1.This Act may be cited as
the Promoting Accountability,
Transparency, Innovation, Efficiency, and Timeliness at FDA Act of
2012
or the PATIENTS' FDA Act
.
2.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.
<enum>I</enum><header>Ensuring greater
transparency and accountability in FDA regulatory decisionmaking</header>
<section id="idECC9976A1CDD4C56AB2C0EB431974470"><enum>101.</enum><header>Advancing
regulatory science to promote public health and innovation</header>
<subsection id="idB1A3D36843C342E6887D9BAB3B2D861D"><enum>(a)</enum><header>In
general</header><text>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 <quote>Secretary</quote>) 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.</text>
</subsection><subsection id="id4E1993A2F24949B2A88A63A4BAE4B923"><enum>(b)</enum><header>Requirements</header><text>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—</text>
<paragraph id="idD64EFC68C5A24E5997952CB44023C5B7"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="idAC5846AE4C9E4426A38F6D49784705CC"><enum>(2)</enum><text>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;</text>
</paragraph><paragraph id="idc5a607dab17344138512cc1f6d9282b6"><enum>(3)</enum><text>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;</text>
</paragraph><paragraph id="id5df1043d8c2d44e38e3a42300fed2d78"><enum>(4)</enum><text>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</text>
</paragraph><paragraph id="id8a4eb49f5cb344a6ab568ce5bc610201"><enum>(5)</enum><text>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—</text>
<subparagraph id="idCDECDBF711F6437D9C386BA92C85311A"><enum>(A)</enum><text>development,
updating, and consistent application of guidance documents that support medical
product decisionmaking; and</text>
</subparagraph><subparagraph id="id7677644FE0B94FF2BF06CA2390236D28"><enum>(B)</enum><text>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).</text>
</subparagraph></paragraph></subsection><subsection id="id0b7156d01df64e4eab0620a18a4fb6fd"><enum>(c)</enum><header>Annual
performance reports</header><text>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—</text>
<paragraph id="id3a01b828bb75423f8fc582290351d3d0"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="id7ef5efa42d6b4acbace5d8288e98479e"><enum>(2)</enum><text>the integration
and adoption of advances in regulatory science as set forth in paragraph (5) of
such subsection; and</text>
</paragraph><paragraph id="id33d4febe04fb4d6da3f4f97bef37e255"><enum>(3)</enum><text>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.</text>
</paragraph></subsection><subsection id="id796BCCA40AAB412C983FC68039971039"><enum>(d)</enum><header>Independent
assessment</header><text>Not later than January 1, 2016, the Comptroller
General of the United States shall submit to Congress a report—</text>
<paragraph id="idAA80BA55CD5E4287A27E5DED70BD5860"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="id7AA0DA5E145840568312F0903117238D"><enum>(2)</enum><text>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.</text>
</paragraph></subsection><subsection id="idF99EBC8CC9F94AA09E85F9F23F295A55"><enum>(e)</enum><header>Medical
product</header><text>In this section, the term <term>medical product</term>
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)).</text>
</subsection></section><section id="id907F34E97CED4CA3BC23B46854E5A93F"><enum>102.</enum><header>Reporting with
respect to prescription drugs</header><text display-inline="no-display-inline">Section 736B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h–2) is amended—</text>
<paragraph id="idC75F6F9161F94F818BE3958EFF7E4124"><enum>(1)</enum><text display-inline="yes-display-inline">by amending subsection (a) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id59B7F658AC064D2F984A4924E7732535" style="OLC">
<subsection id="id33287e44911f4b59a7badbed0414cf55"><enum>(a)</enum><header>Performance
report</header><text>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—</text>
<paragraph id="id3a2d22430317456b8bac4b62dd6f9585"><enum>(1)</enum><text>the progress of
the Food and Drug Administration in achieving the goals identified in the
document entitled, <quote>PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through 2017</quote>, 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</text>
</paragraph><paragraph id="id539253a10a2d4a33be867187f362ede7"><enum>(2)</enum><text>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—</text>
<subparagraph id="ide7db40ef00914df386425a6905fe3366"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="idC5DE44D76355419B9E1651C0988CDBA7"><enum>(B)</enum><text>the number of
such applications that did not meet the goals described in paragraph
(1);</text>
</subparagraph><subparagraph id="idc78004da2df449f7976ff8b68e049d5e"><enum>(C)</enum><text>the percentage of
such applications approved by each review division and branch;</text>
</subparagraph><subparagraph id="id529824bb912a4737a44413b704ecbb47"><enum>(D)</enum><text>the percentage of
such applications found to be approvable by each review division and
branch;</text>
</subparagraph><subparagraph id="idd59238de34ab4934b64a1accf137c48b"><enum>(E)</enum><text>the percentage of
such applications that were issued complete response letters by each review
division and branch;</text>
</subparagraph><subparagraph id="ide9509f99614d4ade848218eea9ef0905"><enum>(F)</enum><text>the percentage of
such applications that were subject to a refuse-to-file action by each review
division and branch;</text>
</subparagraph><subparagraph id="id481c63988c63416f8bfbb83f6bbd7b5c"><enum>(G)</enum><text>the percentage of
such applications withdrawn by each review division and branch;</text>
</subparagraph><subparagraph id="ida84e9d6735d649d28f64031a1f203535"><enum>(H)</enum><text>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;</text>
</subparagraph><subparagraph id="id60bb6d89ca744ea592138f55f6c03d97"><enum>(I)</enum><text>the mean and
median time to final decision, including approval, per such application by each
review division and branch;</text>
</subparagraph><subparagraph id="id2251e0ec25de4e048afc5b43e83a6586"><enum>(J)</enum><text>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;</text>
</subparagraph><subparagraph id="id6DA0D47698134C69AA287FD5AB9FF6A4"><enum>(K)</enum><text>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</text>
</subparagraph><subparagraph id="id9bbaf40caeb740169599774a37d391c6"><enum>(L)</enum><text>the number of
full-time equivalent positions and overall budget assigned to each review
division and branch.</text>
</subparagraph></paragraph></subsection><subsection id="id419f8a81b944430abe18e3f5d50ec9c5"><enum>(b)</enum><header>Inclusion</header><text>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.</text>
</subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id94604E7E6E5B443BA54765EB8C0085D5"><enum>(2)</enum><text>in subsection
(b), by inserting <quote>, 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</quote>
before the period at the end.</text>
