Sec. 202. Authority to assess and use generic new animal drug fees

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Subsection

(b)of section 741 ( 21 U.S.C. 379j–21 ) is amended to read as follows: Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2019 through 2023, the fees required under subsection

(a)shall be established to generate a total revenue amount of $18,336,340. Of the total revenue amount established for a fiscal year under paragraph (1)— 25 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug); 37.5 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and 37.5 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors). . Section 741(c) ( 21 U.S.C. 379j–21(c) ) is amended— by redesignating paragraphs

(2)through

(4)as paragraphs

(3)through (5), respectively; and by inserting after paragraph

(1)the following: For fiscal year 2020 and subsequent fiscal years, the revenue amounts established under subsection

(b)shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of— one; the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available. The adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year. . Paragraph

(3)of section 741(c) ( 21 U.S.C. 379j–21(c) ), as redesignated, is amended to read as follows: For fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection

(b)are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs

(B)and (C). With respect to such adjustment— this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary; and the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies. For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph

(A)increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase. Under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2). . Paragraph

(4)of section 741(c) ( 21 U.S.C. 379j–21(c) ), as redesignated, is amended by— striking 2018 each place it appears and inserting 2023 ; and striking 2019 and inserting 2024 . Subsection

(d)of section 741 ( 21 U.S.C. 379j–21 ) is amended to read as follows: The Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection

(a)where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication. Fees under this section shall not apply with respect to any person who— not later than September 30, 2023, submits a supplemental abbreviated application for a generic new animal drug approved under section 512, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3); and otherwise would be subject to fees under this section solely on the basis of such supplemental abbreviated application. . Section 741(g) ( 21 U.S.C. 379j–21 ) is amended by striking paragraph

(3)and inserting the following paragraphs: For each of the fiscal years 2019 through 2023, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection

(b)for the fiscal year, as adjusted or otherwise affected under subsection (c). If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as described in paragraph (1). .

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21 USC 379j–21
21 USC 379j–21(c)

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Sec. 202

Authority to assess and use generic new animal drug fees

Cite21 USC 379j–21

Cite21 USC 379j–21(c)

Cites 2Cited by 0 across 0 sources