[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.23]

[Page 186-187]
 
                        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. 17.23  Discovery.

    (a) No later than 60 days prior to the hearing, unless otherwise 
ordered by the presiding officer, a party may make a request to another 
party for production, inspection, and copying of documents that are 
relevant to the issues before the presiding officer. Documents must be 
provided no later than 30 days after the request has been made.
    (b) For the purpose of this part, the term documents includes 
information, reports, answers, records, accounts, papers and other data 
and documentary evidence. Nothing contained in this section may be 
interpreted to require the creation of a document, except that requested 
data stored in an electronic data storage system must be produced in a 
form readily accessible to the requesting party.
    (c) Requests for documents, requests for admissions, written 
interrogatories, depositions, and any forms of discovery, other than 
those permitted under paragraphs (a) and (e) of this section, are not 
authorized.
    (d)(1) Within 10 days of service of a request for production of 
documents, a party may file a motion for a protective order.
    (2) The presiding officer may grant a motion for a protective order, 
in whole or in part, if he or she finds that the discovery sought:
    (i) Is unduly costly or burdensome,
    (ii) Will unduly delay the proceeding, or
    (iii) Seeks privileged information.
    (3) The burden of showing that a protective order is necessary shall 
be on the party seeking the order.
    (4) The burden of showing that documents should be produced is on 
the party seeking their production.

[[Page 187]]

    (e) The presiding officer shall order depositions upon oral 
questions only upon a showing that:
    (1) The information sought cannot be obtained by alternative 
methods, and
    (2) There is a substantial reason to believe that relevant and 
probative evidence may otherwise not be preserved for presentation by a 
witness at the hearing.