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Unified Agenda of Federal Regulatory and Deregulatory Actions
Spring 2001

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 2001 Unified Agenda for the Food and Drug Administration.

Food and Drug Administration—Prerule Stage
Sequence Number Title Regulation Identification Number
831 Natural Rubber-Containing Drugs; User Labeling0910-AB56
832 Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 19960910-AB71
833 Part 600-Biological Products: General (Section 610 Review)0910-AC06

Food and Drug Administration—Proposed Rule Stage
Sequence Number Title Regulation Identification Number
834 Over-the-Counter (OTC) Drug Review0910-AA01
835 Hearing Aids; Professional and Patient Labeling; Conditions for Sale0910-AA39
836 Establishment Registration and Product Listing for Drugs and Biologics0910-AA49
837 Investigational New Drugs: Export Requirements for Unapproved New Drug Products0910-AA61
838 Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs0910-AA86
839 Safety Reporting Requirements for Human Drug and Biological Products0910-AA97
840 Radioactive Drugs for Basic Research0910-AB00
841 Administrative Practices and Procedures; Advisory Opinions and Guidelines0910-AB14
842 Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products0910-AB28
843 Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications0910-AB34
844 Expanded Access to Investigational Therapies0910-AB37
845 Electronic Submission of Adverse Drug Reaction Reports0910-AB42
846 Distinguishing Marks for Drug Products Containing Insulin0910-AB43
847 Pregnancy Labeling0910-AB44
848 Positron Emission Tomography Drugs; Current Good Manufacturing Practices0910-AB63
849 Current Good Manufacturing Practice for Medicated Feeds0910-AB70
850 Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use0910-AB79
851 Repackaging Approval Requirements0910-AB81
852 Stability Testing of Drugs0910-AB82
853 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements0910-AB88
854 Submission in Electronic Format of Certain Labeling Information0910-AB91
855 Fees Relating to Drugs; Waiver and Reduction of Fees0910-AB92
856 Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications0910-AB93
857 Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food0910-AB96
858 Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment0910-AB99
859 Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation0910-AC00
860 Reporting Information Regarding Potential Fabrication or Falsification of Data0910-AC02
861 Status Reports for Quantity Marketed Information for Animal Drug Products Used in Food-Producing Animals0910-AC04
862 Labeling Dietary Supplements for Women Who Are or May Become Pregnant0910-AC09
863 Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers0910-AC10
864 Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of "No Residue"0910-AC13
865 Control of Salmonella Enteritidis in Shell Eggs During Production and Retail0910-AC14
866 Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition0910-AC18
867 Use of Materials Derived from Ruminant Animals in FDA Regulated Products0910-AC19
868 Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk Ingredients from Unapproved Sources0910-AC20

Food and Drug Administration—Final Rule Stage
Sequence Number Title Regulation Identification Number
869 New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)0910-AA02
870 Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals0910-AA45
871 Bioavailability and Bioequivalence Requirements0910-AA51
872 Labeling for Human Prescription Drugs; Revised Format0910-AA94
873 Current Good Manufacturing Practice; Revision of Certain Labeling Controls0910-AA98
874 Use of Ozone-Depleting Substances0910-AA99
875 Exports; Notification and Recordkeeping Requirements0910-AB16
876 Foreign Establishment Registration and Listing0910-AB21
877 FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Later Export0910-AB24
878 Blood Initiative0910-AB26
879 Antibiotic Drug Approval and Exclusivity0910-AB33
880 Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs0910-AB39
881 Supplements and Other Changes to Approved New Animal Drug Applications0910-AB49
882 Revisions to the General Safety Requirements for Biological Products; Direct Final Rule0910-AB51
883 Discontinuation of a Lifesaving Product0910-AB60
884 Supplements and Other Changes to an Approved Application0910-AB61
885 Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims0910-AB66
886 Presubmission Conferences0910-AB68
887 Surgeon's and Patient Examination Gloves; Reclassification0910-AB74
888 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback)0910-AB76
889 Antibiotic Resistance Labeling0910-AB78
890 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications0910-AB80
891 Food Additives: Food Contact Substances Notification System0910-AB94
892 State Certification of Mammography Facilities0910-AB98
893 Examination of Administrative Record and Other Advisory Committee Records0910-AC03
894 Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human Studies Are Unethical0910-AC05
895 Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products0910-AC07
896 Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity0910-AC11
897 Revocation of Conditions for Marketing Digoxin Products for Oral Use0910-AC12

Food and Drug Administration—Long-Term Actions
Sequence Number Title Regulation Identification Number
898 Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports0910-AA04
899 Food Labeling Review0910-AA19
900 Medical Foods0910-AA20
901 Classification of Computer Software Programs That Are Medical Devices0910-AA41
902 Reinventing FDA Food Regulations0910-AA58
903 Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients0910-AA89
904 Direct-to-Consumer Promotion Regulations0910-AA90
905 Investigational Use New Animal Drug Regulations (Section 610 Review)0910-AB02
906 Suitability Determination for Donors of Human Cellular and Tissue-Based Products0910-AB27
907 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed0910-AB50
908 Bulk Drug Substances for Use in Pharmacy Compounding0910-AB57
909 Pharmacy and Physician Compounding of Drug Products0910-AB58
910 Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness0910-AB59
911 Mandatory HACCP Regulations for Manufacturers of Rendered Products0910-AB72
912 Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action0910-AB73
913 Substances Prohibited From Use in Animal Food or Feed0910-AB90
914 Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States0910-AB95
915 Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness0910-AC01
916 Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness0910-AC08
917 Premarket Notice Concerning Bioengineered Foods0910-AC15
918 Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures0910-AC16
919 Institutional Review Boards: Registration Requirements0910-AC17
920 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed Animal Populations0910-AC21

Food and Drug Administration—Completed Actions
Sequence Number Title Regulation Identification Number
921 Biological Products: Reporting of Biological Product Deviations in Manufacturing0910-AA12
922 Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices0910-AA43
923 Drugs Used for Treatment of Narcotic Addicts0910-AA52
924 Establishment Registration and Listing of Human Cells, Tissues, and Cellular and Tissue-Based Products0910-AB05
925 Veterinary Feed Directives0910-AB09
926 Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements0910-AB30
927 Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports0910-AB83
928 Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling Standards0910-AB89

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Unified Agenda Quarterly

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