US Codex
Pub. L.
Notes

Title IX — Additional Provisions

115th Congress · Approved Aug 18, 2017 · 131 Stat. 1005 · Lineage

TITLE IX Additional Provisions

SEC. 901. Technical Corrections.

(a)
Section 3075(a) of the 21st Century Cures Act (Public Law 114–255) is amended—
(1)
in the matter preceding paragraph (1), by striking “ as amended by section 2074” and inserting “ as amended by section 3102”; and
(2)
in paragraph (2), by striking “ section 2074(1)(C)” and inserting “ section 3102(1)(C)”.
(b)
Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking “ identity” and inserting “ identify”.
(c)
Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g(b)) is amended by striking “ randomized” and inserting “ traditional”.
(d)
Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g(d)) is amended by striking “ 2” and inserting “ 3”.
(e)
Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(6)) is amended by striking “ February 1” and replacing with “ May 1”.
(f)
Effective as of the enactment of the 21st Century Cures Act (Public Law 114–255)—
(1)
section 3051(a) of such Act is amended by striking “ by inserting after section 515B” and inserting “ by inserting after section 515A”; and
(2)
section 515C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–3), as inserted by such section 3051(a), is redesignated as section 515B.
(g)
Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–3(f)(2)), as redesignated by subsection (e)(2) of this section, is amended by striking “ a proposed guidance” and inserting “ a draft version of that guidance”.
(h)
Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking “ medical device submissions” and inserting “ medical devices that may be specifically the subject of a review by a classification panel”.

SEC. 902. Annual Report on Inspections.

Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under section 515 of such Act (21 U.S.C. 360e), or clearance of a device under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during the previous calendar year. Such information shall include the following:
(1)
The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, and the median time from the beginning of an inspection to the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)).
(2)
The median time from the issuance of a report pursuant to such section 704(b) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated.
(3)
The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the Secretary concluded that such action was indicated.
(4)
The number of times that a facility was issued a report pursuant to such section 704(b) and approval of an application was delayed due to the issuance of a withhold recommendation.

SEC. 903. Streamlining and Improving Consistency in Performance Reporting.

(a)
PDUFA.— Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as amended by section 103, is further amended by inserting after paragraph (2) the following:

“(3) Real time reporting.—

“(A) In general.—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 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.

“(B) Data.—The Secretary shall post the following data in accordance with subparagraph (A):

“(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(iii) The number of new drug applications and biological licensing applications approved.

“(iv) The number of new drug applications and biological licensing applications filed.

“(4) Rationale for pdufa program changes.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(A) 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 2017 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;

“(B) 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

“(C) for each of 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, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”

(b)
MDUFA.— Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), as amended by section 204, is further amended—
(1)
by striking “ Beginning with” and inserting the following:

“(i) General requirements.—Beginning with”

; and

(2)
by adding at the end the following:

“(ii) Additional information.—Beginning with fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—

“(I) the number of premarket applications filed under section 515 per fiscal year for each review division;

“(II) the number of reports submitted under section 510(k) per fiscal year for each review division; and

“(III) the number of expedited development and priority review designations under section 515C per fiscal year.

“(iii) Real time reporting.—

“(I) In general.—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.

“(II) Data.—The Secretary shall post the following data in accordance with subclause (I):

“(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017; and

“(bb) 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.

“(iv) Rationale for mdufa program changes.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(I) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within 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;

“(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and

“(III) 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.”

(c)
GDUFA.— Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as amended by section 304, is further amended—
(1)
by striking “ Beginning with” and inserting the following:

“(1) General requirements.—Beginning with”

; and

(2)
by adding at the end the following:

“(2) Real time reporting.—

“(A) In general.—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.

“(B) Data.—The Secretary shall post the following data in accordance with subparagraph (A):

“(i) 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.

“(ii) 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.

“(3) Rationale for gdufa program changes.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 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;

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and

“(C) for each of 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, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”

(d)
BsUFA.— Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)), as amended by section 404, is further amended—
(1)
by striking “ Beginning with” and inserting the following:

“(1) General requirements.—Beginning with”

; and

(2)
by adding at the end the following:

“(2) Additional information.—Beginning with fiscal year 2018, 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—

“(A) 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;

“(B) the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and

“(C) the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals letters issued by the agency for such applications.

“(3) Real time reporting.—

“(A) In general.—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) 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.

“(B) Data.—The Secretary shall post the following data in accordance with subparagraph (A):

“(i) The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.

“(ii) The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.

“(4) Rationale for bsufa program changes.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(A) 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 2017 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;

“(B) 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

“(C) for each of 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, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”

SEC. 904. Analysis of Use of Funds.

(a)
PDUFA Reports.—
(1)
Analysis in pdufa performance reports.— Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as amended by section 903(a), is further amended by adding at the end the following:

“(5) Analysis.—For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:

“(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—

“(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;

“(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.

“(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.

“(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.”

(2)
Issuance of corrective action reports.— Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) is amended—
(A)
by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and
(B)
by inserting after subsection (b) the following:

“(c) Corrective Action Report.—Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, 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:

“(1) Goals met.—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) of the Prescription 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 human drug application review process.

“(2) Goals missed.—For any of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

“(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and

“(B) with respect to performance enhancement goals that were not achieved, 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.

“(d) Enhanced Communication.—

“(1) Communications with congress.—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.

“(2) Participation in congressional hearing.—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 part.”

(b)
MDUFA Reports.—
(1)
Analysis in mdufa performance reports.— Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), as amended by section 903(b), is further amended by adding at the end the following:

“(iv) Analysis.—For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:

“(I) The difference between the aggregate number of premarket applications filed under section 515 and aggregate reports submitted under section 510(k) and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—

“(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

“(bb) 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.

