[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 2292 Introduced in Senate (IS)]

112th CONGRESS
  2d Session
                                S. 2292

 To promote accountability, transparency, innovation, efficiency, and 
 timeliness at the Food and Drug Administration for America's patients.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 17, 2012

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

_______________________________________________________________________

                                 A BILL


 
 To promote accountability, transparency, innovation, efficiency, and 
 timeliness at the Food and Drug Administration for America's patients.

    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 ``Promoting Accountability, 
Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 
2012'' or the ``PATIENTS' FDA Act''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
   TITLE I--ENSURING GREATER TRANSPARENCY AND ACCOUNTABILITY IN FDA 
                       REGULATORY DECISIONMAKING

Sec. 101. Advancing regulatory science to promote public health and 
                            innovation.
Sec. 102. Reporting with respect to prescription drugs.
Sec. 103. Reporting with respect to generic drugs.
Sec. 104. Reporting with respect to biosimilars.
Sec. 105. Documentation of regulatory decisions.
Sec. 106. Review of regulations and guidance.
Sec. 107. Leveraging information technology to fulfill FDA's public 
                            health mission.
          TITLE II--RECALIBRATING RISK-BENEFIT CONSIDERATIONS

Sec. 201. Devices.
Sec. 202. Drugs.
     TITLE III--REDUCING UNNECESSARY DELAYS AND REGULATORY BURDENS

Sec. 301. Optimizing global clinical trials.
Sec. 302. Advancing American patients' timely access to innovative 
                            devices.
Sec. 303. Ensuring legal sufficiency and consistency of FDA enforcement 
                            policies.
        TITLE IV--STRENGTHENING ADVISORY COMMITTEES FOR PATIENTS

Sec. 401. Strengthening advisory committees for patients.
            TITLE V--MEDICAL DEVICE REGULATORY IMPROVEMENTS

                  Subtitle A--Premarket Predictability

Sec. 501. Tracking and review of applications for investigational 
                            device exemptions.
Sec. 502. Investigational Device Exemptions.
Sec. 503. Device submission acceptance criteria.
Sec. 504. Transparency in clearance process.
Sec. 505. Restoring regulatory certainty with respect to 510(k) reports 
                            required for certain modifications.
Sec. 506. Meeting the device needs of individual patients.
  Subtitle B--FDA Renewing Efficiency From Outside Reviewer Management

Sec. 511. Persons accredited to review reports under section 510(k) and 
                            make recommendations for initial 
                            classification.
Sec. 512. Persons accredited to conduct inspections.
   TITLE VI--STRENGTHENING MANAGEMENT TO SUPPORT FDA'S PUBLIC HEALTH 
                                MISSION

Sec. 601. Integrated strategy and management plan.
Sec. 602. Independent assessment.

   TITLE I--ENSURING GREATER TRANSPARENCY AND ACCOUNTABILITY IN FDA 
                       REGULATORY DECISIONMAKING

SEC. 101. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC HEALTH AND 
              INNOVATION.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall develop a strategy and 
implementation plan for advancing regulatory science for medical 
products in order to promote the public health and advance innovation 
in regulatory decisionmaking.
    (b) Requirements.--The strategy and implementation plan developed 
under subsection (a) shall be consistent with the user fee performance 
goals in the Prescription Drug User Fee Agreement commitment letter, 
the Generic Drug User Fee Agreement commitment letter, and the 
Biosimilar User Fee Agreement commitment letter transmitted by the 
Secretary to Congress on January 13, 2012, and the Medical Device User 
Fee Agreement published in the Federal Register on March 20, 2012, and 
shall--
            (1) identify a clear vision of the fundamental role of 
        efficient, consistent, and predictable, science-based decisions 
        throughout regulatory decisionmaking of the Food and Drug 
        Administration with respect to medical products;
            (2) identify the regulatory science priorities of the Food 
        and Drug Administration directly related to fulfilling the 
        mission of the agency with respect to decisionmaking concerning 
        medical products and allocation of resources towards these 
        regulatory science priorities;
            (3) identify regulatory and scientific gaps that impede the 
        timely development and review of, and regulatory certainty with 
        respect to, the approval, licensure, or clearance of medical 
        products, including with respect to companion products and new 
        technologies, and facilitating the timely introduction and 
        adoption of new technologies and methodologies in a safe and 
        effective manner;
            (4) identify clear, measurable metrics by which progress on 
        the priorities identified under paragraph (2) and gaps 
        identified under paragraph (3) will be measured by the Food and 
        Drug Administration, including metrics specific to the 
        integration and adoption of advances in regulatory science 
        described in paragraph (5) and improving medical product 
        decisionmaking, in a predictable and science-based manner; and
            (5) set forth how the Food and Drug Administration will 
        ensure that advances in regulatory science for medical products 
        are adopted, as appropriate, on an ongoing basis and in an 
        manner integrated across centers, divisions, and branches of 
        the Food and Drug Administration, including by senior managers 
        and reviewers, including through the--
                    (A) development, updating, and consistent 
                application of guidance documents that support medical 
                product decisionmaking; and
                    (B) the adoption of the tools, methods, and 
                processes under section 566 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360bbb-5).
    (c) Annual Performance Reports.--As part of the annual performance 
reports by the Food and Drug Administration to Congress, the Secretary 
shall annually report on the progress made with respect to--
            (1) advancing the regulatory science priorities and 
        resolving the gaps identified under paragraph (3) of subsection 
        (b), including reporting on specific metrics identified under 
        paragraph (4) of such subsection;
            (2) the integration and adoption of advances in regulatory 
        science as set forth in paragraph (5) of such subsection; and
            (3) the progress made in advancing the regulatory science 
        goals outlined in the Prescription Drug User Fee Agreement 
        commitment letter, the Generic Drug User Fee Agreement 
        commitment letter, and the Biosimilar User Fee Agreement 
        commitment letter transmitted by the Secretary to Congress on 
        January 13, 2012, and the Medical Device User Fee Agreement 
        published in the Federal Register on March 20, 2012.
    (d) Independent Assessment.--Not later than January 1, 2016, the 
Comptroller General of the United States shall submit to Congress a 
report--
            (1) detailing the progress made by the Food and Drug 
        Administration in meeting the priorities and addressing the 
        gaps identified in subsection (b), including any outstanding 
        gaps; and
            (2) containing recommendations, as appropriate, on how 
        regulatory science initiatives for medical products can be 
        strengthened and improved to promote the public health and 
        advance innovation in regulatory decisionmaking.
    (e) Medical Product.--In this section, the term ``medical product'' 
means a drug, as defined in subsection (g) of section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a device, as 
defined in subsection (h) of such section, or a biological product, as 
defined in section 351(i) of the Public Health Service Act (42 U.S.C. 
262(i)).

