conditions on the investigation of new
drugs, including conditions related to the interests of patients.
Section 351 of the Public Health Service Act (42 USC 262) provides
authority to regulate the labeling and shipment of biological products.
Alternatives: With OMB's concurrence FDA previously published proposed
and final rules in an attempt to encourage manufacturers to include
pediatric labeling on drug products for which there was existing safety
and effectiveness data on pediatric patients. These previous attempts,
which included a NPRM published on October 16, 1992 (57 FR 47423), and
a final rule published on December 13, 1994 (59 FR 64240), stopped
short of requiring studies and have not produced a significant increase
in pediatric labeling. This final rule will be a step towards
addressing the current absence of adequate pediatric labeling.
Anticipated Costs and Benefits: Estimated costs will range from $13.5
million to $20.9 million when implemented. The rule will result in
fewer adverse reactions in children (i.e., drug reactions that occur
because of the use of inadvertent drug overdoses or other drug
administration problems that can be avoided with better information on
appropriate pediatric use); and will help prevent the under treatment
of children with potentially safe and effective drug products because
the physician either prescribed an inadequate dosage regimen,
prescribed a less effective drug, or did not prescribe a drug, due to
the physician's uncertainty about whether the drug or the dose was safe
and effective in children. Approved pediatric indications should
therefore increase sales of affected products to pediatric patients.
Risks: None.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 08/15/97 62 FR 43899
NPRM Comment Period End 11/13/97
Final Action 10/00/98
Small Entities Affected: Businesses
Government Levels Affected: None
Agency Contact: Paula Botstein, Director, Office of Drug Evaluation
III, Department of Health and Human Services, Food and Drug
Administration, Center for Drug Evaluation and Research (HFD-103), 5600
Fishers Lane, Room 13B-45, Rockville, MD 20857
Phone: 301 827-3144
Fax: 301 480-3761
Email: botstein@[email protected]
RIN: 0910-AB20
_______________________________________________________________________
995. REVOCATION OF LATHER BRUSHES REGULATION
Priority: Info./Admin./Other
Legal Authority: 42 USC 216; 42 USC 243; 42 USC 264; 42 USC 271
CFR Citation: 21 CFR 1240.70
Legal Deadline: None
Abstract: The final rule would revoke the regulation pertaining to the
treatment, sterilization, handling, storage, marking, and inspection of
lather brushes. The Food and Drug Administration is revoking this
regulation because the regulation is no longer necessary to protect the
public health.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 10/20/97 62 FR 54398
NPRM Comment Period End 01/05/98
Final Action 06/00/98
Small Entities Affected: None
Government Levels Affected: None
[[Page 21972]]
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-AB25
_______________________________________________________________________
996. REMOVAL OF REGULATIONS REGARDING CERTIFICATION OF
ANTIBIOTIC DRUGS
Priority: Other Significant
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 430; 21 CFR 431; 21 CFR 432; 21 CFR 433; 21 CFR
436; 21 CFR 440; 21 CFR 441; 21 CFR 442; 21 CFR 443; 21 CFR 444; 21 CFR
446; 21 CFR 448; 21 CFR 450; 21 CFR 452; 21 CFR 453; ...
Legal Deadline: None
Abstract: This direct final rule will remove 21 CFR parts 430 through
460 (antibiotic monographs and antibiotic certification program
regulations).
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 04/00/98
Small Entities Affected: None
Government Levels Affected: None
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-AB31
_______________________________________________________________________
997. REVOCATION OF ANTIBIOTIC CERTIFICATION REQUIREMENTS;
CONFORMING REVISIONS TO REGULATIONS
Priority: Other Significant
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: Not yet determined
Legal Deadline: None
Abstract: This direct final rule will make conforming changes to 21 CFR
to remove references to section 507 of the Federal Food, Drug, and
Cosmetic Act, and references to deleted monograph sections.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 06/00/98
Small Entities Affected: None
Government Levels Affected: None
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-AB32
_______________________________________________________________________
998. REMOVAL OF REGULATIONS REGARDING CERTIFICATION OF DRUGS
COMPOSED WHOLLY OR PARTLY OF INSULIN
Priority: Other Significant
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 3; 21 CFR 5; 21 CFR 10; 21 CFR 16; 21 CFR 25; 21
CFR 50; 21 CFR 56; 21 CFR 58; 21 CFR 71; 21 CFR 200; 21 CFR 201; 21 CFR
210; 21 CFR 211; 21 CFR 310
Legal Deadline: None
Abstract: This direct final rule will remove all regulations dealing
with the certification of insulin, remove citations to section 506 in
various authority sections in title 21 of the Code of Federal
Regulations, eliminate citations to section 506 in regulations that do
not deal primarily with the certification of insulin, and eliminate
out-of-date provisions dealing with labeling and testing of insulin.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 04/00/98
Small Entities Affected: None
Government Levels Affected: None
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-AB38
_______________________________________________________________________
999. 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 direct final rule will 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 will 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
________________________________________________________________________
Direct Final Rule 07/00/98
Small Entities Affected: None
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
[[Page 21973]]
_______________________________________________________________________
1000. LIST OF DRUGS THAT HAVE BEEN WITHDRAWN OR REMOVED FROM
THE MARKET FOR REASONS OF SAFETY AND EFFECTIVENESS
Priority: Other Significant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115
CFR Citation: Not yet determined
Legal Deadline: None
Abstract: Section 127 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug and
Cosmetic Act (21 U.S.C 353a). Section 503A governs the application of
