Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:
Each person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows:
The fee required by subparagraph (A) shall be due upon submission of the animal drug application or supplemental animal drug application.
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any animal drug application or supplemental animal drug application which is refused for filing.
If an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund the fee under this paragraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.
Each person-
shall pay for each such animal drug product the annual fee established in subsection (c).
Such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of-
Such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable.
Each person-
shall be assessed an annual establishment fee as established in subsection (c) for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application.
The annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee under this paragraph for a fiscal year shall be due upon the later of-
An establishment shall be assessed only one fee per fiscal year under this section.
Each person-
shall be assessed an annual sponsor fee as established under subsection (c).
The fee under this paragraph for a fiscal year shall be due upon the later of-
Each animal drug sponsor shall pay only one such fee each fiscal year.
Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $33,500,000.
Of the total revenue amount established for a fiscal year under paragraph (1)-
Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall-
For fiscal year 2025 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 subparagraph (B). With respect to such adjustment-
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).
For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall-
For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated.
The number of weeks of operating reserves specified in this subparagraph is-
If an adjustment to the operating reserve is made under this paragraph, the Secretary shall publish in the Federal Register notice under paragraph (1) the rationale for the amount of the adjustment and the supporting methodologies.
The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of animal drug applications.
The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that-
In making the finding in paragraph (1)(B), the Secretary may use standard costs.
In paragraph (1)(E), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates.
The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business.
The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications.
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 379h, 379j, 379j-42, or 379j-52 of this title.
An animal drug application or supplemental animal drug application submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational animal drug submission under section 379j-11(5)(B) of this title that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any animal drug application, supplemental animal drug application or investigational animal drug submission from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.
Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2003 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.
If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for animal drug applications, supplemental animal drug applications, investigational animal drug submissions, animal drug sponsors, animal drug establishments and animal drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of animal drug applications.
The fees authorized by this section-
The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications-
Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.
For each of the fiscal years 2024 through 2028, 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 provided in paragraph (1).
In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.
To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.
This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
The Secretary shall-
1So in original. The words "the Secretary shall" also appear at end of introductory provisions.
21 U.S.C. § 379j-12
Termination of SectionFor termination of section by section 2307(a) of Pub. L. 118-15 see Termination Date note below.
EDITORIAL NOTES
