21 CFR 117.277
§ 117.277 Timeframe for issuing a decision on an appeal.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 117.277, § 117.277 Timeframe for issuing a decision on an appeal, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84422
- Permanent ID
ys:prov:84422@1- SHA-256
c3b6081fd06f3941446b74f3e3c4e9d86f0feac146230ac2ef1abdcaee16c6e3
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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), 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.