1
See References in Text note below.
Termination of Section
For termination of section by [section 2316(b) of Pub. L. 118–15], see Termination Date note below.
References in Text
Section 201(b) of the Animal Generic Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2311(b) of the Animal Generic Drug User Fee Amendments of 2023, chapter 2 of subtitle A of title III of div. B of [Pub. L. 118–15], which is set out as a note under section 379j–21 of this title. The Animal Generic Drug User Fee Amendments of 2023 does not contain a section 201(b).
Prior Provisions
A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to section 379l of this title.
Amendments
2023—Subsec. (a). [Pub. L. 118–15, § 2313(1)], (2), substituted “2024” for “2019” and “2023” for “2018”.
Subsec. (b). [Pub. L. 118–15, § 2313(2)], substituted “2024” for “2019”.
Subsec. (d)(1), (5). [Pub. L. 118–15, § 2313(3)], substituted “2028” for “2023”.
2018—Subsec. (a). [Pub. L. 115–234, § 203(1)], (3), substituted “2019” for “2014” and “2018” for “2013”.
Subsec. (b). [Pub. L. 115–234, § 203(2)], (3), substituted “2019” for “2014” and “to the Committee on Health, Education, Labor and Pensions” for “to Committee on Health, Education, Labor, and Pensions”.
Subsec. (d)(1), (5). [Pub. L. 115–234, § 203(4)], substituted “2023” for “2018”.
2013—[Pub. L. 113–14] amended section generally. Prior to amendment, section related to reauthorization of this subpart and reporting requirements.
Statutory Notes and Related Subsidiaries
Effective Date of 2023 Amendment
Amendment by [Pub. L. 118–15] effective Oct. 1, 2023, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2023, see [section 2315 of Pub. L. 118–15], set out as a note under section 379j–21 of this title.
Effective Date of 2018 Amendment
Amendment by [Pub. L. 115–234] effective on Oct. 1, 2018, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2018, see [section 205 of Pub. L. 115–234], set out as a note under section 379j–21 of this title.
Effective Date of 2013 Amendment
Amendment by [Pub. L. 113–14] effective Oct. 1, 2013, see [section 205 of Pub. L. 113–14], set out as a note under section 379j–21 of this title.
Termination Date
[Pub. L. 118–15, div. B, title III, § 2316(b)], Sept. 30, 2023, [137 Stat. 94], provided that: “Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2029.”
[Pub. L. 115–234, title II, § 206(b)], Aug. 14, 2018, [132 Stat. 2435], which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2024, was repealed by [Pub. L. 118–15, div. B, title III, § 2316(c)], Sept. 30, 2023, [137 Stat. 94], effective Oct. 1, 2023.
[Pub. L. 113–14, title II, § 206(b)], June 13, 2013, [127 Stat. 474], which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2019, was repealed by [Pub. L. 115–234, title II, § 206(c)], Aug. 14, 2018, [132 Stat. 2435], effective Oct. 1, 2018.
[Pub. L. 110–316, title II, § 204(b)], Aug. 14, 2008, [122 Stat. 3524], which provided that the amendment made by [section 203 of Pub. L. 110–316] (enacting this section) would cease to be effective Jan. 31, 2014, was repealed by [Pub. L. 113–14, title II, § 206(c)(1)], June 13, 2013, [127 Stat. 474].