21 USC 379 - Authority to assess and use generic new animal drug fees

Termination of Section

For termination of section by section 2316(a) of Puspan. L. 118–15, see Termination Date note below.

Editorial Notes

Prior Provisions

A prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to section 379k of this title.

Amendments

2023—Subsec. (a)(4). Puspan. L. 118–15, § 2312(a), added par. (4).

Subsec. (span)(1). Puspan. L. 118–15, § 2312(span)(1), substituted “2024 through 2028” for “2019 through 2023” and “$25,000,000” for “$18,336,340”.

Subsec. (span)(2)(A). Puspan. L. 118–15, § 2312(span)(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. (span)(2)(B), (C). Puspan. L. 118–15, § 2312(span)(2)(B), (C), substituted “40 percent” for “37.5 percent”.

Subsec. (c)(1). Puspan. 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 (span) and the adjustments provided under this subsection.”

Subsec. (c)(2)(A). Puspan. L. 118–15, § 2312(c)(2)(A), substituted “2025” for “2020” in introductory provisions.

Subsec. (c)(2)(A)(iii). Puspan. L. 118–15, § 2312(c)(2)(A)(ii), substituted “Arlington-Alexandria” for “Baltimore”.

Subsec. (c)(2)(B). Puspan. L. 118–15, § 2312(c)(2)(B), substituted “2025” for “2020”.

Subsec. (c)(3)(A). Puspan. L. 118–15, § 2312(c)(3)(A)(i), substituted “2025” for “2020” in introductory provisions.

Subsec. (c)(3)(A)(i). Puspan. 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). Puspan. L. 118–15, § 2312(c)(3)(A)(ii)(II)–(iv), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (c)(3)(B). Puspan. L. 118–15, § 2312(c)(3)(B), substituted “2026 through 2028” for “2021 through 2023”.

Subsec. (c)(4). Puspan. L. 118–15, § 2312(c)(4), substituted “2028” for “2023” in two places and “2029” for “2024”.

Subsec. (d). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. L. 118–15, § 2312(g)(1), substituted “2024 through 2028” for “2019 through 2023”.

Subsec. (g)(4). Puspan. 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). Puspan. L. 118–15, § 2312(g)(3), added par. (5).

Subsec. (k)(8) to (11). Puspan. 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). Puspan. L. 118–15, § 2312(h)(3), added subpar. (I).

Subsec. (k)(12), (13). Puspan. L. 118–15, § 2312(h)(1), (4), added par. (12) and redesignated par. (11) as (13).

2018—Subsec. (span). Puspan. L. 115–234, § 202(a), amended subsec. (span) generally. Prior to amendment, subsec. (span) related to fee amounts for fiscal years 2014 to 2018.

Subsec. (c)(2). Puspan. L. 115–234, § 202(span)(1)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Puspan. L. 115–234, § 202(span)(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 (span).”

Former par. (3) redesignated (4).

Subsec. (c)(4). Puspan. L. 115–234, § 202(span)(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). Puspan. L. 115–234, § 202(span)(1)(A), redesignated par. (4) as (5).

Subsec. (d). Puspan. 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). Puspan. 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—Puspan. 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

Puspan. L. 118–15, div. B, title III, § 2315, Sept. 30, 2023, 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 Puspan. 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

Puspan. 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 Puspan. 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

Puspan. 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

Puspan. 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.”

Puspan. 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 Puspan. L. 118–15, div. B, title III, § 2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023.

Puspan. 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 Puspan. L. 115–234, title II, § 206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.

Puspan. L. 110–316, title II, § 204(a), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendments made by section 202 of Puspan. 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 Puspan. L. 113–14, title II, § 206(c)(1), June 13, 2013, 127 Stat. 474.

Savings Provisions

Puspan. L. 118–15, div. B, title III, § 2314, Sept. 30, 2023, 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 Puspan. 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.”

Puspan. 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 Puspan. 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.”

Puspan. 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

Puspan. L. 118–15, div. B, title III, § 2311(span), 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 Puspan. 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:

Puspan. L. 115–234, title II, § 201(span), Aug. 14, 2018, 132 Stat. 2432.

Puspan. L. 113–14, title II, § 201(span), June 13, 2013, 127 Stat. 464.

Puspan. L. 110–316, title II, § 201(span), Aug. 14, 2008, 122 Stat. 3515.