Animal & Veterinary

Guidances Under Development for 2017

Center for Veterinary Medicine (CVM) Guidance Documents Under Development
(Expected to publish as drafts or finals by the end of December 2017.)

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 2017.

Center for Veterinary Medicine 2017 Guidance Agenda

Title of GuidanceContact
Draft - Guidance for Industry (GFI #187) – Regulation of Intentionally Altered Genomic DNA in Animals (Revision)Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 301-796-8558, Laura.Epstein@fda.hhs.gov
Draft and Final - Guidance for Industry (GFI #236) - Regulation of Mosquito-Related ProductsLaura R. Epstein, Center for Veterinary Medicine (HFV-1), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 301-796-8558, Laura.Epstein@fda.hhs.gov
Draft Guidance for Industry – Regulation of Genetically Engineered Biopharm Animals and Their FDA-Regulated ProductsLaura R. Epstein, Center for Veterinary Medicine (HFV-1), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 301-796-8558, Laura.Epstein@fda.hhs.gov
Draft Guidance for Industry – Genetically Engineered Animals That Are Intended for Use as Models of Human DiseaseLaura R. Epstein, Center for Veterinary Medicine (HFV-1), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 301-796-8558, Laura.Epstein@fda.hhs.gov
Draft Guidance for Industry – Recommendations for Breeders, Wholesalers, Retailers, and Handlers of Feeder Rodents Used as Animal FoodVic Boddie, Center for Veterinary Medicine (HFV-232), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5618, Vic.Boddie@fda.hhs.gov
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) –Special Considerations, Incentives, and
Programs to Support the 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
Draft Guidance for Industry – Combination New Animal DrugsHilary Hoffman, Center for Veterinary Medicine (HFV-108), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-8406,
hilary.hoffman@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
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 #242) – In Use Stability Studies and Associated Labeling Statement for Multiple-Dose Injectable Animal Drug ProductsKevin Rice, Center for Veterinary Medicine (HFV-140), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855,240-402-0680, jamesk.rice@fda.hhs.gov
Guidance for Industry (GFI #3) – General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing AnimalsJulia 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
Guidance for Industry (GFI #243) – Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods (VICH/GL56)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
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 #171) – Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated ArticlesCharli Long, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0850,
Charli.long-medrano@fda.hhs.gov
Guidance for Industry (GFI #230) – Compounding Animal Drugs from Bulk Drug Substances for Dogs, Cats, and HorsesPatrice Brooks-Gelling, Center for Veterinary Medicine (HFV-200), 7529 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-7384, Patrice.Brooks-Gelling@fda.hhs.gov
Guidance for Industry (GFI #235) –Current Good Manufacturing Practice Requirements 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 #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
Draft Guidance for Industry (GFI #245) – 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 #240) – 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

 

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