; (5) the term license holder means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or the holder of a license under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) for a covered product; (6) the term REMS means a risk evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1 ); (7) the term REMS with ETASU means a REMS that contains elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(f) ); (8) the term Secretary means the Secretary of Health and Human Services; (9) the term single, shared system of elements to assure safe use means a single, shared system of elements to assure safe use under section 505–1(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355–1(f) ); and (10) the term sufficient quantities means an amount of a covered product that allows the eligible product developer to— (A) conduct testing to support an application under— (i) subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ); or (ii) section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) )