; or (ii) a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act. . (b) Technical corrections Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended— (1) in section 505 ( 21 U.S.C. 355 )— (A) in subsection (c)(3)(E), by repealing clause (i); and (B) in subsection (j)(5)(F), by repealing clause (i)