1.This Act may be cited as
the Enhancing Drug Safety and
Innovation Act of 2007
.
<enum>I</enum><header>Risk
evaluation and mitigation strategies</header>
<section id="idEE4B3C28D3C144459C9B4F58B9135AC9"><enum>101.</enum><header>Risk
evaluation and mitigation strategies</header><text display-inline="no-display-inline">Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id9A9767E9F02F422B8EC1A75B185C81BF" style="OLC">
<subsection id="IDe0c06a1b727941a7bd7a5e1591f57122"><enum>(o)</enum><header>Risk evaluation
and mitigation strategy</header>
<paragraph id="IDc71bdad65fdc44fa9305f2d12c338d76"><enum>(1)</enum><header>In
general</header><text>In the case of any drug subject to subsection (b) or to
section 351 of the Public Health Service Act for which a risk evaluation and
mitigation strategy is approved as provided for in this subsection, the
applicant shall comply with the requirements of such strategy.</text>
</paragraph><paragraph id="id34578621FF154279A3B468B5941AF17A"><enum>(2)</enum><header>Definitions</header><text>In
this subsection:</text>
<subparagraph id="id1C40856A159842BF822A5937200E32E2"><enum>(A)</enum><header>Adverse drug
experience</header><text>The term <quote>adverse drug experience</quote> means
any adverse event associated with the use of a drug in humans, whether or not
considered drug related, including—</text>
<clause id="ID4f022740dee14691a768b2f8822bdbef"><enum>(i)</enum><text>an adverse event
occurring in the course of the use of the drug in professional practice;</text>
</clause><clause id="ID458638aac1e14219bc444b7a00062208"><enum>(ii)</enum><text>an adverse event
occurring from an overdose of the drug, whether accidental or
intentional;</text>
</clause><clause id="IDeabfe5e4d2fb4da8ba66828f9af1cbda"><enum>(iii)</enum><text>an adverse
event occurring from abuse of the drug;</text>
</clause><clause id="ID765a27bb52a24af7a39062aec4d3da2b"><enum>(iv)</enum><text>an adverse event
occurring from withdrawal of the drug; and</text>
</clause><clause id="ID7a99d93cf5084dbcbbf4b1e870aafc89"><enum>(v)</enum><text>any failure of
expected pharmacological action of the drug.</text>
</clause></subparagraph><subparagraph id="idFFD2B642590D46A2902366F11DCBD605"><enum>(B)</enum><header>Serious adverse
drug experience</header><text>The term <quote>serious adverse drug
experience</quote> is an adverse event that—</text>
<clause id="ID43f3d3ac4d534d019d39f6f8abd7fcb3"><enum>(i)</enum><text>results
in—</text>
<subclause id="IDd430e7dd63b94945941d669eefcb33b1"><enum>(I)</enum><text>death;</text>
</subclause><subclause id="IDd2e6688a63bd463c8d54e7ca272bdf84"><enum>(II)</enum><text>a adverse drug
experience that places the patient at immediate risk of death from the adverse
drug experience as it occurred (not including an adverse drug experience that
might have caused death had it occurred in a more severe form);</text>
</subclause><subclause id="ID61241dccd6b343b0a6ad7f813e457429"><enum>(III)</enum><text>inpatient
hospitalization or prolongation of existing hospitalization;</text>
</subclause><subclause id="IDf8b10d4c6fbd400bbd1bea524050a589"><enum>(IV)</enum><text>a persistent or
significant incapacity or substantial disruption of the ability to conduct
normal life functions; or</text>
</subclause><subclause id="IDf3ecb15389bc4e29aadc674c9f902d82"><enum>(V)</enum><text>a congenital
anomaly or birth defect; or</text>
</subclause></clause><clause id="IDfce1021ac1d1489d93a74c1cf25cc8f1"><enum>(ii)</enum><text>based on
appropriate medical judgment, may jeopardize the patient and may require a
medical or surgical intervention to prevent an outcome described under clause
(i).</text>
</clause></subparagraph><subparagraph id="id4E6DD21D5A154C3FB67A0301622DE054"><enum>(C)</enum><header>Serious
risk</header><text>The term <term>serious risk</term> means a risk of a serious
adverse drug experience.</text>
</subparagraph><subparagraph id="id388090585E4C491C868C6C7B981AF5F8"><enum>(D)</enum><header>Unexpected
serious risk</header><text>The term <term>unexpected serious risk</term> means
a serious adverse drug experience that is not listed in the labeling of a drug,
or that may be symptomatically and pathophysiologically related to an adverse
drug experience identified in the labeling, but differs from such adverse drug
experience because of greater severity, specificity, or prevalence.</text>
</subparagraph><subparagraph id="idFD18F20683C14DEFAC41EFD6FAF53421"><enum>(E)</enum><header>Signal of a
serious risk</header><text>The term <term>signal of a serious risk</term> means
information related to a serious adverse drug experience associated with use of
a drug and derived from—</text>
<clause id="id7AD432BFA6194D0E9055BFED4EE82D95"><enum>(i)</enum><text>a
clinical trial;</text>
</clause><clause id="id29CBDFE79F904B43B98E6DEC52D3E8C9"><enum>(ii)</enum><text>adverse event
reports;</text>
</clause><clause id="id29EA0B9D887A449394DE61F636F05EB5"><enum>(iii)</enum><text>a post-approval
study, including a study under paragraph (4)(D); or</text>
</clause><clause id="id2D4FB4B0380648DA95CED2D538EA34A5"><enum>(iv)</enum><text>peer-reviewed
biomedical literature.</text>
</clause></subparagraph><subparagraph id="id077666A247E04A3BB68374BF9DD7AB68"><enum>(F)</enum><header>New safety
information</header><text>The term <term>new safety information</term> with
respect to a drug means information about—</text>
<clause id="idDBD898750A6943B48B176D5FE820F6FD"><enum>(i)</enum><text>a
serious risk or an unexpected serious risk associated with use of the drug that
the Secretary has become aware of since the last assessment of the approved
risk evaluation and mitigation strategy for the drug; or</text>
</clause><clause id="idDAE6C58B1EC440FA8EB3E2572747BEC6"><enum>(ii)</enum><text>the
effectiveness of the approved risk evaluation and mitigation strategy for the
drug obtained since the last assessment of such strategy.</text>
</clause></subparagraph></paragraph><paragraph id="IDe9cb4337e340439c87d32a6b35d16417"><enum>(3)</enum><header>Required
elements of a risk evaluation and mitigation strategy</header><text>The risk
evaluation and mitigation strategy for a drug shall require—</text>
<subparagraph id="ID42e8a7e813634514b4ccf4254d69ec5c"><enum>(A)</enum><text>labeling for the
drug for use by health care providers as approved under subsection (c);</text>
</subparagraph><subparagraph id="ID9d89dcd58df04014b5d8ee02fc0511ba"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id067120806C7145B195B81582F87EF4B5"><enum>(i)</enum><text>submission of reports
for the drug as required under subsection (k); and</text>
</clause><clause id="id04B437D92D8E4E92821E76E3F77E3F11" indent="up1"><enum>(ii)</enum><text>for a drug that is a
vaccine—</text>
<subclause id="id762E1F7FF8BE407A801DD6A25BEED18E"><enum>(I)</enum><text>analysis of reports to the Vaccine
Adverse Event Reporting Systems (VAERS); or</text>
</subclause><subclause id="idE756A155071141C3B45AAF6982EF2B31"><enum>(II)</enum><text>surveillance using the Vaccine Safety
Datalink (VSD) or successor databases;</text>
</subclause></clause></subparagraph><subparagraph id="ID2bd8743c37624e5885c0a087bb6d6c1b"><enum>(C)</enum><text>a
pharmacovigilance statement—</text>
<clause id="idEAF2653B4ADC4469A4E5CDC9FBC1C85A"><enum>(i)</enum><text>as to whether the
reports under subparagraph (B)(i) or, for a vaccine, the analysis and
surveillance under subparagraph (B)(ii), and the periodic assessment under
subparagraph (E), are sufficient to assess the serious risks and to identify
unexpected serious risks of the drug; and</text>
</clause><clause commented="no" id="id2A33BAD92DD943E692DD756E47EA8FAC"><enum>(ii)</enum><text>if such reports,
such analysis and surveillance, and such periodic assessment are not sufficient
to assess the serious risks and to identify unexpected serious risks of the
drug, that describes what study or studies of the drug are required under
paragraph (4)(D) or what clinical trial or trials of the drug are required
under paragraph (4)(E);</text>
</clause></subparagraph><subparagraph id="id612DB11DCE9E4CB3A5BEFC9A0C3320B9"><enum>(D)</enum><text>a justification
for the pharmacovigilance statement in subparagraph (C) that takes into
consideration—</text>
<clause id="ID4a89ce7f338241c88ce99e7dc2078afc"><enum>(i)</enum><text>the estimated
size of the treatment population for the drug;</text>
</clause><clause id="ID3f47a6ca5d2b4efe9d5a0dd127da0df8"><enum>(ii)</enum><text>the seriousness
of the disease or condition that the drug is used to treat or prevent;</text>
</clause><clause id="ID22e75bbe0c9e40e7b58be33061d0740f"><enum>(iii)</enum><text>the expected or
actual duration of treatment with the drug;</text>
</clause><clause id="IDd38628c285cd49189c3316199a9a03d7"><enum>(iv)</enum><text>the availability
and safety of a drug or other treatment, if any, for such disease or condition
to which the safety of the drug may be compared; and</text>
</clause><clause id="IDd96d9d46f0ad451fa0f3d254914352ae"><enum>(v)</enum><text>the seriousness
of the risk at issue and its background incidence in the population; and</text>
</clause></subparagraph><subparagraph id="IDadc925b2a4094f1cb837e8f0675c90c4"><enum>(E)</enum><text>a timetable for
submission of assessments of the strategy, that—</text>
<clause id="id16C8E860E1714D9FAB3992D6B742B69D"><enum>(i)</enum><text>shall be no less
frequently than once annually for the first 3 years after the drug is initially
approved under subsection (c) or licensed under section 351 of the Public
Health Service Act, and at a frequency specified in the strategy for subsequent
years;</text>
</clause><clause id="id3C32B0AE5EDD49499A894FB6F99198E3"><enum>(ii)</enum><text>may be increased
or reduced in frequency as necessary as provided for in paragraph
(6)(B)(iv)(VI) ; and</text>
</clause><clause id="id409A2ACAFFD643ADB32943673D4815AA"><enum>(iii)</enum><text>may be
eliminated after the first 3 years if the Secretary determines that serious
risks of the drug have been adequately identified and assessed and are being
adequately managed.</text>
</clause></subparagraph></paragraph><paragraph id="ID644016f70183429d9ee6b200256ed610"><enum>(4)</enum><header>Additional
potential elements of a risk evaluation and mitigation strategy</header>
<subparagraph id="id2AE099855DE94EFA9B1075DB2FAD8FDE"><enum>(A)</enum><header>In
general</header><text>The Secretary may require that the risk evaluation and
mitigation strategy for a drug include 1 or more of the additional elements
described in this paragraph, so long as the Secretary makes the determination
required with respect to each additional included element.</text>
</subparagraph><subparagraph id="ID1325e24649fa48c5a25bfa8c63faf916"><enum>(B)</enum><header>Medguide;
patient package insert</header><text>The risk evaluation and mitigation
strategy for a drug may require that the applicant develop for distribution to
each patient when the drug is dispensed—</text>
<clause id="idF7197FF3853D4D5290BE54727B4FFD4D"><enum>(i)</enum><text>a
Medication Guide, as provided for under part 208 of title 21, Code of Federal
Regulations (or any successor regulations); or</text>
</clause><clause id="idBD7C72BE3A1D4564A8E799C50E99120B"><enum>(ii)</enum><text>a patient
package insert, if the Secretary determines that such insert may help mitigate
a serious risk of the drug.</text>
</clause></subparagraph><subparagraph id="ID64afebc7c88f4d5d92edf242fea66dee"><enum>(C)</enum><header>Communication
plan</header><text>The risk evaluation and mitigation strategy for a drug may
require that the applicant conduct a communication plan to health care
providers, if, with respect to such drug, the Secretary determines that such
plan may support implementation of an element of the strategy. Such plan may
include—</text>
<clause id="IDa84aa47b8c98492cac227457a8031aab"><enum>(i)</enum><text>sending letters
to health care providers;</text>
</clause><clause id="ID4e5e879ea12d4cdfae86b04a740d6322"><enum>(ii)</enum><text>disseminating
information about the elements of the risk evaluation and mitigation strategy
to encourage implementation by health care providers of components that apply
to such health care providers, or to explain certain safety protocols (such as
medical monitoring by periodic laboratory tests); or</text>
</clause><clause id="ID0f4fed423e8e43489b4b1cef8c260ac8"><enum>(iii)</enum><text>disseminating
information to health care providers through professional societies about any
serious risks of the drug and any protocol to assure safe use.</text>
</clause></subparagraph><subparagraph id="ID608509d9f39e421dbc0ddb0b38976362"><enum>(D)</enum><header>Post-approval
studies</header><text>The risk evaluation and mitigation strategy for a drug
may require that the applicant conduct, or provide that the Secretary will
conduct, an appropriate post-approval study, such as a prospective or
retrospective observational study (including through the systematic use of
established health care networks and databases), of the drug (with a target
schedule for completing the study and reporting the results to the Secretary),
if the Secretary determines the reports, analysis and surveillance, and
periodic assessments referred to in paragraph (3)(C) are not sufficient
to—</text>
<clause id="id6200B69434D547878F54004C0EFEB3EC"><enum>(i)</enum><text>assess a signal
of a serious risk with use of the drug; or</text>
</clause><clause id="idAEE743BF0572450B8921B1BCDC5B4730"><enum>(ii)</enum><text>identify
unexpected serious risks in domestic populations who use the drug, including
populations not included in studies used to approve the drug (such as older
people, people with comorbidities, pregnant women, or children).</text>
</clause></subparagraph><subparagraph id="ID86286c0ac22d444fa4940afcb599d8e1"><enum>(E)</enum><header>Post-approval
clinical trials</header><text>The risk evaluation and mitigation strategy for a
drug may require that the applicant for a drug for which there is no effective
approved application under subsection (j) of this section as of the date that
the requirement is first imposed conduct an appropriate post-approval clinical
trial of the drug (with a target schedule for completing the clinical trial and
reporting the results to the Secretary) to be included in the clinical trial
registry database and clinical trial results database provided for under
section 402(i) of the Public Health Service Act, if the Secretary determines
that a study or studies under subparagraph (D) will likely be inadequate to
assess a signal of a serious risk with use of the drug.</text>
</subparagraph><subparagraph commented="no" id="IDcf998ecf17894160bb7bdbc83193efc0"><enum>(F)</enum><header>Preclearance</header>
<clause commented="no" id="idAE7199DECB7843CE9767BA1D59AF4015"><enum>(i)</enum><header>In
general</header><text>The risk evaluation and mitigation strategy for a drug
may require that the applicant submit to the Secretary advertisements of the
drug for preclearance, if the Secretary determines that such preclearance is
necessary to ensure compliance with section 502(n) with respect to the
disclosure of information about a serious risk listed in the labeling of the
drug. The advertisements required to be submitted under the preceding sentence
shall be reviewed and cleared by the Secretary within 45 days of
submission.</text>
</clause><clause commented="no" id="id05450089910B46E2A1F4669005AA1A56"><enum>(ii)</enum><header>Specification
of advertisements</header><text>The Secretary may specify the advertisements
required to be submitted under clause (i).</text>
</clause></subparagraph><subparagraph commented="no" id="ID690f70e393df4dcca95fa4b4ffc1ebcb"><enum>(G)</enum><header>Specific
disclosures</header>
<clause commented="no" id="id2E685D7EAF8E46878AED189E5BEF0758"><enum>(i)</enum><header>In
general</header><text>The risk evaluation and mitigation strategy for a drug
may require that the applicant include in advertisements of the drug a specific
disclosure—</text>
<subclause commented="no" id="IDfe1e0c6e27c14737b28de931665956d9"><enum>(I)</enum><text>of the date the
drug was approved and that the existing information may not have identified or
allowed for full assessment of all serious risks of using the drug, if the
Secretary determines that such disclosure is necessary to protect public health
and safety; or</text>
</subclause><subclause commented="no" id="ID1dd1e91f70974683a0350b08b689aaaa"><enum>(II)</enum><text>about a serious
adverse event listed in the labeling of the drug or a protocol to ensure safe
use described in the labeling of the drug, if the Secretary determines that
such advertisements lacking such disclosure would be false or
misleading.</text>
</subclause></clause><clause commented="no" id="id84A0AC529FE64D3EA061F30A348A846D"><enum>(ii)</enum><header>Specification
of advertisements</header><text>The Secretary may specify the advertisements
required to include a specific disclosure under clause (i).</text>
</clause></subparagraph><subparagraph id="ID408f729b11014c6f85df524bd291f59b"><enum>(H)</enum><header>Temporary
moratorium</header><text>The risk evaluation and mitigation strategy for a drug
may require that for a fixed period after initial approval, not to exceed 2
years, the applicant not issue or cause to be issued direct-to-consumer
advertisements of the drug, if the Secretary determines that disclosure under
subparagraph (G) is inadequate to protect public health and safety, and that
such prohibition is necessary to protect public health and safety while
additional information about serious risks of the drug is collected,
considering—</text>
<clause id="ID1fc0f847bfe646acb7531c9c418e4def"><enum>(i)</enum><text>the number of
patients who may be treated with the drug;</text>
</clause><clause id="ID1c9f71277c2d41e9a7d6214e090a7900"><enum>(ii)</enum><text>the seriousness
of the condition for which the drug will be used;</text>
</clause><clause id="ID7dfc57340b2a4f4d96d01ffe97db025b"><enum>(iii)</enum><text>the serious
adverse events listed in the labeling of the drug;</text>
</clause><clause id="ID861f3466b3724695a27daf8168c26289"><enum>(iv)</enum><text>the extent to
which patients have access to other approved drugs in the pharmacological class
of the drug and with the same intended use as the drug; and</text>
</clause><clause id="ID630f82e7309f44e0848f9c571f2b380b"><enum>(v)</enum><text>the extent to
which clinical trials used to approve the drug may not have identified serious
risks that might occur among patients expected to be treated with the
drug.</text>
</clause></subparagraph></paragraph><paragraph id="IDf8deb1edfac8447d8c522143a7bf4ba0"><enum>(5)</enum><header>Restrictions on
distribution or use</header>
<subparagraph id="ID128e27d728aa4702ba0db5eb406ae249"><enum>(A)</enum><header>In
general</header><text>If the Secretary determines that a drug shown to be
effective can be safely used only if distribution or use of such drug is
restricted, the Secretary may require as elements of the risk evaluation and
mitigation strategy such restrictions on distribution or use as are needed to
assure safe use of the drug.</text>
</subparagraph><subparagraph id="idAC0B8B0AEE8841C7BC76FB47DE31B55B"><enum>(B)</enum><header>Limits on
restrictions</header><text>Such restrictions under subparagraph (A)
shall—</text>
<clause id="ID706ddadf0ff648b58f5bc50f8e8bf591"><enum>(i)</enum><text>be commensurate
with the specific risk presented by the drug;</text>
</clause><clause id="IDd78e629fda3c4026aa8a4c36d65ec0d5"><enum>(ii)</enum><text>not be unduly
burdensome on patient access to the drug, particularly for patients with
serious or life-threatening diseases or conditions; and</text>
</clause><clause id="id4C9D562272D24185A57BAE75515A7764"><enum>(iii)</enum><text>to the extent
practicable, conform with restrictions on distribution or use for other drugs
with similar risks, so as to minimize the burden on the health care delivery
system.</text>
</clause></subparagraph><subparagraph id="ID0cdd64cb72da418d8d1f5ee6e49143df"><enum>(C)</enum><header>Elements</header><text>The
restrictions on distribution or use described under subparagraph (A) shall
include 1 or more goals to evaluate or mitigate a serious risk listed in the
labeling of the drug and may require that—</text>
<clause id="ID2a2bf2d99be043a2875583adce0787ca"><enum>(i)</enum><text>health care
providers that prescribe the drug have special training or experience, or are
specially certified;</text>
</clause><clause id="IDcbb2c6a726be40aeac3c4f91e1f3d62d"><enum>(ii)</enum><text>pharmacies,
practitioners, or health care settings that dispense the drug are specially
certified;</text>
</clause><clause id="idF543A067E2BC47549118548F0D58B4C6"><enum>(iii)</enum><text>the drug be
