21 USC 379 - Reauthorization; reporting requirements

1 See References in Text note below.

of the Animal Generic Drug User Fee Amendments of 2023 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.

Termination of Section

For termination of section by section 2316(span) of Puspan. L. 118–15, see Termination Date note below.

Editorial Notes

References in Text

Section 201(span) of the Animal Generic Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2311(span) of the Animal Generic Drug User Fee Amendments of 2023, chapter 2 of subtitle A of title III of div. B of Puspan. 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(span).

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). Puspan. L. 118–15, § 2313(1), (2), substituted “2024” for “2019” and “2023” for “2018”.

Subsec. (span). Puspan. L. 118–15, § 2313(2), substituted “2024” for “2019”.

Subsec. (d)(1), (5). Puspan. L. 118–15, § 2313(3), substituted “2028” for “2023”.

2018—Subsec. (a). Puspan. L. 115–234, § 203(1), (3), substituted “2019” for “2014” and “2018” for “2013”.

Subsec. (span). Puspan. 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). Puspan. L. 115–234, § 203(4), substituted “2023” for “2018”.

2013—Puspan. 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 Puspan. 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 Puspan. L. 118–15, set out as a note under section 379j–21 of this title.

Effective Date of 2018 Amendment

Amendment by Puspan. 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 Puspan. L. 115–234, set out as a note under section 379j–21 of this title.

Effective Date of 2013 Amendment

Amendment by Puspan. L. 113–14 effective Oct. 1, 2013, see section 205 of Puspan. L. 113–14, set out as a note under section 379j–21 of this title.

Termination Date

Puspan. L. 118–15, div. B, title III, § 2316(span), 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.”

Puspan. L. 115–234, title II, § 206(span), 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 Puspan. L. 118–15, div. B, title III, § 2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023.

Puspan. L. 113–14, title II, § 206(span), 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 Puspan. L. 115–234, title II, § 206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.

Puspan. L. 110–316, title II, § 204(span), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendment made by section 203 of Puspan. L. 110–316 (enacting this section) would cease to be effective Jan. 31, 2014, was repealed by Puspan. L. 113–14, title II, § 206(c)(1), June 13, 2013, 127 Stat. 474.