SEC. 102. REPORTING WITH RESPECT TO PRESCRIPTION DRUGS.

    Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h-2) is amended--
            (1) by amending subsection (a) to read as follows:
    ``(a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Health Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives a report concerning--
            ``(1) the progress of the Food and Drug Administration in 
        achieving the goals identified in the document entitled, `PDUFA 
        Reauthorization Performance Goals and Procedures Fiscal Years 
        2013 through 2017', and included in the Prescription Drug User 
        Fee Agreement commitment letter transmitted by the Secretary to 
        Congress on January 13, 2012, during such fiscal year and the 
        future plans of the Food and Drug Administration for meeting 
        the goals; and
            ``(2) the progress of each review division and branch 
        within the Center for Drug Evaluation and Research and the 
        Center for Biologics Evaluation and Research in achieving such 
        goals, and the plans of each such division and branch for 
        meeting the goals, including--
                    ``(A) the number of applications for approval of a 
                new drug under section 505(b) of this Act or a new 
                biological product under section 351(a) of the Public 
                Health Service Act filed per fiscal year by each review 
                division and branch;
                    ``(B) the number of such applications that did not 
                meet the goals described in paragraph (1);
                    ``(C) the percentage of such applications approved 
                by each review division and branch;
                    ``(D) the percentage of such applications found to 
                be approvable by each review division and branch;
                    ``(E) the percentage of such applications that were 
                issued complete response letters by each review 
                division and branch;
                    ``(F) the percentage of such applications that were 
                subject to a refuse-to-file action by each review 
                division and branch;
                    ``(G) the percentage of such applications withdrawn 
                by each review division and branch;
                    ``(H) the total number of review cycles per such 
                approval and the average, mean, and median number of 
                review cycles per such application by each review 
                division and branch;
                    ``(I) the mean and median time to final decision, 
                including approval, per such application by each review 
                division and branch;
                    ``(J) the average total time to decision by each 
                review division and branch, including the number of 
                days spent during the review by the Food and Drug 
                Administration and days spent by the sponsor responding 
                to a complete response letter;
                    ``(K) the percentage of applications that are 
                considered as fast track products under section 506 and 
                through accelerated approval by each review division 
                and branch; and
                    ``(L) the number of full-time equivalent positions 
                and overall budget assigned to each review division and 
                branch.
    ``(b) Inclusion.--The report under this section for a fiscal year 
shall include information on all previous cohorts for which the 
Secretary has not given a complete response on all human drug 
applications and supplements in the cohort.''; and
            (2) in subsection (b), by inserting ``, including a 
        qualitative and quantitative report with respect to how user 
        fees and appropriated funds are used for the drug review 
        process, including the percentage of review time devoted to 
        activities related to the review of applications under 
        subsections (b) and (j) of section 505 and subsections (a) and 
        (k) of section 351 of the Public Health Service Act'' before 
        the period at the end.

SEC. 103. REPORTING WITH RESPECT TO GENERIC DRUGS.

    Part 2 of subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g et seq.) is amended by adding at the 
end the following:

``SEC. 736C. REPORTING WITH RESPECT TO GENERIC DRUGS.

    ``(a) In General.--Beginning with fiscal year 2013, not later than 
120 days after the end of each fiscal year for which fees are collected 
under this part, the Secretary shall prepare and submit to the 
Committee on Health Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report concerning--
            ``(1) the progress of the Food and Drug Administration in 
        achieving the goals identified in the Generic Drug User Fee Act 
        (GDUFA) proposal of the Food and Drug Administration, as set 
        forth in the Generic Drug User Fee Agreement commitment letter 
        dated January 13, 2012, during such fiscal year and the future 
        plans of the Food and Drug Administration for meeting the 
        goals; and
            ``(2) the progress of the Office of Generic Drugs within 
        the Center for Drug Evaluation and Research and the Office of 
        Regulatory Affairs in achieving such goals, and the plans of 
        the Office of Generic Drugs, the Center for Drug Evaluation and 
        the Office of Regulatory Affairs in meeting the goals, 
        including--
                    ``(A)(i) the progress in completing review of 
                applications under section 505(j) of the Federal Food, 
                Drug, and Cosmetic Act, amendments to such 
                applications, and prior approval supplements with 
                respect to such applications that have been pending for 
                more than 10 months, including applications under 
                section 505(j) that have been pending for more than 10 
                months as of October 1, 2012, and prior approval 
                supplements to such applications that have been pending 
                for more than 180 days as of October 1, 2012;
                    ``(ii) the total number of applications under 
                section 505(j), amendments to such applications, and 
                prior approval supplements with respect to such 
                applications that have been pending for more than 10 
                months; and
                    ``(iii) the average total time it takes to review 
                and reach a final decision on--
                            ``(I) applications under section 505(j);
                            ``(II) major and minor amendments to 
                        applications under section 505(j); and
                            ``(III) prior approval supplements with 
                        respect to applications under section 505(j);
                    ``(B) the number of such applications that did not 
                meet the goals described in paragraph (1);
                    ``(C) the total number of review cycles per 
                approval of an application described in subclause (I), 
                (II), or (III) of subparagraph (A)(iii) and the 
                average, mean, and median number of review cycles per 
                such application by each review division and branch;
                    ``(D) the number of meetings granted to industry 
                and the number of meeting requests submitted by 
                industry;
                    ``(E) the mean and median time to final decision, 
                including approval, per such application by the Office 
                of Generic Drugs;
                    ``(F) the median time frames and ranges for 
                reporting decisions with respect to good manufacturing 
                practices to the Office of Generic Drugs following 
                completion of inspections;
                    ``(G) the median time frames for completing 
                requested foreign and domestic inspections;
                    ``(H) the total number of review cycles per such 
                approval and the average, mean, and median number of 
                review cycles per such application;
                    ``(I) the average total time to decision by the 
                Office of Generic Drugs, including the number of days 
                spent during the review by the Food and Drug 
                Administration and days spent by the sponsor responding 
                to a complete response; and
                    ``(J) the number of full-time equivalent positions 
                and overall budget assigned to the Office of Generic 
                Drugs and each unit of the Food and Drug 
                Administration.
    ``(b) Inclusion.--The report under this section for a fiscal year 
shall include information on all previous cohorts for which the 
Secretary has not given a complete response on all human drug 
applications and supplements in the cohort.
    ``(c) Fiscal Report.--Beginning not later than fiscal year 2013, 
not later than 120 days after the end of each fiscal year, the 
Secretary shall prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report on the 
implementation of the authority for any user fees with respect to 
generic drugs during such fiscal year, and the use, by the Food and 
Drug Administration, of any such fees collected for such fiscal year, 
including a qualitative and quantitative report with respect to how 
user fees and appropriated funds are used for the drug review process, 
including the percentage of review time devoted to direct review of 
applications under section (j) of section 505.''.

