1.Short
title; table of contents; references in Act
(a)This Act may be cited
as the Transforming the Regulatory
Environment to Accelerate Access to Treatments
or
TREAT
Act
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of
contents; references in Act.
TITLE I—Elevating FDA and Empowering Operational
Excellence
Sec. 101. Mission statement.
Sec. 102. Management Review Board.
TITLE II—Advancing regulatory science and innovation
Sec. 201. Chief innovation officer.
Sec. 202. Enhancing access to external scientific and medical
expertise.
TITLE III—Enabling modernized patient-centric clinical
development
Sec. 301. Enhancement of accelerated
patient access to new medical treatments.
Sec. 302. Electronic health records.
Sec. 303. Disclosure to drug sponsors of reasons for
non-approval of a new drug application.
(c)Except as otherwise
specified, amendments made by this Act to a section or other provision of law
are amendments to such section or other provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 301 et seq.).
<enum>I</enum><header>Elevating FDA and
Empowering Operational Excellence</header>
<section id="id4814898394B3414DA695CCAA63E9695E"><enum>101.</enum><header>Mission
statement</header><text display-inline="no-display-inline">Section 1003(b) (21
U.S.C. 393(b)) is amended—</text>
<paragraph id="idAE469F70BFE3463DAF77F780DD770528"><enum>(1)</enum><text>by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively;</text>
</paragraph><paragraph id="idD6049B94888D44EBB5BF48EE9B80074E"><enum>(2)</enum><text>by inserting
after paragraph (2), the following:</text>
<quoted-block display-inline="no-display-inline" id="id3C69246F76EF46408C128A31058BF75E" style="OLC">
<paragraph id="idA999D8DB5C7E41C8B76C8EA4D22FEE58"><enum>(3)</enum><text>advance medical
innovation, and strive to make novel products available to those who need them,
by incorporating modern scientific tools, standards, methodologies, and
approaches to ensure the timely and effective review, and the expeditious
clearance, licensure, or approval, as appropriate, of innovative drugs,
devices, and other regulated products;</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="idF9E113E0FED942048492842810C00A46"><enum>(3)</enum><text>in paragraph (5),
as so redesignated, by striking <quote>(1) through (3)</quote> and inserting
<quote>(1) through (4)</quote>.</text>
</paragraph></section><section id="id4AF6A3D3FF05482A8FCFC38C37B9A83E"><enum>102.</enum><header>Management
Review Board</header><text display-inline="no-display-inline">Chapter VII (21
U.S.C. 371 et seq.) is amended by inserting after section 713 the
following:</text>
<quoted-block display-inline="no-display-inline" id="id41F786755C2A4ABEBE64F9EDC015CD1D" style="OLC">
<section id="idAF29E7C998874FCBA4A21975AF9AC389"><enum>714.</enum><header>Management
Review Board</header>
<subsection id="ID68a9343338204a09a779ee792a53a228"><enum>(a)</enum><header>In
general</header><text>Not later than 60 days after the date of enactment of the
<short-title>TREAT Act</short-title>, the Secretary shall
establish an advisory council within the Food and Drug Administration to be
known as the Management Review Board (referred to in this section as the
<quote>Board</quote>).</text>
</subsection><subsection id="id12E08869251742CC8A63C19D565EEC79"><enum>(b)</enum><header>Duties</header>
<paragraph id="id63CFF5886EE146D9A9C1E2EDCE818D5D"><enum>(1)</enum><header>In
general</header><text>The Board shall provide advice to the Secretary regarding
the management and organization of the Food and Drug Administration.</text>
</paragraph><paragraph id="IDb54bdcc658ac412691d006b8163f1a4d"><enum>(2)</enum><header>Reports</header><text>The
Board shall—</text>
<subparagraph id="IDa7871349b41d4aadbfc38c075ecebd4d"><enum>(A)</enum><text>periodically
review the organization and responsibilities of individual offices, centers,
and divisions within the Food and Drug Administration (referred to in this
section as the <term>Administration</term>) in order to determine the optimal
allocation of responsibilities and to improve the efficiency and effectiveness
of each office, center, and division in achieving individual and overall
missions of the Administration;</text>
</subparagraph><subparagraph commented="no" id="ID2aa8808881c44ed784b3906a9e250cb2"><enum>(B)</enum><text>issue proposed
and final reports on whether and to what extent changes should be made to the
management and organization of the Administration to further the
Administration’s mission as set forth in section 1003(b); and</text>
</subparagraph><subparagraph id="IDad838e01f9144f9f8c09dd2d9052f428"><enum>(C)</enum><text>for any proposal
for organizational changes to which the Board gives significant consideration
as a recommendation, consider—</text>
<clause id="IDf727740b332f41b19e6ae5c246c1f9b7"><enum>(i)</enum><text>the budgetary and
operational consequences of the proposed change; and</text>
</clause><clause id="IDd725d41fda2e4ba1a1aa2e9133cc9fcc"><enum>(ii)</enum><text>an estimation of
the level of resources that would be needed to implement the proposed
change.</text>
</clause></subparagraph></paragraph><paragraph id="IDffaaa2e6235b4605a639b53477d92b81"><enum>(3)</enum><header>Consultation</header><text>In
carrying out paragraph (2), the Board shall consult with—</text>
<subparagraph id="ID8da54ed0bfe040108aa64a99c86bea85"><enum>(A)</enum><text>the heads of
centers and divisions within the Administration who are not members of the
Board;</text>
</subparagraph><subparagraph id="IDfee0046469204734a94e8a1122828e96"><enum>(B)</enum><text>other scientific
leaders who are officers or employees of the Administration and are not members
of the Board; and</text>
</subparagraph><subparagraph id="ID2020717cab3244b5807a23b41aea8d81"><enum>(C)</enum><text>organizations
representing regulated industries, venture capital, patients, and disease
research, and that are not otherwise represented on the Board.</text>
</subparagraph></paragraph><paragraph id="ID4adaaa8157f3494d857fe28f7e2453d8"><enum>(4)</enum><header>Topics for
review</header>
<subparagraph id="IDf3ef674f2de94bd9990c67c68d946455"><enum>(A)</enum><header>Request of
Secretary</header><text>The Secretary may, at any time, submit requests about
management or organizational issues to the Board for assessment.</text>
</subparagraph><subparagraph id="ID3df7485f5088402ea044d0f66d89c3a9"><enum>(B)</enum><header>Public
input</header><text>The Board shall seek input from the public on management
and organizational issues that should be assessed by the Board, at such times
as determined appropriate by the Board.</text>
