21 CFR 20.28 - Food and Drug Administration determinations of confidentiality.

Regulations last checked for updates: Feb 10, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart B [§ 20.20 - § 20.34]

§ 20.28 - Food and Drug Administration determinations of confidentiality.

A determination that data or information submitted to the Food and Drug Administration will be held in confidence and will not be available for public disclosure shall be made only in the form of a regulation published or cross-referenced in this part.

[42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003]

authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393,1401; 42 U.S.C. 241,242,242a,242l,242n,243,262,263,263b-263n,264,265,300u,300aa

source: 42 FR 15616, Mar. 22, 1977, unless otherwise noted.

cite as: 21 CFR 20.28