Sec. 2312. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES
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## SEC. 2312 AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES ###
(a)Generic Investigational New Animal Drug File Fee Section 741(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(a)) is amended by adding at the end the following: > > #### “(4) Generic investigational new animal drug file fee > > > ##### “(A) In general > > > ###### “(i) New file request > > Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c). > > > ###### “(ii) New submission to established file > > Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c). > > > ##### “(B) Payment > > > ###### “(i) New file request > > The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file. > > > ###### “(ii) New submission to established file > > The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file. > > > ##### “(C) Exceptions > > > ###### “(i) Terminating an existing generic investigational new animal drug file > > If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission. > > > ###### “(ii) Transferring an existing generic investigational new animal drug file > > If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.” > . ###
(b)Fee Revenue Amounts Section 741(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j- 21(b)) is amended— ####
(1)in paragraph (1)— #####
(A)by striking “2019 through 2023” and inserting “2024 through 2028”; and #####
(B)by striking “$18,336,340” and inserting “$25,000,000”; and ####
(2)in paragraph (2)— #####
(A)in subparagraph (A)— ######
(i)by striking “25 percent” and inserting “20 percent”; and ######
(ii)by inserting before the semicolon at the end the following: “and fees under subsection (a)(4) (relating to generic investigational new animal drug files)”; #####
(B)in subparagraph (B), by striking “37.5 percent” and inserting “40 percent”; and #####
(C)in subparagraph (C), by striking “37.5 percent” and inserting “40 percent”. ###
(c)Annual Fee Setting; Adjustments ####
(1)Annual fee setting Section 741(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(1)) is amended to read as follows: > > #### “(1) Annual fee setting > > The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year— > > > ##### “(A) > > abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year; > > > ##### “(B) > > generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection
(b)and the adjustments provided under this subsection; and > > > ##### “(C) > > a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A).” > . ####
(2)Inflation adjustment Section 741(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(2)) is amended— #####
(A)in subparagraph (A)— ######
(i)in the matter preceding clause (i), by striking “2020” and inserting “2025”; and ######
(ii)in clause (iii), by striking “Baltimore” and inserting “Arlington-Alexandria”; and #####
(B)in subparagraph (B), by striking “2020” and inserting “2025”. ####
(3)Workload adjustment Section 741(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(3)) is amended— #####
(A)in subparagraph (A)— ######
(i)in the matter preceding clause (i), by striking “2020” and inserting “2025”; ######
(ii)in clause (i)— ######
(I)by striking “and investigational generic new animal drug protocol submissions” and inserting “investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests”; and ######
(II)by striking “; and” and inserting a semicolon; ######
(iii)by redesignating clause
(ii)as clause (iii); and ######
(iv)by inserting after clause
(i)the following: > > ### “(ii) > > if the workload adjustment calculated by the Secretary under clause
(i)exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and” > ; and #####
(B)in subparagraph (B), by striking “2021 through 2023” and inserting “2026 through 2028”. ####
(4)Final year adjustment Section 741(c)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(4)) is amended— #####
(A)by striking “2023” each place it appears and inserting “2028”; and #####
(B)by striking “2024” and inserting “2029”. ###
(d)Fee Waiver or Reduction; Exemption From Fees Subsection
(d)of section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) is amended to read as follows: > > ### “(d) Fee Waiver or Reduction > > The Secretary shall grant a waiver from, or a reduction of, one 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.” > . ###
(e)Effect of Failure to Pay Fees Section 741(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(e)) is amended by striking “The Secretary may discontinue” and inserting “A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection
(a)shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue”. ###
(f)Assessment of Fees Section 741(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j- 21(f)(2)) is amended by striking “sponsors, and generic new animal drug products at any time” and inserting “products, generic new animal drug sponsors, and generic investigational new animal drug files at any time”. ###
(g)Crediting and Availability of Fees Section 741(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(g)) is amended— ####
(1)in paragraph (3), by striking “2019 through 2023” and inserting “2024 through 2028”; ####
(2)by striking the second paragraph
(4)(relating to Offset), as added by section 202 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113-14); and ####
(3)by adding at the end the following: > > #### “(5) Recovery of collection shortfalls > > The amount of fees otherwise authorized to be collected under this section shall be increased— > > > ##### “(A) > > for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3); > > > ##### “(B) > > for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and > > > ##### “(C) > > for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3).” > . ###
(h)Definitions Section 741(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(k)) is amended— ####
(1)by redesignating paragraphs (8), (9), (10), and
(11)as paragraphs (9), (10), (11), and (13), respectively; ####
(2)by inserting after paragraph
(7)the following: > > #### “(8) Generic investigational new animal drug meeting request > > The term ‘generic investigational new animal drug meeting request’ means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.” > ; ####
(3)in paragraph
(11)(as so redesignated), by adding at the end the following: > > ###### “(I) > > The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.” > ; and ####
(4)by inserting after paragraph
(11)(as so redesignated) the following: > > #### “(12) Request to establish a generic investigational new animal drug file > > The term ‘request to establish a generic investigational new animal drug file’ means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.” > .
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Sec. 2312
AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES
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