21 U.S.C. § 379j-21
Beginning with respect to fiscal year 2009, the Secretary shall assess and collect fees in accordance with this section as follows:
Each person that submits, on or after July 1, 2008, an abbreviated application for a generic new animal drug shall be subject to a fee as established in subsection (c) for such an application.
The fee required by subparagraph (A) shall be due upon submission of the abbreviated application.
If an abbreviated application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
An abbreviated application which is subject to the criteria in section 360b(d)(4) of this title and submitted on or after October 1, 2013 shall be subject to a fee equal to 50 percent of the amount of the abbreviated application fee established in subsection (c).
The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any abbreviated application which is refused for filing.
If an abbreviated application is withdrawn after the application was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the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 after the application was filed. The Secretary shall have the sole discretion to refund the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.
Each person-
shall pay for each such generic new animal drug product the annual fee established in subsection (c).
Such fee shall be payable for the fiscal year in which the generic new 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title, or is submitted for relisting under section 360 of this title if the generic new animal drug product has been withdrawn from listing and relisted.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 generic new animal drug product for a fiscal year in which the fee is payable.
Each person-
shall be assessed an annual generic new animal drug sponsor fee as established under subsection (c).
Such fee shall be due each fiscal year upon the later of-
Each generic new animal drug sponsor shall pay only 1 such fee each fiscal year, as follows:
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).
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).
The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file.
The fee required by subparagraph (A)(ii) shall be due upon the first submission to the 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.
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.
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 $25,000,000.
Of the total revenue amount established for a fiscal year under paragraph (1)-
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-
For fiscal year 2025 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of-
The adjustment made each fiscal year after fiscal year 2025 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.
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 each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment-
For each of fiscal years 2026 through 2028, 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 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 2028, 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 abbreviated applications for generic new animal drugs for the first 3 months of fiscal year 2029. If the Food and Drug Administration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in excess of 3 months of such operating reserves, then this adjustment shall 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 2028.
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 abbreviated applications for generic new animal drugs.
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.
An abbreviated application for a generic new animal drug 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 submission for a generic new animal drug 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. 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 review of any abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug 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 2008 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 abbreviated applications, generic new animal drug products, generic new animal drug sponsors, and generic investigational new animal drug files 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 abbreviated applications for generic new animal drugs.
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 abbreviated applications for generic new animal drugs-
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).
The amount of fees otherwise authorized to be collected under this section shall be increased-
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 abbreviated applications for generic new animal drugs, be reduced to offset the number of officers, employees, and advisory committees so engaged.
In this section and section 379j-22 of this title:
The terms "abbreviated application for a generic new animal drug" and "abbreviated application" mean an abbreviated application for the approval of any generic new animal drug submitted under section 360b(b)(2) of this title. Such term does not include a supplemental abbreviated application for a generic new animal drug.
The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by-
The term "costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs" means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for-
The term "final dosage form" means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.
The term "generic new animal drug" means a new animal drug that is the subject of an abbreviated application.
The term "generic new animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.
The term "generic new animal drug sponsor" means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.
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.
The terms "investigational submission for a generic new animal drug" and "investigational submission" mean-
The term "person" includes an affiliate thereof (as such term is defined in section 379g(11) of this title).
The term "process for the review of abbreviated applications for generic new animal drugs" means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions:
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.
The terms "supplemental abbreviated application for a generic new animal drug" and "supplemental abbreviated application" mean a request to the Secretary to approve a change in an approved abbreviated application.
21 U.S.C. § 379j-21
Termination of SectionFor termination of section by section 2316(a) of Pub. L. 118-15 see Termination Date note below.
EDITORIAL NOTES
PRIOR PROVISIONSA prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to section 379k of this title.
