,,ii #aaeth ,,congress #ast ,session ,s4 #ajfb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #d1 #bjag,mr4 ,burr 7for himself and ,mr4 ,young7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to increase reporting transparency and accountability with respect to ,food and ,drug ,administration user fees4 #a4 ,short title ,this ,act may be cited as the ,,fda ,reporting ,transparency and ,accountability ,act4 #b4 ,streamlining and improving consistency in performance reporting 7a7 ,,pdufa ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a77 is amended-- 7#a7 in paragraph 7#a77;,b7-- 7,a7 in each of clauses 7i71 7ii71 and 7v71 by inserting and the number of complete response letters issued for such applications before the semicolon2 7,b7 in each of clauses 7iii7 and 7iv71 by inserting and the number of complete response letters issued for such supplements before the semicolon2 7,c7 in clause 7vi71 by inserting and the number of designations and denials issued by the agency for such applications before the semicolon2 7,d7 in clause 7vii71 by striking 2 and and inserting and the number of designations and denials issued by the agency for such applications22 and 7,e7 in clause 7viii7 by striking the period and inserting and the number of designations and denials issued by the agency for such applications22 and 7#b7 by inserting after paragraph 7#b7 the following3 7#c7 ,real time reporting 7,a7 ,in general ,beginning with fiscal year #bjah1 every #cj calendar days1 the ,secretary shall post the data described in subparagraph 7,b7 on the ,internet website of the ,food and ,drug ,administration and remove from such website duplicative data from the annual performance report4 7,b7 ,data ,the following data is required to be posted in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance issued by the ,center for ,drug ,evaluation and ,research or the ,center for ,biologics ,evaluation and ,research1 and the justification for the issuance and finalization of each such guidance4 7ii7 ,the number and titles of public meetings held by the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research each fiscal year4 7iii7 ,the list of standard new drug applications and biologics license applications1 by fiscal year of receipt4 7iv7 ,the number of filed applications by each review division4 7#d7 ,capacity planning and improved time reporting ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under paragraph 7#a7-- 7,a7 the number of full-time equivalents agreed upon and the number of appropriated full time equivalents at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 identification by name of all time reporting categories that ,food and ,drug ,administration uses for capacity planning and time reporting with respect to the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 pursuant to the resource capacity planning and modernized time reporting implementation plan2 7,c7 the processes by which the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner require reporting on the amount of an employee's time that is dedicated to the review of human drug applications1 including information regarding employees dedicated to such activities on a full-time basis1 and employees dedicated to such activities on a part-time basis2 and 7,d7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the number of employees described in subparagraph 7,c7 7both full-time equivalents and employees dedicated to such activities on a part-time basis7 for whom time reporting is required as described in subparagraph 7,c71 and the number of such employees required to estimate time dedicated to the review of human drug applications4 4 7b7 ,,mdufa ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a77 is amended-- 7#a7 by striking ,beginning with and inserting the following3 7i7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7ii7 ,additional information ,beginning with fiscal year #bjah1 the annual report under this subparagraph shall include the progress of the ,center for ,devices and ,radiological ,health in achieving the goals1 and future plans for meeting the goals1 including1 for each review division-- 7,i7 the number of premarket applications filed under section #eae per fiscal year for each review division1 and the number of approvable letters1 major deficiency letters1 not approvable letters1 and denials for such applications2 7,,ii7 the number of reports filed under section #eaj7k7 per fiscal year for each review division and the number of devices cleared or not substantially equivalent for such reports2 and 7,,iii7 the number of expedited access pathway designations for a fiscal year for each review division and the number of cleared or approved devices or denials for such applications4 7iii7 ,real time reporting 7,i7 ,in general ,beginning with fiscal year #bjah1 the ,secretary shall1 every #cj calendar days1 post the data described in subclause 7,,ii7 on the ,internet website of the ,food and ,drug ,administration and remove from such website duplicative data from the annual report under this subparagraph4 7,,ii7 ,data ,the following data is required to be posted in accordance with subclause 7,i73 7aa7 ,the number and titles of draft and final guidance issued by the ,center for ,devices and ,radiological ,health and the justification for the issuance and finalization of such guidance4 7bb7 ,the number and titles of public meetings held by the ,center for ,devices and ,radiological ,health each fiscal year4 4 7c7 ,,gdufa ,section #gdd;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a77 is amended-- 7#a7 by striking ,beginning with and inserting the following3 7#a7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7#b7 ,additional information ,beginning with fiscal year #bjah1 the report under this subsection shall include the progress of the ,office of ,generic ,drugs in achieving the goals1 and future plans for meeting the goals1 including-- 7,a7 the number of original abbreviated new drug applications filed per fiscal year2 7,b7 the number of amendments to abbreviated new drug applications filed per fiscal year2 and 7,c7 the number of actions taken delineated by the type of action1 including final approvals1 tentative approvals1 complete response letters1 and the number of refuse to