</subparagraph></paragraph><paragraph id="ID317673db5dc2457688d87a6182c8a9fc"><enum>(5)</enum><header>Powers</header><text>The
Board may secure directly from the Administration such information as is
necessary or appropriate for the Board to review issues under
consideration.</text>
</paragraph><paragraph commented="no" id="ID5e85b12163434ef9972953388e6f49ef"><enum>(6)</enum><header>Conflict of
interest exemption</header><text>Notwithstanding any other provision of law,
the Board shall not be subject to section 712.</text>
</paragraph></subsection><subsection id="ID8b63aab3c58147cd8028c1961afb301a"><enum>(c)</enum><header>Composition of
board</header>
<paragraph id="ID697e59cc849446ef8bd04b044147254c"><enum>(1)</enum><header>In
general</header><text>The Board shall consist of—</text>
<subparagraph id="IDcdf5b57acba04d4886bce12ac826994d"><enum>(A)</enum><text>the Secretary,
who shall be a permanent nonvoting member on an ex officio basis; and</text>
</subparagraph><subparagraph id="ID0b01704587904f9fab1e204e492efbae"><enum>(B)</enum><text>21 additional
members, all of whom shall be voting members, in accordance with paragraph
(2).</text>
</subparagraph></paragraph><paragraph id="IDc30dbbc0b1f4486d9f45706b9f769c3f"><enum>(2)</enum><header>Voting
members</header><text>The membership of the Board shall consist of the
following:</text>
<subparagraph id="IDc9ad0aa9b1e14756ab46b6a101f21cdc"><enum>(A)</enum><header>Officers and
employees of the food and drug administration</header><text>The Secretary shall
designate not less than 9 individuals who are directors of centers within the
Administration, directors of divisions within such Administration, or other
similarly senior officials within such Administration.</text>
</subparagraph><subparagraph id="IDb77bf756c306402dad28ae4f94ab0ee9"><enum>(B)</enum><header>Other
members</header><text>The Secretary shall designate other individuals from
among individuals who are not officers or employees of the United States. Such
members shall include—</text>
<clause id="ID3ad218f626154279ae42decb30578269"><enum>(i)</enum><text>individuals
representing the interests of public or private academic medical centers,
physicians, and patient advocacy and disease research organizations;</text>
</clause><clause id="IDe550c61ebfa043fba6aecdb664fa771d"><enum>(ii)</enum><text>individuals
representing the interests of industries regulated by the Administration, which
shall include at least 1 representative from each of the pharmaceutical,
biotechnology, medical device, and food industries; and</text>
</clause><clause id="ID97cc3ee583cd41d5b8979cbdeae37568"><enum>(iii)</enum><text>individuals
with broad expertise regarding how the Administration functions and with
experience in successfully managing or consulting for large scientific research
or other organizations (other than public or private entities described under
clause (i)).</text>
</clause></subparagraph></paragraph><paragraph id="IDf58a53fd30ea4d25920dd01c1f9b0d77"><enum>(3)</enum><header>Term;
vacancies</header>
<subparagraph id="ID0efa98554cfa474fa022d786e2079ce9"><enum>(A)</enum><header>Terms</header><text>The
members appointed under paragraph (2)(B) shall be appointed for a term of 3
years, which may be renewed once.</text>
</subparagraph><subparagraph id="ID71b4b625aa6a47feaccb24a614e7a1a5"><enum>(B)</enum><header>Vacancies</header><text>A
vacancy on the Board—</text>
<clause id="IDce6e6301050246168bafa911f142d663"><enum>(i)</enum><text>shall not affect
the powers of the Board; and</text>
</clause><clause id="IDbfe9676a69e248d3a1a6dd2239c21fa1"><enum>(ii)</enum><text>shall be filled
in the same manner as the original appointment was made.</text>
</clause></subparagraph></paragraph></subsection><subsection id="IDd99e1c910cfe4be8bee74a3584a1e8bf"><enum>(d)</enum><header>Chair</header><text>The
Chair of the Board shall be selected by the Secretary from among the members of
the Board appointed under subsection (c)(1). The term of office of the Chair
shall be 3 years.</text>
</subsection><subsection id="IDfbcd299dad3e4ce2a8b4a44663cf58a9"><enum>(e)</enum><header>Meetings</header>
<paragraph id="ID984764dcfb1f43139f73679cc074a480"><enum>(1)</enum><header>In
general</header><text>The Board shall meet at the call of the Chair or upon the
request of the Secretary, but not fewer than 6 times with respect to issuing
any particular report under subsection (b)(2). The location of the meetings of
the Board is subject to the approval of the Secretary.</text>
</paragraph><paragraph id="ID62058fd869bd494783fce2fe4d2e5799"><enum>(2)</enum><header>Particular
meetings to receive public input</header><text>Of the meetings held under
paragraph (1) with respect to proposals for management or organizational
changes being considered under subsection (b)(2)—</text>
<subparagraph id="ID4c94231670714e74b9b36e2921c248d7"><enum>(A)</enum><text>1 or more shall
be directed towards receiving input from the pharmaceutical, medical device,
and biotechnology industries, clinical researchers, and the physician and
medical research communities to address regulatory and scientific needs and
opportunities related to such proposals;</text>
</subparagraph><subparagraph id="ID0d1047640fd547faaf1147e5873e49e3"><enum>(B)</enum><text>1 or more shall
be directed towards receiving input from patient advocacy, disease research
organizations, and consumer groups to address patient and consumer needs and
opportunities related to such proposals; and</text>
</subparagraph><subparagraph id="IDaad9bf0f4f694370a65a57e6f0537fea"><enum>(C)</enum><text>1 or more shall
be directed towards receiving input from food, cosmetic, and dietary supplement
industries to address regulatory and scientific needs and opportunities related
to such proposals.</text>
</subparagraph></paragraph><paragraph id="IDe7e1cc5d29a4456cae2de9c9bfe20a97"><enum>(3)</enum><header>Availability of
information</header><text>For each meeting held under this subsection, the
Secretary shall post on the Internet Web site of the Administration a summary
of the proceedings.</text>
</paragraph></subsection><subsection commented="no" id="ID93bc09fc8224419288a495af5bcaa9cb"><enum>(f)</enum><header>Compensation</header><text>Without
regard to the provisions of title 5, United States Code, governing appointments
in the competitive service, and without regard to provisions of chapter 51 and
subchapter III of chapter 53 of such title relating to classification and
General Schedule pay rates, the Secretary may—</text>
<paragraph commented="no" id="IDd18de167554f4db490a53d8b51dfaa0b"><enum>(1)</enum><text>establish the
