Title: FDA Reporting Transparency and Accountability Act
Policy area: Health

Summary:
FDA Reporting Transparency and Accountability Act
This bill expands reporting requirements related to the performance of the Food and Drug Administration (FDA), including to require additional information on timeliness and personnel and publication every 30 days of information regarding FDA guidance and meetings.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 1062 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                S. 1062

 To increase reporting transparency and accountability with respect to 
                Food and Drug Administration user fees.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 4, 2017

  Mr. Burr (for himself and Mr. Young) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To increase reporting transparency and accountability with respect to 
                Food and Drug Administration user fees.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Reporting Transparency and 
Accountability Act''.

SEC. 2. 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)) is amended--
            (1) in paragraph (1)(B)--
                    (A) in each of clauses (i), (ii), and (v), by 
                inserting ``and the number of complete response letters 
                issued for such applications'' before the semicolon;
                    (B) in each of clauses (iii) and (iv), by inserting 
                ``and the number of complete response letters issued 
                for such supplements'' before the semicolon;
                    (C) in clause (vi), by inserting ``and the number 
                of designations and denials issued by the agency for 
                such applications'' before the semicolon;
                    (D) in clause (vii), by striking ``; and'' and 
                inserting ``and the number of designations and denials 
                issued by the agency for such applications;''; and
                    (E) in clause (viii) by striking the period and 
                inserting ``and the number of designations and denials 
                issued by the agency for such applications;''; and
            (2) by inserting after paragraph (2) the following:
            ``(3) Real time reporting.--
                    ``(A) In general.--Beginning with fiscal year 2018, 
                every 30 calendar days, the Secretary shall post the 
                data described in subparagraph (B) on the Internet 
                website of the Food and Drug Administration and remove 
                from such website duplicative data from the annual 
                performance report.
                    ``(B) Data.--The following data is required to be 
                posted in accordance with subparagraph (A):
                            ``(i) 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 Research, and the 
                        justification for the issuance and finalization 
                        of each such guidance.
                            ``(ii) 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 year.
                            ``(iii) The list of standard new drug 
                        applications and biologics license 
                        applications, by fiscal year of receipt.
                            ``(iv) The number of filed applications by 
                        each review division.
            ``(4) Capacity planning and improved time reporting.--
        Beginning with fiscal year 2020, the Secretary shall include in 
        the annual report under paragraph (1)--
                    ``(A) 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 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner;
                    ``(B) 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 Research, the Center 
                for Biologics Evaluation and Research, the Office of 
                Regulatory Affairs, and the Office of the Commissioner, 
                pursuant to the `resource capacity planning and 
                modernized time reporting implementation plan';
                    ``(C) the processes by which 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 require 
                reporting on the amount of an employee's time that is 
                dedicated to the review of human drug applications, 
                including information regarding employees dedicated to 
                such activities on a full-time basis, and employees 
                dedicated to such activities on a part-time basis; and
                    ``(D) 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 
                described in subparagraph (C) (both full-time 
                equivalents and employees dedicated to such activities 
                on a part-time basis) for whom time reporting is 
                required as described in subparagraph (C), and the 
                number of such employees required to estimate time 
                dedicated to the review of human drug applications.''.
    (b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)) is 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, for each review 
                        division--
                                    ``(I) the number of premarket 
                                applications filed under section 515 
                                per fiscal year for each review 
                                division, and the number of approvable 
                                letters, major deficiency letters, not 
                                approvable letters, and denials for 
                                such applications;
                                    ``(II) the number of reports filed 
                                under section 510(k) per fiscal year 
                                for each review division and the number 
                                of devices cleared or not substantially 
                                equivalent for such reports; and
                                    ``(III) 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 
                                applications.
                            ``(iii) Real time reporting.--
                                    ``(I) In general.--Beginning with 
                                fiscal year 2018, the Secretary shall, 
                                every 30 calendar days, post the data 
                                described in subclause (II) on the 
                                Internet website of the Food and Drug 
                                Administration and remove from such 
                                website duplicative data from the 
                                annual report under this subparagraph.
                                    ``(II) Data.--The following data is 
                                required to be posted in accordance 
                                with subclause (I):
                                            ``(aa) 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 guidance.
                                            ``(bb) The number and 
                                        titles of public meetings held 
                                        by the Center for Devices and 
                                        Radiological Health each fiscal 
                                        year.''.
    (c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-43(a)) is 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 Office of Generic Drugs in achieving the goals, 
        and future plans for meeting the goals, including--
                    ``(A) the number of original abbreviated new drug 
                applications filed per fiscal year;
                    ``(B) the number of amendments to abbreviated new 
                drug applications filed per fiscal year; and
                    ``(C) the number of actions taken delineated by the 
                type of action, including final approvals, tentative 
                approvals, complete response letters, and the number of 
                `refuse to receive' letters issued by the Food and Drug 
                Administration per fiscal year.
            ``(3) Real time reporting.--
                    ``(A) In general.--Beginning with fiscal year 2018, 
                the Secretary shall, every 30 calendar days, post the 
                data described in subparagraph (B) on the Internet 
                website of the Food and Drug Administration and remove 
                from such website duplicative data from the annual 
                report under this subsection.
                    ``(B) Data.--The following data is required to be 
                posted in accordance with subparagraph (A):
                            ``(i) 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 guidance.
                            ``(ii) The number and titles of public 
                        meetings held by the Office of Generic Drugs 
                        each fiscal year.''.
    (d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-53(a)) is 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 Center for Biologics Evaluation and Research 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 or complete response letters 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 or complete response 
                letters issued by the agency for such applications.
            ``(3) Real time reporting.--
                    ``(A) In general.--Beginning with fiscal year 2018, 
                the Secretary shall, every 30 calendar days, post the 
                data described in subparagraph (B) on the Internet 
                website of the Food and Drug Administration and remove 
                from such website duplicative data from the annual 
                report under this subsection.
                    ``(B) Data.--The following data is required to be 
                posted in accordance with subparagraph (A):
                            ``(i) 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 guidance.
                            ``(ii) 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 year.''.
            ``(4) Capacity planning and time reporting.--Beginning with 
        fiscal year 2020, the Secretary shall include in the annual 
        report under this subsection--
                    ``(A) 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 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner;
                    ``(B) 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 Research, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs and the Office of the Commissioner;
                    ``(C) the process by which 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 require 
                reporting on the amount of an employee's time that is 
                dedicated to the review of biosimilar biological 
                product applications, including information regarding 
                both employees dedicated to such activities on a full-
                time basis, and employees dedicated to such activities 
                on a part-time basis; and
                    ``(D) 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 actual number of 
                employees described in subparagraph (C) (both full-time 
                equivalents and employees dedicated to such activities 
                on a part-time basis) for whom time reporting is 
                required as described in subparagraph (C), and the 
                number of such employees required to estimate time 
                dedicated to the review of biosimilar biological 
                product applications.''.

