Federal Register Notices
Federal Register notices issued by the Center for Veterinary Medicine.
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2017 Notices
- Notification of Withdrawal of New Animal Drug Application
July 12, 2017; 82 FR 32188 Notice of Agency Information Collection Activities; Announcement of OMB Approvals
July 3, 2017; 82 FR 30875Waivers from Requirements of the Sanitary Transportation of Human and Animal Food Rule; Correction
July 3, 2017; 82 FR 30730Notice of Agency Information Collection Activities; Extralabel Drug Use in Animals
June 26, 2017; 82 FR 28858- Notice of Agency Information Collection Activities; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
June 20, 2017; 82 FR 28069 Notice of Agency Information Collection Activities; Animal Generic Drug User Fee Act Cover Sheet
June 15, 2017; 82 FR 27512Notice of Agency Information Collection Activities; Recordkeeping and Records Access Requirements for Food Facilities
June 14, 2017; 82 FR 27263Notice of Agency Information Collection Activities; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
June 7, 2017; 82 FR 26489Notice of Filing of Food Additive Petition (Animal Use); BASF Corp.
May 30, 2017; 82 FR 24611Notice of Agency Information Collection Activities; Announcement of OMB Approvals
May 25, 2017; 82 FR 24130Notification of Withdrawal of Approval of New Animal Drug Application 009-505
May 10, 2017; 82 FR 21694Final Rule; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsorship
May 10, 2017; 82 FR 21688Notice of Agency Information Collection Activities; Certification of Identity for Freedom of Information Act and Privacy Act Requests
April 25, 2017; 82 FR 19049Notice of Agency Information Collection Activities; Focus Groups as Used by the FDA (All FDA-Regulated Products)
April 21, 2017; 82 FR 18763Notice of Agency Information Collection Activities; Tracking Network for PETNet, LivestockNet, and SampleNet
April 18, 2017; 82 FR 18293Notice of Filing of Food Additive Petition (Animal Use); Canadian Oilseed Processor Association
April 18, 2017; 82 FR 18268Notice of Extension of Comment Period; Regulation of Intentionally Altered Genomic DNA in Animals
April 13, 2017; 82 FR 17844Notice of Extension of Comment Period; Genome Editing in New Plant Varieties Used for Foods
April 13, 2017; 82 FR 17840Notification of Waivers from Requirements of the Sanitary Transportation of Human and Animal Food Rule
April 6, 2017; 82 FR 16733Final Rule; Technical Amendment; Requirements to Submit Prior Notice of Imported Food
March 30, 2017; 60 FR 15627Notification of Withdrawal of New Animal Drug Application
March 1, 2017; 82 FR 12170Final Rule; Technical Amendment; New Animal Drugs
March 1, 2017; 82 FR 12167Final Rule; Technical Amendment; New Animal Drugs for Use in Animal Feed
February 24, 2017; 82 FR 11510Notification of Withdrawal of Approval of New Animal Drug Applications
February 24, 2017; 82 FR 11509Notification of Withdrawal of Approval of New Animal Drug Application (ANADA 200-524)
February 24, 2017; 82 FR 11509Final Rule; Technical Amendment; New Animal Drugs
February 24, 2017; 82 FR 11506Notice of Availability of Draft Guidance for Industry; Regulation of Mosquito-Related Products
January 19, 2017; 82 FR 6574Notice of Availability of Draft Guidance for Industry; Regulation of Intentionally Altered Genomic DNA in Animals
January 19, 2017; 82 FR 6561Notice of Public Hearing; Strategic Partnerships to Enhance the Safety of Imported Foods
January 17, 2017; 82 FR 4896Notice of Agency Information Collection Activities; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
January 5, 2017; 82 FR 1349Notice of Availability of Draft Guidance for Industry; Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods
January 5, 2017; 82 FR 1342Notice of Availability of Draft Guidance for Industry; In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products
January 4, 2017; 82 FR 851
2016 Notices
Notice of Filing of Food Additive Petition (Animal Use); Reopening of Comment Period; Novus International, Inc.