SEC. 104. REPORTING WITH RESPECT TO BIOSIMILARS.

    Part 2 of subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g et seq.), as amended by section 103, 
is further amended by adding at the end the following:

``SEC. 736D. REPORTING WITH RESPECT TO BIOSIMILARS.

    ``(a) Performance Report.--Beginning with fiscal year 2013, not 
later than 120 days after the end of each fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning--
            ``(1) the progress of the Food and Drug Administration in 
        achieving the goals identified in the Biosimilars User Fee Act 
        (BSUFA) proposal of the Food and Drug Administration, as set 
        forth in the Biosimilar User Fee Agreement commitment letter 
        dated January 13, 2012, during such fiscal year and the future 
        plans of the Food and Drug Administration for meeting the 
        goals; and
            ``(2) the progress of each review division and branch 
        within the Center for Drug Evaluation and Research and the 
        Center for Biologics Evaluation and Research in achieving the 
        goals, and the plans of each such division and branch for 
        meeting the goals, including--
                    ``(A) the number of applications for approval under 
                section 351(k) of the Public Health Service Act filed 
                per fiscal year by each review division and branch;
                    ``(B) the number of such applications that did not 
                meet the goals described in paragraph (1) and the total 
                time elapsed since such applications were submitted, 
                including the time such application was with the Food 
                and Drug Administration and the time such application 
                was with the sponsor;
                    ``(C) the percentage of such applications approved 
                by each review division and branch;
                    ``(D) the percentage of such applications that were 
                issued complete response letters by each review 
                division and branch;
                    ``(E) the percentage of such applications that were 
                subject to a refuse-to-file action by each review 
                division and branch;
                    ``(F) the percentage of such applications withdrawn 
                by the sponsor by each review division and branch;
                    ``(G) the total number of review cycles per each 
                approval and the average, mean, and median review 
                cycles per such application (or for all approvals) by 
                each review division and branch;
                    ``(H) the mean and median time to final decision, 
                including approval, per such application by each review 
                division and branch; and
                    ``(I) the number of full-time equivalent positions 
                and overall budget assigned to each review division and 
                branch.
    ``(b) Inclusion.--The report under this subsection for a fiscal 
year shall include information on all previous cohorts for which the 
Secretary has not given a complete response on all applications under 
section 351(k) of the Public Health Service Act in the cohort.
    ``(c) Fiscal Report.--Beginning not later than fiscal year 2013, 
not later than 120 days after the end of each fiscal year, the 
Secretary shall prepare and submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House a report on the implementation of the 
authority for any user fees with respect to biological products 
approved under section 351(k) of the Public Health Service Act during 
such fiscal year, and the use, by the Food and Drug Administration, of 
any such fees collected for such fiscal year, including a qualitative 
and quantitative report with respect to how user fees and appropriated 
funds are used for the drug review process, including the percentage of 
review time devoted to direct review of applications under subsections 
(a) and (k) of section 351 of the Public Health Service Act.''.

SEC. 105. DOCUMENTATION OF REGULATORY DECISIONS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by adding at the end the following:

``SEC. 524A. AGENCY DOCUMENTATION OF SIGNIFICANT DECISIONS REGARDING 
              DRUGS AND DEVICES.

    ``(a) Documentation of Rationale for Significant Decisions.--The 
Secretary shall document the scientific and regulatory rationale for 
any significant decision--
            ``(1) of the Center for Drug Evaluation and Research 
        regarding an application under subsection (b) or (j) of section 
        505;
            ``(2) of the Center for Biologics Evaluation and Research 
        regarding an application under subsection (a) or (k) of section 
        351 of the Public Health Service Act; and
            ``(3) of the Center for Devices and Radiological Health 
        regarding submission or review of a report under section 
        510(k), an application under section 515, or an application for 
        an exemption under section 520(g).
    ``(b) Provision of Documentation.--Upon request, the Secretary 
shall furnish such documentation to the person who is seeking to 
submit, or who has submitted, such report or application.''.

SEC. 106. REVIEW OF REGULATIONS AND GUIDANCE.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary of Health and Human Services shall review all regulations and 
guidance of the Food and Drug Administration with respect to human 
medical products (as defined in section 101) to ensure consistency 
with--
     (a) the requirements of the Federal, Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.); and
    (b) the regulatory principles of the benefits of such regulations 
and guidance justifying the costs and adoption of the least burdensome 
approaches to such regulation and guidance as outlined in Executive 
Order 13563, dated January 18, 2011.

SEC. 107. LEVERAGING INFORMATION TECHNOLOGY TO FULFILL FDA'S PUBLIC 
              HEALTH MISSION.