dispensed to patients only in certain health care settings, such as
hospitals;</text>
</clause><clause id="ID13fc205f973146f0b3adb22ba3bb5d1b"><enum>(iv)</enum><text>the drug be
dispensed to patients with evidence or other documentation of safe-use
conditions, such as laboratory test results;</text>
</clause><clause id="ID715a9e697def4024b4c70c07c893b326"><enum>(v)</enum><text>each patient
using the drug be subject to certain monitoring; or</text>
</clause><clause id="ID8584fe7578e7425c9d9fca9a44f987a1"><enum>(vi)</enum><text>each patient
using the drug be enrolled in a registry.</text>
</clause></subparagraph><subparagraph id="ID4782eb8ecbf840d4acbe24217ab59417"><enum>(D)</enum><header>Implementation
System</header><text>The restrictions on distribution or use described under
subparagraph (A) may require a system through which the applicant is able
to—</text>
<clause id="ID384ce8d9e87b4701bb34022c2bd364d2"><enum>(i)</enum><text>monitor and
evaluate implementation of the restrictions by health care providers,
pharmacists, patients, and other parties in the health care system who are
responsible for implementing the restrictions;</text>
</clause><clause id="ID06833534aebb437c80610593b053159c"><enum>(ii)</enum><text>work to improve
implementation of the restrictions by health care providers, pharmacists,
patients, and other parties in the health care system who are responsible for
implementing the restrictions; and</text>
</clause><clause id="ID9076bc97c12f4c66abb4fb276b2b036c"><enum>(iii)</enum><text>stop
distribution of the drug to those health care providers, pharmacists, and other
parties in the health care system—</text>
<subclause id="IDe8cdeb421e4544e6ac801319c0a52f77"><enum>(I)</enum><text>who are
responsible for implementing the restrictions; and</text>
</subclause><subclause id="IDbd72b9cae95b40dda5784448ff1d9293"><enum>(II)</enum><text>whom the
applicant knows have failed to meet their responsibilities for implementing the
restrictions, after the applicant has informed such party of such failure and
such party has not remedied such failure.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="IDd5e980aaaadd4be69fec07bc42bb4cb9"><enum>(6)</enum><header>Submission and
review of risk evaluation and mitigation strategy</header>
<subparagraph id="ID815903c63aa84a348d611bd3a2884b4f"><enum>(A)</enum><header>Proposed risk
evaluation and mitigation strategy</header>
<clause id="idFCCA520A4A204A408C4417BCA11EF42A"><enum>(i)</enum><header>Initial
approval</header><text>An applicant shall include a proposed risk evaluation
and mitigation strategy in an application under subsection (b) or section 351
of the Public Health Service Act for initial approval of the drug.</text>
</clause><clause id="id5F4B00C71A424A3186EC77A8FC7AB713"><enum>(ii)</enum><header>Approval of
new indication</header><text>If no risk evaluation and mitigation strategy for
the drug is in effect under this subsection and the drug may not be dispensed
without a prescription, the applicant shall include a proposed risk evaluation
and mitigation strategy in an application, including in a supplemental
application, seeking a new indication for such drug.</text>
</clause><clause id="idE7766FF63D474C96BA23208A076030E2"><enum>(iii)</enum><header>Contents</header><text>A
proposed risk evaluation and mitigation strategy—</text>
<subclause id="ID726a765daf334185a2d7cd9c04017319"><enum>(I)</enum><text>shall include the
minimal elements required under paragraph (3); and</text>
</subclause><subclause id="ID3ebecdf83553464ca8675dd8ac1b55b4"><enum>(II)</enum><text>may also include
additional elements as provided for under paragraphs (4) and (5).</text>
</subclause></clause></subparagraph><subparagraph id="ID8dc86c12239e4f84bc26f2e6a42ae916"><enum>(B)</enum><header>Assessment and
modification of a risk evaluation and mitigation strategy</header>
<clause id="ID1fe422aee12d498da9ad705b0dd31fad"><enum>(i)</enum><header>Voluntary
assessments</header><text>The applicant may submit to the Secretary an
assessment of, and propose a modification to, the approved risk evaluation and
mitigation strategy for a drug at any time.</text>
</clause><clause id="id41D0B07C25F945419A1242CE87660DE3"><enum>(ii)</enum><header>Required
assessments</header><text>The applicant shall submit an assessment of, and may
propose a modification to, the approved risk evaluation and mitigation strategy
for a drug—</text>
<subclause id="ID571009b91e8e49b195205d8f040ed1f7"><enum>(I)</enum><text>when submitting a
supplemental application for a new indication under subsection (b) or section
351 of the Public Health Service Act, unless the drug may be dispensed without
a prescription and the risk evaluation and mitigation strategy for the drug
includes only the elements under paragraph (3);</text>
</subclause><subclause id="IDafdf4bdb9ddb4e108d79c2f5c206922f"><enum>(II)</enum><text>when required by
the strategy, as provided for in the timetable under paragraph (3)(E);</text>
</subclause><subclause id="IDfa20c66a6fd64884bd132e47111795fc"><enum>(III)</enum><text>within a time
specified by the Secretary, not to be less than 45 days, when ordered by the
Secretary, if the Secretary determines that new safety information indicates
that an element under paragraph (3) or (4) should be modified or included in
the strategy;</text>
</subclause><subclause id="IDdc990b6d449d4776847e629e387e1c90"><enum>(IV)</enum><text>within 90 days
when ordered by the Secretary, if the Secretary determines that new safety
information indicates that an element under paragraph (5) should be modified or
included in the strategy; or</text>
</subclause><subclause id="ID3480a88abea34310a47da7bc8272ddcf"><enum>(V)</enum><text>within 15 days
when ordered by the Secretary, if the Secretary determines that there may be a
cause for action by the Secretary under subsection (e).</text>
</subclause></clause><clause id="IDeeb2cfd03e5e4cee87302eb8249b7edc"><enum>(iii)</enum><header>Assessment</header><text>An
assessment of the approved risk evaluation and mitigation strategy for a drug
shall include—</text>
<subclause id="IDe47b8ab46f1b4313a049edd6013ddd05"><enum>(I)</enum><text>with respect to
any goal under paragraph (5), an assessment of how well the restrictions on
distribution or use are meeting the goal or whether the goal or such
restrictions should be modified;</text>
</subclause><subclause id="IDed98c26a691744b4a2574015e27e2d06"><enum>(II)</enum><text>with respect to
any post-approval study required under paragraph (4)(D), the status of such
study, including whether any difficulties completing the study have been
encountered; and</text>
</subclause><subclause id="IDa3bfb45ee0934b15b57b4db1828ddf19"><enum>(III)</enum><text>with respect to
any post-approval clinical trial required under paragraph (4)(E), the status of
such clinical trial, including whether enrollment has begun, the number of
participants enrolled, the expected completion date, whether any difficulties
completing the clinical trial have been encountered, and registration
information with respect to requirements under section 402(i) of the Public
Health Service Act.</text>
</subclause></clause><clause commented="no" id="IDfe6f980041ca49ba9b6454ad55aa9420"><enum>(iv)</enum><header>Modification</header><text>A
modification (whether an enhancement or a reduction) to the approved risk
evaluation and mitigation strategy for a drug may include the addition or
modification of any element under subparagraph (A), (C), or (D) of paragraph
(3) or the addition, modification, or removal of any element under paragraph
(4) or (5), such as—</text>
<subclause commented="no" id="ID6c01aae6812741eea9b7ae905150bb37"><enum>(I)</enum><text>a labeling
change, including the addition of a boxed warning;</text>
</subclause><subclause commented="no" id="IDd65ed8fc78f742f08d83cf29f992a0f9"><enum>(II)</enum><text>adding a
post-approval study or clinical trial requirement;</text>
</subclause><subclause commented="no" id="ID5e6dc422eede43378c1ff904ae7b7ee3"><enum>(III)</enum><text>modifying a
post-approval study or clinical trial requirement (such as a change in trial
design due to legitimate difficulties recruiting participants);</text>
</subclause><subclause commented="no" id="id5FF7B55C3CC046F5A0A1A0097CD943E1"><enum>(IV)</enum><text>adding,
modifying, or removing a restriction on advertising under subparagraph (F),
(G), or (H) of paragraph (4);</text>
</subclause><subclause commented="no" id="ID4d86898141304a7397d20ca6112e6e90"><enum>(V)</enum><text>adding,
modifying, or removing a restriction on distribution or use under paragraph
(5); or</text>
</subclause><subclause id="IDebf88ea72ace418ba06ad33cbbdb4d92"><enum>(VI)</enum><text>modifying the
timetable for assessments of the strategy under paragraph (3)(E), including to
eliminate assessments.</text>
</subclause></clause></subparagraph><subparagraph id="ID4587ed59bb5a441687fe9ef2ce251d15"><enum>(C)</enum><header>Review</header><text>The
Secretary shall promptly review the proposed risk evaluation and mitigation
strategy for a drug submitted under subparagraph (A), or an assessment of the
approved risk evaluation and mitigation strategy for a drug submitted under
subparagraph (B).</text>
</subparagraph><subparagraph id="ID9464812f80b44514882bfe7e9e735c78"><enum>(D)</enum><header>Discussion</header><text>The
Secretary shall initiate discussions of the proposed risk evaluation and
mitigation strategy for a drug submitted under subparagraph (A), or of an
assessment of the approved risk evaluation and mitigation strategy for a drug
submitted under subparagraph (B), with the applicant to determine a
strategy—</text>
<clause id="ID8800787036164883bc0a662b22ea2ab5"><enum>(i)</enum><text>if the proposed
strategy or assessment is submitted as part of an application or supplemental
application under subparagraph (A) or (B)(ii)(I), not less than 60 days before
the action deadline for the application 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);</text>
</clause><clause id="IDdc944a00a2be4b0d8f43a56edbc09c7e"><enum>(ii)</enum><text>if the
assessment is submitted under subclause (II) or (III) of subparagraph (B)(ii),
not later than 20 days after such submission;</text>
</clause><clause id="IDac858340ea4b4f0d83268168cdb73190"><enum>(iii)</enum><text>if the
assessment is submitted under subparagraph (B)(i) or under subparagraph
(B)(ii)(IV), not later than 30 days after such submission; or</text>
</clause><clause id="ID339554957bff408485fb9663d7f61323"><enum>(iv)</enum><text>if the
assessment is submitted under subparagraph (B)(ii)(V), not later than 10 days
after such submission.</text>
</clause></subparagraph><subparagraph id="ID01fe9c1d15fd4140a38ec93fc1ad64e8"><enum>(E)</enum><header>Action</header>
<clause id="id192DDFA12A8446F2B719740E5D7895F5"><enum>(i)</enum><header>In
general</header><text>Unless the applicant requests the dispute resolution
process described under subparagraph (F), the Secretary shall approve and
describe the risk evaluation and mitigation strategy for a drug, or any
modification to the strategy—</text>
<subclause id="id92D4936DEBF846A2B7BB372C9A9DEF5A"><enum>(I)</enum><text>as part of the
action letter on the application, when a proposed strategy is submitted under
subparagraph (A) or an assessment of the strategy is submitted under
subparagraph (B)(ii)(I); or</text>
</subclause><subclause id="idBC7EF546B9AF4107AE90348A9C9F8E80"><enum>(II)</enum><text>in an order,
which shall be made public, issued not later than 50 days after the date
discussions of such modification begin under subparagraph (C), when an
assessment of the strategy is under subparagraph (B)(i) or under subclause
(II), (III), (IV), or (V) of subparagraph (B)(ii).</text>
</subclause></clause><clause id="idBC2CBA3B0C7E4402BEF70F9938107EDE"><enum>(ii)</enum><header>Inaction</header><text>An
approved risk evaluation and mitigation strategy shall remain in effect until
the Secretary acts, if the Secretary fails to act as provided under clause
(i).</text>
</clause></subparagraph><subparagraph id="ID33803b9e0b324311afa8a9a2dc49fc31"><enum>(F)</enum><header>Dispute
resolution</header>
<clause id="ID2138d1a9eccd4336815fd76060aec096"><enum>(i)</enum><header>Request for
review</header><text>Not earlier than 15 days, and not later than 35 days,
after discussions under subparagraph (D) have begun, the applicant may request
in writing that a dispute about the strategy be reviewed by the Drug Safety
Oversight Board.</text>
</clause><clause id="ID703e7bb8896a4ade8e0760560eeb2201"><enum>(ii)</enum><header>Scheduling
review</header><text>If the applicant requests review under clause (i), the
Secretary—</text>
<subclause id="idD583FE338D63424F82DA61D81B8613E3"><enum>(I)</enum><text>shall schedule
the dispute for review at 1 of the next 2 regular meetings of the Drug Safety
Oversight Board, whichever meeting date is more practicable; or</text>
</subclause><subclause id="id21590B6465DB4B76A2B29F96CD4E61CC"><enum>(II)</enum><text>may convene a
special meeting of the Drug Safety Oversight Board to review the matter more
promptly, including to meet an action deadline on an application (including a
supplemental application).</text>
</subclause></clause><clause id="idA6206D63FA234A29AAE819CDB0B0381B"><enum>(iii)</enum><header>Agreement
after discussion or administrative appeals</header>
<subclause id="id94527125CADD4A7E85BC30FCB0E86801"><enum>(I)</enum><header>Further
discussion or administrative appeals</header><text>A request for review under
clause (i) shall not preclude further discussions to reach agreement on the
risk evaluation and mitigation strategy, and such a request shall not preclude
the use of administrative appeals within the Food and Drug Administration to
reach agreement on the strategy, including appeals as described 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) for procedural or scientific matters involving the review of
human drug applications and supplemental applications that cannot be resolved
at the divisional level.</text>
</subclause><subclause id="ID8f4b44a596c64f20ae218dda87b89a89"><enum>(II)</enum><header>Agreement
terminates dispute resolution</header><text>At any time before a decision and
order is issued under clause (vi), the Secretary and the applicant may reach an
agreement on the risk evaluation and mitigation strategy through further
discussion or administrative appeals, terminating the dispute resolution
process, and the Secretary shall issue an action letter or order, as
appropriate, that describes the strategy.</text>
</subclause></clause><clause id="IDb75c238a9cdb466e868e942e0ca20a0f"><enum>(iv)</enum><header>Meeting of the
board</header><text>At the meeting of the Drug Safety Oversight Board described
in clause (ii), the Board shall—</text>
<subclause id="ID6b3308e48f46489d97d4aea2829b0431"><enum>(I)</enum><text>hear from both
parties; and</text>
</subclause><subclause id="ID3a69c379bb244aa8bc436e1056f09cd5"><enum>(II)</enum><text>review the
dispute.</text>
</subclause></clause><clause id="ID252b22b64b004a10bbbe5c7f240c8455"><enum>(v)</enum><header>Recommendation
of the Board</header><text>Not later than 5 days after such meeting of the Drug
Safety Oversight Board, the Board shall provide a written recommendation on
resolving the dispute to the Secretary.</text>
</clause><clause id="ID29869ff4650a4172a8986861477fe929"><enum>(vi)</enum><header>Action by the
secretary</header>
<subclause id="id06C85BE95F6D4119A9DD58EBF9FEF015"><enum>(I)</enum><header>Action
letter</header><text>With respect to a proposed risk evaluation and mitigation
strategy submitted under subparagraph (A) or to an assessment of the strategy
submitted under subparagraph (B)(ii)(I), the Secretary shall issue an action
letter that resolves the dispute not later than the later of—</text>
<item id="id2217915A81284298972BDD424E87B5B9"><enum>(aa)</enum><text>the action
deadline referred to in subparagraph (D)(i); or</text>
</item><item id="id2BCF6E8BB71943ECB31A6468528BC114"><enum>(bb)</enum><text>7
days after receiving the recommendation of the Drug Safety Oversight
Board.</text>
</item></subclause><subclause id="id38F1AF356DC44D0790F2E428A167DDF5"><enum>(II)</enum><header>Order</header><text>With
respect to an assessment of the risk evaluation and mitigation strategy under
subparagraph (B)(i) or under subclause (II), (III), (IV), or (V) of
subparagraph (B)(ii), the Secretary shall issue an order, which shall be made
public, that resolves the dispute not later than 7 days after receiving the
recommendation of the Drug Safety Oversight Board.</text>
</subclause></clause><clause id="id0E035F66705843E190582F36BED4EAAA"><enum>(vii)</enum><header>Inaction</header><text>An
approved risk evaluation and mitigation strategy shall remain in effect until
the Secretary acts, if the Secretary fails to act as provided for under clause
(vi).</text>
</clause><clause id="id10BE0C7DA51F4D76AA97F3EBEFB989FB"><enum>(viii)</enum><header>Effect on
action deadline</header><text>With respect to the application or supplemental
application in which a proposed risk evaluation and mitigation strategy is
submitted under subparagraph (A) or in which an assessment of the strategy is
submitted under subparagraph (B)(ii)(I), the Secretary shall be considered to
have met the action deadline referred to in subparagraph (D)(i) with respect to
such application if the applicant requests the dispute resolution process
described in this subparagraph and if the Secretary—</text>
<subclause id="id766D24994A104977B67A010C99D701A6"><enum>(I)</enum><text>has initiated the
discussions described under subparagraph (D) not less than 60 days before such
action deadline; and</text>
</subclause><subclause id="id9BFC5D628D9F4A5AB81B7469A9B6BA45"><enum>(II)</enum><text>has complied
with the timing requirements of scheduling review by the Drug Safety Oversight
Board, providing a written recommendation, and issuing an action letter under
clauses (ii), (v), and (vi), respectively.</text>
</subclause></clause><clause id="id5928A0D1170348C88E72FADB53F9084D"><enum>(ix)</enum><header>Disqualification</header><text>No
individual who is an employee of the Food and Drug Administration and who
reviews a drug or who participated in an administrative appeal under clause
(iii)(I) with respect to such drug may serve on the Drug Safety Oversight Board
at a meeting under clause (iv) to review a dispute about the risk evaluation
and mitigation strategy for such drug.</text>
</clause><clause id="id7F742E43313D4E92BBE8403AE4FA3853"><enum>(x)</enum><header>Additional
expertise</header><text>The Drug Safety Oversight Board may add members with
relevant expertise from the Food and Drug Administration, including the Office
of Pediatrics, the Office of Women's Health, or the Office of Rare Diseases, or
from other Federal public health or health care agencies, for a meeting under
clause (iv) of the Drug Safety Oversight Board.</text>
</clause></subparagraph><subparagraph commented="no" id="id465FF774417442A29EB6E63D2362B4C4"><enum>(G)</enum><header>Use of advisory
committees</header><text>The Secretary may convene a meeting of 1 or more
advisory committees of the Food and Drug Administration to—</text>
<clause commented="no" id="id408AF7C83EDC49CCB99A3463119610C9"><enum>(i)</enum><text>review a concern
about the safety of a drug or class of drugs, including before an assessment of
the risk evaluation and mitigation strategy or strategies of such drug or drugs
is required to be submitted under subclause (II), (III), (IV), or (V) of
subparagraph (B)(ii);</text>
</clause><clause commented="no" id="IDcf7defc0abce4ec1b4aed07ab8966260"><enum>(ii)</enum><text>review the risk
evaluation and mitigation strategy or strategies of a drug or group of drugs;
or</text>
</clause><clause commented="no" id="ID71570f6e0fae45248fde5f424fa997fb"><enum>(iii)</enum><text>with the
consent of the applicant, review a dispute under subparagraph (F).</text>
</clause></subparagraph><subparagraph id="IDebff1fffd8b045f7b5c64e6b89180716"><enum>(H)</enum><header>Process for
addressing Drug Class Effects</header>
<clause id="ID07e35ea7bae84948aaf7c6e69d78e296"><enum>(i)</enum><header>In
general</header><text>When a concern about a serious risk of a drug may be
related to the pharmacological class of the drug, the Secretary may defer
assessments of the approved risk evaluation and mitigation strategies for such
drugs until the Secretary has convened, after appropriate public notice, 1 or
more public meetings to consider possible responses to such concern.</text>
</clause><clause id="ID6da86c42506c48baae16babf9ec0a270"><enum>(ii)</enum><header>Public
