[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: 21CFR12.94]
[Page 127.128]
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. 12.94 Receipt of evidence.
(a) A hearing consists of the development of evidence and the
resolution of factual issues as set forth in this subpart and in the
prehearing order.
(b) All orders, transcripts, written statements of position, written
direct testimony, written interrogatories and responses, and any other
written material submitted in the proceeding is a part of the
administrative record of the hearing, and will be promptly placed on
public display in the office of the Division of Dockets Management,
except as provided in Sec. 12.105.
(c) Written evidence, identified as such, is admissible unless a
participant objects and the presiding officer excludes it on objection
of a participant or on the presiding officer's own initiative.
(1) The presiding officer may exclude written evidence as
inadmissible only if--
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive;
(ii) Exclusion of part or all of the written evidence of a
participant is necessary to enforce the requirements of this subpart; or
(iii) The evidence was not submitted as required by Sec. 12.85.
(2) Items of written evidence are to be submitted as separate
documents, sequentially numbered, except that a voluminous document may
be submitted in the form of a cross-reference to the documents filed
under Sec. 12.85.
(3) Written evidence excluded by the presiding officer as
inadmissible remains a part of the administrative record, as an offer of
proof, for judicial review.
(d) Testimony, whether on direct or on cross-examination, is
admissible as evidence unless a participant objects and the presiding
officer excludes it.
(1) The presiding officer may exclude oral evidence as inadmissible
only if--
[[Page 128]]
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive; or
(ii) Exclusion of part or all of the evidence is necessary to
enforce the requirements of this part.
(2) If oral evidence is excluded as inadmissible, the participant
may take written exception to the ruling in a brief to the Commissioner,
without taking oral exception at the hearing. Upon review, the
Commissioner may reopen the hearing to permit the evidence to be
admitted if the Commissioner determines that its exclusion was erroneous
and prejudicial.
(e) The presiding officer may schedule conferences as needed to
monitor the program of the hearing, narrow and simplify the issues, and
consider and rule on motions, requests, and other matters concerning the
development of the evidence.
(f) The presiding officer will conduct such proceedings as are
necessary for the taking of oral testimony, for the oral examination of
witnesses by the presiding officer on the basis of written questions
previously submitted by the parties, and for the conduct of cross-
examination of witnesses by the parties. The presiding officer shall
exclude irrelevant or repetitious written questions and limit oral
cross-examination to prevent irrelevant or repetitious examination.
(g) The presiding officer shall order the proceedings closed for the
taking of oral testimony relating to matters specified in Sec.
10.20(j)(2)(i) (a) and (b). Such closed proceedings will be conducted in
accordance with Sec. 10.20(j)(3). Participation in closed proceedings
will be limited to the witness, the witness' counsel, and Federal
Government executive branch employees and special government employees.
Closed proceedings will be permitted only for, and will be limited to,
oral testimony directly relating to matters specified in Sec.
10.20(j)(3).
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