1.This Act may be cited as the Food and
Drug Administration Revitalization Act
.
<enum>I</enum><header display-inline="yes-display-inline">Prescription drug user fees</header>
<section commented="no" display-inline="no-display-inline" id="idEBC2953F709C4678BEC5F4072BB08F8D" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Short title; references in title</header>
<subsection commented="no" display-inline="no-display-inline" id="id17cc913c-4b6f-419c-90eb-3dc048dafb55"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote><short-title>Prescription Drug User Fee Amendments
of 2007</short-title></quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id7e7fa21a-b3ed-448c-8ed4-ccba04a8cffe"><enum>(b)</enum><header display-inline="yes-display-inline">References in title</header><text display-inline="yes-display-inline">Except as otherwise specified, whenever in
this title an amendment is expressed in terms of an amendment to a section or
other provision, the reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="idd1aac643-aff6-482e-84a1-dccca27b958f" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Drug fees</header><text display-inline="no-display-inline">Section 735 (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g</external-xref>) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id1d82c7f6-cff6-4698-8528-3a7e1798c0ed"><enum>(1)</enum><text display-inline="yes-display-inline">by striking the section designation and all
that follows through <quote>For purposes of this subchapter:</quote> and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id63ff6d90-78b8-4a1c-8029-2ee429b6ce4c" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idc9a7b619-ae64-4fa4-b95e-576de461fc13" section-type="subsequent-section"><enum>735.</enum><header display-inline="yes-display-inline">Drug fees</header>
<subsection commented="no" display-inline="no-display-inline" id="idf03fbcaf-f25b-4ca8-ba14-4630d84085ea"><enum>(a)</enum><header display-inline="yes-display-inline">Purpose</header><text display-inline="yes-display-inline">It is the purpose of this part that the
fees authorized under this part be dedicated toward expediting the drug
development process, the process for the review of human drug applications, and
postmarket drug safety, as set forth in the goals identified for purposes of
this part in the letters from the Secretary to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman of the
Committee on Energy and Commerce of the House of Representatives, as set forth
in the Congressional Record.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ide95c84c6-c81e-4c02-bd88-b014ef18e93a"><enum>(b)</enum><header display-inline="yes-display-inline">Reports</header>
<paragraph commented="no" display-inline="no-display-inline" id="id3c5f9895-546a-493a-8c6b-df7ab01c5432"><enum>(1)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">For fiscal years 2008 through 2012, not
later than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives, a report
concerning the progress of the Food and Drug Administration in achieving the
goals identified in the letters described in subsection (a) during such fiscal
year and the future plans of the Food and Drug Administration for meeting the
goals. The report for a fiscal year shall include information on all previous
cohorts for which the Secretary has not given a complete response on all human
drug applications and supplements in the cohort.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5d3ad816-d4ef-4767-979b-c007b7da8a30"><enum>(2)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">For fiscal years 2008 through 2012, not
later than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives, a report on
the implementation of the authority for such fees during such fiscal year and
the use, by the Food and Drug Administration, of the fees collected during such
fiscal year for which the report is made.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id34dcad65-5633-4306-b3b6-5fefdd228c6d"><enum>(3)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">The Secretary shall make the reports
required under paragraphs (1) and (2) available to the public on the Internet
website of the Food and Drug Administration.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5cbd6218-55cb-4a1c-a67c-c6ab4ae7d4d3"><enum>(c)</enum><header display-inline="yes-display-inline">Reauthorization</header>
<paragraph commented="no" display-inline="no-display-inline" id="id6b550b12-addf-495b-a936-6b992ba1eb80"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In developing recommendations to present to
Congress with respect to the goals, and plans for meeting the goals, for the
process for the review of human drug applications for the first 5 fiscal years
after fiscal year 2012, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id9ecbcb16-65d5-4ef4-9c4c-1b323fdaaa29"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the
House of Representatives;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id58efa1ea-5524-4267-bba9-67f2382db2c4"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor,
and Pensions of the Senate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcfe05399-4c95-494a-9bb3-b631656f07fc"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3f9ac168-c548-4c2e-9de1-437ee5ff010d"><enum>(D)</enum><text display-inline="yes-display-inline">health care professionals;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3ef23c91-d89a-42d1-97ec-7b57b7bd849f"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer
advocacy groups; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id322d275e-45a4-41b4-8074-236888196d8b"><enum>(F)</enum><text display-inline="yes-display-inline">the regulated industry.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida6aaf469-f864-4525-aca8-6cbcb5b71bc0"><enum>(2)</enum><header display-inline="yes-display-inline">Public review of
recommendations</header><text display-inline="yes-display-inline">After
negotiations with the regulated industry, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id023c3bec-af7c-4071-8c0c-40e8749d6089"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under
paragraph (1) to the Congressional committees specified in such
paragraph;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd318d5a8-65d4-42e5-843b-ce22db54a037"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal
Register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id880e67f8-9ced-4d92-b2b8-93ba66043dc7"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the
public to provide written comments on such recommendations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf4a220ed-987c-4a1b-9cba-de3ab8881a83"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may
present its views on such recommendations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfa98fc23-783f-4a87-8022-296b4be74692"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views
and comments, revise such recommendations as necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0b45c032-10e8-4961-855e-49e51aecf6df"><enum>(3)</enum><header display-inline="yes-display-inline">Transmittal of
recommendations</header><text display-inline="yes-display-inline">Not later
than January 15, 2012, the Secretary shall transmit to Congress the revised
recommendations under paragraph (2), a summary of the views and comments
received under such paragraph, and any changes made to the recommendations in
response to such views and comments.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idc91e0582-9578-4eab-bcc1-caf6e172cb73"><enum>(d)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this
part:</text>
</subsection></section><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2d0584b0-b950-4f7c-a5ac-dc027d3da7c4"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (d)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idb0ba9a2b-dbe6-425c-b50e-6af85914e7f0"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="idd0e2de66-070b-438b-ade4-e3bcdb9f9d60"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking
<quote>505(b)(1), </quote> and inserting <quote>505(b), or</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idc60fc6e7-ba3e-4704-a69a-f66441b877a0"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking subparagraph (B);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idba688d58-b8c5-411c-8dcd-669284544be7"><enum>(iii)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (C) as
subparagraph (B); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="iddc1430c5-28f0-4a5b-a863-d7f036b6a2f9"><enum>(iv)</enum><text display-inline="yes-display-inline">in the matter following subparagraph (B),
as so redesignated, by striking <quote>subparagraph (C)</quote> and inserting
<quote>subparagraph (B)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide01ddebc-04a0-470f-bb8b-bb12fee94847"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (3)(C), by—</text>
<clause commented="no" display-inline="no-display-inline" id="id487841b3-ff94-48fc-805d-ad79f834b0d2"><enum>(i)</enum><text display-inline="yes-display-inline">striking <quote>the list</quote> and
inserting <quote>the list (not including the discontinued section of such
list)</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5195deee-7645-47ff-85d1-88b723baecd1"><enum>(ii)</enum><text display-inline="yes-display-inline">striking <quote>a list</quote> and
inserting <quote>a list (not including the discontinued section of such a
list)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida32b375b-7f69-4ba8-8e10-752f478be59e"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (4), by inserting before the
period at the end the following: <quote>(such as capsules, tablets, and
lyophilized products before reconstitution)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9eece782-b037-451f-9b6b-baf665e19b9f"><enum>(D)</enum><text display-inline="yes-display-inline">by amending paragraph (6)(F) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id40ac86cf-29a0-4b48-9cd8-0af4c9f619aa" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id29460e79-c06e-4493-85ff-c8c2f98e6e7d"><enum>(F)</enum><text display-inline="yes-display-inline">In the case of drugs approved under human
drug applications or supplements, postmarket safety activities,
including—</text>
<clause commented="no" display-inline="no-display-inline" id="ida76eb0ef-9fd5-4bc8-91b3-8891c4ecd647"><enum>(i)</enum><text display-inline="yes-display-inline">collecting, developing, and reviewing
safety information on approved drugs (including adverse event reports);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id91ae2e4b-062e-4de6-8808-152bd62184b1"><enum>(ii)</enum><text display-inline="yes-display-inline">developing and using improved adverse event
data collection systems (including information technology systems); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idc4f9067e-11f0-4b73-9139-a70566ffae98"><enum>(iii)</enum><text display-inline="yes-display-inline">developing and using improved analytical
tools to assess potential safety problems (including by accessing external data
bases).</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id00386ad8-f3d4-4a63-b4fe-14a6c72e9956"><enum>(E)</enum><text display-inline="yes-display-inline">in paragraph (8)—</text>
<clause commented="no" display-inline="no-display-inline" id="idd86490d1-508a-4308-9577-5015b4464e6c"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>April of the preceding
fiscal year</quote> and inserting <quote>October of the preceding fiscal
year</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id26e48062-ef9d-4c13-aae1-bd5c80372c82"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>April 1997</quote> and
inserting <quote>October 1996</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id04c9cf32-80f2-4531-977f-5e32cba72eec"><enum>(F)</enum><text display-inline="yes-display-inline">by redesignating paragraph (9) as paragraph
(10); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6ed8c7f8-b4b4-4a29-89bd-2ea8b7e0c0d2"><enum>(G)</enum><text display-inline="yes-display-inline">by inserting after paragraph (8) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id7d26c95c-5c3d-44ee-b98a-a4dab9a12bc8" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idf4af37a5-1abd-4178-a7da-c1516d34576f"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>person</term> includes an
affiliate of such
person.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="id3c49e5d5-8307-4313-9e57-10102822dc29" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Authority to assess and use drug
fees</header>
<subsection commented="no" display-inline="no-display-inline" id="ideacca37f-a8dd-4e6a-bc49-f051704438c8"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Section 736(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(a)</external-xref>) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idaf639602-18fb-4c6d-b07a-85756c2504e6"><enum>(1)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph (1), by
striking <quote>2003</quote> and inserting <quote>2008</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8e5b7429-f441-43c3-af15-62930a4b335e"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="iddab5a012-d743-449d-87e6-d65f70475aa1"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (D)—</text>
<clause commented="no" display-inline="no-display-inline" id="id2479413f-aa0a-46e6-a71e-32e2280a344e"><enum>(i)</enum><text display-inline="yes-display-inline">in the heading, by inserting
<quote><header-in-text level="subparagraph" style="OLC">or withdrawn before
filing</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">refund of fee if application refused for
filing</header-in-text></quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id1f3395cc-e4b0-4b1c-87f4-b9a40b6014ae"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting before the period at the end
the following: <quote>or withdrawn without a waiver before
filing</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3b431272-f51e-46c5-8aa5-2708f018529a"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (E) and (F)
as subparagraphs (F) and (G), respectively; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id73628d0b-bc7d-42fa-bd0c-2da2114344f9"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (D) the
following:</text>
<quoted-block display-inline="no-display-inline" id="ide28a08fc-3f6f-4d4e-815c-e4dc87ba4c1d" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ide433c39b-33f9-4ac0-8922-a9371a712491"><enum>(E)</enum><header display-inline="yes-display-inline">Fee for application previously refused for
filing or withdrawn before filing</header><text display-inline="yes-display-inline">An application or supplement that has been
refused for filing or that was withdrawn before filing, if filed under protest
or resubmitted, shall be subject to the fee under subparagraph (A) (unless an
exception under subparagraph (C) or (F) applies or the fee is waived or reduced
under subsection (d)), without regard to previous payment of such a fee and the
refund of 75 percent of that fee under subparagraph
(D).</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id52701c64-e896-410e-88f3-8de3d2fe383b"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id0b0175c5-372f-4e91-b7c1-0c9ba347ef65"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking
<quote>subparagraph (B)</quote> and inserting <quote>subparagraphs (B) and
(C)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3f314148-3dfc-4a1e-989f-6d10a54a6151"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9c1b31f5-e6a2-460a-a4a3-4822858e5728" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id5962c814-3963-480b-a8d9-02af2873b18e"><enum>(C)</enum><header display-inline="yes-display-inline">Special rules for compounded positron
emission tomography drugs</header>
<clause commented="no" display-inline="no-display-inline" id="id329f71a1-5dc3-4df6-b5bd-f29b48e91700"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in clause (ii), each
person who is named as the applicant in an approved human drug application for
a compounded positron emission tomography drug shall be subject under
subparagraph (A) to one-fifth of an annual establishment fee with respect to
each such establishment identified in the application as producing compounded
positron emission tomography drugs under the approved application.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idc9da8bba-1733-45f8-ace5-235a51a91102"><enum>(ii)</enum><header display-inline="yes-display-inline">Exception from annual establishment
fee</header><text display-inline="yes-display-inline">Each person who is named
as the applicant in an application described in clause (i) shall not be
assessed an annual establishment fee for a fiscal year if the person certifies
to the Secretary, at a time specified by the Secretary and using procedures
specified by the Secretary, that—</text>
<subclause commented="no" display-inline="no-display-inline" id="id8e4b6190-7e8b-4a73-a5aa-2d2552293f7c"><enum>(I)</enum><text display-inline="yes-display-inline">the person is a not-for-profit medical
center that has only 1 establishment for the production of compounded positron
emission tomography drugs; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idabc2d308-681b-47c0-b203-ac0e1ca9dda4"><enum>(II)</enum><text display-inline="yes-display-inline">at least 95 percent of the total number of
doses of each compounded positron emission tomography drug produced by such
establishment during such fiscal year will be used within the medical
center.</text>
</subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id2f37434f-e3c2-4de9-bed8-b3980bdb107f"><enum>(b)</enum><header display-inline="yes-display-inline">Fee revenue amounts</header><text display-inline="yes-display-inline">Section 736(b) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(b)</external-xref>) is
amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id4b7e9d16-16bb-4264-bb00-2bdaed3b8be5" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idb056bf0f-e842-4ec7-842a-c742f7bd320a"><enum>(b)</enum><header display-inline="yes-display-inline">Fee revenue amounts</header><text display-inline="yes-display-inline">Except as provided in subsections (c), (d),
(f), and (g), fees under subsection (a) shall be established to generate the
following revenue amounts, in each fiscal year beginning with fiscal year 2008
and continuing through fiscal year 2012: $392,783,000, plus an adjustment for
workload on $354,893,000 of this amount. Such adjustment shall be made in
accordance with the workload adjustment provisions in effect for fiscal year
2007, except that instead of commercial investigational new drug applications
submitted to the Secretary, all commercial investigational new drug
applications with a submission during the previous 12-month period shall be
used in the determination. One-third of the revenue amount shall be derived
from application fees, one-third from establishment fees, and one-third from
product
fees.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idd084243c-b610-4824-914b-d9c5cf8538b9"><enum>(c)</enum><header display-inline="yes-display-inline">Adjustments to fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5f959dcf-5fe0-4a40-937c-d5941ed5c857"><enum>(1)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">Section 736(c)(1) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(c)(1)</external-xref>) is
amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id526efab4-0dac-497c-9630-9703043f854c"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A) by
striking <quote>The revenues established in subsection (b)</quote> and
inserting <quote>Beginning with fiscal year 2009, the revenues established in
subsection (b)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd952d9fc-3fd4-4c07-8846-de8fa5f529ef"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (A) by striking
<quote>or</quote> at the end;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0b0161ce-cff8-4449-89b8-7a58e7612dc0"><enum>(C)</enum><text display-inline="yes-display-inline">in subparagraph (B) by striking the period
at the end and inserting <quote>, or,</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4332061f-112a-4740-8d92-e89eae4336fe"><enum>(D)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (B) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id88a8b0b0-8ac9-4ced-9919-a940ab30a5b3" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id4b41f7da-494d-447c-8ab6-2257a50c9d3d"><enum>(C)</enum><text display-inline="yes-display-inline">the average annual change in the cost, per
full-time equivalent position of the Food and Drug Administration, of all
personnel compensation and benefits paid with respect to such positions, for
the first 5 fiscal years of the previous 6 fiscal
years.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7f24a20b-dad2-4a28-925a-2ff8f4777073"><enum>(E)</enum><text display-inline="yes-display-inline">in the matter following subparagraph (C)
(as added by this paragraph), by striking <quote>fiscal year 2003</quote> and
inserting <quote>fiscal year 2008</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id051a413c-7b50-42cb-b6d1-0e5f66a118f8"><enum>(2)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">Section 736(c)(2) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(c)(2)</external-xref>) is
amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ide39498f2-cf9d-490e-ad66-905532fb0d85"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding subparagraph (A,)
by striking <quote>2004</quote> and inserting <quote>2009</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ided97a857-3811-46d4-b23a-8a523c1cafe0"><enum>(B)</enum><text display-inline="yes-display-inline">in the first sentence of subparagraph
(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="idbbcdbd17-8b96-46d5-ab63-f304be249bdf"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>, commercial
investigational new drug applications</quote> and inserting <quote>(adjusted
for changes in review activities)</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idd836b372-acf3-4b83-bb3b-dfea186438eb"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting before the period at the end
<quote>, and the change in the number of commercial investigational new drug
applications with a submission during the previous 12-month period (adjusted
for changes in review activities)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd52c2cb9-7234-409f-b89c-d942507c7d5a"><enum>(C)</enum><text display-inline="yes-display-inline">in subparagraph (B), by adding at the end
the following new sentence: <quote>Further, any adjustment for changes in
review activities made in setting fees and fee revenue amounts for fiscal year
2009 may not result in the total workload adjustment being more than 2
percentage points higher than it would be absent the adjustment for changes in
review activities.</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide2debb67-fddc-4ecf-8746-6ce9f698ccc9"><enum>(D)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idb7d94cac-2350-492c-a8bd-37ad0bb6a0a7" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id477d3294-8b5b-437b-8420-a57a0ef51a49"><enum>(C)</enum><text display-inline="yes-display-inline">The Secretary shall contract with an
independent accounting firm to study the adjustment for changes in review
activities applied in setting fees for fiscal year 2009 and to make
recommendations, if warranted, on future changes in the methodology for
calculating the adjustment for changes in review activity. After review of the
recommendations by the independent accounting firm, the Secretary shall make
appropriate changes to the workload adjustment methodology in setting fees for
fiscal years 2010 through 2012. If the study is not conducted, no adjustment
for changes in review activities shall be made after fiscal year
2009.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idce22eee6-6b5a-4131-8c05-209f46b7999b"><enum>(3)</enum><header display-inline="yes-display-inline">Rent and rent-related cost
adjustment</header><text display-inline="yes-display-inline">Section 736(c) (21
U.S.C. 379h(c)) is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idc0c3e96c-ad22-4fa5-89bf-d8411950b847"><enum>(A)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3), (4), and
(5) as paragraphs (4), (5), and (6), respectively; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9b89bd1b-0085-4812-8772-af4c804b572b"><enum>(B)</enum><text display-inline="yes-display-inline">by inserting after paragraph (2) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id08856fb0-923a-458e-a540-f7bd80bc8efa" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idca3d9715-b1b3-4c39-8607-5e4efcb34bd2"><enum>(3)</enum><header display-inline="yes-display-inline">Rent and rent-related cost
adjustment</header><text display-inline="yes-display-inline">Beginning with
fiscal year 2010, the Secretary shall, before making the adjustments under
paragraphs (1) and (2), reduce the fee amounts established in subsection (b),
if actual costs paid for rent and rent-related expenses are less than
$11,721,000. The reductions made under this paragraph, if any, shall not exceed
the amounts by which costs fell below $11,721,000, and shall not exceed
$11,721,000 in any fiscal
year.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb2e3a644-b4c4-4a9c-bc5c-6231cf71fe17"><enum>(4)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">Section 736(c) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(c)</external-xref>) is
amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idae31dcfc-0b73-4472-ad36-27a8582c84ba"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (4), as redesignated by this
subsection—</text>
<clause commented="no" display-inline="no-display-inline" id="idc28733b5-e6e7-42a3-b03b-3ccac9f17550"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>2007</quote> each place
it appears and inserting <quote>2012</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ide04df1ad-d6b8-49e4-81ed-3c2cc1856d17"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>2008</quote> and
inserting <quote>2013</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8b4c5c56-9379-4ffe-9e94-04c8db849ddb"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (5), as redesignated by this
subsection, by striking <quote>2002</quote> and inserting
<quote>2007</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ide8c3e364-126a-4cf8-97d2-229d062ef944"><enum>(d)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header><text display-inline="yes-display-inline">Section 736(d) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(d)</external-xref>) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id38da7d49-6307-443d-8eed-b59764c98c5e"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), in the matter preceding
subparagraph (A), by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id92206b1d-525c-4b71-9e87-b7212802dc3e"><enum>(A)</enum><text display-inline="yes-display-inline">inserting <quote>to a person who is named
as the applicant</quote> after <quote>The Secretary shall grant</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2fba18d0-5f7d-4834-9f4d-2f74416fdcb0"><enum>(B)</enum><text display-inline="yes-display-inline">inserting <quote>to that person</quote>
after <quote>a waiver from or a reduction of one or more fees assessed</quote>;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7a3408d8-33f3-4cef-9950-ef594e62696b"><enum>(C)</enum><text display-inline="yes-display-inline">striking <quote>finds</quote> and inserting
<quote>determines</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc057acc4-17bc-4ed8-bd52-fd8b5a35327e"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (2) and (3) as
paragraphs (3) and (4), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id83e8d3c3-bfcf-4ee2-a4c7-f0453e727655"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id9a7797af-bcfc-475c-905f-b7f8b2a4f297" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idefa3b451-0696-4d23-8f2c-78418d957fd8"><enum>(2)</enum><header display-inline="yes-display-inline">Evaluation</header><text display-inline="yes-display-inline">For the purpose of determining whether to
grant a waiver or reduction of a fee under paragraph (1), the Secretary shall
consider only the circumstances and assets of the applicant and any affiliate
of the applicant.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id009c1135-ffcf-4cd9-a16b-e7137dce1770"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (4), as redesignated by this
subsection, in subparagraph (A), by inserting before the period at the end
<quote>, and that does not have a drug product that has been approved under a
human drug application and introduced or delivered for introduction into
interstate commerce</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ida1fb4982-d92d-4aee-a796-f1f26eae1bd0"><enum>(e)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id63ce27cc-a04a-4f81-9974-b5344aebf7ab"><enum>(1)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">Section
736(g)(3) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(g)(3)</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id69c19c03-dde5-48f0-a8b4-6c18fbab9c3b" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id1dbf325a-c231-44a9-b6f4-998eceb8be88"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated for fees under this section such sums as are
authorized to be assessed and collected under this section in each of fiscal
years 2008 through
2012.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb244888b-8669-4db0-baeb-790e1cfbb133"><enum>(2)</enum><header display-inline="yes-display-inline">Offset</header><text display-inline="yes-display-inline">Section 736(g)(4) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(g)(4)</external-xref>) is
amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idce41cc97-e3f9-4ce3-a02b-7db6b709dda4" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id275208c4-bdfa-4b2d-b3b0-0b26070a8248"><enum>(4)</enum><header display-inline="yes-display-inline">Offset</header><text display-inline="yes-display-inline">If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, plus the amount estimated to be
collected for fiscal year 2011, exceeds the amount of fees specified in
aggregate in appropriation Acts for such fiscal years, the aggregate amount in
excess shall be credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be subtracted from the
amount of fees that would otherwise be authorized to be collected under this
section pursuant to appropriation Acts for fiscal year
2012.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id2ebf8e38-b542-4ebf-8f28-fcc01f090c67"><enum>(f)</enum><header display-inline="yes-display-inline">Conforming amendments</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5fa11333-16b0-4693-b19e-b159cbe8e90e"><enum>(1)</enum><text display-inline="yes-display-inline">Section 736(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(a)</external-xref>), as
amended by this section, is amended—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1cf03900-b2cc-42c2-b58b-e2999e8f9f08"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A), by striking
<quote>subsection (c)(4)</quote> each place it appears and inserting
<quote>subsection (c)(5)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idefb59b4a-d15b-472f-afb0-bc96d253e6ab"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking
<quote>subsection (c)(4)</quote> and inserting <quote>subsection
(c)(5)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id738cca10-f6ee-4a23-a9b9-cb1dc9f62d1d"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking
<quote>subsection (c)(4)</quote> and inserting <quote>subsection
(c)(5)</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd6d181d2-0c51-4174-a490-7444f304fa1b"><enum>(2)</enum><text display-inline="yes-display-inline">Section 736A(h)(3), as added by section 104
of this title, is amended by striking <quote>735(3)</quote> and inserting
<quote>735(d)(3)</quote>.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id90f8045a-a8f4-421b-8671-14ab0a6d5110" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Authority to assess and use prescription
drug advertising fees</header><text display-inline="no-display-inline">Chapter
VII, subchapter C, part 2 (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g et seq.</external-xref>) is amended by adding after
section 736 the following new section:</text>
<quoted-block display-inline="no-display-inline" id="id435401a2-b5c3-41b4-9262-80c6caf604e5" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id22a70f90-fb72-4ff5-90d7-b8b59e9e158c" section-type="subsequent-section"><enum>736A.</enum><header display-inline="yes-display-inline">Program to assess and use fees for the
advisory review of prescription drug advertising</header>
<subsection commented="no" display-inline="no-display-inline" id="id55ac71b6-f4f9-41a5-b339-201dcac4bd9f"><enum>(a)</enum><header display-inline="yes-display-inline">Types of direct-to-consumer television
advertisement review fees</header><text display-inline="yes-display-inline">Beginning with fiscal year 2008, the
Secretary shall assess and collect fees in accordance with this section as
follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id7d73a0e6-6d46-4e5e-a5ef-96f4b0e9bee4"><enum>(1)</enum><header display-inline="yes-display-inline">Advisory review fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id99fbd914-6c8d-432a-a886-a5f38800aa03"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B),
each person that on or after October 1, 2007, submits a proposed
direct-to-consumer television advertisement for advisory review by the
Secretary prior to its initial public dissemination shall be subject to a fee
established under subsection (c)(3).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida8b7887a-fbc0-48da-9ac1-7ab1bc013a2a"><enum>(B)</enum><header display-inline="yes-display-inline">Exception for required
submissions</header><text display-inline="yes-display-inline">A
direct-to-consumer television advertisement that is required to be submitted to
the Secretary prior to initial public dissemination shall not be assessed a fee
unless the sponsor designates it as a submission for advisory review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4726a6aa-24dd-4d12-982b-3b7666767319"><enum>(C)</enum><header display-inline="yes-display-inline">Payment</header><text display-inline="yes-display-inline">The fee required by subparagraph (A) shall
be due not later than October 1 of the fiscal year in which the
direct-to-consumer television advertisement shall be submitted to the Secretary
for advisory review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id544fcafc-4aa7-4b83-96d0-f556e1936800"><enum>(D)</enum><header display-inline="yes-display-inline">Modification of advisory review
fee</header>
<clause commented="no" display-inline="no-display-inline" id="idda1a452b-a332-4af9-990d-cce51fee3a69"><enum>(i)</enum><header display-inline="yes-display-inline">Late payment</header><text display-inline="yes-display-inline">If, on or before November 1 of the fiscal
year in which the fees are due, a person has not paid all fees that were due
and payable for advisory reviews identified in response to the Federal Register
notice described in subsection (c)(3)(A), the fees shall be regarded as late.
