[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: 21CFR12.92]
[Page 126-127]
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. 12.92 Prehearing conference procedure.
(a) Participants in a hearing are to appear at the prehearing
conference prepared to discuss and resolve all matters specified in
paragraph (b) of this section.
(1) To expedite the hearing, participants are encouraged to prepare
in advance for the prehearing conference. Participants should cooperate
with each other, and request information and begin preparation of
testimony at the earliest possible time. Failure of a participant to
appear at the prehearing conference or to raise matters that could
reasonably be anticipated and resolved at that time will not delay the
progress of the hearing, and constitutes a waiver of the rights of the
participant regarding such matters as objections to the agreements
reached, actions taken, or rulings issued by the presiding officer and
may be grounds for striking the participation under Sec. 12.45.
(2) Participants shall bring to the prehearing conference the
following specific information, which will be filed with the Division of
Dockets Management under Sec. 12.80:
(i) Any additional information to supplement the submission filed
under Sec. 12.85, which may be filed if approved under Sec. 12.85(c).
(ii) A list of all witnesses whose testimony will be offered, orally
or in writing, at the hearing, with a full curriculum vitae for each.
Additional witnesses may later be identified, with the approval of the
presiding officer, on a showing that the witness was not reasonably
available at the time of the prehearing conference or the relevance of
the witness' views could not reasonably have been foreseen at that time.
(iii) All prior written statements including articles and any
written statement signed or adopted, or a recording or transcription of
an oral statement made, by persons identified as witnesses if--
(a) The statement is available without making request of the witness
or any other person;
(b) The statement relates to the subject matter of the witness'
testimony; and
(c) The statement either was made before the time the person agreed
to become a witness or has been made publicly available by the person.
(b) The presiding officer will conduct a prehearing conference for
the following purposes:
(1) To determine the areas of factual disagreement to be considered
at the hearing. The presiding officer may hold conferences off the
record in an effort to reach agreement on disputed factual questions.
(2) To identify the most appropriate techniques for developing
evidence on issues in controversy and the manner and sequence in which
they will be used, including, where oral examination is to be conducted,
the sequence in which witnesses will be produced for, and the time and
place of, oral examination. The presiding officer may consider--
(i) Submission of narrative statements of position on factual issues
in controversy;
(ii) Submission of evidence or identification of previously
submitted evidence to support such statements, such as affidavits,
verified statements of fact, data, studies, and reports;
(iii) Exchange of written interrogatories directed to particular
witnesses;
(iv) Written requests for the production of additional
documentation, data, or other relevant information;
(v) Submission of written questions to be asked by the presiding
officer of a specific witness; and
(vi) Identification of facts for which oral examination and/or
cross-examination is appropriate.
(3) To group participants with substantially like interests for
presenting evidence, making motions and objections, including motions
for summary decision, filing briefs, and presenting oral argument.
(4) To hear and rule on objections to admitting into evidence
information submitted under Sec. 12.85.
(5) To obtain stipulations and admissions of facts.
(6) To take other action that may expedite the hearing.
[[Page 127]]
(c) The presiding officer shall issue, orally or in writing, a
prehearing order reciting the actions taken at the prehearing conference
and setting forth the schedule for the hearing. The order will control
the subsequent course of the hearing unless modified by the presiding
officer for good cause.
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