The Unified Agenda of Federal Regulatory and Deregulatory Actions, (also know
as the semi-annual regulatory agenda) is published in the spring and fall of
each year. Since 1978, Federal agencies have been required by Executive orders
to publish agendas of regulatory and deregulatory activities. The Regulatory
Plan, which is published as part of the fall edition of the Agenda, identifies
regulatory priorities and contains additional detail about the most important
significant regulatory actions that agencies expect to take in the coming year.
Following is the portion of the Spring 2000 Unified Agenda for the Food
and Drug Administration.
| Food and Drug Administration--Proposed Rule Stage
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 936
| Hearing Aids; Professional and Patient Labeling; Conditions for Sale
| 0910-AA39 |
|
| 937
| Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
| 0910-AA49 |
|
| 938
| Investigational New Drugs: Export Requirements for Unapproved New Drug Products
| 0910-AA61 |
|
| 939
| Suspected Adverse Drug Reaction Reporting and Recordkeeping Requirements for Marketed OTC Drugs
| 0910-AA86 |
|
| 940
| Direct-to-Consumer Promotion Regulations
| 0910-AA90 |
|
| 941
| Labeling for Human Prescription Drugs; Revised Format
| 0910-AA94 |
|
| 942
| Suspected Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products
| 0910-AA97 |
|
| 943
| Radioactive Drugs for Basic Research
| 0910-AB00 |
|
| 944
| Administrative Practices and Procedures; Advisory Opinions and Guidelines
| 0910-AB14 |
|
| 945
| Blood Initiative
| 0910-AB26 |
|
| 946
| Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products
| 0910-AB28 |
|
| 947
| Antibiotic Drug Approval and Exclusivity
| 0910-AB33 |
|
| 948
| Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
| 0910-AB34 |
|
| 949
| Expanded Access to Investigational Therapies
| 0910-AB37 |
|
| 950
| Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs
| 0910-AB39 |
|
| 951
| Electronic Submission of Adverse Drug Reaction Reports
| 0910-AB42 |
|
| 952
| Distinguishing Marks for Drug Products Containing Insulin
| 0910-AB43 |
|
| 953
| Pregnancy Labeling
| 0910-AB44 |
|
| 954
| Pharmacy and Physician Compounding of Drug Products
| 0910-AB58 |
|
| 955
| Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness
| 0910-AB59 |
|
| 956
| Discontinuation of a Life-Saving Product
| 0910-AB60 |
|
| 957
| Positron Emission Tomography Drugs; Current Good Manufacturing Practices
| 0910-AB63 |
|
| 958
| Presubmission Conferences
| 0910-AB68 |
|
| 959
| Current Good Manufacturing Practice for Medicated Feeds
| 0910-AB70 |
|
| 960
| Mandatory HACCP Regulations for Manufacturers of Rendered Products
| 0910-AB72 |
|
| 961
| CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection
| 0910-AB76 |
|
| 962
| Antibiotic Resistance Labeling
| 0910-AB78 |
|
| 963
| Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use
| 0910-AB79 |
|
| 964
| Repackaging Approval Requirements
| 0910-AB81 |
|
| 965
| Stability Testing of Drugs
| 0910-AB82 |
|
| 966
| Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements
| 0910-AB88 |
|
| 967
| Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling Standards; Direct Final Rule
| 0910-AB89 |
|
| 968
| Submission in Electronic Format of Certain Labeling Information
| 0910-AB91 |
|
| 969
| Fees Relating to Drugs; Waiver and Reduction of Fees
| 0910-AB92 |
|
| 970
| Skip Lot Testing
| 0910-AB93 |
|
| 971
| Food Additives: Food Contact Substances Notification System
| 0910-AB94 |
|
| 972
| Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States
| 0910-AB95 |
|
| 973
| Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food
| 0910-AB96 |
|
| 974
| State Certification of Mammography Facilities
| 0910-AB98 |
|
| 975
| Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment
| 0910-AB99 |
|
| 976
| Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation
| 0910-AC00 |
|
| 977
| Reporting Information Regarding Potential Research Misconduct
| 0910-AC02 |
|
| 978
| Examination of Administrative Record and Other Advisory Committee Records
| 0910-AC03 |
| Food and Drug Administration--Final Rule Stage
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 979
| Over-the-Counter (OTC) Drug Review
| 0910-AA01 |
|
| 980
| New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
| 0910-AA02 |
|
| 981
| Biological Products: Reporting of Biological Product Deviations in Manufacturing
| 0910-AA12 |
|
| 982
| Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices
