PUBLIC LAW 108–136—NOV. 24, 2003
117 STAT. 1685
‘‘(A) IN GENERAL.—A declaration under this subsection shall terminate upon the earlier of— ‘‘(i) a determination by the Secretary, in consultation with the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist; or ‘‘(ii) the expiration of the one-year period beginning on the date on which the declaration is made. ‘‘(B) RENEWAL.—Notwithstanding subparagraph (A), the Secretary may renew a declaration under this subsection, and this paragraph shall apply to any such renewal. ‘‘(C) DISPOSITION OF PRODUCT.—If an authorization under this section with respect to an unapproved product ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product. ‘‘(3) ADVANCE NOTICE OF TERMINATION.—The Secretary shall provide advance notice that a declaration under this subsection will be terminated. The period of advance notice shall be a period reasonably determined to provide— ‘‘(A) in the case of an unapproved product, a sufficient period for disposition of the product, including the return of such product (except such quantities of product as are necessary to provide for continued use consistent with subsection (f)(2)) to the manufacturer (in the case of a manufacturer that chooses to have such product returned); and ‘‘(B) in the case of an unapproved use of an approved product, a sufficient period for the disposition of any labeling, or any information under subsection (e)(2)(B)(ii), as the case may be, that was provided with respect to the emergency use involved. ‘‘(4) PUBLICATION.—The Secretary shall promptly publish in the Federal Register each declaration, determination, advance notice of termination, and renewal under this subsection. ‘‘(c) CRITERIA FOR ISSUANCE OF AUTHORIZATION.—The Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Director of the National Institutes of Health and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the circumstances of the emergency involved), the Secretary concludes— ‘‘(1) that an agent specified in a declaration under subsection (b) can cause a serious or life-threatening disease or condition; ‘‘(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and wellcontrolled clinical trials, if available, it is reasonable to believe that— ‘‘(A) the product may be effective in diagnosing, treating, or preventing— ‘‘(i) such disease or condition; or ‘‘(ii) a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this Act, or licensed under
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Federal Register, publication.