    (a) HHS Report.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall--
            (1) report to Congress on--
                    (A) the milestones and a completion date for 
                developing and implementing a comprehensive information 
                technology strategic plan to align the information 
                technology systems modernization projects with the 
                strategic goals of the Food and Drug Administration, 
                including results-oriented goals, strategies, 
                milestones, performance measures;
                    (B) efforts to finalize and approve a comprehensive 
                inventory of the information technology systems of the 
                Food and Drug Administration that includes information 
                describing each system, such as costs, system function 
                or purpose, and status information, and incorporate use 
                of the system portfolio into the information investment 
                management process of the Food and Drug Administration;
                    (C) the ways in which the Food and Drug 
                Administration uses the plan described in subparagraph 
                (A) to guide and coordinate the modernization projects 
                and activities of the Food and Drug Administration, 
                including the interdependencies among projects and 
                activities; and
                    (D) the extent to which the Food and Drug 
                Administration has fulfilled or is implementing 
                recommendations of the Government Accountability Office 
                with respect to the Food and Drug Administration and 
                information technology; and
            (2) develop--
                    (A) a documented enterprise architecture program 
                management plan that includes the tasks, activities, 
                and timeframes associated with developing and using the 
                architecture and addresses how the enterprise 
                architecture program management will be performed in 
                coordination with other management disciplines, such as 
                organizational strategic planning, capital planning and 
                investment control, and performance management; and
                    (B) a skills inventory, needs assessment, gap 
                analysis, and initiatives to address skills gaps as 
                part of a strategic approach to information technology 
                human capital planning.
    (b) GAO Report.--Not later than January 1, 2016, the Comptroller 
General of the United States shall issue a report regarding the 
strategic plan described in subsection (a) and related actions carried 
out by the Food and Drug Administration. Such report shall assess the 
progress the Food and Drug Administration has made on--
            (1) the development and implementation of a comprehensive 
        information technology strategic plan, including the results-
        oriented goals, strategies, milestones, and performance 
        measures identified in subparagraph (a);
            (2) the effectiveness of the comprehensive information 
        technology strategic plan in subparagraph (a), including the 
        results-oriented goals and performance measures; and
            (3) the extent to which the Food and Drug Administration 
        has fulfilled recommendations of the Government Accountability 
        Office with respect to such agency and information technology.

          TITLE II--RECALIBRATING RISK-BENEFIT CONSIDERATIONS

SEC. 201. DEVICES.

    Section 513(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(a)) is amended--
            (1) in paragraph (2)--
                    (A) by redesignating subparagraphs (A) through (C) 
                as clauses (i) through (iii), respectively,
                    (B) by striking ``(2) For'' and inserting ``(2)(A) 
                For''; and
                    (C) by adding at the end the following:
            ``(B) The Secretary shall assess the safety and 
        effectiveness of a device as required under subparagraph (A) 
        from the perspective of a reasonable patient in the intended 
        use population who would assign the most value to the effect 
        the device purports to have or is represented to have under the 
        conditions of use prescribed, recommended, or suggested in the 
        labeling or proposed labeling, and who would be willing to 
        accept the probable risks that may be associated with the use 
        of the device as prescribed, recommended, or suggested in the 
        labeling or proposed labeling.'';
            (2) by redesignating paragraph (3) as paragraph (4); and
            (3) by inserting after paragraph (2) the following:
            ``(3)(A) The safety of a device is, for purposes of this 
        section and sections 514 and 515, to be determined in 
        accordance with regulations promulgated by the Secretary, on 
        the basis of information contained in the application and valid 
        scientific evidence derived from well-controlled 
        investigations. The Secretary shall not find a lack of 
        reasonable assurance of safety unless information contained in 
        the application or valid scientific evidence demonstrates that 
        there is a reasonable probability of a risk of injury or 
        illness from the proposed use of the device that is not 
        outweighed by the probable benefit to health from the device.
            ``(B) The Secretary may determine there is not reasonable 
        assurance of safety with respect to a device only after 
        identifying in writing--
                    ``(i) the probable risk of injury or illness;
                    ``(ii) the scientific evidence that reasonably 
                supports the Secretary's determination; and
                    ``(iii) the type of data or information, consistent 
                with the least burdensome provisions of this Act, that 
                would demonstrate a benefit that would exceed the 
                probable risk.''.

SEC. 202. DRUGS.

    Section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(d)) is amended by adding at the end the following:
``In assessing the safety and effectiveness of a drug under this 
subsection, the Secretary shall implement a structured benefit-risk 
assessment framework in the new drug approval process to facilitate the 
balanced consideration of benefits and risks, a consistent and 
systematic approach to the discussion and regulatory decisionmaking, 
and the communication of the benefits and risks of new drugs.''.

     TITLE III--REDUCING UNNECESSARY DELAYS AND REGULATORY BURDENS

SEC. 301. OPTIMIZING GLOBAL CLINICAL TRIALS.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 568. OPTIMIZING GLOBAL CLINICAL TRIALS.

    ``For purposes of eliminating costly and scientifically unnecessary 
clinical trials, enhancing the efficiency of medical products 
development, and facilitating the Food and Drug Administration and the 
acceptance of foreign clinical data of other health authorities, the 
Food and Drug Administration shall--
            ``(1) work with other regulatory authorities of similar 
        standing, medical research companies, and international 
        organizations to foster and encourage uniform, scientifically-
        driven clinical trial standards around the world; and
            ``(2) enhance the commitment to provide the least 
        burdensome, consistent parallel scientific advice to 
        manufacturers seeking simultaneous global development of new 
        medical products in order to minimize the need for conduct and 
        duplication of clinical studies, preclinical studies, or non-
        clinical studies.''.

SEC. 302. ADVANCING AMERICAN PATIENTS' TIMELY ACCESS TO INNOVATIVE 
              DEVICES.

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(g)) is amended by adding at the end the following:
            ``(8) In the case of a person intending to investigate the 
        safety or effectiveness of a class II or a class III device 
        that--
                    ``(A) has a valid marketing authorization by the 
                appropriate authority in Australia, Canada, Israel, 
                Japan, New Zealand, Switzerland, or South Africa or in 
                the European Union or a country in the European 
                Economic Area (the countries in the European Union and 
                the European Free Trade Association), or such other 
                authority recognized by the Secretary; and
                    ``(B) has a history of use pursuant to its 
                marketing authorization with no device-related serious 
                unanticipated adverse event reports,
        the Secretary shall permit an exemption for clinical testing of 
        such device for the purpose of developing data to obtain 
        clearance or approval for the commercial distribution of such 
        device.''.

SEC. 303. ENSURING LEGAL SUFFICIENCY AND CONSISTENCY OF FDA ENFORCEMENT 
              POLICIES.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.), as amended by section 301, is further 
amended by adding at the end the following:

``SEC. 569. WARNING LETTERS.