Board; and</text>
</paragraph><paragraph commented="no" id="IDb4c65966f98a44d98376305e107bb90b"><enum>(2)</enum><text>appoint and fix
the compensation of the members of the Board, except that officers and
employees of the United States shall not receive additional compensation for
service as members of such groups.</text>
</paragraph></subsection><subsection id="ID3dddc551086a4521bc07c79455f03007"><enum>(g)</enum><header>Reports</header>
<paragraph commented="no" id="IDe06cfa9d70864e81a8ef0fc470763f4d"><enum>(1)</enum><header>Public
comment</header>
<subparagraph commented="no" id="id9894824F8C2E496FB683905143BF07FB"><enum>(A)</enum><header>Proposed
reports</header><text>Each proposed report issued under subsection (b)(2) shall
be posted on the Internet Web site of the Administration and made available for
public comment for not less than 60 days prior to being made final and being
submitted under paragraph (2).</text>
</subparagraph><subparagraph commented="no" id="IDf752da0885af455a86ffe6d452dcf548"><enum>(B)</enum><header>Final
reports</header><text>Not later than 90 days after receiving comments from the
public on a proposed report under subparagraph (A), the Board shall post a
final report on such Internet Web site incorporating an overview of comments
accepted or rejected.</text>
</subparagraph></paragraph><paragraph id="IDa615c5493e04405489601b376fe10a13"><enum>(2)</enum><header>Congressional
and Secretary review</header><text>Each final report issued under subsection
(b)(2) shall be submitted to the—</text>
<subparagraph id="IDe9ab40fab3b546b6a8485adee545274a"><enum>(A)</enum><text>the Committee on
Health, Education, Labor, and Pensions and the Committee on Appropriations of
the Senate;</text>
</subparagraph><subparagraph id="ID3d653013172b429790ccfe26aa603c7f"><enum>(B)</enum><text>the Committee on
Energy and Commerce and the Committee on Appropriations of the House of
Representatives; and</text>
</subparagraph><subparagraph id="ID2755942a30f4472f891d6b66a1544e8b"><enum>(C)</enum><text>the
Secretary.</text>
</subparagraph></paragraph><paragraph id="ID277ea4737cf944d2ab68d4d000958184"><enum>(3)</enum><header>Timing and
frequency of reports</header><text>Not later than January 31, 2015, the Board
shall issue the first report under subsection (b)(2) and shall issue subsequent
reports not less than once every 5 years thereafter.</text>
</paragraph></subsection><subsection id="ID8e8d79bb888949aebf20bf88bb026e88"><enum>(h)</enum><header>Process for
review of recommended organizational or management changes</header><text>With
respect to recommendations for organizational or management changes made in a
report issued under subsection (b)(2), the Secretary shall, except as provided
in subsection (i)(2), implement the recommendations in accordance with the
following process:</text>
<paragraph id="IDa79112351e78425db2d46786f9d54926"><enum>(1)</enum><text>Not later than
100 days after the report is submitted to the Secretary under subsection
(g)(2), the Secretary shall initiate the applicable processes under subsection
(i).</text>
</paragraph><paragraph id="ID9575ef25010e414e8a9a647f3ad50bcf"><enum>(2)</enum><text>The
recommendations shall be fully implemented not later than the expiration of the
3-year period beginning on the date on which such process is initiated.</text>
</paragraph></subsection><subsection id="ID686a0368a2294bcf8567a930eca1d1fb"><enum>(i)</enum><header>Action by the
Secretary</header>
<paragraph id="ID7b0b1bb17ab34ecc8226105b5d23eeee"><enum>(1)</enum><header>In
general</header><text>Not less than 60 days prior to implementing any major
organizational or management change recommended under subsection (b)(2), the
Secretary shall provide notice to the congressional committees specified in
subsection (g)(2) of the Secretary’s agreement with the recommendation and the
timeline for implementation.</text>
</paragraph><paragraph id="IDe3bee03bf3d54feba1c9479dd5426827"><enum>(2)</enum><header>Objection</header><text>Subsection
(h) shall not apply to a recommendation for an organizational or management
change made in a report issued under subsection (b)(2) if, not later than 90
days after the report is submitted to the Secretary under subsection (g)(2),
the Secretary submits to the committees specified in such subsection a notice
indicating that the Secretary objects to the recommended change, and setting
forth the reasons for such objection. For purposes of this paragraph, an
objection by the Secretary may be made to the entirety of the recommended
organizational changes contained in a report issued under subsection (b)(2), or
to 1 or more aspects of any proposed change or changes.</text>
</paragraph><paragraph id="IDa7e3aa16e0da4008a1e1a06f784dc65f"><enum>(3)</enum><header>Implementation</header><text>Any
aspect of a proposed change not objected to by the Secretary in a notice under
paragraph (2) shall be implemented in accordance with subsection (h), except as
the Secretary may be directed otherwise by
law.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>II</enum><header>Advancing
regulatory science and innovation</header>
<section id="ID3f33951463cc4e678be6723f106c5b6a"><enum>201.</enum><header>Chief
innovation officer</header><text display-inline="no-display-inline">Chapter X
is amended—</text>
<paragraph id="ID68b04e9e6e6f4e76833657bcc53f9c3b"><enum>(1)</enum><text>by redesignating
the second section 1011 (21 U.S.C. 399c) (as added by section 209(a) of Public
Law 111–353) as section 1011A; and</text>
</paragraph><paragraph id="IDbe47a7a3ccea46bfae6a67b280af2a0c"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idCFD256B72D6C4EEF92C2953FC70910AE" style="OLC">
<section id="id8C9D13D8937E477BB3B12A6EBD591D0F"><enum>1013.</enum><header>Office of the
Chief Innovation Officer</header>
<subsection id="ID7d4bbc43b45343d4b7d03402035a4511"><enum>(a)</enum><header>Establishment;
appointment</header><text>The Secretary shall establish within the Office of
the Commissioner an office to be known as the Office of the Chief Innovation
Officer. The Secretary shall appoint a Chief Innovation Officer to lead such
Office.</text>
</subsection><subsection id="ID4f758c274d8f432084b9a0b47866d9d4"><enum>(b)</enum><header>Duties</header><text>The
Chief Innovation Officer shall—</text>
<paragraph id="ID33be6ad43ff64694ac01b17b8de16b9d"><enum>(1)</enum><text>identify
promising new scientific and regulatory approaches to ensure the rapid
development, testing, and review of new drugs and devices, which may include
the validation and qualification of biomarkers, the adoption of novel models or