receive letters issued by the ,food and ,drug ,administration per fiscal year4 7#c7 ,real time reporting 7,a7 ,in general ,beginning with fiscal year #bjah1 the ,secretary shall1 every #cj calendar days1 post the data described in subparagraph 7,b7 on the ,internet website of the ,food and ,drug ,administration and remove from such website duplicative data from the annual report under this subsection4 7,b7 ,data ,the following data is required to be posted in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance issued by the ,office of ,generic ,drugs and the justification for the issuance and finalization of such guidance4 7ii7 ,the number and titles of public meetings held by the ,office of ,generic ,drugs each fiscal year4 4 7d7 ,bs,u,f,a ,section #gdd;,i7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 is amended-- 7#a7 by striking ,beginning with and inserting the following3 7#a7 ,general requirements ,beginning with 2 and 7#b7 by adding at the end the following3 7#b7 ,additional information ,beginning with fiscal year #bjah1 the report under this subsection shall include the progress of the ,center for ,biologics ,evaluation and ,research in achieving the goals1 and future plans for meeting the goals1 including-- 7,a7 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 cohort2 7,b7 the number of original biosimilar biological product applications filed per fiscal year1 and the number of approvals or complete response letters issued by the agency for such applications2 and 7,c7 the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals or complete response letters issued by the agency for such applications4 7#c7 ,real time reporting 7,a7 ,in general ,beginning with fiscal year #bjah1 the ,secretary shall1 every #cj calendar days1 post the data described in subparagraph 7,b7 on the ,internet website of the ,food and ,drug ,administration and remove from such website duplicative data from the annual report under this subsection4 7,b7 ,data ,the following data is required to be posted in accordance with subparagraph 7,a73 7i7 ,the number and titles of draft and final guidance issued by the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research and the justification for the issuance and finalization of such guidance4 7ii7 ,the number and titles of public meetings held by the ,center for ,drug ,evaluation and ,research and the ,center for ,biologic ,evaluation and ,research each fiscal year4 4 7#d7 ,capacity planning and time reporting ,beginning with fiscal year #bjbj1 the ,secretary shall include in the annual report under this subsection-- 7,a7 the number of full-time equivalents agreed upon and the number of appropriated full time equivalents at the ,food and ,drug ,administration by each division within the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner2 7,b7 identification by name of all time reporting categories that the ,food and ,drug ,administration uses for capacity planning and time reporting under the resource capacity planning and modernized time reporting implementation plan for the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs and the ,office of the ,commissioner2 7,c7 the process by which the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner require reporting on the amount of an employee's time that is dedicated to the review of biosimilar biological product applications1 including information regarding both employees dedicated to such activities on a full-time basis1 and employees dedicated to such activities on a part-time basis2 and 7,d7 for each of the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 the ,office of ,regulatory ,affairs1 and the ,office of the ,commissioner1 the actual number of employees described in subparagraph 7,c7 7both full-time equivalents and employees dedicated to such activities on a part-time basis7 for whom time reporting is required as described in subparagraph 7,c71 and the number of such employees required to estimate time dedicated to the review of biosimilar biological product applications4 4 #c4 ,,fda analysis of use of funds 7a7 ,,pdufa reports 7#a7 ,analysis in ,,pdufa performance reports ,section #gcf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a771 as amended by section #b7;a71 is further amended by adding at the end the following3 7#e7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the number of human drug applications filed and the number of approvals or complete response letters issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 such applications pending with the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research that did not meet the goals for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7iii7 the most common causes within the agency for missing such goals4 7,b7 ,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 for the corresponding fiscal year4 7,c7 ,external or other circumstances impacting the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 or the ,food and ,drug ,administration1 that impacted the ability of the agency to meet review time and performance enhancement goals4 4 7#b7 ,issuance of corrective action reports ,section #gcf;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7 is amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 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 ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate upon submission of the performance report in subsection 7a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#c71 that each of the goals for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the human drug application review process4 7#b7 ,goals missed ,for each of the goals for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7,a7 a detailed description of the circumstances under which each drug application that missed the review goal time was approved during the first cycle review1 as applicable2 7,b7 aggregate data on the circumstances for all unapproved drug applications for which the review goal time was missed2 and 7,c7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal1 while maintaining standards of approval1 for the current fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with ,congress ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding the contents of the