---
kind: "section"
citation: "21 C.F.R. § 117.277"
title: "21"
number: "117.277"
heading: "Timeframe for issuing a decision on an appeal."
url: "https://uscodex.org/cfr/21/117.277"
---

# §117.277. Timeframe for issuing a decision on an appeal.

- (a) 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.
- (b) If you appeal the order and request an informal hearing:
  - (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 [§ 117.270(c)(4)](/cfr/21/117.270.md?p=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.

## Notes

### 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.