21 C.F.R. § 13.1   Scope.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 13—PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
Subpart A—General Provisions

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§ 13.1   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 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.

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