Sec. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES
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## SEC. 103 AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES ###
(a)Fee Revenue Amounts Section 740(b) (21 U.S.C. 379j-12(b)) is amended— ####
(1)in paragraph (1)— #####
(A)in subparagraph (A)— ######
(i)by striking “2014” and inserting “2019”; and ######
(ii)by striking “$23,600,000” and inserting “$30,331,240”; and #####
(B)in subparagraph (B)— ######
(i)by striking “2015 through 2018” and inserting “2020 through 2023”; and ######
(ii)by striking “$21,600,000” and inserting “$29,931,240”; and ####
(2)in paragraph (2), in the matter preceding subparagraph (A), by striking “determined” and inserting “established”. ###
(b)Annual Fee Setting; Adjustments ####
(1)Inflation adjustment Section 740(c)(2) (21 U.S.C. 379j-12(c)(2)) is amended— #####
(A)in the matter preceding subparagraph (A)— ######
(i)by striking “For fiscal year 2015” and inserting “(A) For fiscal year 2020”; and ######
(ii)by inserting “multiplying such revenue amounts by” before “an amount”; #####
(B)by redesignating subparagraphs (A), (B), and
(C)as clauses (i), (ii), and (iii), respectively; #####
(C)by striking the flush text at the end; and #####
(D)by adding at the end the following new subparagraph: > > ##### “(B) Compounded basis > > 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.” > . ####
(2)Workload adjustments Paragraph
(3)of section 740(c) (21 U.S.C. 379j-12(c)) is amended to read as follows: > > #### “(3) Workload adjustments > > > ##### “(A) In general > > 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— > > > ###### “(i) > > 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 > > > ###### “(ii) > > the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies. > > > ##### “(B) Reduction of workload-based increase by amount of certain excess collections > > 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. > > > ##### “(C) Rule of application > > 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).” > . ####
(3)Final year adjustment Section 740(c)(4) (21 U.S.C. 379j-12(c)(4)) is amended— #####
(A)by striking “2018” each place it appears and inserting “2023”; and #####
(B)by striking “2019” and inserting “2024”. ###
(c)Exemptions From Fees Section 740(d) (21 U.S.C. 379j-12(d)) is amended— ####
(1)in the subsection heading, by inserting “; Exemptions From Fees” after “Reduction”; ####
(2)by striking the heading of paragraph
(1)and inserting “Waiver or reduction”; and ####
(3)by adding at the end the following: > > #### “(4) Exemptions from fees > > > ##### “(A) Certain labeling supplements to add number of approved application > > Fees under this section shall not apply with respect to any person who— > > > ###### “(i) > > 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 > > > ###### “(ii) > > otherwise would be subject to fees under this section solely on the basis of such supplemental application. > > > ##### “(B) Certain animal drug applications > > 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.” > . ###
(d)Crediting and Availability of Fees ####
(1)Authorization of appropriations Section 740(g)(3) (21 U.S.C. 379j-12(g)(3)) is amended— #####
(A)by striking “2014 through 2018” and inserting “2019 through 2023”; #####
(B)by striking “determined” and inserting “established”; and #####
(C)by striking “paragraph (4)” and inserting “paragraph (5)”. ####
(2)Excess collections Section 740(g) (21 U.S.C. 379j-12(g)) is amended by striking paragraph
(4)and inserting the following: > > #### “(4) Excess collections > > 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 provided in paragraph (1). > > > #### “(5) Recovery of collection shortfalls > > > ##### “(A) In general > > Subject to subparagraph (B)— > > > ###### “(i) > > 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); > > > ###### “(ii) > > 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 > > > ###### “(iii) > > 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). > > > ##### “(B) Reduction of shortfall-based fee increase by prior year excess collections > > > ###### “(i) In general > > 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). > > > ###### “(ii) Workload-based fee accounting > > 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. > > > ##### “(C) Rule of application > > 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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Sec. 103
AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES
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