[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.37]

[Page 191]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17--CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
Sec. 17.37  Witnesses.

    (a) Except as provided in paragraph (b) of this section, testimony 
at the hearing shall be given orally by witnesses under oath or 
affirmation.
    (b) Direct testimony shall be admitted in the form of a written 
declaration submitted under penalty of perjury. Any such written 
declaration must be provided to all other parties along with the last 
known address of the witness. Any prior written statements of witnesses 
proposed to testify at the hearing shall be exchanged as provided in 
Sec. 17.25(a).
    (c) The presiding officer shall exercise reasonable control over the 
manner and order of questioning witnesses and presenting evidence so as 
to:
    (1) Make the examination and presentation effective for the 
ascertainment of the truth;
    (2) Avoid undue consumption of time; and
    (3) Protect witnesses from harassment or undue embarrassment.
    (d) The presiding officer shall permit the parties to conduct such 
cross-examination as may be required for a full disclosure of the facts.
    (e) At the discretion of the presiding officer, a witness may be 
cross-examined on relevant matters without regard to the scope of his or 
her direct examination. To the extent permitted by the presiding 
officer, a witness may be cross-examined on relevant matters with regard 
to the scope of his or her direct examination. To the extent permitted 
by the presiding officer, cross-examination on matters outside the scope 
of direct examination shall be conducted in the manner of direct 
examination and may proceed by leading questions only if the witness is 
a hostile witness, an adverse party, or a witness identified with an 
adverse party.
    (f) Upon motion of any party, the presiding officer may order 
witnesses excluded so that they cannot hear the testimony of the other 
witnesses. This rule does not authorize exclusion of:
    (1) A party who is an individual;
    (2) In the case of a party that is not an individual, an officer or 
employee of the party designated to be the party's sole representative 
for purposes of the hearing; or
    (3) An individual whose presence is shown by a party to be essential 
to the presentation of its case, including an individual employed by a 
party engaged in assisting counsel for the party.
    (g) If a witness' testimony is submitted in writing prior to cross-
examination, the cross-examining party need not subpoena the witness or 
pay for his or her travel to the hearing. The sponsoring party is 
responsible for producing the witness at its own expense, and failure to 
do so shall result in the striking of the witness' testimony.