[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.

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