21 U.S.C. § 379 — Confidential information

This section lets the Secretary share certain confidential information under specific safeguards. (a) Contractors. The Secretary may give information that would otherwise be exempt from disclosure under section 552(a) of title 5, because of the trade-secret exemption in section 552(b)(4), to someone outside the Department, if the Secretary decides that person needs it for contract work related to running this chapter, and the Secretary (or a Department employee) is not barred from using that information either. Before giving it out, the Secretary must require the recipient to follow security precautions the Secretary sets by regulation. (b) Ability to receive and protect confidential information obtained from foreign governments. (1) The Secretary does not have to disclose, under the Freedom of Information Act (section 552 of title 5) or any other law, drug-related information from a foreign government agency if: (A) the information concerns inspecting a facility, is part of an investigation, alerts the United States to a possible need for investigation, or concerns a drug with a reasonable probability of causing serious harm or death to people or animals; (B) the information was voluntarily given to the U.S. government on condition that it not be made public; and (C) the information is covered by a written agreement between the Secretary and the foreign government. (2) That written agreement must state how long this protection lasts. After that date, this protection no longer applies, though other legal protections — including the Freedom of Information Act and section 247d–7e(e)(1) of title 42, where they apply — still do. If the agreement sets no date, the protection lasts no more than 36 months. (3) Nothing here lets any official withhold information from Congress, or information a U.S. court has ordered disclosed. (4) For purposes of the Freedom of Information Act, this subsection counts as one of the specific nondisclosure statutes described in section 552(b)(3)(B) of title 5. (c) Authority to enter into memoranda of understanding for purposes of information exchange. The Secretary may make written agreements to share information referenced in section 331(j) of this title with foreign governments, following these rules: (1) The Secretary can only agree to share information with a foreign government the Secretary has certified as having the authority and demonstrated ability to protect trade secret information from disclosure. Only the Commissioner of Food and Drugs — not anyone else — can make that certification. (2) The written agreement must include the foreign government's promise to protect the shared information from disclosure, unless the sponsor gives written permission or the Secretary declares a public health emergency under section 247d of title 42 that relates to the information. (3) The Secretary may only share section 331(j) information with a certified, agreement-bound foreign government in two situations: (A) information about inspecting a facility, if the Secretary reasonably believes — or the agreement establishes — that the government could get the information anyway, and the agreement limits its use to the government's own civil regulatory purposes; or (B) other information, as part of an investigation or to flag a possible need for one, if the Secretary has reasonable grounds to believe a drug has a reasonable probability of causing serious harm or death to people or animals. (4) Nothing in this subsection limits the Secretary's ability to make other confidential-information-sharing agreements that other laws already allow.