“(II) 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.

“(III) 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.”

(2)
Issuance of corrective action reports.— Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended—
(A)
by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and
(B)
by inserting after paragraph (1) the following:

“(2) Corrective action report.—Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, 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:

“(A) Goals met.—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.

“(B) Goals missed.—For 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 that the Secretary determines to not have been met, the corrective action report shall include—

“(i) a justification for such determination;

“(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 515 or notifications submitted under section 510(k) missed the review goal times but were approved during the first cycle review, as applicable;

“(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and

“(iv) 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.

“(3) Enhanced communication.—

“(A) Communications with congress.—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.

“(B) Participation in congressional hearing.—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 part.”

(c)
GDUFA Reports.—
(1)
Analysis in gdufa performance reports.— Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as amended by section 903(c) is further amended by adding at the end the following:

“(4) Analysis.—For each fiscal year, the Secretary shall include in the report an analysis of the following:

“(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—

“(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

“(ii) 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.

“(B) 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.

“(C) 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.”

(2)
Issuance of corrective action reports.— Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) is amended—
(A)
by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and
(B)
by inserting after subsection (b) the following:

“(c) Corrective Action Report.—Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, 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:

“(1) Goals met.—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.

“(2) Goals missed.—For 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 that the Secretary determines to not have been met, the corrective action report shall include—

“(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

“(B) 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.

“(d) Enhanced Communication.—

“(1) Communications with congress.—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.

“(2) Participation in congressional hearing.—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 part.”

(d)
BsUFA Reports.—
(1)
Analysis in bsufa performance reports.— Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)) as amended by section 903(d) is further amended by adding at the end the following:

“(5) Analysis.—For each fiscal year, the Secretary shall include in the report an analysis of the following:

“(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—

“(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

“(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.

“(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.

“(C) The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.”

(2)
Issuance of corrective action reports.— Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53), as amended by section 404, is further amended—
(A)
by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and
(B)
by inserting after subsection (b) the following:

“(c) Corrective Action Report.—Beginning with fiscal year 2018, and for each fiscal year for which fees are collected under this part, 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:

“(1) Goals met.—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) of the Biosimilar 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 biosimilar biological product application review process.

“(2) Goals missed.—For each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

“(A) a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

“(B) with respect to performance enhancement goals that were not achieved, 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.

“(d) Enhanced Communication.—

“(1) Communications with congress.—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.

“(2) Participation in congressional hearing.—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 part.”

SEC. 905. Facilities Management.

(a)
Evaluation.—
(1)
Study.— The Comptroller General of the United States shall conduct a study on the expenses incurred by the Food and Drug Administration related to facility maintenance and renovation in fiscal years 2012 through 2019. The study under this paragraph shall include the following:
(A)
A review of purchases and expenses differentiated by appropriated funds, and resources authorized by the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) and this Act, as applicable, that contributed to—
(i)
the maintenance of scientific equipment and any existing facility plan or plans to maintain previously purchased scientific equipment;
(ii)
the renovation of facilities in the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, and the purpose of such renovation including the need for the renovation;
(iii)
the assets purchased or repaired under the “repair of facilities and acquisition” authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.);
(iv)
the maintenance and repair of facilities and fixtures, including a description of any unanticipated repairs and maintenance as well as scheduled repairs maintenance, and the budget plan for the scheduled or anticipated maintenance;
(v)
the acquisition of furniture, a description of the furniture purchased, and the purpose of the furniture including purchases for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health; and
(vi)
the acquisition of other necessary materials and supplies by product category under the authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).
(B)
An analysis of the Food and Drug Administration’s ability to further its public health mission and review medical products by incurring the expenses listed in clauses (i) through (vi) of subparagraph (A). In conducting the analysis, the Comptroller General shall request information from and consult with appropriate employees, including staff and those responsible for the fiscal decisions regarding facility maintenance and renovation for the agency.
(2)
Report.—
(A)
In general.— The Comptroller General shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives not later than July 30, 2020, containing the results of the study under paragraph (1).
(B)
Recommendations.— As part of the report under this paragraph, the Comptroller General may provide recommendations, as applicable, on methods through which the Food and Drug Administration may improve planning for—
(i)
the maintenance, renovation, and repair of facilities;
(ii)
the purchase of furniture or other acquisitions; and
(iii)
ways the Food and Drug Administration may allocate the expenses described in clauses (i) and (ii) of paragraph (1)(A), as informed by the analysis under paragraph (1)(B).
(b)
Administration.—
(1)
PDUFA.— Section 736(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end the following:

“(3) Limitation.—Beginning on October 1, 2023, the authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.”

(2)
MDUFA.— Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the end the following:

“(3) Limitation.—Beginning on October 1, 2023, the authorities under section 737(9)(C) shall include only leasing and necessary scientific equipment.”

(3)
GDUFA.— Section 744B(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(e)) is amended—
(A)
in the subsection heading, by striking “ Limit” and inserting “ Limitations”;
(B)
by striking “ The total amount” and inserting the following:

“(1) In general.—The total amount”

; and

(C)
by adding at the end the following:

“(2) Leasing and necessary equipment.—Beginning on October 1, 2023, the authorities under section 744A(11)(C) shall include only leasing and necessary scientific equipment.”

(4)
BsUFA.— Section 744H(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(e)(2)(B)) is amended—
(A)
in the subparagraph heading, by striking “ limitation” and inserting “ limitations”;
(B)
by striking “ The fees authorized” and inserting the following:

“(i) In general.—The fees authorized”

; and

(C)
by adding at the end the following:

“(ii) Leasing and necessary equipment.—Beginning on October 1, 2023, the authorities under section 744G(9)(C) shall include only leasing and necessary scientific equipment.”