§ 13.1. Scope.
107 words·~1 min read·
/us/cfr/t21/s§ 13.1A 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)The Commissioner concludes, as a matter of discretion, that it is in the public interest to hold a public hearing before a Public Board of Inquiry (Board) with respect to any matter before FDA;
(b)Under specific sections of this chapter a matter before FDA is subject to a hearing before a Board; or
(c)Under § 12.32, a person who has a right to an opportunity for a formal evidentiary public hearing waives that opportunity and requests that a Board act as an administrative law tribunal concerning the matters involved, and the Commissioner decides to accept this request.