AMENDMENTS2023-Subsec. (a)(4). Pub. L. 118-15, §2312(a), added par. (4).Subsec. (b)(1). Pub. L. 118-15, §2312(b)(1), substituted "2024 through 2028" for "2019 through 2023" and "$25,000,000" for "$18,336,340".Subsec. (b)(2)(A). Pub. L. 118-15, §2312(b)(2)(A), substituted "20 percent" for "25 percent" and inserted before semicolon at end "and fees under subsection (a)(4) (relating to generic investigational new animal drug files)".Subsec. (b)(2)(B), (C). Pub. L. 118-15, §2312(b)(2)(B), (C), substituted "40 percent" for "37.5 percent".Subsec. (c)(1). Pub. L. 118-15, §2312(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, 2008, for that fiscal year, abbreviated application fees, 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." Subsec. (c)(2)(A). Pub. L. 118-15, §2312(c)(2)(A), substituted "2025" for "2020" in introductory provisions.Subsec. (c)(2)(A)(iii). Pub. L. 118-15, §2312(c)(2)(A)(ii), substituted "Arlington-Alexandria" for "Baltimore".Subsec. (c)(2)(B). Pub. L. 118-15, §2312(c)(2)(B), substituted "2025" for "2020". Subsec. (c)(3)(A). Pub. L. 118-15, §2312(c)(3)(A)(i), substituted "2025" for "2020" in introductory provisions.Subsec. (c)(3)(A)(i). Pub. L. 118-15, §2312(c)(3)(A)(ii)(I), substituted "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" for "and investigational generic new animal drug protocol submissions".Subsec. (c)(3)(A)(ii), (iii). Pub. L. 118-15, §2312(c)(3)(A)(ii)(II)-(iv), added cl. (ii) and redesignated former cl. (ii) as (iii).Subsec. (c)(3)(B). Pub. L. 118-15, §2312(c)(3)(B), substituted "2026 through 2028" for "2021 through 2023".Subsec. (c)(4). Pub. L. 118-15, §2312(c)(4), substituted "2028" for "2023" in two places and "2029" for "2024".Subsec. (d). Pub. L. 118-15, §2312(d), amended subsec. (d) generally. Prior to amendment, subsec. (d) related to fee waiver or reduction and exemption from fees.Subsec. (e). Pub. L. 118-15, §2312(e), substituted "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" for "The Secretary may discontinue". Subsec. (f)(2). Pub. L. 118-15, §2312(f), substituted "products, generic new animal drug sponsors, and generic investigational new animal drug files at any time" for "sponsors, and generic new animal drug products at any time".Subsec. (g)(3). Pub. L. 118-15, §2312(g)(1), substituted "2024 through 2028" for "2019 through 2023". Subsec. (g)(4). Pub. L. 118-15, §2312(g)(2), struck out par. (4) relating to offset. Text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2014 through 2017, the excess amount 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 fiscal year 2018."Subsec. (g)(5). Pub. L. 118-15, §2312(g)(3), added par. (5).Subsec. (k)(8) to (11). Pub. L. 118-15, §2312(h)(1), (2), added par. (8) and redesignated former pars. (8) to (10) as (9) to (11), respectively. Former par. (11) redesignated (13).Subsec. (k)(11)(I). Pub. L. 118-15, §2312(h)(3), added subpar. (I).Subsec. (k)(12), (13). Pub. L. 118-15, §2312(h)(1), (4), added par. (12) and redesignated par. (11) as (13).2018-Subsec. (b). Pub. L. 115-234, §202(a), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts for fiscal years 2014 to 2018.Subsec. (c)(2). Pub. L. 115-234, §202(b)(1)(B), added par. (2). Former par. (2) redesignated (3).Subsec. (c)(3). Pub. L. 115-234, §202(b)(1)(A), (2), redesignated par. (2) as (3) and amended it generally. Prior to amendment, text read as follows: "The fee revenues shall be adjusted each fiscal year after fiscal year 2014 to reflect changes in review workload. With respect to such adjustment:"(A) This adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary. The Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies. "(B) Under no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b)."Former par. (3) redesignated (4).Subsec. (c)(4). Pub. L. 115-234, §202(b)(1)(A), (3), redesignated par. (3) as (4) and substituted "2023" for "2018" in two places and "2024" for "2019". Former par. (4) redesignated (5). Subsec. (c)(5). Pub. L. 115-234, §202(b)(1)(A), redesignated par. (4) as (5).Subsec. (d). Pub. L. 115-234, §202(c), amended subsec. (d) generally. Prior to amendment, text read as follows: "The Secretary shall grant a waiver from or a reduction of 1 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."Subsec. (g)(3), (4). Pub. L. 115-234, §202(d), added par. (3) and par. (4) relating to excess collections and struck out former par. (3) which related to authorization of appropriations for fiscal years 2014 to 2018.2013- Pub. L. 113-14 amended section generally. Prior to amendment, section related to authority to assess and use generic new animal drug fees.
