[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: 21CFR13.20]

[Page 144]
 
                        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 B--Hearing Procedures
 
Sec. 13.20  Submissions to a Board.


    (a) Submissions are to be filed with the Dockets Management Branch 
under Sec. 10.20.
    (b) The person making a submission shall serve copies of it on each 
participant in the proceeding, except as provided in Secs. 13.10(b)(2) 
and 13.45. Submissions of documentary data and information need not be 
sent to each participant, but any accompanying transmittal letter, 
summary, statement of position, certification under paragraph (d) of 
this section, or similar document must be.
    (c) A submission must be mailed to the address shown in the notice 
of appearance or personally delivered.
    (d) All submissions are to be accompanied by a certificate of 
service, or a statement that service is not required.
    (e) No written submission or other portion of the administrative 
record may be held in confidence, except as provided in 
Secs. 13.10(b)(2) and 13.45.
    (f) A participant who believes that compliance with the requirements 
of this section constitutes an unreasonable financial burden may submit 
to the Commissioner a petition to participate in forma pauperis in the 
form and manner specified in Sec. 12.82.