December 30, 2016; 81 FR 96405Notification of Availability; Questions and Answers Regarding Food Facility Registration (Seventh Edition)
December 27, 2016; 81 FR 95068Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
December 27, 2016; 81 FR 95026Notification of Withdrawal of Approval of New Animal Drug Applications
December 27, 2016; 81 FR 95025Final Rule; New Animal Drugs for Use in Animal Feed; Technical Amendment
December 27, 2016; 81 FR 94991Final Rule; Oral Dosage Form New Animal Drugs; Technical Amendment
December 27, 2016; 81 FR 94987Notice of Agency Information Collection Activities; Reporting Associated with Designated New Animal Drugs for Minor Use and Minor Species
December 22, 2016; 81 FR 93941Notice of Agency Information Collection Activities; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
December 21, 2016; 81 FR 93689Notice of Availability of Guidance for Industry; Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
December 20, 2016; 81 FR 92834Notice of Agency Information Collection Activities; OMB Approvals
December 19, 2016; 81 FR 91939Notice of Availability of Guidance for Industry; Bioequivalence: Blood Level Bioequivalence Study
December 16, 2016; 81 FR 91179Notice of FSMA Third-Party Certification Program User Fee Rate for Fiscal Year 2017
December 14, 2016; 81 FR 90363Notice of Agency Information Collection Activities; Announcement of OMB Approvals
December 14, 2016; 81 FR 90363Final Rule; Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications to Provide for the User Fee Program
December 14, 2016; 81 FR 90186Notice of Agency Information Collection Activities; Animal Feed Regulatory Program Standards
December 13, 2016; 81 FR 89947Final Rule; Correction; Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Animal Drugs
December 13, 2016; 81 FR 89848Notice of Availability of Guidance for Industry; Third-Party Certification Body Accreditation for Food Safety Audits
December 7, 2016; 81 FR 88099Notice of Availability of Compliance Policy Guide 615.115 on Extralabel Use of Medicated Feeds for Minor Species
December 5, 2016; 81 FR 87566Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
November 30, 2016; 81 FR 86268Notice of Extension of Comment Period; Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
November 29, 2016; 81 FR 85977Notice of Filing of Food Additive Petition (Animal Use); Novus International, Inc.; Correction
November 29, 2016; 81 FR 85972Direct Final Rule; New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date
November 29, 2016; 81 FR 85873Notice of Availability of Report of CVM Working Group on the Regulation of ADAA Combination Drug Medicated Feeds
November 21, 2016; 81 FR 83244Notice of Availability of Guidance for Industry; Voluntary Qualified Importer Program
November 14, 2016; 81 FR 79502Notice of Filing of Food Additive Petition (Animal Use); Novus International, Inc.
November 8, 2016; 81 FR 78528Notice of Availability of Draft Guidance for Industry; Questions and Answers Regarding Food Facility Registration (Seventh Edition)
November 8, 2016; 81 FR 78526Notice of Availability of Draft Revised Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
November 2, 2016; 81 FR 76360Notice of Availability; Small Entity Compliance Guide; What You Need to Know About the FDA Regulation: CGMP, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
November 1, 2016; 81 FR 75693Notice of Availability of Guidance for Industry; Describing a Hazard that Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA FSMA
October 31, 2016; 81 FR 75349Proposed Rule; New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
October 28, 2016; 81 FR 74962Notice of Agency Information Collection Activities; Animal Drug User Fee Cover Sheet
October 21, 2016; 81 FR 72810Notice of Agency Information Collection Activities; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
October 17, 2016;81 FR 71513Notice of Agency Information Collection Activities; Current Good Manufacturing Practice Regulations for Medicated Feeds
October 17, 2016; 81 FR 71508Notice of Agency Information Collection Activities; Animal Drug User Fee Act Waivers and Reductions
October 17, 2016; 81 FR 71506Notice of Agency Information Collection Activities; Guidance for Industry on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway
October 4, 2016; 81 FR 68434Notice of Filing of Food Additive Petition (Animal Use); BASF Corp.
