# 21 CFR § 20.81: Data and information previously disclosed to the public

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-20.81

## Section

- **Citation:** 21 CFR § 20.81
- **Heading:** Data and information previously disclosed to the public
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL > PART 20—PUBLIC INFORMATION > Subpart E—Limitations on Exemptions

## Text

(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 commercial 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.
(b) Any statement relating to prior public disclosure is subject to the False Reports to the Government Act, 18 U.S.C. 1001.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 59 FR 536, Jan. 5, 1994; 68 FR 25287, May 12, 2003]

## Nearby sections

- [21 CFR § 20.1 § 20.1 Testimony by Food and Drug Administration employees.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.1.md)
- [21 CFR § 20.2 § 20.2 Production of records by Food and Drug Administration employees.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.2.md)
- [21 CFR § 20.3 § 20.3 Certification and authentication of Food and Drug Administration records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.3.md)
- [21 CFR § 20.20 § 20.20 Policy on disclosure of Food and Drug Administration records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.20.md)
- [21 CFR § 20.21 § 20.21 Uniform access to records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.21.md)
- [21 CFR § 20.22 § 20.22 Partial disclosure of records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.22.md)
- [21 CFR § 20.23 § 20.23 Request for existing records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.23.md)
- [21 CFR § 20.24 § 20.24 Preparation of new records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.24.md)
- [21 CFR § 20.25 § 20.25 Retroactive application of regulations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.25.md)
- [21 CFR § 20.26 § 20.26 Electronic availability and indexes of certain records.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.26.md)
- [21 CFR § 20.27 § 20.27 Submission of records marked as confidential.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.27.md)
- [21 CFR § 20.28 § 20.28 Food and Drug Administration determinations of confidentiality.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.28.md)
- [21 CFR § 20.29 § 20.29 Prohibition on withdrawal of records from Food and Drug Administration files.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.29.md)
- [21 CFR § 20.30 § 20.30 Food and Drug Administration Division of Freedom of Information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-20.30.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-20.81. Check the current official text before relying on it. Not legal advice.