methodologies to enhance clinical trial design, clinical data evaluation, or
predictive toxicology, and the coordination and optimization of efficient
review processes for drugs, and devices;</text>
</paragraph><paragraph id="ID30cb97422f6b4adcaaac8f3703cb2ccd"><enum>(2)</enum><text>ensure that such
approaches are integrated into operations at all applicable levels of the Food
and Drug Administration, and harmonized with the approaches of other applicable
agencies;</text>
</paragraph><paragraph id="ID2fe4f7abef3644bc9419f00c9820f0f3"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id9ABD98A921124AA18BCD051B3B4B3571"><enum>(A)</enum><text>consider the
recommendations of internal and external bodies involved in advancing
innovation in regulatory science activities, such as those described in
paragraph (1); and</text>
</subparagraph><subparagraph id="idB6775FC6BDF246AFBFDF907487CFD499" indent="up1"><enum>(B)</enum><text>make such recommendations available on
the Internet Web site of the Food and Drug Administration;</text>
</subparagraph></paragraph><paragraph id="ID9bcd36abff474ae6a27f862c8c2b981d"><enum>(4)</enum><text>develop pilot
programs to implement and incorporate the recommendations considered under
paragraph (3) into the regulatory review and approval processes of such
Administration; and</text>
</paragraph><paragraph id="IDa6257bd70c134bdca0d359199f7c7484"><enum>(5)</enum><text>in consultation
with the heads of the centers and offices within such Administration, implement
other pilot programs as the Chief Innovation Officer determines appropriate,
and ensure participation by cross-disciplinary teams in such implementation, as
applicable.</text>
</paragraph></subsection><subsection id="ID5e62066a360c4ee0aaebe0821f66b8d6"><enum>(c)</enum><header>Reports and
implementation plans</header>
<paragraph id="IDe6a1df3c03de4ebbab0fe4dfca5854f4"><enum>(1)</enum><header>Reports</header><text>The
Chief Innovation Officer shall publish a report summarizing the consideration
of applicable recommendations evaluated under subsection (b)(3) at least once
every 2 years. Such reports shall—</text>
<subparagraph id="IDed449bcbd2844845845f927015c0a97e"><enum>(A)</enum><text>provide an
explanation as to whether, how, and why such recommendations will be
implemented by the Food and Drug Administration;</text>
</subparagraph><subparagraph id="ID026e1b0630b74cc48f679616894c01e5"><enum>(B)</enum><text>provide a
description of pilot programs being implemented and the progress of such
Administration with respect to the integration of new scientific and regulatory
approaches into its operations in order to accelerate the rapid development,
review, approval, and patient access to new drugs and devices;</text>
</subparagraph><subparagraph id="IDf73b78f762d64f818923aa10dcf031b6"><enum>(C)</enum><text>be made available
for public comment for not less than 60 days prior to being made final;</text>
</subparagraph><subparagraph id="IDfa26520309a1434b8f309588a48fefac"><enum>(D)</enum><text>following public
comment, be finalized by the Chief Innovation Officer to include an overview of
public comments accepted or rejected; and</text>
</subparagraph><subparagraph id="IDd116091cb8af4bf2b8d16635a882a792"><enum>(E)</enum><text>once finalized,
be made available on the Internet Web site of such Administration and submitted
to—</text>
<clause id="ID9841663745eb4f8094ca45885c51ae38"><enum>(i)</enum><text>the Committee on
Health, Education, Labor and Pensions of the Senate; and</text>
</clause><clause id="ID5f4957e7aa42425eb18b7bd89b251abb"><enum>(ii)</enum><text>the Committee on
Energy and Commerce of the House of Representatives.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="ID045688e27bb84d92ab9d5b8fc4c62240"><enum>(2)</enum><header>Public comment
regarding implementation of pilot programs</header><text>The Chief Innovation
Officer shall make each plan to implement a pilot program under subsection
(b)(4) available for public comment for not less than 60 days before the
implementation of the pilot program.</text>
</paragraph></subsection><subsection commented="no" id="id25960FA42E4B4500916DC09DF9E74755"><enum>(d)</enum><header>Maintenance of
authority of centers</header><text>Nothing in this section limits the authority
or ability of the individual Centers of the Food and Drug Administration to
carry out any of the actions described in this
section.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="idAC87BB1A916A4A76B9342378E853BB2C"><enum>202.</enum><header>Enhancing
access to external scientific and medical expertise</header>
<subsection id="id198D7AAEA641469CAF32ED860372CDE7"><enum>(a)</enum><header>Advisory
Committees</header>
<paragraph id="idD51C2B191E5C44C3A0BDEE210EB612BA"><enum>(1)</enum><header>Conflicts of
interest</header><text>Section 712(c)(2) (21 U.S.C. 379d–1(c)(2)) is
amended—</text>
<subparagraph id="idD521FCD3B1D84079AC9896C7620B827C"><enum>(A)</enum><text>in subparagraph
(A), by striking <quote>financial interest that could be affected by the advice
given to the Secretary with respect to such matter</quote> and inserting
<quote>financial interest in the outcome of such matter that is direct and
predictable</quote>;</text>
</subparagraph><subparagraph id="idEDFB8FD836724464A979526519E5CA84"><enum>(B)</enum><text>by striking
subparagraph (B) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idD07A3DF6CCE44E7D805ED41D80F2CC38" style="OLC">
<subparagraph id="id35282C12766E45108440264F96BD1C8B"><enum>(B)</enum><header>Waiver</header>
<clause id="idEE9C53D0C1DE40E0BE54F76D75E07BEC"><enum>(i)</enum><header>In
general</header><text>If the Secretary makes a determination described in
clause (ii), the Secretary may grant a waiver of the prohibition in
subparagraph (A) to permit a member described in such subparagraph to—</text>
<subclause id="ID56c7293393cf40f1850668a1d8d1b402"><enum>(I)</enum><text>participate as a
non-voting member with respect to a particular matter considered in a committee
meeting; or</text>
</subclause><subclause id="IDb3e09e66e5a6461a909f0d22c7d3fce6"><enum>(II)</enum><text>participate as a
voting member with respect to a particular matter considered in a committee
meeting.</text>
</subclause></clause><clause id="id68A0B4F774FF4C929FC44266CBFD3710"><enum>(ii)</enum><header>Determination</header><text>A
determination described under this clause may be based on 1 or both of the
following determinations:</text>
<subclause id="ID4c975a0d5151469da49b6357c1c88d53"><enum>(I)</enum><text>The need for the
services of the individual on the committee outweighs the potential for a
