21 C.F.R. § 20.60

Applicability of exemptions

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(a) The exemptions established in this subpart shall apply to all Food and Drug Administration records, except as provided in subpart E of this part. Accordingly, a record that is ordinarily available for public disclosure in accordance with the provisions in subpart F of this part or of another regulation cross-referenced in § 20.100(c) is not available for such disclosure to the extent that it falls within an exemption contained in this subpart, except as provided by the limitations on exemptions specified in subpart E of this part. For example, correspondence that is ordinarily disclosable under § 20.103 is not disclosable to the extent that it contains trade secrets exempt from disclosure under § 20.61 and is not subject to discretionary release under § 20.82.

(b) Where application of one or more exemptions results in a record being disclosable in part and nondisclosable in part, the rule established in § 20.22 shall apply.

Notes of Decisions

Cited in 3 cases, 1981–2009 · leading case: In Re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 632 F. Supp. 2d 1370 (M.D. Ga. 2009).

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In Re Mentor Corp. ObTape Transobturator Sling Prods. Liab. Litig., 632 F. Supp. 2d 1370 (M.D. Ga. 2009). · cites it 6× “Furthermore, Plaintiffs argue that 21 C.F.R. § 20.60 limits section 20.63 by providing that “[t]he exemption! ] .”

Waelde v. Merck, 94 F.R.D. 27 (E.D. Mich. 1981). “See 21 CFR §§ 20.60 , 20.61, 20.100(17) and 314.”

Pub. Citizen Health Rsch. Grp. v. Food & Drug Admin., 997 F. Supp. 56 (D.D.C. 1998). “430(f) without consideration of the entire regulatory context is misplaced, and that the proper regulation to look to in order to resolve this matter is 21 C.F.R. § 20.60 (“Applicability of Exemptions”).”

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