    ``(a) In General.--Before a warning letter with respect to a drug 
or device is issued, the Office of the Chief Counsel shall review such 
warning letter to ensure that such warning letter is legally sufficient 
and consistent with all policies of the Food and Drug Administration.
    ``(b) Warning Letter.--For purposes of this section, the term 
`warning letter' shall include all notices of alleged violations, 
including untitled letters.''.

        TITLE IV--STRENGTHENING ADVISORY COMMITTEES FOR PATIENTS

SEC. 401. STRENGTHENING ADVISORY COMMITTEES FOR PATIENTS.

    (a) Finding.--Congress finds that--
            (1) as science becomes more specialized, it becomes more 
        difficult for general scientists to keep up with the scientific 
        advances in the many areas that the Food and Drug 
        Administration regulates;
            (2) it is necessary for the Food and Drug Administration to 
        be able to draw upon essential medical and scientific expertise 
        across specialized areas in order to fulfill its public health 
        mission;
            (3) the programs with respect to advisory committees under 
        the Food and Drug Administration should be strengthened and 
        improved to ensure that the Food and Drug Administration is 
        able to be advised by the most qualified medical and scientific 
        subject experts; and
            (4) an appropriate balance should be restored with respect 
        to conflict of interest considerations for advisory committees 
        and experts advising the Food and Drug Administration to ensure 
        that the Food and Drug Administration is able to draw upon the 
        most qualified medical and scientific experts.
    (b) Advisory Committees and Special Government Employees.--
Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 371 et seq.) is amended by adding at the end the following:

``SEC. 714. STRENGTHENING ADVISORY COMMITTEES.

    ``(a) Increasing Numbers of Medical and Scientific Specialists 
Providing Expertise and Annual Report.--
            ``(1) Special government employees.--In this section, the 
        term `special Government employee' has the meaning given the 
        term in section 202 of title 18, United States Code.
            ``(2) Increasing numbers.--The Secretary, acting through 
        the Commissioner of Food and Drugs, shall collaborate with 
        stakeholders, including consumer groups, patient groups, 
        academia, and industry representatives, to increase the number 
        of special Government employees across medical and scientific 
        specialties in areas where the Secretary lacks specific 
        scientific, medical, or technical expertise necessary for the 
        performance of its regulatory responsibilities.
            ``(3) Annual reports.--The Secretary, acting through the 
        Commissioner of Food and Drugs, shall submit an annual report, 
        as part of the annual user fee agreement performance report, on 
        the management of the pool of special Government employees of 
        the Food and Drug Administration by citing--
                    ``(A) the total number of such employees;
                    ``(B) the employees' specific areas of expertise;
                    ``(C) the turnover by resignation of such 
                employees;
                    ``(D) new special Government employee appointments;
                    ``(E) the frequency of participation by special 
                Government employees in decisions by the Food and Drug 
                Administration or advice provided to the Food and Drug 
                Administration; and
                    ``(F) the total number of applicants not selected 
                to serve as special government employees.
    ``(b) Template for Advisory Committee Bylaws.--The Secretary, 
acting through the Commissioner of Food and Drugs, shall--
            ``(1) publish a standardized template for the bylaws of 
        advisory committees established under this Act; and
            ``(2) require each of such advisory committees to compile 
        and publish online an annual report containing, at a minimum--
                    ``(A) a list of the members of the advisory 
                committee, the business address of each member, and the 
                dates of each member's term;
                    ``(B) a list of the Chair and any other designated 
                leaders of the Advisory Committee;
                    ``(C) a list of any vacancies on the advisory 
                committee and the length of any vacancy;
                    ``(D) the advisory committee's functions, 
                expenditures, the dates and places of meetings, and the 
                attendance of members present at such meetings; and
                    ``(E) a summary of the advisory committee's 
                activities and recommendations made during the fiscal 
                year.
    ``(c) Template for Publication of CVs.--
            ``(1) In general.--The Secretary, acting through the 
        Commissioner of Food and Drugs, shall collaborate with 
        stakeholders, including consumer groups, patient groups, 
        academia, and industry representatives, to publish a 
        standardized template as guidance for special Government 
        employees of the Food and Drug Administration and members of 
        advisory committees established under this Act to use in 
        publicizing their curriculum vitae.
            ``(2) Content of template.--The standardized template 
        described in paragraph (1) shall be consistent with the 
        following:
                    ``(A) Peer-reviewed research shall be separated 
                from non-peer-reviewed research.
                    ``(B) The template shall include a separate list of 
                research that has been submitted for review but not yet 
                published.
                    ``(C) The template shall include a separate list of 
                non-research publications.
                    ``(D) The template shall include general 
                information about the topic and date in cases where the 
                research or grant subject matter has been redacted.
                    ``(E) All items shall be listed in chronological 
                order beginning with the most recent.
    ``(d) Affidavits.--The Secretary may require members of advisory 
committees established under this Act to sign an affidavit stating that 
the member has read the majority of the briefing materials pertinent to 
the decision or advice and agrees to the code of conduct to serve as a 
special government employee.
    ``(e) Report.--
            ``(1) In general.--Not later than January 1, 2017, the 
        Secretary, acting through the Commissioner of Food and Drugs, 
        shall report to Congress on the issue of temporary members 
        serving on advisory committees established under this Act.
            ``(2) Content of report.--The report described in paragraph 
        (1) shall include the following information:
                    ``(A) How many temporary members have served on 
                advisory committees established under this Act and how 
                many temporary members served on each advisory 
                committee.
                    ``(B) What percentage of such temporary members 
                were called upon to offer subject matter expertise in 
                voting or to reach a quorum.
                    ``(C) Whether temporary members offer expertise on 
                an issue being decided.
                    ``(D) Whether temporary members being called upon 
                merely to reach a quorum.
                    ``(E) How temporary members are selected.''.

            TITLE V--MEDICAL DEVICE REGULATORY IMPROVEMENTS

                  Subtitle A--Premarket Predictability

SEC. 501. TRACKING AND REVIEW OF APPLICATIONS FOR INVESTIGATIONAL 
              DEVICE EXEMPTIONS.

    Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end 
the following:
    ``(8)(A) Upon the submission of an application for an exemption for 
a device under this subsection, the submission of a request to classify 
a device under section 513, or the submission of a report for a device 
under section 510(k), whichever occurs first, the Secretary shall 
assign a tracking number to the device.
    ``(B) The Secretary shall use such tracking number to record the 
following interactions between the Secretary and applicant with respect 
to the device:
            ``(i) Submission or approval of an application for an 
        exemption under this subsection.
            ``(ii) Submission of a request to classify the device under 
        section 513.
            ``(iii) Submission or clearance of a report under section 
        510(k).
            ``(iv) Any meeting or meeting request, including in 
        anticipation of the submission of such an application or 
        report.
            ``(v) Submission or approval of an application under 
        section 515(c).
            ``(vi) Any formal or informal request by the Secretary for 
        additional information.
            ``(vii) Any deficiency letter.
            ``(viii) Any response by the applicant to a request 
        described in clause (v) or a deficiency letter.
            ``(ix) Any written submission by the applicant to the Food 
        and Drug Administration.
            ``(x) Any other matter, as determined appropriate by the 
        Secretary.
    ``(9) Upon the submission of an application for an exemption under 
this subsection for a device, the Secretary shall assign, to review the 
application, a reviewer with prior review experience with that type of 
device or technology or other relevant expertise.''.

SEC. 502. INVESTIGATIONAL DEVICE EXEMPTIONS.

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(g)) is amended--
            (1) in paragraph (2)(B)(ii), by inserting ``safety and 
        effectiveness'' after ``Secretary of''; and
            (2) in paragraph (4), by adding at the end the following:
                    ``(C) Consistent with paragraph (1), the Secretary 
                shall not disapprove an application under this 
                subsection because the Secretary determines--
                            ``(i) that the investigation may not 
                        support a substantial equivalence or de novo 
                        classification determination or approval of the 
                        device;
                            ``(ii) that the investigation may not meet 
                        a requirement, including a data requirement, 
                        relating to the approval or clearance of a 
                        device; or
                            ``(iii) that an additional or different 
                        investigation may be necessary to support 
                        clearance or approval of the device.''.

SEC. 503. DEVICE SUBMISSION ACCEPTANCE CRITERIA.

    (a) In General.--To ensure more efficient and timely evaluation of 
devices, the Secretary of Health and Human Services (referred to in 
this section as the ``Secretary'') shall revise the device submission 
acceptance criteria utilized by the Secretary under chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) as in 
effect on the date of enactment of this Act and implement such revised 
criteria.
    (b) Description; Content.--
            (1) Description.--The revised acceptance criteria described 
        under subsection (a) shall be objective and consistent with the 
        Federal Food, Drug, and Cosmetic Act and regulations issued 
        under such Act (as in effect on the date of enactment of this 
        Act).
            (2) Content.--Under such revised criteria, the Secretary's 
        decision to refuse to accept or file a device submission shall 
        be consistent with the requirements for such submission as set 
        forth in the Federal Food, Drug, and Cosmetic Act and the 
        regulations issued under such Act (as in effect on the date of 
        enactment of this Act), and shall not be based on criteria 
        inconsistent with the Federal Food, Drug, and Cosmetic Act or 
        such regulations.
    (c) Report.--Not later than 2 years after the date of enactment of 
this Act, the Comptroller General of the United States shall issue a 
report regarding the device submission acceptance criteria. The 
Comptroller General shall, in consultation with persons accredited 
under section 523 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360m), assess and report on the clarity of the revised device 
submission acceptance criteria under this section, and the 
effectiveness of the outcome measures adopted by the Center for Device 
and Radiological Health to ensure the consistent, appropriate, and 
predictable application of such device submission acceptance criteria 
consistent with the Federal Food, Drug, and Cosmetic Act and 
regulations issued under such Act (as in effect on the date of 
enactment of this Act).

SEC. 504. TRANSPARENCY IN CLEARANCE PROCESS.

    (a) Publication of Detailed Decision Summaries.--Section 520(h) (21 
U.S.C. 360j(h)) is amended by adding at the end the following:
    ``(5) Subject to subsection (c) and section 301(j), the Secretary 
shall regularly publish detailed decision summaries for each clearance 
of a device under section 510(k).''.
    (b) Application.--The requirement of section 520(h)(5) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), 
applies only with respect to clearance of a device occurring after the 
date of the enactment of this Act.

SEC. 505. RESTORING REGULATORY CERTAINTY WITH RESPECT TO 510(K) REPORTS 
              REQUIRED FOR CERTAIN MODIFICATIONS.

    (a) In General.--Section 510(n) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(n)) is amended--
            (1) by striking ``(n) The Secretary'' and inserting 
        ``(n)(1) The Secretary''; and
            (2) by adding at the end the following:
    ``(2) A report under subsection (k) is not required for a 
modification to a device that has been classified into class I or II 
under subsection (f)(1) or (i) of section 513 if--
            ``(A) the change is--
                    ``(i) validated by same method applied to the 
                classified device undergoing modification, or a current 
                validation method that is equivalent to the validation 
                method applied to the device undergoing modification;
                    ``(ii) the validation identified under clause (i) 
                includes all changes to the last version of the device 
                that the Secretary found substantially equivalent to a 
                predicate device, within the meaning of subsections 
                (f)(1) and (i) of section 513; and
                    ``(iii) the validation of the modified device 
                reveals that the safety and effectiveness results are 
                consistent with the validation results of the 
                unmodified device;
            ``(B) the device's intended use remains the same; and
            ``(C) the information identified under subparagraphs (A) 
        and (B) is documented and maintained as part of the design file 
        subject to inspection by the Secretary under section 704(a) for 
        a period of time equal to the design life of the device, or 2 
        years from the date of the first commercial distribution of the 
        modified device, whichever occurs later.''.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary shall promulgate a final 
regulation to implement section 510(n)(2) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), including to define the 
phrase ``significantly affect the safety or effectiveness of the 
device'' consistent with the substantive criteria of clauses (i) 
through (iii) of section 510(n)(2)(A).
    (c) Annual Report.--The Secretary shall annually submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives, a 
report that specifies, with respect to the preceding 2-year period--
            (1) the number of reports submitted under subsection 510(k) 
        for a modification or change to a device that was cleared under 
        such subsection prior to such modification or change; and
            (2) the number of such reports submitted in response to--
                    (A) a request from the Secretary,
                    (B) an observation made by the Secretary during an 
                inspection of an applicant's facility; or
                    (C) any other enforcement action initiated by the 
                Secretary.