meetings</header><text>Such public meetings may include—</text>
<subclause id="ID8caab8566c124c76a7067f195132337f"><enum>(I)</enum><text>1 or more
meetings of the applicants for such drugs;</text>
</subclause><subclause id="IDd51d4e3cb4414004a153320cbbf28e69"><enum>(II)</enum><text>1 or more
meetings of 1 or more advisory committees of the Food and Drug Administration,
as provided for under subparagraph (G); or</text>
</subclause><subclause id="ID4da0c953a6204236a05077bab33f68ef"><enum>(III)</enum><text>1 or more
workshops of scientific experts and other stakeholders.</text>
</subclause></clause><clause id="idD36ECBCE9B0B41F9BBAAFBDF41E077E3"><enum>(iii)</enum><header>Action</header><text>After
considering the discussions from any meetings under clause (ii), the Secretary
may—</text>
<subclause id="ID0c53160064a44d67925d2f3f9364b924"><enum>(I)</enum><text>announce in the
Federal Register a planned regulatory action, including a modification to each
risk evaluation and mitigation strategy, for drugs in the pharmacological
class;</text>
</subclause><subclause id="ID3b7e2fa77f1642e0b6e3b2b8fcf88ea9"><enum>(II)</enum><text>seek public
comment about such action; and</text>
</subclause><subclause id="ID8521715029ef499d9b1db0dc3584e32e"><enum>(III)</enum><text>after seeking
such comment, issue an order addressing such regulatory action.</text>
</subclause></clause></subparagraph><subparagraph id="ID051540dd785c4debacbb3fcfd6e1ca29"><enum>(I)</enum><header>International
Coordination</header><text>The Secretary may coordinate the timetable for
submission of assessments under paragraph (3)(E), a study under paragraph
(4)(D), or a clinical trial under paragraph (4)(E), with efforts to identify
and assess the serious risks of such drug by the marketing authorities of other
countries whose drug approval and risk management processes the Secretary deems
comparable to the drug approval and risk management processes of the United
States.</text>
</subparagraph><subparagraph id="id6665F78DD25542418C6C92CADA782B03"><enum>(J)</enum><header>Effect</header><text>Use
of the processes described in subparagraphs (H) and (I) shall not delay action
on an application or a supplement to an application for a drug.</text>
</subparagraph><subparagraph id="idC5CCFCFBF1BF42AC9A1FB6DF55A314A9"><enum>(K)</enum><header>No effect on
labeling changes that do not require preapproval</header><text>In the case of a
labeling change to which section 314.70 of title 21, Code of Federal
Regulations (or any successor regulation), applies for which the submission of
a supplemental application is not required or for which distribution of the
drug involved may commence upon the receipt by the Secretary of a supplemental
application for the change, the submission of an assessment of the approved
risk evaluation and mitigation strategy for the drug under this subsection is
not required.</text>
</subparagraph></paragraph><paragraph id="id9FEA43ADFA8B43CBB312802AB309EA1E"><enum>(7)</enum><header>Drug safety
oversight board</header>
<subparagraph id="id18B42AE4B53349DC93E851A7D0D45D57"><enum>(A)</enum><header>In
general</header><text>There is established a Drug Safety Oversight
Board.</text>
</subparagraph><subparagraph id="id49FE49AEACDD42C69CC7C3B7283B7A8B"><enum>(B)</enum><header>Composition;
meetings</header><text>The Drug Safety Oversight Board shall—</text>
<clause id="IDdcacc803b2c24cc99b31cb3829bb5113"><enum>(i)</enum><text>be composed of
scientists and health care practitioners who are appointed by the
Secretary;</text>
</clause><clause id="ID64b9f5e352fd4ec59cd6fc6e20832984"><enum>(ii)</enum><text>include
representatives from offices throughout the Food and Drug
Administration;</text>
</clause><clause id="ID91c4c6f05b014572885533bfee09842b"><enum>(iii)</enum><text>include at
least 1 representative from each of the National Institutes of Health, the
Department of Health and Human Services (other than the Food and Drug
Administration), and the Veterans Health Administration; and</text>
</clause><clause id="IDde451bc69e424297aab7c328166ce722"><enum>(iv)</enum><text>meet at least
monthly to provide oversight and advice to the Secretary on the management of
important drug safety
issues.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="ID897206f3cfd541469a3add8b66006f72"><enum>102.</enum><header>Enforcement</header>
<subsection commented="no" id="ID53f1f2d2a0784ad2ae62060bbdb6176e"><enum>(a)</enum><header>Misbranding</header><text>Section
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9FACF3812D3549C99CA3CD3B0E175D5C" style="OLC">
<subsection commented="no" id="idB464A8F89CB04CEC9198087D0C0E451A"><enum>(x)</enum><text>If it is a drug
subject to an approved risk evaluation and mitigation strategy under section
505(o) and the applicant for such drug fails to—</text>
<paragraph id="ID3507fd0654b54216bab22734e7ab1f62"><enum>(1)</enum><text>make a labeling
change required by such strategy after the Secretary has completed review of,
and acted on, an assessment of such strategy under paragraph (6) of such
section; or</text>
</paragraph><paragraph id="IDbb2afe9219b64b8ba2ae0db0389077c2"><enum>(2)</enum><text>comply with a
requirement of such strategy with respect to advertising as provided for under
subparagraph (F), (G), or (H) of paragraph (4) of such
section.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="id64E0131B4DC64C30A825BC99A032221F"><enum>(b)</enum><header>Civil
penalties</header><text>Section 303(f) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 333(f)) is amended—</text>
<paragraph commented="no" id="idA37BD0DF12694CB79D68A3F3FA694DA8"><enum>(1)</enum><text>by redesignating
paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6),
respectively;</text>
</paragraph><paragraph commented="no" id="id6B3C85A3D2F1489FA9E1C1A4BCE9CA48"><enum>(2)</enum><text>by inserting
after paragraph (2) the following:</text>
<quoted-block display-inline="no-display-inline" id="idC0F09AE9D3B746708C124B01A75C42B7" style="OLC">
<paragraph commented="no" id="id9E5E77C97E9F42D681BD614A1D9A3B8E"><enum>(3)</enum><text>An applicant (as
such term is used in section 505(o)) who knowingly fails to comply with a
requirement of an approved risk evaluation and mitigation strategy under such
section 505(o) shall be subject to a civil money penalty of not less than
$15,000 and not more than $250,000 per violation, and not to exceed $1,000,000
for all such violations adjudicated in a single
proceeding.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="idA7B4383F61F647E7AE8D0CF9BFE9493E"><enum>(3)</enum><text>in paragraph
(2)(C), by striking <quote>paragraph (3)(A)</quote> and inserting
<quote>paragraph (4)(A)</quote>;</text>
</paragraph><paragraph commented="no" id="idC2496A8CE26B41429C3F06F1DD3A2EBC"><enum>(4)</enum><text>in paragraph (4),
as so redesignated, by striking <quote>paragraph (1) or (2)</quote> each place
it appears and inserting <quote>paragraph (1), (2), or (3)</quote>; and</text>
</paragraph><paragraph commented="no" id="id079C9844573C4C4085CDEE9373FFA360"><enum>(5)</enum><text>in paragraph (6),
as so redesignated, by striking <quote>paragraph (4)</quote> each place it
appears and inserting <quote>paragraph (5)</quote>.</text>
</paragraph></subsection></section><section id="ID161e8ad871344cd7be7a1c1c468b14cb"><enum>103.</enum><header>Regulation of
biological products</header><text display-inline="no-display-inline">Section
351 of the Public Health Service Act (42 U.S.C. 262) is amended—</text>
<paragraph id="id8F12CDD2C0654828803E0F0D863935D7"><enum>(1)</enum><text>in subsection
(a)(2), by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idC9266A183F2242F988DDDC6DDE41FECF" style="OLC">
<subparagraph id="id10490212C59148498EF05291CC19B0E2" indent="up2"><enum>(D)</enum><header>Risk evaluation and mitigation
strategy</header><text>A person that submits an application for a license under
this paragraph shall submit to the Secretary as part of the application a
proposed risk evaluation and mitigation strategy as described under section
505(o) of the Federal Food, Drug, and Cosmetic
Act.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id4CF319E849AB427987C474E6D3CF59CE"><enum>(2)</enum><text>in subsection
(j), by inserting <quote>, including the requirements under section 505(o) of
such Act,</quote> after <quote>, and Cosmetic Act</quote>.</text>
</paragraph></section><section id="ID3c7c3f3b971146fb8b7a7662fbc11e6f"><enum>104.</enum><header>No effect on
withdrawal or suspension of approval</header><text display-inline="no-display-inline">Section 505(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at the end the
following: <quote>The Secretary may withdraw the approval of an application
submitted under this section, or suspend the approval of such an application,
as provided under this subsection, without first ordering the applicant to
submit an assessment of the approved risk evaluation and mitigation strategy
for the drug under subsection (o)(6)(B)(ii)(V).</quote>.</text>
</section><section commented="no" id="ID6536b0accc704aac8968386ddbb1e35a"><enum>105.</enum><header>Drugs subject
to an abbreviated new drug application</header><text display-inline="no-display-inline">Section 505(j)(2) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idBF3C42BF78DB4D1E951C068F94B9E324" style="OLC">
<subparagraph commented="no" id="id2E5F8ABF58234E399B3481579F93AB9C" indent="up2"><enum>(D)</enum><header>Risk evaluation and mitigation
strategy requirement</header>
<clause commented="no" id="idB21FECF3219E4DFBAD430A8F7562099C"><enum>(i)</enum><header>In general</header><text>A drug that
is the subject of an abbreviated new drug application under this subsection
shall be subject to only the following elements of the risk evaluation and
mitigation strategy required under subsection (o) for the applicable listed
drug:</text>
<subclause commented="no" id="id542D4EC104AB40EDBF43C2D82B9658FD"><enum>(I)</enum><text>Labeling, as required under
subsection (o)(3)(A) for the applicable listed drug.</text>
</subclause><subclause commented="no" id="id769358E19A2847ED93B28A1A63B7C024"><enum>(II)</enum><text>Submission of reports, as required
under subsection (o)(3)(B)(i) for the applicable listed drug.</text>
</subclause><subclause commented="no" id="idAD1A2DA7E352409C9024952037CBC106"><enum>(III)</enum><text>A Medication Guide or patient
package insert, if required under subsection (o)(4)(B) for the applicable
listed drug.</text>
</subclause><subclause commented="no" id="id4BC0553C9073469F90DEE698106FFB3F"><enum>(IV)</enum><text>Preclearance of advertising, if
required under subsection (o)(4)(F) for the applicable listed drug.</text>
</subclause><subclause commented="no" id="id1F4E52E605234323B4DA0DCFB1464399"><enum>(V)</enum><text>Specific disclosures in
advertising, if required under subsection (o)(4)(G) for the applicable listed
drug.</text>
</subclause><subclause commented="no" id="id3A634BA05755490EBFFF6091589BE8D8"><enum>(VI)</enum><text>A temporary moratorium on
direct-to-consumer advertising, if required under subsection (o)(4)(H) for the
applicable listed drug.</text>
</subclause><subclause commented="no" id="id99C80233978142AC844455CCEA2B059A"><enum>(VII)</enum><text>Restrictions on distribution or
use, if required under subsection (o)(5) for the applicable listed drug, except
that such drug may use a different, comparable aspect of such restrictions on
distribution or use as are needed to assure safe use of such drug if —</text>
<item commented="no" id="id86E97949C1E444E2A65586C01024EAD1"><enum>(aa)</enum><text>the corresponding aspect of the
restrictions on distribution or use for the applicable listed drug is claimed
by a patent that has not expired or is a method or process that as a trade
secret is entitled to protection; and</text>
</item><item commented="no" id="idE806706E6A5B479D8E0459CDE4FA21CD"><enum>(bb)</enum><text>the applicant certifies that it has
sought a license for use of such aspect of the restrictions on distribution or
use for the applicable listed drug.</text>
</item></subclause></clause><clause commented="no" id="id22ED8850F56140C4BAC56EE91907F946"><enum>(ii)</enum><header>Action by
Secretary</header><text>For an applicable listed drug for which a drug is
approved under this subsection, the Secretary—</text>
<subclause commented="no" id="id148C2CBD7AC64AB4BE50A55FC8A413EF"><enum>(I)</enum><text>shall undertake any communication
plan to health care providers required under section (o)(4)(C) for the
applicable listed drug;</text>
</subclause><subclause commented="no" id="id6F15C145AC1B4132A90B0986CEF63424"><enum>(II)</enum><text>shall conduct any post-approval
study required under subsection (o)(4)(D) for the applicable listed
drug;</text>
</subclause><subclause commented="no" id="idC4B3212D406B4F9EB75A7D2F6C3AC4CF"><enum>(III)</enum><text>shall inform the applicant for a
drug approved under this subsection if the risk evaluation and mitigation
strategy for the applicable listed drug is modified; and</text>
</subclause><subclause commented="no" id="idCC71E9A017E3408EAA88A4EABD21972F"><enum>(IV)</enum><text>in order to minimize the burden on
the health care delivery system of different restrictions on distribution or
use for the drug approved under this subsection and the applicable listed drug,
may seek to negotiate a license under which the applicant for such drug may use
an aspect of the restrictions on distribution or use, if required under
subsection (o)(5) for the applicable listed drug, that is claimed by a patent
that has not expired or is a method or process that as a trade secret is
entitled to
protection.</text>
</subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="id357DEE875B9C4282BC81F74CC20CE022"><enum>106.</enum><header>Conforming
amendments</header>
<subsection commented="no" id="id39F189A1F2C04B089443C1C647989CBC"><enum>(a)</enum><header>Preclearance of
advertisements</header><text>Section 502(n)(3)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)(3)(A)) is amended by inserting <quote>(or
when required under section 505(o)(4)(F))</quote> after <quote>except in
extraordinary circumstances</quote>.</text>
</subsection><subsection commented="no" id="id28662C4C3FB840C1A2DA15BA15F08DBB"><enum>(b)</enum><header>Content of new
drug application</header><text>Section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)) is amended—</text>
<paragraph id="ID92a9a700057141999e475e9dfbc770ce"><enum>(1)</enum><text>in subparagraph
(F), by striking <quote>and</quote>; and</text>
</paragraph><paragraph id="IDb2a138ff3af64641ba1d5bbddcffb140"><enum>(2)</enum><text>in subparagraph
(G), by striking the period and inserting the following: “, and (H) a proposed
risk evaluation and mitigation strategy as described under subsection
(o).”.</text>
</paragraph></subsection></section><section commented="no" id="id2FF9618AB6D94CC0976ACD0B9BE85FA7"><enum>107.</enum><header>Resources</header>
<subsection commented="no" id="id516A2A64B4B44427A25C53FEF488E802"><enum>(a)</enum><header>User
fees</header><text>Subparagraph (F) of section 735(6) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g(6)) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idD2D584DC91524DDA94C9FCA90BB55409" style="OLC">
<subparagraph commented="no" id="idB2334243E6514E17B11EA7E84BDB0FD0"><enum>(F)</enum><text>Reviewing and
implementing risk evaluation and mitigation strategies, and collecting,
developing, and reviewing safety information on drugs, including adverse event
reports.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="idC55E51A864AF41219A3DCBC2ACC80D6E"><enum>(b)</enum><header>Workload
adjustment</header><text>Subparagraph (A) of section 736(c)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(2)) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id5AE4E335546045B69C543FDF710772A3" style="OLC">
<subparagraph id="IDbd73e2dd6edf40b2b488474cc4dd02a8"><enum>(A)</enum><text>The adjustment
shall be determined by the Secretary based on a weighted average of the change
in the total number of human drug applications, commercial investigational new
drug applications, efficacy supplements, manufacturing supplements, assessments
of risk evaluation and mitigation strategies, and uses of dispute resolution
under the process for reviewing and assessing risk evaluation and mitigation
strategies. The Secretary shall publish in the Federal Register the fee
revenues and fees resulting from the adjustment and supporting
methodologies.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="id46E354EEDB364180B9D051D34C462C9E"><enum>(c)</enum><header>Strategic Plan
for information technology</header><text>Not later than 1 year after the date
of enactment of this title, the Secretary of Health and Human Services
(referred to in this Act as the <quote>Secretary</quote>) shall submit to the
Committee on Health, Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representatives, a strategic plan
on information technology that includes—</text>
<paragraph commented="no" id="id5B8005D3A2344602BDE7849BA22B1167"><enum>(1)</enum><text>an assessment of
the information technology infrastructure, including systems for data
collection, access to data in external health care databases, data mining
capabilities, personnel, and personnel training programs, needed by the Food
and Drug Administration to—</text>
<subparagraph commented="no" id="id991AFA8190B240D183F3D99C591963F1"><enum>(A)</enum><text>comply with the
requirements of this title (and the amendments made by this title);</text>
</subparagraph><subparagraph commented="no" id="idA4C69BF0724946E1A8B98E972E405129"><enum>(B)</enum><text>achieve
interoperability within and among the Centers of the Food and Drug
Administration and between the Food and Drug Administration and product
application sponsors; and</text>
</subparagraph><subparagraph commented="no" id="idBE9AC8E93A7243B6A2DB2B04D3B47B4F"><enum>(C)</enum><text>utilize
electronic health records;</text>
</subparagraph></paragraph><paragraph commented="no" id="id617F140DBF434003910C612E8D02AF84"><enum>(2)</enum><text>an assessment of
the extent to which the current information technology assets of the Food and
Drug Administration are sufficient to meet the needs assessments under
paragraph (1);</text>
</paragraph><paragraph commented="no" id="id65F152CE9F4A42DBAC2FA4422DB73F0B"><enum>(3)</enum><text>a plan for
enhancing the information technology assets of the Food and Drug Administration
toward meeting the needs assessments under paragraph (1); and</text>
</paragraph><paragraph commented="no" id="id73EC4845446C475D9252F68BFAC511B9"><enum>(4)</enum><text>an assessment of
additional resources needed to so enhance the information technology assets of
the Food and Drug Administration.</text>
</paragraph></subsection></section><section id="ID91155f53395049b9b3a422e7786ef6ff"><enum>108.</enum><header>Drug
labeling</header>
<subsection id="ID01547daab62a446c8efe498808b8f50c"><enum>(a)</enum><header>Accessible
repository of drug labeling</header><text>Not later than the effective date of
this title, the Secretary, through the Commissioner of Food and Drugs, and the
Director of the National Institutes of Health, shall establish a searchable
repository of structured, electronic product information, including the
approved professional labeling and any required patient labeling of each drug
approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42
U.S.C. 262) in order to improve patient safety through accessible product
information, support initiatives to improve patient care by better management
of health care information, and provide standards for drug information. Such
repository shall be made publicly accessible on the Internet website of the
National Library of Medicine and through a link on the homepage of the Internet
website of the Food and Drug Administration.</text>
</subsection><subsection id="IDfb3c8c7976a143689dc5766c699fdbff"><enum>(b)</enum><header>Posting upon
approval</header><text>The Secretary shall post in the repository under
subsection (a) the approved professional labeling and any required patient
labeling of a drug approved under such section 505 or licensed under such
section 351 not later than 21 days after the date the drug is approved,
including in a supplemental application with respect to a labeling
change.</text>
</subsection><subsection id="IDc5c8391c26e6481686771dff3e11be0f"><enum>(c)</enum><header>Report</header><text>The
Secretary shall report annually to the Committee on Health, Education, Labor
and Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives on the status of the repository under subsection (a),
and on progress in posting structured electronic product information, including
