Federal Register Notices
Federal Register notices issued by the Center for Veterinary Medicine.
2023 Notices
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Federal-State Food Regulatory Program Standards
April 28, 2023; 88 FR 26320 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
April 28, 2023; 88 FR 26318 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
April 27, 2023; 88 FR 25658 - Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Satisfaction Surveys
April 25, 2023; 88 FR 24992 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys
April 20, 2023; 88 FR 24423 - Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration
April 11, 2023; 88 FR 21680 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
April 11, 2023; 88 FR 21679 - Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
April 10, 2023; 88 FR 21195 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
April 10, 2023; 88 FR 21193 - Human User Safety in New and Abbreviated New Animal Drug Applications; Draft Guidance for Industry; Availability
April 5, 2023; 88 FR 20170 - Infectious Otitis Externa Drugs for Topical Use in Dogs; Draft Guidance for Industry; Availability
March 31, 2023; 88 FR 19312 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
March 21, 2023; 88 FR 16990 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
March 20, 2023; 88 FR 16543 - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Draft Guidance for Industry; Availability
March 16, 2023; 88 FR 16268 - The Use of Published Literature in Support of New Animal Drug Approvals; Guidance for Industry; Availability
March 16, 2023; 88 FR 16267 - Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)
March 13, 2023; 88 FR 15417 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address
March 10, 2023; 88 FR 14893 - Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability; Extension of Comment Period
March 7, 2023; 88 FR 14170 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
February 27, 2023; 88 FR 12366 - Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings
February 7, 2023; 88 FR 7981 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
February 6, 2023; 88 FR 7741 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
January 31, 2023; 88 FR 6281 - Practices To Prevent Unsafe Contamination of Animal Feed From Drug Carryover; Guidance for Industry; Availability
January 30, 2023; 88 FR 5896 - Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability; Extension of Comment Period
January 20, 2023; 88 FR 3743 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry; Availability
January 11, 2023; 88 FR 1503 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
January 6, 2023; 88 FR 1076
- Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
December 22, 2022; 87 FR 78694 - Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
December 22, 2022; 87 FR 78687 - Enforcement Policy Regarding Federal Veterinarian-Client-Patient Relationship Requirements To Facilitate Veterinary Telemedicine During the COVID-19 Outbreak; Withdrawal of Guidance
December 21, 2022; 87 FR 78111 - Best Practices for Convening a GRAS Panel; Guidance for Industry; Availability
December 21, 2022; 87 FR 77983 - Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability
December 19, 2022; 87 FR 77619 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
December 15, 2022; 87 FR 76630 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
December 15, 2022; 87 FR 76628 - Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Confirmation of Effective Date
December 14, 2022; 87 FR 76425 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
December 14, 2022; 87 FR 76418 - Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability
November 30, 2022; 87 FR 73560 - Animal Drug User Fee Act; Public Meeting; Request for Comments
November 21, 2022; 87 FR 70833 - Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability; Request for Comments
November 17, 2022; 87 FR 69032 - Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Public Meeting; Request for Comments
November 17, 2022; 87 FR 69030 - Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
November 7, 2022; 87 FR 67040 - Agency Information Collection Activities; Proposed Collection; Comment Request; Federal-State Food Regulatory Program Standards
November 3, 2022; 87 FR 66307 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Supply-Chain Programs and Onsite Audits; Announcement of Effective Date
October 31, 2022; 87 FR 65527 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Best Practices for Convening a Generally Recognized as Safe Panel
October 27, 2022; 87 FR 65081 - Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry; Availability
October 21, 2022; 87 FR 64054 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
October 20, 2022; 87 FR 63786 - Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Guidance for Industry; Availability
October 20, 2022; 87 FR 63784 - Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Guidance for Industry; Availability
October 20, 2022; 87 FR 63783 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments; Extension of Comment Period
October 20, 2022; 87 FR 63782 - Laboratory Accreditation for Analyses of Foods; Small Entity Compliance Guide; Availability
October 20, 2022; 87 FR 63686 - Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds; Guidance for Industry; Availability
October 19, 2022; 87 FR 63501 - Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices
October 18, 2022; 87 FR 62977 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
October 7, 2022; 87 FR 61090 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
September 30, 2022; 87 FR 59441 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address
September 29, 2022; 87 FR 58957 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Abbreviated New Animal Drug Applications
September 22, 2022; 87 FR 57905 - Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Notice
September 15, 2022; 87 FR 56681 - Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Proposed Rule
September 15, 2022; 87 FR 56604 - Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Direct Final Rule
September 15, 2022; 87 FR 56583 - Prior Notice of Imported Food Questions and Answers (Edition 4); Draft Guidance for Industry; Availability
September 13, 2022; 87 FR 55932 - Public Information
September 13, 2022; 87 FR 55907 - Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
August 29, 2022; 87 FR 52681 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
August 24, 2022; 87 FR 51995 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