SEC. 506. MEETING THE DEVICE NEEDS OF INDIVIDUAL PATIENTS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 515A the following:

``SEC. 515B. MEETING THE DEVICE NEEDS OF INDIVIDUAL PATIENTS.

    ``(a) Custom Devices.--Sections 514 and 515 shall not apply to any 
device modified to meet the individual needs of a specific patient if 
such device--
            ``(1) in order to comply with the order of an individual 
        physician or dentist (or any other specially qualified person 
        designated under regulations promulgated by the Secretary after 
        an opportunity for an oral hearing), necessarily deviates from 
        an otherwise applicable performance standard or requirement 
        prescribed by or under section 515;
            ``(2) is not generally available in the United States in 
        finished form and no other devices are domestically available 
        to treat the unique pathology or physiological condition of the 
        specific patient;
            ``(3) is intended to meet the special needs of such 
        physician or dentist (or other specially qualified person so 
        designated)--
                    ``(A) in the course of the professional practice of 
                such physician or dentist (or other specially qualified 
                person so designated);
                    ``(B) the need for which has been documented in the 
                patient's medical record by such physician or dentist 
                (or other specially qualified person so designated); 
                and
                    ``(C) is for use by the individual patient 
                described in subparagraph (B); and
            ``(4) is--
                    ``(A) assembled from components or manufactured on 
                a case-by-case basis;
                    ``(B) premanufactured and finished on a case-by-
                case basis; or
                    ``(C) a modification to an existing, legally 
                marketed device.
    ``(b) Limitations.--Subsection (a) shall apply to a device only 
if--
            ``(1) such device includes particular features to 
        accommodate a specific patient's unique anatomical, 
        physiological, or clinical needs;
            ``(2) such device is for the purpose of treating 
        sufficiently rare patient conditions, such that conducting 
        clinical investigations would be impractical; and
            ``(3) production of such device is limited to no more than 
        10 units per year of a particular device meeting a specific 
        patient need or exhibiting a specific feature.''.

  Subtitle B--FDA Renewing Efficiency From Outside Reviewer Management

SEC. 511. PERSONS ACCREDITED TO REVIEW REPORTS UNDER SECTION 510(K) AND 
              MAKE RECOMMENDATIONS FOR INITIAL CLASSIFICATION.

    (a) Time Period for Review of Recommendations of Accredited 
Persons.--Section 523(a) (21 U.S.C. 360m(a)) is amended--
            (1) in paragraph (1), by striking ``reviewing reports'' and 
        inserting ``reviewing, and making recommendations to the 
        Secretary regarding, reports''; and
            (2) in paragraph (2), by amending subparagraph (B) to read 
        as follows:
                    ``(B) Time period for review.--Not later than 30 
                days after the date on which the Secretary is notified 
                under subparagraph (A) by an accredited person with 
                respect to a recommendation regarding a report 
                submitted under section 510(k) or an initial 
                classification of a device, the Secretary shall make a 
                determination with respect to the recommendation.''.
    (b) Access to Device Information.--Section 523(a)(2) (21 U.S.C. 
360m(a)(2)), as amended by subsection (a)(2), is amended by adding at 
the end the following:
                    ``(D) Access to device information.--
                            ``(i) In general.--Subject to section 
                        301(j), for the purpose of providing accredited 
                        persons with additional information to review 
                        reports submitted under section 510(k) and make 
                        recommendations regarding the initial 
                        classification of devices, the Secretary shall 
                        regularly publish--
                                    ``(I) detailed decision summaries 
                                for each substantial equivalence 
                                determination under section 513(f)(1) 
                                and each initial classification under 
                                section 513(f)(2); and
                                    ``(II) total product life cycles 
                                information for each device classified 
                                under section 513(f).
                            ``(ii) Requirement.--Any information 
                        published under this subparagraph shall be 
                        consistent with the requirements of part 20 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations).''.
    (c) Accreditation.--Section 523(b) (21 U.S.C. 360m(b)) is amended--
            (1) in paragraph (2)--
                    (A) in the heading of subparagraph (C), by 
                inserting ``and training'' after ``auditing'';
                    (B) in subparagraph (C)--
                            (i) in clause (i), by striking ``and'' at 
                        the end;
                            (ii) by redesignating clause (ii) as clause 
                        (iii); and
                            (iii) by inserting after clause (i) the 
                        following:
                            ``(ii) provide for the initial training and 
                        periodic updating of training of such person; 
                        and''; and
                    (C) by adding at the end the following:
                    ``(E) Periodic reaccreditation.--
                            ``(i) Period.--Subject to suspension or 
                        withdrawal under subparagraph (B), any 
                        accreditation under this section shall be valid 
                        for a period of 3 years after its issuance.
                            ``(ii) Response to reaccreditation 
                        request.--Upon the submission of a request by 
                        an accredited person for reaccreditation under 
                        this section, the Secretary shall approve or 
                        deny such request not later than 60 days after 
                        receipt of the request.
                            ``(iii) Criteria.--Not later than 120 days 
                        after the date of the enactment of this 
                        subparagraph, the Secretary shall establish and 
                        publish in the Federal Register criteria to 
                        reaccredit or deny reaccreditation to persons 
                        under this section. The reaccreditation of 
                        persons under this section shall specify the 
                        particular activities under subsection (a) for 
                        which such persons are reaccredited.'';
            (2) in paragraph (3)--
                    (A) in subparagraph (A), by inserting ``a sole 
                practitioner or'' after ``may not be'';
                    (B) in subparagraph (B), by striking ``such a 
                manufacturer, supplier, or vendor'' and inserting ``a 
                manufacturer, supplier, or vendor of devices of the 
                type for which such person is accredited''; and
                    (C) in subparagraph (D), by striking ``devices'' 
                and inserting ``devices of the type for which such 
                person is accredited'';
            (3) by striking paragraph (4) (relating to selection of 
        accredited persons); and
            (4) by redesignating paragraph (5) as paragraph (4).
    (d) Duration of Authority.--Section 523(c) (21 U.S.C. 360m(c)) is 
amended by striking ``October 1, 2012'' and inserting ``October 1, 
2017''.
    (e) Report.--Section 523(d) (21 U.S.C. 360m(d)) is amended by 
striking ``January 10, 2007'' and inserting ``January 15, 2015''.

