21 USC 379 - Reauthorization; reporting requirements

1 See References in Text note below.

of the Biosimilar User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.

2 So in original.

letters issued by the agency for such applications.

Termination of Section

For termination of section by section 4005(span) of Puspan. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 401(span) of the Biosimilar User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 4001(span) of the Biosimilar User Fee Amendments of 2022, title IV of div. F of Puspan. L. 117–180, which is set out as a note under section 379j–51 of this title. The Biosimilar User Fee Amendments of 2022 does not contain a section 401(span).

Section 4001(span) of the Biosimilar User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 4001(span) of title IV of div. F of Puspan. L. 117–180, which is set out as a note under section 379j–51 of this title.

Codification

Amendments made by section 904(d)(2) of Puspan. L. 115–52, effective Aug. 18, 2017, were executed after the amendments made by section 404(3)–(5) of Puspan. L. 115–52, effective Oct. 1, 2017, to reflect the probable intent of Congress and the directory language of section 904(d)(2) of Puspan. L. 115–52, which expressly amended this section “as amended by section 404” of Puspan. L. 115–52. See 2017 Amendment notes below.

Amendments

2022—Puspan. L. 117–180, § 4004(2), substituted “Biosimilar User Fee Amendments of 2022” for “Biosimilar User Fee Amendments of 2017” wherever appearing.

Subsec. (a)(1). Puspan. L. 117–180, § 4004(1), substituted “Not” for “Beginning with fiscal year 2018, not”.

Subsec. (a)(2). Puspan. L. 117–180, § 4004(3), substituted “The” for “Beginning with fiscal year 2018, the” in introductory provisions.

Subsec. (a)(3)(A). Puspan. L. 117–180, § 4004(4), 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)(4)(A). Puspan. L. 117–328, § 3626(d)(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 401(span) of the Biosimilar 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)(4)(B). Puspan. L. 117–328, § 3626(d)(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 the process for the review of biosimilar biological product applications, including identifying drivers of such changes; and”.

Subsec. (a)(4)(D). Puspan. L. 117–328, § 3626(d)(1)(C), (D), added subpar. (D).

Subsec. (span). Puspan. L. 117–180, § 4004(5), substituted “Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart” for “Not later than 120 days after the end of fiscal year 2018 and each subsequent fiscal year for which fees are collected under this subpart”.

Subsec. (c). Puspan. L. 117–180, § 4004(6), substituted “For” for “Beginning with fiscal year 2018, and for” in introductory provisions.

Subsec. (f)(1). Puspan. L. 117–180, § 4004(7)(A), substituted “fiscal year 2027” for “fiscal year 2022” in introductory provisions.

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

Subsec. (f)(3). Puspan. L. 117–328, § 3626(d)(2)(B), added par. (3). Former par. (3) redesignated (6).

Puspan. L. 117–180, § 4004(7)(B), substituted “January 15, 2027” for “January 15, 2022”.

Subsec. (f)(4) to (7). Puspan. L. 117–328, § 3626(d)(2), added pars. (4) and (7) and redesignated formers pars. (2) and (3) as (5) and (6), respectively.

2017—Subsec. (a). Puspan. L. 115–52, § 903(d), designated existing provisions as par. (1), inserted heading, and added pars. (2) to (4).

Puspan. L. 115–52, § 404(1), substituted “2018” for “2013” and “Biosimilar User Fee Amendments of 2017” for “Biosimilar User Fee Act of 2012”.

Subsec. (a)(5). Puspan. L. 115–52, § 904(d)(1), added par. (5).

Subsec. (span). Puspan. L. 115–52, § 404(2), substituted “2018” for “2013”.

Subsec. (c). Puspan. L. 115–52, § 904(d)(2), added subsec. (c). Former subsec. (c) redesignated (e).

Subsecs. (d), (e). Puspan. L. 115–52, § 904(d)(2), added subsec. (d) and redesignated subsec. (c) as (e). Former subsec. (d), as redesignated by section 404(4) of Puspan. L. 115–52, redesignated (f). See Amendment notes below.

Puspan. L. 115–52, § 404(3)–(5), redesignated subsec. (e) as (d), substituted “2022” for “2017” in pars. (1) and (3), and struck out former subsec. (d) which related to a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications.

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

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 biosimilar biological product applications received on or after Oct. 1, 2022, see section 4006 of Puspan. L. 117–180, set out as a note under section 379j–51 of this title.

Effective Date of 2017 Amendment

Amendment by section 404 of Puspan. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Puspan. L. 115–52, set out as a note under section 379j–51 of this title.

Effective and Termination Dates

Puspan. L. 117–180, div. F, title IV, § 4005(span), Sept. 30, 2022, 136 Stat. 2166, provided that:

“Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) shall cease to be effective January 31, 2028.”

Puspan. L. 115–52, title IV, § 405(span), Aug. 18, 2017, 131 Stat. 1035, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Puspan. L. 117–180, div. F, title IV, § 4005(c), Sept. 30, 2022, 136 Stat. 2166.

[Puspan. L. 117–180, div. F, title IV, § 4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(span) of Puspan. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Puspan. L. 112–144, title IV, § 404(span), July 9, 2012, 126 Stat. 1038, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Puspan. L. 115–52, title IV, § 405(c)(1), Aug. 18, 2017, 131 Stat. 1035.

[Puspan. L. 115–52, title III, § 405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(span) of Puspan. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Section effective Oct. 1, 2012, see section 405 of Puspan. L. 112–144, set out as a note under section 379j–51 of this title.