Federal Register Notices
Federal Register notices issued by the Center for Veterinary Medicine.
2025 Notices
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
January 21, 2025; 90 FR 6797 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
January 17, 2025; 90 FR 5900 - Use of Cannabis-Derived Products, Including Cannabidiol, in Veterinary Practice; Request for Information
January 16, 2025; 90 FR 4746 - National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments
January 10, 2025; 90 FR 2007 - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request
January 7, 2025; 90 FR 1157 - Heritable Intentional Genomic Alterations in Animals: The Approval Process; Guidance for Industry; Availability
January 7, 2025; 90 FR 1156 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease; Draft Guidance for Industry; Availability
January 7, 2025; 90 FR 1144 - Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability
January 7, 2025; 90 FR 1143 - Food and Drug Administration Animal Food Ingredient Consultation; Guidance for Industry; Availability
January 7, 2025; 90 FR 1138 - Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
January 6, 2025; 90 FR 563
- Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files
December 30, 2024; 89 FR 106493 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels
December 19, 2024; 89 FR 103838 - Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availability
December 4, 2024; 89 FR 96263 - Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability
December 3, 2024; 89 FR 95799 - Food and Drug Administration's Best Practices for Food and Drug Administration Communication With Interested Parties: Draft Report for Public Comment; Availability
December 3, 2024; 89 FR 95798 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
December 2, 2024; 89 FR 95101 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
November 29, 2024; 89 FR 94740 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
October 28, 2024; 89 FR 85423 - 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 Animal Food
October 24, 2024; 89 FR 84895 - Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution
October 24, 2024; 89 FR 84887 - Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability
October 24, 2024; 89 FR 84819 - Linde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
October 18, 2024; 89 FR 83883 - Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food; Guidance for Industry; Availability
October 15, 2024; 89 FR 83017 - Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability
October 2, 2024; 89 FR 80255 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
October 1, 2024; 89 FR 79930 - Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Availability
September 30, 2024; 89 FR 79623 - Statement of Organization, Functions, and Delegations of Authority
September 30, 2024; 89 FR 79622 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Draft Guidance for Industry; Availability
September 30, 2024; 89 FR 79614 - Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability
September 17, 2024; 89 FR 76117 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
September 6, 2024; 89 FR 72854 - Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast
September 5, 2024; 89 FR 72315 - Food Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Whey
August 22, 2024; 89 FR 67856 - Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability
August 9, 2024; 89 FR 65368 - Pre-Market Animal Food Ingredient Review Programs; Request for Comments
August 9, 2024; 89 FR 65363 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
August 9, 2024; 89 FR 65362 - Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Guidance for Industry; Availability
August 9, 2024; 89 FR 65294 - Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025
July 31, 2024; 89 FR 61465 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025
July 31, 2024; 89 FR 61459 - 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); Guidance for Industry; Availability
July 25, 2024; 89 FR 60433 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use
July 9, 2024; 89 FR 56385 - Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Guidance for Industry; Availability
June 26, 2024; 89 FR 53428 - Priority Zoonotic Animal Drug Designation and Review Process; Guidance for Industry; Availability
June 26, 2024; 89 FR 53427 - Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availability
June 24, 2024; 89 FR 52470 - Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry; Availability
June 24, 2024; 89 FR 52468 - Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection; Guidance for Industry, Revision 1; Availability
June 21, 2024; 89 FR 52062 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
June 21, 2024; 89 FR 52060 - Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Guidance for Industry; Availability
June 21, 2024; 89 FR 52058 - Human User Safety in New and Abbreviated New Animal Drug Applications; Guidance for Industry; Availability
June 21, 2024; 89 FR 52053 - Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address
June 21, 2024; 89 FR 51966 - Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
June 18, 2024; 89 FR 51738 - First Annual Animal Drug User Fee Educational Conference; Public Meeting
June 18, 2024; 89 FR 51531 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Correction
June 17, 2024; 89 FR 51352 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
June 17, 2024; 89 FR 51351 - Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose
June 7, 2024; 89 FR 48507 - 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
June 5, 2024; 89 FR 48172 - Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation
June 3, 2024; 89 FR 47463 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1); Draft Guidance for Industry; Availability
May 23, 2024; 89 FR 45663 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
May 22, 2024; 89 FR 44996 - Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period
May 22, 2024; 89 FR 44944 - Program Policy and Procedures Manual Guide 1240.3605 Regulating Animal Foods With Drug Claims; Withdrawal
May 20, 2024; 89 FR 43857 - Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
May 15, 2024; 89 FR 42361 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
May 15, 2024; 89 FR 42354 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Pharmaceutical Development; Draft Guidance for Industry; Availability
May 6, 2024; 89 FR 37230 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
May 2, 2024; 89 FR 35838 - Heritable Intentional Genomic Alterations in Animals: The Approval Process; Draft Guidance for Industry; Availability
May 2, 2024; 89 FR 35834 - Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach; Guidance for Industry; Availability
May 2, 2024; 89 FR 35832 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
April 30, 2024; 89 FR 34256 - Raw Data for Safety and Effectiveness Studies; Draft Guidance for Industry; Availability
April 29, 2024; 89 FR 33371 - Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Guidance for Industry (Revised); Availability
April 29, 2024; 89 FR 33366 - Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product