</paragraph></section><section commented="no" id="id73A59C10FD314FDEBCA99FECC9E125AE"><enum>103.</enum><header>Reporting with
respect to generic drugs</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id2F7571A2448E49D28888B8E3A01A93BD" style="OLC">
<section id="id921F3D11C63B4314AF5374C65E8560CD"><enum>736C.</enum><header>Reporting
with respect to generic drugs</header>
<subsection commented="no" id="id16EA16586C37403491BB49EC2F12912A"><enum>(a)</enum><header>In
general</header><text>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—</text>
<paragraph id="id437617885ed34f32a1b9cbe62bc67439"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="id9a132879d72044d686d236f750c8ec07"><enum>(2)</enum><text>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—</text>
<subparagraph id="id23f7aa76803546ff9940e2fc8acc62f1"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="idD26736FCEDEA4285BBB372C0FD7FAFE4"><enum>(i)</enum><text>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;</text>
</clause><clause commented="no" id="id4445517AE5F14D20BDC315F783311532" indent="up1"><enum>(ii)</enum><text>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</text>
</clause><clause id="id5589F47EF70548609D92DD41AE3AF092" indent="up1"><enum>(iii)</enum><text>the average total time it takes
to review and reach a final decision on—</text>
<subclause id="id0ABB9B7F18814C21AEF3A8664E497C52"><enum>(I)</enum><text>applications under section 505(j);</text>
</subclause><subclause id="id4DCBF392D82C4935BCFBE32FFC671896"><enum>(II)</enum><text>major and minor amendments to
applications under section 505(j); and</text>
</subclause><subclause id="idD173B2F8BE8849D7A66E8972828C69E6"><enum>(III)</enum><text>prior approval supplements with respect
to applications under section 505(j);</text>
</subclause></clause></subparagraph><subparagraph id="idb1a87c6239914f81ba0a09b0c9c24429"><enum>(B)</enum><text>the number of
such applications that did not meet the goals described in paragraph
(1);</text>
</subparagraph><subparagraph id="id29f30fa190a344519e76be35a238d4d7"><enum>(C)</enum><text>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;</text>
</subparagraph><subparagraph id="idb495806165e844a1a14ecabd3e1ee879"><enum>(D)</enum><text>the number of
meetings granted to industry and the number of meeting requests submitted by
industry;</text>
</subparagraph><subparagraph id="ide80f5969b3e940f79231902659bfebb9"><enum>(E)</enum><text>the mean and
median time to final decision, including approval, per such application by the
Office of Generic Drugs;</text>
</subparagraph><subparagraph id="id489821992f62490db5e84bd1f12d98eb"><enum>(F)</enum><text>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;</text>
</subparagraph><subparagraph id="id4eccf5ec11964190b8217186ab0be710"><enum>(G)</enum><text>the median time
frames for completing requested foreign and domestic inspections;</text>
</subparagraph><subparagraph id="id0022121118204baf858c41660179da27"><enum>(H)</enum><text>the total number
of review cycles per such approval and the average, mean, and median number of
review cycles per such application;</text>
</subparagraph><subparagraph id="idf610db2b81794a26a9cfa4e1cb6d02bb"><enum>(I)</enum><text>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</text>
</subparagraph><subparagraph id="id6c1424b0a0134fceafab147f8b22203f"><enum>(J)</enum><text>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.</text>
</subparagraph></paragraph></subsection><subsection id="idee73684f6a6e47e0b3026ef8e5581e45"><enum>(b)</enum><header>Inclusion</header><text>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.</text>
</subsection><subsection id="idFA215EB8997042D996A7C2EFACD0AC4C"><enum>(c)</enum><header>Fiscal
report</header><text>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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="id4D428FBFE14043DB9F09AEACFE77C35C"><enum>104.</enum><header>Reporting with
respect to biosimilars</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id729d8922209b43abb81009e63e03e379" style="OLC">
<section id="id44BE4D4C726D4FE2AA3B8C3FD6521F78"><enum>736D.</enum><header>Reporting
with respect to biosimilars</header>
<subsection id="id8dc567c0666e46b79bdd15af89bfac0b"><enum>(a)</enum><header>Performance
report</header><text>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—</text>
<paragraph id="id4690016a4d784dd086f84b41d4ac965c"><enum>(1)</enum><text>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</text>
</paragraph><paragraph id="id93f77883f064440fad02c8c645f67cd6"><enum>(2)</enum><text>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—</text>
<subparagraph id="id4dc0a4219b144b1aa4cd27dd68fde48a"><enum>(A)</enum><text>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;</text>
</subparagraph><subparagraph id="id603c66ab34b8404b9d3b964d42d1e7ab"><enum>(B)</enum><text>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;</text>
</subparagraph><subparagraph id="id707f124ab7524d669de335a086cf7c3f"><enum>(C)</enum><text>the percentage of
such applications approved by each review division and branch;</text>
</subparagraph><subparagraph id="ide040abc0dd11449c80002a52288458be"><enum>(D)</enum><text>the percentage of
such applications that were issued complete response letters by each review
division and branch;</text>
</subparagraph><subparagraph id="idf9ef1577efad44458c9d024002f46d5c"><enum>(E)</enum><text>the percentage of
such applications that were subject to a refuse-to-file action by each review
division and branch;</text>
</subparagraph><subparagraph id="id53c5fcffc78740e196a459a833252f7c"><enum>(F)</enum><text>the percentage of
such applications withdrawn by the sponsor by each review division and
branch;</text>
</subparagraph><subparagraph id="ide6777e233f194a1dbd8887e536c33dfe"><enum>(G)</enum><text>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;</text>
</subparagraph><subparagraph id="idae74f0d19a594a4481a187f6b18629ba"><enum>(H)</enum><text>the mean and
median time to final decision, including approval, per such application by each
review division and branch; and</text>
</subparagraph><subparagraph id="id2d5a3075e247419f822512127a86f2c9"><enum>(I)</enum><text>the number of
full-time equivalent positions and overall budget assigned to each review
division and branch.</text>
</subparagraph></paragraph></subsection><subsection id="idceeeb06843b946f8b45f57a24b6d997d"><enum>(b)</enum><header>Inclusion</header><text>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.</text>
</subsection><subsection id="id87B72827FA8A442B9598BBDC1FBAEA3C"><enum>(c)</enum><header>Fiscal
report</header><text>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.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="idFCBCB5AB64CA439DA7029EF42E9BB01F"><enum>105.</enum><header>Documentation
of regulatory decisions</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id3300327CE0DF420E96B55FE3E834BB14" style="OLC">
<section commented="no" id="id42949E1C756D45E1B61CFA819C70C199"><enum>524A.</enum><header>Agency
documentation of significant decisions regarding drugs and devices</header>