August 22, 2022; 87 FR 51435 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Caprines (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49864 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49861 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49860 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Ovines (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49858 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus gallus (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49857 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; “Effectiveness of Anthelmintics: Specific Recommendations for Felines (Revision 1)”; Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49855 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; “Effectiveness of Anthelmintics: Specific Recommendations for Equines (Revision 1)”; Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49854 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49853 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines (Revision 1); Draft Guidance for Industry; Availability
August 12, 2022; 87 FR 49851 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
August 11, 2022; 87 FR 49596 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
August 10, 2022; 87 FR 48677 - Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
August 10, 2022; 87 FR 48665 - Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
August 3, 2022; 87 FR 47343 - Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
August 1, 2022; 87 FR 46961 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2023
July 28, 2022; 87 FR 45339 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023
July 28, 2022; 87 FR 45331 - Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2023
July 28, 2022; 87 FR 45328 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2023
July 28, 2022; 87 FR 45323 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2023
July 28, 2022; 87 FR 45319 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities
July 27, 2022; 87 FR 45112 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
July 25, 2022; 87 FR 44122 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2); Draft Guidance for Industry; Availability
July 18, 2022; 87 FR 42728 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry; Availability
July 8, 2022; 87 FR 40846 - Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
July 7, 2022; 87 FR 40537 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
July 6, 2022; 87 FR 40256 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
June 17, 2022; 87 FR 36514 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of Human and Animal Food
June 15, 2022; 87 FR 36133 - Antimicrobial Drug Use in Companion Animals; Extension of Comment Period
June 13, 2022; 87 FR 35790 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
June 8, 2022; 87 FR 34882 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug Applications and Veterinary Master Files
June 8, 2022; 87 FR 34880 - Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
May 23, 2022; 87 FR 31302 - Practices To Prevent Unsafe Contamination of Animal Feed From Drug Carryover; Draft Guidance for Industry; Availability
May 10, 2022; 87 FR 28018 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
May 5, 2022; 87 FR 26764 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
May 3, 2022; 87 FR 26210 - The Accredited Third-Party Certification Program: Questions and Answers; Draft Guidance for Industry; Availability
April 29, 2022; 87 FR 25432 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Notification and Recordkeeping Requirements
April 25, 2022; 87 FR 24321 - The Use of Published Literature in Support of New Animal Drug Applications; Draft Guidance for Industry; Availability
April 20, 2022; 87 FR 23523 - Lists of Bulk Drug Substances for Compounding: Office Stock Drugs for Use in Nonfood-Producing Animals or Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species; Request for Nominations
April 14, 2022; 87 FR 22222 - Compounding Animal Drugs From Bulk Drug Substances; Guidance for Industry; Availability
April 14, 2022; 87 FR 22212 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers
April 11, 2022; 87 FR 21126 - Anitox Corporation; Filing of Food Additive Petition (Animal Use)
April 11, 2022; 87 FR 21069 - Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid
April 11, 2022; 87 FR 21018 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
April 7, 2022; 87 FR 20432 - Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments; Extension of Comment Period
March 31, 2022; 87 FR 18750 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
March 29, 2022; 87 FR 17942 - Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
March 18, 2022; 87 FR 15436 - Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry; Availability
March 14, 2022; 87 FR 14169 - Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
March 4, 2022; 87 FR 12401 - Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds; Draft Guidance for Industry; Availability
March 2, 2022; 87 FR 11719 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Veterinary Master Files
March 2, 2022; 87 FR 11713 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
February 28, 2022; 87 FR 11079 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
February 28, 2022; 87 FR 10964 - Agency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal Food
February 24, 2022; 87 FR 10369 - Antimicrobial Drug Use in Companion Animals; Request for Comments
February 16, 2022; 87 FR 8848 - Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications
February 16, 2022; 87 FR 8846 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
February 7, 2022; 87 FR 6872 - Laboratory Accreditation for Analyses of Foods; Correction
February 2, 2022; 87 FR 5660 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
January 28, 2022; 87 FR 4626 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
January 28, 2022; 87 FR 4625 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
January 28, 2022; 87 FR 4620 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels
January 28, 2022; 87 FR 4614 - Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers
January 28, 2022; 87 FR 4607 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exports Notification and Recordkeeping Requirements
January 25, 2022; 87 FR 3811 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities
January 13, 2022; 87 FR 2159 - Scientific Data and Information Related to the Residue of Carcinogenic Concern for the New Animal Drug Carbadox; Public Hearing; Request for Comments
January 13, 2022; 87 FR 2093
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
