Sec. 301. Reporting requirements

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Section 740A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–13 ), as amended by section 104, is further amended— in subsection (a)— by striking Beginning with and inserting the following: Beginning with ; and by adding at the end the following: The report under paragraph

(1)shall include the following: Data, analysis and discussion of the changes in the number of individuals hired and funded by fees collected pursuant to section 740, and data, analysis, and discussion of the number of full-time equivalents in the animal drug review program, including a breakdown by funding from fees collected pursuant to section 740 versus budget authority, and by each office within the Center for Veterinary Medicine, the Office of Regulatory Affairs, and the Office of the Commissioner. Data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of animal drug applications, including identifying— the drivers of such changes; and changes in the total cost per full-time equivalent in the animal drug review program. Data, analysis, and discussion of changes in the average full-time equivalent hours required to complete review of each type of animal drug application. For fiscal years 2024 and 2025 , of the meeting requests from animal drug sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary. ; and in subsection (d)— in paragraph (5), by inserting a comma after paragraph

(4); by redesignating paragraph

(6)as paragraph (7); by inserting after paragraph

(5)the following: The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. ; and in paragraph

(7)(as so redesignated)— in subparagraph (A)— by striking Before presenting the recommendations developed under paragraphs

(1)through

(5)to Congress, the Secretary and inserting The Secretary ; and by inserting before the period at the end the following: , not later than 30 days after each such negotiation meeting ; and in subparagraph (B), by inserting , in sufficient detail, after shall summarize .

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21 USC 379j–13

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Sec. 301

Reporting requirements

Cite21 USC 379j–13

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