SEC. 3. FDA 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 2(a), 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 number of human 
                drug applications filed and the number of approvals or 
                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;
                            ``(ii) 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 goals; and
                            ``(iii) the most common causes within the 
                        agency for missing such goals.
                    ``(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 for the corresponding fiscal year.
                    ``(C) External or other circumstances impacting the 
                Center for Drug Evaluation and Research, the Center for 
                Biologics Evaluation and Research, or the Food and Drug 
                Administration, that impacted the ability of the agency 
                to meet review time and performance enhancement 
                goals.''.
            (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) 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 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 upon submission of the performance report 
in subsection (a) for the corresponding fiscal year. 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)(3), that 
        each of the goals for the corresponding fiscal year have been 
        met, the corrective action report shall include a summary of 
        goals met, and recommendations on ways in which the Secretary 
        can improve and streamline the human drug application review 
        process.
            ``(2) Goals missed.--For each of the goals for the 
        corresponding fiscal year that the Secretary determines to not 
        have been met, the corrective action report shall include a 
        detailed justification for such determination and--
                    ``(A) a detailed description of the circumstances 
                under which each drug application that missed the 
                review goal time was approved during the first cycle 
                review, as applicable;
                    ``(B) aggregate data on the circumstances for all 
                unapproved drug applications for which the review goal 
                time was missed; and
                    ``(C) 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, while 
                maintaining standards of approval, for the current 
                fiscal year.
    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable, 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 
        Health, Education, Labor, 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 (c)(2) and the annual 
        performance reports under subsection (a).
            ``(2) Participation in congressional hearing.--Each fiscal 
        year, as applicable, 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 Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, regarding 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.
            ``(3) 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 30 business days.''.
    (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 2(b), is further 
        amended by adding at the end the following:
                            ``(iv) Analysis.--For each fiscal year, the 
                        Secretary shall include in the report an 
                        analysis of the following:
                                    ``(I) The difference between the 
                                number of premarket applications filed 
                                under section 515 and applications 
                                filed under section 510(k) and the 
                                number of major deficiency letters, not 
                                approvable letters, and denials for 
                                such applications issued by the agency, 
                                accounting for--
                                            ``(aa) such applications 
                                        filed during one fiscal year 
                                        for which a decision is not 
                                        scheduled to be made until the 
                                        following fiscal year;
                                            ``(bb) 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 goals; and
                                            ``(cc) the most common 
                                        causes within the agency for 
                                        missing such goals.
                                    ``(II) Relevant data to determine 
                                whether the Center Devices and 
                                Radiological Health have met 
                                performance enhancement goals for the 
                                corresponding fiscal year.
                                    ``(III) 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 goals.''.
            (2) Issuance of corrective action reports.--Section 738A(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
        2(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, 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 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 
        upon submission of the performance report in paragraph (1)(A) 
        for the corresponding fiscal year. 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)(iii), that each of the goals for the 
                corresponding fiscal year have been met, the corrective 
                action report shall include a summary of goals met, and 
                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 for the 
                corresponding fiscal year that the Secretary determines 
                to not have been met, the corrective action report 
                shall include a detailed justification for such 
                determination and--
                            ``(i) a detailed description of the 
                        circumstances under which each application or 
                        report submitted under section 515 or section 
                        510(k) missed the review goal time but was 
                        approved during the first cycle review, as 
                        applicable;
                            ``(ii) aggregate data on the circumstances 
                        for all unapproved medical device applications 
                        for which the review goal time was missed; and