December 30, 2021; 86 FR 74417 - Laboratory Accreditation for Analyses of Foods; Final Rule
December 3, 2021; 86 FR 68728 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
November 19, 2021; 86 FR 64943 - Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
November 9, 2021; 86 FR 62178 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address
November 8, 2021; 86 FR 61682 - Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance
November 5, 2021; 86 FR 61279 - Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
November 1, 2021; 86 FR 60249 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
October 20, 2021; 86 FR 57992 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels
October 8, 2021; 86 FR 56277 - Use of Real-World Data and Real-World Evidence To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
October 6, 2021; 86 FR 55623 - Biomarkers and Surrogate Endpoints in Clinical Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
October 6, 2021; 86 FR 55619 - Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs; Guidance for Industry; Availability
October 6, 2021; 86 FR 55617 - Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability
October 6, 2021; 86 FR 55616 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
October 1, 2021; 86 FR 54457 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards
October 1, 2021; 86 FR 54454 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
October 1, 2021; 86 FR 54453 - Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
September 23, 2021; 86 FR 52912 - Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability
September 23, 2021; 86 FR 52911 - Import Tolerances for Residues of Unapproved New Animal Drugs in Food
September 21, 2021; 86 FR 52401 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
September 9, 2021; 86 FR 50544 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
September 3, 2021; 86 FR 49543 - Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments; Extension of Comment Period
August 26, 2021; 86 FR 47647 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
August 25, 2021; 86 FR 47501 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2022
July 28, 2021; 86 FR 40595 - Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2022
July 28, 2021; 86 FR 40580 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2022
July 28, 2021; 86 FR 40575 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022
July 28, 2021; 86 FR 40571 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2022
July 23, 2021; 86 FR 39028 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Guidance for Industry; Availability
July 14, 2021; 86 FR 37159 - Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
July 14, 2021; 86 FR 37037 - Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue
July 14, 2021; 86 FR 37035 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
July 9, 2021; 86 FR 36284 - Biomin Holding GmbH; Filing of Food Additive Petition (Animal Use)
July 7, 2021; 86 FR 35806 - Eligibility for the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Request for Comments
June 24, 2021; 86 FR 33303 - Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments
June 15, 2021; 86 FR 31720 - Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available as Over-the-Counter; Guidance for Industry; Availability
June 11, 2021; 86 FR 31317 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use
June 10, 2021; 86 FR 30953 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
June 10, 2021; 86 FR 30952 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered To Be Soluble in Aqueous Media; Guidance for Industry; Availability
May 21, 2021; 86 FR 27633 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
May 19, 2021; 86 FR 27092 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
May 14, 2021; 86 FR 26532 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards
May 14, 2021; 86 FR 26528 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
May 10, 2021; 86 FR 24867 - Canadian Oilseed Processors Association; Withdrawal of Food Additive Petition (Animal Use)
May 7, 2021; 86 FR 24564 - Ag Chem Resources, LLC; Filing of Food Additive Petition (Animal Use); Correction
April 26, 2021; 86 FR 21984 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
April 13, 2021; 86 FR 19270 - Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
April 12, 2021; 86 FR 18991 - Animal Drug User Fee Act; Public Meeting; Request for Comments
April 12, 2021; 86 FR 18989 - Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Reopening of the Comment Period
April 12, 2021; 86 FR 18988 - Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
April 12, 2021; 86 FR 18987 - Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
April 12, 2021; 86 FR 18986 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
April 9, 2021; 86 FR 18543 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
April 1, 2021; 86 FR 17156 - New Animal Drugs; Approval of New Animal Drug Applications
April 1, 2021; 86 FR 17061 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections
April 1, 2021; 86 FR 17061 - Electronic Import Entries; Technical Amendments
April 1, 2021; 86 FR 17059 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
March 26, 2021; 86 FR 16221 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address
March 19, 2021; 86 FR 14815 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
March 16, 2021; 86 FR 14436 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
March 8, 2021; 86 FR 13181 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
March 4, 2021; 86 FR 12690 - Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper; Request for Comments; Extension of Comment Period
February 23, 2021; 86 FR 10979 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
February 23, 2021; 86 FR 10819 - New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and Toluene; Orgotein for Injection; Tetracycline Tablets; Final Rule; Technical Amendment
February 23, 2021; 86 FR 10818 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine
February 22, 2021; 86 FR 10581 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
January 13, 2021; 86 FR 2674 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
January 13, 2021; 86 FR 2673 - Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper; Request for Comments
January 11, 2021; 86 FR 1979 - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Recall Regulations
January 8, 2021; 86 FR 1508 - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Participation in the Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
January 8, 2021; 86 FR 1504