FDA Releases Draft Guidance on Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices

On February 13, 2020, the Food and Drug Administration (FDA) announced the availability of Draft Guidance for Industry #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices.”  When finalized, the guidance document will help industry submit information for efficient consultations with FDA’s Center for Veterinary Medicine regarding both animal feed petitions and GRAS Notices.

The draft details what information FDA would expect to review when receiving different requests (e.g., a request to review the adequacy of existing data from a completed study versus a request to review a study protocol).  The guidance also includes FDA timeline “goals” for reviewing certain types of submissions.  For example, FDA’s goal for commenting on a study protocol without method validation or preliminary data is 50 days from the date of submission receipt, whereas the goal for commenting on a study protocol with method validation or preliminary data is 130 days from the date of submission receipt.

FDA is accepting comments on the draft guidance through April 13, 2020.  Comments may be submitted here.