Sec. 8. Definitions
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In this Act— the term antimicrobial drug — subject to subparagraph (B), means— an antibiotic drug, as defined in section 201(jj) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(jj) ); or a biological product, as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ), that exhibits antimicrobial activity; and excludes— any antifungal drug; and any vaccine; the term Committee means the Committee on Critical Need Antimicrobials established under section 2; and the term Secretary means the Secretary of Health and Human Services.
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