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.
- 21 CFR 10.20 — Submission of Documents to Division of Dockets Management; Computation of Time; Availability for Public Disclosure.
- 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 14.171 — Utilization of an Advisory Committee on the Initiative of FDA.
- 21 CFR 20.111 — Data and Information Submitted Voluntarily to the Food and Drug Administration.
- 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 123.9 — Records.
- 21 CFR 814.9 — Confidentiality of Data and Information in a Premarket Approval Application (PMA) File.
- 21 CFR 71.15 — Confidentiality of Data and Information in Color Additive Petitions.
- 21 CFR 16.60 — Hearing Procedure.
- 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.
- 21 CFR 20.80 — Applicability of Limitations on Exemptions.
- 21 CFR 14.27 — Determination to Close Portions of Advisory Committee Meetings.
- 21 CFR 1.243 — Is Food Registration Information Available to the Public?