§ 303(a)(3)(A), amended subpar. (C) generally. Prior to amendment, subpar. (C) related to publication of notice for fiscal years 2013 to 2017.
Subsec. (a)(2)(E)(i). Pub. L. 115-52, § 303(a)(3)(B)(i), substituted "on the earlier of - " for "no later than", inserted subcl. (I) designation before "the date", substituted "; or" for period at end, and added subcl. (II).
Subsec. (a)(2)(E)(ii)(I). Pub. L. 115-52, § 303(a)(3)(B)(ii), substituted "notice provided for in subparagraph (C)" for "notice provided for in clause (i) or (ii) of subparagraph (C), as applicable".
Subsec. (a)(3). Pub. L. 115-52, § 303(a)(4)(A), struck out "and prior approval supplement" after "application" in heading.
Subsec. (a)(3)(A). Pub. L. 115-52, § 303(a)(4)(B), struck out "or a prior approval supplement to an abbreviated new drug application" after "application".
Subsec. (a)(3)(B), (C). Pub. L. 115-52, § 303(a)(4)(C), amended subpars. (B) and (C) generally. Prior to amendment, subpars. (B) and (C) related to notice for fiscal years 2013 to 2017 and fee due dates, respectively.
Subsec. (a)(3)(D). Pub. L. 115-52, § 303(a)(4)(D), inserted in heading ", is withdrawn prior to being received, or is no longer received" after "received" and in text substituted cls. (i) and (ii) for "The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application or prior approval supplement to an abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 355(j)(5)(A) of this title for a cause other than failure to pay fees."
Subsec. (a)(3)(E). Pub. L. 115-52, § 303(a)(4)(E), struck out "or prior approval supplement" after "new drug application".
Subsec. (a)(3)(F). Pub. L. 115-52, § 303(a)(4)(F), substituted "2017" for "2012" and "subsection (d)(2)" for "subsection (d)(3)" in introductory provisions.
Subsec. (a)(4)(A). Pub. L. 115-52, § 303(a)(5)(A)(i), substituted "in at least one generic drug submission that is" for ", or intended to be identified, in at least one generic drug submission that is pending or" in introductory provisions.
Subsec. (a)(4)(A)(i). Pub. L. 115-52, § 303(a)(5)(A)(ii), substituted "in at least one generic drug submission that is" for "or intended to be identified in at least one generic drug submission that is pending or".
Subsec. (a)(4)(A)(ii). Pub. L. 115-52, § 303(a)(5)(A)(iii), substituted "is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such" for "produces, or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II active pharmaceutical ingredient drug master file referenced in such a".
Subsec. (a)(4)(A)(iii). Pub. L. 115-52, § 303(a)(5)(A)(i), (iv), substituted "in at least one generic drug submission that is" for ", or intended to be identified, in at least one generic drug submission that is pending or" and "only to the fee attributable to the manufacture of the finished