conflict of interest created by the financial interest involved.</text>
</subclause><subclause id="IDed886f7361af449aa3e0cb266904713d"><enum>(II)</enum><text>The financial
interest is not so substantial as to be deemed likely to affect the integrity
of the services provided by that
individual.</text>
</subclause></clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id650CA0375C664BEE8DBFA2DD9D6CCD7D"><enum>(C)</enum><text>by striking
subparagraph (C).</text>
</subparagraph></paragraph><paragraph id="idF25D03FDB8BA41BCB5E58F9E1267F7B3"><enum>(2)</enum><header>Patient group
representatives</header><text>Section 505(n)(3) (21 U.S.C. 355(n)(3)) is
amended—</text>
<subparagraph id="id21431072B45345E28887BB3794B92CBD"><enum>(A)</enum><text>in subparagraph
(C), by striking <quote>; and</quote> and inserting a semicolon;</text>
</subparagraph><subparagraph id="idC08110EC699D4413A6543730E76A5828"><enum>(B)</enum><text>in subparagraph
(D), by striking the period at the end and inserting <quote>; and</quote>;
and</text>
</subparagraph><subparagraph id="id670F4A918A4C4D9C90EB52F1A43FB4DA"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id22589AE1392F462BBEC50EC5B2096005" style="OLC">
<subparagraph id="IDc1436a889f8245ad9c680b9330f25e36"><enum>(E)</enum><text>2 or more members
who are medical or scientific experts selected from a pool of nominations
provided by patient advocacy or disease research organizations whose interests
are in the specific disease or diseases proposed to be treated by the drug
under
consideration.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="idFE6471F4BBB642F59999F74D02E73740"><enum>(3)</enum><header>Revised
regulations</header>
<subparagraph commented="no" id="id3FDF6A5B24DB43D0B93A094B41B10EC1"><enum>(A)</enum><header>In
general</header><text>The Secretary of Health and Human Services shall revise
and update the regulations of the Food and Drug Administration relating to the
application of the Federal Advisory Committee Act (5 U.S.C. App.) to reflect
updated understanding of the scope of such Act, as embodied in regulations of
the General Services Administration (as in effect on the date of enactment of
this Act) and case law.</text>
</subparagraph><subparagraph commented="no" id="idDEDF10F311D44D80A88C5442CB8E99F5"><enum>(B)</enum><header>Content</header><text>The
revised and updated regulations under subparagraph (A) shall explicitly
encourage officials of the Food and Drug Administration to utilize, to the
maximum extent possible, the flexibility and exceptions provided by the Federal
Advisory Committee Act to interact with stakeholder groups outside the confines
of the advisory committees of such Act, including patient advocacy
organizations, disease specialty societies, and others.</text>
</subparagraph></paragraph></subsection><subsection id="ID2d0bfc09f4154cda943d50527c142bb9"><enum>(b)</enum><header>Chief Medical
Policy Officers</header><text>Chapter X (21 U.S.C. 391 et seq.), as amended by
section 201, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idBF3AEB7243B24D118F0DD62E9FC98752" style="OLC">
<section id="id1D11DB132CB046AEB79EEEA64F1CB841"><enum>1014.</enum><header>Chief Medical
Policy Officers</header>
<subsection id="ID6fc0b93b707f4244bb5f86298ad429bb"><enum>(a)</enum><header>Establishment</header><text>The
Secretary shall establish an Office of the Chief Medical Policy Officer within
each of the following Offices of the Food and Drug Administration:</text>
<paragraph id="ID103ac10c651141d096e7d2419d0bf877"><enum>(1)</enum><text>The Office of the
Director of the Center for Drug Evaluation and Research.</text>
</paragraph><paragraph id="ID48311d0d03d1425f9c0f431cdc48007e"><enum>(2)</enum><text>The Office of the
Director of the Center for Biologics Evaluation and Research.</text>
</paragraph><paragraph commented="no" id="ID09c48415b1d54485b1fa96cd3a784e5a"><enum>(3)</enum><text>The Office of the
Director of the Center for Devices and Radiological Health.</text>
</paragraph></subsection><subsection id="id57064454D36947898AA0DEBC4C858ED1"><enum>(b)</enum><header>Selection</header><text>Each
Chief Medical Policy Officer shall be selected from the Senior Executive
Service by the Secretary.</text>
</subsection><subsection id="IDf25c5ad5cad54481ad1a99e04f5bb90f"><enum>(c)</enum><header>Duties</header><text>Each
Chief Medical Policy Officer shall—</text>
<paragraph id="ID263816a843f34239a0670d904629ddd0"><enum>(1)</enum><text>in coordination
with the Chief Innovation Officer, center Directors, and other Chief Medical
Policy Officers, develop proactive and consistent approaches for the centers
within the Food and Drug Administration and the divisions within such
Administration that review applications for drug or device approval to address
emerging medical and scientific policy issues bearing on new product review
processes, including by—</text>
<subparagraph id="ID9ba5fb5629a5456f8cddb77651d0dd1f"><enum>(A)</enum><text>advising on and
regularly reviewing the implementation of such approaches by such centers and
divisions; and</text>
</subparagraph><subparagraph id="ID217284e3e6fd4d3280c329bf2ed183e7"><enum>(B)</enum><text>implementing peer
learning programs to ensure the effective and consistent review and approval of
new drugs and devices, including the incorporation of new scientific and
regulatory approaches recommended by the Chief Innovation Officer under section
1013(b);</text>
</subparagraph></paragraph><paragraph id="ID7692c99e9f9e4a8f81b55d06f6fbbbfc"><enum>(2)</enum><text>in coordination
with the center Directors, sponsors, and relevant patient advocacy and disease
research organizations, promote earlier and improved utilization of advisory
committees throughout the drug and device development and review processes,
including at the investigational testing phase, and recommend as appropriate
the utilization of authorities by the Secretary under section 1007 in cases
where the ability to obtain sufficient external experts for such advisory
committees is limited;</text>
</paragraph><paragraph id="ID22be32f5d2514d429f1690410c1e19ab"><enum>(3)</enum><text>in coordination
with the Office of Special Medical Programs and appropriate Center medical and
scientific officers, improve reviewer access to external experts outside of the
advisory committee process, including utilization of authorities in section
1004;</text>
</paragraph><paragraph id="IDb93c69da4f064642b1aee3d9a4ee57c4"><enum>(4)</enum><text>periodically
solicit input from industry, academia, and patient advocacy and disease