September 30, 2016; 81 FR 67260Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
September 30, 2016; 81 FR 67153Final Rule; Technical Amendment; Approval of New Animal Drug Applications; Change of Sponsor's Address
September 30, 2016; 81 FR 67149Notice of Availability of Guidance for Industry; Veterinary Feed Directive Common Format Question and Answers
September 22, 2016; 81 FR 65360Final Rule; Announcement of Effective Date; Definition of Qualified Auditor
September 19, 2016; 81 FR 64060- Notice of Availability of Draft Revised Guidance for Industry; Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
September 16, 2016; 81 FR 63775 Notice of Withdrawal of Approval of Part of a New Animal Drug Application; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
September 14, 2016; 81 FR 63191Notice of Request for Comments; Judicious Use of Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration
September 14, 2016; 81 FR 63187Final Rule; New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
September 14, 2016; 81 FR 63053Notice of Approvals of Agency Information Collection Activities
September 12, 2016; 81 FR 62743Substances Generally Recognized as Safe; Correction
September 8, 2016; 81 FR 62004Notice of Agency Information Collection Activities; Animal Generic Drug User Fee Act Cover Sheet
September 2, 2016; 81 FR 60707Notice of Agency Information Collection Activities; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
September 2, 2016; 81 FR 60706Notice of Agency Information Collection Activities; Abbreviated New Animal Drug Applications
September 2, 2016; 81 FR 60705Notification of Public Hearing; Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products
September 1, 2016; 81 FR 60299Final Rule; Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs and Animal Drugs
August 31, 2016; 81 FR 60169Notification of Withdrawal of New Animal Drug Application; New Animal Drugs for Use in Animal Feed
August 29, 2016; 81 FR 59135Final Rule; Technical Amendment; New Animal Drugs
August 29, 2016; 81 FR 59131Notice of Availability of Draft Guidance for Industry; Human Food By-Products for Use as Animal Food
August 25, 2016; 81 FR 58521Notice of Availability of Draft Guidance for Industry; Current Good Manufacturing Practice Requirements for Food for Animals
August 25, 2016; 81 FR 58519Proposed Rule; New Animal Drugs for Use in Animal Feed; Category Definitions
August 24, 2016; 81 FR 57818Proposed Rule; Disqualification of a Clinical Investigator
August 24, 2016; 81 FR 57812Direct Final Rule; New Animal Drugs for Use in Animal Feed; Category Definitions
August 24, 2016; 81 FR 57796Final Rule; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules; FSMA
August 24, 2016; 81 FR 57784Notice of Agency Information Collection Activities; Reporting Associated with Designated New Animal Drugs for Minor Use and Minor Species
August 22, 2016; 81 FR 56658Final Rule; Substances Generally Recognized as Safe
August 17, 2016; 81 FR 54959Notice of Agency Information Collection Activities; Voluntary Qualified Importer Program Guidance for Industry
August 17, 2016; 81 FR 54809Final Rule; New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correcting Amendments
August 11, 2016; 81 FR 52995Notice of Agency Information Collection Activities; Certification of Identity for Freedom of Information Act and Privacy Act Requests
August 4, 2016; 81 FR 51455Notice of FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017
August 1, 2016; 81 FR 50525Notice of Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2017
July 28, 2016; 81 FR 49669Notice of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2017
July 28, 2016; 81 FR 49664Final Rule; New Animal Drugs; Change of Sponsor
July 26, 2016; 81 FR 48700Notice of Availability of Draft Guidance for Industry; General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals
July 21, 2016; 81 FR 47397Final Rule; Amendments to Registration of Food Facilities