<subsection commented="no" id="id9aa4abfb4fea4656b0e193c7d1805dc2"><enum>(a)</enum><header>Documentation
of rationale for significant decisions</header><text>The Secretary shall
document the scientific and regulatory rationale for any significant
decision—</text>
<paragraph commented="no" id="id0604ABC295C44FB2A2F5A2E5AC7B7AA4"><enum>(1)</enum><text>of the Center for
Drug Evaluation and Research regarding an application under subsection (b) or
(j) of section 505;</text>
</paragraph><paragraph commented="no" id="id5BCBACE351E542D8B153351A5206DB3D"><enum>(2)</enum><text>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</text>
</paragraph><paragraph commented="no" id="idBB663D23898B4741ACDDA6CD75C28B7A"><enum>(3)</enum><text>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).</text>
</paragraph></subsection><subsection commented="no" id="idca82e387515040f898206eaa1aeeb696"><enum>(b)</enum><header>Provision of
documentation</header><text>Upon request, the Secretary shall furnish such
documentation to the person who is seeking to submit, or who has submitted,
such report or
application.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id751A3A8084C3407C812FE83CBFA8C247"><enum>106.</enum><header>Review of
regulations and guidance</header><text display-inline="no-display-inline">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—</text>
<subsection id="idFBA9529C3B024460B097DA8D3A820707"><enum>(a)</enum><text display-inline="yes-display-inline">the requirements of the Federal, Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and</text>
</subsection><subsection id="id9540188B22054F7BB4DF9F68AB1AC636"><enum>(b)</enum><text display-inline="yes-display-inline">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.</text>
</subsection></section><section id="id71ECCACFB8CF4DE49D612106B98EDC0A"><enum>107.</enum><header>Leveraging
information technology to fulfill FDA's public health mission</header>
<subsection id="id46BD774C226E494EACE30D07FA6478BD"><enum>(a)</enum><header>HHS
report</header><text display-inline="yes-display-inline">Not later than 1 year
after the date of enactment of this Act, the Secretary of Health and Human
Services shall—</text>
<paragraph id="idCD4CF4ED801F4C6DB9C4803BD9F4E62B"><enum>(1)</enum><text display-inline="yes-display-inline">report to Congress on—</text>
<subparagraph id="id5A5BCEC91F2648B2A7E3C3B60F411BC4"><enum>(A)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph id="idDDCF3A561A5F4D5B9F386E31E3CDE762"><enum>(B)</enum><text display-inline="yes-display-inline">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;</text>
</subparagraph><subparagraph id="id96925C0148A34164A6D86A30569BABC5"><enum>(C)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph id="idEBF9F30E48BD4E8CB32FBD9844B3F22C"><enum>(D)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph></paragraph><paragraph id="id2F01E713A9514AF8B0629D3D9906A22F"><enum>(2)</enum><text display-inline="yes-display-inline">develop—</text>
<subparagraph id="idD9B5D1E6817C4917B2C56A1E96F9D5C3"><enum>(A)</enum><text display-inline="yes-display-inline">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</text>
</subparagraph><subparagraph id="id1F29AB71C0E34599A83D830C66922469"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph></paragraph></subsection><subsection id="id7E3466438C04486095CE5DFA833B3196"><enum>(b)</enum><header>GAO
report</header><text>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—</text>
<paragraph id="idFA8B40FC93EB40B39386D55CAF05F141"><enum>(1)</enum><text>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);</text>
</paragraph><paragraph id="idD357553ABDB34057A3AE679818206CF3"><enum>(2)</enum><text>the effectiveness
of the comprehensive information technology strategic plan in subparagraph (a),
including the results-oriented goals and performance measures; and</text>
</paragraph><paragraph id="id1A82B55AFD7243A7B6C7435AC6019F61"><enum>(3)</enum><text>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.</text>
</paragraph></subsection></section><enum>II</enum><header>Recalibrating
risk-benefit considerations</header>
<section id="id440970F4CE7D4FB2AD205B75A67A19BC"><enum>201.</enum><header>Devices</header><text display-inline="no-display-inline">Section 513(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(a)) is amended—</text>
<paragraph id="id8E0C3C9D8D714A7E8FEBEE9606F72552"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph id="id994565F9D5E748AA90D7D0785C921331"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (A) through
(C) as clauses (i) through (iii), respectively,</text>
</subparagraph><subparagraph id="id442247072E374890816E90216B8091AD"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>(2) For</quote> and
inserting <quote>(2)(A) For</quote>; and</text>
</subparagraph><subparagraph id="id25927CA1FE0C45EC843C62963F9AD217"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id01CED48D974242088C078F7FDD1F7645" style="OLC">
<subparagraph id="id521E8E00F70E4CB9A6FCFF3784EDE821" indent="up1"><enum>(B)</enum><text>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.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id7F13B8D8FEB9408DA2173A8518051906"><enum>(2)</enum><text>by redesignating
paragraph (3) as paragraph (4); and</text>
</paragraph><paragraph id="id1C0865B31AD8472E864A14BC7F8193ED"><enum>(3)</enum><text>by inserting
after paragraph (2) the following:</text>
<quoted-block display-inline="no-display-inline" id="idFF593F99133A47ABA1C813FAC6172AE9" style="OLC">
<paragraph id="id9521679921304E999F414A704B6B2E16"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id7BD07CEBD241437ABAA7D6C10D12835D"><enum>(A)</enum><text>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.</text>
</subparagraph><subparagraph id="id6867DEFCE2E643599A31D3C46A314EF1" indent="up1"><enum>(B)</enum><text>The Secretary may determine there is
not reasonable assurance of safety with respect to a device only after
identifying in writing—</text>
<clause id="idA1074BCE715747898BDC9FCBD0E624CA"><enum>(i)</enum><text>the probable risk of injury or
illness;</text>
</clause><clause id="idC55638D26E7D40F395DF4A5AD34DA042"><enum>(ii)</enum><text>the scientific evidence that
reasonably supports the Secretary’s determination; and</text>
</clause><clause id="idF6E178AB6F294BE18C1E3F7EC41E63CB"><enum>(iii)</enum><text>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.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" id="idBD0BFAFDA5904AE5BAF9C95D0EBB01AE"><enum>202.</enum><header>Drugs</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="idDAAD317FE1B246BFA12B754361A2B242" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="subsection">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.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>III</enum><header>Reducing
unnecessary delays and regulatory burdens </header>
<section id="id28B778FC6B414607AEAD52D1D9A8F945"><enum>301.</enum><header>Optimizing
global clinical trials</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id33A71E8C20904699BAFB4AB7AF21129D" style="OLC">
