‘‘(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: 

(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; 

(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’’; 

‘‘(C) 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.’’; 

‘‘(B)(i) is for such a drug— 

‘‘(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 

Summary. 

