21 USC 379 - Confidential information

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)

Time limitations

(3)

Disclosures not affected

(4)

Relation to other law

(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 331(j) of this title to foreign governments subject to the following criteria:

(1)

Certification

(2)

Written agreement

(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 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)

Effect of subsection

(June 25, 1938, ch. 675, § 708, as added Pub. L. 94–295, § 8, May 28, 1976, 90 Stat. 582; amended Pub. L. 112–144, title VII, § 710, July 9, 2012, 126 Stat. 1070.)

cite as: 21 USC 379

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