<section id="id551A105DC62F45A39F93BC87EC3798D6"><enum>568.</enum><header>Optimizing
global clinical trials</header><text display-inline="no-display-inline">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—</text>
<paragraph id="idC54C265AAEA5444DA76C5009A6DA6840"><enum>(1)</enum><text display-inline="yes-display-inline">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</text>
</paragraph><paragraph id="id1F49A8F4597842B78F0CE673BB3B7E1A"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id2F3596FBB62C46D6AD39272DDB9CA30E"><enum>302.</enum><header>Advancing
American patients' timely access to innovative devices</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="idDD8C35803A7A4F6F84FDB5B649D38501" style="OLC">
<paragraph id="idEA477E5F312849F5AEA10859A2A3DC9B"><enum>(8)</enum><text>In the case of a
person intending to investigate the safety or effectiveness of a class II or a
class III device that—</text>
<subparagraph id="id6313AD27B0374761A279D4F2183A35ED"><enum>(A)</enum><text>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</text>
</subparagraph><subparagraph id="id9ED46A19BAF741EDBCF13D5A508AD3A1"><enum>(B)</enum><text>has a history of
use pursuant to its marketing authorization with no device-related serious
unanticipated adverse event reports,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">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.</continuation-text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id4C8594940624476DAEBD78A6AF714EDB"><enum>303.</enum><header>Ensuring legal
sufficiency and consistency of FDA enforcement policies</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id93752E290A004FDD9F963FC9390A1B7F" style="OLC">
<section id="id9183C59484174602A362A5C9DA3C8E51"><enum>569.</enum><header>Warning
letters</header>
<subsection id="id84EE20CFB43D463782F37F33C57685A7"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection id="id1B19476FFD7042ECA1CA2601D62ACF93"><enum>(b)</enum><header>Warning
letter</header><text display-inline="yes-display-inline">For purposes of this
section, the term <term>warning letter</term> shall include all notices of
alleged violations, including untitled
letters.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>IV</enum><header>Strengthening
Advisory Committees for patients</header>
<section id="id9770EB5F81B543B2B992E06620EC1F13"><enum>401.</enum><header>Strengthening
advisory committees for patients</header>
<subsection id="id7CDBC6A86CE8410EBA0BAAD9B2F1A533"><enum>(a)</enum><header>Finding</header><text>Congress
finds that—</text>
<paragraph id="id43260DEBDBFD4BCCBDEB06FC9382B690"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="id10a5570689f14c57b3f2956f37587f6f"><enum>(2)</enum><text>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;</text>
</paragraph><paragraph id="id8B75465DFB6142DBA97B21E674C5F45C"><enum>(3)</enum><text>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</text>
</paragraph><paragraph id="id43A16F0C0F4B4294BD2AD3EFA131A042"><enum>(4)</enum><text>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.</text>
</paragraph></subsection><subsection id="idAE6CC127CDB6436AB2095AC79341CD09"><enum>(b)</enum><header>Advisory
committees and special government employees</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id9E72407AAA104DF89E0388892B7049C8" style="OLC">
<section id="id5F1967B89236484FB02628CF80022B89"><enum>714.</enum><header>Strengthening
advisory committees</header>
<subsection id="idE0983E1F93DB4E4F9D4EDBB32BD29ECC"><enum>(a)</enum><header>Increasing
numbers of medical and scientific specialists providing expertise and annual
report</header>
<paragraph id="id5122CEB33CCF4DB3A83DC9F05F920E8B"><enum>(1)</enum><header>Special
government employees</header><text>In this section, the term <term>special
Government employee</term> has the meaning given the term in section 202 of
title 18, United States Code.</text>
</paragraph><paragraph id="idE0CA73AFA4484097B5F3928E48F2D824"><enum>(2)</enum><header>Increasing
numbers</header><text>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.</text>
</paragraph><paragraph id="id603a34bfe7bd47c9b7a9ab60d049f9f4"><enum>(3)</enum><header>Annual
reports</header><text>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—</text>
<subparagraph id="idEFCC1873C1EB4137BEE6991C18646599"><enum>(A)</enum><text>the total number
of such employees;</text>
</subparagraph><subparagraph id="id42F22419709C4969BDF9A02E1DB41E16"><enum>(B)</enum><text>the employees'
specific areas of expertise;</text>
</subparagraph><subparagraph id="id8CE965DDDE784087A0A305FCC452BF0B"><enum>(C)</enum><text>the turnover by
resignation of such employees;</text>
</subparagraph><subparagraph id="id323E1C02D66843C9BDFA29AEB5A8BCB5"><enum>(D)</enum><text>new special
Government employee appointments;</text>
</subparagraph><subparagraph id="id4B297861F0314ABAB52657E8DA110002"><enum>(E)</enum><text>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</text>
</subparagraph><subparagraph id="idFB1B63067D9444E79D4ADF9B41C90348"><enum>(F)</enum><text>the total number
of applicants not selected to serve as special government employees.</text>
</subparagraph></paragraph></subsection><subsection id="idc1af10155d0247e982cce9bf7315a346"><enum>(b)</enum><header>Template for
advisory committee bylaws</header><text>The Secretary, acting through the
Commissioner of Food and Drugs, shall—</text>
<paragraph id="id1BA417244CE04EDE8FD4F97273FA49A1"><enum>(1)</enum><text>publish a
standardized template for the bylaws of advisory committees established under
this Act; and</text>
</paragraph><paragraph id="id50555FD8C3E44AED891164FEB4B6F201"><enum>(2)</enum><text>require each of
such advisory committees to compile and publish online an annual report
containing, at a minimum—</text>
<subparagraph id="id5E640A20965542C399BDB1E7E7447466"><enum>(A)</enum><text>a list of the
members of the advisory committee, the business address of each member, and the
dates of each member's term;</text>
</subparagraph><subparagraph id="id165DF99A3E49480BA57079007758BDAA"><enum>(B)</enum><text>a list of the
Chair and any other designated leaders of the Advisory Committee;</text>
</subparagraph><subparagraph id="id6ff148b88a604446b328153ae6fc2132"><enum>(C)</enum><text>a list of any
vacancies on the advisory committee and the length of any vacancy;</text>
</subparagraph><subparagraph id="idA932A171C2184AE5AE0512C49DCAE94A"><enum>(D)</enum><text>the advisory
committee's functions, expenditures, the dates and places of meetings, and the
attendance of members present at such meetings; and</text>
</subparagraph><subparagraph id="id9CD64DB9C17A43CF9A226BB6CF998213"><enum>(E)</enum><text>a summary of the
advisory committee's activities and recommendations made during the fiscal
year.</text>
</subparagraph></paragraph></subsection><subsection id="id7270817515bb4119aec5a7418aa7d870"><enum>(c)</enum><header>Template for
publication of CVs</header>
<paragraph id="id4255648F433C4181B1E01223A4E1F7A2"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="idC1CA4736B83C45ABB24895ED60273764"><enum>(2)</enum><header>Content of
