Animal & Veterinary

Guidances Under Development for 2018

Center for Veterinary Medicine (CVM) Guidance Documents Under Development
(Expected to publish as drafts or finals by the end of December 2018.)

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. This list includes Compliance Policy Guides.

Guidance for Industry (GFI)

Title of Guidance Contact
GFI #187 – Regulation of Intentionally Altered Genomic DNA in Animals (Revision) Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 301-796-8558, Laura.Epstein@fda.hhs.gov
Draft GFI #251 – Animals of Food-Producing Species with Intentional Genomic Alterations for Use as Models of Disease Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 301-796-8558, Laura.Epstein@fda.hhs.gov
Draft 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
GFI #210 – The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species Dorothy 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 GFI – Combination New Animal Drugs Hilary 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 GFI – New Chemical Entity Exclusivity for Certain Combination New Animal Drug Products Urvi 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 GFI #253 – Good Manufacturing Practices for Animal Cells, Tissues, and Cell or Tissue-Based Products Lynne Boxer, Center for Veterinary Medicine (HFV-114), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-0611, Lynne.Boxer@fda.hhs.gov
Draft GFI #254 – Donor Eligibility for New Animal Drugs Lynne Boxer, Center for Veterinary Medicine (HFV-114), 7500 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-0611, Lynne.Boxer@fda.hhs.gov
Draft GFI #228 – Designing Effectiveness Studies for Drugs Intended to Enhance Animal Production (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
Draft GFI #49 – Target Animal Safety and Drug Effectiveness Studies for Antimicrobial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products) (Revision) Joshua Hayes, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0585, joshua.hayes@fda.hhs.gov
Annex to GFI #73 – Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV (VICH GL3(R)) Mai X. 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
GFI #242 – In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products Kevin 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
Draft GFI #250 – Chemistry, Manufacturing, and Controls (CMC) Information to be Submitted for Competitive Exclusion Animal Drug Products Michael J. Popek, Center for Veterinary Medicine (HFV-144), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0671, michael.popek@fda.hhs.gov 
Draft GFI #255 – Elemental Impurities in Animal Drug Products – Questions and Answers Michael Brent, Center for Veterinary Medicine (HFV-146), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0647, michael.brent@fda.hhs.gov
GFI #3 – General Principles for Evaluating the Human Food Safety of New Animal Drugs 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
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
Draft GFI #257 – Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species (VICH GL57) 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 GFI #152 – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern (Revision) Jeffrey Gilbert, Center for Veterinary Medicine, (HFV-157), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0706, jeff.gilbert@fda.hhs.gov
Draft GFI #197 – Documenting Electronic Data Files and Statistical Analysis Programs (Revision) Virginia Recta, Center for Veterinary Medicine (HFV-160), and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0840, virginia.recta@fda.hhs.gov
Draft GFI #171 – Waivers from the Requirement to Demonstrate Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles (Revision) Charli Long, Center for Veterinary Medicine (HFV-172), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0850,
Charli.long-medrano@fda.hhs.gov
GFI #245 – Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Jeanette 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 GFI #246 – Hazard Analysis and Risk-Based Preventive Control: Supply-Chain Program Jeanette 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 GFI #240 – Proprietary Names for New Animal Drugs Tomislav 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 GFI #120 – Veterinary Feed Directive Regulation Questions and Answers (Revision) Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-5944, dragan.momcilogic@fda.hhs.gov
Draft GFI #256 – Compounding Animal Drugs from Bulk Drug Substances Eric 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

Compliance Policy Guide (CPG)
(Sub Chapter 600 – Veterinary Drugs; Sub Chapter 660 – Animal Feed)

Title of CPG Contact
Draft CPG Sec. 654.200 – Teat Dips and Udder Washes for Dairy Cows and Goats (Revision) Diana Link, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6215, Diana.Link@fda.hhs.gov
Draft CPG Sec. 655.100 – Devices for Use in Animals (Revision) Diana Link, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6215, Diana.Link@fda.hhs.gov
Draft CPG Sec. 665.100 – Animal Food Ingredients Listed in the Official Publication of AAFCO (Revision) Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft CPG Sec. 665.300 – Use of Type A Medicated Article Brand Names in Feed Labels (Revision) Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Food and Drug Administration, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov

 

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