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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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3-6 - CONFIDENTIALITY

3-6 - CONFIDENTIALITY
     3-6-1 - Written Assurances
     3-6-2 - Receive and Review FDA Information
     3-6-3 - Sharing Non-public Information under 21 C.F.R. § 20.88 (State)
     3-6-4 - Sharing Non-public Information under 21 C.F.R. § 20.85 (Federal)

 3-6 - CONFIDENTIALITY

 3-6-1 - Written Assurances

State or local officials seeking commissioning and Commissioned Officials considered for renewal are asked to attest in writing, e.g., through the Acceptance of Commission form (Exhibit 3-2), that they understand that any non-public information FDA provides for review is entitled to significant protection under Federal law. The official further understands that if they make any unauthorized disclosures of non-public information they may be committing a criminal violation under Federal Law (21 U.S.C. § 331(j) and 18 U.S.C. § 1905).

 3-6-2 - Receive and Review FDA Information

FDA may provide a state or local official, who is commissioned to “receive and review FDA information”, with information that is protected from disclosure to the public by the Freedom of Information Act (see 21 CFR § 20.84). Examples of non-public information include confidential commercial information, trade secrets, and other non-public information, such as personal privacy information. Whenever FDA provides a commissioned official, in accordance with the Act and FDA regulations, with non-public information, FDA should indicate that the information is non-public, e.g., by affixing a transmittal letter which cautions the recipient against further disclosure. The document’s envelope should be identified "To Be Opened By Addressee Only."

See Exhibit 3-11 for a Model letter used to transmit non-public information.

 3-6-3 - Sharing Non-public Information under 21 C.F.R. § 20.88 (State)

FDA may share certain non-public information pursuant 21 CFR 20.88 with state and local officials, including those officials who are not commissioned. For FDA to share confidential commercial information, there must be a written statement from the state agency establishing that the State government agency has the authority to protect confidential commercial information from disclosure and a written commitment that the State government agency will not further disclose any such information provided to it. This is called a 20.88 agreement. Trade secrets and information prohibited from disclosure under the Privacy Act may not be shared under 20.88 agreements.

ORA's Office of Partnerships has established a number of 20.88 agreements which provide a streamlined process for information sharing related to food (including animal feed) and cosmetics. For other 20.88 agreements, contact ORA's Office of Policy and Risk Management.

 3-6-4 - Sharing Non-public Information under 21 C.F.R. § 20.85 (Federal)

FDA may share certain non-public information to the other Federal agency under 21 C.F.R. § 20.85 (Disclosure to other Federal government departments and agencies). Contact ORA’s Office of Policy and Risk Management (HFC-230) for further details.