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FDA offers FAP, GRAS pre-submission guidance

Agency releases draft guidance on stakeholder consultations for development of animal food additive petitions and GRAS notices.

On Feb. 12, the U.S. Food & Drug Administration released a draft guidance describing the recommended types of information for stakeholders — industry, academia, other organizations or an individual — to include in consultations with FDA before submitting an animal food additive petition (FAP) or a notice concluding that a substance is "generally recognized as safe" (GRAS) for its intended use in animal food to the agency.

FDA said pre-submission consultations are intended to help stakeholders comply with the applicable requirements for an FAP or a GRAS notice, making the submission process more efficient and effective and facilitating the introduction of safe new products onto the market.

"Draft GFI #262: Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices," when finalized, will facilitate pre-submission consultations between FDA and stakeholders by providing non-binding recommendations for submissions to investigational food additive (IFA) files, using foreign data in a submission, describing circumstances under which the submission of study protocols is recommended, an explanation of FDA’s review process for IFA submissions and best practices for communication between FDA and stakeholders regarding these regulatory submissions, the agency said.

The draft guidance strongly encourages stakeholders to contact FDA’s Center for Veterinary Medicine early in the FAP or GRAS notice development process by emailing Animalfood-premarket@fda.hhs.gov. Engaging with the agency while these submissions are still in progress allows stakeholders to discuss questions and concerns as they arise and has the potential to improve the quality and success of FAPs or GRAS notice submissions, FDA said.

FDA is accepting public comments on this draft guidance for 60 days from the date of the notice of availability in the Federal Register. To electronically submit comments to the docket, visit www.regulations.gov, and type FDA-2020-D-0064 into the search box. For assistance in submitting electronic comments, see www.regulations.gov/help.

To submit comments to the docket by mail, be sure to include docket number FDA-2020-D-0064 on each page of your written comments, and send to the following address:

Dockets Management Staff
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments will be accepted at any time but should be submitted no later than April 13, 2020, to ensure that FDA takes the information into consideration before it begins work on the final version of this guidance.

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