Regulatory Information
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Fall 2006: 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 Spring 2006 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1005 | Over-the-Counter (OTC) Drug Review—Sunscreen Products | 0910-AF43 |
| 1006 | Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality Systems Regulations (Section 610 Review) | 0910-AF71 |
| 1007 | Package Size Limitation for Sodium Phosphates Oral Solution and Warning and Direction Statements for Oral and Rectal Sodium Phosphates for Over-the-Counter Laxative Use (Section 610 Review) | 0910-AF73 |
| 1008 | Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use: Required Alcohol Warning (Section 610 Review) | 0910-AF74 |
| 1009 | Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients (Section 610 Review) | 0910-AF75 |
| 1010 | Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific Reagents (Section 610 Review) | 0910-AF76 |
| 1011 | Amended Economic Impact Analysis of Final Rule on User Labeling on Natural Rubber-Containing Medical Device (Section 610 Review) | 0910-AF77 |
| 1012 | Financial Disclosure by Clinical Investigators (Section 610 Review) | 0910-AF79 |
| 1013 | Beverages: Bottled Water (Section 610 Review) | 0910-AF80 |
| 1014 | Food Labeling; Nutrient Content Claims: Definition for "High Potency" and Definition of "Antioxidant" for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Section 610 Review) | 0910-AF83 |
| Food and Drug Administration—Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1015 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen and Separate Classification of Oxygen Conserving Devices | 0910-AC30 |
| 1016 | Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg Plan Seq No. 36) | 0910-AC52 |
| 1017 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
| 1018 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 37) | 0910-AF11 |
| 1019 | Charging for Investigational Drugs | 0910-AF13 |
| 1020 | Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 38) | 0910-AF14 |
| 1021 | Blood Initiative—Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | 0910-AF25 |
| 1022 | Over-the-Counter (OTC) Drug Review—Internal Analgesic Products | 0910-AF36 |
| 1023 | Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use | 0910-AF37 |
| 1024 | Over-the-Counter (OTC) Drug Review—Ophthalmic Products | 0910-AF39 |
| 1025 | Over-the-Counter (OTC) Drug Review—Oral Health Care Products | 0910-AF40 |
| 1026 | Over-the-Counter (OTC) Drug Review—Skin Bleaching Products | 0910-AF53 |
| 1027 | Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants | 0910-AF54 |
| 1028 | Over-the-Counter (OTC) Drug Review—Stimulant Drug Products | 0910-AF56 |
| 1029 | Label Requirement for Food That Has Been Refused Admission Into the United States (Reg Plan Seq No. 39) | 0910-AF61 |
| 1030 | Over-the-Counter Antidiarrheal Drug Products | 0910-AF63 |
| 1031 | Index of Legally Marketed Unapproved New Animal Drugs for Minor Species | 0910-AF67 |
| 1032 | Over-the-Counter (OTC) Drug Review—Poison Treatment Drug Products | 0910-AF68 |
| 1033 | Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products | 0910-AF69 |
| 1034 | Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products | 0910-AF70 |
| 1035 | Import Tolerances for Animal Drugs | 0910-AF78 |
| 1036 | Current Good Manufacturing Practice for Combination Products | 0910-AF81 |
| 1037 | Postmarket Safety Reporting for Combination Products | 0910-AF82 |
| 1038 | Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma | 0910-AF84 |
| 1039 | Revision of the Requirements for Live Vaccine Processing | 0910-AF85 |
| 1040 | Medical Device Reporting; Electronic Submission Requirements (Reg Plan Seq No. 40) | 0910-AF86 |
| 1041 | Laser Products; Amendment to Performance Standard | 0910-AF87 |
| 1042 | Electronic Registration and Listing for Devices (Reg Plan Seq No. 41) | 0910-AF88 |
| 1043 | Regulations on Fixed-Combination Drug Products | 0910-AF89 |
| 1044 | Use of Ozone-Depleting Substances; Removal of Essential Use Designations [epinephrine] | 0910-AF92 |
| 1045 | Use of Ozone-Depleting Substances; Removal of Essential Use Designations [flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil]. | 0910-AF93 |
| References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. | ||
| Food and Drug Administration—Final Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1046 | Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs | 0910-AA49 |
| 1047 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 1048 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications | 0910-AB34 |
| 1049 | 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) | 0910-AB76 |
| 1050 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 42) | 0910-AB88 |
| 1051 | Additional Safeguards for Children in Clinical Investigations | 0910-AC07 |
| 1052 | Prevention of Salmonella Enteritidis in Shell Eggs | 0910-AC14 |
| 1053 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 1054 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 1055 | Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria | 0910-AC32 |
| 1056 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs | 0910-AC35 |
| 1057 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Reg Plan Seq No. 43) | 0910-AC41 |
| 1058 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
| 1059 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
| 1060 | Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 0910-AF15 |
| 1061 | 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 |
| 1062 | Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms With Spermicidal Lubricant | 0910-AF21 |
| 1063 | Blood Initiative—Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; and Technical Amendment | 0910-AF26 |
| 1064 | Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports | 0910-AF27 |
| 1065 | Infant Formula Quality Factors | 0910-AF28 |
| 1066 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products | 0910-AF31 |
| 1067 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products | 0910-AF32 |
| 1068 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products | 0910-AF33 |
| 1069 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products | 0910-AF34 |
| 1070 | Over-the-Counter (OTC) Drug Review—External Analgesic Products | 0910-AF35 |
| 1071 | Over-the-Counter (OTC) Drug Review—Laxative Drug Products | 0910-AF38 |
| 1072 | Over-the-Counter (OTC) Drug Review—Skin Protectant Products | 0910-AF42 |
| 1073 | Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products | 0910-AF44 |
| 1074 | Over-the-Counter (OTC) Drug Review—Weight Control Products | 0910-AF45 |
| 1075 | Over-the-Counter (OTC) Drug Review—Dandruff, Seborrheic Dermatitis, and Psoriasis Products | 0910-AF49 |
| 1076 | Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products | 0910-AF51 |
| 1077 | Over-the-Counter (OTC) Drug Review—Antacid Products | 0910-AF52 |
| 1078 | Supplements and Other Changes to Approved New Animal Drug Applications | 0910-AF59 |
| 1079 | Designation of New Animal Drugs for Minor Uses or Minor Species | 0910-AF60 |
| 1080 | Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation | 0910-AF65 |
| 1081 | Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile | 0910-AF90 |
| References in boldface appear in the Regulatory Plan in part II of this issue of the Federal Register. | ||
| Food and Drug Administration—Long-Term Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1082 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 1083 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 1084 | 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 |
| 1085 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
| 1086 | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls | 0910-AF08 |
| 1087 | Health Claims | 0910-AF09 |
| 1088 | Cochineal Extract and Carmine Label Declaration | 0910-AF12 |
| 1089 | Food Labeling; Prominence of Calories | 0910-AF22 |
| 1090 | 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 | 0910-AF23 |
| 1091 | Substances Prohibited From Use in Animal Food or Feed | 0910-AF46 |
| 1092 | Use of Materials Derived From Cattle in Human Food and Cosmetics | 0910-AF47 |
| Food and Drug Administration—Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1093 | Revocation of the Status of Specific Products; Group A Streptococcus | 0910-AF20 |
| 1094 | Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle | 0910-AF48 |
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