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 the 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).

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3-6-2 - “Receive and Review”

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.

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3-6-3 - Personal Privacy Information

The Privacy Act of 1974 has an impact on cooperating officials because FDA:

1. might ask the candidate for a commission to supply personal information;

2. might conduct a background check of the candidate;

3. will maintain a personnel file on the commissioned official in the FDA Regional Office and DFSR; and

4. if permitted by the Privacy Act, might give the commissioned official personal privacy information protected by that law. Files maintained on commissioned officials are subject to the Privacy Act. A commissioned official may review his or her own file by requesting a copy of it from RFDD under the Privacy Act. All other questions about a commissioned officials file should be addressed to FDA’s Division Freedom of Information (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

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3-6-4 - Sharing Non-public Information under 21 C.F.R. § 20.88 (State)

For state or local officials, if the agency head (or other management) cannot or will not accept a commission, FDA may consider using the "Confidentiality Commitment Form," under 21 CFR § 20.88, to enable the agency to share non-public information with the state. This form and its use are covered under the current "Information Disclosure Manual" section entitled "FDA Information Disclosure Procedures - Sharing Non-Public Information with State or Local Government Officials,” dated November 6, 2001.

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3-6-5 - Sharing Non-public Information under 21 C.F.R. § 20.85 (Federal)

For Federal officials, the MOU should contain provisions about the sharing of non-public information. If FDA determines that it is unable to share non-public information with a particular Federal official, because that individual is not commissioned, FDA is not precluded from considering whether to disclose 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 Division of Compliance Policy (HFC-230) for further details, and refer to the Information Disclosure Manual section entitled "FDA Information Disclosure Procedures - Sharing Non-Public Information with Federal Government Officials,” dated November 6, 2001.

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