GROUNDS FOR PRESIDENTIAL WAIVER OF REQUIREMENT FOR INFORMED CONSENT OR OPTION TO REFUSE REGARDING ADMINISTRATION OF DRUGS NOT APPROVED FOR GENERAL USE.

SEC. 726. GROUNDS FOR PRESIDENTIAL WAIVER OF REQUIREMENT FOR INFORMED CONSENT OR OPTION TO REFUSE REGARDING ADMINISTRATION OF DRUGS NOT APPROVED FOR GENERAL USE.(a) Investigational New Drugs.—Section 1107(f) of title 10, United States Code, is amended—(1) in paragraph (1), by striking “obtaining consent—” and all that follows through “(C) is” and inserting “obtaining consent is”; and(2) by striking paragraph (2) and inserting the following new paragraph:“(2) The waiver authority provided in paragraph (1) shall not be construed to apply to any case other than a case in which prior consent for administration of a particular drug is required by reason of a determination by the Secretary of Health and Human Services that such drug is subject to the investigational new drug requirements of section 505(i) of the Federal Food, Drug, and Cosmetic Act.”.(b) Emergency Use Drugs.—Section 1107a(a) of such title is amended—(1) by inserting “(A)” after “President.—(1)”;118 STAT. 1993(2) by striking “is not feasible,” and all that follows through “members affected, or”; and(3) by adding at the end the following new subparagraph:“(B) The waiver authority provided in subparagraph (A) shall not be construed to apply to any case other than a case in which an individual is required to be informed of an option to accept or refuse administration of a particular product by reason of a determination by the Secretary of Health and Human Services that emergency use of such product is authorized under section 564 of the Federal Food, Drug, and Cosmetic Act.”.