Page:United States Statutes at Large Volume 118.djvu/884

 118 STAT. 854 PUBLIC LAW 108–276—JULY 21, 2004 ‘‘(2) APPROVAL STATUS OF PRODUCT.—An authorization under paragraph (1) may authorize an emergency use of a product that— ‘‘(A) is not approved, licensed, or cleared for commercial distribution under a provision of law referred to in such paragraph (referred to in this section as an ‘unapproved product’); or ‘‘(B) is approved, licensed, or cleared under such a provision, but which use is not under such provision an approved, licensed, or cleared use of the product (referred to in this section as an ‘unapproved use of an approved product’). ‘‘(3) RELATION TO OTHER USES.—An emergency use author ized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a provision of law referred to in such paragraph. ‘‘(4) DEFINITIONS.—For purposes of this section: ‘‘(A) The term ‘biological product’ has the meaning given such term in section 351 of the Public Health Service Act. ‘‘(B) The term ‘emergency use’ has the meaning indicated for such term in paragraph (1). ‘‘(C) The term ‘product’ means a drug, device, or biological product. ‘‘(D) The term ‘unapproved product’ has the meaning indicated for such term in paragraph (2)(A). ‘‘(E) The term ‘unapproved use of an approved product’ has the meaning indicated for such term in paragraph (2)(B). ‘‘(b) DECLARATION OF EMERGENCY.— ‘‘(1) IN GENERAL.—The Secretary may declare an emergency justifying the authorization under this subsection for a product on the basis of— ‘‘(A) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radio logical, or nuclear agent or agents; ‘‘(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces of attack with a specified biological, chemical, radiological, or nuclear agent or agents; or ‘‘(C) a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents. ‘‘(2) TERMINATION OF DECLARATION.— ‘‘(A) IN GENERAL.—A declaration under this subsection shall terminate upon the earlier of— ‘‘(i) a determination by the Secretary, in consulta tion as appropriate with the Secretary of Homeland

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