21 CFR 20.81 - Data and information previously disclosed to the public.
(a) Any Food and Drug Administration record that is otherwise exempt from public disclosure pursuant to subpart D of this part is available for public disclosure to the extent that it contains data or information that have previously been disclosed in a lawful manner to any member of the public, other than an employee or consultant or pursuant to other commerical arrangements with appropriate safeguards for secrecy.
(1) For purposes of this section, an individual shall be deemed to be a consultant only if disclosure of the information was necessary in order to perform that specific consulting service and the purpose of the disclosure was solely to obtain that service. The number of consultants who have received such information shall have been limited to the number reasonably needed to perform that particular consulting service.
(2) For purposes of this section, other commercial arrangements shall include licenses, contracts, and similar legal relationships between business associates.
(3) For purposes of this section, data and information disclosed to clinical investigators or members of institutional review committees, whether required by regulations of the Food and Drug Administration, or made voluntarily, if accompanied by appropriate safeguards to assure secrecy and otherwise in accordance with this section, are not deemed to have been previously disclosed to any member of the public within the meaning of paragraph (a) of this section.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 20 after this date.
- 21 CFR 314.430 — Availability for Public Disclosure of Data and Information in an Application or Abbreviated Application.
- 21 CFR 514.11 — Confidentiality of Data and Information in a New Animal Drug Application File.
- 21 CFR 571.1 — Petitions.
- 21 CFR 10.65 — Meetings and Correspondence.
- 21 CFR 171.1 — Petitions.
- 21 CFR 108.25 — Acidified Foods.
- 21 CFR 108.35 — Thermal Processing of Low-Acid Foods Packaged in Hermetically Sealed Containers.
- 21 CFR 601.51 — Confidentiality of Data and Information in Applications for Biologics Licenses.
- 21 CFR 720.8 — Confidentiality of Statements.
- 21 CFR 71.15 — Confidentiality of Data and Information in Color Additive Petitions.
- 21 CFR 860.5 — Confidentiality and Use of Data and Information Submitted in Connection With Classification and Reclassification.
- 21 CFR 120.12 — Records.
- 21 CFR 516.171 — Confidentiality of Data and Information in an Index File.