Standard: HHS - 21 CFR PART 13

PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

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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.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 13
Publish Date: 2015-04-01
Page Count: 5
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
21 CFR PART 13 Change Type: COMPLETE REVISION Update Date: 2016-04-01 Status: ACTV
21 CFR PART 13 Change Type: STCH Update Date: 2014-04-01 Status: INAC

Standards That Reference This Standard

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