21 CFR 12.1 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 1.1 To § 99.501) — Food And Drug Administration, Department Of Health And Human Services (§ 1.1 To § 99.501) — General (§ 1.1 To § 99.501) — Formal Evidentiary Public Hearing (§ 12.1 To § 12.159) — General Provisions (§ 12.1) — Scope.

4 Aug 2016

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.

21 CFR 12.1