TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 17 - CIVIL MONEY PENALTIES HEARINGS

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.

  (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.