corrective action reports described in subsection 7c77#b7 and the annual performance reports under subsection 7a74 7#b7 ,participation in ,congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 regarding the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7#c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publicly available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 7b7 ,,mdufa reports 7#a7 ,analysis in ,,mdufa performance reports ,section #gch;,a7a77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#a7;a77#a77;,a771 as amended by section #b7;b71 is further amended by adding at the end the following3 7iv7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,i7 ,the difference between the number of premarket applications filed under section #eae and applications filed under section #eaj7k7 and the number of major deficiency letters1 not approvable letters1 and denials for such applications issued by the agency1 accounting for-- 7aa7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7bb7 such applications pending with the ,center for ,devices and ,radiological ,health that did not meet the goals for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7cc7 the most common causes within the agency for missing such goals4 7,,ii7 ,relevant data to determine whether the ,center ,devices and ,radiological ,health have met performance enhancement goals for the corresponding fiscal year4 7,,iii7 ,external or other circumstances impacting the ,center ,devices and ,radiological ,health or the ,food and ,drug ,administration that impacted the ability of the agency to meet review time and performance enhancement goals4 4 7#b7 ,issuance of corrective action reports ,section #gch;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;h-#b7;a77 is amended-- 7,a7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#d7 and 7#e71 respectively2 and 7,b7 by inserting after paragraph 7#a7 the following3 7#b7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 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 ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate upon submission of the performance report in paragraph 7#a77;,a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7,a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under paragraph 7#a77;,a77iii71 that each of the goals for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the medical device application review process4 7,b7 ,goals missed ,for each of the goals for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7i7 a detailed description of the circumstances under which each application or report submitted under section #eae or section #eaj7k7 missed the review goal time but was approved during the first cycle review1 as applicable2 7ii7 aggregate data on the circumstances for all unapproved medical device applications for which the review goal time was missed2 and 7iii7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal1 while maintaining standards of approval1 for the current fiscal year4 7#c7 ,enhanced communication 7,a7 ,communications with congress ,each fiscal year1 as applicable1 representatives from the ,center for ,devices and ,radiological ,health shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding the contents of the corrective action reports described in paragraph 7#b7 and the annual performance reports under paragraph 7#a74 7,b7 ,participation in congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,devices and ,radiological ,health shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the corrective action reports under paragraph 7#b74 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7,c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publicly available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 7c7 ,,gdufa reports 7#a7 ,analysis in ,,gdufa performance reports ,section #gdd;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7;a771 as amended by section #b7;c7 is further amended by adding at the end the following3 7#d7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the number of abbreviated new drug applications filed and the number of approvals or complete response letters issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 such applications pending with the ,office of ,generic ,drugs that did not meet the goals for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7iii7 the most common causes within the agency for missing such goals4 7,b7 ,relevant data to determine whether the ,office of ,generic ,drugs has met the performance enhancement goals for the corresponding fiscal year4 7,c7 ,external or other circumstances impacting the ,office of ,generic ,drugs or the ,food and ,drug ,administration that impacted the ability of the agency to meet review time and performance enhancement goals4 4 7#b7 ,issuance of corrective action reports ,section #gdd;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#dc7 is amended-- 7,a7 by redesignating subsections 7c7 and 7d7 as subsections 7e7 and 7f71 respectively2 and 7,b7 inserting after subsection 7b7 the following3 7c7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 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 ,health1 ,education1 ,labor1 and ,pensions and the ,committee on ,appropriations of the ,senate upon submission of the performance report in section #gdd;,c7a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#d71 that each of the goals for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the abbreviated new drug application review process4 7#b7 ,goals missed ,for each of the goals for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7,a7 a detailed description of the circumstances under which each abbreviated new drug application missed the review goal time but was approved during the first cycle review1 as applicable2 7,b7 aggregate data on the circumstances for all unapproved abbreviated new drug applications for which the review goal time was missed2 and 7,c7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal for the current fiscal year4 7d7 ,enhanced communication 7#a7 ,communications with congress ,each fiscal year1 as applicable1 representatives from the ,office of ,generic ,drugs shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding the contents of the corrective