Page:United States Statutes at Large Volume 112 Part 3.djvu/241

 PUBLIC LAW 105-261—OCT. 17, 1998 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 Applicability. Code (as added by paragraph (1)), shall apply to the administration 10 USC 1107 of an investigational new drug or a drug unapproved for its applied °°**- use to a member of the Araied 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 10 USC 1107 under the regulations required under paragraph (4) of section 505(i) °ote. 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". SEC. 732. HEALTH BENEFITS FOR ABUSED DEPENDENTS OF MEMBERS OF THE ARMED FORCES. Section 1076(e) of title 10, United States Code, is amended— (1) by amending paragraph (1) to read as follows: "(1) Subject to paragraph (3), the administering Secretary shall fiimish an abused dependent of a former member of a uniformed

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