research organizations on emerging scientific and medical policy issues bearing
on new product review processes, including clinical trial methodologies;
and</text>
</paragraph><paragraph id="IDc7cfd0391c554196b1517be72a788c6d"><enum>(5)</enum><text>coordinate with
the Chief Innovation Officer in the implementation of pilot programs under
section 1013(b).</text>
</paragraph></subsection><subsection commented="no" id="id301E35F0D715455EB6F1228F468EE8E2"><enum>(d)</enum><header>External
experts</header><text display-inline="yes-display-inline">When serving as
officers or employees of the United States, the experts described under
subsection (c)(3) shall be considered special government employees as defined
in section 202(a) of title 18, United States
Code.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>III</enum><header>Enabling
modernized patient-centric clinical development</header>
<section id="id546198B563BF47D1803CC3D2A9B0FED3"><enum>301.</enum><header>Enhancement of
accelerated patient access to new medical treatments</header>
<subsection id="id25E9603603DE4CACAEB2E594A613BCA9"><enum>(a)</enum><header>Findings; Sense
of Congress</header>
<paragraph id="id4B9E699945E34E9CAAB0042B80E471D9"><enum>(1)</enum><header>Findings</header><text>Congress
makes the following findings:</text>
<subparagraph id="ID8b06ecf8a5774ac59cfcd19f56f1a8ae"><enum>(A)</enum><text>The Food and Drug
Administration (referred to in this section as the <quote>FDA</quote>) serves a
critical role in helping to assure that new medicines are safe and effective.
Regulatory innovation is 1 element of the Nation’s strategy to address serious
and life-threatening diseases or conditions by promoting investment in and
development of innovative treatments for unmet medical needs.</text>
</subparagraph><subparagraph id="IDd843aa53e7ba4edda26a80c67ae94c45"><enum>(B)</enum><text>During the 2
decades following the establishment of the accelerated approval mechanism,
advances in medical sciences, including genomics, molecular biology, and
bioinformatics, have provided an unprecedented understanding of the underlying
biological mechanism and pathogenesis of disease. A new generation of modern,
targeted medicines is under development to treat serious and life-threatening
diseases, some applying drug development strategies based on biomarkers or
pharmacogenomics, predictive toxicology, clinical trial enrichment techniques,
and novel clinical trial designs, such as adaptive clinical trials.</text>
</subparagraph><subparagraph id="ID199d3f8ab85a43f5a45518d954b4a3f1"><enum>(C)</enum><text>As a result of
these remarkable scientific and medical advances, the FDA should be encouraged
to implement more broadly effective processes for the expedited development and
review of innovative new medicines intended to address unmet medical needs for
serious or life-threatening diseases or conditions, including those for rare
diseases or conditions, using a broad range of surrogate or clinical endpoints
and modern scientific tools earlier in the drug development cycle when
appropriate. This may result in fewer, smaller, or shorter clinical trials for
the intended patient population or targeted subpopulation without compromising
or altering the high standards of the FDA for the approval of drugs.</text>
</subparagraph><subparagraph id="ID4850b263b89f4f2f8a360b984a0b1d3e"><enum>(D)</enum><text>Patients benefit
from expedited access to safe and effective innovative therapies to treat unmet
medical needs for serious or life-threatening diseases or conditions.</text>
</subparagraph><subparagraph id="ID2947b9b1ebfa4c33afb4990a2c947a9a"><enum>(E)</enum><text>For these
reasons, the statutory authority in effect on the day before the date of
enactment of this Act governing expedited approval of drugs for serious or
life-threatening diseases or conditions should be amended in order to enhance
the authority of the FDA to consider appropriate scientific data, methods, and
tools, and to expedite development and access to novel treatments for patients
with a broad range of serious or life-threatening diseases or
conditions.</text>
</subparagraph></paragraph><paragraph id="idC9302FD150D8445E8301FDF81D9B959C"><enum>(2)</enum><header>Sense of
Congress</header><text>It is the sense of Congress that the Food and Drug
Administration should apply the accelerated approval and fast track provisions
set forth in section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356), as amended by this section, to the greatest extent possible to help
expedite the development and availability to patients of treatments for serious
or life-threatening diseases or conditions while maintaining appropriate safety
and effectiveness standards for such treatments.</text>
</paragraph></subsection><subsection id="idC6652EFA71744A3EA9D88092F22D1C63"><enum>(b)</enum><header>Expedited
approval of drugs for serious or life-Threatening diseases or
conditions</header><text>Section 506 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idE67B2E2906EC427E95DAA35C0BDD02C2" style="OLC">
<section id="idCD9480451A254EDFB8CBE652D84620F6"><enum>506.</enum><header>Expedited
approval of drugs for serious or life-threatening diseases or
conditions</header>
<subsection id="idC237C07D608E44D78E0E43773923825E"><enum>(a)</enum><header>Designation of
drug as fast track product</header>
<paragraph id="id749DD557C2DB4B7B890103BCF8ED7B21"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall,
at the request of the sponsor of a new drug, facilitate the development and
expedite the review of such drug if it is intended, whether alone or in
combination with one or more other drugs, for the treatment of a serious or
life-threatening disease or condition, and it demonstrates the potential to
address unmet medical needs for such a disease or condition. (In this section,
such a drug is referred to as a <quote>fast track product</quote>.)</text>
</paragraph><paragraph id="IDf252eb570dd74afb9810887ccbf242e3"><enum>(2)</enum><header>Request for
designation</header><text>The sponsor of a new drug may request the Secretary
to designate the drug as a fast track product. A request for the designation
may be made concurrently with, or at any time after, submission of an
application for the investigation of the drug under section 505(i) or section
351(a)(3) of the Public Health Service Act.</text>
</paragraph><paragraph id="ID984b3cfcc9a041e0bb19415ad1bf2091"><enum>(3)</enum><header>Designation</header><text>Within
60 calendar days after the receipt of a request under paragraph (2), the
Secretary shall determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the Secretary finds that the