posting of information regarding drugs approved prior to the effective date of
this title.</text>
</subsection><subsection id="ID80b1875beee14892aaf842d1b57d81d7"><enum>(d)</enum><header>Medication
guides</header><text>Not later than the effective date of this title, the
Secretary, through the Commissioner of Food and Drugs, shall establish on the
Internet website for the repository under subsection (a), a link to a list of
each drug, whether approved under such section 505 or licensed under such
section 351, for which a Medication Guide, as provided for under part 208 of
title 21, Code of Federal Regulations (or any successor regulations), is
required.</text>
</subsection></section><section id="IDaaf265baba754d9abb4f81e31889c9d0"><enum>109.</enum><header>Effective date
and applicability</header>
<subsection id="ID7c621b42a385458283ec5f267e194b13"><enum>(a)</enum><header>Effective
date</header><text>This title shall take effect 180 days after the date of
enactment of this Act.</text>
</subsection><subsection id="IDc6241ae44ce148a1a77e60d7c97a3fe5"><enum>(b)</enum><header>Drugs deemed To
have risk evaluation and mitigation strategies</header>
<paragraph id="ID6b1d7ced5fac4190928a58703f4a27ae"><enum>(1)</enum><header>In
general</header><text>A drug that was approved before the effective date of
this title shall be deemed to have an approved risk evaluation and mitigation
strategy under section 505(o) of the Federal Food, Drug, and Cosmetic Act (as
added by this title) if there are in effect on the effective date of this title
restrictions on distribution or use—</text>
<subparagraph id="ID894c33e4dfd245f2843ce65ce839c44c"><enum>(A)</enum><text>required under
section 314.520 or section 601.42 of title 21, Code of Federal Regulations;
or</text>
</subparagraph><subparagraph id="IDe5613c7f258f4a03bc85ec9ddb7598e0"><enum>(B)</enum><text>otherwise agreed
to by the applicant and the Secretary for such drug.</text>
</subparagraph></paragraph><paragraph id="ID1e76e12b61e04f5e982060265390988c"><enum>(2)</enum><header>Risk evaluation
and mitigation strategy</header><text>The approved risk evaluation and
mitigation strategy deemed in effect for a drug under paragraph (1) shall
consist of the elements described in subparagraphs (A) and (B) of paragraph (3)
of such section 505(o) and any other additional elements under paragraphs (4)
and (5) in effect for such drug on the effective date of this title.</text>
</paragraph><paragraph id="ID77a265cc77964a9c8b50e77ee5838f9a"><enum>(3)</enum><header>Notification</header><text>Not
later than 30 days after the effective date of this title, the Secretary shall
notify the applicant for each drug described in paragraph (1)—</text>
<subparagraph id="id4B1CF4224A6543258AC0608A457D2C78"><enum>(A)</enum><text>that such drug is
deemed to have an approved risk evaluation and mitigation strategy pursuant to
such paragraph; and</text>
</subparagraph><subparagraph id="id68E9A4EE19F748798E55D3BDF03B3E0F"><enum>(B)</enum><text>of the date,
which shall be no earlier than 6 months after the applicant is so notified, by
which the applicant shall submit to the Secretary an assessment of such
approved strategy under paragraph (6)(B) of such section 505(o).</text>
</subparagraph></paragraph><paragraph id="idBEA26F666E794486B49BCEFA4735949A"><enum>(4)</enum><header>Enforcement
Only after Assessment and Review</header><text>Neither the Secretary nor the
Attorney General may seek to enforce a requirement of a risk evaluation and
mitigation strategy deemed in effect under paragraph (1) before the Secretary
has completed review of, and acted on, the first assessment of such strategy
under such section 505(o).</text>
</paragraph></subsection><subsection id="ID4f7537b4caaa4ec981471e06b95b2ef1"><enum>(c)</enum><header>Other drugs
approved before the effective date</header><text>The Secretary, on a
case-by-case basis, may require the applicant for a drug approved before the
effective date of this title to which subsection (b) does not apply to submit a
proposed risk evaluation and mitigation strategy in accordance with the
timeframes provided for in subclause (III), (IV), or (V), as applicable, of
paragraph (6)(B)(ii) of such section 505(o) if the Secretary determines
that—</text>
<paragraph id="ID5227eee5c68541fdb0557b3ec11074f5"><enum>(1)</enum><text>an element
described under paragraph (3)(A) of such section 505(o) may require
modification; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7d951e9e5ef341c1ace85cd73b21f172"><enum>(2)</enum><text>a standard for
adding an element described in paragraph (4) or (5) of such section 505(o) that
is not in effect with respect to such drug may apply to such drug.</text>
</paragraph></subsection></section><enum>II</enum><header>Reagan-Udall
Institute for Applied Biomedical Research</header>
<section id="ID0eb90637548f4e0a91127ac4f6071f6f"><enum>201.</enum><header>The
Reagan-Udall Institute for Applied Biomedical Research</header>
<subsection id="idC84D76A7984C4147BE1741B3A9CE1054"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as amended by
Public Law 109–462, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7C2F98ABDEDE43F1A377231692B546F8" style="OLC">
<subchapter id="id80E3B17EFC994A3DBE5907ED9050E52D"><enum>I</enum><header>Reagan-Udall
Institute for Applied Biomedical Research</header>
<section id="ID5d2f8ef44f4d4a86b0dadee48ac45e2c"><enum>770.</enum><header>Establishment
and functions of the Institute</header>
<subsection id="ID2fb32e47797d4a22a48315184e75a8fb"><enum>(a)</enum><header>In
general</header><text>The Secretary shall establish a nonprofit corporation to
be known as the Reagan-Udall Institute for Applied Biomedical Research
(referred to in this subchapter as the <quote>Institute</quote>). The Institute
shall be headed by an Executive Director, appointed by the members of the Board
of Directors under subsection (e). The Institute shall not be an agency or
instrumentality of the United States Government.</text>
</subsection><subsection commented="no" id="ID9105c23306d84c3c88f2c965229080cd"><enum>(b)</enum><header>Purpose of
Institute</header><text>The purpose of the Institute is to advance the Critical
Path Initiative of the Food and Drug Administration to modernize medical
product development, accelerate innovation, and enhance product safety.</text>
</subsection><subsection id="ID40aa674cff8241f3b731402f4bc30490"><enum>(c)</enum><header>Duties of the
Institute</header><text>The Institute shall—</text>
<paragraph id="ID756e180f62dc467ca597ecfbd1717315"><enum>(1)</enum><text>taking into
consideration the 2004 report published by the Food and Drug Administration
entitled <quote>Innovation or Stagnation? Challenge and Opportunity on the
Critical Path to New Medical Products</quote>, identify unmet needs in the
sciences of developing, manufacturing, and evaluating the safety and
effectiveness of diagnostics, devices, biologics, and drugs, including—</text>
<subparagraph id="ID74708c71da7b405a99b5079514f8574e"><enum>(A)</enum><text>the
identification and validation of biomarkers for use in diagnostic, device,
biologic, and drug development;</text>
</subparagraph><subparagraph id="ID47af4e28c3124e80bfe4fe739bc3ce82"><enum>(B)</enum><text>the development
and validation of animal models for human disease and medical product
safety;</text>
</subparagraph><subparagraph id="ID5e2994490fda4eb2a73d9fcd865e8bbc"><enum>(C)</enum><text>pharmacogenomics
and inter-individual variability in drug, biologic, and device response;</text>
</subparagraph><subparagraph id="ID2c89d74b0738432494d8082f417e49af"><enum>(D)</enum><text>the development
of data analysis technology and methodology for use in device, biologic, drug,
and diagnostic development;</text>
</subparagraph><subparagraph id="IDa93ffb7a33c34d4e9f04f8684adb2737"><enum>(E)</enum><text>advancing
improvements to the design and conduct of clinical trials;</text>
</subparagraph><subparagraph id="IDa8fd460253f140f989adc0f245d06da5"><enum>(F)</enum><text>toxicological
quality assessment technologies;</text>
</subparagraph><subparagraph id="ID67fd0b2af0934312b980afdcf2418cf5"><enum>(G)</enum><text>diagnostic,
device, biologic, and drug manufacturing, design, and materials science;</text>
</subparagraph><subparagraph id="ID715c884277f545b38cca5c9a36be33b6"><enum>(H)</enum><text>failure mode
assessment for medical product development;</text>
</subparagraph><subparagraph id="IDe65289c829224a0ebd0e193b51915a16"><enum>(I)</enum><text>improving adverse
event reporting and analysis;</text>
</subparagraph><subparagraph id="IDcea852d44772481897035848cbbc6ef0"><enum>(J)</enum><text>bridging
engineering data and clinical performance for devices; and</text>
</subparagraph><subparagraph id="IDe996515bdf2b48158c46d55eb73f8a4d"><enum>(K)</enum><text>computer
modeling;</text>
</subparagraph></paragraph><paragraph id="ID905d50c83866436eabea63bdff90a0b9"><enum>(2)</enum><text>establish goals
and priorities in order to meet the unmet needs identified in paragraph
(1);</text>
</paragraph><paragraph id="IDa9c553b5642e4a1ca09987f36d856c90"><enum>(3)</enum><text>in consultation
with the Secretary, assess existing and proposed Federal intramural and
extramural research and development programs relating to the goals and
priorities established under paragraph (2) and facilitate and encourage
interagency coordination of such programs;</text>
</paragraph><paragraph id="id3A108B97B9EE4D0FACAB5981E9311E0E"><enum>(4)</enum><text>award grants to,
or enter into contracts or cooperative agreements with, scientists and entities
to advance the goals and priorities established under paragraph (2);</text>
</paragraph><paragraph id="id238ECAEF92F640B4A76E6A182AA0A18D"><enum>(5)</enum><text>recruit meeting
participants and hold or sponsor (in whole or in part) meetings as appropriate
to further the goals and priorities established under paragraph (2);</text>
</paragraph><paragraph id="IDefd9313360cd4cbf9053047a782c51a4"><enum>(6)</enum><text>release and
publish information and data and, to the extent practicable, license,
distribute, and release material, reagents, and techniques to maximize,
promote, and coordinate the availability of such material, reagents, and
techniques for use by the Food and Drug Administration, nonprofit
organizations, and academic and industrial researchers to further the goals and
priorities established under paragraph (2);</text>
</paragraph><paragraph id="ID7e558a6132b14301a6221a4604975ce8"><enum>(7)</enum><text>ensure
that—</text>
<subparagraph id="idF89B6BE7BC414BE49725FF92B147AD5A"><enum>(A)</enum><text>action is taken
as necessary to obtain patents for inventions developed by the Institute or
with funds from the Institute;</text>
</subparagraph><subparagraph id="idEA13757DE8F9453696BC0C020F6E84F2"><enum>(B)</enum><text>action is taken
as necessary to enable the licensing of inventions developed by the Institute
or with funds from the Institute; and</text>
</subparagraph><subparagraph id="id17AD56ED51A74FD28536FD4241D644C1"><enum>(C)</enum><text>executed
licenses, memoranda of understanding, material transfer agreements, contracts,
and other such instruments promote, to the maximum extent practicable, the
broadest conversion to commercial and noncommercial applications of licensed
and patented inventions of the Institute to further the goals and priorities
established under paragraph (2);</text>
</subparagraph></paragraph><paragraph id="idEED99915F39840D89FFE582E358BF304"><enum>(8)</enum><text>provide objective
clinical and scientific information to the Food and Drug Administration and,
upon request, to other Federal agencies to assist in agency determinations of
how to ensure that regulatory policy accommodates scientific advances;</text>
</paragraph><paragraph id="idCCB23BBEB3344277AC6650549F7B83DB"><enum>(9)</enum><text>conduct annual
assessments of the unmet needs identified in paragraph (1); and</text>
</paragraph><paragraph id="idEC27189A240745768C53D66A856858D4"><enum>(10)</enum><text>carry out such
other activities consistent with the purposes of the Institute as the Board
determines appropriate.</text>
</paragraph></subsection><subsection id="ID0dad4278748d445fb72655b24a5c0430"><enum>(d)</enum><header>Board of
directors</header>
<paragraph id="ID52ded8691a1b4f658bc2cc6176af5f93"><enum>(1)</enum><header>Establishment</header>
<subparagraph id="ID69abf14ee2a44fbbbeee21f3cc69486d"><enum>(A)</enum><header>In
general</header><text>The Institute shall have a Board of Directors (referred
to in this subchapter as the <quote>Board</quote>), which shall be composed of
ex officio and appointed members in accordance with this subsection. All
appointed members of the Board shall be voting members.</text>
</subparagraph><subparagraph id="IDb266b4ff751c4061a961e05198221e30"><enum>(B)</enum><header>Ex officio
members</header><text>The ex officio members of the Board shall be—</text>
<clause id="IDa77cb04cb8aa40908588c0111f60d74d"><enum>(i)</enum><text>the immediate
past Chair of Board of Directors of the Institute;</text>
</clause><clause id="IDcf5e8a7d157b4310abb5ba174e83ea39"><enum>(ii)</enum><text>the Commissioner
of Food and Drugs;</text>
</clause><clause id="IDd9a0f5ffb2844926941432abae22b587"><enum>(iii)</enum><text>the Director of
the National Institutes of Health;</text>
</clause><clause commented="no" id="id0FB401BBAFF64CFE88DE5F15C51DCE90"><enum>(iv)</enum><text>the Director of
the Centers for Disease Control and Prevention; and</text>
</clause><clause commented="no" id="idCBA8B6BDE4584DB0B86A0ABC2D09CBE7"><enum>(v)</enum><text>the Director of
the Agency for Healthcare Research and Quality.</text>
</clause></subparagraph><subparagraph id="ID82ac93bda1424ee28a4e1305072a15ce"><enum>(C)</enum><header>Appointed
members</header>
<clause id="id012EC0326380401CA386A1AF84F7D6DB"><enum>(i)</enum><header>In
general</header><text>The ex officio members of the Board under subparagraph
(B) shall, by majority vote, appoint to the Board 12 individuals. Of such
appointed members—</text>
<subclause id="IDff89560da427400787ae3f68182c1db4"><enum>(I)</enum><text>4 shall be
representatives of the general pharmaceutical, device, and biotechnology
industries;</text>
</subclause><subclause id="IDd7957b34f02946cf882f72d85c181f38"><enum>(II)</enum><text>3 shall be
representatives of academic research organizations;</text>
</subclause><subclause id="IDa53d6aebc9ab42b08afa939de34672d0"><enum>(III)</enum><text>2 shall be
representatives of Government agencies, including the Food and Drug
Administration and the National Institutes of Health;</text>
</subclause><subclause id="id97D824FD4CBC4BC49DA8C9EED176E8E9"><enum>(IV)</enum><text>2 shall be
representatives of patient advocacy organizations; and</text>
</subclause><subclause id="idABB6A251F4B84FC694BB5A541F263A65"><enum>(V)</enum><text>1 shall be a
representative of health care providers.</text>
</subclause></clause><clause id="idE33DB63558994B649B706E5BF169BCA4"><enum>(ii)</enum><header>Requirement</header><text>The
ex officio members shall ensure the Board membership includes individuals with
expertise in areas including clinical pharmacology, biomedical informatics,
product safety, process improvement and pharmaceutical sciences, and medical
device and biomedical engineering.</text>
</clause></subparagraph><subparagraph commented="no" id="IDBFD8DEED15004514A1531307916F5F2D"><enum>(D)</enum><header>Initial
meeting</header>
<clause commented="no" id="id3AF6F977EE6140FEA0B321BA36B25F8A"><enum>(i)</enum><header>In
general</header><text>Not later than 30 days after the date of the enactment of
the Enhancing Drug Safety and Innovation Act of 2007, the Secretary shall
convene a meeting of the ex officio members of the Board to—</text>
<subclause commented="no" id="id552C5BB8682D413FB9285ECA20E39F49"><enum>(I)</enum><text>incorporate the
Institute; and</text>
</subclause><subclause commented="no" id="idD1EBA39F71C7466CA0224FED7D704BC7"><enum>(II)</enum><text>appoint the
members of the Board in accordance with subparagraph (C).</text>
</subclause></clause><clause commented="no" id="id637E6C4D630E4FABA3D3621516ACC671"><enum>(ii)</enum><header>Service of ex
officio members</header><text>Upon the appointment of the members of the Board
under clause (i)(II), the terms of service of the ex officio members of the
Board as members of the Board shall terminate.</text>
</clause><clause id="ID1388d4bc46c5469f820105fccd30ff67"><enum>(iii)</enum><header>Chair</header><text>The
ex officio members of the Board under subparagraph (B) shall designate an
appointed member of the Board to serve as the Chair of the Board.</text>
</clause></subparagraph></paragraph><paragraph id="idC4054B128BBC460CA6E720977A0CA7C2"><enum>(2)</enum><header>Duties of
board</header><text>The Board shall—</text>
<subparagraph id="IDae2c0409babc40fe87b17f002e79aaa7"><enum>(A)</enum><text>establish by-laws
for the Institute that—</text>
<clause id="ID8e766d265b5e47c88e861757c2e2ac79"><enum>(i)</enum><text>are published in
the Federal Register and available for public comment;</text>
</clause><clause id="ID95d1a7cdec1c464d9c65e1c2a5ce61b2"><enum>(ii)</enum><text>establish
policies for the selection of the officers, employees, agents, and contractors
of the Institute;</text>
</clause><clause id="ID881b9b3947bf417e8cdbbaf2e5000115"><enum>(iii)</enum><text>establish
policies, including ethical standards, for the acceptance, solicitation, and
disposition of donations and grants to the Institution and for the disposition
of the assets of the Institute;</text>
</clause><clause id="ID3ed870a73ae24df3901f76acabccc642"><enum>(iv)</enum><text>establish
policies whereby any individual who is an officer, employee, or member of the
Board of the Institute may not personally or substantially participate in the
consideration or determination by the Institute of any matter that would
directly or predictably affect any financial interest of the individual or a
relative (as such term is defined in section 109(16) of the Ethics in
Government Act of 1978) of the individual, of any business organization or
other entity, or of which the individual is an officer or employee or is
negotiating for employment, or in which the individual has any other financial
interest;</text>
</clause><clause id="ID6c7aaf673f504d559bacfdac242b6abf"><enum>(v)</enum><text>establish
licensing, distribution, and publication policies that support the widest and
least restrictive use by the public of information and inventions developed by
the Institute or with Institute funds to carry out the duties described in
paragraphs (6) and (7) of subsection (c);</text>
</clause><clause id="IDb39ece3ba068477ea9fc9ae6eb4238c4"><enum>(vi)</enum><text>specify
principles for the review of proposals and awarding of grants and contracts
that include peer review and that are substantially consistent with those of
the Foundation for the National Institutes of Health;</text>
</clause><clause id="ID9cb0db97cf8541e999cc42d3d1235604"><enum>(vii)</enum><text>specify a
process for annual Board review of the operations of the Institute; and</text>
</clause><clause id="IDf948659e4dfd4de8804c08d75f183df8"><enum>(viii)</enum><text>establish
specific duties of the Executive Director;</text>
</clause></subparagraph><subparagraph id="IDcebf87e921264edcadf31fdcc8cc2f9f"><enum>(B)</enum><text>prioritize and
provide overall direction to the activities of the Institute;</text>
</subparagraph><subparagraph id="ID31049838f07d432480fdaf5e62704b7e"><enum>(C)</enum><text>evaluate the
performance of the Executive Director; and</text>
</subparagraph><subparagraph id="IDc2e7208a9a5943a3aef06b26e7f8f611"><enum>(D)</enum><text>carry out any
other necessary activities regarding the functioning of the Institute.</text>
</subparagraph></paragraph><paragraph id="ID4ee4e4b233314d17adb2def2c88ae0f5"><enum>(3)</enum><header>Additional
board functions</header><text>The Board may coordinate and collaborate with
other entities to conduct research, education, and outreach, and to modernize
the sciences of developing, manufacturing, and evaluating the safety and
effectiveness of diagnostics, devices, biologics, and drugs.</text>
</paragraph><paragraph id="ID03792ecfbd614d188200cbc93a5fddd8"><enum>(4)</enum><header>Terms and
vacancies</header>
<subparagraph id="ID82d8d837a486404ea802bafcf04c23bf"><enum>(A)</enum><header>Term</header><text>The
term of office of each member of the Board appointed under paragraph (1)(C)
shall be 4 years, except that the terms of offices for the initial appointed
members of the Board shall expire on a staggered basis as determined by the ex
officio members.</text>
</subparagraph><subparagraph id="IDe01afaff6cd04704bd70daaa235f977e"><enum>(B)</enum><header>Vacancy</header><text>Any
