21 U.S.C. § 379j-22
Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b)1 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.
Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with-
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall-
Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
After negotiations with the regulated industry, the Secretary shall-
Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), 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.
Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.
The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
1See References in Text note below.
21 U.S.C. § 379j-22
Termination of SectionFor termination of section by section 2316(b) of Pub. L. 118-15 see Termination Date note below.
EDITORIAL NOTES
REFERENCES IN TEXTSection 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 PROVISIONSA prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to section 379l of this title.
AMENDMENTS2023-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.