Such fees shall be due and payable 20 days before any direct-to-consumer
television advertisement is submitted by such person to the Secretary for
advisory review. Notwithstanding any other provision of this section, such fees
shall be due and payable for each of those advisory reviews in the amount of
150 percent of the advisory review fee established for that fiscal year
pursuant to subsection (c)(3).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id68170b5e-321c-4aad-8f60-f07d576f9590"><enum>(ii)</enum><header display-inline="yes-display-inline">Late notice of submission</header><text display-inline="yes-display-inline">If any person submits any
direct-to-consumer television advertisements for advisory review that are in
excess of the number identified by that person in response to the Federal
Register notice described in subsection (c)(3)(A), that person must pay a fee
for each of those advisory reviews in the amount of 150 percent of the advisory
review fee established for that fiscal year pursuant to subsection (c)(3). Fees
under this subparagraph shall be due 20 days before the direct-to-consumer
television advertisement is submitted by such person to the Secretary for
advisory review.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfb1e8a37-465c-4766-9f63-5ba4043893e4"><enum>(E)</enum><header display-inline="yes-display-inline">Limits</header>
<clause commented="no" display-inline="no-display-inline" id="id4b4f9068-3025-4636-a751-b4e441d4f5f3"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The payment of a fee under this paragraph
for a fiscal year entitles the person that pays the fee to acceptance for
advisory review by the Secretary of 1 direct-to-consumer television
advertisement and acceptance of 1 resubmission for advisory review of the same
advertisement. The advertisement shall be submitted for review in the fiscal
year for which the fee was assessed, except that a person may carry over no
more than 1 paid advisory review submission to the next fiscal year.
Resubmissions may be submitted without regard to the fiscal year of the initial
advisory review submission.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ida79ea133-4fe6-4b1a-a386-553aa32e383d"><enum>(ii)</enum><header display-inline="yes-display-inline">No refund</header><text display-inline="yes-display-inline">Except as provided by subsection (f), fees
paid under this paragraph shall not be refunded.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id304abc2d-2de5-40cd-9c58-04040f3422b4"><enum>(iii)</enum><header display-inline="yes-display-inline">No waiver, exemption, or
reduction</header><text display-inline="yes-display-inline">The Secretary shall
not grant a waiver, exemption, or reduction of any fees due or payable under
this section.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3d93ca42-aaeb-45d9-83fb-3e508605cbd2"><enum>(iv)</enum><header display-inline="yes-display-inline">Non-transferability</header><text display-inline="yes-display-inline">The right to an advisory review is not
transferable, except to a successor in interest.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd58ee617-75de-4791-a702-ed7372045e8a"><enum>(2)</enum><header display-inline="yes-display-inline">Operating reserve fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id7e701740-e3c7-49c5-9743-f95383eb4589"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person that, on or after October 1,
2007, is assessed an advisory review fee under paragraph (1) shall be subject
to an operating reserve fee established under subsection (d)(2) only in the
first fiscal year in which an advisory review fee is assessed.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbdd9bbc4-5fe9-4054-838c-a04d1fd69ae6"><enum>(B)</enum><header display-inline="yes-display-inline">Payment</header><text display-inline="yes-display-inline">Except as provided in subparagraph (C), the
fee required by subparagraph (A) shall be due not later than October 1 of the
first fiscal year in which the person is required to pay an advisory review fee
under paragraph (1).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idceee376a-ca4d-4f0c-b4cc-61bbad976633"><enum>(C)</enum><header display-inline="yes-display-inline">Late notice of submission</header><text display-inline="yes-display-inline">If, in the first fiscal year of a person's
participation in the Program, that person submits any direct-to-consumer
television advertisements for advisory review that are in excess of the number
identified by that person in response to the Federal Register notice described
in subsection (c)(3)(A), that person must pay an operating reserve fee for each
of those advisory reviews equal to the advisory review fee for each submission
established under paragraph (1)(D)(ii). Fees required by this subparagraph
shall be in addition to the fees required under subparagraph (B), if any. Fees
under this subparagraph shall be due 20 days before any direct-to-consumer
television advertisement is submitted by such person to the Secretary for
advisory review.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idbfcc28b1-cffd-47a9-8e81-a1be64b43d75"><enum>(b)</enum><header display-inline="yes-display-inline">Advisory review fee revenue
amounts</header><text display-inline="yes-display-inline">Fees under subsection
(a)(1) shall be established to generate revenue amounts of $6,250,000 for each
of fiscal years 2008 through 2012, as adjusted pursuant to subsection
(c).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id884e6488-ccd9-4e22-bc56-434affa19b41"><enum>(c)</enum><header display-inline="yes-display-inline">Adjustments</header>
<paragraph commented="no" display-inline="no-display-inline" id="ide426a89a-f0f3-410c-bc33-29400da060c4"><enum>(1)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">Beginning with fiscal year 2009, the
revenues established in subsection (b) shall be adjusted by the Secretary by
notice, published in the Federal Register, for a fiscal year to reflect the
greater of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idfe686c15-e5a1-4729-9c84-f1f829153fa5"><enum>(A)</enum><text display-inline="yes-display-inline">the total percentage change that occurred
in the Consumer Price Index for all urban consumers (all items; United States
city average), for the 12-month period ending June 30 preceding the fiscal year
for which fees are being established;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide8e72e03-4811-47d2-a32d-24d9a80dd48e"><enum>(B)</enum><text display-inline="yes-display-inline">the total percentage change for the
previous fiscal year in basic pay under the General Schedule in accordance with
<external-xref legal-doc="usc" parsable-cite="usc/5/5332">section 5332</external-xref> of title 5, as adjusted by any locality-based comparability
payment pursuant to section 5304 of such title for Federal employees stationed
in the District of Columbia; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida8bacd1c-8354-4677-8260-020b50dfbcf5"><enum>(C)</enum><text display-inline="yes-display-inline">the average annual change in the cost, per
full-time equivalent position of the Food and Drug Administration, of all
personnel compensation and benefits paid with respect to such positions, for
the first 5 fiscal years of the previous 6 fiscal years.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">The adjustment made each fiscal year
by this paragraph shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2008 under this
subsection.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idca76c2ad-16fa-4738-9511-030aae16ba4a"><enum>(2)</enum><header display-inline="yes-display-inline">Workload adjustment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idc25621ae-b630-4d8c-aed9-40f79d27b665"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning with fiscal year 2009, after the
fee revenues established in subsection (b) of this section are adjusted for a
fiscal year for inflation in accordance with paragraph (1), the fee revenues
shall be adjusted further for such fiscal year to reflect changes in the
workload of the Secretary with respect to the submission of proposed
direct-to-consumer television advertisements for advisory review prior to
initial broadcast.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8265f605-3f02-4829-b0d2-e926b2b02795"><enum>(B)</enum><header display-inline="yes-display-inline">Determination of workload
adjustment</header>
<clause commented="no" display-inline="no-display-inline" id="idf5aaa4e7-8ebe-4e11-b97c-4e55a8ba77b6"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The workload adjustment under this
paragraph for a fiscal year shall be determined by the Secretary—</text>
<subclause commented="no" display-inline="no-display-inline" id="idd19004dc-ab46-483f-82e8-dd9c91a24496"><enum>(I)</enum><text display-inline="yes-display-inline">based upon the number of direct-to-consumer
television advertisements identified pursuant to paragraph (3)(A) for that
fiscal year, excluding allowable previously paid carry over submissions;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id04794bd6-28bb-4313-a1f6-249dbd49dcf3"><enum>(II)</enum><text display-inline="yes-display-inline">by multiplying the number of such
advertisements projected for that fiscal year that exceeds 150 by $27,600
(adjusted each year beginning with fiscal year 2009 for inflation in accordance
with paragraph (1)).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id83d09af5-1da3-4c18-85f6-be9c8857330b"><enum>(ii)</enum><header display-inline="yes-display-inline">Publication in Federal
Register</header><text display-inline="yes-display-inline">The Secretary shall
publish in the Federal Register, as part of the notice described in paragraph
(1), the fee revenues and fees resulting from the adjustment made under this
paragraph and the supporting methodologies.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id964cdb03-bb3b-45e3-94cf-933605d66095"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Under no circumstances shall the adjustment
made under this paragraph result in fee revenues for a fiscal year that are
less than the fee revenues established for the prior fiscal year.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcba72db8-1470-4896-b72b-7c4ee50f34a3"><enum>(3)</enum><header display-inline="yes-display-inline">Annual fee setting</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id2f0a13f5-9f10-4cd4-a8c7-650cc27cfb17"><enum>(A)</enum><header display-inline="yes-display-inline">Number of advertisements</header><text display-inline="yes-display-inline">The Secretary shall, 120 days before the
start of each fiscal year, publish a notice in the Federal Register requesting
any person to notify the Secretary within 30 days of the number of
direct-to-consumer television advertisements the person intends to submit for
advisory review by the Secretary in the next fiscal year. Notification to the
Secretary of the number of advertisements a person intends to submit for
advisory review prior to initial broadcast shall be a legally binding
commitment by that person to pay the annual advisory review fee for that number
of submissions on or before October 1 of the fiscal year in which the
advertisement is intended to be submitted. A person shall at the same time also
notify the Secretary if such person intends to use a paid submission from the
previous fiscal year under subsection (a)(1)(E)(i). If such person does not so
notify the Secretary, all submissions for advisory review shall be subject to
advisory review fees.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idce7174b4-7dbd-4cd3-bbbe-dceef4307431"><enum>(B)</enum><header display-inline="yes-display-inline">Annual fee</header><text display-inline="yes-display-inline">The Secretary shall, 60 days before the
start of each fiscal year, establish, for the next fiscal year, the
direct-to-consumer television advertisement advisory review fee under
subsection (a)(1), based on the revenue amounts established under subsection
(b), the adjustments provided under this subsection and the number of
direct-to-consumer television advertisements identified pursuant to
subparagraph (A), excluding allowable previously paid carry over submissions.
