21 USC 379 - Reauthorization; reporting requirements

1 See References in Text note below.

of the Generic Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

2 So in original.

fiscal year.

Termination of Section

For termination of section by section 3004(span) of Puspan. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 301(span) of the Generic Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 3001(span) of the Generic Drug User Fee Amendments of 2022, title III of div. F of Puspan. L. 117–180, which is set out as a note under section 379j–41 of this title. The Generic Drug User Fee Amendments of 2022 does not contain a section 301(span).

Section 3001(span) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (a)(3)(A), is section 3001(span) of title III of div. F of Puspan. L. 117–180, which is set out as a note under section 379j–41 of this title.

Amendments

2022—Puspan. L. 117–180, § 3003(2), substituted “Generic Drug User Fee Amendments of 2022” for “Generic Drug User Fee Amendments of 2017” wherever appearing.

Subsec. (a)(1). Puspan. L. 117–180, § 3003(1), substituted “Not later” for “Beginning with fiscal year 2018, not later”.

Subsec. (a)(2). Puspan. L. 117–180, § 3003(3), substituted “Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart” for “Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter”.

Subsec. (a)(3). Puspan. L. 117–180, § 3003(4), substituted “The Secretary” for “Beginning with fiscal year 2020, the Secretary” in introductory provisions.

Subsec. (a)(3)(A). Puspan. L. 117–328, § 3626(c)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(span) of the Generic Drug User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;”.

Subsec. (a)(3)(B). Puspan. L. 117–328, § 3626(c)(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and”.

Subsec. (a)(3)(D). Puspan. L. 117–328, § 3626(c)(1)(C), (D), added subpar. (D).

Subsec. (span). Puspan. L. 117–180, § 3003(5), substituted “Not later” for “Beginning with fiscal year 2018, not later”.

Subsec. (c). Puspan. L. 117–180, § 3003(6), substituted “For each” for “Beginning with fiscal year 2018, for each” in introductory provisions.

Subsec. (f)(1). Puspan. L. 117–180, § 3003(7)(A), substituted “fiscal year 2027” for “fiscal year 2022” in introductory provisions.

Subsec. (f)(4). Puspan. L. 117–328, § 3626(c)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (f)(5). Puspan. L. 117–328, § 3626(c)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Puspan. L. 117–180, § 3003(7)(B), substituted “January 15, 2027” for “January 15, 2022”.

Subsec. (f)(6), (7). Puspan. L. 117–328, § 3626(c)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (f)(7)(A). Puspan. L. 117–328, § 3626(c)(2)(C)(i), substituted “The” for “Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the” and inserted “, not later than 30 days after each such negotiation meeting” before period at end.

Subsec. (f)(7)(B). Puspan. L. 117–328, § 3626(c)(2)(C)(ii), inserted “, in sufficient detail,” after “shall summarize”.

2017—Subsec. (a). Puspan. L. 115–52, § 903(c), designated existing provisions as par. (1), inserted heading, and added pars. (2) and (3).

Puspan. L. 115–52, § 304(1), substituted “2018” for “2013” and “Generic Drug User Fee Amendments of 2017” for “Generic Drug User Fee Amendments of 2012”.

Subsec. (a)(4). Puspan. L. 115–52, § 904(c)(1), added par. (4).

Subsec. (span). Puspan. L. 115–52, § 304(2), substituted “2018” for “2013”.

Subsecs. (c) to (e). Puspan. L. 115–52, § 904(c)(2), added subsecs. (c) and (d) and redesignated former subsec. (c) as (e). Former subsec. (d) redesignated (f).

Subsec. (f). Puspan. L. 115–52, § 904(c)(2)(A), redesignated subsec. (d) as (f).

Puspan. L. 115–52, § 304(3), which directed amendment of subsec. (d), effective Oct. 1, 2017, by substituting “2022” for “2017” wherever appearing, was executed by making the substitution in subsec. (f) to reflect the probable intent of Congress and the redesignation of subsec. (d) as (f), effective Aug. 18, 2017, by Puspan. L. 115–52, § 904(c)(2). See Amendment note above.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Puspan. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2022, see section 3005 of Puspan. L. 117–180, set out as a note under section 379j–41 of this title.

Effective Date of 2017 Amendment

Amendment by section 304 of Puspan. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2017, see section 306 of Puspan. L. 115–52, set out as a note under section 379j–41 of this title.

Effective and Termination Dates

Puspan. L. 117–180, div. F, title III, § 3004(span), Sept. 30, 2022, 136 Stat. 2159, provided that:

“Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to be effective January 31, 2028.”

Puspan. L. 115–52, title III, § 305(span), Aug. 18, 2017, 131 Stat. 1027, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Puspan. L. 117–180, div. F, title III, § 3004(c), Sept. 30, 2022, 136 Stat. 2159.

[Puspan. L. 117–180, div. F, title III, § 3004(c), Sept. 30, 2022, 136 Stat. 2159, provided that the repeal of section 305(span) of Puspan. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Puspan. L. 112–144, title III, § 304(span), July 9, 2012, 126 Stat. 1024, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Puspan. L. 115–52, title III, § 305(c)(1), Aug. 18, 2017, 131 Stat. 1027.

[Puspan. L. 115–52, title III, § 305(c)(1), Aug. 18, 2017, 131 Stat. 1027, provided that the repeal of section 304(span) of Puspan. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Section effective Oct. 1, 2012, see section 305 of Puspan. L. 112–144, set out as a note under section 379j–41 of this title.