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2023 AMENDMENT Pub. L. 118-15, div. B, title III, §23152315,, 137 Stat. 94, provided that: "The amendments made by this chapter [chapter 2 (§§2311-2316) of subtitle A of title III of div. B of Pub. L. 118-15 amending this section and section 379j-22 of this title and repealing provisions set out as notes under this section and section 379j-22 of this title] shall take effect on October 1, 2023, or the date of the enactment of this Act [Sept. 30, 2023], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), as amended by this chapter, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2023, regardless of the date of enactment of this Act."
EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115-234, title II, §205, Aug. 14, 2018, 132 Stat. 2435, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115-234 set out as a Short Title of 2018 Amendment note under section 301 of this title] shall take effect on October 1, 2018, or the date of the enactment of this Act [Aug. 14, 2018], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j-21 et seq.], as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act."
EFFECTIVE DATE OF 2013 AMENDMENT Pub. L. 113-14, title II, §205, June 13, 2013, 127 Stat. 474, provided that: "The amendments made by this title [amending this section and section 379j-22 of this title and repealing provisions set out as notes under this section and section 379j-22 of this title] shall take effect on October 1, 2013, or the date of enactment of this Act [June 13, 2013], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j-21 et seq.], as amended by this title, shall be assessed for all abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2013, regardless of the date of enactment of this Act."
TERMINATION DATE Pub. L. 118-15, div. B, title III, §2316(a), Sept. 30, 2023, 137 Stat. 94, provided that: "Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) shall cease to be effective October 1, 2028." Pub. L. 115-234, title II, §206(a), Aug. 14, 2018, 132 Stat. 2435, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) would cease to be effective Oct. 1, 2023, was repealed by Pub. L. 118-15, div. B, title III, §2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023. Pub. L. 113-14, title II, §206(a), June 13, 2013, 127 Stat. 474, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115-234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018. Pub. L. 110-316, title II, §204(a), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendments made by section 202 of Pub. L. 110-316 (enacting this section and amending sections 379k, 379l, and 379o of this title) would cease to be effective Oct. 1, 2013, was repealed by Pub. L. 113-14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.
SAVINGS PROVISIONS Pub. L. 118-15, div. B, title III, §23142314,, 137 Stat. 94, provided that: "Notwithstanding the amendments made by this chapter [chapter 2 (§§2311-2316) of subtitle A of title III of div. B of Pub. L. 118-15 amending this section and section 379j-22 of this title and repealing provisions set out as notes under this section and section 379j-22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), as in effect on the day before the date of enactment of this chapter [Sept. 30, 2023], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024." Pub. L. 115-234, title II, §204, Aug. 14, 2018, 132 Stat. 2435, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115-234 set out as a Short Title of 2018 Amendment note under section 301 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), as in effect on the day before the date of enactment of this title [Aug. 14, 2018], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019." Pub. L. 113-14, title II, §204, June 13, 2013, 127 Stat. 474, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379j-22 of this title and repealing provisions set out as notes under this section and section 379j-22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j-21 et seq.], as in effect on the day before the date of enactment of this title [June 13, 2013], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2014."
FINDINGS Pub. L. 118-15, div. B, title III, §2311(b), Sept. 30, 2023, 137 Stat. 90, provided that: "Congress finds that the fees authorized by the amendments made in this chapter [chapter 2 (§§2311-2316) of subtitle A of title III of div. B of Pub. L. 118-15 amending this section and section 379j-22 of this title and repealing provisions set out as notes under this section and section 379j-22 of this title] will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record."Similar provisions were contained in the following prior acts: Pub. L. 115-234, title II, §201(b), Aug. 14, 2018, 132 Stat. 2432. Pub. L. 113-14, title II, §201(b), June 13, 2013, 127 Stat. 464. Pub. L. 110-316, title II, §201(b), Aug. 14, 2008, 122 Stat. 3515.