[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: 21CFR13.25]

[Page 165]
 
                        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. 13.25  Disclosure of data and information by the participants.

    (a) Before the notice of hearing is published under Sec. 13.5, the 
director of the center responsible for the matters involved in the 
hearing must submit to the Division of Dockets Management --
    (1) The relevant portions of the existing administrative record of 
the proceeding. Portions of the administrative record not relevant to 
the issues in the hearing are not part of the administrative record;
    (2) A list of all persons whose views will be presented orally or in 
writing at the hearing;
    (3) All documents in the director's files containing factual 
information, whether favorable or unfavorable to the director's 
position, which relate to the issues involved in the hearing. Files 
means the principal files in the center in which documents relating to 
the issues in the hearing are ordinarily kept, e.g., the food additive 
master file and the food additive petition in the case of issues 
concerning a food additive, or the new drug application in the case of 
issues concerning a new drug. Internal memoranda reflecting the 
deliberative process, and attorney work product and material prepared 
specifically for use in connection with the hearing, are not required to 
be submitted;
    (4) All other documentary information relied on; and
    (5) A signed statement that, to the best of the director's knowledge 
and belief, the submission complies with this section.
    (b) Within the time prescribed in the notice of hearing published 
under Sec. 13.5, each participant shall submit to the Division of 
Dockets Management all information specified in paragraph (a)(2) through 
(5) of this section and any objections that the administrative record 
filed under paragraph (a)(1) of this section is incomplete. With respect 
to the information specified in paragraph (a)(3) of this section, 
participants are to exercise reasonable diligence in identifying 
documents in files comparable to those described in that paragraph.
    (c) The submissions required by paragraphs (a) and (b) of this 
section may be supplemented later in the proceeding, with the approval 
of the Board, on a showing that the views of the persons or the material 
contained in the supplement was not known or reasonably available when 
the initial submission was made or that the relevance of the views of 
the persons or the material contained in the supplement could not 
reasonably have been foreseen.
    (d) The failure to comply substantially and in good faith with this 
section in the case of a participant constitutes a waiver of the right 
to participate further in the hearing and in the case of a party 
constitutes a waiver of the right to a hearing.
    (e) The Chairman rules on questions relating to this section. Any 
participant dissatisfied with a ruling may petition the Commissioner for 
interlocutory review.

[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 
FR 9035, Mar. 3, 1989]