To modify and limit certain exemptions to the Freedom of Information Act.

SA 2142. Mr. LEAHY submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:

On page 192, strike line 10 through line 21 and insert the following:

(2) by adding at the end the following:

“(b) Ability to Receive and Protect Confidential Information Obtained From Foreign Government Agencies Relating to Drug Inspections.--

“(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 drug inspections obtained from a foreign government agency, if--

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

“(B) the foreign government agency, in writing, requests that the information be kept confidential; and

“(C) the Secretary determines that the requirements under subparagraphs (A) and (B) have been satisfied.

“(2) Time limitations.--A foreign government agency may specify in a request described in paragraph (1)(B) that the voluntarily-provided information be withheld from disclosure for a specified time period. Such information may not be withheld under this subsection after the date specified. If no such date is specified, the withholding period shall not exceed 3 years.

“(3) Disclosures not affected.--Nothing in this subsection 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. For purposes of section 552 of title 5, United States Code, this subsection shall be considered a statute described in section 552(b)(3)(B).