template</header><text>The standardized template described in paragraph (1)
shall be consistent with the following:</text>
<subparagraph id="id90BF666B3A214A539C7FFCEA855FD9A7"><enum>(A)</enum><text>Peer-reviewed
research shall be separated from non-peer-reviewed research.</text>
</subparagraph><subparagraph id="id073BC54E569848439E29DB9CC755A989"><enum>(B)</enum><text>The template
shall include a separate list of research that has been submitted for review
but not yet published.</text>
</subparagraph><subparagraph id="id0B7B9E4B21464578B9BAFF24956A0694"><enum>(C)</enum><text>The template
shall include a separate list of non-research publications.</text>
</subparagraph><subparagraph id="id2D02D47607D9400D974273099275DC00"><enum>(D)</enum><text>The template
shall include general information about the topic and date in cases where the
research or grant subject matter has been redacted.</text>
</subparagraph><subparagraph id="idDBEF9CC80D694E3E8BFD99405E015FD7"><enum>(E)</enum><text>All items shall
be listed in chronological order beginning with the most recent.</text>
</subparagraph></paragraph></subsection><subsection id="ide63e26673e404e5480e1968da5553cd7"><enum>(d)</enum><header>Affidavits</header><text>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.</text>
</subsection><subsection id="id7bfea6f75db446b5abc886dc3b816b01"><enum>(e)</enum><header>Report</header>
<paragraph id="id34D7A7171E5F4BBB8EB916CB65AF64D7"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="id8B494181EBDD4AD1A5E3E6F5BEC74BA6"><enum>(2)</enum><header>Content of
report</header><text>The report described in paragraph (1) shall include the
following information:</text>
<subparagraph id="id13ff9107edf54975853816f77c46b4b5"><enum>(A)</enum><text>How many
temporary members have served on advisory committees established under this Act
and how many temporary members served on each advisory committee.</text>
</subparagraph><subparagraph id="idcc39241250a74f738ba0686303a64aba"><enum>(B)</enum><text>What percentage
of such temporary members were called upon to offer subject matter expertise in
voting or to reach a quorum.</text>
</subparagraph><subparagraph id="id5a77ffa32b384e74a9185f23f30418df"><enum>(C)</enum><text>Whether temporary
members offer expertise on an issue being decided.</text>
</subparagraph><subparagraph id="idc0b1796ed7354c5c8c730f048564c7ad"><enum>(D)</enum><text>Whether temporary
members being called upon merely to reach a quorum.</text>
</subparagraph><subparagraph id="id5d994c4228bd41288e07623ddff89fb1"><enum>(E)</enum><text>How temporary
members are
selected.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>V</enum><header>Medical device
regulatory improvements</header>
<subtitle id="idFF8C4390B871475AA4DAA4A588555B86"><enum>A</enum><header>Premarket
predictability</header>
<section id="HA270DE8078064863988EA1EAB3D524D8"><enum>501.</enum><header>Tracking and
review of applications for investigational device exemptions</header><text display-inline="no-display-inline">Section 520(g) (21 U.S.C. 360j(g)) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H6B81E6B185F547F8952446E3B7F8F57E" style="OLC">
<paragraph id="HB277965A9D044D01B07FE9C543B40D9C" indent="up1"><enum>(8)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HCB6C07E7269D485293BE4776112E89C1"><enum>(A)</enum><text display-inline="yes-display-inline">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.</text>
</subparagraph><subparagraph id="H563740CF8B814B4CBFE90E94C2FD45AF" indent="up1"><enum>(B)</enum><text>The Secretary shall use such tracking
number to record the following interactions between the Secretary and applicant
with respect to the device:</text>
<clause id="H4B8E41D2115F49DBA0D4AFDFAEE198D5"><enum>(i)</enum><text>Submission or approval of an
application for an exemption under this subsection.</text>
</clause><clause id="HA0B6959FC2CE42F48CF664312EFFFD5E"><enum>(ii)</enum><text>Submission of a request to classify
the device under section 513.</text>
</clause><clause id="H5485587E1B8B47F0B9D8FE038F6CF987"><enum>(iii)</enum><text>Submission or clearance of a report
under section 510(k).</text>
</clause><clause id="HF28190597EAD46DE9A718D7F44D4CA89"><enum>(iv)</enum><text>Any meeting or meeting request,
including in anticipation of the submission of such an application or
report.</text>
</clause><clause id="H236AE52F5F124E3C82438FB885B834DB"><enum>(v)</enum><text>Submission or approval of an
application under section 515(c).</text>
</clause><clause id="HA96A7209417544A6B0A085508750B3D1"><enum>(vi)</enum><text>Any formal or informal request by the
Secretary for additional information.</text>
</clause><clause id="H5FDF89AA13DB4114B2562B030AA2F293"><enum>(vii)</enum><text>Any deficiency letter.</text>
</clause><clause id="H926F117D8A904B74966D7057B475CC23"><enum>(viii)</enum><text>Any response by the applicant to a
request described in clause (v) or a deficiency letter.</text>
</clause><clause id="HCA4BC1885BB74B5B9ADFBB679D650853"><enum>(ix)</enum><text>Any written submission by the
applicant to the Food and Drug Administration.</text>
</clause><clause id="H1FB89C7F5CEE4DBDA328370BFE2970DE"><enum>(x)</enum><text>Any other matter, as determined
appropriate by the Secretary.</text>
</clause></subparagraph></paragraph><paragraph id="HE6699B2C4C3C462EB0E64DD23F1A8498" indent="up1"><enum>(9)</enum><text display-inline="yes-display-inline">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.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="HF177792389424D90975E82A93FCD7B4B"><enum>502.</enum><header>Investigational
Device Exemptions</header><text display-inline="no-display-inline">Section
520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is
amended—</text>
<paragraph id="id808EA224C05E475C86604EFEA1A224AC"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2)(B)(ii), by inserting
<quote>safety and effectiveness</quote> after <quote>Secretary of</quote>;
and</text>
</paragraph><paragraph id="id7A666A779EF74D2186457681047E7D99"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (4), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id7DF3AE5EAFCF4590A2879D1184AC4636" style="OLC">
<subparagraph id="id2490D8BFF34940C391207FAEA6E0A4B9"><enum>(C)</enum><text display-inline="yes-display-inline">Consistent with paragraph (1), the
Secretary shall not disapprove an application under this subsection because the
Secretary determines—</text>
<clause id="id703D5EDB84BF4DF2B44E1BC56804783E"><enum>(i)</enum><text display-inline="yes-display-inline">that the investigation may not support a
substantial equivalence or de novo classification determination or approval of
the device;</text>
</clause><clause id="idCCAAD2C3C0C94509B1D41B9B4D1EFE97"><enum>(ii)</enum><text display-inline="yes-display-inline">that the investigation may not meet a
requirement, including a data requirement, relating to the approval or
clearance of a device; or</text>
</clause><clause id="id2708715104A84F5295C2884A3E376F5A"><enum>(iii)</enum><text display-inline="yes-display-inline">that an additional or different