vacancy in the membership of the Board—</text>
<clause id="id0744ECACD83C4419B593C6A6A9D671F3"><enum>(i)</enum><text>shall not affect
the power of the remaining members to execute the duties of the Board;
and</text>
</clause><clause commented="no" id="id18D5D463CD874501BA47272F4D508A39"><enum>(ii)</enum><text>shall be filled
by appointment by the individuals described in clauses (i) through (v) of
paragraph (1)(B) by majority vote.</text>
</clause></subparagraph><subparagraph id="ID90148d3a007347459166701485656ba6"><enum>(C)</enum><header>Partial
term</header><text>If a member of the Board does not serve the full term
applicable under subparagraph (A), the individual appointed under subparagraph
(B) to fill the resulting vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.</text>
</subparagraph><subparagraph id="ID807df6efe585419eb7320200cf5835fd"><enum>(D)</enum><header>Serving past
term</header><text>A member of the Board may continue to serve after the
expiration of the term of the member until a successor is appointed.</text>
</subparagraph></paragraph><paragraph id="IDe43d5793a8a248a7b417e49b5c0e980a"><enum>(5)</enum><header>Compensation</header><text>Members
of the Board may not receive compensation for service on the Board. Such
members may be reimbursed for travel, subsistence, and other necessary expenses
incurred in carrying out the duties of the Board, as set forth in the bylaws
issued by the Board.</text>
</paragraph></subsection><subsection commented="no" id="ID79E30121D7474CF6A48C20F90B65442A"><enum>(e)</enum><header>Incorporation</header><text>The
ex officio members of the Board shall serve as incorporators and shall take
whatever actions necessary to incorporate the Institute.</text>
</subsection><subsection commented="no" id="IDE5356B78CDD5400EA370B59AB319AD3B"><enum>(f)</enum><header>Nonprofit
status</header><text>The Institute shall be considered to be a corporation
under section 501(c) of the Internal Revenue Code of 1986, and shall be subject
to the provisions of such section.</text>
</subsection><subsection id="ID7ca1d1d90584491f9f2607ecd0e07811"><enum>(g)</enum><header>Executive
Director</header>
<paragraph id="ID3af75d1ad3c74866863ff22d70631c79"><enum>(1)</enum><header>In
general</header><text>The Board shall appoint an Executive Director who shall
serve at the pleasure of the Board. The Executive Director shall be responsible
for the day-to-day operations of the Institute and shall have such specific
duties and responsibilities as the Board shall prescribe.</text>
</paragraph><paragraph id="ID0226b8a095834702b8600bbc9aa28b4d"><enum>(2)</enum><header>Compensation</header><text>The
compensation of the Executive Director shall be fixed by the Board but shall
not be greater than the compensation of the Commissioner of Food and
Drugs.</text>
</paragraph></subsection><subsection id="IDef448985e1a547108899a9298a9a5b12"><enum>(h)</enum><header>Administrative
powers</header><text>In carrying out this subchapter, the Board, acting through
the Executive Director, may—</text>
<paragraph id="id3D888A0767AD4E838710A012C8706E4B"><enum>(1)</enum><text>adopt, alter, and
use a corporate seal, which shall be judicially noticed;</text>
</paragraph><paragraph id="IDe1fd682b49df4bfaa50750fc4298b815"><enum>(2)</enum><text>hire, promote,
compensate, and discharge 1 or more officers, employees, and agents, as may be
necessary, and define their duties;</text>
</paragraph><paragraph id="ID4666cb7a29634b36bc353370ab98d3d9"><enum>(3)</enum><text>prescribe the
manner in which—</text>
<subparagraph id="ID72a75c99eaef4665af6589f041bf1f68"><enum>(A)</enum><text>real or personal
property of the Institute is acquired, held, and transferred;</text>
</subparagraph><subparagraph id="ID59cd004ba5f1407ca9962e4067f1f1c6"><enum>(B)</enum><text>general
operations of the Institute are to be conducted; and</text>
</subparagraph><subparagraph id="IDbc019f4e2ffe49248f35346bef499045"><enum>(C)</enum><text>the privileges
granted to the Board by law are exercised and enjoyed;</text>
</subparagraph></paragraph><paragraph commented="no" id="ID259b27e0422345658cf71f48b9d5b2ea"><enum>(4)</enum><text>with the consent
of the applicable executive department or independent agency, use the
information, services, and facilities of such department or agencies in
carrying out this section;</text>
</paragraph><paragraph id="ID9485fbbdc5cc4722915df3bd17613530"><enum>(5)</enum><text>enter into
contracts with public and private organizations for the writing, editing,
printing, and publishing of books and other material;</text>
</paragraph><paragraph id="ID43023703e4f34da49b2c129d1521cf86"><enum>(6)</enum><text>hold, administer,
invest, and spend any gift, devise, or bequest of real or personal property
made to the Institute under subsection (i);</text>
</paragraph><paragraph commented="no" id="ID4fb7d725da8e47f8b61c6ee49716f12e"><enum>(7)</enum><text>enter into such
other contracts, leases, cooperative agreements, and other transactions as the
Board considers appropriate to conduct the activities of the Institute;</text>
</paragraph><paragraph id="ID4035cc79a14241deab2215c14e25cbcb"><enum>(8)</enum><text>modify or consent
to the modification of any contract or agreement to which it is a party or in
which it has an interest under this subchapter;</text>
</paragraph><paragraph id="ID2d3be665883e46789485a006fc4e6b0b"><enum>(9)</enum><text>take such action
as may be necessary to obtain patents and licenses for devices and procedures
developed by the Institute and its employees;</text>
</paragraph><paragraph id="IDbf48808a88354cff9ff2ae24c5a4d5dc"><enum>(10)</enum><text>sue and be sued
in its corporate name, and complain and defend in courts of competent
jurisdiction;</text>
</paragraph><paragraph id="ID6e738c7e4ef24a6aaeb0c6f24203d54b"><enum>(11)</enum><text>appoint other
groups of advisors as may be determined necessary to carry out the functions of
the Institute; and</text>
</paragraph><paragraph id="IDc88976403bfe4e86b65096ade2076766"><enum>(12)</enum><text>exercise other
powers as set forth in this section, and such other incidental powers as are
necessary to carry out its powers, duties, and functions in accordance with
this subchapter.</text>
</paragraph></subsection><subsection id="id0627B60CDFAB443A8086230630C41B80"><enum>(i)</enum><header>Acceptance of
funds from other sources</header><text>The Executive Director may solicit and
accept on behalf of the Institute, any funds, gifts, grants, devises, or
bequests of real or personal property made to the Institute, including from
private entities, for the purposes of carrying out the duties of the
Institute.</text>
</subsection><subsection id="idE51B58E0D90349DE9B3E50983C37CA8D"><enum>(j)</enum><header>Service of
Federal employees</header><text>Federal Government employees may serve on
committees advisory to the Institute and otherwise cooperate with and assist
the Institute in carrying out its functions, so long as such employees do not
direct or control Institute activities.</text>
</subsection><subsection id="idAC7EF3F3E84749F093A59DB0BBFE6619"><enum>(k)</enum><header>Detail of
government employees</header><text>Federal Government employees may be detailed
from Federal agencies with or without reimbursement to those agencies to the
Institute at any time, and such detail shall be without interruption or loss of
civil service status or privilege. Each such employee shall abide by the
statutory, regulatory, ethical, and procedural standards applicable to the
employees of the agency from which such employee is detailed and those of the
Institute.</text>
</subsection><subsection id="id7A0623E998CA404D97FB0BADF28A8AF0"><enum>(l)</enum><header>Annual
reports</header>
<paragraph id="idC472A69D59C740BC9E372B7DBEDAB874"><enum>(1)</enum><header>Reports to
Institute</header><text>Any recipient of a grant, contract, or cooperative
agreement from the Institute under this section shall submit to the Institute a
report on an annual basis for the duration of such grant, contract, or
cooperative agreement, that describes the activities carried out under such
grant, contract, or cooperative agreement.</text>
</paragraph><paragraph id="idD7A155A868494463A2C13B3727A4B67F"><enum>(2)</enum><header>Report to
FDA</header><text>Beginning with fiscal year 2009, the Executive Director shall
submit to the Commissioner an annual report that—</text>
<subparagraph id="idF8C2BF3DC10F4F09B75F8C085FFC7D25"><enum>(A)</enum><text>details the
progress of the Institute in furthering the goals and priorities established
under subsection (c)(2); and</text>
</subparagraph><subparagraph id="IDb3ddff4fd2a14aff9b5b312847c603b8"><enum>(B)</enum><text>provides
recommendations for incorporating such progress into regulatory and product
review activities of the Food and Drug Administration.</text>
</subparagraph></paragraph><paragraph id="id6ADA13544ABE407F9BA48AF32A682B6B"><enum>(3)</enum><header>Report to
Congress</header><text>Beginning with fiscal year 2009, the Executive Director
shall submit to the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of Representatives an
annual report that—</text>
<subparagraph id="idA2B825E6CF72431C846A2199C4A566BA"><enum>(A)</enum><text>describes the
activities of the Institute and of the recipients of a grant, contract, or
cooperative agreement under this section, including the practical impact of the
Institute on medical product development;</text>
</subparagraph><subparagraph id="idA9DA005E8EA74C07B7C8CADE8169B039"><enum>(B)</enum><text>provides a
specific accounting of the source of all funds used by the Institute to carry
out such activities; and</text>
</subparagraph><subparagraph id="idCECEC11D687241048083A913F3711369"><enum>(C)</enum><text>describes how
such funds were used by the Institute.</text>
</subparagraph></paragraph></subsection><subsection id="id19F3189C5FB34F3CAB80812E4574EFE3"><enum>(m)</enum><header>Separation of
funds</header><text>The Executive Director shall ensure that the funds received
from the Treasury are held in separate accounts from funds received from
entities under subsection (i).</text>
</subsection><subsection id="id96E27B5F83314E49BFF51619E980B0DB"><enum>(n)</enum><header>Authorization
of appropriations</header><text>There are authorized to be appropriated such
sums as may be necessary for each of fiscal years 2008 through 2013 to carry
out subsections (a), (b), and (d) through
(m).</text>
</subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID41bd91d5d3384cf6a621522e9229198e"><enum>(b)</enum><header>Other Institute
provisions</header><text display-inline="yes-display-inline">Chapter VII (21
U.S.C. 371 et seq.) (as amended by subsection (a)) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id65B1A3BD7594409FB7FC2BDF95F37825" style="OLC">
<section id="IDd6b82541c38e4303a5556cd233d76382"><enum>771.</enum><header>Location of
Institute</header>
<subsection id="ID9f41a1631f4843b3b395e005407e80fe"><enum>(a)</enum><header>In
general</header><text>The Institute shall, if practicable, be located not more
than 20 miles from the District of Columbia.</text>
</subsection><subsection commented="no" id="idA6ADB8F1058540E6BD510B9A63E31033"><enum>(b)</enum><header>Use of
space</header><text>The Secretary shall consult with the Administrator of
General Services to ensure the most cost-efficient arrangement for the leasing
or purchase of real property for adequate facilities which, if practicable,
shall be located at the Food and Drug Administration, to meet the needs of the
Institute in carrying out this subchapter.</text>
</subsection></section><section commented="no" id="id40A981DAA2324131B6FCFA3DDEE56E5A"><enum>772.</enum><header>Activities of
the Food and Drug Administration</header>
<subsection commented="no" id="id788D96523AD044C4992A27288875FFF9"><enum>(a)</enum><header>In
general</header><text>The Commissioner shall receive and assess the report
submitted to the Commissioner by the Executive Director of the Institute under
section 770(l)(2).</text>
</subsection><subsection commented="no" id="id72D872A4B963442BADC21046A19C1935"><enum>(b)</enum><header>Report to
Congress</header><text display-inline="yes-display-inline">The Commissioner
shall submit to the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee on Energy and
Commerce and the Committee on Appropriations of the House of Representatives an
annual report that describes the implementation of any recommendations included
in the report described under subsection
(a).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>III</enum><header>Clinical
trials</header>
<section id="idEFD8887C660743D6973B6DA383036069"><enum>301.</enum><header>Clinical trial
registry database and clinical trial results database</header>
<subsection id="id4DAB89F9A38A4DEAABDB37F9F6834CFE"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Subsection (i) of
section 402 of the Public Health Service Act (42 U.S.C. 282), as amended by
Public Law 109–482, is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idC27E38658BCE4B4A8729A3EBEE4A8934" style="OLC">
<subsection id="id28846695FF3F4B2AB5350604E9337968"><enum>(i)</enum><header>Clinical trial
registry database; clinical trial results database</header>
<paragraph id="id925EA086AC5143B3B9B081049FF4B45F"><enum>(1)</enum><header>Definitions;
requirement</header>
<subparagraph id="idC36800BC1DBF42FA8B1F834BAD681E9C"><enum>(A)</enum><header>Definitions</header><text>In
this subsection:</text>
<clause id="id0CB5AD83644345F1AAC0688A1F2EB0BE"><enum>(i)</enum><header>Clinical trial
information</header><text>The term <term>clinical trial information</term>
means those data elements that are necessary to complete an entry in the
clinical trial registry database under paragraph (2) or the clinical trial
results database under paragraph (3), as applicable.</text>
</clause><clause id="id155072CDA44B481684797E7022AE0446"><enum>(ii)</enum><header>Completion
date</header><text>The term <term>completion date</term> means, with respect to
a clinical trial, the date on which the last patient enrolled in the clinical
trial has completed his or her last medical visit of the clinical trial,
whether the clinical trial concluded according to the prespecified protocol
plan or was terminated.</text>
</clause><clause id="idEB9B054467654B419C9E2DA5968E1DD8"><enum>(iii)</enum><header>Drug</header><text>The
term <term>drug</term> means a drug as defined in section 201(g) of the Federal
Food, Drug, and Cosmetic Act or a biological product as defined in section 351
of this Act.</text>
</clause><clause id="id0B0613422E434FE2ACB6B35AF59A55AF"><enum>(iv)</enum><header>Responsible
party</header><text>The term <term>responsible party</term>, with respect to a
clinical trial of a drug, means the sponsor of the clinical trial or the
principal investigator of such clinical trial if so designated by such
sponsor.</text>
</clause></subparagraph><subparagraph id="id8DA86750221C4548B7A05B6C1B61FDAB"><enum>(B)</enum><header>Requirement</header><text>The
Secretary shall develop a mechanism by which—</text>
<clause id="idF00F770241334AE2814D6934173DD65A"><enum>(i)</enum><text>the responsible
party for each applicable clinical trial shall submit the identity and contact
information of such responsible party to the Secretary at the time of
submission of clinical trial information under paragraph (2); and</text>
</clause><clause id="idA3AFEE956D854FEB8867A39A8CF64454"><enum>(ii)</enum><text>other Federal
agencies may identify the responsible party for an applicable clinical
trial.</text>
</clause></subparagraph></paragraph><paragraph id="id231FEAF54E584E4CA5D5A518E85251C9"><enum>(2)</enum><header>Clinical trial
registry database</header>
<subparagraph id="id6C848FC1511644E983AAA6B67E4FB7DF"><enum>(A)</enum><header>Applicable
clinical trial</header>
<clause id="id43127489B4AF49D384ADCB4D96C8484E"><enum>(i)</enum><header>In
general</header><text>For purposes of this paragraph the term <term>applicable
clinical trial</term> means—</text>
<subclause id="IDc5b208b6f7fe45d88cf303310e7551c4"><enum>(I)</enum><text>a therapeutic or
chemopreventive clinical trial to verify the efficacy and establish
appropriate doses for the drug conducted before the drug is approved under
section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act;</text>
</subclause><subclause id="id1E52F8FD8F0246D9956B94908DFA8A3E"><enum>(II)</enum><text>a therapeutic or
chemopreventive confirmatory clinical trial;</text>
</subclause><subclause id="ID8929e994c3ae491690cc48f78f785c1a"><enum>(III)</enum><text>a clinical
trial conducted after the drug is approved under such section 505 or licensed
under such section 351; or</text>
</subclause><subclause id="IDfb5deeeef62a4684ab9c49620480b843"><enum>(IV)</enum><text>a
pharmacokinetic study to support a pediatric indication for the drug.</text>
</subclause></clause><clause id="id89FBE85C00264AB885B46CF4C46F5DA6"><enum>(ii)</enum><header>Exceptions</header>
<subclause id="id2EF23641554846D0B4EC324BD646AFE1"><enum>(I)</enum><header>Certain
exploratory trials</header><text>A clinical trial under clause (i)(I) does not
include an exploratory clinical trial that is intended solely to assess safety,
solely to evaluate pharmacokinetics, or solely to verify efficacy.</text>
</subclause><subclause id="idAE463B2485F543139EA30F156230EEB9"><enum>(II)</enum><header>Observational
studies</header><text>A clinical trial under clause (i) does not include an
observational study.</text>
</subclause></clause></subparagraph><subparagraph id="idA1139C39DB06401F94437A93D0B8478D"><enum>(B)</enum><header>Establishment</header>
<clause id="id2F7862720A9B4FEDA77885CF4B4DC749"><enum>(i)</enum><header>In
general</header><text>To enhance patient enrollment and provide a mechanism to
track subsequent progress of clinical trials, the Secretary, acting through the
Director of NIH, shall establish and administer a clinical trial registry
database in accordance with this subsection (referred to in this subsection as
the <quote>registry database</quote>). The Director of NIH shall ensure that
the registry database is made publicly available through the Internet.</text>
</clause><clause id="ID9813901cbaef4468893e46009cd551c3"><enum>(ii)</enum><header>Content</header><text>The
Secretary shall promulgate regulations for the submission to the registry
database of clinical trial information that—</text>
<subclause id="ID62a60d3c4876463e98543d3e847a9615"><enum>(I)</enum><text>conforms to the
International Clinical Trials Registry Platform trial registration data set of
the World Health Organization;</text>
</subclause><subclause id="id7D5C924C7EB14F71909F34741F1597A0"><enum>(II)</enum><text>includes the
city, State, and zip code for each clinical trial location;</text>
</subclause><subclause id="ID3eb6995274084a689785e61ca40e61cc"><enum>(III)</enum><text>if the drug is
not approved under section 505 of the Federal Food, Drug, and Cosmetic Act or
licensed under section 351 of this Act, specifies whether or not there is
expanded access to the drug under section 561 of the Federal Food, Drug, and
Cosmetic Act for those who do not qualify for enrollment in the clinical trial
and how to obtain information about such access; and</text>
</subclause><subclause id="id2D793EC540C44505A7B4FE3D83688EF7"><enum>(IV)</enum><text>requires the
inclusion of such other data elements to the registry database as
appropriate.</text>
</subclause></clause></subparagraph><subparagraph id="id16FF02CA450646B59BE1233136D18074"><enum>(C)</enum><header>Format and
structure</header>
<clause id="idD49524E75F554DAA8420A8383F2C56F5"><enum>(i)</enum><header>Searchable
categories</header><text>The Director of NIH shall ensure that the public may
search the entries in the registry database by 1 or more of the following
criteria:</text>
<subclause id="id59D34172AD7243FDA93F0ECBCA3B5629"><enum>(I)</enum><text>The indication
being studied in the clinical trial, using Medical Subject Headers (MeSH)
descriptors.</text>
</subclause><subclause id="idFF78867FAA544869B9BD0D288122CE2C"><enum>(II)</enum><text>The safety issue
being studied in the clinical trial.</text>
</subclause><subclause id="idEF50FC062925410593ABF10EBE2866B6"><enum>(III)</enum><text>The enrollment
status of the clinical trial.</text>
</subclause><subclause id="id903FD636DDDC46B989EEB5CA087F770D"><enum>(IV)</enum><text>The sponsor of
the clinical trial.</text>
</subclause></clause><clause id="IDa5036e66a8d24a61b193acd2b662a70e"><enum>(ii)</enum><header>Format</header><text>The
Director of the NIH shall ensure that the registry database is easily used by
patients, and that entries are easily compared.</text>