                            ``(iii) 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, while 
                        maintaining standards of approval, for the 
                        current fiscal year.
            ``(3) Enhanced communication.--
                    ``(A) Communications with congress.--Each fiscal 
                year, as applicable, representatives from the Center 
                for Devices and Radiological Health 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 regarding the contents of the 
                corrective action reports described in paragraph (2) 
                and the annual performance reports under paragraph (1).
                    ``(B) Participation in congressional hearing.--Each 
                fiscal year, as applicable, representatives from the 
                Center for Devices and Radiological Health 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 corrective action reports under paragraph (2). 
                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) 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 30 business days.''.
    (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 2(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 number of 
                abbreviated new drug applications filed and the number 
                of approvals or 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;
                            ``(ii) 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 goals; and
                            ``(iii) the most common causes within the 
                        agency for missing such goals.
                    ``(B) Relevant data to determine whether the Office 
                of Generic Drugs has met the performance enhancement 
                goals for the corresponding fiscal year.
                    ``(C) 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 
                goals.''.
            (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) 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 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 upon submission of the performance report 
in section 744C(a) for the corresponding fiscal year. 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 for the corresponding fiscal year have been 
        met, the corrective action report shall include a summary of 
        goals met, and 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 for the 
        corresponding fiscal year that the Secretary determines to not 
        have been met, the corrective action report shall include a 
        detailed justification for such determination and--
                    ``(A) 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 review, as applicable;
                    ``(B) aggregate data on the circumstances for all 
                unapproved abbreviated new drug applications for which 
                the review goal time was missed; and
                    ``(C) 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 year.
    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable, representatives from the Office of Generic 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 
        regarding the contents of the corrective action reports 
        described in subsection (c)(2) and the annual performance 
        reports under subsection (a).
            ``(2) Participation in congressional hearing.--Each fiscal 
        year, as applicable, representatives from the Center for Drug 
        Evaluation and Research 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.
            ``(3) 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 30 business days.''.
    (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 2(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 number of 
                biosimilar biological product applications and 
                supplements filed and the number of approvals or 
                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;
                            ``(ii) 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 goals; and
                            ``(iii) the most common causes within the 
                        agency for missing such goals.
                    ``(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 for the corresponding 
                fiscal year.
                    ``(C) External or other circumstances impacting the 
                Center for Drug Evaluation and Research, the Center for 
                Biologics Evaluation and Research, and the Food and 
                Drug Administration that impacted the ability of the 
                agency to meet review time and performance enhancement 
                goals.''.
            (2) Issuance of corrective action reports.--Section 744I of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53) is 
        amended--
                    (A) by redesignating subsections (c), (d), and (e) 
                as subsections (d), (e), and (f), respectively; and
                    (B) inserting after subsection (a) the following:
    ``(b) 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 upon 
submission of the performance report in section 744I(a) for the 
corresponding fiscal year. 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 for the corresponding fiscal year have been 
        met, the corrective action report shall include a summary of 
        goals met, and 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 for the 
        corresponding fiscal year that the Secretary determines to not 
        have been met, the corrective action report shall include a 
        detailed justification for such determination and--
                    ``(A) 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 review, as applicable;
                    ``(B) aggregate data on the circumstances for all 
                biosimilar biological product applications for which 
                the review goal time was missed; and
                    ``(C) 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 year.
    ``(c) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable, 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 
        Health, Education, Labor, 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 (b) and the annual performance 
        reports under subsection (a).
            ``(2) Participation in congressional hearing.--Each fiscal 
        year, as applicable, 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 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.
            ``(3) 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 30 business days.''.

