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Unified Agenda of Federal Regulatory and Deregulatory Actions
June 2004

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 June 2004 Unified Agenda for the Food and Drug Administration.

Food and Drug Administration--Prerule Stage
Sequence Number Title Regulation Identification Number
833 Safety Reporting Requirements for Human Drug and Biological Products0910-AA97
834 Food Labeling; Prominence of Calories0910-AF22
835 Food Labeling; Serving Sizes0910-AF23
836 Over-the-Counter (OTC) Drug Review—Sunscreen Products0910-AF43


Food and Drug Administration--Proposed Rule Stage
Sequence Number Title Regulation Identification Number
837 Foreign and Domestic Establishment Registration and Listing Requirements for Drugs and Biologics0910-AA49
838 Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications0910-AB34
839 Prevention of Salmonella Enteritidis in Shell Eggs0910-AC14
840 Exception From General Requirements for Informed Consent; Request for Comments and Information0910-AC25
841 Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen0910-AC30
842 Food Standards: General Principles and Food Standards Modernization0910-AC54
843 Positron Emission Tomography Drugs; Current Good Manufacturing Practices0910-AC55
844 Reporting Information Regarding Falsification of Data0910-AC59
845 Definition of "Serious Adverse Health Consequences" Under the Public Health Security and Bioterrorism Preparedness and Response Act of 20020910-AF06
846 Health Claims0910-AF09
847 Quality Standard Regulation Establishing Allowable Level for Arsenic in Bottled Water0910-AF10
848 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation 0910-AF11
849 Cochineal Extract and Carmine Label Declaration0910-AF12
850 Charging for Investigational Drugs0910-AF13
851 Treatment Use of Investigational Drugs 0910-AF14
852 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Derivatives of Blood0910-AF16
853 Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol0910-AF18
854 Revocation of the Status of Specific Products; Group A Streptococcus0910-AF20
855 Latex Condoms: Special Controls0910-AF21
856 Blood Initiative—Regulations for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use0910-AF25
857 Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products0910-AF32
858 Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products0910-AF33
859 Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products0910-AF34
860 Over-the-Counter (OTC) Drug Review—Internal Analgesic Products0910-AF36
861 Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use0910-AF37
862 Over-the-Counter (OTC) Drug Review—Weight Control Products0910-AF45


Food and Drug Administration--Final Rule Stage
Sequence Number Title Regulation Identification Number
863 Investigational New Drugs: Export Requirements for Unapproved New Drug Products0910-AA61
864 Labeling for Human Prescription Drugs; Revised Format0910-AA94
865 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement0910-AB28
866 CGMP for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback)0910-AB76
867 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements0910-AB88
868 Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products0910-AC07
869 Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration0910-AC32
870 Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components0910-AC34
871 Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 20020910-AC39
872 Registration of Food and Animal Feed Facilities0910-AC40
873 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 20020910-AC41
874 Presubmission Conferences0910-AC44
875 Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application 0910-AF15
876 Blood Initiative—Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma0910-AF26
877 Over-the-Counter (OTC) Drug Review—Antiperspirant Products0910-AF30
878 Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products0910-AF31
879 Over-the-Counter (OTC) Drug Review—Ophthalmic Products0910-AF39
880 Over-the-Counter (OTC) Drug Review—Skin Protectant Products0910-AF42
881 Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products0910-AF44


Food and Drug Administration--Long-Term Actions
Sequence Number Title Regulation Identification Number
882 Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food0910-AB96
883 Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations0910-AC21
884 Requirements for Submission of In Vivo Bioequivalence Data0910-AC23
885 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs0910-AC35
886 Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements0910-AC50
887 Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics0910-AC52
888 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements0910-AC53
889 Food Labeling: Food Allergen Ingredient Labeling0910-AF07
890 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls0910-AF08
891 Current Good Manufacutring Practices; Quality Control Procedures; Notification Requirements; Records and Reports0910-AF27
892 Infant Formula Quality Factors0910-AF28
893 Over-the-Counter (OTC) Drug Review—External Analgesic Products0910-AF35
894 Over-the-Counter (OTC) Drug Review—Laxative Drug Products0910-AF38
895 Over-the-Counter (OTC) Drug Review—Oral Health Care Products0910-AF40


Food and Drug Administration--Completed Actions
Sequence Number Title Regulation Identification Number
896 Over-the-Counter (OTC) Drug Review0910-AA01
897 Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports0910-AA04
898 Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients0910-AA89
899 Blood Initiative0910-AB26
900 Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products0910-AB27
901 Supplements and Other Changes to an Approved Application0910-AB61
902 Current Good Manufacturing Practice for Medicated Feeds0910-AB70
903 Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format0910-AB91
904 Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products0910-AC19
905 Bar Code Label Requirements for Human Drug Products and Blood0910-AC26
906 Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 20020910-AC38
907 Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed0910-AC43
908 Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review0910-AC56
909 Revision of the Requirements for Spore-Forming Microorganisms0910-AC57
910 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Part 110) (Completion of a Section 610 Review)0910-AC58
911 Over-the-Counter (OTC) Drug Review—Antidiarrheal Products0910-AF29


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