</clause></subparagraph><subparagraph id="id69BA85FCA1FF4A95948F15ABA003898E"><enum>(D)</enum><header>Data
submission</header><text>The responsible party for an applicable clinical trial
shall submit to the Director of NIH for inclusion in the registry database the
clinical trial information described in subparagraph (B)(ii).</text>
</subparagraph><subparagraph id="idFB516B4152EA4448BDB53B045D250824"><enum>(E)</enum><header>Truthful
clinical trial information</header>
<clause id="idBF2E0A5D13AE43F5A15DC80347ABD166"><enum>(i)</enum><header>In
general</header><text>The clinical trial information submitted by a responsible
party under this paragraph shall not be false or misleading in any
particular.</text>
</clause><clause id="id1EC0225865EB4EDDBF6C35B3F83F53F2"><enum>(ii)</enum><header>Effect</header><text>Clause
(i) shall not have the effect of requiring clinical trial information with
respect to an applicable clinical trial to include information from any source
other than such clinical trial.</text>
</clause></subparagraph><subparagraph id="id3842A65A51244FAD944564BE34AD478F"><enum>(F)</enum><header>Changes in
clinical trial status</header>
<clause id="IDb3839a7360524aedb507b457b0bfef32"><enum>(i)</enum><header>Enrollment</header><text>The
responsible party for an applicable clinical trial shall update the enrollment
status not later than 30 days after the enrollment status of such clinical
trial changes.</text>
</clause><clause id="idA8A7E6614B8D423F800C96C0D6CEA8A0"><enum>(ii)</enum><header>Completion</header><text>The
responsible party for an applicable clinical trial shall report to the Director
of NIH that such clinical trial is complete not later than 30 days after the
completion date of the clinical trial.</text>
</clause></subparagraph><subparagraph id="idAA6B2FD0213F4756A0DEEBC8D8FFCAEF"><enum>(G)</enum><header>Timing of
submission</header><text>The clinical trial information for an applicable
clinical trial required to be submitted under this paragraph shall be submitted
not later than 14 days after the first patient is enrolled in such clinical
trial.</text>
</subparagraph></paragraph><paragraph id="idF2276BE39C83450799DFCD36A916E975"><enum>(3)</enum><header>Clinical trials
results database</header>
<subparagraph id="id7949F6D7CF314B1884E28BA74991C9B0"><enum>(A)</enum><header>Applicable
clinical trial</header>
<clause id="id8A1B137EEC2B475FB9757E8DFF7AA915"><enum>(i)</enum><header>In
general</header><text>For purposes of this paragraph, the term <term>applicable
clinical trial</term> means—</text>
<subclause id="IDe8312a8524fb44d6856e09f0c9f93d43"><enum>(I)</enum><text>a clinical trial
conducted before the drug is approved under section 505 of the Federal Food,
Drug, and Cosmetic Act or licensed under section 351 of this Act that
is—</text>
<item id="IDaa3ea019cd2741adaef32e4f46da8f31"><enum>(aa)</enum><text>a
therapeutic or chemopreventive confirmatory clinical trial;</text>
</item><item id="ID2f506eb2031c4f4194f177a8b96c863b"><enum>(bb)</enum><text>a
clinical trial for a drug approved as a fast-track product under section 506 of
the Federal Food, Drug, and Cosmetic Act, if such clinical trial is used to
form the primary basis of an efficacy claim for such drug; or</text>
</item><item id="idFEA23BA4C35445D482A0EB32C6662F69"><enum>(cc)</enum><text>if
required by the Secretary under subparagraph (G)(i), a clinical trial described
in paragraph (2)(A)(i)(I);</text>
</item></subclause><subclause id="ID44141fc426984b688de52bb25ef2d3b1"><enum>(II)</enum><text>a clinical trial
completed after the drug is approved under such section 505 or licensed under
such section 351; or</text>
</subclause><subclause id="idA02B4BDED6A04EDFA492AC68816BE3E0"><enum>(III)</enum><text>a
pharmacokinetic study to support a pediatric indication for the drug.</text>
</subclause></clause><clause commented="no" id="IDbef3cfae79474e05aa3f019b3922f595"><enum>(ii)</enum><header>Exceptions</header>
<subclause commented="no" id="id5330078235344A25B8F4D889247A589D"><enum>(I)</enum><header>Certain
exploratory trials</header><text>A clinical trial under clause (i)(I) does not
include an exploratory clinical trial that is intended solely to assess safety,
solely to evaluate pharmacokinetics, or solely to verify efficacy.</text>
</subclause><subclause commented="no" id="ID5d83a5928c57409dbabeeffb709e484e"><enum>(II)</enum><header>Observation
studies</header><text>A clinical trial under clause (i) does not include an
observational study.</text>
</subclause></clause></subparagraph><subparagraph id="id0533B96A96C7499CB8A326BC8678EE5A"><enum>(B)</enum><header>Establishment</header><text>To
ensure that results of clinical trials are made public and that patients and
providers have current information regarding the results of clinical trials,
the Secretary, acting through the Director of NIH, shall establish and
administer a clinical trial results database in accordance with this subsection
(referred to in this subsection as the <quote>results database</quote>).</text>
</subparagraph><subparagraph id="id314158FEF60C48D88E3D469162515D4B"><enum>(C)</enum><header>Searchable
categories</header><text>The Director of NIH shall ensure that the public may
search the entries in the results database by 1 or more of the
following:</text>
<clause id="id64B6BB0040A14CAD95E492FEE2346F73"><enum>(i)</enum><text>The indication
studied in the clinical trial, using Medical Subject Headers (MeSH)
descriptors.</text>
</clause><clause id="id6177260F09C24958A17DA5FAFF99A115"><enum>(ii)</enum><text>The safety issue
studied in the clinical trial.</text>
</clause><clause id="ID31693b9c99494a60919d18513a63fea2"><enum>(iii)</enum><text>Whether an
application for the tested indication is approved, pending approval, withdrawn,
or not submitted.</text>
</clause><clause id="ID3004f9f44cf8462cb1a75dddcd903027"><enum>(iv)</enum><text>The phase of the
clinical trial.</text>
</clause><clause id="IDe0d9367c5a3d4fd79cd02a74814d5f8f"><enum>(v)</enum><text>The name of the
drug that is the subject of the clinical trial.</text>
</clause><clause id="id5A321878D32A4A33B9425AF4BF4C2413"><enum>(vi)</enum><text>Within the
documents described in subclauses (II) and (III) of subparagraph (D)(ii), the
following information, as applicable:</text>
<subclause id="id778F27847F784F02AF33610D35B3CB00"><enum>(I)</enum><text>The sponsor of
the clinical trial.</text>
</subclause><subclause id="id470BA19578CA4BCCAED19FA80ACBAD16"><enum>(II)</enum><text>Each financial
sponsor of the clinical trial.</text>
</subclause></clause></subparagraph><subparagraph id="idEF9F38A6B7254A4AB3078CD15A95E362"><enum>(D)</enum><header>Contents</header>
<clause id="id6BDB935D803548719DEA0D1B09773058"><enum>(i)</enum><header>In
general</header><text>The responsible party for an applicable clinical trial
shall submit to the Director of NIH for inclusion in the results database the
clinical trial information described in clause (ii).</text>
</clause><clause id="id24AB3759900B4C258C725C7F8B8E0DD4"><enum>(ii)</enum><header>Required
elements</header><text>In submitting clinical trial information for an
applicable clinical trial to the Director of NIH for inclusion in the results
database, the responsible party shall include, with respect to such clinical
trial, the following information:</text>
<subclause id="id5B1E176A414E4FFDA0BFF88738FC572E"><enum>(I)</enum><text>The information
described in clauses (i) through (v) of subparagraph (C).</text>
</subclause><subclause id="ID4428a5b1ad2748cea9bf481380db58af"><enum>(II)</enum><text>A
non-promotional summary document that is written in non-technical,
understandable language for patients that includes the following:</text>
<item id="ID270d600043024ec0b1fafb76a547b83d"><enum>(aa)</enum><text>The purpose of
the clinical trial.</text>
</item><item id="id207496DB423B4ACEBF354F8132458BBC"><enum>(bb)</enum><text>The sponsor of
the clinical trial.</text>
</item><item id="ID560c23b83981450f9820c0979198e140"><enum>(cc)</enum><text>A
point of contact for information about the clinical trial.</text>
</item><item id="ID0ccd25f8a9c64a55852a6abdb04d04c8"><enum>(dd)</enum><text>A
description of the patient population tested in the clinical trial.</text>
</item><item id="IDc39d871f623a4f99bff8aed31df9cfd8"><enum>(ee)</enum><text>A
general description of the clinical trial and results, including a description
of and the reasons for any changes in the clinical trial design that occurred
since the date of submission of clinical trial information for inclusion in the
registry database established under paragraph (2) and a description of any
significant safety information.</text>
</item></subclause><subclause id="id39F0FDBAD6004CF480439A8C50A7545A"><enum>(III)</enum><text>A
non-promotional summary document that is technical in nature that includes the
following:</text>
<item id="id67F3FFC2BE82408F9C2FA0A5C02C8FC9"><enum>(aa)</enum><text>The purpose of
the clinical trial.</text>
</item><item id="id46844FD608F841EA9ADFE5EC9A2AD9C9"><enum>(bb)</enum><text>The sponsor of
the clinical trial.</text>
</item><item id="idDBEA344D2E224AD8A7B4F0D6D77A3929"><enum>(cc)</enum><text>Each financial
sponsor of the clinical trial.</text>
</item><item id="id95CF49D663064D49BF391FAD65468A83"><enum>(dd)</enum><text>A
point of contact for scientific information about the clinical trial.</text>
</item><item id="idC734BC98E058414DA102795CB8C8312B"><enum>(ee)</enum><text>A
description of the patient population tested in the clinical trial.</text>
</item><item id="id881245C065CE47D7A9AD8042D942EE17"><enum>(ff)</enum><text>A
general description of the clinical trial and results, including a description
of and the reasons for any changes in the clinical trial design that occurred
since the date of submission of clinical trial information for the clinical
trial in the registry database established under paragraph (2).</text>
</item><item id="id0D33BA7FA49C4DF2B22CE160FADCCDB6"><enum>(gg)</enum><text>Summary data
describing the results, including—</text>
<subitem id="idE4547EB2E3E44BF1A4C8ECE7D8B8FB56"><enum>(AA)</enum><text>whether the
primary endpoint was achieved, including relevant statistics;</text>
</subitem><subitem id="id93E3CF24A87E4D5CA583ED7717D994BB"><enum>(BB)</enum><text>an assessment of
any secondary endpoints, if applicable, including relevant statistics;
and</text>
</subitem><subitem id="id7A6CFAB5CD164413AFE208B6DEA6E54B"><enum>(CC)</enum><text>any significant
safety information, including a summary of the incidence of serious adverse
events observed in the clinical trial and a summary of the most common adverse
events observed in the clinical trial and the frequencies of such
events.</text>
</subitem></item></subclause><subclause id="ID52e99faf1fbc4d6daddfcd99275ca14b"><enum>(IV)</enum><text>A link to
available peer-reviewed publications based on the results of the clinical
trial.</text>
</subclause><subclause id="id96732321091A4B549FB94436E70CE819"><enum>(V)</enum><text>The completion
date of the clinical trial.</text>
</subclause><subclause id="ID7103307bc7a54c9e8590e3e18edd054f"><enum>(VI)</enum><text>A link to the
Internet web posting of any adverse regulatory actions taken by the Food and
Drug Administration, such as a warning letter, that was substantively based on
the clinical trial design, outcome, or representation made by the applicant
about the design or outcome of the clinical trial.</text>
</subclause></clause></subparagraph><subparagraph id="id86E0DBCB0E7B4103AE3201FED0BCEA54"><enum>(E)</enum><header>Timing</header><text>A
responsible party shall submit to the Director of NIH for inclusion in the
results database clinical trial information for an applicable clinical trial
not later than 1 year after the completion date of the clinical trial as
reported under paragraph (2)(F)(ii).</text>
</subparagraph><subparagraph id="id105CCAA4647D4FEABE3E96D296DE5344"><enum>(F)</enum><header>Truthful
clinical trial information</header>
<clause id="id1EE586289A724FB8B145BF6A92D81A9F"><enum>(i)</enum><header>In
general</header><text>The clinical trial information submitted by a responsible
party under this paragraph shall not be false or misleading in any
particular.</text>
</clause><clause id="id2B41D2E727634DB8ACB33586B0F0E9D1"><enum>(ii)</enum><header>Effect</header><text>Clause
(i) shall not have the effect of requiring clinical trial information with
respect to an applicable clinical trial to include information from any source
other than such clinical trial.</text>
</clause></subparagraph><subparagraph id="idD3C1F727A2DA48D0B2670CD6CEC60F08"><enum>(G)</enum><header>Inclusion of
earlier-stage clinical trials</header>
<clause id="id2B80D693053B47A6BC3460EBEB8FA420"><enum>(i)</enum><header>In
general</header><text>The Secretary may, subject to clause (ii), require
through rulemaking the submission of clinical trial information for the
clinical trials described in paragraph (2)(A)(i)(I) to the Director of NIH for
inclusion in the results database.</text>
</clause><clause id="idC4ADEE5773844E8F9D689D702D810992"><enum>(ii)</enum><header>Conditions for
requiring inclusion of earlier-stage trials</header><text>The Secretary may
promulgate regulations pursuant to clause (i) if—</text>
<subclause id="id697FD84DCA274CE3A77B026C2737B693"><enum>(I)</enum><text>the Comptroller
General of the United States has submitted to the Secretary the report
described under clause (iii); and</text>
</subclause><subclause id="id1FE5C0739F664F849788D28DB9FFA38A"><enum>(II)</enum><text>such report
recommends the inclusion in the results database of clinical trial information
for the clinical trials described under paragraph (2)(A)(i)(I).</text>
</subclause></clause><clause id="idCC7ABFCBFD2D4F10A02C206FC7CA7A3E"><enum>(iii)</enum><header>Study by
GAO</header><text>Not earlier than 2 years after the results database has been
established, the Comptroller General of the United States shall initiate a
report that—</text>
<subclause id="id73903D167EF04B0289F5507A747A7F0D"><enum>(I)</enum><text>evaluates the
operation of the database, including with respect to cost, burden on drug
sponsors and agencies, and the value to patients and health care providers of
inclusion in the results database of clinical trial information with respect to
clinical trials described in paragraph (2)(A)(i)(I);</text>
</subclause><subclause id="idAC866CC2F7C24911B4994669F5DFAF1B"><enum>(II)</enum><text>recommends
whether or not clinical trial information for such clinical trials should be
included in the results database;</text>
</subclause><subclause id="id5796B7B83C914A7C897002EE33B95FB7"><enum>(III)</enum><text>if the
recommendation under subclause (II) is to include the clinical trial
information for such clinical trials in the results database, recommends
whether such information should be included in the same format as the clinical
trial information of other applicable clinical trials, or if modifications are
necessary;</text>
</subclause><subclause id="idDDC102E2A0134730BF8959FF1D77E2F3"><enum>(IV)</enum><text>provides
recommendations for any modifications described under subclause (III);
and</text>
</subclause><subclause id="idF14CC2C38C914BAAA57A46F6923F00EF"><enum>(V)</enum><text>is submitted to
the Committee on Health, Education, Labor, and Pensions of the Senate, the
Committee on Energy and Commerce of the House of Representatives, and the
Secretary.</text>
</subclause></clause></subparagraph><subparagraph id="id596FA9FFF5CF4744AF294350DEAEE198"><enum>(H)</enum><header>Change in
regulatory status</header><text>The responsible party for an applicable
clinical trial shall inform the Director of NIH of a change in the regulatory
status submitted under subparagraph (C)(ii) of a drug that is the subject of an
applicable clinical trial within 30 days of such change, so that the Director
can update the results database accordingly.</text>
</subparagraph><subparagraph id="ID1f1f235a23174d8d866df739efb02cc0"><enum>(I)</enum><header>Public
availability of results</header>
<clause id="ID461f17f0a13d4ccdbc7052f21b91d5b9"><enum>(i)</enum><header>Pre-approval
studies</header><text>Except as provided in clause (iv), with respect to an
applicable clinical trial that is completed before the drug is initially
approved under section 505 of the Federal Food, Drug, and Cosmetic Act or
initially licensed under section 351 of this Act, the Director of NIH shall
make publicly available on the results database the clinical trial information
submitted for such clinical trial not later than 30 days after—</text>
<subclause id="IDf5254804da6d42a7934e7b6307e68d17"><enum>(I)</enum><text>the drug is
approved under such section 505 or licensed under such section 351; or</text>
</subclause><subclause id="IDb06ea56c288942eaaf46a1df782daa3b"><enum>(II)</enum><text>the Secretary
issues a not approvable letter for the drug under such section 505 or such
section 351.</text>
</subclause></clause><clause id="ID7fb05c1f46fb4f31a1ba6dd5ae760dae"><enum>(ii)</enum><header>Post-approval
studies</header><text>Except as provided in clauses (iii) and (iv), with
respect to an applicable clinical trial that is completed after the drug is
initially approved under such section 505 or initially licensed under such
section 351, the Director of NIH shall make publicly available on the results
database the clinical trial information submitted for such clinical trial not
later than 30 days after the date of such submission.</text>
</clause><clause id="ID962c05ebcb0a47a1af768636056d4e6c"><enum>(iii)</enum><header>Seeking
approval of a new use for the drug</header>
<subclause id="id117A1D2B65174E66938325045D21DEAB"><enum>(I)</enum><header>In
general</header><text>If the manufacturer of the drug is the sponsor or a
financial sponsor of the applicable clinical trial, and such manufacturer
certifies to the Director of NIH that such manufacturer has filed, or will file
within 1 year, an application seeking approval under such section 505 or
licensing under such section 351 for the use studied in such clinical trial
(which use is not included in the labeling of the approved drug), then the
Director of NIH shall make publicly available on the results database the
clinical trial information submitted for such clinical trial on the earlier of
the date that is 30 days after the date—</text>
<item id="ID309cf0a06409458ab9c20697fd075596"><enum>(aa)</enum><text>the application
is approved under such section 505 or licensed such section 351;</text>
</item><item id="ID62dd2a3b832642188723d140707515fa"><enum>(bb)</enum><text>the Secretary
issues a not approvable letter for the application under such section 505 or
such section 351; or</text>
</item><item id="ID535bad0b84fc4be78831e910e0468ad3"><enum>(cc)</enum><text>the application
under such section 505 or such section 351 is withdrawn.</text>
</item></subclause><subclause id="idC78C7C9187DC46BAABB6D921C6AAE987"><enum>(II)</enum><header>Limitation on
certification</header><text>A manufacturer shall not make a certification under
subclause (I) with respect to an applicable clinical trial unless the
manufacturer makes such a certification with respect to each applicable
clinical trial that is required to be submitted in an application for approval
of the use studied in the clinical trial involved.</text>
</subclause><subclause id="idCA9564559862490487544C143A827B8A"><enum>(III)</enum><header>2-year
limitation</header><text>The clinical trial information subject to subclause
(I) shall be made publicly available on the results database on the date that
is 2 years after the date the certification referred to in subclause (I) was
made to the Director of NIH, if a regulatory action referred to in item (aa),
(bb), or (cc) of subclause (I) has not occurred by such date.</text>
</subclause></clause><clause id="IDee3a31fed3994ff9809f4b2a2d9e8aec"><enum>(iv)</enum><header>Seeking
publication</header>
<subclause id="idFE0F0B603B314DFC842160F9D7625346"><enum>(I)</enum><header>In
general</header><text>If the principal investigator of the applicable clinical
trial is seeking publication in a peer-reviewed biomedical journal of a
manuscript based on the results of the clinical trial and the responsible party
so certifies to the Director of NIH—</text>
<item id="id3222BE318EDF495E8AFEC19D0564A58C"><enum>(aa)</enum><text>the responsible
party shall notify the Director of NIH of the publication date of such
manuscript not later than 15 days after such date; and</text>
</item><item id="id680E37E8B8314A718F6222B785F71830"><enum>(bb)</enum><text>the Director of
NIH shall make publicly available on the results database the clinical trial
information submitted for such clinical trial on the date that is 30 days after
the publication date of such manuscript.</text>
