; (3) in section 524(a)(4) ( 21 U.S.C. 360n(a)(4) ), by amending subparagraph (C) to read as follows: (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. ; (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— (I) that contains no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal 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) or 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 (5) in section 565A(a)(4) (21 U.S.C. 360bbb–4a(a)(4)), by amending subparagraph (D) to read as follows: (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)