§ 12.1. Scope.
50 words·~1 min read·
/us/cfr/t21/s§ 12.1A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The procedures in this part apply when—
(a)A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or
(b)The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.