Regulatory Information
Fall 2004: Unified Agenda of Federal Regulatory and Deregulatory Actions
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 Fall 2004 Unified Agenda for the Food and Drug Administration.
Food and Drug Administration--Prerule Stage | ||
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Sequence Number | Title | Regulation Identification Number |
926 | Food Labeling; Prominence of Calories (Reg Plan Seq No. 41) | 0910-AF22 |
927 | Food Labeling; Serving Sizes of Products That Can Reasonably Be Consumed at One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes (Reg Plan Seq No. 42) | 0910-AF23 |
928 | Over-the-Counter (OTC) Drug Review—Sunscreen Products |
Food and Drug Administration--Proposed Rule Stage | ||
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Sequence Number | Title | Regulation Identification Number |
929 | Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Certain Biological Drugs, and Animal Drugs (Reg Plan Seq No. 43) | 0910-AA49 |
930 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
931 | Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics | 0910-AC52 |
932 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
933 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
934 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
935 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
936 | Health Claims | 0910-AF09 |
937 | Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled Water | 0910-AF10 |
938 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation | 0910-AF11 |
939 | Cochineal Extract and Carmine Label Declaration | 0910-AF12 |
940 | Charging for Investigational Drugs | 0910-AF13 |
941 | Treatment Use of Investigational Drugs | 0910-AF14 |
942 | Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures | 0910-AF16 |
943 | Revocation of the Status of Specific Products; Group A Streptococcus | 0910-AF20 |
944 | Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms with Spermicidal Lubricant | 0910-AF21 |
945 | Blood Initiative—Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | 0910-AF25 |
946 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products | 0910-AF32 |
947 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products | 0910-AF33 |
948 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products | 0910-AF34 |
949 | Over-the-Counter (OTC) Drug Review—Internal Analgesic Products | 0910-AF36 |
950 | Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use | 0910-AF37 |
951 | Over-the-Counter (OTC) Drug Review—Weight Control Products | 0910-AF45 |
952 | Substances Prohibited From Use in Animal Food or Feed (Reg Plan Seq No. 44) | 0910-AF46 |
953 | Over-the-Counter (OTC) Drug Review—Dandruff, Seborrheic Dermatitis, and Psoriasis Products | 0910-AF49 |
954 | Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products | 0910-AF51 |
955 | Over-the-Counter (OTC) Drug Review—Skin Bleaching Prodcuts | 0910-AF53 |
956 | Use of Materials Derived From Cattle In Human and Animal Medical Products (Reg Plan Seq No. 45) | 0910-AF54 |
957 | Requirements for Human and Animal Medical Products Manufactured From, Processed With, or Otherwise Containing Material From Cattle (Reg Plan Seq No. 46) | 0910-AF55 |
Food and Drug Administration--Final Rule Stage | ||
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Sequence Number | Title | Regulation Identification Number |
958 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
959 | Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products (Reg Plan Seq No. 47) | 0910-AA94 |
960 | Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq No. 48) | 0910-AA97 |
961 | Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement (Reg Plan Seq No. 49) | 0910-AB28 |
962 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications | 0910-AB34 |
963 | CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) (Reg Plan Seq No. 50) | 0910-AB76 |
964 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 51) | 0910-AB88 |
965 | Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products | 0910-AC07 |
966 | Prevention of Salmonella Enteritidis in Shell Eggs (Reg Plan Seq No. 52) | 0910-AC14 |
967 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
968 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
969 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
970 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan Seq No. 53) | 0910-AC35 |
971 | Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No. 54) | 0910-AC39 |
972 | Registration of Food and Animal Feed Facilities (Reg Plan Seq No. 55) | 0910-AC40 |
973 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No. 56) | 0910-AC41 |
974 | Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 0910-AF15 |
975 | Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol (Reg Plan Seq No. 57) | 0910-AF18 |
976 | Blood Initiative—Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma | 0910-AF26 |
977 | Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports | 0910-AF27 |
978 | Infant Formula Quality Factors | 0910-AF28 |
979 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products | 0910-AF31 |
980 | Over-the-Counter (OTC) Drug Review—Ophthalmic Products | 0910-AF39 |
981 | Over-the-Counter (OTC) Drug Review—Skin Protectant Products | 0910-AF42 |
982 | Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products | 0910-AF44 |
983 | Use of Materials Derived From Cattle in Human Food and Cosmetics (Reg Plan Seq No. 58) | 0910-AF47 |
984 | Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle (Reg Plan Seq No. 59) | 0910-AF48 |
985 | Over-the-Counter (OTC) Drug Review—Antacid Products (Sodium Bicarbonate Labeling) | 0910-AF52 |
Food and Drug Administration--Long-Term Actions | ||
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Sequence Number | Title | Regulation Identification Number |
986 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
987 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
988 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
989 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
990 | Food Labeling: Trans Fatty Acids in Nutrition Labeling: Consumer Research To Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements | 0910-AC50 |
991 | Food Labeling: Food Allergen Ingredient Labeling | 0910-AF07 |
992 | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls | 0910-AF08 |
993 | Over-the-Counter (OTC) Drug Review—External Analgesic Products | 0910-AF35 |
994 | Over-the-Counter (OTC) Drug Review—Laxative Drug Products | 0910-AF38 |
995 | Over-the-Counter (OTC) Drug Review—Oral Health Care Products | 0910-AF40 |