action reports described in subsection 7c77#b7 and the annual performance reports under subsection 7a74 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7#c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publicly available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 7d7 ,bs,u,f,a reports 7#a7 ,analysis in ,bs,u,f,a performance reports ,section #gdd;,i7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;a77 as amended by section #b7;d7 is further amended by adding at the end the following3 7#e7 ,analysis ,for each fiscal year1 the ,secretary shall include in the report an analysis of the following3 7,a7 ,the difference between the number of biosimilar biological product applications and supplements filed and the number of approvals or complete response letters issued by the agency1 accounting for-- 7i7 such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year2 7ii7 such applications pending with the ,center for ,drug ,evaluation and ,research or the ,center for ,biologics ,evaluation and ,research that did not meet the goals for the corresponding fiscal year and the future plans of the ,food and ,drug ,administration to meet these goals2 and 7iii7 the most common causes within the agency for missing such goals4 7,b7 ,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 for the corresponding fiscal year4 7,c7 ,external or other circumstances impacting the ,center for ,drug ,evaluation and ,research1 the ,center for ,biologics ,evaluation and ,research1 and the ,food and ,drug ,administration that impacted the ability of the agency to meet review time and performance enhancement goals4 4 7#b7 ,issuance of corrective action reports ,section #gdd;,i of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7 is amended-- 7,a7 by redesignating subsections 7c71 7d71 and 7e7 as subsections 7d71 7e71 and 7f71 respectively2 and 7,b7 inserting after subsection 7a7 the following3 7b7 ,corrective action report ,beginning with fiscal year #bjah1 and for each fiscal year for which fees are collected under this part1 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 ,health1 ,education1 ,labor1 and ,pensions and ,committee on ,appropriations of the ,senate upon submission of the performance report in section #gdd;,i7a7 for the corresponding fiscal year4 ,the report shall include the following information1 as applicable3 7#a7 ,goals met ,for each fiscal year1 if the ,secretary determines1 based on the analysis under subsection 7a77#e71 that each of the goals for the corresponding fiscal year have been met1 the corrective action report shall include a summary of goals met1 and recommendations on ways in which the ,secretary can improve and streamline the biosimilar biological product application review process4 7#b7 ,goals missed ,for each of the goals for the corresponding fiscal year that the ,secretary determines to not have been met1 the corrective action report shall include a detailed justification for such determination and-- 7,a7 a detailed description of the circumstances under which each biosimilar biological product application missed the review goal time but was approved during the first cycle review1 as applicable2 7,b7 aggregate data on the circumstances for all biosimilar biological product applications for which the review goal time was missed2 and 7,c7 the performance enhancement goals that were not achieved during the previous fiscal year and a detailed description of efforts the agency has put in place for the current fiscal year to improve the ability of the agency to meet each such goal for the current fiscal year4 7c7 ,enhanced communication 7#a7 ,communications with congress ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall meet with representatives from the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding the contents of the corrective action reports described in subsection 7b7 and the annual performance reports under subsection 7a74 7#b7 ,participation in congressional hearing ,each fiscal year1 as applicable1 representatives from the ,center for ,drug ,evaluation and ,research and the ,center for ,biologics ,evaluation and ,research shall participate in a public hearing before the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to report on the contents described in the reports under this section4 ,such hearing shall occur not later than #abj days after the end of each fiscal year for which fees are collected under this part4 7#c7 ,publicly available updates ,the ,secretary shall provide an update on progress made for the corrective action report during the following fiscal year on the publicly available ,internet website of the ,food and ,drug ,administration every #cj business days4 4 #d4 ,prohibiting use of funds for facility maintenance 7a7 ,,pdufa ,section #gce7g77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;g7#g77;,c77 is amended by striking renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies and inserting and necessary scientific equipment4 7b7 ,,mdufa ,section #gcg7i77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;i7#i77 is amended by striking renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies and inserting and necessary scientific equipment4 7c7 ,,gdufa ,section #gdd;,a7#aa77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da7aa77;,c77 is amended by striking renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies and inserting and necessary scientific equipment4 7d7 ,bs,u,f,a ,section #gdd;,g7#i77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ea7i77;,c77 is amended by striking renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies and inserting and necessary scientific equipment4 #e4 ,information on ,,it contracting ,section #gcf;,b7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgh;h-#b7;b77 is amended-- 7#a7 by striking report on the and inserting 8report on-- 7#a7 the 2 7#b7 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7#b7 the amount of the fees collected that are invested in the information technology infrastructure of the ,food and ,drug ,administration1 the entities receiving contracts to develop such infrastructure1 the length of such contracts 7including renewals71 and the progress such entities have made toward meeting the goals described in such contracts4 4