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  1. Guidance for Industry

Guidances Under Development for 2024

Center for Veterinary Medicine (CVM) Guidance Documents Under Development

(Expected to publish as drafts or finals by the end of December 2024.)

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
Draft GFI #49 – Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis (Revision) Paulette Salmon, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-6556, paulette.salmon@fda.hhs.gov
Draft GFI #80 – Utility Studies for Anti-Salmonella Animal Food Additives (Revision) Xin Li, Center for Veterinary Medicine (HFV-222), 7500 Standish Place, Rockville, MD 20855, 240-402-5899, xin.li@fda.hhs.gov
GFI #120 – Veterinary Feed Directive Regulation Questions and Answers (Revision) Kelly Louviere, Center for Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855, 240-402-5815, kelly.louviere@fda.hhs.gov
GFI #152 – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern (Revision) Ruby Singh, Center for Veterinary Medicine (HFV-150), 7500 Standish Pl., Rockville, MD  20855, 240-402-0794, ruby.singh@fda.hhs.gov
GFI #187A – Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach 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 #187B – Heritable Intentional Genomic Alterations in Animals: The Approval Process 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 #210 – The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species Lucy Lee, Center for Veterinary Medicine (HFV-50), 7500 Standish Place, Rockville, MD 20855, 240-402-0563, lucy.lee@fda.hhs.gov
Draft GFI #217 – Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Revision) Prajwal Regmi, Center for Veterinary Medicine (HFV-135), 7500 Standish Place, Rockville, MD 20855, 240-402-0577 prajwal.regmi@fda.hhs.gov
Draft GFI #227 – Chemistry, Manufacturing, and Control (CMC) Technical Section Filing Strategies (Revision) Heather Longstaff, Center for Veterinary Medicine (HFV-145), 7500 Standish Place, Rockville, MD 20855, 240-402-0651, heather.longstaff@fda.hhs.gov
Draft GFI #228 – Designing Effectiveness Studies for Drugs Intended to Enhance Animal Production (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production) Christina Edwards, Center for Veterinary Medicine (HFV-137), 7500 Standish Place, Rockville, MD 20855, 240-402-0824, christina.edwards@fda.hhs.gov
Draft GFI #251 – Heritable Intentional Genomic Alterations in Animals of Food-Producing Species 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 #260 – Type VII Veterinary Master File for Pre-Investigational Development and Research Involving Novel or Rapidly Evolving Technologies Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
GFI #273 – Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals John Mussman, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-0589, john.mussman@fda.hhs.gov
GFI #276 – Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs  Steve Fleischer, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0809, steven.fleischer@fda.hhs.gov
Draft GFI #277 – Diversion or Reconditioning of Damaged, Contaminated, or Adulterated Food for Use as Animal Food Jennifer Erickson, Center for Veterinary Medicine (HFV-230). 7500 Standish Place, Rockville, MD 20855, 240-402-7382, jennifer.erickson@fda.hhs.gov
GFI #278 – Human User Safety in New and Abbreviated New Animal Drug Applications Steve Fleischer, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0809, steven.fleischer@fda.hhs.gov
GFI #279 – Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting Ian Henricks, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 208585, 240-402-0853, ian.hendricks@fda.hhs.gov
GFI #281 – Infectious Otitis Externa Drugs for Topical Use in Dogs Lea Cranford, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0615, lea.cranford@fda.hhs.gov
GFI #282 – Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals Christa Johnson, Center for Veterinary Medicine (HFV-112), 7500 Standish Place, Rockville, MD 20855, 240-402-0258, christa.johnson@fda.hhs.gov
GFI #284 – Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Foods Karen Donnelly, Center for Veterinary Medicine (HFV-228), 7500 Standish Place, 240-402-9802, karen.donnelly2@fda.hhs.gov
Draft GFI #285 – Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs  Amy Simms, Center for Veterinary Medicine (HFV-147), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, amy.simms@fda.hhs.gov
Draft GFI #287 – Raw Data for Safety and Effectiveness Studies Laurie Hanna, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-0586, laurie.hanna@fda.hhs.gov
Draft GFI #288 – Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use  Lijuan He, Center for Veterinary Medicine (HFV-140), 7500 Standish Place, Rockville, MD 20855, 301-796-5122, lijuan.he@fda.hhs.gov
Draft GFI #292 – Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles  Heather Longstaff, Center for Veterinary Medicine (HFV-145), 7500 Standish Place, Rockville, MD 20855, 240-402-0651, heather.longstaff@fda.hhs.gov
Draft GFI #___ – New Chemical Entity Exclusivity for Certain Combination New Animal Drug Products Dominique Martinez, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD  20855, 240-402-8989, dominique.martinez@fda.hhs.gov
Draft GFI #___ – Feed-Use Combinations: Recommendations for Satisfying Approval Requirements Under the Animal Drug Availability Act (ADAA) Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
Draft GFI #___ – Other Combination New Animal Drugs: Recommendations for Satisfying Approval Requirements Hilary Hoffman, Center for Veterinary Medicine (HFV-101), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.gov
Draft GFI #___ – Food Ingredients for the Control of Simple Halitosis (Bad Breath) in Pets Sara Sklenka, Center for Veterinary Medicine (HFV-221), 7500 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov
Draft GFI #___ – Considerations for Species Grouping in Aquaculture Drug Development for Freshwater-Reared Salmonids and Catfish Cassandra Fox, Center for Veterinary Medicine (HFV-170), 7500 Standish Place, Rockville, MD 20855, 240-402-1893, cassandra.fox@fda.hhs.gov
Draft GFI #___ – Predicted Environmental Concentrations (PEC) of Animal Drugs Used in Terrestrial Species Andrew Miglino, Center for Veterinary Medicine (HFV-160), 7500 Standish Place, Rockville, MD 20855, 240-402-1086, andrew.miglino@fda.hhs.gov
Draft GFI #___ – Biomass Drug Substances  Amy Simms, Center for Veterinary Medicine (HFV-147), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, amy.simms@fda.hhs.gov
Draft GFI #___ – Type B and C Medicated Feeds Heather Longstaff, Center for Veterinary Medicine (HFV-145), 7500 Standish Place, Rockville, MD 20855, 240-402-0651, heather.longstaff@fda.hhs.gov
Draft GFI #___ – Post-Approval CMC Changes: New Drug Substance Source and Drug Product Manufacturing Sites Amy Simms, Center for Veterinary Medicine (HFV-147), 7500 Standish Place, Rockville, MD 20855, 240-402-0648, amy.simms@fda.hhs.gov

Compliance Policy Guide (CPG)
(Sub Chapter 600-659 – Veterinary Drugs; Sub Chapter 660-699 – Animal Feed)

Title of CPG Contact
Draft CPG Sec. 654.200 – Teat Dips and Udder Washes for Dairy Cows and Goats (Revision) Nick Duckworth, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Rockville, MD 20855, 240-402-5616, nick.duckworth@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-221), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.gov

 

 
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