drug meets the criteria, the Secretary shall designate the drug as a fast track
product and shall take such actions as are appropriate to expedite the
development and review of the application for approval of such product.</text>
</paragraph></subsection><subsection id="idBC75AD2A1F9E406DA9078D543BEDF21B"><enum>(b)</enum><header>Accelerated
approval of a drug for a serious or life-Threatening disease or condition,
including a fast track product</header>
<paragraph id="idA46FCF2291414A6D85D37080D1E9A3A6"><enum>(1)</enum><header>In
general</header>
<subparagraph id="id23F084F0ABEF4403814AB093A37E4ED3"><enum>(A)</enum><header>Accelerated
approval</header><text>The Secretary may approve an application for approval of
a product for a serious or life-threatening disease or condition, including a
fast track product, under section 505(c) or section 351(a) of the Public Health
Service Act upon a determination that the product has an effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit, or on a
clinical endpoint, including an endpoint that can be measured earlier than
irreversible morbidity or mortality, that is reasonably likely to predict an
effect on irreversible morbidity or mortality or other clinical benefit, taking
into account the severity or rarity of the condition and the availability of
alternative treatments. The approval described in the preceding sentence is
referred to in this section as <quote>accelerated approval</quote>.</text>
</subparagraph><subparagraph id="idA8B820E670D841389899F9A56E6672A9"><enum>(B)</enum><header>Evidence</header><text>The
evidence to support that an endpoint is reasonably likely to predict clinical
benefit under subparagraph (A) may include epidemiological, pathophysiological,
therapeutic or other evidence developed using biomarkers, for example, or other
scientific methods or tools.</text>
</subparagraph></paragraph><paragraph id="idDE597B668F7446A2B14A24F826F39438"><enum>(2)</enum><header>Limitation</header><text>Approval
of a product under this subsection may be subject to 1 or both of the following
requirements:</text>
<subparagraph id="IDd8850ce52e634ad0af4a57d4d19d3fa5"><enum>(A)</enum><text>That the sponsor
conduct appropriate post-approval studies to verify and describe the predicted
effect on irreversible morbidity or mortality or other clinical benefit.</text>
</subparagraph><subparagraph id="IDe45f3d51fd784e50af6d98f3c6bdd99e"><enum>(B)</enum><text>That the sponsor
submit copies of all promotional materials related to the product during the
preapproval review period and, following approval and for such period
thereafter as the Secretary determines to be appropriate, at least 30 days
prior to dissemination of the materials.</text>
</subparagraph></paragraph><paragraph id="id3CFC9F47B55B407A9CA5ED497B17B0DD"><enum>(3)</enum><header>Expedited
withdrawal of approval</header><text>The Secretary may withdraw approval of a
product approved under accelerated approval using expedited procedures (as
prescribed by the Secretary in regulations which shall include an opportunity
for an informal hearing) if—</text>
<subparagraph id="IDad1fc860e0e54f699ceccfa9e5ab8f8a"><enum>(A)</enum><text>the sponsor fails
to conduct any required post-approval study of the drug with due
diligence;</text>
</subparagraph><subparagraph id="ID48f0fed8277c455c9eafab4f348324df"><enum>(B)</enum><text>a study required
to verify and describe the predicted effect on irreversible morbidity or
mortality or other clinical benefit of the product fails to verify and describe
such effect or benefit;</text>
</subparagraph><subparagraph id="ID4ec84decfa244aee8acf742d852e3103"><enum>(C)</enum><text>other evidence
demonstrates that the product is not safe or effective under the conditions of
use; or</text>
</subparagraph><subparagraph id="ID9aeb9e5e7609431892feabf2d474a9b0"><enum>(D)</enum><text>the sponsor
disseminates false or misleading promotional materials with respect to the
product.</text>
</subparagraph></paragraph></subsection><subsection id="id12E4475CBBC84C95912559D39BB01D10"><enum>(c)</enum><header>Review of
incomplete applications for approval of a fast track product</header>
<paragraph id="idC6B33E0CD60B48B29D620F7D3787C578"><enum>(1)</enum><header>In
general</header><text>If the Secretary determines, after preliminary evaluation
of clinical data submitted by the sponsor, that a fast track product may be
effective, the Secretary shall evaluate for filing, and may commence review of
portions of, an application for the approval of the product before the sponsor
submits a complete application. The Secretary shall commence such review only
if the applicant—</text>
<subparagraph id="ID4b120e782844458da9476bcbf6031e7b"><enum>(A)</enum><text>provides a
schedule for submission of information necessary to make the application
complete; and</text>
</subparagraph><subparagraph id="ID55a23a2dc83648bfb56642fa64b751fa"><enum>(B)</enum><text>pays any fee that
may be required under section 736.</text>
</subparagraph></paragraph><paragraph id="id713103005A534B68885BF7F2BC66BE41"><enum>(2)</enum><header>Exception</header><text>Any
time period for review of human drug applications that has been agreed to by
the Secretary and that has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under section 736 to expedite
the drug development process and the review of human drug applications) shall
not apply to an application submitted under paragraph (1) until the date on
which the application is complete.</text>
</paragraph></subsection><subsection id="idBD5779746B61422A9C4BEE6B8F74F142"><enum>(d)</enum><header>Awareness
efforts</header><text>The Secretary shall—</text>
<paragraph id="IDa5dccd99fdd84f84a21480e7576509b5"><enum>(1)</enum><text>develop and
disseminate to physicians, patient organizations, pharmaceutical and
biotechnology companies, and other appropriate persons a description of the
provisions of this section applicable to accelerated approval and fast track
products; and</text>
</paragraph><paragraph id="IDe04a5d3e0cad4c12a48641824866f5f6"><enum>(2)</enum><text>establish a
program to encourage the development of surrogate and clinical endpoints,
including biomarkers, and other scientific methods and tools that can assist
the Secretary in determining whether the evidence submitted in an application
is reasonably likely to predict clinical benefit for serious or
life-threatening conditions for which significant unmet medical needs
exist.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id25A4D91E395D4209A68BFD6190913254"><enum>(c)</enum><header>Guidance;