investigation may be necessary to support clearance or approval of the
device.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id872B783EF112469F915FACE49CE12FAD"><enum>503.</enum><header>Device
submission acceptance criteria</header>
<subsection id="id8F4F4B31BFC642089F165880436ABDC3"><enum>(a)</enum><header>In
general</header><text>To ensure more efficient and timely evaluation of
devices, the Secretary of Health and Human Services (referred to in this
section as the <quote>Secretary</quote>) 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.</text>
</subsection><subsection id="id743144345B2C4A97A84EDC3947C14DB7"><enum>(b)</enum><header>Description;
Content</header>
<paragraph id="id5DFAB36C25494307971480C60D263B0D"><enum>(1)</enum><header>Description</header><text>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).</text>
</paragraph><paragraph id="id48B56C62526A41F9B1BAE7429C9087C0"><enum>(2)</enum><header>Content</header><text>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.</text>
</paragraph></subsection><subsection id="idCD72EB0540E240AA9C9749F6FE82E760"><enum>(c)</enum><header>Report</header><text>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).</text>
</subsection></section><section id="H1968FD9ECDDE42C993588BE40F1BFE43"><enum>504.</enum><header>Transparency in
clearance process</header>
<subsection id="HDB446EA31187499ABE01CD9F3509F315"><enum>(a)</enum><header>Publication of
detailed decision summaries</header><text display-inline="yes-display-inline">Section 520(h) (21 U.S.C. 360j(h)) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HAD0D809107594E9799A464CE89E1C66C" style="OLC">
<paragraph id="H5EC5125E10A046839F74E293BFC46823" indent="up1"><enum>(5)</enum><text display-inline="yes-display-inline">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).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H4C742B60CE6645EBBCB2A3EAA56BA1C6"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">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.</text>
</subsection></section><section id="H94FC7A5504324DA7A05BE5E2C3CA759B"><enum>505.</enum><header>Restoring
regulatory certainty with respect to 510(<enum-in-header>k</enum-in-header>)
reports required for certain modifications</header>
<subsection id="H3C0BF022DA44439AB18273774C65C974"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 510(n) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(n)) is amended—</text>
<paragraph id="HA3F1D040F7924ABAB630B365567253CA"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(n) The
Secretary</quote> and inserting <quote>(n)(1) The Secretary</quote>; and</text>
</paragraph><paragraph id="H448C80F0B15A4445A629A846674D82E8"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HFEA202DB0F094F31AEE8307777C398BB" style="OLC">
<paragraph id="H0648DAAC0E424EC6B3E7879725D77C7D" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">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—</text>
<subparagraph id="H86FFBA6012D34BCEB4FE55BB83710345"><enum>(A)</enum><text>the change is—</text>
<clause id="id436F3EC5DBD244498B3FAB264D6C6EC3"><enum>(i)</enum><text>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;</text>
</clause><clause id="idD31918A2A2F64AB784943F8A2D7477BC"><enum>(ii)</enum><text>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</text>
</clause><clause id="idD6D9A3F464CB4774BEC444067AAB7608"><enum>(iii)</enum><text>the validation of the modified
device reveals that the safety and effectiveness results are consistent with
the validation results of the unmodified device;</text>
</clause></subparagraph><subparagraph id="H832509ECB07B41D683EFCE50EEA3BF3C"><enum>(B)</enum><text>the device’s intended use remains the
same; and</text>
</subparagraph><subparagraph id="id924F2DBF9E404BEBAE14AAE254C3DC75"><enum>(C)</enum><text>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.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HC43AD4725F6844888CD1B13FE8488EEE"><enum>(b)</enum><header>Regulations</header><text display-inline="yes-display-inline">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 <quote>significantly
affect the safety or effectiveness of the device</quote> consistent with the
substantive criteria of clauses (i) through (iii) of section
510(n)(2)(A).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id4B03FC68A1B748CF8B461C5C3CE20D53"><enum>(c)</enum><header>Annual
report</header><text>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—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idA61191BC843F4E959D69423907F437A2"><enum>(1)</enum><text>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</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCC04C2BDEB4046E795DF379A74C5DC60"><enum>(2)</enum><text>the number of
such reports submitted in response to—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2192A737C353431CB3D66E2BBA6F8169"><enum>(A)</enum><text>a request from
the Secretary,</text>
</subparagraph><subparagraph id="id54299ef1f118454abe56351a57e8f91e"><enum>(B)</enum><text>an observation
made by the Secretary during an inspection of an applicant's facility;
or</text>
</subparagraph><subparagraph id="idD5725B3EBA6949C9837D0EF3CC75A441"><enum>(C)</enum><text>any other
enforcement action initiated by the Secretary.</text>
</subparagraph></paragraph></subsection></section><section id="idE69C0A021990492F913FC2AD2FD38B35"><enum>506.</enum><header>Meeting the
device needs of individual patients</header><text display-inline="no-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="id57D8D21D33FD4C1396F7F8374E0FD22C" style="OLC">
<section id="id85A2EC9EC2D44A78B7A20F083D987764"><enum>515B.</enum><header>Meeting the
device needs of individual patients</header>
<subsection id="id9128F5B640434A4A8B91B9769192EC2B"><enum>(a)</enum><header>Custom
devices</header><text>Sections 514 and 515 shall not apply to any device
modified to meet the individual needs of a specific patient if such
device—</text>
<paragraph id="idC2A0E9EA829A4D0EA8D12499AD620969"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="idFAF31354DC9546A2B0493F0C7D35A999"><enum>(2)</enum><text>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;</text>
</paragraph><paragraph id="idd21bd89c78844b40aaf462ef26309b02"><enum>(3)</enum><text>is intended to
meet the special needs of such physician or dentist (or other specially
qualified person so designated)—</text>
<subparagraph id="ideba518a5fb3d43188c52f96828b049c1"><enum>(A)</enum><text>in the course of
the professional practice of such physician or dentist (or other specially
qualified person so designated);</text>
</subparagraph><subparagraph id="id731cbd1177704e5d8ec6c38f096446ef"><enum>(B)</enum><text>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</text>
</subparagraph><subparagraph id="iddc036cdb29e64dc380ff534317828599"><enum>(C)</enum><text>is for use by the
individual patient described in subparagraph (B); and</text>
</subparagraph></paragraph><paragraph id="idacf06a9746dd46cab9b3e98399c996e2"><enum>(4)</enum><text>is—</text>
<subparagraph id="idBB90CC37C89A43A18D863D5127766ADF"><enum>(A)</enum><text>assembled from
