135 STAT. 257  PUBLIC LAW 117–9—APR. 23, 2021  ‘‘(B) a biological product, no active ingredient of which  has been approved in any other application under section  351 of the Public Health Service Act; or  ‘‘(2) if the Secretary does not refer a drug or biological  product described in paragraph (1) to a Food and Drug Adminis- tration advisory committee prior to such approval, provide in  the action letter on the application for the drug or biological  product a summary of the reasons why the Secretary did not  refer the drug or biological product to an advisory committee  prior to approval.’’; and  (E) in subsection (u)(1), in the matter preceding  subparagraph (A)—  (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)), by  striking ‘‘active ingredient (including any ester or salt of the  active ingredient)’’ each place it appears and inserting ‘‘active  moiety (as defined by the Secretary in section 314.3 of title  21, Code of Federal Regulations (or any successor regulations))’’;  (3) in section 524(a)(4) (21 U.S.C. 360n(a)(4)), by amending  subparagraph (C) to read as follows:  ‘‘(C) is for—  (4) in section 529(a)(4) (21 U.S.C. 360ff(a)(4)), by striking  subparagraphs (A) and (B) and inserting the following:  ‘‘(A) is for a drug or biological product that is for  the prevention or treatment of a rare pediatric disease;  ‘‘(B)(i) is for such a drug—  Summary.  (i) by striking ‘‘active ingredient (including any  ester or salt of the active ingredient)’’ and inserting  ‘‘active moiety (as defined by the Secretary in section  314.3 of title 21, Code of Federal Regulations (or any  successor regulations))’’; and  (ii) by striking ‘‘same active ingredient’’ and  inserting ‘‘same active moiety’’;  ‘‘(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.’’;  ‘‘(I) that contains no active moiety (as defined by  the Secretary in section 314.3 of title 21, Code of Fed- eral Regulations (or any successor regulations)) that  has been previously approved in any other application  under subsection (b)(1), (b)(2), or (j) of section 505;  and  ‘‘(II) that is the subject of an application submitted  under section 505(b)(1); or  ‘‘(ii) is for such a biological product—  ‘‘(I) that contains no active ingredient that has  been previously approved in any other application  under section 351(a) or 351(k) of the Public Health  Service Act; and  ‘‘(II) that is the subject of an application submitted  under section 351(a) of the Public Health Service Act;’’;  and 