July 14, 2016; 81 FR 45911Notice and Request for Comments; FDA Foods and Veterinary Medicine Program's Strategic Plan for Fiscal Years 2016-2025
July 14, 2016; 81 FR 45507Notice of OMB Approvals of Agency Information Collection Activities
July 11, 2016; 81 FR 44875Notice of Extension of Comment Period; Agency Information Collection Activities; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
June 30, 2016; 81 FR 42713Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate; Extension of Comment Period
June 27, 2016; 81 FR 41441Notice of Availability of Guidance for Industry; Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications
June 17, 2016; 81 FR 39651Notice of Availability of Draft Guidance for Industry; Prior Notice of Imported Food Questions and Answers (Edition 3)
June 16, 2016; 81 FR 39183Notice of Availability of Draft Guidance for Industry; Oncology Drugs for Companion Animals
June 10, 2016; 81 FR 37605Notice of Agency Information Collection Activities; Medicated Feed Mill License Application
June 10, 2016; 81 FR 37602Notification of Withdrawal of Approval of New Animal Drug Application
June 8, 2016; 81 FR 36790Final Rule; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsorship
June 8, 2016; 81 FR 36787Notice of Agency Information Collection Activities; Reporting Associated with New Animal Drug Applications
June 3, 2016; 81 FR 35774Final Rule; Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
June 3, 2016; 81 FR 35610Notice of Availability of Draft Guidance for Industry; Qualified Facility Attestation Using Form FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)
May 16, 2016; 81 FR 30219Notice of Agency Information Collection Activities; Abbreviated New Animal Drug Applications
May 11, 2016; 81 FR 29273Final Rule; Antimicrobial Animal Drug Sales and Distribution Reporting
May 11, 2016; 81 FR 29129Notice of Public Meetings; FSMA; Focus on Strategic Implementation of Prevention-Oriented Import Safety Programs
May 9, 2016; 81 FR 28035Notice of Agency Information Collection Activities; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
May 5, 2016; 81 FR 27140Notice of Availability of Compliance Policy Guide 690.150; Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases
May 2, 2016; 81 FR 26236Reopening of Comment Period; Recommendations on the Regulation of Combination Drug Medicated Feeds
April 29, 2016; 81 FR 25677Final Rule; Correcting Amendments; Approval of New Animal Drug Applications; Changes of Sponsorship
April 28, 2016; 81 FR 25328Final Rule; Technical Amendment; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
April 28, 2016; 81 FR 25326Notice of Opportunity for Hearing; Correction; Carbadox in Medicated Swine Feed
April 21, 2016; 81 FR 23499Notice of Public Meeting; Animal Drug User Fee Act
April 20, 2016; 81 FR 23313Notice of Public Meeting; Animal Generic Drug User Fee Act
April 20, 2016; 81 FR 23311Notice of Availability of Guidance for Industry; Distributor Labeling for New Animal Drugs
April 20, 2016; 81 FR 23307Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate
April 20, 2016; 81 FR 23305Stakeholder Consultation Meetings on Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate
April 20, 2016; 81 FR 23304Final Rule; Technical Amendment; Approval of New Animal Drug Applications; Changes of Sponsorship
April 18, 2016; 81 FR 22520Notice of Availability of Draft Guidance for Industry; Data Integrity and Compliance with Current Good Manufacturing Practice
April 15, 2016; 81 FR 22281Notice of Extension of Comment Period; Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes
April 14, 2016; 81 FR 22092Notice of Agency Information Collection Activities; Animal Feed Regulatory Program Standards
April 12, 2016; 81 FR 21578Notice of Opportunity for Hearing; Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed
April 12, 2016; 81 FR 21559Notice of Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
April 11, 2016; 81 FR 21355Notice of Agency Information Collection Activities; Guidance for Industry on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway
