21 CFR § 20.28
Food and Drug Administration determinations of confidentiality
June 25, 2020
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]