21 C.F.R. § 15.1 Scope.
The procedures in this part apply when:
(a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administation.
(b) The act or regulation specifically provides for a public hearing before the Commissioner on a matter, e.g., § 330.10(a)(8) relating to over-the-counter drugs and sections 520 (b) and (f)(1)(B), and 521 of the act relating to proposals to allow persons to order custom devices, to proposed device good manufacturing practice regulations, and to proposed exemptions from preemption of State and local device requirements under § 808.25(e).
(c) A person who has right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead requests under § 12.32 a public hearing before the Commissioner, and the Commissioner, as a matter of discretion, accepts the request.