Sec. 103. Authority to assess and use animal drug fees

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Section 740(b) ( 21 U.S.C. 379j–12(b) ) is amended— in paragraph (1)— in subparagraph (A)— by striking 2014 and inserting 2019 ; and by striking $23,600,000 and inserting $30,331,240 ; and in subparagraph (B)— by striking 2015 through 2018 and inserting 2020 through 2023 ; and by striking $21,600,000 and inserting $29,931,240 ; and in paragraph (2), in the matter preceding subparagraph (A), by striking determined and inserting established . Section 740(c)(2) ( 21 U.S.C. 379j–12(c)(2) ) is amended— in the matter preceding subparagraph (A)— by striking For fiscal year 2015 and inserting

(A)For fiscal year 2020 ; and by inserting multiplying such revenue amounts by before an amount ; by redesignating subparagraphs (A), (B), and

(C)as clauses (i), (ii), and (iii), respectively; by striking the flush text at the end; and by adding at the end the following new subparagraph: 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 740(c) ( 21 U.S.C. 379j–12(c) ) 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 such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraphs

(B)and (C). With respect to such adjustment— such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary; and the Secretary shall publish in the Federal Register the fees resulting from such 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 the 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). . Section 740(c)(4) ( 21 U.S.C. 379j–12(c)(4) ) is amended— by striking 2018 each place it appears and inserting 2023 ; and by striking 2019 and inserting 2024 . Section 740(d) ( 21 U.S.C. 379j–12(d) ) is amended— in the subsection heading, by inserting after ; exemptions from fees ; reduction by striking the heading of paragraph

(1)and inserting ; and Waiver or reduction by adding at the end the following: Fees under this section shall not apply with respect to any person who— not later than September 30, 2023, submits a supplemental animal drug application relating to a new animal drug application approved under section 512, solely to add the new animal drug 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 application. Fees under paragraphs (2), (3), and

(4)of subsection

(a)shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H. . Section 740(g)(3) ( 21 U.S.C. 379j–12(g)(3) ) is amended— by striking 2014 through 2018 and inserting 2019 through 2023 ; by striking determined and inserting established ; and by striking paragraph

(4)and inserting paragraph

(5). Section 740(g) ( 21 U.S.C. 379j–12(g) ) is amended by striking paragraph

(4)and inserting the following: 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). Subject to subparagraph (B)— for fiscal year 2021, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2019 falls below the amount of fees authorized for fiscal year 2019 under paragraph (3); for fiscal year 2022, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2020 falls below the amount of fees authorized for fiscal year 2020 under paragraph (3); and for fiscal year 2023, the amount of fees otherwise authorized to be collected under this section shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2021 and 2022 (including estimated collections for fiscal year 2022) falls below the cumulative amount of fees authorized for such fiscal years under paragraph (3). Subject to clause (ii), the Secretary shall, in such manner as the Secretary determines appropriate, reduce any fee increase otherwise applicable for a fiscal year under subparagraph

(A)by the amount of any excess collections under this section for preceding fiscal years (after fiscal year 2018). In applying clause (i), the Secretary shall account for the reduction of workload-based fee revenue increases by excess collections under subsection (c)(3)(B), in such manner as needed to provide that no portion of any excess collections described in clause

(i)is applied for purposes of reducing fee increases under both such subsection (c)(3)(B) and this paragraph. Under no circumstances shall adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted or otherwise affected under subsection (c). .

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21 USC 379j–12(b)
21 USC 379j–12(c)(2)
21 USC 379j–12(c)
21 USC 379j–12(c)(4)
21 USC 379j–12(d)
21 USC 379j–12(g)(3)
21 USC 379j–12(g)

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cites case law

Sec. 103

Authority to assess and use animal drug fees

Cite21 USC 379j–12(b)

Cite21 USC 379j–12(c)(2)

Cite21 USC 379j–12(c)

Cite21 USC 379j–12(c)(4)

Cite21 USC 379j–12(d)

Cites 7 · showing 5Cited by 0 across 0 sources