The annual advisory review fee shall be established by dividing the fee revenue
for a fiscal year (as adjusted pursuant to this subsection) by the number of
direct-to-consumer television advertisements identified pursuant to
subparagraph (A), excluding allowable previously paid carry over
submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id92a43edb-a7f0-47f7-a34c-20e34a41d753"><enum>(C)</enum><header display-inline="yes-display-inline">Fiscal year 2008 fee limit</header><text display-inline="yes-display-inline">Notwithstanding subsection (b), the fee
established under subparagraph (B) for fiscal year 2008 may not be more than
$83,000 per submission for advisory review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide919bf8c-8a70-4a4d-ae72-88696eae8cbb"><enum>(D)</enum><header display-inline="yes-display-inline">Annual fee limit</header><text display-inline="yes-display-inline">Notwithstanding subsection (b), the fee
established under subparagraph (B) for a fiscal year after fiscal year 2008 may
not be more than 50 percent more than the fee established for the prior fiscal
year.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1fafa35b-b5cb-4d40-8248-9467c7613c7a"><enum>(E)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">The total amount of fees obligated for a
fiscal year may not exceed the total costs for such fiscal year for the
resources allocated for the process for the advisory review of prescription
drug advertising.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id59fde21d-1325-4a0d-8cd7-59c6de3eccc1"><enum>(d)</enum><header display-inline="yes-display-inline">Operating reserves</header>
<paragraph commented="no" display-inline="no-display-inline" id="id38f6d1e1-f485-495f-b2f8-976a35d2670b"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall establish in the Food
and Drug Administration salaries and expenses appropriation account without
fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve,
of at least $6,250,000 in fiscal year 2008, to continue the Program in the
event the fees collected in any subsequent fiscal year pursuant to subsection
(c)(3) do not generate the fee revenue amount established for that fiscal
year.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id36ab2399-e2f4-406e-95ce-4aff9d1b8ec1"><enum>(2)</enum><header display-inline="yes-display-inline">Fee setting</header><text display-inline="yes-display-inline">The Secretary shall establish the operating
reserve fee under subsection (a)(2)(A) for each person required to pay the fee
by multiplying the number of direct-to-consumer television advertisements
identified by that person pursuant to subsection (c)(3)(A) by the advisory
review fee established pursuant to subsection (c)(3) for that fiscal year. In
no case shall the operating reserve fee assessed be less than the operating
reserve fee assessed if the person had first participated in the Program in
fiscal year 2008.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="iddbd1078e-204d-4748-a0e9-4d6e76d0d308"><enum>(3)</enum><header display-inline="yes-display-inline">Use of operating reserve</header><text display-inline="yes-display-inline">The Secretary may use funds from the
reserves under this subsection only to the extent necessary in any fiscal year
to make up the difference between the fee revenue amount established for that
fiscal year under subsection (b) and the amount of fees collected for that
fiscal year pursuant to subsection (a), or to pay costs of ending the Program
if it is terminated pursuant to subsection (f) or if it is not reauthorized
after fiscal year 2012.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id80bbceb7-2055-4450-a149-f7f57319dd53"><enum>(4)</enum><header display-inline="yes-display-inline">Refund of operating reserves</header><text display-inline="yes-display-inline">Within 120 days of the end of fiscal year
2012, or if the Program is terminated pursuant to subsection (f), the
Secretary, after setting aside sufficient operating reserve amounts to
terminate the Program, shall refund all amounts remaining in the operating
reserve on a pro rata basis to each person that paid an operating reserve fee
assessment. In no event shall the refund to any person exceed the total amount
of operating reserve fees paid by such person pursuant to subsection
(a)(2).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id3d08bb87-48eb-4003-8d12-1ea807742273"><enum>(e)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header><text display-inline="yes-display-inline">Notwithstanding any other law or regulation
of the Secretary, a submission for advisory review of a direct-to-consumer
television advertisement submitted by a person subject to fees under subsection
(a) shall be considered incomplete and shall not be accepted for review by the
Secretary until all fees owed by such person under this section have been
paid.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id6ee3e7ad-467e-4eec-a3e8-106c93c41a56"><enum>(f)</enum><header display-inline="yes-display-inline">Effect of inadequate funding of
Program</header>
<paragraph commented="no" display-inline="no-display-inline" id="id841680f5-866a-4595-b660-957e5947282f"><enum>(1)</enum><header display-inline="yes-display-inline">First fiscal year</header><text display-inline="yes-display-inline">If on November 1, 2007, or 120 days after
enactment of the <short-title>Prescription Drug User Fee
Amendments of 2007</short-title>, whichever is later, the Secretary has
received less than $11,250,000 in advisory review fees and operating reserve
fees combined, the Program shall be terminated and all collected fees shall be
refunded.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide452662a-660e-42c1-9dd9-7e7102e15506"><enum>(2)</enum><header display-inline="yes-display-inline">Subsequent fiscal years</header><text display-inline="yes-display-inline">Beginning in fiscal year 2009, if, on
November 1 of a fiscal year, the combination of the operating reserves, annual
fee revenues from that fiscal year, and unobligated fee revenues from prior
fiscal years is less than $9,000,000, adjusted for inflation (in accordance
with subsection (c)(1)), the Program shall be terminated, and the Secretary
shall notify all participants, retain any money from the unused advisory review
fees and the operating reserves needed to terminate the Program, and refund the
remainder of the unused fees and operating reserves. To the extent required to
terminate the Program, the Secretary shall first use unobligated advisory
review fee revenues from prior fiscal years, then the operating reserves, and
then unused advisory review fees from the relevant fiscal year.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9b393f7f-edc7-4e5f-91b8-9e063af19e77"><enum>(g)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id581d7964-ba21-4e01-bef9-015f157f0f45"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Fees authorized under subsection (a) shall
be collected and available for obligation only to the extent and in the amount
provided in advance in appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may be transferred from
the Food and Drug Administration salaries and expenses appropriation account
without fiscal year limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums transferred shall be
available solely for the process for the advisory review of prescription drug
advertising.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id05a0b9b7-d706-4f69-9bf2-1fbe2e3cbed8"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation
Acts</header><text display-inline="yes-display-inline">The fees authorized by
this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id8645fe8b-cfed-483e-9a3f-fb6d8347db5d"><enum>(A)</enum><text display-inline="yes-display-inline">shall be retained in each fiscal year in an
amount not to exceed the amount specified in appropriation Acts, or otherwise
made available for obligation for such fiscal year; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd5696bc3-5125-4e77-a98d-6f98b77c12c9"><enum>(B)</enum><text display-inline="yes-display-inline">shall be available for obligation only if
appropriated budget authority continues to support at least the total combined
number of full-time equivalent employees in the Food and Drug Administration,
Center for Drug Evaluation and Research, Division of Drug Marketing,
Advertising, and Communications, and the Center for Biologics Evaluation and
Research, Advertising and Promotional Labeling Branch supported in fiscal year
2007.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id87dc0310-688f-476e-863b-6df6e48371fa"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated for fees under this section not less than
$6,250,000 for each of fiscal years 2008, 2009, 2010, 2011, and 2012, as
adjusted to reflect adjustments in the total fee revenues made under this
section, plus amounts collected for the reserve fund under subsection
(d).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcfa783ef-bd18-4dd9-b157-4f7acd6ca326"><enum>(4)</enum><header display-inline="yes-display-inline">Offset</header><text display-inline="yes-display-inline">Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees specified in
appropriation Acts for such fiscal year shall be credited to the appropriation
account of the Food and Drug Administration as provided in paragraph (1), and
shall be subtracted from the amount of fees that would otherwise be collected
under this section pursuant to appropriation Acts for a subsequent fiscal
year.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idcdc56074-2cb4-4eaf-a624-03393fd662d6"><enum>(h)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idd8d2e5ee-a5f7-4cea-8025-858ff1e29f21"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>advisory review</term> means
reviewing and providing advisory comments regarding compliance of a proposed
advertisement with the requirements of this Act prior to its initial public
dissemination.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf97b85d6-8407-4a80-b789-3fd3ed25b709"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>carry over submission</term>
means a submission for an advisory review for which a fee was paid in a fiscal
year that is submitted for review in the following fiscal year.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id408298fa-f17a-4ccc-86d9-4fe9dc073c05"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>direct-to-consumer
television advertisement</term> means an advertisement for a prescription drug
product as defined in section 735(3) intended to be displayed on any television
channel for less than 2 minutes.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id61eb82fb-78fe-48ab-9543-1db97ce6489c"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>person</term> includes an
individual, a partnership, a corporation, and an association, and any affiliate
thereof or successor in interest.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id03c15932-ccb6-4cfa-9359-0a1e1b74e734"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>process for the advisory
review of prescription drug advertising</term> means the activities necessary
to review and provide advisory comments on proposed direct-to-consumer
television advertisements prior to public dissemination and, to the extent the
Secretary has additional staff resources available under the Program that are
not necessary for the advisory review of direct-to-consumer television
advertisements, the activities necessary to review and provide advisory
comments on other proposed advertisements and promotional material prior to
public dissemination.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc0ba5853-7f9e-4448-a090-5f22cc96ec07"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>Program</term> means the
Program to assess, collect, and use fees for the advisory review of
prescription drug advertising established by this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idae3bb7a8-2005-4b5f-afe6-d61034263b7e"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>resources allocated for the
process for the advisory review of prescription drug advertising</term> means
the expenses incurred in connection with the process for the advisory review of
prescription drug advertising for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idd02bf403-b52b-4424-9ff7-7297fc84086d"><enum>(A)</enum><text display-inline="yes-display-inline">officers and employees of the Food and Drug
Administration, contractors of the Food and Drug Administration, advisory
committees, and costs related to such officers, employees, and committees, and
to contracts with such contractors;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id717bfa81-b9b6-4c5d-807b-1969d54719d2"><enum>(B)</enum><text display-inline="yes-display-inline">management of information, and the
acquisition, maintenance, and repair of computer resources;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6a6dd7d5-6cbc-46f0-a114-1b2c44f1e340"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance, and repair of fixtures,
furniture, scientific equipment, and other necessary materials and
supplies;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idef41c6dd-dc0d-41e2-90ee-40dffddc0813"><enum>(D)</enum><text display-inline="yes-display-inline">collection of fees under this section and
accounting for resources allocated for the advisory review of prescription drug
advertising; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4708ece5-5558-4f66-9462-5cec32593dc4"><enum>(E)</enum><text display-inline="yes-display-inline">terminating the Program under subsection
(f)(2), if necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id03d1767e-bd6a-45e8-9680-59d0e1695e8a"><enum>(8)</enum><text display-inline="yes-display-inline">The term <term>resubmission</term> means a
subsequent submission for advisory review of a direct-to-consumer television
advertisement that has been revised in response to the Secretary's comments on
an original submission. A resubmission may not introduce significant new
concepts or creative themes into the television advertisement.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id032c89e6-9b52-4dca-a00d-20a0b3115401"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>submission for advisory
review</term> means an original submission of a direct-to-consumer television
advertisement for which the sponsor voluntarily requests advisory comments
before the advertisement is publicly disseminated.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id0D89F61ACEEE437CA51DFE7E507E23EF" section-type="subsequent-section"><enum>736B.</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="no-display-inline">This part shall cease to be effective on
October 1, 2012, except that subsection (b) of section 736 with respect to
reports shall cease to be effective on January 31,
2013.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id3fdbbfea-29dd-480c-b1c3-0ebba6971609" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">Notwithstanding section
