Regulatory Information
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Fall 2000: 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 2000 Unified Agenda for the Food and Drug Administration.
| Food and Drug Administration--Prerule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1112 |
Natural Rubber-Containing Drugs; User Labeling
|
0910-AB56 |
| 1113 |
Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of 1996
|
0910-AB71 |
| 1114 |
Substances Prohibited From Use in Animal Food or Feed
|
0910-AB90 |
| 1115 |
Part 600-Biological Products: General (Section 610 Review)
|
0910-AC06 |
| Food and Drug Administration--Proposed Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1116 |
Hearing Aids; Professional and Patient Labeling; Conditions for Sale (RegPlan Seq. No. 32)
|
0910-AA39 |
| 1117 |
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
|
0910-AA49 |
| 1118 |
Investigational New Drugs: Export Requirements for Unapproved New Drug Products
|
0910-AA61 |
| 1119 |
Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs
|
0910-AA86 |
| 1120 |
Labeling for Human Prescription Drugs; Revised Format (RegPlan Seq. No. 33)
|
0910-AA94 |
| 1121 |
Safety Reporting Requirements for Human Drug and Biological Products (RegPlan Seq. No. 34)
|
0910-AA97 |
| 1122 |
Radioactive Drugs for Basic Research
|
0910-AB00 |
| 1123 |
Administrative Practices and Procedures; Advisory Opinions and Guidelines
|
0910-AB14 |
| 1124 |
Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products (RegPlan Seq. No. 35)
|
0910-AB28 |
| 1125 |
Applications for FDA Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications
|
0910-AB34 |
| 1126 |
Expanded Access to Investigational Therapies
|
0910-AB37 |
| 1127 |
Electronic Submission of Adverse Drug Reaction Reports
|
0910-AB42 |
| 1128 |
Distinguishing Marks for Drug Products Containing Insulin
|
0910-AB43 |
| 1129 |
Pregnancy Labeling
|
0910-AB44 |
| 1130 |
Pharmacy and Physician Compounding of Drug Products (RegPlan Seq. No. 36)
|
0910-AB58 |
| 1131 |
Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness
|
0910-AB59 |
| 1132 |
Discontinuation of a Lifesaving Product
|
0910-AB60 |
| 1133 |
Positron Emission Tomography Drugs; Current Good Manufacturing Practices (RegPlan Seq. No. 37)
|
0910-AB63 |
| 1134 |
Current Good Manufacturing Practice for Medicated Feeds
|
0910-AB70 |
| 1135 |
CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV (Lookback) (RegPlan Seq. No. 38)
|
0910-AB76 |
| 1136 |
Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use
|
0910-AB79 |
| 1137 |
Stability Testing of Drugs
|
0910-AB82 |
| 1138 |
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements (RegPlan Seq. No. 39)
|
0910-AB88 |
| 1139 |
Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling Standards
|
0910-AB89 |
| 1140 |
Submission in Electronic Format of Certain Labeling Information
|
0910-AB91 |
| 1141 |
Fees Relating to Drugs; Waiver and Reduction of Fees
|
0910-AB92 |
| 1142 |
Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final Specifications
|
0910-AB93 |
| 1143 |
Marking Requirements for and Prohibitions on the Reimportation of Imported Food Products That Have Been Refused Admission into the United States
|
0910-AB95 |
| 1144 |
Requirements Pertaining to Sampling Services and Private Laboratories Used in Connection with Imported Food
|
0910-AB96 |
| 1145 |
Medical Devices, Medical Device Establishment Registration and Listing Requirements; Amendment
|
0910-AB99 |
| 1146 |
Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Gene Therapy or Xenotransplantation (RegPlan Seq. No. 40)
|
0910-AC00 |
| 1147 |
Reporting Information Regarding Potential Fabrication or Falsification
|
0910-AC02 |
| 1148 |
Examination of Administrative Record and Other Advisory Committee Records
|
0910-AC03 |
| 1149 |
Status Reports for Quantity Marketed Information for Animal Drug Products Used in Food-Producing Animals
|
0910-AC04 |
| 1150 |
Additional Safeguards for Children in Clinical Investigations
|
0910-AC07 |
| 1151 |
Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
|
0910-AC08 |
| 1152 |
Labeling Dietary Supplements for Women Who Are or May Become Pregnant
|
0910-AC09 |
| 1153 |
Overwrap For Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers
|
0910-AC10 |
| 1154 |
Revocation of Conditions for Marketing Digoxin Products for Oral Use
|
0910-AC12 |
| 1155 |
Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of ``No Residue''
|
0910-AC13 |
| 1156 |
Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (RegPlan Seq. No. 41)
|
0910-AC14 |
| 1157 |
Premarket Notice Concerning Bioengineered Foods (RegPlan Seq. No. 42)
|
0910-AC15 |
