C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 20—PUBLIC INFORMATION › Subpart E—Limitations on Exemptions

21 C.F.R. § 20.83

Disclosure required by court order

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(a) Records of the Food and Drug Administration which the Commissioner has determined are not available for public disclosure, in the form of a regulation published or cross-referenced in this part, shall nevertheless be made available for public disclosure in compliance with a final court order requiring such disclosure.

(b) Where the Food and Drug Administration record ordered disclosed under paragraph (a) of this section is a record about an individual that is not available for public disclosure under § 20.63, the Food and Drug Administration shall attempt to notify the individual who is the subject of the record of the disclosure, by sending a notice to the individual's last known address.

(c) Paragraph (b) of this section shall not apply where the name or other personal identifying information is deleted prior to disclosure.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25287, May 12, 2003]
Notes of Decisions
Cited in 3 cases, 1993–2015 · leading case: Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993).
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Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993). · cites it 10× “While the need for confidentiality as determined by the FDA, and as promised on form 1639 and expressed in the regulations, may yield to a proper court order under 21 C.F.R. § 20.83 (a), here the trial court ordered full disclosure without according any weight to the public…”
in Re Benevis, LLC, Dentistry of Brownsville, P.C., & Kool Smiles, P.C. (Tex. App. 2015). · cites it 4× “expressed in the regulations, may yield to a proper court order under 21 C.F.R. § 20.83 (a), here the trial court ordered full disclosure without according any weight to the public © 2015 Thomson Reuters.”
Joann Mostovoy & Vadim Mostovoy, in Their Own Right & as Best Friends of Their Son, Vjm v. Sec'y of Health & Human Servs. (Fed. Cl. 2013). “21 C.F.R. § 20.83 (a). Any order issued by this court would be unlikely to compromise the protection accorded to confidential business information and thus, would allow FDA to redact the produced documents.”
— 21 C.F.R. § 20.83(a) — 2 cases
Eli Lilly & Co. v. Marshall, 850 S.W.2d 155 (Tex. 1993). “While the need for confidentiality as determined by the FDA, and as promised on form 1639 and expressed in the regulations, may yield to a proper court order under 21 C.F.R. § 20.83 (a), here the trial court ordered full disclosure without according any weight to the public…”
in Re Benevis, LLC, Dentistry of Brownsville, P.C., & Kool Smiles, P.C. (Tex. App. 2015). “expressed in the regulations, may yield to a proper court order under 21 C.F.R. § 20.83 (a), here the trial court ordered full disclosure without according any weight to the public © 2015 Thomson Reuters.”
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