April 29, 2024; 89 FR 33230 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms
April 26, 2024; 89 FR 32445 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Records: Electronic Signatures
April 26, 2024; 89 FR 32439 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed
March 27, 2024; 89 FR 21257 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
March 26, 2024; 89 FR 20986 - Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
March 21, 2024; 89 FR 20218 - Manufacture of Batches in Support of Original New Animal Drug Applications, Abbreviated New Animal Drug Applications, and Conditional New Animal Drug Applications; Draft Guidance for Industry; Availability
March 18, 2024; 89 FR 19326 - Labeling Requirements for Approved or Conditionally Approved New Animal Drugs
March 12, 2024; 89 FR 18262 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
February 29, 2024; 89 FR 14882 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
February 27, 2024; 89 FR 14407 - Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
February 6, 2024; 89 FR 8208 - Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
January 30, 2024; 89 FR 5767 - Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability
January 26, 2024; 89 FR 5244 - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability
January 25, 2024; 89 FR 4956 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
January 11, 2024; 89 FR 1921 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
January 9, 2024; 89 FR 1100 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
January 9, 2024; 89 FR 1099 - Food and Drug Administration's Draft Report and Plan on Best Practices for Guidance; Availability
January 3, 2024; 89 FR 380
- Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Chromium Propionate; Correction
December 27, 2023; 88 FR 89460 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
December 22, 2023; 88 FR 88635 - Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Guidance for Industry; Availability
December 22, 2023; 88 FR 88634 - Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate
December 19, 2023; 88 FR 87670 - Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability
December 18, 2023; 88 FR 87433 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
December 6, 2023; 88 FR 84696 - Using Relative Supersaturation To Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability
November 30, 2023; 88 FR 83552 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
November 27, 2023; 88 FR 82906 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualitative Feedback on Agency Service Delivery
November 27, 2023; 88 FR 82905 - Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Extension of the Comment Period
November 24, 2023; 88 FR 82384 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method
November 7, 2023; 88 FR 76760 - Phibro Animal Health Corp.; Proposal To Withdraw Approval of New Animal Drug Applications for Carbadox in Medicated Swine Feed; Opportunity for a Hearing
November 7, 2023; 88 FR 76756 - Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
November 1, 2023; 88 FR 74939 - Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Availability
October 26, 2023; 88 FR 73602 - Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
October 25, 2023; 88 FR 73349 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Standardized Reporting Forms for Food and Drug Administration Federally Funded Public Health Projects and Agreements
October 25, 2023; 88 FR 73347 - Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
October 24, 2023; 88 FR 73031 - Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024
October 23, 2023; 88 FR 72767 - Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024
October 23, 2023; 88 FR 72763 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
October 20, 2023; 88 FR 72486 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration
October 19, 2023; 88 FR 72083 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
October 18, 2023; 88 FR 71876 - Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability
October 13, 2023; 88 FR 70887 - Agency Information Collection Activities; Proposed Collection; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed
October 12, 2023; 88 FR 70676 - 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
October 12, 2023; 88 FR 70663 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
October 11, 2023; 88 FR 70422 - Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
September 26, 2023; 88 FR 66009 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
September 19, 2023; 88 FR 64441 - Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals; Draft Guidance for Industry; Availability
September 15, 2023; 88 FR 63586 - Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
August 31, 2023; 88 FR 60213 - Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine
August 31, 2023; 88 FR 60212 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys
August 31, 2023; 88 FR 60211 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Satisfaction Surveys
August 30, 2023; 88 FR 59928 - Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability; Reopening of the Comment Period
August 16, 2023; 88 FR 55702 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
August 16, 2023; 88 FR 55559 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug and Animal Generic Drug User Fee Submissions
August 11, 2023; 88 FR 54620 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Qualified Importer Program
August 10, 2023; 88 FR 54322 - 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
August 8, 2023; 88 FR 53500 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
August 3, 2023; 88 FR 51326 - Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2024
July 28, 2023; 88 FR 48893 - Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2024
July 28, 2023; 88 FR 48889 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2024
July 28, 2023; 88 FR 48861 - Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
July 27, 2023; 88 FR 48406 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
July 21, 2023; 87 FR 47151 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
July 21, 2023; 87 FR 47147 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
June 30, 2023; 88 FR 42374 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
June 29, 2023; 88 FR 42080 - Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Guidance for Industry; Availability
June 28, 2023; 88 FR 41966 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries
June 28, 2023; 88 FR 41964 - Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
June 27, 2023; 88 FR 41541 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
June 12, 2023; 88 FR 38058 - Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability
June 8, 2023; 88 FR 37551 - Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
May 22, 2023; 88 FR 32775 - Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer Program
May 11, 2023; 88 FR 30315 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
May 4, 2023; 88 FR 28562 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
May 3, 2023; 88 FR 27693 - 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