| 0910-AA43 |
|
| 983
| Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals
| 0910-AA45 |
|
| 984
| Bioavailability and Bioequivalence Requirements
| 0910-AA51 |
|
| 985
| Drugs Used for Treatment of Narcotic Addicts
| 0910-AA52 |
|
| 986
| Reinventing FDA Food Regulations
| 0910-AA58 |
|
| 987
| Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening Illnesses
| 0910-AA84 |
|
| 988
| Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation
| 0910-AA88 |
|
| 989
| Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients
| 0910-AA89 |
|
| 990
| Current Good Manufacturing Practice; Revision of Certain Labeling Controls
| 0910-AA98 |
|
| 991
| Use of Ozone-Depleting Substances
| 0910-AA99 |
|
| 992
| Veterinary Feed Directives
| 0910-AB09 |
|
| 993
| Exports; Notification and Recordkeeping Requirements
| 0910-AB16 |
|
| 994
| Foreign Establishment Registration and Listing
| 0910-AB21 |
|
| 995
| 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 |
|
| 996
| Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements
| 0910-AB30 |
|
| 997
| Supplements and Other Changes to Approved New Animal Drug Applications
| 0910-AB49 |
|
| 998
| Revisions to the General Safety Requirements for Biological Products; Direct Final Rule
| 0910-AB51 |
|
| 999
| Bulk Drug Substances for Use in Pharmacy Compounding
| 0910-AB57 |
|
| 1000
| Supplements and Other Changes to an Approved Application
| 0910-AB61 |
|
| 1001
| Classification of Sheep as a Minor Species for All Data Collection Purposes
| 0910-AB69 |
|
| 1002
| Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action
| 0910-AB73 |
|
| 1003
| 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications
| 0910-AB80 |
|
| 1004
| Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports
| 0910-AB83 |
|
| 1005
| Amendment of Various Device Regulations to Reflect Current American Society for Testing and Materials Citations
| 0910-AB84 |
|
| 1006
| Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness
| 0910-AC01 |
|
| 1007
| Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human Studies Are Unethical
| 0910-AC05 |
| Food and Drug Administration--Long-Term Actions
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 1008
| Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports
| 0910-AA04 |
|
| 1009
| Food Labeling Review
| 0910-AA19 |
|
| 1010
| Medical Foods
| 0910-AA20 |
|
| 1011
| Classification of Computer Software Programs That Are Medical Devices
| 0910-AA41 |
|
| 1012
| Debarment Certification Regulations for Drug Applications
| 0910-AA76 |
|
| 1013
| Investigational New Drug Applications; Request for Information and Comments
| 0910-AA83 |
|
| 1014
| Establishment Registration and Listing of Human Cellular and Tissue-Based Products
| 0910-AB05 |
|
| 1015
| Suitability Determination for Donors of Human Cellular and Tissue-Based Products
| 0910-AB27 |
|
| 1016
| Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed
| 0910-AB50 |
|
| 1017
| Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims
| 0910-AB66 |
|
| 1018
| Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996 and the Safe Level Provisions of the Animal Medicinal Drug Use Clarification Act of 1994
| 0910-AB71 |
|
| 1019
| Surgeon's and Patient Examination Gloves; Reclassification
| 0910-AB74 |
|
| 1020
| Substances Prohibited From Use in Animal Food or Feed
| 0910-AB90 |
|
| 1021
| Status Reports for Quantity Marketed Information for Animal Drug Products Used in Food-Producing Animals
| 0910-AC04 |
| Food and Drug Administration--Completed Actions
|
|---|
|
| Sequence Number | Title | Regulation Identifier Number |
|
| 1022
| Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures
| 0910-AA08 |
|
| 1023
| Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
| 0910-AA74 |
|
| 1024
| New Drug Applications; Drug Master File
| 0910-AA78 |
|
| 1025
| New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification
| 0910-AB12 |
|
| 1026
| 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 |
|
| 1027
| Medicated Feed Mill Licenses
| 0910-AB18 |
|
| 1028
| 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 |
|
| 1029
| Public Information; Communications With State and Foreign Government Officials
| 0910-AB22 |
|
| 1030
| Progestational Drug Products for Human Use; Requirements for Labeling Directed to the Patient
| 0910-AB45 |
|
| 1031
| Pediatric Exclusivity
| 0910-AB62 |
|
| 1032
| Designated Journals
| 0910-AB67 |
|
| 1033
| Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body
| 0910-AB97 |
