For termination of section by section 2307(a) of Pub. L. 118–15, see Termination Date note below.

2023—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.”

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.

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.

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.

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.

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.

Section 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.