SEC. 512. PERSONS ACCREDITED TO CONDUCT INSPECTIONS.

    Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking 
``October 1, 2012'' and inserting ``October 1, 2017''.

   TITLE VI--STRENGTHENING MANAGEMENT TO SUPPORT FDA'S PUBLIC HEALTH 
                                MISSION

SEC. 601. INTEGRATED STRATEGY AND MANAGEMENT PLAN.

    (a) Strategic Integrated Management Plan.--Not later than 1 year 
after the date of enactment of this Act, the Secretary shall submit to 
Congress a strategic integrated management plan for the Center for Drug 
Evaluation and Research, the Center for Biologics Evaluation and 
Research, and the Center for Devices and Radiological Health. Such 
strategic management plan shall--
            (1) identify strategic institutional goals and priorities 
        for the Center for Drug Evaluation and Research, the Center for 
        Biologics Evaluation and Research, and the Center for Devices 
        and Radiological Health;
            (2) describe the actions the Secretary will take to 
        recruit, retain, train, and continue to develop the workforce 
        at the Center for Drug Evaluation and Research, the Center for 
        Biologics Evaluation and Research, and the Center for Devices 
        and Radiological Health to fulfill the public health mission of 
        the Food and Drug Administration; and
            (3) identify results-oriented, outcome-based measures that 
        the Secretary will use to measure the progress of achieving the 
        strategic goals and priorities identified under paragraph (1) 
        and the effectiveness of the actions identified under paragraph 
        (2), including metrics to ensure that managers and reviewers of 
        the Center for Drug Evaluation and Research, the Center for 
        Biologics Evaluation and Research, and the Center for Devices 
        and Radiological Health are familiar with and appropriately and 
        consistently apply the requirements under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including new 
        requirements under the 2012 user fee agreements.
    (b) Report.--Not later than January 1, 2016, the Comptroller 
General of the United States shall issue a report regarding the 
strategic management plan described in subsection (a) and related 
actions carried out by the Food and Drug Administration. Such report 
shall--
            (1) assess the effectiveness of the actions described in 
        paragraph (2) in recruiting, retaining, training, and 
        developing the workforce at the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, and 
        the Center for Devices and Radiological Health in fulfilling 
        the public health mission of the Food and Drug Administration;
            (2) assess the effectiveness of the measures identified 
        under paragraph (2) in gauging progress against the strategic 
        goals and priorities identified under paragraph (1);
            (3) assess the extent to which the Center for Drug 
        Evaluation and Research, the Center for Biologics Evaluation 
        and Research, and the Center for Devices and Radiological 
        Health are using the identified results-oriented set of 
        performance measures in tracking their workload by strategic 
        goals and the effectiveness of such measures;
            (4) assess the extent to which performance information is 
        collected, analyzed, and acted on by managers; and
            (5) make recommendations, as appropriate, regarding how the 
        strategic management plan and related actions of the Center for 
        Drug Evaluation and Research, the Center for Biologics 
        Evaluation and Research, and the Center for Devices and 
        Radiological Health could be improved to fulfill the public 
        health mission of the Food and Drug Administration in as 
        efficient and effective manner as possible.

SEC. 602. INDEPENDENT ASSESSMENT.

    (a) In General.--The Secretary shall contract with a private, 
independent consulting firm capable of performing the technical 
analysis, management assessment, and program evaluation tasks required 
to conduct a comprehensive assessment of the process for the review of 
drug applications under subsections (b) and (j) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b), (j)) and 
subsections (a) and (k) of section 351 of the Public Health Service Act 
(42 U.S.C. 262(a), (k)). The assessment shall address the premarket 
review process of drugs by the Food and Drug Administration, using an 
assessment framework that draws from appropriate quality system 
standards, including management responsibility, documents controls and 
records management, and corrective and preventive action.
    (b) Participation.--Representatives of the Food and Drug 
Administration and manufacturers of drugs subject to user fees under 
part 2 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g et seq.) shall participate in a 
comprehensive assessment of the process for the review of drug 
applications under section 505 of the Federal Food, Drug, and Cosmetic 
Act and section 351 of the Public Health Service Act. The assessment 
shall be conducted in phases.
    (c) First Contract.--The Secretary shall award the contract for the 
first assessment under this section not later than March 31, 2013. Such 
contractor shall evaluate the implementation of recommendations and 
publish a written assessment not later than February 1, 2016.
    (d) Findings and Recommendations.--
            (1) In general.--The Secretary shall publish the findings 
        and recommendations under this section that are likely to have 
        a significant impact on review times not later than 6 months 
        after the contract is awarded. Final comprehensive findings and 
        recommendations shall be published not later than 1 year after 
        the contract is awarded.
            (2) Implementation plan.--The Food and Drug Administration 
        shall publish an implementation plan not later than 6 months 
        after the date of receipt of each set of recommendation.
    (e) Scope of Assessment.--The assessment under this section shall 
include the following:
            (1) Identification of process improvements and best 
        practices for conducting predictable, efficient, and consistent 
        premarket reviews that meet regulatory review standards.
            (2) Analysis of elements of the review process that consume 
        or save time to facilitate a more efficient process. Such 
        analysis shall include--
                    (A) consideration of root causes for inefficiencies 
                that may affect review performance and total time to 
                decision;
                    (B) recommended actions to correct any failures to 
                meet user fee program goals; and
                    (C) consideration of the impact of combination 
                products on the review process.
            (3) Assessment of methods and controls of the Food and Drug 
        Administration for collecting and reporting information on 
        premarket review process resource use and performance.
            (4) Assessment of effectiveness of the reviewer training 
        program of the Food and Drug Administration.
            (5) Recommendations for ongoing periodic assessments and 
        any additional, more detailed or focused assessments.
    (f) Requirements.--The Secretary shall--
            (1) analyze the recommendations for improvement 
        opportunities identified in the assessment, develop and 
        implement a corrective action plan, and ensure it 
        effectiveness;
            (2) incorporate the findings and recommendations of the 
        contractors, as appropriate, into the management of the 
        premarket review program of the Food and Drug Administration; 
        and
            (3) incorporate the results of the assessment in a Good 
        Review Management Practices guidance document, which shall 
        include initial and ongoing training of Food and Drug 
        Administration staff, and periodic audits of compliance with 
        the guidance.
                                 <all>