PROCESS FOR WAIVING INFORMED CONSENT REQUIREMENT FOR ADMINISTRATION OF CERTAIN DRUGS TO MEMBERS OF ARMED FORCES FOR PURPOSES OF A PARTICULAR MILITARY OPERATION.

SEC. 731. PROCESS FOR WAIVING INFORMED CONSENT REQUIREMENT FOR ADMINISTRATION OF CERTAIN DRUGS TO MEMBERS OF ARMED FORCES FOR PURPOSES OF A PARTICULAR MILITARY OPERATION. (a) Limitation and Waiver.— (1) Section 1107 of title 10, United States Code, is amended— (A) by redesignating subsection (f) as subsection (g); and (B) by inserting after subsection (e) the following new subsection (f): “(f) Limitation and Waiver.— (1) In the case of the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member’s participation in a particular military operation, the requirement that the member provide prior consent to receive the drug in accordance with the prior consent requirement imposed under section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be waived only by the President. The President may grant such a waiver only if the President determines, in writing, that obtaining consent— “(A) is not feasible; “(B) is contrary to the best interests of the member; or “(C) is not in the interests of national security. “(2) In making a determination to waive the prior consent requirement on a ground described in subparagraph (A) or (B) of paragraph (1), the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior consent requirement on that ground. “(3) The Secretary of Defense may request the President to waive the prior consent requirement with respect to the administration of an investigational new drug or a drug unapproved for its applied use to a member of the armed forces in connection with the member’s participation in a particular military operation. With respect to any such administration— “(A) the Secretary may not delegate to any other official the authority to request the President to waive the prior consent requirement for the Department of Defense; and “(B) if the President grants the requested waiver, the Secretary shall submit to the chairman and ranking minority member of each congressional defense committee a notification of the waiver, together with the written determination of the President under paragraph (1) and the Secretary’s justification for the request or requirement under subsection (a) for the member to receive the drug covered by the waiver. 112 STAT. 2071 “(4) In this subsection: “(A) The term ‘relevant FDA regulations’ means the regulations promulgated under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). “(B) The term ‘prior consent requirement’ means the requirement included in the relevant FDA regulations pursuant to section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)). “(C) The term ‘congressional defense committee’ means each of the following: “(i) The Committee on Armed Services and the Committee on Appropriations of the Senate. “(ii) The Committee on National Security and the Committee on Appropriations of the House of Representatives.”. (2) subsection (f) of section 1107 of title 10, United States Code (as added by paragraph (1)), shall apply to the administration of an investigational new drug or a drug unapproved for its applied use to a member of the Armed Forces in connection with the member’s participation in a particular military operation on or after the date of the enactment of this Act. (3) A waiver of the requirement for prior consent imposed under the regulations required under paragraph (4) of section 505(i) of the Federal Food, Drug, and Cosmetic Act (or under any antecedent provision of law or regulations) that has been granted under that section (or antecedent provision of law or regulations) before the date of the enactment of this Act for the administration of a drug to a member of the Armed Forces in connection with the member’s participation in a particular military operation may be applied in that case after that date only if— (A) the Secretary of Defense personally determines that the waiver is justifiable on each ground on which the waiver was granted; (B) the President concurs in that determination in writing; and (C) the Secretary submits to the chairman and ranking minority member of each congressional committee referred to in section 1107(f)(4)(C) of title 10, United States Code (as added by paragraph (1))— (i) a notification of the waiver; (ii) the President’s written concurrence; and (iii) the Secretary’s justification for the request or for the requirement under subsection 1107(a) of such title for the member to receive the drug covered by the waiver. (b) Time and Form of Notice.— (1) subsection (b) of such section is amended by striking out “, if practicable” and all that follows through “first administered to the member”. (2) subsection (c) of such section is amended by striking out“unless the Secretary of Defense determines” and all that follows through “alternative method”.