[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR13.5]

[Page 140]
 
                        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. 13.5  Notice of a hearing before a Board.

    If the Commissioner determines that a Board should be established to 
conduct a hearing on any matter, a notice of hearing will be published 
in the Federal Register setting forth the following information:
    (a) If the hearing is under Sec. 13.1 (a) or (b), all applicable 
information described in Sec. 12.32(e).
    (1) Any written document that is to be the subject matter of the 
hearing will be published as a part of the notice, or the notice will 
refer to it if the document has already been published in the Federal 
Register or state that the document is available from the Dockets 
Management Branch or an agency employee designated in the notice.
    (2) For purposes of a hearing under Sec. 13.1 (a) or (b), all 
participants who file a notice of participation under 
Sec. 12.32(e)(6)(ii) are deemed to be parties and entitled to 
participate in selection of the Board under Sec. 13.15(b).
    (b) If the hearing is in lieu of a formal evidentiary hearing, as 
provided in Sec. 13.1(c), all of the information described in 
Sec. 12.32(e).

[44 FR 22348, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982]