April 8, 2016; 81 FR 20647Final Rule; Sanitary Transportation of Human and Animal Food
April 6, 2016; 81 FR 20091Notice of Availability of Guidance for Industry; Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs
April 4, 2016; 81 FR 19195Correction: Approval of New Animal Drug Applications; Changes of Sponsorship
April 1, 2016; 81 FR 18749Final Rule; Approval of New Animal Drug Applications; Changes of Sponsorship
March 30, 2016; 81 FR 17604Notice of Agency Information Collection Activities; Environmental Impact Considerations
March 24, 2016; 81 FR 15729Notice of Filing of Food Additive Petition (Animal Use); Global Nutrition International
March 21, 2016; 81 FR 14995Notice of Availability of Draft Guidance for Industry; Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications
March 18, 2016; 81 FR 14859Final Rule; Use of Materials Derived from Cattle in Human Food and Cosmetics
March 18, 2016; 81 FR 14718Notice of Agency Information Collection Activities; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
March 15, 2016; 81 FR 13803Notice of Agency Information Collection Activities; Tracking Network for PETNet, LivestockNet, and SampleNet
March 15, 2016; 81 FR 13794Notice of Availability; Draft Environmental Assessment and Preliminary Finding of No Significant Impact; Investigational Use of Oxitec OX513A Mosquitoes
March 14, 2016; 81 FR 13371Notice of Agency Information Collection Activities; Medicated Feed Mill License Application
March 9, 2016; 81 FR 12509Notice of Availability of Guidance for Industry; Ensuring Safety of Animal Feed Maintained and Fed On-Farm
March 9, 2016; 81 FR 12498Final Rule; New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations
March 7, 2016; 81 FR 11664Notice of Agency Information Collection Activities; Reporting Associated with New Animal Drug Applications
March 2, 2016; 81 FR 10871Notice of Agency Information Collection Activities; Adverse Event Reporting; Electronic Submissions
February 29, 2016; 81 FR 10252Notice of Agency Information Collection Activities; Food Additive Petitions and Investigational Food Additive Exemptions
February 29, 2016; 81 FR 10250Notice of Public Meeting; FSMA: Prevention-Oriented Import System Regulations and Implementation
February 26, 2016; 81 FR 9761Notice of Agency Information Collection Activities; Substances Generally Recognized as Safe: Notification Procedure
February 18, 2016; 81 FR 8206Final Rule; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals; Technical Amendment
January 22, 2016; 81 FR 3716Notice of Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib Mesylate Tablets
January 21, 2016; 81 FR 3432Notice of Availability of Guidance for Industry; Target Animal Safety Data Presentation and Statistical Analysis
January 21, 2016; 81 FR 3429Final Rule; Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
January 21, 2016; 81 FR 3324Notice of Availability of Draft Guidance for Industry; Modified Release Veterinary Parenteral Dosage Forms
January 19, 2016; 81 FR 2874
2015 Notices
Final Rule; New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
December 22, 2015; 80 FR 79474Notification of Withdrawal of Approval of New Animal Drugs for Use in Animal Feed; Nitarsone
December 18, 2015; 80 FR 78970- Final Rule; Withdrawal of Approval of New Animal Drugs for Use in Animal Feed; Nitarsone
December 18, 2015; 80 FR 78970 Notification of Withdrawal of Approval of New Animal Drug Applications
December 9, 2015; 80 FR 76387Final Rule; Technical Amendments; New Animal Drugs
December 9, 2015; 80 FR 76384Notice of Availability of Draft Guidance for Industry; Veterinary Feed Directive Common Format Questions and Answers
December 1, 2015; 80 FR 75119Final Rule; Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications
November 27, 2015; 80 FR 74569Final Rule; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
November 27, 2015; 80 FR 74225Notice of Filing of Food Additive Petition (Animal Use); BASF Corp.
