[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR13.1]

[Page 162-163]
 
                        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.




                      Subpart A_General Provisions

Sec.
13.1 Scope.
13.5 Notice of a hearing before a Board.
13.10 Members of a Board.
13.15 Separation of functions; ex parte communications; administrative 
          support.

[[Page 163]]

                      Subpart B_Hearing Procedures

13.20 Submissions to a Board.
13.25 Disclosure of data and information by the participants.
13.30 Proceedings of a Board.

              Subpart C_Records of a Hearing Before a Board

13.40 Administrative record of a Board.
13.45 Examination of administrative record.
13.50 Record for administrative decision.

    Authority: 5 U.S.C. 551-558, 701-721; 15 U.S.C. 1451-1461; 21 U.S.C. 
141-149, 321-393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 
262, 263b-263n, 264.

    Source: 44 FR 22348, Apr. 13, 1979, unless otherwise noted.



    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.