[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: 21CFR17.25]

[Page 188]
 
                        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. 17.25  Exchange of witness lists, witness statements, and exhibits.

    (a) At least 30 days before the hearing, or by such other time as is 
specified by the presiding officer, the parties shall exchange witness 
lists, copies of prior written statements of proposed witnesses, and 
copies of proposed hearing exhibits, including written testimony.
    (b)(1) If a party objects to the proposed admission of evidence not 
exchanged in accordance with paragraph (a) of this section, the 
presiding officer will exclude such evidence if he or she determines 
that the failure to comply with paragraph (a) of this section should 
result in its exclusion.
    (2) Unless the presiding officer finds that extraordinary 
circumstances justified the failure to make a timely exchange of witness 
lists under paragraph (a) of this section, he or she must exclude from 
the party's hearing evidence the testimony of any witness whose name 
does not appear on the witness list.
    (3) If the presiding officer finds that extraordinary circumstances 
existed, the presiding officer must then determine whether the admission 
of the testimony of any witness whose name does not appear on the 
witness lists exchanged under paragraph (a) of this section would cause 
substantial prejudice to the objecting party. If the presiding officer 
finds that there is not substantial prejudice, the evidence may be 
admitted. If the presiding officer finds that there is substantial 
prejudice, the presiding officer may exclude the evidence, or at his or 
her discretion, may postpone the hearing for such time as is necessary 
for the objecting party to prepare and respond to the evidence.
    (c) Unless a party objects within 5 days prior to the hearing, 
documents exchanged in accordance with paragraph (a) of this section 
will be deemed to be authentic for the purpose of admissibility at the 
hearing.