November 24, 2015; 80 FR 73153Final Rule; New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct
November 24, 2015; 80 FR 73104Notice of Agency Information Collection Activities; Adverse Event Reporting; Electronc Submissions
November 18, 2015; 80 FR 72071Notice of Agency Information Collection Activities; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
November 13, 2015; 80 FR 70236Notice of Agency Information Collection Activities; Food Additive Petitions and Investigational Food Additive Exemptions
October 21, 2015; 80 FR 63795Notice of Availability of Guidance for Industry; Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle
October 19, 2015; 80 FR 63231Notification of Withdrawal of New Animal Drugs for Use in Animal Feed; Penicillin G Procaine
October 13, 2015; 80 FR 61298Final Rule; Technical Amendment; Approval/Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
October 13, 2015; 80 FR 61293Notice of Availability; Guidance for Industry; Submitting Food Canning Establishment Registration Forms and Food Process Filing Forms in Electronic or Paper Format
October 8, 2015; 80 FR 60909Reopening of Comment Period: Identification of Alternative In Vitro Bioequivalence Pathways
October 2, 2015; 80 FR 59787Notice of Availability; Guidance for Industry; Small Entity Compliance Guide; Veterinary Feed Directive Regulation Questions and Answers
September 30, 2015; 80 FR 58602Notice of Agency Information Collection Activities; Electronic User Fee Payment Request Forms
September 24, 2015; 80 FR 57621Notice of Public Meeting: FSMA; Final Rules to Establish Requirements for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human and Animal Food
September 22, 2015; 80 FR 57136Notice of Agency Information Collection Activities; Animal Food Labeling; Declaration of Certifiable Color Additives
September 21, 2015; 80 FR 57002Notice of Availability; Draft Compliance Policy Guide Crotalaria spp. Seeds in Grains
September 21, 2015; 80 FR 57000Notice: Consumer Comments - Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets
September 18, 2015; 80 FR 56469Notice of Agency Information Collection Activities; Substances Generally Recognized as Safe; Notification Procedure
September 17, 2015; 80 FR 55857Proposed Rule; User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
September 17, 2015; 80 FR 55802Notice of Availability; Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities Conducted in a Facility Co-Located on a Farm
September 17, 2015; 80 FR 56359Final Rule; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals
September 17, 2015; 80 FR 56169Notice of Agency Information Collection Activities; New Animal Drugs for Investigational Use
September 10, 2015; 80 FR 54569Notice of Certification Fees; Animal Food; Export Certificates
September 10, 2015; 80 FR 54569Notice of Availability: Draft Guidance for Industry; Distributor Labeling for New Animal Drugs
September 10, 2015; 80 FR 54568Notice of Agency Information Collection Activities; Environmental Impact Considerations
September 8, 2015; 80 FR 53807Final Rule; Technical Amendments; Approval of New Animal Drug Applications
September 4, 2015; 80 FR 53458Notice of Availability; Guidance for Industry: Two-Phased Chemistry, Manufacturing, and Controls Technical Sections
September 1, 2015; 80 FR 52766Notice of Availability of Guidance for Industry: VICH; Electronic Exchange of Documents; Electronic File Format
September 1, 2015; 80 FR 52756Notice of Public Meeting: Collecting On-Farm Antimicrobial Use and Resistance Data; Request for Comments
August 20, 2015; 80 FR 50638- Notice of Extension of Comment Period; Compounding Animal Drug from Bulk Drug Substances; Draft Guidance for Industry
August 17, 2015; 80 FR 49247 Notice of Filing of Food Additive Petition (Animal Use); Adisseo France S.A.S.