Federal law to the practice of pharmacy compounding. Section
503A(b)(1)(C) directs FDA to publish a list of drug products that have
been withdrawn or removed from the market for reasons of safety or
effectiveness. Section 503A(d)(1) directs that the list be issued as a
regulation. Drugs on the list may not be compounded by pharmacists or
licensed practioners.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Final Action 06/00/98
Small Entities Affected: 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-AB40
_______________________________________________________________________
1001. STREAMLINING CLINICAL RESEARCH
Priority: Other Significant
Legal Authority: PL 105-115, sec 117
CFR Citation: 21 CFR 312
Legal Deadline: None
Abstract: This direct final rule will amend the clinical hold
regulations to require the Food and Drug Administration (FDA), in
situations in which FDA has placed a clinical investigation on clinical
hold, to respond in writing to a sponsor's written request to lift the
clinical hold within 30 days of receipt of the request.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 06/00/98
Small Entities Affected: None
Government Levels Affected: None
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-AB41
_______________________________________________________________________
1002. MEDICAL DEVICES; IDE MODIFICATIONS
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 360j(g)
CFR Citation: 21 CFR 812
Legal Deadline: Final, Statutory, November 21, 1998.
Abstract: Under the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-15). FDA must publish a regulation under which the
sponsor of a device with an investigational device exemption that is in
effect may make developmental changes to the device that do not
constitute a significant change in design or basic principles of
operation and that are made in response to information gathered during
the course of the investigation, and changes that do not affect the
validity of the data, the scientific soundness of the investigational
plan or the rights, safety or welfare of the human subjects.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 11/00/98
Small Entities Affected: 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: 301 827-2974
RIN: 0910-AB53
_______________________________________________________________________
1003. DISPUTE RESOLUTION
Priority: Substantive, Nonsignificant
Unfunded Mandates: Undetermined
Legal Authority: PL 105-115, sec 404
CFR Citation: 21 CFR 10
Legal Deadline: Final, Statutory, November 21, 1998.
Abstract: The Food and Drug Administration (FDA) is amending its
regulations governing the review of agency decisions by inserting a
statement that a sponsor, applicant, or manufacturer of a drug or
device may request the review of a scientific controversy by an FDA
advisory panel or committee. This action is being taken to clarify that
review of scientific disputes by outside experts and advisory
committees is available.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
Direct Final Rule 11/00/98
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Suzanne O'Shea, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Office of the
Commissioner (HF-7), 5600 Fishers Lane, Suite 13C-26, Rockville, MD
20857
Phone: 301 827-3390
RIN: 0910-AB54
[[Page 21974]]
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________
1004. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND
REPORTS
Priority: Other Significant
Legal Authority: 21 USC 350a
CFR Citation: 21 CFR 107; 21 CFR 106
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
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 00/00/00
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)
Small Entities Affected: None
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AC46.
Agency Contact: Carolyn W. Miles, Nutritionist, 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: 202 401-9858
RIN: 0910-AA04
_______________________________________________________________________
1005. 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 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 describing the provisions for
exemptions for low-volume food products of small businesses that were
established by the Nutrition Labeling and Education Act Amendments of
1993. On August 18, 1993, FDA published a proposal concerning the
placement of the nutrition facts panel on food labels. Finally, on July
18, 1994, FDA published proposed revised guidelines for the voluntary
declaration of nutrition labeling for raw produce and fish. A final
rule concerning the placement of the nutrition facts panel was
published on April 5, 1995. A final rule establishing reference daily
intakes based on the 9th and 10th editions of Recommended Dietary
Allowances was published on December 28, 1995.
FDA published a final rule on August 2, 1996, on nutrient content
claims and health claims to remove the provisions that exempted
restaurant menus from the requirements for how nutrient content claims
and health claims are to be made. FDA published a final rule on August
7, 1996, describing provisions for an 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 in 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) 00/00/00
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)
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD89.
Agency Contact: Elizabeth J. Campbell, 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
_______________________________________________________________________
1006. 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
[[Page 21975]]
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 00/00/00
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
_______________________________________________________________________
1007. AMALGAM INGREDIENT LABELING
Priority: Substantive, Nonsignificant
Legal Authority: 21 USC 352
CFR Citation: 21 CFR 801
Legal Deadline: None
Abstract: Certain dental amalgams may contain ingredients which may
cause some persons severe adverse reactions. Therefore, FDA would
propose that labeling for dental amalgams must include the ingredients
so that health professionals may choose the appropriate dental material
for the patient.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
NPRM 00/00/00
Small Entities Affected: Undetermined
Government Levels Affected: None
Additional Information: Previously reported under RIN 0905-AE39.
