Regulation Text
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.
Authority
5 U.S.C. 551-558,701-721;15 U.S.C. 1451-1461;21 U.S.C. 141-149,321-393,467f,679,821,1034;28 U.S.C. 2112;42 U.S.C. 201,262,263b-263n,264.