August 13, 2015; 80 FR 48471Notice of Agency Information Collection Activities; Irradiation in the Production, Processing and Handling of Food
August 11, 2015; 80 FR 48113Notice of Availability of Guidance: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
August 6, 2015; 80 FR 46990Notice of Availability of Guidance for Industry: Use of Nanomaterials in Food for Animals
August 5, 2015; 80 FR 46587Notice of FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
August 3, 2015; 80 FR 46020Notice of Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2016
August 3, 2015; 80 FR 46012Notice of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2016
August 3, 2015; 80 FR 45993Notice of Availability of Guidance for Industry; VICH; Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products
July 31, 2015; 80 FR 45660Notice of Agency Information Collection Activities; Veterinary Feed Directive
July 30, 2015; 80 FR 45541Notice of Extension of Comment Period; Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products
July 30, 2015; 80 FR 45540Notice of Availability; Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and FDA Staff
July 24, 2015; 80 FR 44137Proposed Rule; User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
July 24, 2015; 80 FR 43987Notice of Cooperative Agreement for Research, Education, and Outreach in Support of the FDA Food Safety Modernization Act
July 21, 2015; 80 FR 43095Notice of Extension of Nomination Period; List of Bulk Drug Substances that May Be Used By an Outsourcing Facility to Compound Drugs for Use in Animals
July 20, 2015; 80 FR 42827Notice of Filing of Food Additive Petition (Animal Use); Alzchem AG
July 16, 2015; 80 FR 42069Notice of Agency Information Collection Activities; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
July 1, 2015; 80 FR 37622Notice of Agency Information Collection Activities; Animal Food Labeling; Declaration of Certifiable Color Additives
June 30, 2015; 80 FR 37269Notice of Agency Information Collection Activities; Electronic User Fee Payment Request Forms
June 26, 2015; 80 FR 36822Correction: Notice of Request for Nominations; List of Bulk Drug Substances that May Be Used by an Outsourcing Facility to Compound Drugs for Use in Animals
June 25, 2015; 80 FR 36543Notice of Agency Information Collection Activities: New Animal Drugs for Investigational Uses
June 23, 2015; 80 FR 35956Final Rule: Veterinary Feed Directive; Correction
June 23, 2015; 80 FR 35841Final Rule: Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Meal
June 22, 2015; 80 FR 35568Notice of Agency Information Collection Activities: Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
June 19, 2015; 80 FR 35367Final Rule; Technical Amendments; New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
June 16, 2015; 80 FR 34276Notice of Availability; Guidance for Industry: Recommendations for Preparation and Submission of Animal Food Additive Petitions
June 12, 2015; 80 FR 33528Notice of Availability; Guidance for Industry: Cell-Based Products for Animal Use
June 12, 2015; 80 FR 33522Notice of Agency Information Collection Activities; Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type A Medicated Articles
June 12, 2015; 80 FR 33521Reopening of Comment Period; Identification of Alternative In Vitro Bioequivalence Pathways
June 10, 2015; 80 FR 32963Notice of Availability of Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers
June 5, 2015; 80 FR 32136Notice of Withdrawal of Approval of New Animal Drug Application; Chlortetracycline
June 4, 2015; 80 FR 31909Veterinary Feed Directive Final Rule
June 3, 2015; 80 FR 31707Notice of Availability; Draft Revised Guidance for Industry: Veterinary Feed Directive Regulation Questions and Answers
June 3, 2015; 80 FR 31520Notice of Availability; Draft Guidance for Industry: VICH; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food
June 1, 2015; 80 FR 31041Notice of Integrated Food Safety System Online Collaboration Development
May 28, 2015; 80 FR 30470Notice of Agency Information Collection Activities; Substances Prohibited from Use in Animal Food or Feed
May 22, 2015; 80 FR 29721Proposed Rule: Antimicrobial Animal Drug Sales and Distribution Reporting
May 20, 2015; 80 FR 28863Notice of Availability of Draft Guidance for Industry; Compounding Animal Drugs from Bulk Drug Substances
May 19, 2015; 80 FR 28624Notice of Request for Nominations; List of Bulk Substances that May Be Used by an Outsourcing Facility to Compound Drugs for Use in Animals