509 of the Prescription Drug User Fee Amendments of 2002 (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g</external-xref> note),
and notwithstanding the amendments made by this title, part 2 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the
day before the date of enactment of this title, shall continue to be in effect
with respect to human drug applications and supplements (as defined in such
part as of such day) that on or after October 1, 2002, but before October 1,
2007, were accepted by the Food and Drug Administration for filing with respect
to assessing and collecting any fee required by such part for a fiscal year
prior to fiscal year 2008.</text>
</section><section commented="no" display-inline="no-display-inline" id="id1961eff5-9888-4be0-b43f-a3088ec46a3c" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Technical amendment</header><text display-inline="no-display-inline">Section 739 (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-11">21 U.S.C. 379j–11</external-xref>) is amended
in the matter preceding paragraph (1), by striking <quote>subchapter</quote>
and inserting <quote>part</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="id16c408b1-a43e-46da-aa0c-123114c9bef3" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Effective dates</header>
<subsection commented="no" display-inline="no-display-inline" id="idac1b78ed-0cf5-45e3-9117-e3cd27eded96"><enum>(a)</enum><header display-inline="yes-display-inline">In General</header><text display-inline="yes-display-inline">Except as provided in subsection (b), the
amendments made by this title shall take effect October 1, 2007.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idd609f69c-87e9-4606-bd0f-6720ef7a5084"><enum>(b)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The amendment made by section 104 of this
title shall take effect on the date of enactment of this title.</text>
</subsection></section><enum>II</enum><header display-inline="yes-display-inline">Drug Safety</header>
<section commented="no" display-inline="no-display-inline" id="idB97409F5F7274E768ED95ACD7A72DC59" section-type="subsequent-section"><enum>200.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This title may be cited as the
<quote>Enhancing Drug Safety and Innovation Act of 2007</quote>.</text>
</section><subtitle commented="no" id="id3818653A107B4491BA5DF8AAB5D59B18" level-type="subsequent" style="OLC"><enum>A</enum><header display-inline="yes-display-inline">Risk Evaluation and Mitigation
Strategies</header>
<section commented="no" display-inline="no-display-inline" id="id68837CE9656A44108A7311195EFB2EEB" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Routine active surveillance and
assessment</header>
<subsection commented="no" display-inline="no-display-inline" id="idD9740A5D7EC74530803BF92D06F9D385"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subsection (k) of section 505 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id47598352EAFA4C61871D5220E1B5AB3B" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idFC5106250D874F54B07F6CE8D5C6BE34"><enum>(3)</enum><header display-inline="yes-display-inline">Routine active surveillance and
assessment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idCA8F4D1040874382BD886A57F91B6130"><enum>(A)</enum><header display-inline="yes-display-inline">Development of the postmarket risk
identification and analysis system</header><text display-inline="yes-display-inline">The Secretary shall, not later than 2 years
after the date of enactment of the Enhancing Drug Safety and Innovation Act of
2007, act in collaboration with academic institutions and private entities
to—</text>
<clause commented="no" display-inline="no-display-inline" id="id0C743DADB3F54DE2AB45AB10A6A22E29"><enum>(i)</enum><text display-inline="yes-display-inline">establish minimum standards for collection
and transmission of postmarketing data elements from electronic health data
systems; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id911F2357DDD948ACAAA067EB7506E9DA"><enum>(ii)</enum><text display-inline="yes-display-inline">establish, through partnerships, a
validated and integrated postmarket risk identification and analysis system to
integrate and analyze safety data from multiple sources, with the goals of
including, in aggregate—</text>
<subclause commented="no" display-inline="no-display-inline" id="id8825201A2CFF42D4BD410EB02C80F770"><enum>(I)</enum><text display-inline="yes-display-inline">at least 25,000,000 patients by July 1,
2010; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idFEFFBEF7EA89435B810A5A9A9F7ACA86"><enum>(II)</enum><text display-inline="yes-display-inline">at least 100,000,000 patients by July 1,
2012.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8A672647DCB34FB599DE9018D7FD41EB"><enum>(B)</enum><header display-inline="yes-display-inline">Data collection activities</header>
<clause commented="no" display-inline="no-display-inline" id="id7533E8EABEB24098B2371D1E7DD114D1"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall, not later than 1 year
after the establishment of the minimum standards and the identification and
analysis system under subparagraph (A), establish and maintain an active
surveillance infrastructure—</text>
<subclause commented="no" display-inline="no-display-inline" id="id204F0CB89BD24596A3E4D690E520DD61"><enum>(I)</enum><text display-inline="yes-display-inline">to collect and report data for
pharmaceutical postmarket risk identification and analysis, in compliance with
the regulations promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id3D7CD3B349E444678AD3415B4F3D8F59"><enum>(II)</enum><text display-inline="yes-display-inline">that includes, in addition to the
collection and monitoring (in a standardized form) of data on all serious
adverse drug experiences (as defined in subsection (o)(2)(C)) required to be
submitted to the Secretary under paragraph (1), and those events voluntarily
submitted from patients, providers, and drug, when appropriate, procedures
to—</text>
<item commented="no" display-inline="no-display-inline" id="idF949741519D4453096C9C3C3D5500522"><enum>(aa)</enum><text display-inline="yes-display-inline">provide for adverse event surveillance by
collecting and monitoring Federal health-related electronic data (such as data
from the Medicare program and the health systems of the Department of Veterans
Affairs);</text>
</item><item commented="no" display-inline="no-display-inline" id="id8648D6B5764743BC98DA2041DA56B14E"><enum>(bb)</enum><text display-inline="yes-display-inline">provide for adverse event surveillance by
collecting and monitoring private sector health-related electronic data (such
as pharmaceutical purchase data and health insurance claims data);</text>
</item><item commented="no" display-inline="no-display-inline" id="idA3885343E50E4629B3BF2C8D82742930"><enum>(cc)</enum><text display-inline="yes-display-inline">provide for adverse event surveillance by
monitoring standardized electronic health records, as available;</text>
</item><item commented="no" display-inline="no-display-inline" id="id772EFA801ACC4F0EB2A5224B76B36FD9"><enum>(dd)</enum><text display-inline="yes-display-inline">provide for adverse event surveillance by
collecting and monitoring other information as the Secretary deems necessary to
create a robust system to identify adverse events and potential drug safety
signals;</text>
</item><item commented="no" display-inline="no-display-inline" id="id68BD72ACCDDE458398B4AE6FE13E54DA"><enum>(ee)</enum><text display-inline="yes-display-inline">enable the program to identify certain
trends and patterns with respect to data reported to the program;</text>
</item><item commented="no" display-inline="no-display-inline" id="id6B52BD365344496FA4F3F13570D32114"><enum>(ff)</enum><text display-inline="yes-display-inline">enable the program to provide regular
reports to the Secretary concerning adverse event trends, adverse event
patterns, incidence and prevalence of adverse events, laboratory data, and
other information determined appropriate, which may include data on comparative
national adverse event trends; and</text>
</item><item commented="no" display-inline="no-display-inline" id="id7008D77375164B3F8E106AF25C8354A1"><enum>(gg)</enum><text display-inline="yes-display-inline">enable the program to export data in a form
appropriate for further aggregation, statistical analysis, and
reporting.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id8AC9B0F1CFA342FBA981DF35375D83F1"><enum>(ii)</enum><header display-inline="yes-display-inline">Timeliness of reporting</header><text display-inline="yes-display-inline">The procedures developed under clause (i)
shall ensure that such data are collected, monitored, and reported in a timely,
routine, and automatic manner, taking into consideration the need for data
completeness, coding, cleansing, and transmission.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idDD346EFD36584033AE79C6718EC7ADEE"><enum>(iii)</enum><header display-inline="yes-display-inline">Private sector resources</header><text display-inline="yes-display-inline">To ensure the establishment of the active
surveillance infrastructure by the date described under clause (i), the
Secretary may, on a temporary or permanent basis, implement systems or products
developed by private entities.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id16899A7ACEEA4716B583061A0A64DC4D"><enum>(iv)</enum><header display-inline="yes-display-inline">complementary approaches</header><text display-inline="yes-display-inline">To the extent the active surveillance
infrastructure established under clause (i) is not sufficient to gather data
and information relevant to priority drug safety questions, the Secretary shall
develop, support, and participate in complementary approaches to gather and
analyze such data and information, including—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID9e4e850cd5ed499f953a4608c949ae77"><enum>(I)</enum><text display-inline="yes-display-inline">approaches that are complementary with
respect to assessing the safety of use of a drug in domestic populations not
included in the trials used to approve the drug (such as older people, people
with comorbidities, pregnant women, or children); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4a2f1770e10945bbb972fb1093cbd00e"><enum>(II)</enum><text display-inline="yes-display-inline">existing approaches such as the Vaccine
Adverse Event Reporting System and the Vaccine Safety Datalink or successor
databases.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idC1709ADF3E1B4DFBA42D9C88542E4127"><enum>(v)</enum><header display-inline="yes-display-inline">Authority for contracts</header><text display-inline="yes-display-inline">The Secretary may enter into contracts with
public and private entities to fulfill the requirements of this
subparagraph.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC8944717EE18456C8085669AF18A686C"><enum>(C)</enum><header display-inline="yes-display-inline">Risk identification and analysis</header>
<clause commented="no" display-inline="no-display-inline" id="IDfc03a9706ce943d8ba1d5efdc978022e"><enum>(i)</enum><header display-inline="yes-display-inline">Purpose</header><text display-inline="yes-display-inline">To carry out this paragraph, the Secretary
shall establish collaborations with other Government, academic, and private
entities, including the Centers for Education and Research on Therapeutics
under section 912 of the Public Health Service Act, to provide for the risk
identification and analysis of the data collected under subparagraph (B) and
data that is publicly available or is provided by the Secretary, in order
to—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDc02d79ff9de84130b41cb606103e136d"><enum>(I)</enum><text display-inline="yes-display-inline">improve the quality and efficiency of
postmarket drug safety risk-benefit analysis;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID23e5f93f24de458493beecb7e6368bea"><enum>(II)</enum><text display-inline="yes-display-inline">provide the Secretary with routine access
to expertise to study advanced drug safety data; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID1ef1c49f1e0d419ba123f1f42f3698ea"><enum>(III)</enum><text display-inline="yes-display-inline">enhance the ability of the Secretary to
make timely assessments based on drug safety data.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id8824FFC1E787436A9DCAEF4129E37AD3"><enum>(ii)</enum><header display-inline="yes-display-inline">Public process for priority
questions</header><text display-inline="yes-display-inline">At least
biannually, the Secretary shall seek recommendations from the Drug Safety and
Risk Management Advisory Committee (or successor committee) and from other
advisory committees, as appropriate, to the Food and Drug Administration
on—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDa1db178f221946bb933df8768421294c"><enum>(I)</enum><text display-inline="yes-display-inline">priority drug safety questions; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDf9c5447c6a184c61b5953237b8c433d6"><enum>(II)</enum><text display-inline="yes-display-inline">mechanisms for answering such questions,
including through—</text>
<item commented="no" display-inline="no-display-inline" id="ID57c640b0f9f249b2b67cd58b00a0a05e"><enum>(aa)</enum><text display-inline="yes-display-inline">routine active surveillance under
subparagraph (B); and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID0eb96d7505df46088861513cdab4faf8"><enum>(bb)</enum><text display-inline="yes-display-inline">when such surveillance is not sufficient,
postmarket studies under subsection (o)(4)(B) and postapproval clinical trials
under subsection (o)(4)(C).</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDf680524cc67b4341be0fbeffbf36a801"><enum>(iii)</enum><header display-inline="yes-display-inline">Procedures for the development of drug
safety collaborations</header>
<subclause commented="no" display-inline="no-display-inline" id="idE6E7FBF29A41407DAE4E34713DE1076E"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
the establishment of the active surveillance infrastructure under subparagraph
(B), the Secretary shall establish and implement procedures under which the
Secretary may routinely collaborate with a qualified entity to—</text>
<item commented="no" display-inline="no-display-inline" id="ID21dea54b6af249cb98f40a3779d511ca"><enum>(aa)</enum><text display-inline="yes-display-inline">clean, classify, or aggregate data
collected under subparagraph (B) and data that is publicly available or is
provided by the Secretary;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDbe71aa226da240dbb80a3e48f9dee347"><enum>(bb)</enum><text display-inline="yes-display-inline">allow for prompt investigation of priority
drug safety questions, including—</text>
<subitem commented="no" display-inline="no-display-inline" id="id1F5C17DB490A40D48C8216C4D43A99BE"><enum>(AA)</enum><text display-inline="yes-display-inline">unresolved safety questions for drugs or
