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

---
identifier: "/us/cfr/t21/s20.28"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 20.28 - Food and Drug Administration determinations of confidentiality."
title_number: 21
title_name: "Food and Drugs"
section_number: "20.28"
section_name: "Food and Drug Administration determinations of confidentiality."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "20"
part_name: "PUBLIC INFORMATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1."
regulatory_source: "42 FR 15616, Mar. 22, 1977, unless otherwise noted."
cfr_part: "20"
---


# 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]