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 C—Procedures and Fees

21 C.F.R. § 20.53

Use of private contractor for copying

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The Food and Drug Administration may furnish requested records to a private contractor for copying after deletion of all nondisclosable data and information. Under these circumstances, the Food and Drug Administration will charge the person requesting the records for all of the fees involved pursuant to § 20.45.

[42 FR 15616, Mar. 22, 1977. Redesignated and amended at 68 FR 25286, 25287, May 12, 2003]
Notes of Decisions
Cited in 5 cases, 1982–2004 · leading case: James T. Campbell v. Dep't of Health & Human Servs. & Eli Lilly & Co., 682 F.2d 256 (D.C. Cir. 1982).
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James T. Campbell v. Dep't of Health & Human Servs. & Eli Lilly & Co., 682 F.2d 256 (D.C. Cir. 1982). “Pursuant to its established policy requiring the submitter of confidential commercial information to defend the trade secret status of such materials in FOIA litigation, see 21 C.F.R. § 20.53 (1981), 7 the FDA had notified the company of Campbell’s resort to judicial remedies.”
Allen Greenberg v. Food & Drug Admin., 803 F.2d 1213 (D.C. Cir. 1986). “Technicare, in addition to FDA and HHS, is a party to this action pursuant to 21 C.F.R. § 20.53 (1985). Under that regulation, when a challenge is made to an FDA decision to deny a FOIA request under Exemption 4, the party who submitted the information to the agency is required…”
N. Conant Webb, M.D. v. Dep't of Health & Human Servs., 696 F.2d 101 (D.C. Cir. 1982). “21 C.F.R. § 20.53 (1982). 15 . Safety and effectiveness data include “all studies and tests of a drug on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability.”
Appleton v. Food & Drug Admin., 310 F. Supp. 2d 194 (D.D.C. 2004). “FDA provided notification to the LS manufacturers pursuant to 21 C.F.R. § 20.53 , which FDA subsequently redesignated as 21 C.”
Anderson v. Sec'y of Health & Human Servs., 80 F.3d 1500 (10th Cir. 1996). “21 C.F.R. § 20.53 . After Dow withdrew its claims of confidentiality the government promptly provided copies of the documents.”
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