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GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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


Docket Number:
FDA-2020-D-0064
Issued by:
Guidance Issuing Office
Office of Foods and Veterinary Medicine, 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.

Questions?

Contact Point
Ciro Ruiz-Feria
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place, HFV-229
Rockville, MD 20855