components or manufactured on a case-by-case basis;</text>
</subparagraph><subparagraph id="id85BDE3B46EBE481B8C677666A519C6C4"><enum>(B)</enum><text>premanufactured
and finished on a case-by-case basis; or</text>
</subparagraph><subparagraph id="id544D289B9273490492596C720060E93C"><enum>(C)</enum><text>a modification to
an existing, legally marketed device.</text>
</subparagraph></paragraph></subsection><subsection id="id731DDD52939243D6BAC319FAB6625443"><enum>(b)</enum><header>Limitations</header><text>Subsection
(a) shall apply to a device only if—</text>
<paragraph id="id477a0cda413e44fda519fda5aa767dc1"><enum>(1)</enum><text>such device
includes particular features to accommodate a specific patient’s unique
anatomical, physiological, or clinical needs;</text>
</paragraph><paragraph id="id2a00a0b8d1ac4be891ce5269f9fe124a"><enum>(2)</enum><text>such device is
for the purpose of treating sufficiently rare patient conditions, such that
conducting clinical investigations would be impractical; and</text>
</paragraph><paragraph id="id8c85ad8afa264d9ca90746492d94462a"><enum>(3)</enum><text>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.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle id="H81C810B9EE1B4834A9AE316A271928E7"><enum>B</enum><header>FDA renewing
efficiency from outside reviewer management</header>
<section commented="no" id="HF376C49C7F304D0681B12451BC79AD7B"><enum>511.</enum><header>Persons
accredited to review reports under section
510<enum-in-header>(k)</enum-in-header> and make recommendations for initial
classification</header>
<subsection commented="no" id="HA5BA3FBAC5754E5EAE27AA924ABA0CB5"><enum>(a)</enum><header>Time period for
review of recommendations of accredited persons</header><text display-inline="yes-display-inline">Section 523(a) (21 U.S.C. 360m(a)) is
amended—</text>
<paragraph commented="no" id="H4444121058B24A9DB61C9430D6DB51CE"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>reviewing reports</quote> and inserting <quote>reviewing,
and making recommendations to the Secretary regarding, reports</quote>;
and</text>
</paragraph><paragraph commented="no" id="HD84F63367B2F4CFD95D3DFDF1F8B7521"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2), by amending subparagraph
(B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HC298F7D53F7C4D35A9C5CEA10EF933CC" style="OLC">
<subparagraph commented="no" id="H66B57204F917442D847A18EE38943619"><enum>(B)</enum><header>Time period for
review</header><text display-inline="yes-display-inline">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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="H8E0B5C9FFB9C4BCC9380A98D7C244DD1"><enum>(b)</enum><header>Access to device
information</header><text display-inline="yes-display-inline">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:</text>
<quoted-block display-inline="no-display-inline" id="H0A98622922374210A9B48051B21404F2" style="OLC">
<subparagraph commented="no" id="HB95E16ECCB824A88909C1A73DB31C6DE"><enum>(D)</enum><header>Access to device
information</header>
<clause commented="no" id="id49CC7D0861B8461482337D54DA522AA8"><enum>(i)</enum><header>In
general</header><text display-inline="yes-display-inline">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—</text>
<subclause commented="no" id="H6DD922EF404D412DA9668D40554068D5"><enum>(I)</enum><text>detailed decision
summaries for each substantial equivalence determination under section
513(f)(1) and each initial classification under section 513(f)(2); and</text>
</subclause><subclause commented="no" id="H0C4433DFC65B488096690DAB3567CCC3"><enum>(II)</enum><text>total product
life cycles information for each device classified under section 513(f).</text>
</subclause></clause><clause commented="no" id="idB9BF69C92F494AC2B8C6CFD2A61B367A"><enum>(ii)</enum><header>Requirement</header><text>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).</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H7B8FD49CA31F4721A368AD6F12FD0827"><enum>(c)</enum><header>Accreditation</header><text display-inline="yes-display-inline">Section 523(b) (21 U.S.C. 360m(b)) is
amended—</text>
<paragraph commented="no" id="H4072F5B45AC043A9B955FD846B427C5B"><enum>(1)</enum><text>in paragraph
(2)—</text>
<subparagraph commented="no" id="HE877A0C33BBD4966B454FE34C4716440"><enum>(A)</enum><text>in the heading of
subparagraph (C), by inserting <quote><header-in-text level="subparagraph" style="OLC">and training</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">auditing</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" id="HA18F9F4FCE114EEC97C1B419E3AEA936"><enum>(B)</enum><text>in subparagraph
(C)—</text>
<clause commented="no" id="H207BEC851A1B4D669D15884CE6392AFD"><enum>(i)</enum><text>in clause (i), by
striking <quote>and</quote> at the end;</text>
</clause><clause commented="no" id="H3C3471992FA8450BAA7085351A366770"><enum>(ii)</enum><text>by redesignating
clause (ii) as clause (iii); and</text>
</clause><clause commented="no" id="H45DFB0F861204339A813A9980737A31B"><enum>(iii)</enum><text>by inserting
after clause (i) the following:</text>
<quoted-block display-inline="no-display-inline" id="HAA16AC6CEAC143D5898A9AD13E053729" style="OLC">
<clause commented="no" id="H83B6A390C1DA4670A667EED9ACF987D2"><enum>(ii)</enum><text display-inline="yes-display-inline">provide for the initial training and
periodic updating of training of such person;
and</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" id="H7F08FE47F12A4894ADB95537B270FE26"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB5CCF2AA233048E58FB364601935C3D2" style="OLC">
<subparagraph commented="no" id="H4EC504746CE44071B3B2F582BDFAAE24"><enum>(E)</enum><header>Periodic
reaccreditation</header>
<clause commented="no" id="HA862FEFAF52046B28148103E9A0A2534"><enum>(i)</enum><header>Period</header><text>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.</text>
</clause><clause commented="no" id="HD5663E7D94F74700975C770B7A89F41B"><enum>(ii)</enum><header>Response to
reaccreditation request</header><text>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.</text>
</clause><clause commented="no" id="H9189A9F613F6450B951C9F98FEF73C5F"><enum>(iii)</enum><header>Criteria</header><text>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.</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="H18D2127BE28C44DCAEFD1645A80AB22B"><enum>(2)</enum><text>in paragraph
(3)—</text>
<subparagraph commented="no" id="H6B8E0DB208744F9BA4203D2BA5ECF896"><enum>(A)</enum><text>in subparagraph
(A), by inserting <quote>a sole practitioner or</quote> after <quote>may not
be</quote>;</text>
</subparagraph><subparagraph commented="no" id="H7FE05F9565554DBABC5E766DC20080E5"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking
<quote>such a manufacturer, supplier, or vendor</quote> and inserting <quote>a
manufacturer, supplier, or vendor of devices of the type for which such person
is accredited</quote>; and</text>
</subparagraph><subparagraph commented="no" id="HC9C5137E83304F2AA7236E20F974F943"><enum>(C)</enum><text>in subparagraph
