CVM GFI #262 Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices December 2020

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0064
• Issued by: Center for Veterinary Medicine

This guidance describes the types of information the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends be included in: 

1. pre-petition consultations prior to submission of food additive petitions (FAP) for food additives intended for use in animal food;
2. pre-submission consultations regarding an animal food substance for which an entity plans to provide notice of its conclusion that the intended use of the substance is generally recognized as safe (GRAS) under FDA’s animal food GRAS Notification program; or
3. a Food Use Authorization (FUA) request to permit the use, in human or animal foods, of animal products derived from animals that have been administered an investigational substance intended for use in animal food.

This guidance is intended to help you submit information for effective and efficient pre-submission consultations and preparation of an FUA request.  This guidance also provides detailed information that will help you navigate FDA’s current process for pre-submission consultations and FUA requests.

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Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0064.

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