Sec. 904. ANALYSIS OF USE OF FUNDS
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## 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.” > .
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