Page:United States Statutes at Large Volume 116 Part 1.djvu/669

 PUBLIC LAW 107-188-JUNE 12, 2002 116 STAT. 643 (b) or (c) to such product is not necessary to protect public health and safety. " (ii) CERTAIN PROCESSES. —Regulations under subsections (b) and (c) shall set forth the procedures for applying for an exemption under clause (i). In the Deadline. case of investigational products authorized under any of the Acts specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption not later than 14 days after the first date on which both of the following conditions have been met by the person requesting the exemption: "(I) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary. "(II) The person has notified the Secretary that the investigation has been authorized under such an Act. "(3) PUBLIC HEALTH EMERGENCIES.— The Secretary may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the timely participation of the person in a response to a domestic or foreign public health emergency (whether determined under section 319(a) or otherwise) that involves a listed agent or toxin. With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that the Secretary, after review of whether such exemption remains necessary, may provide one extension of an additional 30 days. "(4) AGRICULTURAL EMERGENCIES.—Upon request of the Secretary of Agriculture, after the granting by such Secretary of an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of 2002 pursuant to a finding that there is an agricultural emergency, the Secretary of Health and Human Services may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, to provide for the timely participation of the person in a response to the agricultural emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human Services may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days. "(h) DISCLOSURE OF INFORMATION.— "(1) NONDISCLOSURE OF CERTAIN INFORMATION.— No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following: "(A) Any registration or transfer documentation submitted under subsections (b) and (c) for the possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a specific registered person. "(B) The national database developed pursuant to subsection (d), or any other compilation of the registration or transfer information submitted under subsections (b)

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