(5) in section 565A(a)(4) (21 U.S.C. 360bbb–4a(a)(4)), by amending subparagraph (D) to read as follows: 

(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)— 

(2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 355a(c)(1)(A)(i)(II)), by striking ‘‘(c)(3)(D)’’ and inserting ‘‘(c)(3)(E)’’. 

Approved April 23, 2021. 

‘‘(D) is for— 

‘‘(i) a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 505(b)(1); 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.’’. 

(A) in subsection (c)(3)(E), by repealing clause (i); and 

(B) in subsection (j)(5)(F), by repealing clause (i); and 

