21 CFR 17.23
§ 17.23 Discovery.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 17.23, § 17.23 Discovery, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83263
- Permanent ID
ys:prov:83263@1- SHA-256
e8b85f1115b8cec51dd78389556755ddbd6c0aab370c014b735ade4aebb0b51c
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.