classes of drugs; and</text>
</subitem><subitem commented="no" display-inline="no-display-inline" id="id4904F60B7322438A9E4D12720E57CDD0"><enum>(BB)</enum><text display-inline="yes-display-inline">for a newly-approved drug: safety signals
from clinical trials used to approve the drug and other preapproval trials;
rare, serious drug side effects; and the safety of use in domestic populations
not included in the trials used to approve the drug (such as older people,
people with comorbidities, pregnant women, or children);</text>
</subitem></item><item commented="no" display-inline="no-display-inline" id="id5A01F53893D74D4294D711D5777DFC03"><enum>(cc)</enum><text display-inline="yes-display-inline">perform advanced research and analysis on
identified drug safety risks;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDa0e9613cb5264f2a8d4913163ff94920"><enum>(dd)</enum><text display-inline="yes-display-inline">convene an expert advisory committee to
oversee the establishment of standards for the ethical and scientific uses for,
and communication of, postmarketing data collected under subparagraph (B),
including advising on the development of effective research methods for the
study of drug safety questions;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDbefd3f19d3f54096bde830e47a9e5f8a"><enum>(ee)</enum><text display-inline="yes-display-inline">focus postmarket studies under subsection
(o)(4)(B) and postapproval clinical trials under subsection (o)(4)(C) more
effectively on cases for which reports under paragraph (1) and other safety
signal detection is not sufficient to resolve whether there is an elevated risk
of a serious adverse event associated with the use of a drug; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID6be63afbc7c04f25b9829cdc565831c0"><enum>(ff)</enum><text display-inline="yes-display-inline">carry out other activities as the Secretary
deems necessary to carry out the purposes of this paragraph.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID9694661a3925450fad778224671013d5"><enum>(II)</enum><header display-inline="yes-display-inline">Request for specific
methodology</header><text display-inline="yes-display-inline">The procedures
described in subclause (I) shall permit the Secretary to request that a
specific methodology be used by the qualified entity. The qualified entity
shall work with the Secretary to finalize the methodology to be used.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID1168957c8758470ca828c0f7a2a062a8"><enum>(iv)</enum><header display-inline="yes-display-inline">Use of analyses</header><text display-inline="yes-display-inline">The Secretary shall provide the analyses
described under this subparagraph, including the methods and results of such
analyses, about a drug to the sponsor or sponsors of such drug.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5fb7a817e95f4f638e722f749f4e0b18"><enum>(v)</enum><header display-inline="yes-display-inline">Qualified entities</header>
<subclause commented="no" display-inline="no-display-inline" id="id0461B7E1CBE040EAA04A447DB2CE4842"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall enter into contracts
with a sufficient number of qualified entities to develop and provide
information to the Secretary in a timely manner.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idB556B83F312743CE9005013B90768C10"><enum>(II)</enum><header display-inline="yes-display-inline">Qualification</header><text display-inline="yes-display-inline">The Secretary shall enter into a contract
with an entity under subclause (I) only if the Secretary determines that the
entity—</text>
<item commented="no" display-inline="no-display-inline" id="ID9204104eafd44aec869f08f0b578a58d"><enum>(aa)</enum><text display-inline="yes-display-inline">has the research capability and expertise
to conduct and complete the activities under this paragraph;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID974df5d168b542eaab13b68f53fcc4c6"><enum>(bb)</enum><text display-inline="yes-display-inline">has in place an information technology
infrastructure to support adverse event surveillance data and operational
standards to provide security for such data;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID02c4e6817519406ebe6a0a630ac80d9d"><enum>(cc)</enum><text display-inline="yes-display-inline">has experience with, and expertise on, the
development of drug safety and effectiveness research using electronic
population data;</text>
</item><item commented="no" display-inline="no-display-inline" id="ID1735d452673242bdabf8244dc39486da"><enum>(dd)</enum><text display-inline="yes-display-inline">has an understanding of drug development
and risk/benefit balancing in a clinical setting; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID8c767537768648c2b64d6bd51f6e8cb6"><enum>(ee)</enum><text display-inline="yes-display-inline">has a significant business presence in the
United States.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="idF05B275C2F484058B3F20E8AFB0F476A"><enum>(vi)</enum><header display-inline="yes-display-inline">Contract requirements</header><text display-inline="yes-display-inline">Each contract with a qualified entity shall
contain the following requirements:</text>
<subclause commented="no" display-inline="no-display-inline" id="IDec8f2a24163a44709fbff1e060ec7d18"><enum>(I)</enum><header display-inline="yes-display-inline">Ensuring privacy</header><text display-inline="yes-display-inline">The qualified entity shall provide
assurances that the entity will not use the data provided by the Secretary in a
manner that violates—</text>
<item commented="no" display-inline="no-display-inline" id="IDd1c83b38ebc0418980cedaa988c1d73b"><enum>(aa)</enum><text display-inline="yes-display-inline">the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability Act of 1996;
or</text>
</item><item commented="no" display-inline="no-display-inline" id="IDb7520938e04a49018a2b2ab52fa8800b"><enum>(bb)</enum><text display-inline="yes-display-inline">sections 552 or 552a of title 5, United
States Code, with regard to the privacy of individually-identifiable
beneficiary health information.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="IDd2da052ca5d0447b9343e8b474256e5d"><enum>(II)</enum><header display-inline="yes-display-inline">Component of another
organization</header><text display-inline="yes-display-inline">If a qualified
entity is a component of another organization—</text>
<item commented="no" display-inline="no-display-inline" id="IDf219f51f77ea4218a9571ba15824392a"><enum>(aa)</enum><text display-inline="yes-display-inline">the qualified entity shall maintain the
data related to the activities carried out under this paragraph separate from
the other components of the organization and establish appropriate security
measures to maintain the confidentiality and privacy of such data; and</text>
</item><item commented="no" display-inline="no-display-inline" id="IDa955a7f909a6488fb41ac8a05f38db58"><enum>(bb)</enum><text display-inline="yes-display-inline">the entity shall not make an unauthorized
disclosure of such data to the other components of the organization in breach
of such confidentiality and privacy requirement.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="id7719C52212E54CFFB0CCD536F7EAA810"><enum>(III)</enum><header display-inline="yes-display-inline">Termination or nonrenewal</header><text display-inline="yes-display-inline">If a contract with a qualified entity under
this subparagraph is terminated or not renewed, the following requirements
shall apply:</text>
<item commented="no" display-inline="no-display-inline" id="IDa7e7f2557c2a40b8ab6d16553a80a793"><enum>(aa)</enum><header display-inline="yes-display-inline">Confidentiality and privacy
protections</header><text display-inline="yes-display-inline">The entity shall
continue to comply with the confidentiality and privacy requirements under this
paragraph with respect to all data disclosed to the entity.</text>
</item><item commented="no" display-inline="no-display-inline" id="ID556708bdc70c4fab8f8a01eda80dc7a8"><enum>(bb)</enum><header display-inline="yes-display-inline">Disposition of data</header><text display-inline="yes-display-inline">The entity shall return to the Secretary
all data disclosed to the entity or, if returning the data is not practicable,
destroy the data.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDcbcad0b65bbf42a382f22470f6e49f8f"><enum>(vii)</enum><header display-inline="yes-display-inline">Competitive procedures</header><text display-inline="yes-display-inline">The Secretary shall use competitive
procedures (as defined in section 4(5) of the Federal Procurement Policy Act)
to enter into contracts under clause (v).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID2d638212f4144d6fb11f68927b5d1b7d"><enum>(viii)</enum><header display-inline="yes-display-inline">Review of contract in the even of a merger
or acquisition</header><text display-inline="yes-display-inline">The Secretary
shall review the contract with a qualified entity under this paragraph in the
event of a merger or acquisition of the entity in order to ensure that the
requirements under this subparagraph will continue to be met.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd22312fc13fa4df38e1edf037a00cfab"><enum>(D)</enum><header display-inline="yes-display-inline">Coordination</header><text display-inline="yes-display-inline">In carrying out this paragraph, the
Secretary shall provide for appropriate communications to the public,
scientific, public health, and medical communities, and other key stakeholders,
and provide for the coordination of the activities of private entities,
professional associations, or other entities that may have sources of
surveillance
data.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDac8b5c6185e94ce58ddf063d8c108de7"><enum>(b)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">To carry out
activities under the amendment made by this section for which funds are made
available under section 736 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h), there are authorized to be appropriated to carry out the
amendment made by this section, in addition to such funds, $25,000,000 for each
of fiscal years 2008 through 2012.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id6A65550E2FCB4A49950BCE215ED757DF" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Risk evaluation and mitigation
strategies</header><text display-inline="no-display-inline">Section 505 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9A9767E9F02F422B8EC1A75B185C81BF" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="IDe0c06a1b727941a7bd7a5e1591f57122"><enum>(o)</enum><header display-inline="yes-display-inline">Risk evaluation and mitigation
strategy</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDc71bdad65fdc44fa9305f2d12c338d76"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id34578621FF154279A3B468B5941AF17A"><enum>(2)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subsection:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1C40856A159842BF822A5937200E32E2"><enum>(A)</enum><header display-inline="yes-display-inline">Adverse drug experience</header><text display-inline="yes-display-inline">The term <term>adverse drug
experience</term> means any adverse event associated with the use of a drug in
humans, whether or not considered drug related, including—</text>
<clause commented="no" display-inline="no-display-inline" id="ID4f022740dee14691a768b2f8822bdbef"><enum>(i)</enum><text display-inline="yes-display-inline">an adverse event occurring in the course of
the use of the drug in professional practice;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID458638aac1e14219bc444b7a00062208"><enum>(ii)</enum><text display-inline="yes-display-inline">an adverse event occurring from an overdose
of the drug, whether accidental or intentional;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDeabfe5e4d2fb4da8ba66828f9af1cbda"><enum>(iii)</enum><text display-inline="yes-display-inline">an adverse event occurring from abuse of
the drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID765a27bb52a24af7a39062aec4d3da2b"><enum>(iv)</enum><text display-inline="yes-display-inline">an adverse event occurring from withdrawal
of the drug; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID7a99d93cf5084dbcbbf4b1e870aafc89"><enum>(v)</enum><text display-inline="yes-display-inline">any failure of expected pharmacological
action of the drug.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id077666A247E04A3BB68374BF9DD7AB68"><enum>(B)</enum><header display-inline="yes-display-inline">New safety information</header><text display-inline="yes-display-inline">The term <term>new safety
information</term> with respect to a drug means information about—</text>
<clause commented="no" display-inline="no-display-inline" id="idDBD898750A6943B48B176D5FE820F6FD"><enum>(i)</enum><text display-inline="yes-display-inline">a serious risk or an unexpected serious
risk with use of the drug that the Secretary has become aware of since the
later of—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID5c81da10afc1412296c42730c4e1db65"><enum>(I)</enum><text display-inline="yes-display-inline">the date of initial approval of the drug
under this section or initial licensure of the drug under section 351 of the
Public Health Service Act; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idB6A42A60AAD74D4F9A82F6AD01DFBF9C"><enum>(II)</enum><text display-inline="yes-display-inline">if applicable, the last assessment of the
approved risk evaluation and mitigation strategy for the drug; or</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idDAE6C58B1EC440FA8EB3E2572747BEC6"><enum>(ii)</enum><text display-inline="yes-display-inline">the effectiveness of the approved risk
evaluation and mitigation strategy for the drug obtained since the later
of—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID2634086ee73c4794996983987d2cfd67"><enum>(I)</enum><text display-inline="yes-display-inline">the approval of such strategy; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idF3371106DC3B40A19D9BAB3A83C9B166"><enum>(II)</enum><text display-inline="yes-display-inline">the last assessment of such
strategy.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFFD2B642590D46A2902366F11DCBD605"><enum>(C)</enum><header display-inline="yes-display-inline">Serious adverse drug
experience</header><text display-inline="yes-display-inline">The term
<quote>serious adverse drug experience</quote> is an adverse drug experience
that—</text>
<clause commented="no" display-inline="no-display-inline" id="ID43f3d3ac4d534d019d39f6f8abd7fcb3"><enum>(i)</enum><text display-inline="yes-display-inline">results in—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDd430e7dd63b94945941d669eefcb33b1"><enum>(I)</enum><text display-inline="yes-display-inline">death;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDd2e6688a63bd463c8d54e7ca272bdf84"><enum>(II)</enum><text display-inline="yes-display-inline">the placement of 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 commented="no" display-inline="no-display-inline" id="ID61241dccd6b343b0a6ad7f813e457429"><enum>(III)</enum><text display-inline="yes-display-inline">inpatient hospitalization or prolongation
