[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: 21CFR13.20]
[Page 133]
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 Division of Dockets
Management 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 Sec. Sec.
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 Sec. Sec.
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.
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