Animal & Veterinary

Guidances Under Development for 2016

Center for Veterinary Medicine (CVM) Guidance Documents Under Development
(Expected to publish as drafts or finals by the end of December 2016.)

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.

The CVM Guidance Documents Under Development list has been updated to include those documents expected to publish by the end of 2016.

Center for Veterinary Medicine 2016 Guidance Agenda

Title of GuidanceContact
Draft Guidance for Industry (GFI #187) – Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (Revision)Larisa Rudenko, Center for Veterinary Medicine (HFV-2), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-0709, larisa.rudenko@fda.hhs.gov
Draft Guidance for Industry – Regulation of Genetically Engineered Biopharm Animals and Their FDA-Regulated ProductsLarisa Rudenko, Center for Veterinary Medicine (HFV-2), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-0709, larisa.rudenko@fda.hhs.gov
Draft Guidance for Industry (GFI #170) – Animal Drug User Fees and Fee Waivers and Reductions (Revision)Diane Heinz, Center for Veterinary Medicine (HFV-6), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5692, diane.heinz@fda.hhs.gov
Draft Guidance For Industry (GFI #61) - FDA Approval of New Animal Drugs for Minor Uses and for Minor Species (Revision)Margaret Oeller, Center for Veterinary Medicine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Draft Guidance for Industry (GFI #210) – The Index of Legally Marketed Unapproved New Animal Drugs for Minor SpeciesDorothy Bailey, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0565, dorothy.bailey@fda.hhs.gov
Guidance for Industry (GFI #224) – Bioequivalence: Blood Level Bioequivalence Study (VICH GL52)Marilyn Martinez, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0635, marilyn.martinez@fda.hhs.gov
Draft Guidance for Industry – Combination New Animal DrugsHerman 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 – New Chemical Entity Exclusivity for Certain Combination New Animal Drug ProductsUrvi Desai, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0689, urvi.desai@fda.hhs.gov
Draft Guidance for Industry (GFI #237) – Oncology Drugs for Companion AnimalsChristopher Loss, Center for Veterinary Medicine (HFV-116), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-0619, christoper.loss@fda.hhs.gov
Guidance for Industry (GFI #156) – Comparability Protocols – Chemistry, Manufacturing, and Controls InformationDennis Bensley, Center for Veterinary Medicine (HFV-140), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-0696, dennis.bensley@fda.hhs.gov
Draft Guidance for Industry (GFI #238) – Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of SpecificationsGregory 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 #234) – Question-Based Review for the Chemistry Manufacturing and Controls Technical Section of Animal Drug ApplicationsJulie 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 (GFI #3) – General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (Revision)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 (GFI #116) – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (VICH GL23) (Revision)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
Guidance for Industry (GFI #232) – Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD) – (VICH GL54)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
Guidance for Industry (GFI #226) – Target Animal Safety Data Presentation and Statistical AnalysisVirginia Recta, Center for Veterinary Medicine (HFV-160), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0840, virginia.recta@fda.hhs.gov
Draft 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 (GFI #235) – Animal Food Current Good Manufacturing PracticesJeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov
Draft Guidance for Industry (GFI #236) – Hazard Analysis and Risk-Based Preventive Controls for Food for AnimalsJeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov
Draft Guidance for Industry (GFI #239) – Human Food By-Products for Use as Animal FoodJeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov
Small Entity Compliance Guide – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for AnimalsJeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov
Guidance for Industry (GFI #231) –Distributor Labeling for New Animal DrugsDorothy McAdams, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5763, dorothy.mcadams@fda.hhs.gov
Draft Guidance for Industry – Proprietary Names for New Animal DrugsTomislav Modric, Center for Veterinary Medicine (HFV-216), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5853, tomislav.modric@fda.hhs.gov
Draft Guidance for Industry (GFI #80) – Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds (Revision)Xin Li, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5899, xin.li@fda.hhs.gov
Guidance for Industry (GFI #203) – Ensuring Safety of Animal Food Maintained and Fed On-FarmPhares Okelo, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5921, phares.okelo@fda.hhs.gov
Guidance for Industry (GFI #233) – Veterinary Feed Directive (VFD) Common Format - Questions and AnswersDragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5944, dragan.momcilovic@fda.hhs.gov
Draft Compliance Policy Guide Sec. 615.115 – Extralabel Use of Medicated Feeds for Minor Species (Revision)Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5944, dragan.momcilovic@fda.hhs.gov
Compliance Policy Guide Sec. 690.150 – Labeling and Marketing of Dog and Cat Food Products Intended to Diagnose, Cure, Mitigate, Treat, or Prevent DiseasesWilliam Burkholder, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5900, william.burkholder@fda.hhs.gov
Draft Compliance Policy Guide Sec 665.xxx – Animal Food Ingredients Listed in the Official Publication of AAFCOMika Alewynse, Center for Veterinary Medicine (HFV-229), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5843, mika.alewynse@fda.hhs.gov
Guidance for Industry (GFI #230) – Compounding Animal Drugs from Bulk Drug SubstancesEric Nelson, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5642, eric.nelson@fda.hhs.gov
Draft Guidance for Industry – Marketed Unapproved New Animal DrugsEric Nelson, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5642, eric.nelson@fda.hhs.gov
Draft Guidance for Industry – Drugs for Use in Ornamental FishEric Nelson, Center for Veterinary Medicine (HFV-230), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5642, eric.nelson@fda.hhs.gov
Draft Guidance for Industry – Good Production Practices on Feeder RodentsEric Nelson, Center for Veterinary Medicine (HFV-230), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5642, eric.nelson@fda.hhs.gov

 

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