§ 379j–22. Reauthorization; reporting requirements
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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— the Committee on Energy and Commerce of the House of Representatives; the Committee on Health, Education, Labor, and Pensions of the Senate; scientific and academic experts; veterinary professionals; representatives of patient and consumer advocacy groups; and the regulated industry. Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall— publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a); provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and publish the comments on the Food and Drug Administration’s Internet Web site. 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— present the recommendations developed under paragraph
(1)to the congressional committees specified in such paragraph; publish such recommendations in the Federal Register; provide for a period of 30 days for the public to provide written comments on such recommendations; hold a meeting at which the public may present its views on such recommendations; and after consideration of such public views and comments, revise such recommendations as necessary. 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. ( June 25, 1938, ch. 675, § 742 , as added Pub. L. 110–316, title II, § 203 , Aug. 14, 2008 , 122 Stat. 3522 ; amended Pub. L. 113–14, title II, § 203 , June 13, 2013 , 127 Stat. 472 ; Pub. L. 115–234, title II, § 203 , Aug. 14, 2018 , 132 Stat. 2435 ; Pub. L. 118–15, div. B, title III, § 2313 , Sept. 30, 2023 , 137 Stat. 93 .) For termination of section by section 2316(b) of Pub. L. 118–15 , see Termination Date note below.
Connections13 cite this · traces to 3
Cited by 13 sections
statute-compilations
register
- NoticesNotice: Request for notification of participation
- NoticesNotice of public meeting; request for comments
- Rules and RegulationsNotice of public meeting; request for comments
- NoticesNotice; request for notification of participation
- Rules and RegulationsNotice; request for notification of participation
- NoticesNotice of public meeting; request for comments
10 references not yet in our index
- Pub. L. 110-316
- 122 Stat. 3522
- 127 Stat. 472
- 132 Stat. 2435
- 137 Stat. 93
- 21 USC 379j–21
- 137 Stat. 94
- 21 USC 379j–22
- 127 Stat. 474
- 122 Stat. 3524
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cites case law
§ 379j–22
Reauthorization; reporting requirements
Fed. Reg.×6
Stat. Comp.×6
Bills×1
Pub. L.Pub. L. 110-316
Stat.122 Stat. 3522
Stat.127 Stat. 472
Stat.132 Stat. 2435
Stat.137 Stat. 93
Cites 13 · showing 8Cited by 13 across 3 sources