of existing hospitalization;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDf8b10d4c6fbd400bbd1bea524050a589"><enum>(IV)</enum><text display-inline="yes-display-inline">a persistent or significant incapacity or
substantial disruption of the ability to conduct normal life functions;
or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDf3ecb15389bc4e29aadc674c9f902d82"><enum>(V)</enum><text display-inline="yes-display-inline">a congenital anomaly or birth defect;
or</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDfce1021ac1d1489d93a74c1cf25cc8f1"><enum>(ii)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id4E6DD21D5A154C3FB67A0301622DE054"><enum>(D)</enum><header display-inline="yes-display-inline">Serious risk</header><text display-inline="yes-display-inline">The term <term>serious risk</term> means a
risk of a serious adverse drug experience.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID82c8f1901ae942bfbe7f874923d6a07e"><enum>(E)</enum><header display-inline="yes-display-inline">Signal of a serious risk</header><text display-inline="yes-display-inline">The term <term>signal of a serious
risk</term> means information related to a serious adverse drug experience
derived from—</text>
<clause commented="no" display-inline="no-display-inline" id="ID2322ac0183224943bcb1698fe3817a30"><enum>(i)</enum><text display-inline="yes-display-inline">a clinical trial;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID286927e0dc0c4d6ba3e9d004e74e23d2"><enum>(ii)</enum><text display-inline="yes-display-inline">adverse event reports under subsection
(k)(1);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5fd66b786a284c8d98cba665c3f26ab5"><enum>(iii)</enum><text display-inline="yes-display-inline">routine active surveillance under
subsection (k)(3);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDb827068f4b09447ab024ad5280552ecd"><enum>(iv)</enum><text display-inline="yes-display-inline">a postapproval study, including a study
under paragraph (4)(B); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID793e5344ecba4818b9b8a33026303454"><enum>(v)</enum><text display-inline="yes-display-inline">peer-reviewed biomedical literature.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id388090585E4C491C868C6C7B981AF5F8"><enum>(F)</enum><header display-inline="yes-display-inline">Unexpected serious risk</header><text display-inline="yes-display-inline">The term <term>unexpected serious
risk</term> means a serious adverse drug experience that—</text>
<clause commented="no" display-inline="no-display-inline" id="id87B70C117AFE49F295ECC604885E3DD0"><enum>(i)</enum><text display-inline="yes-display-inline">is not listed in the labeling of a drug;
or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5bc469d197204c07a6e52f7273e80571"><enum>(ii)</enum><text display-inline="yes-display-inline">is symptomatically and pathophysiologically
related to an adverse drug experience listed in the labeling of the drug, but
differs from such adverse drug experience because of greater severity,
specificity, or prevalence.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe9cb4337e340439c87d32a6b35d16417"><enum>(3)</enum><header display-inline="yes-display-inline">Required elements of a risk evaluation and
mitigation strategy</header><text display-inline="yes-display-inline">If a risk
evaluation and mitigation strategy for a drug is required, such strategy shall
include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDb277a46aa55a4041bc6ba4939a53ce92"><enum>(A)</enum><text display-inline="yes-display-inline">the labeling for the drug for use by health
care providers as approved under subsection (c);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc30e1319c4b24f06ba008abee9bd3f23"><enum>(B)</enum><text display-inline="yes-display-inline">a timetable for submission of assessments
of the strategy, that—</text>
<clause commented="no" display-inline="no-display-inline" id="ID92a4e5d4b97c44239e0f054534b5fd39"><enum>(i)</enum><text display-inline="yes-display-inline">for a drug no active ingredient (including
any ester or salt of the active ingredient) of which has been approved in any
other application under this section or section 351 of the Public Health
Service Act—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDf838f1abe88844d594b095587b9f4f09"><enum>(I)</enum><text display-inline="yes-display-inline">shall be no less frequently than 18 months
and 3 years after the drug is initially approved and at a frequency specified
in the strategy for subsequent years; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID86760f205c7b4b259d9f17af382ed787"><enum>(II)</enum><text display-inline="yes-display-inline">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>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID029bd9ef5a6b447aa2e3e990bb0fc830"><enum>(ii)</enum><text display-inline="yes-display-inline">for a drug other than a drug described
under clause (i), shall occur at a frequency determined by the Secretary;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDd605b8d3f02940afb968bf855b47ed14"><enum>(iii)</enum><text display-inline="yes-display-inline">may be increased or reduced in frequency as
necessary as provided for in paragraph (7)(B)(v)(VI).</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe9192d15bee2421ea12ba719de5bb8b6"><enum>(4)</enum><header display-inline="yes-display-inline">Additional potential evaluation elements of
a risk evaluation and mitigation strategy</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDec372b02faf64f15bac29a14361332fe"><enum>(A)</enum><header display-inline="yes-display-inline">Risk evaluation</header><text display-inline="yes-display-inline">If a risk evaluation and mitigation
strategy for a drug is required, such strategy may include 1 or more of the
additional evaluation elements described in this paragraph, so long as the
Secretary makes the determination required with respect to each additional
included element.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID641abd2a317a4abb806b7a043d0e6910"><enum>(B)</enum><header display-inline="yes-display-inline">Postapproval studies</header><text display-inline="yes-display-inline">If the Secretary determines that the
reports under subsection (k)(1) and routine active surveillance as available
under subsection (k)(3) (including available complementary approaches under
subsection (k)(3)(B)(iv)) will not be sufficient to—</text>
<clause commented="no" display-inline="no-display-inline" id="IDfcdd2f4addce4211928b4f7e6ddb89ec"><enum>(i)</enum><text display-inline="yes-display-inline">assess a signal of a serious risk with use
of a drug; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID500c392abdc94e9aba50b5a838042042"><enum>(ii)</enum><text display-inline="yes-display-inline">identify, based on a review of a
demonstrated pattern of use of the drug, unexpected serious risks in a domestic
population, including older people, people with comorbidities, pregnant women,
or children,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">the risk evaluation and mitigation
strategy for the drug may require that the applicant conduct an appropriate
postapproval study, such as a prospective or retrospective observational study,
of the drug (which shall include a timeframe specified by the Secretary for
completing the study and reporting the results to the Secretary).</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID344cf98f521643cfa75b6c0b49e7379f"><enum>(C)</enum><header display-inline="yes-display-inline">Postapproval clinical trials</header><text display-inline="yes-display-inline">If the Secretary determines that the
reports under subsection (k)(1), routine active surveillance as available under
subsection (k)(3) (including available complementary approaches under
subsection (k)(3)(B)(iv)), and a study or studies under subparagraph (B) will
likely be inadequate to assess a signal of a serious risk with use of a drug,
and there is no effective approved application for the drug under subsection
(j) as of the date that the requirement is first imposed, the risk evaluation
and mitigation strategy for the drug may require that the applicant conduct an
appropriate postapproval clinical trial of the drug (which shall include a
timeframe specified by the Secretary for completing the clinical trial and
reporting the results to the Secretary) to be included in the clinical trial
registry data bank provided for under subsections (i) and (j) of section 402 of
the Public Health Service Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID644016f70183429d9ee6b200256ed610"><enum>(5)</enum><header display-inline="yes-display-inline">Additional potential communication elements
of a risk evaluation and mitigation strategy</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id2AE099855DE94EFA9B1075DB2FAD8FDE"><enum>(A)</enum><header display-inline="yes-display-inline">Risk communication</header><text display-inline="yes-display-inline">If a risk evaluation and mitigation
strategy for a drug is required, such strategy may include 1 or more of the
additional communication elements described in this paragraph, so long as the
Secretary makes the determination required with respect to each additional
included element.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1325e24649fa48c5a25bfa8c63faf916"><enum>(B)</enum><header display-inline="yes-display-inline">Medguide; patient package
insert</header><text display-inline="yes-display-inline">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 either or both of the
following:</text>
<clause commented="no" display-inline="no-display-inline" id="idF7197FF3853D4D5290BE54727B4FFD4D"><enum>(i)</enum><text display-inline="yes-display-inline">A Medication Guide, as provided for under
part 208 of title 21, Code of Federal Regulations (or any successor
regulations).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idBD7C72BE3A1D4564A8E799C50E99120B"><enum>(ii)</enum><text display-inline="yes-display-inline">A patient package insert, if the Secretary
determines that such insert may help mitigate a serious risk listed in the
labeling of the drug.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID64afebc7c88f4d5d92edf242fea66dee"><enum>(C)</enum><header display-inline="yes-display-inline">Communication plan</header><text display-inline="yes-display-inline">If the Secretary determines that a
communication plan to health care providers may support implementation of an
element of the risk evaluation and mitigation strategy for a drug, such as a
labeling change, the strategy may require that the applicant conduct such a
plan, which may include—</text>
<clause commented="no" display-inline="no-display-inline" id="IDa84aa47b8c98492cac227457a8031aab"><enum>(i)</enum><text display-inline="yes-display-inline">sending letters to health care
providers;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4e5e879ea12d4cdfae86b04a740d6322"><enum>(ii)</enum><text display-inline="yes-display-inline">disseminating information about the
elements of the 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 commented="no" display-inline="no-display-inline" id="ID0f4fed423e8e43489b4b1cef8c260ac8"><enum>(iii)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDcf998ecf17894160bb7bdbc83193efc0"><enum>(D)</enum><header display-inline="yes-display-inline">Prereview</header>
<clause commented="no" display-inline="no-display-inline" id="idAE7199DECB7843CE9767BA1D59AF4015"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the Secretary determines that prereview
of advertisements is necessary to ensure the inclusion of a true statement in
such advertisements of information in brief summary relating to a serious risk
listed in the labeling of a drug, or relating to a protocol to ensure the safe
use described in the labeling of the drug, the risk evaluation and mitigation
strategy for the drug may require that the applicant submit to the Secretary
advertisements of the drug for prereview not later than 45 days before
dissemination of the advertisement</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id05450089910B46E2A1F4669005AA1A56"><enum>(ii)</enum><header display-inline="yes-display-inline">Specification of
advertisements</header><text display-inline="yes-display-inline">The Secretary
may specify the advertisements required to be submitted under clause
(i).</text>
</clause></subparagraph><subparagraph commented="no" id="ID690f70e393df4dcca95fa4b4ffc1ebcb"><enum>(E)</enum><header>Specific
disclosures</header>
<clause id="ID1a49597ed9834b9bbb389594ffdb1d2b"><enum>(i)</enum><header>Serious risk;
safety protocol</header><text>If the Secretary determines that advertisements
lacking a specific disclosure about a serious risk listed in the labeling of a
drug or about a protocol to ensure safe use described in the labeling of the
drug would be false or misleading, the risk evaluation and mitigation strategy
for the drug may require that the applicant include in advertisements of the
drug such disclosure.</text>
</clause><clause id="IDd364896a25684ac88323857d7ae01db4"><enum>(ii)</enum><header>Date of
approval</header><text>If the Secretary determines that advertisements lacking
a specific disclosure of the date a drug was approved and disclosure of a
serious risk would be false or misleading, the risk evaluation and mitigation
strategy for the drug may require that the applicant include in advertisements
of the drug such disclosure.</text>
</clause><clause commented="no" id="id84A0AC529FE64D3EA061F30A348A846D"><enum>(iii)</enum><header>Specification
of advertisements</header><text>The Secretary may specify the advertisements
required to include a specific disclosure under clause (i) or (ii).</text>
</clause><clause commented="no" id="id13F446551DE64ECA8C5D46158D173937"><enum>(iv)</enum><header>Required
safety surveillance</header><text>If the approved risk evaluation and
mitigation strategy for a drug requires the specific disclosure under clause
(ii), the Secretary shall—</text>
<subclause id="IDa411c534c5c24e08bcac603646aac4f9"><enum>(I)</enum><text>consider
identifying and assessing all serious risks of using the drug to be a priority
safety question under subsection (k)(3)(B);</text>
</subclause><subclause id="ID34fd331d48dc4dc2b65c58c7723c657f"><enum>(II)</enum><text>not less
frequently than every 3 months, evaluate the reports under subsection (k)(1)
and the routine active surveillance as available under subsection (k)(3) with
respect to such priority drug safety question to determine whether serious
risks that might occur among patients expected to be treated with the drug have
been adequately identified and assessed;</text>
</subclause><subclause id="ID0a9d319616104f83b213bfdc76dd78bd"><enum>(III)</enum><text>remove such
specific disclosure requirement as an element of such strategy if such serious
