§379 — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can give information that is normally kept from the public under the Freedom of Information Act to someone outside the Department if that person needs it to do work under a contract that helps run the laws in this chapter and the Secretary is allowed to use the information. Anyone who gets the information must follow security rules the Secretary sets. Information about drugs that comes from a foreign government can be kept from the public if three things are true: it deals with inspections, investigations, warnings, or a drug that could cause serious harm or death; the foreign government shared it voluntarily on the condition it not be released; and there is a written agreement with the Secretary. That agreement must say how long the protection lasts; if it gives no date, the protection lasts no more than 36 months. This rule does not let officials hide information from Congress or from a U.S. court order. The Secretary can also make agreements to share certain FDA information with foreign governments that the FDA Commissioner has certified can protect trade secrets. Those agreements must say the foreign government will keep the information secret until the drug sponsor agrees to release it or the Secretary declares a relevant public health emergency.

Title 21, §379

Food and Drugs — Source: USLM XML via OLRC

(a)The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in connection with an activity which is undertaken under contract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or employee of the Department) is not prohibited from using such information. The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may by regulation prescribe.

(b)(1)The Secretary shall not be required to disclose under section 552 of title 5 (commonly referred to as the “Freedom of Information Act”), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—

(A)the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;

(B)the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and

(C)the information is covered by, and subject to, a written agreement between the Secretary and the foreign government.

(2)The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.

(3)Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.

(4)For purposes of section 552 of title 5, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552.

(c)The Secretary may enter into written agreements to provide information referenced in section 331(j) of this title to foreign governments subject to the following criteria:

(1)The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.

(2)The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 247d of title 42 that is relevant to the information.

(3)The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 331(j) of this title in only the following circumstances:

(A)Information concerning the inspection of a facility may be provided to a foreign government if—

(i)the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and

(ii)the written agreement executed under paragraph (2) limits the recipient’s use of the information to the recipient’s civil regulatory purposes.

(B)Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

(4)Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.

Editorial Notes

Amendments

2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

§379 Confidential information

Summary

Title 21, §379

Notes & Related Subsidiaries

Editorial Notes

Amendments

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