StacksVerified U.S. regulatory reference

21 CFR §12.1

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The procedures in this part apply when—
  1. (a)A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or
  2. (b)The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.