officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, § 744H, as added Pub. L. 112-144, title IV, § 402, July 9, 2012, 126 Stat. 1029; amended Pub. L. 114-255, div. A, title III, § 3101(a)(2)(V), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115-52, title IV, § 403, title IX, § 905(b)(4), Aug. 18, 2017, 131 Stat. 1028, 1090; Pub. L. 116-136, div. A, title III, § 3856(b)(1), Mar. 27, 2020, 134 Stat. 458.)
Termination of SectionFor termination of section by section 405(a) of Pub. L. 115-52, see Effective and Termination Dates note below.
Editorial Notes
Amendments2020 - Subsec. (f)(2)(B). Pub. L. 116-136, § 3856(b)(1), amended Pub. L. 115-52, § 905(b)(4). See 2017 Amendment note below.
2017 - Subsec. (a). Pub. L. 115-52, § 403(a)(1), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.
Subsec. (a)(1). Pub. L. 115-52, § 403(a)(2), substituted "Biosimilar biological product" for "Biosimilar" in heading.
Subsec. (a)(1)(A)(i). Pub. L. 115-52, § 403(a)(3), substituted "(c)(5)" for "(b)(1)(A)".
Subsec. (a)(1)(B)(i). Pub. L. 115-52, § 403(a)(4), substituted "(c)(5) for the biosimilar biological product development program" for "(b)(1)(B) for biosimilar biological product development".
Subsec. (a)(1)(B)(ii). Pub. L. 115-52, § 403(a)(5), substituted "annual biosimilar biological product development fee" for "annual biosimilar biological product development program fee" in introductory provisions.
Subsec. (a)(1)(B)(iii). Pub. L. 115-52, § 403(a)(6), substituted "annual biosimilar biological product development fee" for "annual biosimilar development program fee".
Subsec. (a)(1)(B)(iv). Pub. L. 115-52, § 403(a)(7), added cl. (iv).
Subsec. (a)(1)(C). Pub. L. 115-52, § 403(a)(8), substituted "for a product, effective October 1 of a fiscal year, by," for "for a product effective October 1 of a fiscal year by," in introductory provisions.
Subsec. (a)(1)(D)(i). Pub. L. 115-52, § 403(a)(9)(A), inserted ", if the person seeks to resume participation in such program," before "pay a fee" in introductory provisions.
Subsec. (a)(1)(D)(i)(I). Pub. L. 115-52, § 403(a)(9)(B), inserted "by such person" after "grants a request".
Subsec. (a)(1)(D)(i)(II). Pub. L. 115-52, § 403(a)(9)(C), inserted "by such person" after "discontinued)".
Subsec. (a)(1)(E). Pub. L. 115-52, § 403(a)(10), struck out "biosimilar development program" after "pay" in heading.
Subsec. (a)(1)(F). Pub. L. 115-52, § 403(a)(11)(A), struck out "biosimilar development program" after "regarding" in heading.
Subsec. (a)(1)(F)(i). Pub. L. 115-52, § 403(a)(11)(B), amended cl. (i) generally. Prior to amendment, text read as follows: "The Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D)."
Subsec. (a)(2). Pub. L. 115-52, § 403(a)(12)(A), struck out "and supplement" after "application" in heading.
Subsec. (a)(2)(A), (B). Pub. L. 115-52, § 403(a)(12)(B), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) related to the fee for a biosimilar biological product application or a supplement submitted on or after Oct. 1, 2012, and to a reduction in certain fees, respectively.
Subsec. (a)(2)(C). Pub. L. 115-52, § 403(a)(12)(D), struck out "or supplement" after "application".
Subsec. (a)(2)(D). Pub. L. 115-52, § 403(a)(12)(C)-(E), in heading, struck out "or supplement" after "application" and in