amended regulations</header>
<paragraph id="id2250DB4AE0AF47AEBCF8731553671A96"><enum>(1)</enum><header>Draft
guidance</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 issue draft guidance to
implement the amendments made by this section. In developing such guidance, the
Secretary shall specifically consider issues arising under the accelerated
approval and fast track processes under section 506 of the Federal Food, Drug,
and Cosmetic Act, as amended by subsection (b), for drugs designated for a rare
disease or condition under section 526 of such Act (21 U.S.C. 360bb).</text>
</paragraph><paragraph id="id9CCEAAAE524C48D196D3C169F4F54A61"><enum>(2)</enum><header>Final
guidance</header><text>Not later than 1 year after the issuance of draft
guidance under paragraph (1), and after an opportunity for public comment, the
Secretary shall issue final guidance.</text>
</paragraph><paragraph id="idFA31A8BEAD714D879F0C220F8A49D73D"><enum>(3)</enum><header>Conforming
changes</header><text>The Secretary shall issue, as necessary, conforming
amendments to the applicable regulations under title 21, Code of Federal
Regulations, governing accelerated approval.</text>
</paragraph><paragraph id="idB9E73ABCAD644931BB611AA463E1ABE6"><enum>(4)</enum><header>No effect of
inaction on requests</header><text>If the Secretary fails to issue final
guidance or amended regulations as required by this subsection, such failure
shall not preclude the review of, or action on, a request for designation or an
application for approval submitted pursuant to section 506 of the Federal Food,
Drug, and Cosmetic Act, as amended by subsection (b).</text>
</paragraph></subsection><subsection id="id39AC1403DD044667AF7C5F60166165A8"><enum>(d)</enum><header>Independent
review</header><text>The Secretary may, in conjunction with other planned
reviews, contract with an independent entity with expertise in assessing the
quality and efficiency of biopharmaceutical development and regulatory review
programs to evaluate the Food and Drug Administration’s application of the
processes described in section 506 of the Federal Food, Drug, and Cosmetic Act,
as amended by subsection (b), and the impact of such processes on the
development and timely availability of innovative treatments for patients
suffering from serious or life-threatening conditions. Any such evaluation
shall include consultation with regulated industries, patient advocacy and
disease research foundations, and relevant academic medical centers.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idD71ECE9ABBD14F0180220B05C29400B7"><enum>(e)</enum><header>Construction</header><text>The
amendments made by this section to section 506(b) of the Federal Food, Drug,
and Cosmetic Act are intended to encourage the Secretary to utilize innovative
approaches to the assessment of products under accelerated approval while
maintaining appropriate safety and effectiveness standards for such
products.</text>
</subsection></section><section id="id343AF80BF9DE4720AF99DAC0C5244AE4"><enum>302.</enum><header>Electronic
health records</header><text display-inline="no-display-inline">Subchapter A of
chapter VII (21 U.S.C. 371 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="id8128C44D5B1B44CEB6B5FB8C9CC6745B" style="OLC">
<section id="idEFBC9F2C82F147AB9D06C92AE22E4B0D"><enum>715.</enum><header>Clinical
informatics coordinator</header>
<subsection id="id4F8D19B0EEB1404384E2043B0822C7AA"><enum>(a)</enum><header>In
general</header><text>The Secretary shall appoint, within the Office of the
Commissioner, a Clinical Informatics Coordinator.</text>
</subsection><subsection id="id69198EB9FF054FFEAAC0A124C8D5B9BF"><enum>(b)</enum><header>Duties</header><text>The
Clinical Informatics Coordinator shall—</text>
<paragraph id="id4EDE8B85201E4F769A345B993D2B4968"><enum>(1)</enum><text>develop a process
to validate the use of health information technology in clinical research and
encourage the use of new health information technologies in clinical research
protocols; and</text>
</paragraph><paragraph id="idD78702B5EC75462DA0451421F9FD4691"><enum>(2)</enum><text>establish pilot
programs to explore and evaluate the methods of incorporating emerging health
information technology to make the clinical research process more
efficient.</text>
</paragraph></subsection><subsection id="idBDF89D5F24E54B1E973DEC81CA3E1CFA"><enum>(c)</enum><header>Guidance</header><text>Not
later than 1 year after the conclusion of the pilot programs described in
subsection (b)(2), the Secretary shall issue guidance for the conduct of
clinical trials incorporating health information technology. The guidance shall
explain how the Food and Drug Administration will evaluate such information
when reviewing new drug and device
applications.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id8185EE3D488C4440A223369301F21146"><enum>303.</enum><header>Disclosure to
drug sponsors of reasons for non-approval of a new drug
application</header><text display-inline="no-display-inline">Section 505 (21
U.S.C. 355) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2709BE497A0E48A78C895627E2931D57" style="OLC">
<subsection id="id34D38D176E1E4D4193E56E4FCDFAE85E"><enum>(w)</enum><header>Notice of
reasons for denial of a new drug application</header><text>If the Secretary
denies approval of a new drug application under this section or of an
application with respect to a biological product under section 351 of the
Public Health Service Act, the Secretary shall provide to the sponsor of such
drug or biological product—</text>
<paragraph id="idB0E3EF7DDE894F10BDD18659810D16F6"><enum>(1)</enum><text>a written
explanation of the reasons for denying such application, including an
explanation of the specific reasons the Secretary determines that—</text>
<subparagraph id="ID14e1ab5053424ce384bf9c454384acc7"><enum>(A)</enum><text>the data
submitted in the application are inadequate to support approval of the drug or
biological product; and</text>
</subparagraph><subparagraph id="ID6eb42adfb93e4fd4aaeb86db8743e9f1"><enum>(B)</enum><text>labeling, risk
evaluation and mitigation strategies under section 505–1, or postapproval
studies or trials are inadequate to support a determination that the benefits
of approval outweigh the risks; and</text>
</subparagraph></paragraph><paragraph id="IDf069d64f3ec042f78053e5fc1df15d04"><enum>(2)</enum><text>to the extent
practicable, an explanation of what data will be required and what endpoints
will need to be met in order to obtain
approval.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section>