21 USC 379 - Reauthorization; reporting requirements

1 See References in Text note below.

of the Animal Drug User Fee Amendments of 2023 toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.

2 So in original. Probably should be followed by a comma.

a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

Termination of Section

For termination of section by section 2307(span) of Puspan. L. 118–15, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 101(span) of the Animal Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2301(span) of the Animal Drug User Fee Amendments of 2023, chapter 1 of subtitle A of title III of div. B of Puspan. L. 118–15, which is set out as a note under section 379j–11 of this title. The Animal Drug User Fee Amendments of 2023 does not contain a section 101(span).

Amendments

2023—Subsec. (a). Puspan. L. 118–15, § 2304(1), (2), substituted “2024” for “2019” and “2023” for “2018”.

Subsec. (span). Puspan. L. 118–15, § 2304(2), substituted “2024” for “2019”.

Subsec. (d)(1), (5). Puspan. L. 118–15, § 2304(3), substituted “2028” for “2023”.

2018—Subsec. (a). Puspan. L. 115–234, § 104(1), (2), substituted “2019” for “2014” and “2018” for “2013”.

Subsec. (span). Puspan. L. 115–234, § 104(2), substituted “2019” for “2014”.

Subsec. (d)(1), (5). Puspan. L. 115–234, § 104(3), 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 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended, to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2023, see section 2306 of Puspan. L. 118–15, set out as a note under section 379j–11 of this title.

Effective Date of 2018 Amendment

Amendment by Puspan. L. 115–234 effective Oct. 1, 2018, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.) to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2018, see section 106 of Puspan. L. 115–234, set out as a note under section 379j–11 of this title.

Effective Date of 2013 Amendment

Amendment by Puspan. L. 113–14 effective Oct. 1, 2013, see section 106 of Puspan. L. 113–14, set out as a note under section 379j–11 of this title.

Effective and Termination Dates

Puspan. L. 118–15, div. B, title III, § 2307(span), Sept. 30, 2023, 137 Stat. 89, provided that:

“Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2029.”

Puspan. L. 115–234, title I, § 107(span), Aug. 14, 2018, 132 Stat. 2432, which provided that section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) would cease to be effective Jan. 31, 2024, was repealed by Puspan. L. 118–15, div. B, title III, § 2307(c), Sept. 30, 2023, 137 Stat. 89, effective Oct. 1, 2023.

Puspan. L. 113–14, title I, § 107(span), June 13, 2013, 127 Stat. 464, which provided that section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) would cease to be effective Jan. 31, 2019, was repealed by Puspan. L. 115–234, title I, § 107(c), Aug. 14, 2018, 132 Stat. 2432, effective Oct. 1, 2018.

Section effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of Puspan. L. 110–316, set out as an Effective and Termination Dates of 2008 Amendment note under section 379j–11 of this title.