Guidances Under Development for 2023
Center 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 | Contact |
|---|---|
| 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, [email protected] |
| 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, [email protected] |
| 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, [email protected] |
| GFI #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, [email protected] |
| 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, [email protected] |
| 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, [email protected] |
| 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
| Draft 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, [email protected] |
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, [email protected] |
| 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, [email protected] |