(D), by striking <quote>devices</quote> and inserting <quote>devices of the
type for which such person is accredited</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" id="HC0DF019775264A91AC6AE6230EE1B51D"><enum>(3)</enum><text>by striking
paragraph (4) (relating to selection of accredited persons); and</text>
</paragraph><paragraph commented="no" id="H494EE0A01BF449B99FADEBD35CF46DC3"><enum>(4)</enum><text>by redesignating
paragraph (5) as paragraph (4).</text>
</paragraph></subsection><subsection commented="no" id="HFE4ABDAB16594289A45224B41B73FE9C"><enum>(d)</enum><header>Duration of
authority</header><text display-inline="yes-display-inline">Section 523(c) (21
U.S.C. 360m(c)) is amended by striking <quote>October 1, 2012</quote> and
inserting <quote>October 1, 2017</quote>.</text>
</subsection><subsection commented="no" id="H903757C5CF99432FA12BFEE473B41AE9"><enum>(e)</enum><header>Report</header><text display-inline="yes-display-inline">Section 523(d) (21 U.S.C. 360m(d)) is
amended by striking <quote>January 10, 2007</quote> and inserting
<quote>January 15, 2015</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="H7F4A4E7849F44CFAA7B0007EF73EC96F" section-type="subsequent-section"><enum>512.</enum><header>Persons accredited
to conduct inspections</header><text display-inline="no-display-inline">Section
704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking <quote>October 1,
2012</quote> and inserting <quote>October 1, 2017</quote>.</text>
</section></subtitle><enum>VI</enum><header>Strengthening
management to support FDA's public health mission</header>
<section id="id6A78FD5B64BC47FE86EEE3694107C8EA"><enum>601.</enum><header>Integrated
strategy and management plan</header>
<subsection id="id6DEFE8835BBD4B8DAA502905883B09F5"><enum>(a)</enum><header>Strategic
integrated management plan</header><text display-inline="yes-display-inline">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—</text>
<paragraph id="id8ee148d8a55241b2822468a8cbf174e4"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="idfff39729a4474b14b7fbe4fd2ce45fe8"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="id0b991236a83443799a1d64545a861eaa"><enum>(3)</enum><text>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.</text>
</paragraph></subsection><subsection id="ideb59a502294c488286100caa191bb061"><enum>(b)</enum><header>Report</header><text>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—</text>
<paragraph id="id8cdaa90d8c6249118b8a32358acf0bf4"><enum>(1)</enum><text>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;</text>
</paragraph><paragraph id="id0ae2a0b3a4e94eb793a64f48ab5b38fd"><enum>(2)</enum><text>assess the
effectiveness of the measures identified under paragraph (2) in gauging
progress against the strategic goals and priorities identified under paragraph
(1);</text>
</paragraph><paragraph id="id45566b09a9444616b28dff688b7d3ff8"><enum>(3)</enum><text>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;</text>
</paragraph><paragraph id="id1cfc079e38dc47809ae3385f2fe51eed"><enum>(4)</enum><text>assess the extent
to which performance information is collected, analyzed, and acted on by
managers; and</text>
</paragraph><paragraph id="idf41a10d79b60454e9e60a488dae7a110"><enum>(5)</enum><text>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.</text>
</paragraph></subsection></section><section id="id41658EBE82D8477FB982CB9558BC4A8E"><enum>602.</enum><header>Independent
assessment</header>
<subsection id="id1465D8CD0A7B44D6843BCE5522DCCF8E"><enum>(a)</enum><header>In
general</header><text>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.</text>
</subsection><subsection id="id6D82FC653A844B3CB30338BF62F7CBE3"><enum>(b)</enum><header>Participation</header><text>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.</text>
</subsection><subsection id="id5EB923B7C5B44688AAE698D2ADB4F475"><enum>(c)</enum><header>First
contract</header><text>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.</text>
</subsection><subsection id="id3EDFD24444894E85BCE30757B2F907FB"><enum>(d)</enum><header>Findings and
recommendations</header>
<paragraph id="id3D4D7DC3790A4F3BACE6C0749C05B25A"><enum>(1)</enum><header>In
general</header><text>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.</text>
</paragraph><paragraph id="idF17E5E9004884D349F023EC76F92A26A"><enum>(2)</enum><header>Implementation
plan</header><text>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.</text>
</paragraph></subsection><subsection id="id487B5D5D449144F484A51339D0B9D2F9"><enum>(e)</enum><header>Scope of
assessment</header><text>The assessment under this section shall include the
following:</text>
<paragraph id="id4E0231A048DC467AB0250DDA59AFE769"><enum>(1)</enum><text>Identification of
process improvements and best practices for conducting predictable, efficient,
and consistent premarket reviews that meet regulatory review standards.</text>
</paragraph><paragraph id="idAC55930B9F764674BBFB51E31E7B7ADA"><enum>(2)</enum><text>Analysis of
elements of the review process that consume or save time to facilitate a more
efficient process. Such analysis shall include—</text>
<subparagraph id="id94C9614D8E574E0DAF0F32088B035001"><enum>(A)</enum><text>consideration of
root causes for inefficiencies that may affect review performance and total
time to decision;</text>
</subparagraph><subparagraph id="id725AA18C3A1F4817826CFAFEFC7700AC"><enum>(B)</enum><text>recommended
actions to correct any failures to meet user fee program goals; and</text>
</subparagraph><subparagraph id="id5E1580F977514149A35BC5AF6D313A53"><enum>(C)</enum><text>consideration of
the impact of combination products on the review process.</text>
</subparagraph></paragraph><paragraph id="id904E4CD203F74FB3869D148E92F56475"><enum>(3)</enum><text>Assessment of
methods and controls of the Food and Drug Administration for collecting and
reporting information on premarket review process resource use and
performance.</text>
</paragraph><paragraph id="id7FD2C6E016A543D6B595AD7A56A30F19"><enum>(4)</enum><text>Assessment of
effectiveness of the reviewer training program of the Food and Drug
Administration.</text>
</paragraph><paragraph id="id45C909DBD6AA4E51AB28AA381C5AB118"><enum>(5)</enum><text>Recommendations
for ongoing periodic assessments and any additional, more detailed or focused
assessments.</text>
</paragraph></subsection><subsection id="id1CAB1923833B4C56874B86C0A99FCB9F"><enum>(f)</enum><header>Requirements</header><text>The
Secretary shall—</text>
<paragraph id="id00CCF733BB394D1F80AE93817B1EFE77"><enum>(1)</enum><text>analyze the
recommendations for improvement opportunities identified in the assessment,
develop and implement a corrective action plan, and ensure it
effectiveness;</text>
</paragraph><paragraph id="id1B2A8F57D1984A8F9CD90BB127CFA97A"><enum>(2)</enum><text>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</text>
</paragraph><paragraph id="idB63DEA8CF79A495A944A6AA37DE0B408"><enum>(3)</enum><text>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.</text>
</paragraph></subsection></section>