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  1. Guidance for Industry

Guidances Under Development for 2020

Center for Veterinary Medicine (CVM) Guidance Documents Under Development

(Expected to publish as drafts or finals by the end of December 2020.)

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, 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, 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), 7500 Standish Place, Rockville, MD 20855, 240-402-0566,
margaret.oeller@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, Rockville, MD 20855, 240-402-0611, lynne.boxer@fda.hhs.gov
Draft GFI #254 – Donor Eligibility for Animal Cells, Tissues, and Cell- or Tissue-Based Products Lynne Boxer, Center for Veterinary Medicine (HFV-114), 7500 Standish Place, 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), 7500 Standish Place, Rockville, MD 20855, 240-402-0816, amey.adams@fda.hhs.gov
GFI #259 – Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV (VICH GL58) Mai X. Huynh, Center for Veterinary Medicine, (HFV-142), 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, Rockville, MD 20855,240-402-0680, jamesk.rice@fda.hhs.gov
GFI #255 – Elemental Impurities in Animal Drug Products – Questions and Answers Michael Brent, Center for Veterinary Medicine (HFV-146), 7500 Standish Place, Rockville, MD 20855, 240-402-0647, michael.brent@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), 7500 Standish Place, Rockville, MD 20855, 240-402-0706, jeff.gilbert@fda.hhs.gov
GFI #197 – Documenting Electronic Data Files and Statistical Analysis Programs (Revision) Virginia Recta, Center for Veterinary Medicine (HFV-160), 7500 Standish Place, Rockville, MD 20855, 240-402-0840, virginia.recta@fda.hhs.gov
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) Lauren Feeney, Center for Veterinary Medicine (HFV-170), 7500 Standish Place, Rockville, MD 20855, 240-402-0848, lauren.feeney@fda.hhs.gov
GFI #261 - Eligibility Criteria for Expanded Conditional Approval Christopher Loss, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0619, christopher.loss@fda.hhs.gov
GFI #263 - Recommendations for Drug Sponsors for Voluntarily Bringing Under Veterinary Oversight All Medically Important Antimicrobial Drugs in Animals that Continue to be Available as Over-the-Counter Products Cindy Burnsteel, Center for Veterinary Medicine (HFV-130), 7500 Standish Place, Rockville, MD 20855, 240-402-0817, cindy.burnsteel@fda.hhs.gov
GFI #___ - New Chemical Entity Exclusivity for Certain Combination New Animal Drug Products Patrice Brooks-Gelling, Center for Veterinary Medicine (HFV-108), 7500 Standish Place, Rockville, MD  20855, 240-402-7384, patrice.brooks-gelling@fda.hhs.gov
GFI #___ - Feed-Use Combinations: Recommendations for Satisfying Approval Requirements Under the Animal Drug Availability Act (ADAA) Hilary Hoffman, Center for Veterinary Midicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
GFI #___ - Dosage Form Combinations: Recommendations for Satisfying Approval Requirements  Hilary Hoffman, Center for Veterinary Midicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
Draft GFI #106 - The Use of Published Literature in Support of New Animal Drug Applications (Revision) Amey Adams, Center for Veterinary Medicine (HFV- 120), 7500 Standish Place, Rockville, MD 20855, 240-402-0816, amey.adams@fda.hhs.gov
Draft GFI #265 - Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578 susan.storey@fda.hhs.gov
Draft GFI #266 - Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578 susan.storey@fda.hhs.gov
Draft GFI #267 - Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578 susan.storey@fda.hhs.gov
Draft GFI #268 - Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578 susan.storey@fda.hhs.gov
Draft GFI #___ - Recommendations for Sponsors of Medically-Important Antimicrobial Drugs Approved for Use in or on Medicated Feed of Food-Producing Animals for Establishing Appropriately Defined Durations of Use Where None Currently Exist Cindy Burnsteel, Center for Veterinary Medicine (HFV-130), 7500 Standish Place, Rockville, MD 20855, 240-402-0817, cindy.burnsteel@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, Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov
GFI #246 – Hazard Analysis and Risk-Based Preventive Control: Supply-Chain Program Jeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov
GFI #240 – Proprietary Names for New Animal Drugs Tomislav Modric, Center for Veterinary Medicine (HFV-216), 7519 Standish Place, 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, Rockville, MD 20855, 240-402-5944, dragan.momcilogic@fda.hhs.gov
GFI #256 – Compounding Animal Drugs from Bulk Drug Substances Eric Nelson, Center for Veterinary Medicine (HFV-230), 7519 Standish Place, Rockville, MD 20855, 240-402-5642, eric.nelson@fda.hhs.gov
Draft GFI #258 - Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft GFI #262 - Pre-Petition Consultation Process for Animal Food Additives Padmakumar Pillai, Center for Veterinary Medicine (HFV-220), 7519 Standish Place, Rockville, MD 20855, 240-402-5894, padmakumar.pillai@fda.hhs.gov
Draft GFI #___ - Diversion or Reconditioning of Damaged, Contaminated, or Adulterated Food for Use as Animal Food Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft GFI #___ - Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov

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

Title of CPG Contact
Draft CPG Sec. 655.100 – Devices for Use in Animals (Revision) Diana Link, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Rockville, MD 20855, 240-402-6215, diana.link@fda.hhs.gov
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, Rockville, MD 20855, 240-402-6215, diana.link@fda.hhs.gov
Draft CPG Sec. 665.100 – Common or Usual Names of Animal Food Ingredients and the Use of Ingredients Listed in the Official Publication of the Association of American Feed Control Officials in Animal Food (Revision) Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft CPG Sec. 670.100 – Refusals of Formula Information During Inspection of Feed Mills Manufacturing Feeds Requiring Approved Medicated Feed Applications (Revision) Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft CPG Sec. 689.100 – Direct-Fed Microbial Products (Revision) Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft CPG Sec. ___ – Food Ingredients for the Control of Oral Malodor in Pets (New) Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov