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 401(b) 1 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.
The report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including-
Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
The Secretary shall post the following data in accordance with subparagraph (A):
Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)-
For each fiscal year, the Secretary shall include in the report an analysis of the following:
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 on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.
For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:
For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.
For each of the goals identified by the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include-
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.
Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.
The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.
In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with-
Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall-
Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).
The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this subpart to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.
After negotiations with the regulated industry, the Secretary shall-
Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.
The Secretary shall make publicly available, on the public website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.
The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.
1 See References in Text note below.
2 So in original.
21 U.S.C. § 379j-53
Termination of SectionFor termination of section by section 4005(b) of Pub. L. 117-180 see Effective and Termination Dates note set out below.
EDITORIAL NOTES
REFERENCES IN TEXTSection 401(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 4001(b) of the Biosimilar User Fee Amendments of 2022, title IV of div. F of Pub. 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(b).Section 4001(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 4001(b) of title IV of div. F of Pub. L. 117-180 which is set out as a note under section 379j-51 of this title.
CODIFICATIONAmendments made by section 904(d)(2) of Pub. L. 115-52 effective Aug. 18, 2017, were executed after the amendments made by section 404(3)-(5) of Pub. L. 115-52 effective Oct. 1, 2017, to reflect the probable intent of Congress and the directory language of section 904(d)(2) of Pub. L. 115-52 which expressly amended this section "as amended by section 404" of Pub. L. 115-52. See 2017 Amendment notes below.
AMENDMENTS2022- Pub. L. 117-180, §4004(2), substituted "Biosimilar User Fee Amendments of 2022" for "Biosimilar User Fee Amendments of 2017" wherever appearing. Subsec. (a)(1). Pub. L. 117-180, §4004(1), substituted "Not" for "Beginning with fiscal year 2018, not".Subsec. (a)(2). Pub. L. 117-180, §4004(3), substituted "The" for "Beginning with fiscal year 2018, the" in introductory provisions.Subsec. (a)(3)(A). Pub. 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). Pub. 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(b) 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). Pub. 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). Pub. L. 117-328, §3626(d)(1)(C), (D), added subpar. (D).Subsec. (b). Pub. 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). Pub. L. 117-180, §4004(6), substituted "For" for "Beginning with fiscal year 2018, and for" in introductory provisions.Subsec. (f)(1). Pub. L. 117-180, §4004(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.Subsec. (f)(2). Pub. L. 117-328, §3626(d)(2)(B), added par. (2). Former par. (2) redesignated (5).Subsec. (f)(3). Pub. L. 117-328, §3626(d)(2)(B), added par. (3). Former par. (3) redesignated (6). Pub. L. 117-180, §4004(7)(B), substituted "January 15, 2027" for "January 15, 2022". Subsec. (f)(4) to (7). Pub. 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). Pub. L. 115-52, §903(d), designated existing provisions as par. (1), inserted heading, and added pars. (2) to (4). Pub. 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). Pub. L. 115-52, §904(d)(1), added par. (5).Subsec. (b). Pub. L. 115-52, §404(2), substituted "2018" for "2013".Subsec. (c). Pub. L. 115-52, §904(d)(2), added subsec. (c). Former subsec. (c) redesignated (e).Subsecs. (d), (e). Pub. 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 Pub. L. 115-52 redesignated (f). See Amendment notes below. Pub. 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). Pub. L. 115-52, §904(d)(2), redesignated subsec. (d) as (f).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2022 AMENDMENT Amendment by Pub. 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 Pub. 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 Pub. 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 Pub. L. 115-52 set out as a note under section 379j-51 of this title.
EFFECTIVE AND TERMINATION DATES Pub. L. 117-180, div. F, title IV, §4005(b), 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." Pub. L. 115-52, title IV, §405(b), Aug. 18, 2017, 131 Stat. 1035, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117-180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166.[ Pub. L. 117-180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(b) of Pub. L. 115-52 formerly set out above, is effective Oct. 1, 2022.] Pub. L. 112-144, title IV, §404(b), July 9, 2012, 126 Stat. 1038, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115-52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035. [ Pub. L. 115-52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(b) of Pub. L. 112-144 formerly set out above, is effective Oct. 1, 2017.]Section effective Oct. 1, 2012, see section 405 of Pub. L. 112-144 set out as a note under section 379j-51 of this title.