</item></subclause><subclause id="IDacb8e253dd5a453da6e2e893cc8d4ada"><enum>(II)</enum><header>Limitation</header><text>The
clinical trial information subject to subclause (I) shall be made publicly
available on the results database on the date that is 2 years after the date
that the clinical trial information was required to be submitted to the
Director of NIH if the manuscript referred to in such subclause has not been
published by such date.</text>
</subclause></clause></subparagraph><subparagraph id="id2FE1ACA1FFC74E028DB17DB55318A155"><enum>(J)</enum><header>Verification of
submission prior to public availability</header><text>In the case of clinical
trial information that is submitted under this paragraph, but is not made
publicly available pending either regulatory action or publication under clause
(iii) or (iv) of subparagraph (I), as applicable, the Director of NIH shall
respond to inquiries from other Federal agencies and peer-reviewed journals to
confirm that such clinical trial information has been submitted but has not yet
been made publicly available on the results database.</text>
</subparagraph></paragraph><paragraph id="id75A0EA8895D6431F8099210CC340C57B"><enum>(4)</enum><header>Coordination
and compliance</header>
<subparagraph id="idDA9BB20C98D04F17A46D39912AC67F27"><enum>(A)</enum><header>Clinical trials
supported by grants from Federal agencies</header>
<clause id="idF3C68EC6BDD44093A006A8308877ABDA"><enum>(i)</enum><header>In
general</header><text>No Federal agency may release funds under a research
grant to a person who has not complied with paragraphs (2) and (3) for any
applicable clinical trial for which such person is the responsible
party.</text>
</clause><clause id="idDCCB9E2BDD274E0E8736794FFA212A4E"><enum>(ii)</enum><header>Grants from
certain Federal agencies</header><text>If an applicable clinical trial is
funded in whole or in part by a grant from the National Institutes of Health,
the Agency for Healthcare Research and Quality, or the Department of Veterans
Affairs, any grant or progress report forms required under such grant shall
include a certification that the responsible party has made all required
submissions to the Director of NIH under paragraphs (2) and (3).</text>
</clause><clause id="id80B50D6E616441B983E0B24E72E1CA17"><enum>(iii)</enum><header>Verification
by Federal agencies</header><text>The heads of the agencies referred to in
clause (ii), as applicable, shall verify that the clinical trial information
for each applicable clinical trial for which a grantee is the responsible party
has been submitted under paragraph (2) and (3), as applicable, before releasing
funding for a grant to such grantee.</text>
</clause><clause id="idF4B19A834DC747F5987696A174A7002F"><enum>(iv)</enum><header>Notice and
opportunity to remedy</header><text>If the head of an agency referred to in
clause (ii), as applicable, verifies that a grantee has not submitted clinical
trial information as described in clause (iii), such agency head shall provide
notice to such grantee of such non-compliance and allow such grantee 30 days to
correct such non-compliance and submit the required clinical trial
information.</text>
</clause><clause id="id7D69550BF67E452B82554036D85C1992"><enum>(v)</enum><header>Consultation
with other Federal agencies</header><text>The Secretary shall—</text>
<subclause id="idEC6F2AF9CD2F415295CC8591C108CE55"><enum>(I)</enum><text>consult with
other agencies that conduct human studies in accordance with part 46 of title
45, Code of Federal Regulations (or any successor regulations), to determine if
any such studies are applicable clinical trials under paragraph (2) or (3);
and</text>
</subclause><subclause id="id8C66775F01B0499A89B3186E677F1D97"><enum>(II)</enum><text>develop with
such agencies procedures comparable to those described in clauses (ii), (iii),
and (iv) to ensure that clinical trial information for such applicable clinical
trials is submitted under paragraphs (2) and (3).</text>
</subclause></clause></subparagraph><subparagraph id="idCF5B2EF921A0452BA66D5B506D8B761D"><enum>(B)</enum><header>Coordination of
registry database and results database</header>
<clause id="id4F64B9AF85F9418BBA1A8B86A667B81D"><enum>(i)</enum><header>In
general</header><text>Each entry in the registry database under paragraph (2)
shall include a link to the corresponding entry in the results database under
paragraph (3).</text>
</clause><clause id="id1C0A9F3A4BCD4B20B8DF4B8EC2CF7438"><enum>(ii)</enum><header>Missing
entries</header>
<subclause id="id70D1EEC6426D427FB3BBC15C818235CF"><enum>(I)</enum><header>In
general</header><text>If, based on a review of the entries in the registry
database under paragraph (2), the Director of NIH determines that a responsible
party has failed to submit required clinical trial information to the results
database under paragraph (3), the Director of NIH shall inform the responsible
party involved of such failure and permit the responsible party to correct the
failure within 30 days.</text>
</subclause><subclause id="idE3E4E9C07C534775A36573E285D95EE6"><enum>(II)</enum><header>Failure to
correct</header><text>If the responsible party does not correct a failure to
submit required clinical trial information within the 30-day period described
under subclause (I), the Director of NIH shall report such non-compliance to
the scientific peer review committees of the Federal research agencies and to
the Office of Human Research Protections.</text>
</subclause><subclause id="id5FF7CA9BA8D74D0F9D0A8AE442C3B6C4"><enum>(III)</enum><header>Public notice
of failure to correct</header><text>The Director of NIH shall include in the
clinical trial registry database entry and the clinical trial results database
entry for each such clinical trial a notice of any uncorrected failure to
submit required clinical trial information and shall provide that the public
may easily search for such entries.</text>
</subclause></clause></subparagraph><subparagraph id="id315E8CE5B0024DFFBCCD963E69CA616F"><enum>(C)</enum><header>Action on
applications</header>
<clause id="id5DEA7444827A43C19317A81A2C298CDF"><enum>(i)</enum><header>Verification
prior to filing</header><text>The Secretary, acting through the Commissioner of
Food and Drugs, shall verify that the clinical trial information required under
paragraphs (2) and (3) for an applicable clinical trial is submitted pursuant
to such applicable paragraph—</text>
<subclause id="id1301480613A4479F9F179EB31D0D1DD4"><enum>(I)</enum><text>when considering
a drug for an exemption under section 505(i) of the Federal Food, Drug, and
Cosmetic Act, including as the drug progresses through the clinical trials
described under paragraph (2)(A)(i); and</text>
</subclause><subclause id="id627F27BC93CB4D43B4BD329EC8AD8F09"><enum>(II)</enum><text>prior to filing
an application under section 505 of the Federal Food, Drug, and Cosmetic Act or
under section 351 of this Act that includes information from such clinical
trial.</text>
</subclause></clause><clause id="id99391E8640E0478AA1A3C282C67D239E"><enum>(ii)</enum><header>Notification</header><text>If
the responsible party has not submitted such clinical trial information, the
Secretary shall notify the applicant and the responsible party of such
non-compliance and require submission of such results within 30 days.</text>
</clause><clause id="id12A3EF23B5C64A8AB5DAA93EBA0C2EE8"><enum>(iii)</enum><header>Refusal to
file</header><text>If the responsible party does not remedy such non-compliance
within 30 days of receipt of notification under clause (ii), the Secretary
shall refuse to file such application.</text>
</clause></subparagraph><subparagraph id="id6678DA7482854233A3F32249472C3E74"><enum>(D)</enum><header>Content
review</header>
<clause id="IDdc19e81ba8ce49979f07cbe949c6d59d"><enum>(i)</enum><header>In
general</header><text>To assure that the summary documents described in
paragraph (3)(D) are non-promotional, and are not false or misleading in any
particular under paragraph (3)(F), the Secretary shall compare such documents
to the results data of the clinical trial for a representative sample of
applicable clinical trials by—</text>
<subclause id="ID11336835f9794088b07898a2d0c49acc"><enum>(I)</enum><text>acting through
the Commissioner of Food and Drugs to examine the results data for such
clinical trials submitted to Secretary when such data are submitted—</text>
<item id="id76EC11598E1A4BDABB367FEE22619DF5"><enum>(aa)</enum><text>for review as
part of an application under section 505 of the Federal Food, Drug, and
Cosmetic Act or under section 351 of this Act; or</text>
</item><item id="id54A0950326C54173B42B766541176A4D"><enum>(bb)</enum><text>in
an annual status report on the drug under such application;</text>
</item></subclause><subclause id="IDaada551338154b8989d00da01aa26916"><enum>(II)</enum><text>acting with the
Federal agency that funds such clinical trial in whole or in part by a grant to
examine the results data for such clinical trials; and</text>
</subclause><subclause id="IDf868ebe24f9243a69fda7ffc608744d1"><enum>(III)</enum><text>acting through
inspections under section 704 of the Federal Food, Drug, and Cosmetic Act to
examine results data for such clinical trials not described in subclause (I) or
(II).</text>
</subclause></clause><clause id="id9633DEFA881D4A68979DCB9C988DF3A8"><enum>(ii)</enum><header>Notice of
non-compliance</header><text>If the Secretary determines that the clinical
trial information submitted in such a summary document is promotional, or false
or misleading in any particular, the Secretary shall notify the responsible
party and give such party an opportunity to remedy such non-compliance by
submitting the required revised clinical trial information within 30 days of
such notification.</text>
</clause></subparagraph><subparagraph id="idD8D17B728E6F4697B4157DD3135C9875"><enum>(E)</enum><header>Penalty for
non-compliance</header><text>In determining whether to apply a penalty under
section 301(jj) of the Federal Food, Drug, and Cosmetic Act, the Secretary,
acting through the Commissioner of Food and Drugs, shall consider—</text>
<clause id="id9D0B96AB055A4EC49FEEFF3E263CBD81"><enum>(i)</enum><text>whether the
responsible party promptly corrects the non-compliance when provided
notice;</text>
</clause><clause id="idD5D071FD593748DA85957FEDAD6A3122"><enum>(ii)</enum><text>whether the
responsible party has engaged in a pattern or practice of non-compliance;
and</text>
</clause><clause id="idBF005A81415140AEA1CCA01D4C42E9ED"><enum>(iii)</enum><text>the extent to
which the noncompliance involved may have significantly misled healthcare
providers or patients concerning the safety or effectiveness of the drug
involved.</text>
</clause></subparagraph></paragraph><paragraph id="id02DE005A11CA444F9F11C9E65B164D71"><enum>(5)</enum><header>Limitation on
disclosure of clinical trial information</header><text>Disclosure to the public
of clinical trial information submitted to the Director of NIH under this
subsection and requested under section 552 of title 5, United States Code
(commonly known as the Freedom of Information Act) shall be made only as
provided for under paragraphs (2) and (3).</text>
</paragraph><paragraph id="id9F6ABBFCA3454532A06954CAEC55076F"><enum>(6)</enum><header>Authorization
of appropriations</header><text>There are authorized to be appropriated to
carry out this subsection $10,000,000 for each fiscal
year.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id6EBA36A477134E8F8151A689621A1360"><enum>(b)</enum><header>Conforming
amendments</header>
<paragraph commented="no" id="id8A3DB40B0B9143E69597460858BD1DB9"><enum>(1)</enum><header>Prohibited
acts</header><text>Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331), as amended by Public Law 109–462, is amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="idB49F93FD81184734816734C1691AE534" style="OLC">
<subsection commented="no" id="idEA542CC3FDE342DFB512A711D0132278"><enum>(jj)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id70DB2442E3B74BA68D1152AA225B855E"><enum>(1)</enum><text>The failure to submit
clinical trial information as required by section 402(i) of the Public Health
Service Act.</text>
</paragraph><paragraph commented="no" id="idC83D827A9D2A43C9ABD8B46523071E79" indent="up1"><enum>(2)</enum><text>The submission of clinical trial
information under section 402(i) of the Public Health Service Act that is
promotional or false or misleading in any particular under paragraph (2)(E) or
(3)(F) of such section
402(i).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="id6989251F106D411E97D71C99BD87182D"><enum>(2)</enum><header>New
drugs</header>
<subparagraph id="id361DFE2DA9B44D238EBF02A29887EEC6"><enum>(A)</enum><header>Investigational
new drugs</header><text>Section 505(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(i)) is amended—</text>
<clause id="id8E9A06BB68EA4A78AE8BD46D6C2C7C45"><enum>(i)</enum><text>in
paragraph (1)—</text>
<subclause id="id59DF53716DFB4A8C85F92BA8AA375269"><enum>(I)</enum><text>in subparagraph
(C), by striking <quote>and</quote> after the semicolon;</text>
</subclause><subclause id="id7017994461A84A56AFE009FA7D906D39"><enum>(II)</enum><text>in subparagraph
(D), by striking the period at the end and inserting <quote>; and</quote>;
and</text>
</subclause><subclause id="id425C1F2330A44C30A1941C1057D0F737"><enum>(III)</enum><text>by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2D3A68F4367B4E40860B672EBA72A229" style="OLC">
<subparagraph id="idE375CC59628E47149F252B1E24062430" indent="up1"><enum>(E)</enum><text>the submission to the Director of NIH
of clinical trial information for the clinical investigation at issue required
under section 402(i) of the Public Health Service Act for inclusion in the
registry database and the results database described in such
section.</text>
</subparagraph><after-quoted-block>;
</after-quoted-block></quoted-block>
</subclause></clause><clause id="id3CA5039F97FA4E28BEDAE90899937BD7"><enum>(ii)</enum><text>in
paragraph (3)(B)—</text>
<subclause id="id97DCFEFF3A534A5FA2BA5F4853A6A0BD"><enum>(I)</enum><text>in clause (i), by
striking <quote>or</quote> after the semicolon;</text>
</subclause><subclause id="id6ACE563E52EB485496717BC91A9FD65E"><enum>(II)</enum><text>in clause (ii),
by striking the period at the end and inserting <quote>; or</quote>; and</text>
</subclause><subclause id="id27FD1433336540C6875A3970532376C8"><enum>(III)</enum><text>by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id10470F4A4B514AB795646934A7F9C4C9" style="OLC">
<clause id="idD12FFBFB544B416A9DD8783611918BF3" indent="up2"><enum>(iii)</enum><text>clinical trial information for the
clinical investigation at issue was not submitted in compliance with section
402(i) of the Public Health Service
Act.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subclause></clause><clause id="id37E641CC14674664BFF448A49CCB932F"><enum>(iii)</enum><text>in paragraph
(4), by adding at the end the following: <quote>The Secretary shall update such
regulations to require inclusion in the informed consent form a statement that
clinical trial information for such clinical investigation will be submitted
for inclusion in the registry database and results database, as applicable,
described in section 402(i) of the Public Health Service Act.</quote>.</text>
</clause></subparagraph><subparagraph id="idFBAD0B85084D45AE8F1C815E3C6BD925"><enum>(B)</enum><header>Refusal to
approve application</header><text>Section 505(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(d)) is amended—</text>
<clause id="id14AC9961023147D9899F52D770691C8D"><enum>(i)</enum><text>in
the first sentence, by inserting after <quote>or any particular;</quote> the
following: <quote>or (8) the applicant failed to submit the clinical trial
information for any applicable clinical trial submitted as part of the
application to the Director of the National Institutes of Health in compliance
with section 402(i) of the Public Health Service Act;</quote>; and</text>
</clause><clause commented="no" id="idAE5BB76CC53D4F738A43054D95252B82"><enum>(ii)</enum><text>in the second
sentence, by striking <quote>clauses (1) through (6)</quote> and inserting
<quote>paragraphs (1) through (8)</quote>.</text>
</clause></subparagraph></paragraph></subsection><subsection id="idF9B6FDDDED744E6DA6784DF7EC9BE8C3"><enum>(c)</enum><header>Guidance</header><text>Not
later than 180 days after the date of enactment of this Act, the Commissioner
of Food and Drugs, in consultation with the Director of the National Institutes
of Health, shall issue guidance to clarify which clinical trials are applicable
clinical trials (as defined in section 402(i)(2) of the Public Health Service
Act, as amended by this section) and are required to be submitted for inclusion
in the clinical trial registry database described in such section
402(i)(2).</text>
</subsection><subsection commented="no" id="idE04A38EDAFCB4256A0BDE9709EFADA5D"><enum>(d)</enum><header>Preemption</header>
<paragraph commented="no" id="IDd45d10c0fa9a47d390e9545ed3640309"><enum>(1)</enum><header>In
general</header><text>No State or political subdivision of a State may
establish or continue in effect any requirement for the registration of
clinical trials or for the inclusion of information relating to the results of
clinical trials in a database.</text>
</paragraph><paragraph commented="no" id="ID812d4e958ef94f33a24a2313ee5142fd"><enum>(2)</enum><header>Rule of
construction</header><text>The fact of submission of clinical trial
information, if submitted in compliance with section 402(i) of the Public
Health Service Act (as amended by this section), that relates to a use of a
drug not included in the official labeling of the approved drug shall not be
construed by the Secretary or in any administrative or judicial proceeding, as
evidence of a new intended use of the drug that is different from the intended
use of the drug set forth in the official labeling of the drug. The
availability of clinical trial information through the databases under
paragraphs (2) and (3) of such section 402(i), if submitted in compliance with
such section 402(i), shall not be considered as labeling, adulteration, or
misbranding of the drug under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).</text>
</paragraph></subsection><subsection id="id5367BAD9E6D04138AE65EA7C5182D720"><enum>(e)</enum><header>Effective
dates</header>
<paragraph id="idB8D65C274F474A2C99173AD0711D5BB7"><enum>(1)</enum><header>Establishment
of registry database and results database</header><text>Not later than 1 year
after the date of enactment of this Act, the Director of NIH shall establish
the registry database and the results database of clinical trials of drugs in
accordance with section 402(i) of the Public Health Service Act (as amended by
subsection (a)).</text>
</paragraph><paragraph commented="no" id="idAA119C4D28FC481695FDA96BE7C8514E"><enum>(2)</enum><header>Clinical trials
initiated prior to operation of registry database</header><text>The responsible
party (as defined in such section 402(i)) for an applicable clinical trial
under paragraph (2) of such section 402(i) that is initiated after the date of
enactment of this Act and before the date such registry database is established
under paragraph (1) of this subsection, shall submit required clinical trial
information not later than 120 days after the date such registry database is
established.</text>
</paragraph><paragraph commented="no" id="id9B0D00EA6E314005BD0C22CF197386B0"><enum>(3)</enum><header>Clinical trials
initiated after operation of registry database</header><text>The responsible
party (as defined in such section 402(i)) for an applicable clinical trial
under paragraph (2) of such section 402(i) that is initiated after the date
such registry database is established under paragraph (1) of this subsection
shall submit required clinical trial information in accordance with such
paragraph (2).</text>
</paragraph><paragraph commented="no" id="idA5E3FABE8E1B41B79D7D82E65B8252D3"><enum>(4)</enum><header>Trials
completed before operation of results database</header>
<subparagraph commented="no" id="id4A960DCA62D14AB8B33A3809EEE3E1D8"><enum>(A)</enum><header>In
general</header><text>Paragraph (3) of such section 402(i) shall take effect 90
days after the date the results database is established under paragraph (1) of
this subsection with respect to any applicable clinical trial (as defined in
such section 402(i)(3)) that—</text>
<clause commented="no" id="idBBC6BB17D87D46E7A11A497F47B0DD70"><enum>(i)</enum><text>involves a drug
