Code of Federal Regulations Title 21. Food and Drugs § 21.507.77 Timeframe for issuing a decision on an appeal

(1) If FDA grants the request for a hearing and the hearing is held, the presiding officer must provide a 2 calendar day opportunity for the hearing participants to review and submit comments on the report of the hearing under § 507.73(c)(4), and must issue a final decision within 10 calendar days after the hearing is held;  or

(2) If FDA denies the request for a hearing, the presiding officer must issue a final decision on the appeal confirming or revoking the withdrawal within 10 calendar days after the date the appeal is filed.