Source: https://www.law.cornell.edu/uscode/text/21/379j-1
Timestamp: 2019-04-18 13:15:21+00:00

Document:
Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.
the number of expedited development and priority review designations under section 360e–3  of this title per fiscal year.
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 subclause (II) 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 report under this subparagraph.
The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.
for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.
the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.
Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.
The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.
With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).
The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.
For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) of the Medical Device 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 medical device application review process.
the performance enhancement goals that were not achieved during the previous fiscal year and a 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.
Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices 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.
For fiscal years 2018 through 2022, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, 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 during such fiscal year for which the report is made.
The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.
publish the comments on the Food and Drug Administration’s Internet Web site.
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).
after consideration of such public views and comments, revise such recommendations as necessary.
Not later than January 15, 2022, the Secretary shall transmit to 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 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.
The minutes described under subparagraph (A) shall summarize 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.
For termination of section by section 210(b) of Pub. L. 115–52, see Effective and Termination Dates note below.
Section 201(b) of the Medical Device User Fee Amendments of 2017, referred to in subsec. (a)(1)(A), (B), (2), is section 201(b) of Pub. L. 115–52, which is set out as a note under section 379i of this title.
Section 360e–3 of this title, referred to in subsec. (a)(1)(A)(ii)(III), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, § 901(f)(2), Aug. 18, 2017, 131 Stat. 1077.
2017—Subsec. (a)(1)(A). Pub. L. 115–52, § 903(b), designated existing provisions as cl. (i), inserted heading, and added cls. (ii), (iii), and (iv) related to rationale for MDUFA program changes.
Subsec. (a)(1)(A)(i). Pub. L. 115–52, § 204(a)(1)(A), substituted “2018” for “2013” and “the Medical Device User Fee Amendments of 2017” for “the Medical Device User Fee Amendments of 2012”.
Subsec. (a)(1)(A)(iv). Pub. L. 115–52, § 904(b)(1), added cl. (iv) relating to analysis to be included in report.
Subsec. (a)(1)(B). Pub. L. 115–52, § 204(a)(1)(B), substituted “the Medical Device User Fee Amendments of 2017” for “the Medical Device User Fee Amendments Act of 2012”.
Subsec. (a)(2), (3). Pub. L. 115–52, § 904(b)(2)(B), added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively.
Subsec. (a)(4). Pub. L. 115–52, § 904(b)(2)(A), redesignated par. (2) as (4).
Pub. L. 115–52, § 204(a)(2), which directed amendment of par. (2), effective Oct. 1, 2017, by substituting “2018 through 2022” for “2013 through 2017”, was executed by making the substitution in par. (4) to reflect the probable intent of Congress and the redesignation of par. (2) as (4), effective Aug. 18, 2017, by Pub. L. 115–52, § 904(b)(2)(A). See Amendment note above.
Subsec. (a)(5). Pub. L. 115–52, § 904(b)(2)(A), redesignated par. (3) as (5).
Subsec. (b)(1). Pub. L. 115–52, § 204(b)(1), substituted “2022” for “2017” in introductory provisions.
Subsec. (b)(5). Pub. L. 115–52, § 204(b)(2), substituted “2022” for “2017”.
Subsec. (a)(2). Pub. L. 112–144, § 204(b)(2), substituted “2013 through 2017” for “2008 through 2012”.
Subsec. (b)(1). Pub. L. 112–144, § 204(a)(1), substituted “2017” for “2012”.
Subsec. (b)(5). Pub. L. 112–144, § 204(a)(2), substituted “2017” for “2012”.
Amendment by section 204 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.
Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.
Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.
  So in original. Two cls. (iv) have been enacted.

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