Page:United States Statutes at Large Volume 118.djvu/874

 118 STAT. 844 PUBLIC LAW 108–276—JULY 21, 2004 ‘‘(II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and ‘‘(III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act; or ‘‘(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if avail able, from pre clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within eight years after the date of a determination under paragraph (5); or ‘‘(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act. ‘‘(2) DETERMINATION OF MATERIAL THREATS.— ‘‘(A) MATERIAL THREAT.—The Homeland Security Sec retary, in consultation with the Secretary and the heads of other agencies as appropriate, shall on an ongoing basis— ‘‘(i) assess current and emerging threats of chem ical, biological, radiological, and nuclear agents; and ‘‘(ii) determine which of such agents present a material threat against the United States population sufficient to affect national security. ‘‘(B) PUBLIC HEALTH IMPACT; NECESSARY COUNTER MEASURES.—The Secretary shall on an ongoing basis— ‘‘(i) assess the potential public health consequences for the United States population of exposure to agents identified under subparagraph (A)(ii); and ‘‘(ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for which countermeasures are necessary to protect the public health. ‘‘(C) NOTICE TO CONGRESS.—The Secretary and the Homeland Security Secretary shall promptly notify the des ignated congressional committees (as defined in paragraph (10)) that a determination has been made pursuant to subparagraph (A) or (B). ‘‘(D) ASSURING ACCESS TO THREAT INFORMATION.—In making the assessment and determination required under subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is entitled under section 202 of the Homeland Security Act of 2002, including but not limited to information, regardless of its level of classification, relating to current and emerging threats of chemical, biological, radiological, and nuclear agents. ‘‘(3) ASSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF COUNTERMEASURES.—The Secretary, in consultation with the Homeland Security Secretary, shall assess on an ongoing basis the availability and appropriateness of specific counter measures to address specific threats identified under paragraph (2). ‘‘(4) CALL FOR DEVELOPMENT OF COUNTERMEASURES; COMMITMENT FOR RECOMMENDATION FOR PROCUREMENT.—

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