Federal Register Notices
Federal Register notices issued by the Center for Veterinary Medicine.
2022 Notices
- 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New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability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of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Draft Guidance for Industry; Availability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
2021 Notices
- 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
2020 Notices
- Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
December 23, 2020; 85 FR 83968 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
December 21, 2020; 85 FR 83092 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
December 21, 2020; 85 FR 83091 - Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed
December 17, 2020; 85 FR 81930 - Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe Notices; Guidance for Industry; Availability
December 11, 2020; 85 FR 80120 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
December 2, 2020; 85 FR 77469 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
December 1, 2020; 85 FR 77223 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice for Nonclinical Laboratory Studies
December 1, 2020; 85 FR 77219 - In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products; Guidance for Industry; Availability
November 27, 2020; 85 FR 76085 - Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Extension of Comment Period
November 27, 2020; 85 FR 76081 - Ag Chem Resources, LLC; Filing of Food Additive Petition (Animal Use)
November 27, 2020; 85 FR 75971 - Elemental Impurities in Animal Drug Products-Questions and Answers; Guidance for Industry; Availability
November 23, 2020; 85 FR 74736 - Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
November 23, 2020; 85 FR 74732 - Documenting Electronic Data Files and Statistical Analysis Programs; Guidance for Industry; Availability
November 13, 2020; 85 FR 72671 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
November 12, 2020; 85 FR 71925 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
November 12, 2020; 85 FR 71922 - Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability; Extension of Comment Period
November 10, 2020; 85 FR 71659 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
November 4, 2020; 85 FR 70181 - Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Public Meeting; Request for Comments
October 13, 2020; 85 FR 64481 - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
September 22, 2020; 85 FR 59427 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
September 15, 2020; 85 FR 57220 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
August 31, 2020; 85 FR 53822 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)
August 20, 2020; 85 FR 51450 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys
August 20, 2020; 85 FR 51449 - Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine
August 18, 2020; 85 FR 50827 - Final Rule; Technical Amendment; Veterinary Feed Directive Drugs; Contact Information
August 18, 2020; 85 FR 50783 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys
August 17, 2020; 85 FR 50030 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
August 13, 2020; 85 FR 49381 - Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
August 12, 2020; 85 FR 48650 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
August 11, 2020; 85 FR 48542 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method; Correction
August 6, 2020; 85 FR 47798 - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Establishing and Maintaining a List of Manufacturers/Processors of Feed Additives, Premixes, Compound Feed, Distillers’ Dried Grains, and Distillers' Dried Grains with Solubles for Use with Animals with Interest in Exporting to The People's Republic of China
August 6, 2020; 85 FR 47796 - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extralabel Drug Use in Animals
August 6, 2020; 85 FR 47794 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021
August 3, 2020; 85 FR 46669 - Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2021
August 3, 2020; 85 FR 46666 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2021
August 3, 2020; 85 FR 46659 - Proposed Rule; Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices
August 3, 2020; 85 FR 46566 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2021
August 3, 2020; 85 FR 46647 - Guidance Documents Related to Coronavirus Disease 2019; Availability
August 3, 2020; 85 FR 46641 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2021
August 3, 2020; 85 FR 46635 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
July 30, 2020; 85 FR 45888 - Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
July 29, 2020; 85 FR 45505 - New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application
July 28, 2020; 85 FR 45311 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
July 28, 2020; 85 FR 45306 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
July 24, 2020; 85 FR 44905 - Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice for Non-Clinical Laboratory Studies
July 24, 2020; 85 FR 44900 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method
July 20, 2020; 85 FR 43853 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Withdrawal of Notice of Opportunity for Hearing
July 20, 2020; 85 FR 43852 - Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs; Draft Guidance for Industry; Availability
July 15, 2020; 85 FR 42887 - Use of Real-World Data and Real-World Evidence To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability
July 15, 2020; 85 FR 42880 - Biomarkers and Surrogate Endpoints in Clinical Studies To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability
July 15, 2020; 85 FR 42879 - Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability
