[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR13.1]
[Page 131]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 13 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY--Table of Contents
Subpart A General Provisions
Sec. 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 Sec. 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.
[[Page 132]]
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