§ 379. Confidential information

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 8 · 90 Stat. 539

   Enacted · 21 U.S.C. § 379

   June 25, 1938, ch. 675, § 708, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 582

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 708, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 582

   Enacted provision · exact public law section
   Sec. 8. confidential information; presumption Chapter 7 is amended by adding at the end the following new sections: “Sec. 708. The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, 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 Act, 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. “Sec. 709. “presumption In any action to enforce the requirements of this Act 21 USC 379a. respecting a device the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.”.

2. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title VII § 710 · 126 Stat. 993

   1. Amended · 21 U.S.C. § 379

      Pub. L. 112–144 designated existing provisions as subsec. (a)

   2. Inserted · 21 U.S.C. § 379

      Pub. L. 112–144 inserted heading

   3. Added · 21 U.S.C. § 379

      Pub. L. 112–144 added subsecs. (b) and (c)

   Source evidence

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

   Enacted provision · exact public law section
   SEC. 710. EXCHANGE OF INFORMATION.   Section 708 (21 U.S.C. 379) is amended— (1) by striking “confidential information” and all that follows through “The Secretary may provide” and inserting the following: “SEC. 708. CONFIDENTIAL INFORMATION. “(a) Contractors.— The Secretary may provide” ; and (2) by adding at the end the following: “(b) Ability To Receive and Protect Confidential Information Obtained From Foreign Governments.— “(1) In general.— The Secretary shall not be required to disclose under section 552 of title 5, United States Code (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) Time limitations.— 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, United States Code, and section 319L(e)(1) of the Public Health Service Act, 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) Disclosures not affected.— 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) Relation to other law.— For purposes of section 552 of title 5, United States Code, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552. “(c) Authority To Enter Into Memoranda of Understanding for Purposes of Information Exchange.— The Secretary may enter into written agreements to provide information referenced in section 301(j) to foreign governments subject to the following criteria: “(1) Certification.— 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) Written agreement.— 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 319 of the Public Health Service Act that is relevant to the information. “(3) Information exchange.— 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 301(j) 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) Effect of subsection.— 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.” .

4 of 4 references resolved to an enrolled provision