May 19, 2015; 80 FR 28622Notice of Agency Information Collection Activities; Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the Center for Veterinary Medicine
May 14, 2015; 80 FR 27691Notice of Availability of Revised Guidance for Industry; Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
May 13, 2015; 80 FR 27322Notice of Agency Information Collection Activities; Extra Label Drug Use in Animals
May 13, 2015; 80 FR 27321Notice of Availability of Draft Guidance for Industry; Questions and Answers Regarding Mandatory Food Recalls
May 7, 2015; 80 FR 26269Notice of Availability of Guidance for Industry; Administrative Applications and the Phased Review Process
May 6, 2015; 80 FR 26062Notice of Withdrawal of Draft Guidance Documents Published Before December 31, 2013
May 6, 2015; 80 FR 26059Notice of Availability; Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products
April 30, 2015; 80 FR 24260Final Rule; Administrative Detention of Drugs Intended for Human or Animal Use; Correction
April 22, 2015; 80 FR 22403Notice of Agency Information Collection Activities; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
April 15, 2015; 80 FR 20229Notice of Proposed Rulemaking; Amendments to Registration of Food Facilities
April 9, 2015; 80 FR 19159Notification of Withdrawal of New Animal Drug Application; Fomepizole
April 8, 2015; 80 FR 18777Final Rule; Technical Amendments; New Animal Drugs
April 8, 2015; 80 FR 18773Notice of Availability of Guidance for Industry; Residual Solvents in Animal Drug Products; Questions and Answers
April 3, 2015; 80 FR 18239Notice of Agency Information Collection Activities; New Animal Drugs for Investigational Uses
April 2, 2015; 80 FR 17758Notice of Agency Information Collection Activities; Animal Food Labeling; Declaration of Certifiable Color Additives
April 1, 2015; 80 FR 17445Notice of Availability of Draft Guidance for Industry; Target Animal Safety Data Presentation and Statistical Analysis
March 31, 2015; 80 FR 17047Notice of Public Meeting; FSMA: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards
March 24, 2015; 80 FR 15612Notice of Agency Information Collection Activities; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
March 23, 2015; 80 FR 15214Notice of Availability; Draft Guidance for Industry on Ensuring Safety of Animal Feed Maintained and Fed On-Farm
March 20, 2015; 80 FR 15014Notice of Public Meeting; Identification of Alternative In Vitro Bioequivalence Pathways
March 18, 2015; 80 FR 14146Final Rule; Technical Amendment: New Animal Drugs
March 13, 2015; 80 FR 13226Notice of Availability; Revised Guidance for Industry; VICH - Marker Residue Depletion Studies to Establish Product Withdrawal Periods
March 9, 2015; 80 FR 12501Notice of Availability; Revised Guidance for Industry; VICH - Validation of Analytical Methods Used in Residue Depletion Studies
March 9, 2015; 80 FR 12490Notice of Agency Information Collection Activities; Substances Prohibited from Use in Animal Food or Feed
March 9, 2015; 80 FR 12486Oral Dosage Form New Animal Drugs; CFR Correction (21 CFR 520.1193)
March 6, 2015; 80 FR 12081- Oral Dosage Form New Animal Drugs; CFR Correction (21 CFR 520.580)
March 6, 2015; 80 FR 12081 Notice of Availability of Draft Guidance for Industry; Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle
February 24, 2015; 80 FR 9731Notification of Public Meeting; Regulation of Combination Drug Medicated Feeds
February 13, 2015; 80 FR 8092Notification of Public Meeting; Conditional Approval of New Animal Drugs
February 13, 2015; 80 FR 8091Notice of Agency Information Collection Activities; Export of FDA Regulated Products: Export Certificates; Correction
February 13, 2015; 80 FR 8087Notice of Agency Information Collection Activities; Food and Drug Administration Recall Regulations
February 11, 2015; 80 FR 7609Notice of Agency Information Collection Activities; Export of FDA Regulated Products: Export Certificates
February 6, 2015; 80 FR 6728Notice of Agency Information Collection Activities; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine
January 29, 2015; 80 FR 4931Notice of Agency Information Collection Activities; Extralabel Drug Use in Animals
January 23, 2015; 80 FR 3607Notice of Agency Information Collection Activities; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
January 12, 2015; 80 FR 1506Notice of Filing of Food Additive Petition (Animal Use); Humic Products Trade Association
January 6, 2015; 80 FR 422
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