Animal & Veterinary

Guidances Under Development for 2014

CVM Guidance Documents Under Development
(expected to publish as drafts or finals by the end of December 2014)

Introduction

The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the CVM is considering. We currently intend to develop guidance on each topic; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list.

CVM Guidance Documents Under Development list has been updated to include those documents expected to publish by the end of 2014. FDA also publishes an agency-wide Annual Guidance Agenda which includes CVM's Guidance Documents Under Development and is available for public comment.

Center for Veterinary Medicine
2014 Guidance Agenda

Title of Guidance Contact
Guidance For Industry (GFI #79) – Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (Revision) Marcia Larkins, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276-9015, Email: marcia.larkins@fda.hhs.gov
Draft Guidance for Industry – Marketed Unapproved New Animal Drugs Nadine Steinberg, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276-8849, nadine.steinberg@fda.hhs.gov
Compliance Policy Guide – Compounding Nadine Steinberg, Center for Veterinary Medicine, Food and Drug Administration, (HFV-1), 7519 Standish Place, Rockville, MD 20855, 240-276-8849, nadine.steinberg@fda.hhs.gov
Guidance For Industry (GFI #61) - FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision) Margaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0566, margaret.oeller@fda.hhs.gov
Draft Guidance for Industry (GFI #210) – The Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species Margaret Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0566, margaret.oeller@fda.hhs.gov
Draft Guidance for Industry – Electronic Exchange of Documents: File Format Requirements – VICH GL53 Scott Fontana, Center for Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0656, scott.fontana@fda.hhs.gov
Draft Guidance for Industry – Bioequivalence: Blood Level Bioequivalence Study – VICH GL52 Marilyn Martinez, Center for Veterinary Medicine, (HFV-100), Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, 240-402-0635, marilyn.martinez@fda.hhs.gov
Draft Guidance for Industry – Combination New Animal Drugs Herman Schoenemann, Center for Veterinary Medicine, (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0652, herman.schoenemann@fda.hhs.gov
Draft Guidance for Industry (GFI #218) – Cell-Based Products for Use in Animals Lynne Boxer, Center for Veterinary Medicine, (HFV-114), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0611, lynne.boxer@fda.hhs.gov
Draft Guidance for Industry – Designing Effectiveness Studies for Common Animal Production Indications (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production) Amey Adams, Center for Veterinary Medicine, (HFV-126), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0816, amey.adams@fda.hhs.gov
Guidance for Industry (GFI #23) – Medicated Free Choice Feeds (Revision) Dennis Bensley, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry – Medicated Feed Assays Dennis Bensley, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry – Chemistry, Manufacturing and Controls (CMC) Guidances for Generic New Animal Drugs Dennis Bensley, Center for Veterinary Medicine, (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry – Development of In Vivo In Vitro Correlation (IVIVC) for Sustained Released Injectables (SRI) Gregory Hunter, Center for Veterinary Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0675, gregory.hunter@fda.hhs.gov
Draft Guidance for Industry (GFI #57) – Preparation and Submission of Veterinary Master Files (Revision) Gregory Hunter, Center for Veterinary Medicine, (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0675, gregory.hunter@fda.hhs.gov
Guidance for Industry (GFI #219) - Statistical Evaluation of Stability Data - VICH GL51(R) Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0669, mai.huynh@fda.hhs.gov
Draft Guidance for Industry – Question-Based Review for Animal Drugs Julie Bailey, Center for Veterinary Medicine, (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0700, julie.bailey@fda.hhs.gov
Draft Guidance for Industry – Submitting Two-Phased Chemistry, Manufacturing and Controls (CMC) Technical Sections Heather Longstaff, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0651, heather.longstaff@fda.hhs.gov
Guidance for Industry (GFI #207) – Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods – VICH GL48 (Revised) Julia Oriani, Center for Veterinary Medicine, (HFV-151), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0788, Julia.oriani@fda.hhs.gov
Draft Guidance for Industry – Human Food Safety for Protein/Peptide Drugs Kimon Kanelakis, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0827, kimon.kanelakis@fda.hhs.gov
Guidance for Industry (GFI #116) – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing – VICH GL23(R) Tong Zhou, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0826, tong.zhou@fda.hhs.gov
Draft Guidance for Industry – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) – VICH Tong Zhou, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0826, tong.zhou@fda.hhs.gov
Draft Guidance for Industry – Presenting and Analyzing Target Animal Safety Study Data Virginia Recta, Center for Veterinary Medicine, (HFV-164), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0840, virginia.recta@fda.hhs.gov
Guidance for Industry (GFI #171) – Waivers of In Vivo Demonstration (Revision) John Harshman , Center for Veterinary Medicine, (HFV-170), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0845, john.harshman@fda.hhs.gov
Draft Guidance for Industry – Proprietary Names on Drug Labeling Tomislav Modric, Center for Veterinary Medicine (HFV-216), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-276-9078, tomislav.modric@fda.hhs.gov
Draft Guidance for Industry (GFI #222) - Antibiotic Residues in Distillers Grains Used as Animal Food Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6864, sharon.benz@fda.hhs.gov
Guidance for Industry (GFI #80) – Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds (Revised) Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6863, xin.li@fda.hhs.gov
Draft Guidance for Industry – Design and Submission of Distributor Labeling Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6863, xin.li@fda.hhs.gov
Draft Guidance for Industry (GFI #220) – Use of Nanomaterials in Food for Animals Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6856, dragan.momcilovic@fda.hhs.gov
Draft Guidance for Industry (GFI #203) – Ensuring Safety of Animal Food Maintained and Fed On-Farm Phares Okelo, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-453-6862, phares.okelo@fda.hhs.gov  
Compliance Policy Guide – Labeling and Marketing of Dog and Cat Food Products Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases (Final) William Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-453-6865, william.burkholder@fda.hhs.gov
Draft Guidance for Industry - Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients Jonathan Bray, Center for Veterinary Medicine (HFV-232), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-276-9226, jonathan.bray@fda.hhs.gov
Guidance for Industry (GFI #143) – Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms - VICH GL30 Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov
Guidance for Industry (GFI #214) – Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data - VICH GL35(R) Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, margarita.brown@fda.hhs.gov