part_subject: "PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "13.1"
section_subject: "Scope."
cfr_reference: "21 CFR 13.1"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.