July 15, 2020; 85 FR 42876 - Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability
July 15, 2020; 85 FR 42867 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
July 10, 2020; 85 FR 41596 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
July 10, 2020; 85 FR 41594 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
July 10, 2020; 85 FR 41591 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products
July 7, 2020; 85 FR 40655 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
July 6, 2020; 85 FR 40299 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
July 2, 2020; 85 FR 39917 - Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
June 26, 2020; 85 FR 38372 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Qualified Importer Program
June 12, 2020; 85 FR 35937 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Extension of Comment Period
June 12, 2020; 85 FR 35936 - Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide
June 2, 2020; 85 FR 33538 - Notice of Availability of Guidance for Industry; Proprietary Names for New Animal Drugs
June 1, 2020; 85 FR 33162 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food
May 20, 2020; 85 FR 30713 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Practice and Procedures
May 15, 2020; 85 FR 29459 - Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
May 14, 2020; 85 FR 28951 - Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay
May 14, 2020; 85 FR 28898 - Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
May 12, 2020; 85 FR 28010 - Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)
May 11, 2020; 85 FR 27692 - Biomin GmbH; Filing of Food Additive Petition (Animal Use)
May 6, 2020; 85 FR 26902 - Notice of Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
April 30, 2020; 85 FR 23969 - Notice of Availability of Guidance for Industry; Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency
April 30, 2020; 85 FR 23919 - Notice of Availability of Draft Guidance for Industry; Standardized Medicated Feed Assay Limits; Extension of Comment Period
April 27, 2020; 85 FR 23369 - Notice of Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries
April 24, 2020; 85 FR 23048 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Manufacturers/Processors of Feed Additives, Premixes, Compound Feed, Distillers' Dried Grains, and Distillers' Dried Grains With Solubles for Use With Animals With Interest in Exporting to The People's Republic of China
April 16, 2020; 85 FR 21242 - Notice of Availability of Guidance for Industry; International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
April 14, 2020; 85 FR 20693 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
April 7, 2020; 85 FR 19489 - Proposed Rule; Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
April 6, 2020; 85 FR 19114 - Notice of 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
April 3, 2020; 85 FR 18995 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
April 3, 2020; 85 FR 18989 - Notice of Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
April 3, 2020; 85 FR 18984 - Notification of Withdrawal; New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
April 1, 2020; 85 FR 18125 - Final Rule; Technical Amendments; New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses
April 1, 2020; 85 FR 18114 - Notice of Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
March 30, 2020; 85 FR 17583 - Notice of Availability; Temporary Policy Regarding Preventive Controls and Foreign Supplier Verification Programs Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry
March 26, 2020; 85 FR 17008 - Process for Making Available Guidance Documents Related to Coronavirus Disease 2019
March 25, 2020; 85 FR 16949 - Notice of Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
March 17, 2020; 85 FR 15187 - Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
March 13, 2020; 85 FR 14565 - Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Notice of Reopening of the Comment Period
March 11, 2020; 85 FR 14206 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
March 4, 2020; 85 FR 12790 - Proposed Rule; Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
February 28, 2020; 85 FR 11893 - Notice of Availability of Draft Guidance for Industry; Standardized Medicated Feed Assay Limits
February 27, 2020; 85 FR 11369 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
February 21, 2020; 85 FR 10170 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Reopening of Comment Period
February 20, 2020; 85 FR 9783 - Notice of Availability of Draft Guidance for Industry; Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe Notices
February 13, 2020; 85 FR 8297 - Notification of Filing of Food Additive Petition (Animal Use); LANXESS Corporation
February 11, 2020; 85 FR 7682 - Notice of 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
February 10, 2020; 85 FR 7564 - Notice of 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 6, 2020; 85 FR 6955 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys
February 5, 2020; 85 FR 6559 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer Program
February 5, 2020; 85 FR 6556 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications
January 24, 2020; 85 FR 4210 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor's Address
January 24, 2020; 85 FR 4204 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
January 23, 2020; 85 FR 3929 - Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
January 21, 2020; 85 FR 3389 - Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Extension of Comment Period
January 8, 2020; 85 FR 921 - Alaco, Inc., et al.; Proposal To Withdraw Approval of Seven New Animal Drug Applications; Opportunity for a Hearing
January 8, 2020; 85 FR 919 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards
January 8, 2020; 85 FR 907 - Notice of Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
January 7, 2020; 85 FR 714