Regulatory Information
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Fall 2005: 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 2005 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration—Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1002 | Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality Systems Regulations (Section 610 Review) | 0910-AF71 |
| Food and Drug Administration—Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1003 | Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs (Reg Plan Seq No. 43) | 0910-AA49 |
| 1004 | Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed Animal Populations | 0910-AC21 |
| 1005 | Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure Regulators for Use With Medical Oxygen | 0910-AC30 |
| 1006 | Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and Biologics (Reg Plan Seq No. 44) | 0910-AC52 |
| 1007 | Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | 0910-AC53 |
| 1008 | Positron Emission Tomography Drugs; Current Good Manufacturing Practices | 0910-AC55 |
| 1009 | Reporting Information Regarding Falsification of Data | 0910-AC59 |
| 1010 | Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling (Reg Plan Seq No. 45) | 0910-AF11 |
| 1011 | Cochineal Extract and Carmine Label Declaration | 0910-AF12 |
| 1012 | Charging for Investigational Drugs | 0910-AF13 |
| 1013 | Expanded Access to Investigational Drugs for Treatment Use (Reg Plan Seq No. 46) | 0910-AF14 |
| 1014 | 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 |
| 1015 | Revocation of the Status of Specific Products; Group A Streptococcus | 0910-AF20 |
| 1016 | Obstetrical and Gynecological Devices; Designation of Special Control for Condoms and Condoms With Spermicidal Lubricant | 0910-AF21 |
| 1017 | Blood Initiative—Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use | 0910-AF25 |
| 1018 | Over-the-Counter (OTC) Drug Review—Internal Analgesic Products | 0910-AF36 |
| 1019 | Over-the-Counter (OTC) Drug Review—Labeling of Drug Products for OTC Human Use | 0910-AF37 |
| 1020 | Over-the-Counter (OTC) Drug Review—Ophthalmic Products | 0910-AF39 |
| 1021 | Over-the-Counter (OTC) Drug Review—Sunscreen Products | 0910-AF43 |
| 1022 | Over-the-Counter (OTC) Drug Review—Weight Control Products | 0910-AF45 |
| 1023 | Substances Prohibited From Use in Animal Food or Feed | 0910-AF46 |
| 1024 | Over-the-Counter (OTC) Drug Review—Dandruff, Seborrheic Dermatitis, and Psoriasis Products | 0910-AF49 |
| 1025 | Over-the-Counter (OTC) Drug Review—Skin Bleaching Products | 0910-AF53 |
| 1026 | Over-the-Counter (OTC) Drug Review—Stimulant Drug Products | 0910-AF56 |
| 1027 | Designation of New Animal Drugs for Minor Use and Minor Species | 0910-AF60 |
| 1028 | Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation | 0910-AF65 |
| 1029 | Index of Legally Marketed Unapproved New Animal Drugs for Minor Species | 0910-AF67 |
| 1030 | Over-the-Counter (OTC) Drug Review—Poison Treatment Drug Products | 0910-AF68 |
| 1031 | Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products | 0910-AF69 |
| 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 |
| 1032 | Investigational New Drugs: Export Requirements for Unapproved New Drug Products | 0910-AA61 |
| 1033 | Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products (Reg Plan Seq No. 47) | 0910-AA94 |
| 1034 | Safety Reporting Requirements for Human Drug and Biological Products | 0910-AA97 |
| 1035 | Applications for FDA Approval To Market a New Drug; Complete Response Letter; Amendments To Unapproved Applications | 0910-AB34 |
| 1036 | 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 |
| 1037 | Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements (Reg Plan Seq No. 48) | 0910-AB88 |
| 1038 | Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products | 0910-AC07 |
| 1039 | Prevention of Salmonella Enteritidis in Shell Eggs | 0910-AC14 |
| 1040 | Institutional Review Boards: Registration Requirements | 0910-AC17 |
| 1041 | Exception From General Requirements for Informed Consent; Request for Comments and Information | 0910-AC25 |
| 1042 | Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration | 0910-AC32 |
| 1043 | Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs (Reg Plan Seq No. 49) | 0910-AC35 |
| 1044 | Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 0910-AC41 |
| 1045 | Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 0910-AF15 |
| 1046 | Blood Initiative—Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma; and Technical Amendment | 0910-AF26 |
| 1047 | Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports | 0910-AF27 |
| 1048 | Infant Formula Quality Factors | 0910-AF28 |
| 1049 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products | 0910-AF31 |
| 1050 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Nasal Decongestant) Products | 0910-AF34 |
| 1051 | Over-the-Counter (OTC) Drug Review—Laxative Drug Products | 0910-AF38 |
| 1052 | Over-the-Counter (OTC) Drug Review—Skin Protectant Products | 0910-AF42 |
| 1053 | Over-the-Counter (OTC) Drug Review—Vaginal Contraceptive Products | 0910-AF44 |
| 1054 | Use of Materials Derived From Cattle in Human Food and Cosmetics | 0910-AF47 |
| 1055 | Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle | 0910-AF48 |
| 1056 | Over-the-Counter (OTC) Drug Review—Antacid Products | 0910-AF52 |
| 1057 | Supplements and Other Changes to Approved New Animal Drug Applications | 0910-AF59 |
| 1058 | Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review | 0910-AF62 |
| 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 |
| 1059 | Requirements for Submission of In Vivo Bioequivalence Data | 0910-AC23 |
| 1060 | 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 |
| 1061 | Food Standards: General Principles and Food Standards Modernization | 0910-AC54 |
| 1062 | Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls | 0910-AF08 |
| 1063 | Health Claims | 0910-AF09 |
| 1064 | Food Labeling; Prominence of Calories | 0910-AF22 |
| 1065 | 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 |
| 1066 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Bronchodilator) Products | 0910-AF32 |
| 1067 | Over-the-Counter (OTC) Drug Review—Cough/Cold (Combination) Products | 0910-AF33 |
| 1068 | Over-the-Counter (OTC) Drug Review—External Analgesic Products | 0910-AF35 |
| 1069 | Over-the-Counter (OTC) Drug Review—Oral Health Care Products | 0910-AF40 |
| 1070 | Over-the-Counter (OTC) Drug Review—Overindulgence in Food and Drink Products | 0910-AF51 |
| 1071 | Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants | 0910-AF54 |
| 1072 | Label Requirement for Food That Has Been Refused Admission Into the United States | 0910-AF61 |
| 1073 | Over-the-Counter Antidiarrheal Drug Products | 0910-AF63 |
| 1074 | Lowfat and Skim Milk and Lowfat and Nonfat Yogurt Products, Lowfat Cottage Cheese: Rev. of Stand. of Ident.; Food Lab., Nutrient Cont. Claims for Fat, Fatty Acids, and Cholesterol Cont. of Foods (Section 610 Review) | 0910-AF64 |
| 1075 | Over-the-Counter (OTC) Drug Review—Urinary Analgesic Drug Products | 0910-AF70 |
| Food and Drug Administration—Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1076 | Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection With Imported Food | 0910-AB96 |
| 1077 | Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | 0910-AC34 |
| 1078 | Registration of Food and Animal Feed Facilities | 0910-AC40 |
| 1079 | Quality Standard Regulation Establishing an Allowable Level for Arsenic in Bottled Water | 0910-AF10 |
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