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21CFR17.28

§ 17.28 Protective order.

Regulation Text

(a) A party or a prospective witness may file a motion for a protective order with respect to discovery sought by a party or with respect to the hearing, seeking to limit the availability or disclosure of evidence. (b) When issuing a protective order, the presiding officer may make any order which justice requires to protect a party or person from oppression or undue burden or expense, or to protect trade secrets or confidential commercial information, as defined in § 20.61 of this chapter , information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, or other information that would be withheld from public disclosure under 21 CFR part 20 . Such orders may include, but are not limited to, one or more of the following: (1) That the discovery not be had; (2) That the discovery may be had only on specified terms and conditions, including a designation of the time or place; (3) That the discovery may be had only through a method of discovery provided for by this part other than that requested; (4) That certain matters not be inquired into, or that the scope of discovery be limited to certain matters; (5) That the contents of discovery or evidence be sealed; (6) That the information not be disclosed to the public or be disclosed only in a designated way; or (7) That the parties simultaneously file specified documents or information enclosed in sealed envelopes to be opened as directed by the presiding officer.

Authority

15 U.S.C. 1451-1461;21 U.S.C. 141-149,321-394,467f,679,821,1034;28 U.S.C. 2112;42 U.S.C. 201-262,263b,364.

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21CFR17.28 — § 17.28 Protective order. | CFR Explorer | BioRegHub