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-AA33
_______________________________________________________________________
1008. 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 00/00/00
Small Entities Affected: 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: 301 594-4765
RIN: 0910-AA41
_______________________________________________________________________
1009. 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 356; 21 USC 357; 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 00/00/00
NPRM Comment Period End 00/00/00
Small Entities Affected: 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
_______________________________________________________________________
1010. 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.
[[Page 21976]]
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 (ANPR) 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 ANPR 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 ANPR 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) 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 (cont)
Timetable:
Exempt Infant Formula; Plan for Revisions ANPRM 06/12/96 (61 FR
29701) Comment Period End 10/10/96 NPRM 00/00/00
Food Standards of Identity, Quality, and Fill of Container ANPRM 12/
29/95 (60 FR 67492) Comment Period Ends 06/28/96 NPRM 00/00/00
Food, Color Additive, GRAS Regulations ANPRM 06/12/96 (61 FR
29701) Comment Period Ends 09/10/96 NPRM 00/00/00
Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry) NPRM
12/29/95 (60 FR 67490) Comment Period End 03/14/96 Extension of
Comment Period 06/03/96 Final Action 00/00/00
Notification Procedures for Independent GRAS Determinations NPRM 04/
17/97 (62 FR 18938) NPRM Comment Period End 07/16/97 Final Action 00/
00/00
Revocation of Certain Food Labeling and Cosmetic Regulations NPRM 06/
12/96 (61 FR 29708) Comment Period Ends 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 Ends 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 00/00/00 Final Action (Yogurt)
00/00/00
Revocation of Obsolete Regulations NPRM 10/13/95 (60 FR
53480) Comment Period Ends 01/11/96 Final Action 06/03/96 (61 FR
27771) Confirmation of Eff. Date 08/27/96 (61 FR 43963)
Small Entities Affected: Businesses
Government Levels Affected: State
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 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
_______________________________________________________________________
1011. REINVENTION OF ADMINISTRATIVE PROCEDURES REGULATIONS
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: 5 USC 504; 5 USC 551 to 558; 5 USC 701 to 721; 7 USC
138; 7 USC 2271; 15 USC 638; 15 USC 1261 to 1282; 15 USC 1451 to 1461;
15 USC 3701 to 3711; 21 USC 41 to 50; 21 USC 61 to 63; 21 USC 141 to
149; 21 USC 321 to 394
CFR Citation: 21 CFR 1 to 3; 21 CFR 5; 21 CFR 10; 21 CFR 12; 21 CFR 19
to 20; 21 CFR 56; 21 CFR 58
Legal Deadline: None
Abstract: FDA is considering ways to further streamline its
administrative procedure regulations that are outdated or otherwise in
need of reform. The agency is taking this action in response to
President Clinton's March 4, 1995 directive to all Federal agencies to
conduct a page-by-page review of their regulations as part of the
``Reinventing Government'' initiative. FDA plans to reinvent
approximately 45 percent of its regulations to ease the burden on
regulated industry and consumers without sacrificing public health
protection. For those regulations requiring Congressional permission to
reinvent, the Administration will seek legislative changes.
Timetable:
________________________________________________________________________
Action Date FR Cite
________________________________________________________________________
ANPRM 06/04/96 61 FR 28116
NPRM 00/00/00
[[Page 21977]]
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations
Government Levels Affected: State, Local, Tribal, Federal
Agency Contact: Lisa M. Helmanis, Office of Policy (HF-26), Department
of Health and Human Services, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857
Phone: 301 443-3480
Fax: 301 443-2946
RIN: 0910-AA69
_______________________________________________________________________
1012. LONG-TERM CONTRACEPTIVE DRUG PRODUCTS AND MEDICAL DEVICES;
INFORMED CONSENT REQUIREMENTS
Priority: Substantive, Nonsignificant. Major status under 5 USC 801 is
undetermined.
Unfunded Mandates: Undetermined
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 358; 21 USC 360; 21
USC 371; 21 USC 374; 21 USC 379; 42 USC 216; 42 USC 241; ...
CFR Citation: 21 CFR 201; 21 CFR 801
Legal Deadline: None
Abstract: The proposed rule would require that patient labeling for
long-acting contraceptive drugs and medical devices include an informed
consent form that must be signed by the patient before any long-acting
contraceptive is administered. The proposed rule is intended to help
ensure that patients receive adequate information to enable them to
make an informed decision about whether or not to use a long-acting
contraceptive.
Timetable: Next Action Undetermined
Small Entities Affected: Undetermined
Government Levels Affected: Undetermined
Agency Contact: Carol Drew, 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-AA75
_______________________________________________________________________
1013. 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 to 357; 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
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 00/00/00
Small Entities Affected: 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
_______________________________________________________________________