to treat a serious or life-threatening condition; and</text>
</clause><clause commented="no" id="id58769FDD9A334E4DB8BA0B29C120028B"><enum>(ii)</enum><text>is completed
between the date of enactment of this section and such date of establishment
under paragraph (1) of this subsection.</text>
</clause></subparagraph><subparagraph commented="no" id="id7C59CED4608A4C108972B987AB182E11"><enum>(B)</enum><header>Other
trials</header><text>Except as provided in subparagraph (A), paragraph (3) of
such section 402(i) shall take effect 180 days after the date that the results
database is established under paragraph (1) of this subsection with respect to
any applicable clinical trial (as defined in such section 402(i)(3)) that is
completed between the date of enactment of this Act and such date of
establishment under paragraph (1).</text>
</subparagraph><subparagraph id="IDf932319932d7491c9c6743e3d0add65d"><enum>(C)</enum><header>Trials
submitted in an application</header><text>Except as provided in subparagraph
(A), paragraph (3) of such section 402(i) shall take effect for any clinical
trial if—</text>
<clause id="ID2fe111d4208c46728c1d925d8bc5db33"><enum>(i)</enum><text>data from such
clinical trial is submitted in an application or supplement to an application
under section 505 of the Food, Drug, and Cosmetic Act or under section 351 of
the Public Health Service Act that—</text>
<subclause id="id31D0EB76F6E34A49AFA69FD019BF227F"><enum>(I)</enum><text>is submitted 180
days or more after the date that the results database is established under
paragraph (1) of this subsection; and</text>
</subclause><subclause id="idCB2DB2DCA79649699A6989C367C61176"><enum>(II)</enum><text>contains data
from an applicable clinical trial; and</text>
</subclause></clause><clause id="ID860834ac0ca943599c6e51add9f828bf"><enum>(ii)</enum><text>such clinical
trial would otherwise be an applicable clinical trial under such paragraph (3)
except for its date of completion.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="idC4AD8BCDABE945689B9926ACB2DD07A8"><enum>(5)</enum><header>Trials
completed after establishment of results database</header><text>Paragraph (3)
of such section 402(i) shall apply to any applicable clinical trial that is
completed after the date that the results database is established under
paragraph (1) of this subsection.</text>
</paragraph><paragraph commented="no" id="id97B959FD06BD4AC7BA95EFC9A3AB4DA9"><enum>(6)</enum><header>Funding
restrictions</header><text>Subparagraph (A) of paragraph (4) of such section
402(i) shall take effect 210 days after the date that the clinical trial
registry database and the clinical trial results database are established under
paragraph (1) of this subsection.</text>
</paragraph><paragraph commented="no" id="idFA3631AC54EC4356A1C653D66EF4DE63"><enum>(7)</enum><header>Status of
clinicaltrials.gov website</header>
<subparagraph id="IDeaa453e4a8e145559a0505bb4eec9c4b"><enum>(A)</enum><header>In
general</header><text>After receiving public comment and not later than 90 days
after the date of enactment of this Act, the Secretary shall publish in the
Federal Register a notice determining the more efficient approach to
establishing the registry database described in paragraph (2) of such section
402(i) and whether such approach is—</text>
<clause id="ID27535bf23d76490bb38f1d94da435f4d"><enum>(i)</enum><text>that such
registry database should expand and build upon the database described in
section 402(i) of the Public Health Service Act (as in effect on the day before
the date of enactment of this Act); or</text>
</clause><clause id="IDbd7a60afebf7496c80e61740758d6071"><enum>(ii)</enum><text>that such
registry database should supplant the database described in such section 402(i)
(as in effect on the day before the date of enactment of this Act).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1c5dfaffa35e40ccb81c1a527d6969af"><enum>(B)</enum><header>Clinicaltrials.gov
supplanted</header><text>If the Secretary determines to apply the approach
described under subparagraph (A)(ii), the Secretary shall maintain an archive
of the database described in such section 402(i) (as in effect on the day
before the date of enactment of this Act) on the Internet website of the
National Library of Medicine.</text>
</subparagraph></paragraph></subsection></section><enum>IV</enum><header>Conflicts of
interest</header>
<section id="id72B6521E70E64C14B851988E2D188D01"><enum>401.</enum><header>Conflicts of
interest</header>
<subsection id="id58C8D5A475FD452B95651B9E342FC112"><enum>(a)</enum><header>In
general</header><text>Subchapter A of chapter VII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id662A3B04BF7E4911BC36A69F10E3A55E" style="OLC">
<section id="idB853998414564B63A21E0A7286930783"><enum>712.</enum><header>Conflicts of
interest</header>
<subsection id="idF4EA597F8D984719B424CA9D402BB86F"><enum>(a)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph commented="no" id="id2F9771BD3FE14E9D9A41500D64D71F7F"><enum>(1)</enum><header>Advisory
committee</header><text>The term <term>advisory committee</term> means an
advisory committee under the Federal Advisory Committee Act that provides
advice or recommendations to the Secretary regarding activities of the Food and
Drug Administration.</text>
</paragraph><paragraph commented="no" id="idB808C1E204E24605AFF49835FC8BFE22"><enum>(2)</enum><header>Financial
interest</header><text>The term <quote>financial interest</quote> means a
financial interest under section 208(a) of title 18, United States Code.</text>
</paragraph><paragraph id="ID8eba651218a44c6c91ba23c648cc3d5f"><enum>(3)</enum><header>Industry
financial interest</header><text>The term <quote>industry financial
interest</quote>, with respect to appointment for a term to an advisory
committee, means an interest in a company that is a member of the relevant
industry that would be a financial interest were an advisory committee to
consider a particular matter involving such company.</text>
</paragraph><paragraph id="IDd44e9abc746f430da4583932d47cce31"><enum>(4)</enum><header>Relevant
industry</header><text>The term <quote>relevant industry</quote> means—</text>
<subparagraph id="ID0efa8ca76d3d415db0e26228ee065f53"><enum>(A)</enum><text>with respect to
an advisory committee that advises the Secretary on human drugs, biologics, or
devices, the pharmaceutical, biotechnology, and device industries;</text>
</subparagraph><subparagraph id="idE63DD2CDD93A437490FCB8B9F8503443"><enum>(B)</enum><text>with respect to
an advisory committee that advises the Secretary on animal drugs or devices,
the animal drug and the animal device industries; and</text>
</subparagraph><subparagraph id="ID10d1844454154d9292f7f98a437b5516"><enum>(C)</enum><text>with respect to
an advisory committee that advises the Secretary on foods, the food
industry.</text>
</subparagraph></paragraph></subsection><subsection id="id6EF2F131D3604442B67C84669E34DBAC"><enum>(b)</enum><header>Appointments to
advisory committees</header>
<paragraph id="id3CD3DF2CD386421AAF05BDBCD4E0D652"><enum>(1)</enum><header>Disclosure of
industry financial interests</header><text>Each individual under consideration
for a term appointment to an advisory committee shall disclose to the Secretary
all industry financial interests.</text>
</paragraph><paragraph id="IDae181722124940278334fe44664b432e"><enum>(2)</enum><header>Disclosures not
publicly available</header><text>No disclosure required under paragraph (1)
shall be made available to the public.</text>
</paragraph><paragraph id="id191D57CC03754689B9D7BBE7E9B34757"><enum>(3)</enum><header>Evaluation and
criteria</header><text>When considering a term appointment to an advisory
committee, the Secretary—</text>
<subparagraph id="idDD85031C01F8495098F1430E72353BBD"><enum>(A)</enum><text>shall review the
expertise and the industry financial interests, as disclosed under paragraph
(1), of each individual under consideration for the appointment, so as to
appoint the individuals, from among those individuals under consideration for
appointment, who are the most qualified relative to their industry financial
interests that could require a written determination as referred to in section
208(b)(1) of title 18, United States Code, a written certification as referred
to in section 208(b)(3) of title 18, United States Code, or a waiver as
referred to in subsection (c)(3) for service on the committee at a meeting of
the committee; and</text>
</subparagraph><subparagraph id="idB7FF3F80F1BB4AEDA32D162B56689162"><enum>(B)</enum><text>may appoint 2 or
more qualified individuals with similar expertise and whose industry financial
interests are nonoverlapping or minimally overlapping, so as to minimize the
likelihood that an advisory committee will need the expertise of an appointed
individual who requires a written determination as referred to in section
208(b)(1) of title 18, United States Code, a written certification as referred
to in section 208(b)(3) of title 18, United States Code, or a waiver as
referred to in subsection (c)(3) for service on the committee at a meeting of
the committee.</text>
</subparagraph></paragraph></subsection><subsection id="id9151C8012A584D46BF4E8CEA8C3A60FD"><enum>(c)</enum><header>Granting and
disclosure of waivers</header>
<paragraph id="idD22094F817E24381B4FC0C8E19FEA903"><enum>(1)</enum><header>In
general</header><text>Not later then 45 days before a meeting of an advisory
committee, each member of the committee shall disclose to the Secretary all
financial interests in accordance with section 208(b) of title 18, United
States Code.</text>
</paragraph><paragraph id="idE811B95C3F6F4704B623F1CD3FBF894F"><enum>(2)</enum><header>Financial gain
of advisory committee member or family member</header><text>No member of an
advisory committee may vote with respect to any matter considered by the
advisory committee if such member or an immediate family member of such member
could gain financially from the advice given to the Secretary with respect to
such matter.</text>
</paragraph><paragraph id="id1B0BCCD79BC24CFF9449F8ECF5F6AE30"><enum>(3)</enum><header>Waiver</header><text>In
addition to considerations under section 208(b) of title 18, United States
Code, the Secretary may grant a waiver of a conflict of interest requirement if
such waiver is necessary to afford the advisory committee essential
expertise.</text>
</paragraph><paragraph id="ID9e6cd60831b447c58ae2a6a2465de0e7"><enum>(4)</enum><header>Limitation</header><text>In
no case may the Secretary grant a waiver under paragraph (3) for a member of an
advisory committee if the scientific work of such member is under consideration
by the committee.</text>
</paragraph><paragraph id="id38B3F6744F7C48B8A811F28FA159099F"><enum>(5)</enum><header>Disclosure of
waiver</header>
<subparagraph id="idA25160108F644032946E673391028310"><enum>(A)</enum><header>More than 15
days in advance</header><text>As soon as practicable, but in no case later than
15 days prior to a meeting of an advisory committee to which a written
determination as referred to in section 208(b)(1) of title 18, United States
Code, a written certification as referred to in section 208(b)(3) of title 18,
United States Code, or a waiver as referred to in paragraph (3) applies, the
Secretary shall disclose (other than information exempted from disclosure under
section 552 of title 5, United States Code, and section 552a of title 5, United
States Code (popularly known as the Freedom of Information Act and the Privacy
Act of 1974, respectively)) on the Internet website of the Food and Drug
Administration—</text>
<clause id="IDe214b27eea4d4f809429752903f82741"><enum>(i)</enum><text>the financial
interests of the advisory committee member to which such determination,
certification, or waiver applies; and</text>
</clause><clause id="IDb81950b933d74540aa59bb8c6830b8fb"><enum>(ii)</enum><text>the reasons of
the Secretary for such determination, certification, or waiver.</text>
</clause></subparagraph><subparagraph id="id8480EDCA26E94EC188823C37072EB4EA"><enum>(B)</enum><header>Less than 15
days in advance</header><text>In the case of a financial interest that becomes
known to the Secretary less than 30 days prior to a meeting of an advisory
committee to which a written determination as referred to in section 208(b)(1)
of title 18, United States Code, a written certification as referred to in
section 208(b)(3) of title 18, United States Code, or a waiver as referred to
in paragraph (3) applies, the Secretary shall disclose (other than information
exempted from disclosure under section 552 of title 5, United States Code, and
section 552a of title 5, United States Code) on the Internet website of the
Food and Drug Administration, the information described in clauses (i) and (ii)
of subparagraph (A) as soon as the Secretary makes such determination,
certification, or waiver, but in no event later than the date of such
meeting.</text>
</subparagraph></paragraph></subsection><subsection id="id8D31AEA438FB42A88D72E58B932893AE"><enum>(d)</enum><header>Public
record</header><text display-inline="yes-display-inline">The Secretary shall
ensure that the public record and transcript of each meeting of an advisory
committee includes the disclosure required under subsection (c)(5) (other than
information exempted from disclosure under section 552 of title 5, United
States Code, and section 552a of title 5, United States Code).</text>
</subsection><subsection commented="no" id="ID85a6ed47cbd24f24a1405e2a8e2c73dc"><enum>(e)</enum><header>Annual
report</header><text>Not later than January 15 of each year, the Secretary
shall submit a report to the Inspector General of the Department of Health and
Human Services, the Committee on Appropriations and the Committee on Health,
Education, Labor, and Pensions of the Senate, and the Committee on
Appropriations and the Committee on Energy and Commerce of the House of
Representatives—</text>
<paragraph commented="no" id="ID4bac88193d4f43358dd48460254b2cc3"><enum>(1)</enum><text>with respect to
the fiscal year that ended on September 30 of the previous year, the number of
vacancies on each advisory committee, the number of nominees received for each
committee, and the number of such nominees willing to serve;</text>
</paragraph><paragraph commented="no" id="ID47a112c0b626482190320eb427574a57"><enum>(2)</enum><text>with respect to
such year, the aggregate number of disclosures required under subsection (c)(5)
for each meeting of each advisory committee and the percentage of individuals
to whom such disclosures did not apply who served on such committee for each
such meeting;</text>
</paragraph><paragraph commented="no" id="idD3C5708D20AB48F0BFE35A826D7E9689"><enum>(3)</enum><text>with respect to
such year, the number of times the disclosures required under subsection (c)(5)
occurred under subparagraph (B) of such subsection; and</text>
</paragraph><paragraph commented="no" id="ID4610e1367a774b3990ae49e220a350b9"><enum>(4)</enum><text>how the Secretary
plans to reduce the number of vacancies reported under paragraph (1) during the
fiscal year following such
year.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id64F631CD77C640CFAACA9FFAFDF6C92F"><enum>(b)</enum><header>Guidance</header>
<paragraph id="idD0858139CBBB4C768D35AB1539427788"><enum>(1)</enum><header>Nominations</header><text>Not
later than 270 days after the date of enactment of this Act, and after seeking
input from professional medical and scientific societies, the Secretary shall
publish in the Federal Register for public comment a proposed mechanism for
encouraging the nomination of individuals who are classified by the Food and
Drug Administration as academicians or practitioners for service on an advisory
committee.</text>
</paragraph><paragraph id="id8DA6EA69C187498F8C5C5C9D32EC340A"><enum>(2)</enum><header>Waiver
determinations</header><text>Not later than 270 days after the date of
enactment of this Act the Secretary shall issue or revise guidance—</text>
<subparagraph id="ID9b577cf78c894e5b97297063d336b542"><enum>(A)</enum><text>that clarifies
the circumstances in which the Secretary may make a written determination as
referred to in section 208(b)(1) of title 18, United States Code, make a
written certification as referred to in section 208(b)(3) of title 18, United
States Code, or grant a waiver as referred to section 712(c)(3) of the Federal
Food, Drug, and Cosmetic Act (as added by this section), including those
circumstances that—</text>
<clause id="id63B505EA484B4E81AF523EA717B5BC05"><enum>(i)</enum><text>favor the
inclusion of an individual on an advisory committee;</text>
</clause><clause id="id6B93945F1E274366AAFE7F718FBE177A"><enum>(ii)</enum><text>favor making
such a determination, certification, or waiver for an individual on an advisory
committee;</text>
</clause><clause id="id3F98ADC79B8C4F01BE913B51C0B1B43D"><enum>(iii)</enum><text>favor
limitations on an individual's ability to act when making such a determination,
certification, or waiver for the individual on an advisory committee;
and</text>
</clause><clause id="id6CBBDBFA89494E6BAD166605CF8AD43F"><enum>(iv)</enum><text>disfavor the
inclusion of an individual on an advisory committee;</text>
</clause></subparagraph><subparagraph id="IDaf35d835cfd7470bb06c681931996697"><enum>(B)</enum><text>that defines how
financial interests imputed to an individual bear upon his or her eligibility
for service on an advisory committee or for service at a meeting of an advisory
committee; and</text>
</subparagraph><subparagraph id="idE510CA3BEA084DFD8E405758960E4366"><enum>(C)</enum><text>to ensure
consistency within and among the centers of the Food and Drug Administration in
applying section 208(b) of title 18, United States Code, and such section
712(c)(3).</text>
</subparagraph></paragraph><paragraph id="idB28EB9378B3E445CB7D1BDB552A84054"><enum>(3)</enum><header>Periodic
review</header><text>At least once every 5 years, the Secretary shall review
the guidance described under paragraph (2) and update such guidance as
necessary.</text>
</paragraph></subsection><subsection id="id20D64CF3AFB84B889AC7CBB146645360"><enum>(c)</enum><header>Review by
inspector general</header>
<paragraph commented="no" id="id931DA13B16254090BFDF7A6F3645C765"><enum>(1)</enum><header>In
general</header><text>The Inspector General of the Department of Health and
Human Services shall conduct a review, which may include surveys of past or
current members of advisory committees, of the processes of the Food and Drug
Administration for—</text>
<subparagraph id="IDad09fe2738fb4e19993a709e5164e394"><enum>(A)</enum><text>evaluating the
financial interests of a member of such an advisory committee while the member
serves on such a committee and after the member has served on such a committee;
and</text>
</subparagraph><subparagraph id="ID431df831d3f24a22ac4dcef2e4d05bf8"><enum>(B)</enum><text>assuring the
completeness and accuracy of information contained in the disclosures described
in subsections (b)(1) and (c)(1) of such section 712 of the Federal Food, Drug,
and Cosmetic Act (as added by this section).</text>
</subparagraph></paragraph><paragraph id="id25714D5DE70E4D918320695C4802ADA4"><enum>(2)</enum><header>Submission of
report</header><text>Not later than 18 months after the effective date of this
section, the Inspector General of the Department of Health and Human Services
shall submit to Congress a report based on the review required under paragraph
(1), and include any recommendations for the improvement of such
processes.</text>
</paragraph></subsection><subsection id="id026808B5600B459EA87BB1F23FAAD8AD"><enum>(d)</enum><header>Definitions</header><text>For
purposes of this section, the terms <term>advisory committee</term> and
<term>financial interest</term> have the meaning given such terms in section
712 of the Federal Food, Drug, and Cosmetic Act (as added by this
section).</text>
</subsection><subsection id="id91371780926447CEA546BA9103605D56"><enum>(e)</enum><header>Conforming
amendment</header><text>Section 505(n) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(n)) is amended by—</text>
<paragraph id="id7BD09CAD6410429C8BDC8314D297BF02"><enum>(1)</enum><text>striking
paragraph (4); and</text>
</paragraph><paragraph id="id60839C62B8624A58B2894DCCE5FCD52A"><enum>(2)</enum><text>redesignating
paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7),
respectively.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id46B1605E215941628E424965961E3153"><enum>(f)</enum><header>Effective
date</header><text>The amendments made by this section shall take effect on
October 1, 2007.</text>
</subsection></section>