[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: 21CFR12.85]
[Page 123-124]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart E Hearing Procedures
Sec. 12.85 Disclosure of data and information by the participants.
(a) Before the notice of hearing is published under Sec. 12.35, the
director of the center responsible for the matters involved in the
hearing shall submit the following to the Division of Dockets
Management:
(1) The relevant portions of the 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.
[[Page 124]]
(2) 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.
(3) All other documentary data and information relied upon.
(4) A narrative position statement on the factual issues in the
notice of hearing and the type of supporting evidence the director
intends to introduce.
(5) A signed statement that, to the director's best knowledge and
belief, the submission complies with this section.
(b) Within 60 days of the publication of the notice of hearing or,
if no participant will be prejudiced, within another period of time set
by the presiding officer, each participant shall submit to the Division
of Dockets Management all data and 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 data and information specified in
paragraph (a)(2) of this section, participants shall exercise reasonable
diligence in identifying documents in files comparable to those
described in that paragraph.
(c) Submissions required by paragraphs (a) and (b) of this section
may be supplemented later in the proceeding, with the approval of the
presiding officer, upon a showing that the material contained in the
supplement was not reasonably known or available when the submission was
made or that the relevance of the material contained in the supplement
could not reasonably have been forseen.
(d) A participant's failure to comply substantially and in good
faith with this section constitutes a waiver of the right to participate
further in the hearing; failure of a party to comply constitutes a
waiver of the right to a hearing.
(e) Participants may reference each other's submissions. To reduce
duplicative submissions, participants are encouraged to exchange and
consolidate lists of documentary evidence. If a particular document is
bulky or in limited supply and cannot reasonably be reproduced, and it
constitutes relevant evidence, the presiding officer may authorize
submission of a reduced number of copies.
(f) The presiding officer will rule on questions relating to this
section.
[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989]
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