21 USC 379 - Reauthorization; reporting requirements

1 See References in Text note below.

of the Prescription Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and

Termination of Section

For termination of section by section 1005(span) of Puspan. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 101(span) of the Prescription Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 1001(span) of the Prescription Drug User Fee Amendments of 2022, title I of div. F of Puspan. L. 117–180, which is set out as a note under section 379g of this title. The Prescription Drug User Fee Amendments of 2022 does not contain a section 101(span).

Section 1001(span) of the Prescription Drug User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 1001(span) of title I of div. F of Puspan. L. 117–180, which is set out as a note under section 379g of this title.

Amendments

2022—Puspan. L. 117–180, § 1004(2), substituted “Prescription Drug User Fee Amendments of 2022” for “Prescription Drug User Fee Amendments of 2017” wherever appearing.

Subsec. (a)(1). Puspan. L. 117–328, § 3626(a)(1)(A)(ii), inserted concluding provisions.

Puspan. L. 117–180, § 1004(1), substituted “Not” for “Beginning with fiscal year 2018, not” in introductory provisions.

Subsec. (a)(1)(B)(ix). Puspan. L. 117–328, § 3626(a)(1)(A)(i), added cl. (ix).

Subsec. (a)(3)(A). Puspan. L. 117–180, § 1004(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)(B)(v). Puspan. L. 117–328, § 3626(a)(1)(B), added cl. (v).

Subsec. (a)(4). Puspan. L. 117–180, § 1004(4), substituted “The” for “Beginning with fiscal year 2020, the” in introductory provisions.

Subsec. (a)(4)(A). Puspan. L. 117–328, § 3626(a)(1)(C)(i), 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 101(span) of the Prescription 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)(4)(B). Puspan. L. 117–328, § 3626(a)(1)(C)(ii), 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 human drugs, including identifying drivers of such changes; and”.

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

Subsec. (span). Puspan. L. 117–180, § 1004(5), substituted “Not” for “Beginning with fiscal year 2018, not”.

Subsec. (c). Puspan. L. 117–180, § 1004(6), substituted “For” for “Beginning with fiscal year 2018, for” in introductory provisions.

Subsec. (f)(1). Puspan. L. 117–180, § 1004(7)(A), substituted “fiscal year 2027” for “fiscal year 2022” in introductory provisions.

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

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

Puspan. L. 117–180, § 1004(7)(B), substituted “January 15, 2027” for “January 15, 2022”.

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

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

2017—Subsec. (a)(1). Puspan. L. 115–52, § 103(a)(1), substituted “2018” for “2013”.

Subsec. (a)(1)(A). Puspan. L. 115–52, § 103(1)(B), substituted “Prescription Drug User Fee Amendments of 2017” for “Prescription Drug User Fee Amendments of 2012”.

Subsec. (a)(3), (4). Puspan. L. 115–52, § 903(a), added pars. (3) and (4).

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

Subsec. (span). Puspan. L. 115–52, § 103(2), substituted “2018” for “2013”.

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

Subsec. (d). Puspan. L. 115–52, § 904(a)(2)(B), added subsec. (d). Former subsec. (d) redesignated (f).

Puspan. L. 115–52, § 103(3), substituted “2022” for “2017” in pars. (1) and (5).

Subsecs. (e), (f). Puspan. L. 115–52, § 904(a)(2)(A), redesignated subsecs. (c) and (d) as (e) and (f), respectively.

2012—Subsec. (a). Puspan. L. 112–144, § 104(1), amended subsec. (a) generally. Prior to amendment, text read as follows: “Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the 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 human drug applications and supplements in the cohort.”

Subsec. (span). Puspan. L. 112–144, § 104(2), substituted “2013” for “2008”.

Subsec. (d)(1), (5). Puspan. L. 112–144, § 104(3), substituted “2017” for “2012”.

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 human drug applications received on or after Oct. 1, 2022, see section 1006 of Puspan. L. 117–180, set out as a note under section 379g of this title.

Effective Date of 2017 Amendment

Amendment by section 103 of Puspan. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Puspan. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

Amendment by Puspan. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2012, see section 106 of Puspan. L. 112–144, set out as a note under section 379g of this title.

Effective and Termination Dates

Puspan. L. 117–180, div. F, title I, § 1005(span), Sept. 30, 2022, 136 Stat. 2147, provided that:

“Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2028.”

Puspan. L. 115–52, title I, § 104(span), Aug. 18, 2017, 131 Stat. 1012, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Puspan. L. 117–180, div. F, title I, § 1005(c), Sept. 30, 2022, 136 Stat. 2147.

[Puspan. L. 117–180, div. F, title I, § 1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(span) of Puspan. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Puspan. L. 112–144, title I, § 105(span), July 9, 2012, 126 Stat. 1001, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Puspan. L. 115–52, title I, § 104(c), Aug. 18, 2017, 131 Stat 1012.

[Puspan. L. 115–52, title I, § 104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(span) of Puspan. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Puspan. L. 110–85, title I, § 106(span), Sept. 27, 2007, 121 Stat. 842, which provided that the amendment made by section 105 of Puspan. L. 110–85 (enacting this section) would cease to be effective Jan. 31, 2013, was repealed by Puspan. L. 112–144, title I, § 105(c)(1), July 9, 2012, 126 Stat. 1001.

Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Puspan. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.