SEC. 4. PROHIBITING USE OF FUNDS FOR FACILITY MAINTENANCE.

    (a) PDUFA.--Section 735(7)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g(7)(C)) is amended by striking 
``renovation, and repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific equipment, and other 
necessary materials and supplies'' and inserting ``and necessary 
scientific equipment''.
    (b) MDUFA.--Section 737(9)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379i(9)) is amended by striking ``renovation, 
and repair of facilities and acquisition, maintenance, and repair of 
fixtures, furniture, scientific equipment, and other necessary 
materials and supplies'' and inserting ``and necessary scientific 
equipment''.
    (c) GDUFA.--Section 744A(11)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-41(11)(C)) is amended by striking 
``renovation, and repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific equipment, and other 
necessary materials and supplies'' and inserting ``and necessary 
scientific equipment''.
    (d) BsUFA.--Section 744G(9)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-51(9)(C)) is amended by striking 
``renovation, and repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific equipment, and other 
necessary materials and supplies'' and inserting ``and necessary 
scientific equipment''.

SEC. 5. INFORMATION ON IT CONTRACTING.

    Section 736B(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 378h-2(b)) is amended--
            (1) by striking ``report on the'' and inserting ``report 
        on--
            ``(1) the'';
            (2) by striking the period at the end and inserting ``; 
        and''; and
            (3) by adding at the end the following:
            ``(2) the amount of the fees collected that are invested in 
        the information technology infrastructure of the Food and Drug 
        Administration, the entities receiving contracts to develop 
        such infrastructure, the length of such contracts (including 
        renewals), and the progress such entities have made toward 
        meeting the goals described in such contracts.''.
                                 <all>