U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) has issued Program Policy and Procedures Manual (PPM) 1244.3425, formalizing internal evaluation timelines and pre-filing procedures for Generally Recognized as Safe (GRAS) notices submitted for animal food ingredients.
The procedural manual, managed under the CVM’s Office of Surveillance and Compliance Division of Animal Food Ingredients (DAFI), establishes a 30-day pre-file administrative review window upon submission receipt. Once accepted, the filing date marks Day 1 of a structured 180-day evaluation timeframe, which may be extended by up to 90 days under 21 CFR 570.265(b) to hit a maximum 270-day review cap.
Key Review Milestones (Calendar Days)
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Day 0: Filing letter date (if the notice passes the 30-day pre-filing evaluation).
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Day 75: Target date for an internal reviewer meeting.
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Day 90: Target date for FDA to send its first round of questions to the notifier.
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Day 104: Target date for the notifier’s first amendment (an extension of about one week may be permitted).
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Day 134: Target date for a second round of FDA questions (if needed).
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Day 148: Target date for a second amendment (extensions are not planned for this amendment).
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Day 215 or Day 270: Target date for FDA’s final response letter, depending on whether one or two amendments are submitted
