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-
Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.
The report under this subsection 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.
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) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.
The Secretary shall post the following data in accordance with subparagraph (A):
The Secretary shall include in the annual report under paragraph (1)-
For each fiscal year, the Secretary shall include in the report under paragraph (1) 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 the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the 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 in the letters described in section 101(b)1 of the Prescription Drug 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 human drug application review process.
For any of the goals identified in the letters described in section 101(b)1 of the Prescription Drug 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, and plans for meeting the goals, for the process for the review of human drug 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 (4), 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 Web site 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.
1See References in Text note below.
21 U.S.C. § 379h-2
Termination of SectionFor termination of section by section 1005(b) of Pub. L. 117-180 see Effective and Termination Dates note below.
EDITORIAL NOTES
REFERENCES IN TEXTSection 101(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 1001(b) of the Prescription Drug User Fee Amendments of 2022, title I of div. F of Pub. 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(b).Section 1001(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 1001(b) of title I of div. F of Pub. L. 117-180 which is set out as a note under section 379g of this title.
AMENDMENTS2022- Pub. 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). Pub. L. 117-328, §3626(a)(1)(A)(ii), inserted concluding provisions. Pub. L. 117-180, §1004(1), substituted "Not" for "Beginning with fiscal year 2018, not" in introductory provisions.Subsec. (a)(1)(B)(ix). Pub. L. 117-328, §3626(a)(1)(A)(i), added cl. (ix). Subsec. (a)(3)(A). Pub. 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). Pub. L. 117-328, §3626(a)(1)(B), added cl. (v).Subsec. (a)(4). Pub. L. 117-180, §1004(4), substituted "The" for "Beginning with fiscal year 2020, the" in introductory provisions.Subsec. (a)(4)(A). Pub. 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(b) 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). Pub. 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). Pub. L. 117-328, §3626(a)(1)(C)(iii), (iv), added subpar. (D).Subsec. (b). Pub. L. 117-180, §1004(5), substituted "Not" for "Beginning with fiscal year 2018, not".Subsec. (c). Pub. L. 117-180, §1004(6), substituted "For" for "Beginning with fiscal year 2018, for" in introductory provisions.Subsec. (f)(1). Pub. L. 117-180, §1004(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.Subsec. (f)(4). Pub. L. 117-328, §3626(a)(2)(B), added par. (4). Former par. (4) redesignated (5).Subsec. (f)(5). Pub. L. 117-328, §3626(a)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6). Pub. L. 117-180, §1004(7)(B), substituted "January 15, 2027" for "January 15, 2022". Subsec. (f)(6), (7). Pub. L. 117-328, §3626(a)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.Subsec. (f)(7)(A). Pub. 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). Pub. L. 117-328, §3626(a)(2)(C)(ii), inserted ",in sufficient detail," after "shall summarize".2017-Subsec. (a)(1). Pub. L. 115-52, §103(a)(1), substituted "2018" for "2013". Subsec. (a)(1)(A). Pub. 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). Pub. L. 115-52, §903(a), added pars. (3) and (4).Subsec. (a)(5). Pub. L. 115-52, §904(a)(1), added par. (5).Subsec. (b). Pub. L. 115-52, §103(2), substituted "2018" for "2013". Subsec. (c). Pub. L. 115-52, §904(a)(2)(B), added subsec. (c). Former subsec. (c) redesignated (e).Subsec. (d). Pub. L. 115-52, §904(a)(2)(B), added subsec. (d). Former subsec. (d) redesignated (f). Pub. L. 115-52, §103(3), substituted "2022" for "2017" in pars. (1) and (5). Subsecs. (e), (f). Pub. L. 115-52, §904(a)(2)(A), redesignated subsecs. (c) and (d) as (e) and (f), respectively. 2012-Subsec. (a). Pub. 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. (b). Pub. L. 112-144, §104(2), substituted "2013" for "2008". Subsec. (d)(1), (5). Pub. L. 112-144, §104(3), substituted "2017" for "2012".
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 human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117-180 set out as a note under section 379g of this title.
EFFECTIVE DATE OF 2017 AMENDMENT Amendment by section 103 of Pub. 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 Pub. L. 115-52 set out as a note under section 379g of this title.
EFFECTIVE DATE OF 2012 AMENDMENT Amendment by Pub. 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 Pub. L. 112-144 set out as a note under section 379g of this title.
EFFECTIVE AND TERMINATION DATES Pub. L. 117-180, div. F, title I, §1005(b), 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." Pub. L. 115-52, title I, §104(b), Aug. 18, 2017, 131 Stat. 1012, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117-180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147.[Pub. L. 117-180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(b) of Pub. L. 115-52 formerly set out above, is effective Oct. 1, 2022.] Pub. L. 112-144, title I, §105(b), July 9, 2012, 126 Stat. 1001, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115-52, title I, §104(c), Aug. 18, 2017, 131 Stat 1012.[Pub. L. 115-52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(b) of Pub. L. 112-144 formerly set out above, is effective Oct. 1, 2017.] Pub. L. 110-85, title I, §106(b), Sept. 27, 2007, 121 Stat. 842, which provided that the amendment made by section 105 of Pub. L. 110-85 (enacting this section) would cease to be effective Jan. 31, 2013, was repealed by Pub. 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 Pub. L. 110-85 set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.