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                Guidance for Industry

Guidance for Industry

                        Guidance by Number
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          Guidance for Industry
          Guidances Under Development for 2023Guidance for Industry Guidances Under Development for 2023
  
  	
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    PrintCenter for Veterinary Medicine (CVM) Guidance Documents Under Development

(Expected to publish as drafts or finals by the end of December 2023.)

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
			ContactGFI #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.govDraft 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.govDraft 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.govGFI #61 – Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Revision)
			Dorothy Bailey, Center for Veterinary Medicine (HFV-50), 7500 Standish Place, Rockville, MD 20855, 240-402-0565,dorothy.bailey@fda.hhs.govDraft 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.govDraft 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.govGFI #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.govDraft 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.govDraft GFI #___ – Feed-Use Combinations: Recommendations for Satisfying Approval Requirements Under the Animal Drug Availability Act (ADAA)
			Hilary Hoffman, Center for Veterinary Medicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.govDraft GFI #___ – Dosage Form Combinations: Recommendations for Satisfying Approval Requirements
			Hilary Hoffman, Center for Veterinary Medicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.govGFI #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.govDraft GFI #260 – Type VII Veterinary Master File for Research and Development and Low-Risk Determinations
			Hilary Hoffman, Center for Veterinary Medicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, hilary.hoffman@fda.hhs.govDraft 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.govDraft GFI #120 – Veterinary Feed Directive Regulation Questions and Answers (Revision)
			Kelly Louviere, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Rockville, MD 20855, 240-402-5815, kelly.louviere@fda.hhs.govDraft GFI #___ – Food Ingredients for the Control of Simple Halitosis (Bad Breath) in Pets
			Sara Sklenka, Center for Veterinary Medicine (HFV-221), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, sara.sklenka@fda.hhs.govDraft GFI #___ – Diversion or Reconditioning of Damaged, Contaminated, or Adulterated Food for Use as Animal Food
			Jennifer Erickson, Center for Veterinary Medicine (HFV-230). 7519 Standish Place, Rockville, MD 20855, 240-402-7382, jennifer.erickson@fda.hhs.govDraft GFI #___ – Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Foods
			Karen Donnelly, Center for Veterinary Medicine (HFV-228), 7519 Standish Place, 240-402-9802, karen.donnelly2@fda.hhs.govDraft GFI #80 – Utility Studies for Anti-Salmonella Animal Food Additives (Revision)
			Xin Li, Center for Veterinary Medicine (HFV-222), 7519 Standish Place, Rockville, MD 20855, 240-402-5899, xin.li@fda.hhs.govDraft GFI #280___ – Alternate Names for the Labeling of Certain Corn and Sorghum Ingredients Used in Animal Food
			Charlotte Conway, Center for Veterinary Medicine (HFV-222), 7500 Standish Place, Rockville, MD 20855, 240-402-6768, charlotte.conway@fda.hhs.gov

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

Title of CPG
			ContactDraft 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.govDraft 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

                                                                                  Content current as of:
      02/01/2023Guidance for Industry

          
                        Guidance by Number
          Guidances Under Development for 2023
          Newly Added Guidances
          Withdrawn/Replaced Guidances
 
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