[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR13.1]

[Page 142]
 
                        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.