AMENDMENTS2023-Subsec. (a)(1)(A)(ii)(III). Pub. L. 118-15, §2303(a), added subcl. (III).Subsec. (b)(1). Pub. L. 118-15, §2303(b), amended par. (1) generally. Prior to amendment, text read as follows: "Subject to subsections (c), (d), (f), and (g)- "(A) for fiscal year 2019, the fees required under subsection (a) shall be established to generate a total revenue amount of $30,331,240; and"(B) for each of fiscal years 2020 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $29,931,240."Subsec. (c)(1). Pub. L. 118-15, §2303(c)(1), amended par. (1) generally. Prior to amendment, text read as follows: "The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2003, for that fiscal year, animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection."Subsec. (c)(2)(A). Pub. L. 118-15, §2303(c)(2)(A)(i), substituted "2025" for "2020" in introductory provisions.Subsec. (c)(2)(A)(iii). Pub. L. 118-15, §2303(c)(2)(A)(ii), substituted "Arlington-Alexandria" for "Baltimore".Subsec. (c)(2)(B). Pub. L. 118-15, §2303(c)(2)(B), substituted "2025" for "2020".Subsec. (c)(3)(A). Pub. L. 118-15, §2303(c)(3)(A)(i), substituted "2025" for "2020" and "subparagraph (B)" for "subparagraphs (B) and (C)" in introductory provisions.Subsec. (c)(3)(A)(ii), (iii). Pub. L. 118-15, §2303(c)(3)(A)(ii), (iii), added cls. (ii) and (iii) and struck out former cl. (ii) which read as follows: "the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies."Subsec. (c)(3)(B), (C). Pub. L. 118-15, §2303(c)(3)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "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." Subsec. (c)(4). Pub. L. 118-15, §2303(c)(4), amended par. (4) generally. Prior to amendment, text read as follows: "For fiscal year 2023, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first 3 months of fiscal year 2024. If the Food and Drug Administration has carryover balances for the process for the review of animal drug applications in excess of 3 months of such operating reserves, then this adjustment will not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2023."Subsec. (d)(4). Pub. L. 118-15, §2303(d), amended par. (4) generally. Prior to amendment, par. (4) related to exemptions from fees for certain labeling supplements to add number of approved application and for certain animal drug applications.Subsec. (g)(3). Pub. L. 118-15, §2303(e)(1), (2) (A), substituted "2024 through 2028" for "2019 through 2023" and struck out "and paragraph (5)" after "under subsection (c)".Subsec. (g)(5). Pub. L. 118-15, §2303(e)(2)(B), struck out par. (5) which related to recovery of collection shortfalls. 2018-Subsec. (a)(1)(C). Pub. L. 115-234, §304(b), substituted "Exceptions" for "Exception" in heading, designated existing provisions as cl. (i), and added cl. (ii). Subsec. (b)(1)(A). Pub. L. 115-234, §103(a)(1)(A), substituted "2019" for "2014" and "$30,331,240" for "$23,600,000". Subsec. (b)(1)(B). Pub. L. 115-234, §103(a)(1)(B), substituted "2020 through 2023" for "2015 through 2018" and "$29,931,240" for "$21,600,000".Subsec. (b)(2). Pub. L. 115-234, §103(a)(2), substituted "established" for "determined" in introductory provisions.Subsec. (c)(2). Pub. L. 115-234, §103(b)(1), substituted "(A) For fiscal year 2020" for "For fiscal year 2015", redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), added subpar. (B), and struck out concluding provisions which read as follows: "The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under this paragraph."Subsec. (c)(3). Pub. L. 115-234, §103(b)(2), amended par. (3) generally. Prior to amendment, text read as follows: "For fiscal year 2015 and subsequent fiscal years, after the revenue amounts established in subsection (b) are adjusted for inflation in accordance with paragraph (2), the 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. With respect to such adjustment-"(A) 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;"(B) the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies; and"(C) under no circumstances shall such adjustment 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 for inflation under paragraph (2)."Subsec. (c)(4). Pub. L. 115-234, §103(b)(3), substituted "2023" for "2018" in two places and "2024" for "2019".Subsec. (d). Pub. L. 115-234, §103(c)(1), inserted ";exemptions from fees" after "reduction" in heading. Subsec. (d)(1). Pub. L. 115-234, §103(c)(2), substituted "Waiver or reduction" for "In general" in heading. Subsec. (d)(4). Pub. L. 115-234, §103(c)(3), added par. (4).Subsec. (g)(3). Pub. L. 115-234, §103(d)(1), substituted "2019 through 2023" for "2014 through 2018", "established" for "determined", and "paragraph (5)" for "paragraph (4)". Subsec. (g)(4), (5). Pub. L. 115-234, §103(d)(2), added pars. (4) and (5) and struck out former par. (4) which related to offset of overcollections and recovery of collection shortfalls for certain fiscal years.2017-Subsec. (a)(3)(C). Pub. L. 115-52 amended subpar. (C) generally. Prior to amendment, text read as follows:"(i) IN GENERAL.-An establishment shall be assessed only one fee per fiscal year under this section, subject to clause (ii)."(ii) CERTAIN MANUFACTURERS.