| Food and Drug Administration--Final Rule Stage | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1158 |
Over-the-Counter (OTC) Drug Review
|
0910-AA01 |
| 1159 |
New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA)
|
0910-AA02 |
| 1160 |
Biological Products: Reporting of Biological Product Deviations in Manufacturing
|
0910-AA12 |
| 1161 |
Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for Juices (RegPlan Seq. No. 43)
|
0910-AA43 |
| 1162 |
Bioavailability and Bioequivalence Requirements
|
0910-AA51 |
| 1163 |
Drugs Used for Treatment of Narcotic Addicts
|
0910-AA52 |
| 1164 |
Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest of Recipients
|
0910-AA89 |
| 1165 |
Current Good Manufacturing Practice; Revision of Certain Labeling Controls
|
0910-AA98 |
| 1166 |
Use of Ozone-Depleting Substances
|
0910-AA99 |
| 1167 |
Establishment Registration and Listing of Human Cells and Tissue (RegPlan Seq. No. 44)
|
0910-AB05 |
| 1168 |
Veterinary Feed Directives
|
0910-AB09 |
| 1169 |
Exports; Notification and Recordkeeping Requirements
|
0910-AB16 |
| 1170 |
Foreign Establishment Registration and Listing
|
0910-AB21 |
| 1171 |
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 Export
|
0910-AB24 |
| 1172 |
Blood Initiative
|
0910-AB26 |
| 1173 |
Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration Requirements
|
0910-AB30 |
| 1174 |
Antibiotic Drug Approval and Exclusivity
|
0910-AB33 |
| 1175 |
Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs
|
0910-AB39 |
| 1176 |
Supplements and Other Changes to Approved New Animal Drug Applications
|
0910-AB49 |
| 1177 |
Bulk Drug Substances for Use in Pharmacy Compounding
|
0910-AB57 |
| 1178 |
Supplements and Other Changes to an Approved Application
|
0910-AB61 |
| 1179 |
Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims
|
0910-AB66 |
| 1180 |
Presubmission Conferences
|
0910-AB68 |
| 1181 |
Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and Referrals for Other Administrative Action
|
0910-AB73 |
| 1182 |
Surgeon's and Patient Examination Gloves; Reclassification
|
0910-AB74 |
| 1183 |
180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications
|
0910-AB80 |
| 1184 |
Postmarketing Studies for Human Drugs and Licensed Biological Products: Status Reports
|
0910-AB83 |
| 1185 |
Food Additives: Food Contact Substances Notification System
|
0910-AB94 |
| 1186 |
State Certification of Mammography Facilities
|
0910-AB98 |
| 1187 |
Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons of Safety or Effectiveness
|
0910-AC01 |
| 1188 |
Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human Studies Are Unethical
|
0910-AC05 |
| 1189 |
Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity
|
0910-AC11 |
| Food and Drug Administration--Long-Term Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1190 |
Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports
|
0910-AA04 |
| 1191 |
Food Labeling Review
|
0910-AA19 |
| 1192 |
Medical Foods
|
0910-AA20 |
| 1193 |
Classification of Computer Software Programs That Are Medical Devices
|
0910-AA41 |
| 1194 |
Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished Pharmaceuticals
|
0910-AA45 |
| 1195 |
Reinventing FDA Food Regulations
|
0910-AA58 |
| 1196 |
Direct-to-Consumer Promotion Regulations
|
0910-AA90 |
| 1197 |
Investigational Use New Animal Drug Regulations (Section 610 Review)
|
0910-AB02 |
| 1198 |
Suitability Determination for Donors of Human Cellular and Tissue-Based Products
|
0910-AB27 |
| 1199 |
Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed
|
0910-AB50 |
| 1200 |
Revisions to the General Safety Requirements for Biological Products; Direct Final Rule
|
0910-AB51 |
| 1201 |
Mandatory HACCP Regulations for Manufacturers of Rendered Products
|
0910-AB72 |
| 1202 |
Antibiotic Resistance Labeling
|
0910-AB78 |
| 1203 |
Repackaging Approval Requirements
|
0910-AB81 |
| Food and Drug Administration--Completed Actions | ||
|---|---|---|
| Sequence Number | Title | Regulation Identifier Number |
| 1204 |
Debarment Certification Regulations for Drug Applications
|
0910-AA76 |
| 1205 |
Investigational New Drug Applications; Request for Information and Comments
|
0910-AA83 |
| 1206 |
Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening Illnesses
|
0910-AA84 |
| 1207 |
Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation
|
0910-AA88 |
| 1208 |
Classification of Sheep as a Minor Species for All Data Collection Purposes
|
0910-AB69 |
| 1209 |
Amendment of Various Device Regulations to Reflect Current American Society for Testing and Materials Citations
|
0910-AB84 |
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