Source: https://www.law.cornell.edu/uscode/text/21/379j-43
Timestamp: 2019-04-23 18:14:24+00:00

Document:
Beginning with fiscal year 2018, 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 301(b) of the Generic Drug User Fee Amendments of 2017 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
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, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.
The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.
the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.
Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.
The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.
Beginning with fiscal year 2018, 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, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 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 abbreviated new drug application review process.
with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such  fiscal year.
Not less frequently than once every month during negotiations with the generic drug 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).
Not later than January 15, 2022, 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.
Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall make publicly available, on the Internet 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 generic drug industry.
For termination of section by section 305(b) of Pub. L. 115–52, see Effective and Termination Dates note set out below.
Section 301(b) of the Generic Drug User Fee Amendments of 2017, referred to in subsecs. (a) and (c), is section 301(b) of Pub. L. 115–52, which is set out as a note under section 379j–41 of this title.
2017—Subsec. (a). Pub. L. 115–52, § 903(c), designated existing provisions as par. (1), inserted heading, and added pars. (2) and (3).
Pub. 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). Pub. L. 115–52, § 904(c)(1), added par. (4).
Subsec. (b). Pub. L. 115–52, § 304(2), substituted “2018” for “2013”.
Subsecs. (c) to (e). Pub. 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). Pub. L. 115–52, § 904(c)(2)(A), redesignated subsec. (d) as (f).
Pub. 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 Pub. L. 115–52, § 904(c)(2). See Amendment note above.
Amendment by section 304 of Pub. 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 Pub. L. 115–52, set out as a note under section 379j–41 of this title.
Pub. L. 112–144, title III, § 304(b), July 9, 2012, 126 Stat. 1024, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title III, § 305(c)(1), Aug. 18, 2017, 131 Stat. 1027.
Section effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as a note under section 379j–41 of this title.

References: § 903
 § 304
 § 904
 § 304
 § 904
 § 904
 § 304
 § 904
 § 304
 § 305