-If a single establishment manufactures both animal drug products and prescription drug products, as defined in section 379g(3) of this title, such establishment shall be assessed both the animal drug establishment fee and the prescription drug establishment fee, as set forth in section 379h(a)(2) of this title, within a single fiscal year."2013- Pub. L. 113-14 amended section generally. Prior to amendment, section related to authority to assess and use animal drug fees.2008-Subsec. (a)(1)(A)(i). Pub. L. 110-316, §103(a)(1), inserted ",except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title" after "for an animal drug application".Subsec. (a)(1)(A)(ii). Pub. L. 110-316, §103(a)(2), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: "A fee established in subsection (b) of this section for a supplemental animal drug application for which safety or effectiveness data are required, in an amount that is equal to 50 percent of the amount of the fee under clause (i)."Subsec. (b)(1). Pub. L. 110-316, §103(b)(1), substituted "and supplemental and other animal drug application fees" for "and supplemental animal drug application fees" and "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008." Subsec. (b)(2). Pub. L. 110-316, §103(b)(2), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008." Subsec. (b)(3). Pub. L. 110-316, §103(b)(3), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008." Subsec. (b)(4). Pub. L. 110-316, §103(b)(4), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008." Subsec. (c)(1). Pub. L. 110-316, §103(c)(1)-(3), redesignated par. (2) as (1), substituted "The fee revenues shall be adjusted each fiscal year after fiscal year 2009" for "After the fee revenues are adjusted for inflation in accordance with paragraph (1), the fee revenues shall be further adjusted each fiscal year after fiscal year 2004" in introductory provisions, struck out ",as adjusted for inflation under paragraph (1)" before period in subpar. (B), and struck out former par. (1) relating to inflation adjustment.Subsec. (c)(2). Pub. L. 110-316, §103(c)(2), (4), redesignated par. (3) as (2) and substituted "2013" for "2008" in two places and "2014" for "2009". Former par. (2) redesignated (1). Subsec. (c)(3) to (5). Pub. L. 110-316, §103(c)(2), redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2).Subsec. (g)(3)(A) to (E). Pub. L. 110-316, §103(d), amended subpars. (A) to (E) generally. Prior to amendment, subpars. (A) to (E) read as follows:"(A) $5,000,000 for fiscal year 2004;"(B) $8,000,000 for fiscal year 2005; "(C) $10,000,000 for fiscal year 2006;"(D) $10,000,000 for fiscal year 2007; and"(E) $10,000,000 for fiscal year 2008;".Subsec. (g)(4). Pub. L. 110-316, §103(e), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriations Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2023 AMENDMENT Amendment by Pub. L. 118-15 effective Oct. 1, 2023, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as amended, to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2023, see section 2306 of Pub. L. 118-15 set out as a note under section 379j-11 of this title.
EFFECTIVE DATE OF 2018 AMENDMENT Amendment by Pub. L. 115-234 effective Oct. 1, 2018, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.) to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2018, see section 106 of Pub. L. 115-234 set out as a note under section 379j-11 of this title.
EFFECTIVE DATE OF 2017 AMENDMENT Amendment by Pub. L. 115-52 effective Oct. 1, 2017, with fees under subpart 2 of this part to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115-52 set out as a note under section 379g of this title.
EFFECTIVE DATE OF 2013 AMENDMENT Amendment by Pub. L. 113-14 effective Oct. 1, 2013, see section 106 of Pub. L. 113-14 set out as a note under section 379j-11 of this title.
EFFECTIVE DATE OF 2008 AMENDMENT Amendment by Pub. L. 110-316 effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of Pub. L. 110-316 set out as an Effective and Termination Dates of 2008 Amendment note under section 379j-11 of this title.
TERMINATION DATESection to cease to be effective Oct. 1, 2028, see section 2307(a) of Pub. L. 118-15 set out as a note under section 379j-11 of this title. Pub. L. 115-234, title I, §107(a), Aug. 14, 2018, 132 Stat. 2432, which provided that section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12) would cease to be effective Oct. 1, 2023, was repealed by Pub. L. 118-15, div. B, title III, §2307(c), Sept. 30, 2023, 137 Stat. 89, effective Oct. 1, 2023. Pub. L. 113-14, title I, §107(a), June 13, 2013, 127 Stat. 464, which provided that section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115-234, title I, §107(c), Aug. 14, 2018, 132 Stat. 2432, effective Oct. 1, 2018.