§117.277. Timeframe for issuing a decision on an appeal.
21 C.F.R. § 117.277
If you appeal the order without requesting a hearing, the presiding officer must issue a written report that includes a final decision confirming or revoking the withdrawal by the 10th calendar day after the appeal is filed.
If you appeal the order and request an informal hearing:
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 § 117.270(c)(4), and must issue a final decision within 10-calendar days after the hearing is held; or
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Source
Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.