risks have been adequately identified and assessed; and</text>
</subclause><subclause id="IDd110ae567c8f4d7f9affe7fbdee4596e"><enum>(IV)</enum><text>consider whether
a specific disclosure under clause (i) should be required.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC63B3D307AE146E59519B7450FCDCCFC"><enum>(6)</enum><header display-inline="yes-display-inline">Providing safe access for patients to drugs
with known serious risks that would otherwise be unavailable</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idC6D26AD10D5D469BBD994AD9D0533AC9"><enum>(A)</enum><header display-inline="yes-display-inline">Allowing safe access to drugs with known
serious risks</header><text display-inline="yes-display-inline">The Secretary
may require that the risk evaluation and mitigation strategy for a drug include
such elements as are necessary to assure safe use of the drug, because of its
inherent toxicity or potential harmfulness, if the Secretary determines
that—</text>
<clause commented="no" display-inline="no-display-inline" id="id59541006838D4766ABEA7A7311B6113E"><enum>(i)</enum><text display-inline="yes-display-inline">the drug, which has been shown to be
effective, but is associated with a serious adverse drug experience, can be
approved only if, or would be withdrawn unless, such elements are required as
part of such strategy to mitigate a specific serious risk listed in the
labeling of the drug; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id566869A931074A9DB46DD11399ABF715"><enum>(ii)</enum><text display-inline="yes-display-inline">for a drug initially approved without
elements to assure safe use, other elements under paragraphs (3), (4), and (5)
are not sufficient to mitigate such serious risk.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id285A76E04F4D4280BB1ADFCD23C3C2DB"><enum>(B)</enum><header display-inline="yes-display-inline">Assuring access and minimizing
burden</header><text display-inline="yes-display-inline">Such elements to
assure safe use under subparagraph (A) shall—</text>
<clause commented="no" display-inline="no-display-inline" id="ID4d8d2c5a6a984fff9f5a95eabafa9c88"><enum>(i)</enum><text display-inline="yes-display-inline">be commensurate with the specific serious
risk listed in the labeling of the drug;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id8B8EA74ED5844BC2B6711DDAC6C5C5E0"><enum>(ii)</enum><text display-inline="yes-display-inline">within 30 days of the date on which any
element under subparagraph (A) is imposed, be posted publicly by the Secretary
with an explanation of how such elements will mitigate the observed safety
risk;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID18749a4986be472880fce2d6151e8ca2"><enum>(iii)</enum><text display-inline="yes-display-inline">considering such risk, not be unduly
burdensome on patient access to the drug, considering in particular—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID68e9d71c5d0f49e490ae6074f3ebebb8"><enum>(I)</enum><text display-inline="yes-display-inline">patients with serious or life-threatening
diseases or conditions; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID6a6e8fbc5485409d8db072880febc4cb"><enum>(II)</enum><text display-inline="yes-display-inline">patients who have difficulty accessing
health care (such as patients in rural or medically underserved areas);
and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID2e29892cd50a443bb49d6fbe505c5c54"><enum>(iv)</enum><text display-inline="yes-display-inline">to the extent practicable, so as to
minimize the burden on the health care delivery system—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID4d7978cd98014cb686842113f2e18ae4"><enum>(I)</enum><text display-inline="yes-display-inline">conform with elements to assure safe use
for other drugs with similar, serious risks; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDbcb244548a184bc69f9cff4bf18f1c6b"><enum>(II)</enum><text display-inline="yes-display-inline">be designed to be compatible with
established distribution, procurement, and dispensing systems for drugs.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4ce91eeae3d14386a77df60347df7141"><enum>(C)</enum><header display-inline="yes-display-inline">Elements to assure safe use</header><text display-inline="yes-display-inline">The elements to assure safe use under
subparagraph (A) shall include 1 or more goals to mitigate a specific serious
risk listed in the labeling of the drug and, to mitigate such risk, may require
that—</text>
<clause id="id462598E6879846CEA2CF15FCB1E25A7B"><enum>(i)</enum><text>health care
providers who prescribe the drug have particular training or experience, or are
specially certified (which training or certification with respect to the drug
shall be available to any willing provider from a frontier area in a widely
available training or certification method (including an on-line course or via
mail) as approved by the Secretary at minimal cost to the provider);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDb9c8f4594c584f5e8e6e5ba915134fe3"><enum>(ii)</enum><text display-inline="yes-display-inline">pharmacies, practitioners, or health care
settings that dispense the drug are specially certified (which certification
shall be available to any willing provider from a frontier area);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID5c876f35d78a4a69a2cd4d79257cd6ce"><enum>(iii)</enum><text display-inline="yes-display-inline">the drug be dispensed to patients only in
certain health care settings, such as hospitals;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0430081678534e23abdbeb7bf7afb9f1"><enum>(iv)</enum><text display-inline="yes-display-inline">the drug be dispensed to patients with
evidence or other documentation of safe-use conditions, such as laboratory test
results;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID198eb6bb79cb44b3a57ae0e1016a50e9"><enum>(v)</enum><text display-inline="yes-display-inline">each patient using the drug be subject to
certain monitoring; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID55b3b65593204369937a4c6e0cf82f43"><enum>(vi)</enum><text display-inline="yes-display-inline">each patient using the drug be enrolled in
a registry.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID98567af64ec6423588f27a8d84a648ba"><enum>(D)</enum><header display-inline="yes-display-inline">Implementation system</header><text display-inline="yes-display-inline">The elements to assure safe use under
subparagraph (A) that are described in clauses (ii), (iii), or (iv) of
subparagraph (C) may include a system through which the applicant is able to
take reasonable steps to—</text>
<clause commented="no" display-inline="no-display-inline" id="IDa208e929d39d4fc585986228317de0d9"><enum>(i)</enum><text display-inline="yes-display-inline">monitor and evaluate implementation of such
elements by health care providers, pharmacists, and other parties in the health
care system who are responsible for implementing such elements; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID21d4942435f2440dad714bb9334e06e3"><enum>(ii)</enum><text display-inline="yes-display-inline">work to improve implementation of such
elements by such persons.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6ad569fbfc5e430f977b4fe9711a07e2"><enum>(E)</enum><header display-inline="yes-display-inline">Evaluation of elements to assure safe
use</header><text display-inline="yes-display-inline">The Secretary, through
the Drug Safety and Risk Management Advisory Committee (or successor committee)
of the Food and Drug Administration, shall—</text>
<clause commented="no" display-inline="no-display-inline" id="ID72ad1fd9f15a447d9e988d647b88ad24"><enum>(i)</enum><text display-inline="yes-display-inline">seek input from patients, physicians,
pharmacists, and other health care providers about how elements to assure safe
use under this paragraph for 1 or more drugs may be standardized so as not to
be—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID549fb3af1c8f4f9aa9e95ab4e453ddd6"><enum>(I)</enum><text display-inline="yes-display-inline">unduly burdensome on patient access to the
drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID51232a40f8e945fa8b252a868aafad41"><enum>(II)</enum><text display-inline="yes-display-inline">to the extent practicable, minimize the
burden on the health care delivery system;</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDdb375f1bd9d8487383e579367aefa373"><enum>(ii)</enum><text display-inline="yes-display-inline">at least annually, evaluate, for 1 or more
drugs, the elements to assure safe use of such drug to assess whether the
elements—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID643bc1246ae4481fbf8a4900fd147882"><enum>(I)</enum><text display-inline="yes-display-inline">assure safe use of the drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID351f1668300a4d01a69b6f16792d807f"><enum>(II)</enum><text display-inline="yes-display-inline">are not unduly burdensome on patient access
to the drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDcaf0a9d63e17419a936cc4f078b0a8fd"><enum>(III)</enum><text display-inline="yes-display-inline">to the extent practicable, minimize the
burden on the health care delivery system; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID07e3803b1b264ff9a935efe998a29a13"><enum>(iii)</enum><text display-inline="yes-display-inline">considering such input and
evaluations—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDc0775190d45a488bbb2ab8f94e7dfe01"><enum>(I)</enum><text display-inline="yes-display-inline">issue or modify agency guidance about how
to implement the requirements of this paragraph; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDea10e1eb934047b18f913c2d9ca93e4b"><enum>(II)</enum><text display-inline="yes-display-inline">modify elements under this paragraph for 1
or more drugs as appropriate.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id469DFDBDFDF44ADDB7E716F4E80813B3"><enum>(F)</enum><header display-inline="yes-display-inline">Additional mechanisms to assure
access</header><text display-inline="yes-display-inline">The mechanisms under
section 561 to provide for expanded access for patients with serious or
life-threatening diseases or conditions may be used to provide access for
patients with a serious or life-threatening disease or condition, the treatment
of which is not an approved use for the drug, to a drug that is subject to
elements to assure safe use under this paragraph. The Secretary shall
promulgate regulations for how a physician may provide the drug under the
mechanisms of section 561.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4D806F510463405DA4581C0947E11EF7"><enum>(G)</enum><header display-inline="yes-display-inline">Waiver in public health
emergencies</header><text display-inline="yes-display-inline">The Secretary may
waive any requirement of this paragraph during the period described in section
319(a) of the Public Health Service Act with respect to a qualified
countermeasure described under section 319F–1(a)(2) of such Act, to which a
requirement under this paragraph has been applied, if the Secretary has—</text>
<clause commented="no" display-inline="no-display-inline" id="ID64694320098a48bf848f8f6046c4450f"><enum>(i)</enum><text display-inline="yes-display-inline">declared a public health emergency under
such section 319; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID54046f503a404c108a2e43b39335cae3"><enum>(ii)</enum><text display-inline="yes-display-inline">determined that such waiver is required to
mitigate the effects of, or reduce the severity of, such public health
emergency.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id40C265AE4EBD4BCEAA1820B407A233B6"><enum>(7)</enum><header display-inline="yes-display-inline">Submission and review of risk evaluation
and mitigation strategy</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID895abc0f2e404d8dba888ee4f423328e"><enum>(A)</enum><header display-inline="yes-display-inline">Proposed risk evaluation and mitigation
strategy</header>
<clause commented="no" display-inline="no-display-inline" id="ID9eeca1c177294257ad89d9177d77b01c"><enum>(i)</enum><header display-inline="yes-display-inline">Voluntary proposal</header><text display-inline="yes-display-inline">If there is a signal of a serious risk with
a drug, an applicant may include a proposed risk evaluation and mitigation
strategy for the drug in an application, including in a supplemental
application, for the drug under subsection (b) or section 351 of the Public
Health Service Act.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4023b831791a4696a25bd8af0d2a67b4"><enum>(ii)</enum><header display-inline="yes-display-inline">Required proposal</header>
<subclause commented="no" display-inline="no-display-inline" id="ID2290eec3ea904d54a0c5b8b55bc5e37c"><enum>(I)</enum><header display-inline="yes-display-inline">Determination necessary to require a
proposal</header>
<item commented="no" display-inline="no-display-inline" id="id669F9283E06648A09B1614808A0705FF"><enum>(aa)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may require that the
applicant for a drug submit a proposed risk evaluation and mitigation strategy
for a drug if the Secretary (acting through the office responsible for
reviewing the drug and the office responsible for postapproval safety with
respect to the drug) determines that, based on a signal of a serious risk with
the drug, a risk evaluation and mitigation strategy is necessary to assess such
signal or mitigate such serious risk.</text>
</item><item commented="no" display-inline="no-display-inline" id="ID467a5a65b5cf468f98bf9e84e431fb9b"><enum>(bb)</enum><header display-inline="yes-display-inline">Non-delegation</header><text display-inline="yes-display-inline">A determination under item (aa) for a drug
shall be made by individuals at or above the level of individuals empowered to
approve a drug (such as division directors within the Center for Drug
Evaluation and Research).</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID99f090cdc23a440db161713565862b50"><enum>(II)</enum><header display-inline="yes-display-inline">Circumstances in which a proposal may be
required</header><text display-inline="yes-display-inline">The applicant shall
submit a proposed risk evaluation and mitigation strategy for a drug—</text>
<item commented="no" display-inline="no-display-inline" id="IDa0cb99ae3a7f41aaa81528a5e7abd5da"><enum>(aa)</enum><text display-inline="yes-display-inline">in response to a letter from the Secretary
(acting through the office responsible for reviewing the drug and the office
responsible for postapproval safety with respect to the drug) sent regarding an
application, including a supplemental application, for the drug, if the
Secretary determines that data or information in the application indicates that
an element under paragraph (4), (5), or (6) should be included in a strategy
for the drug;</text>
</item><item commented="no" display-inline="no-display-inline" id="IDefaae69a13f747a7b0587334a5098cb4"><enum>(bb)</enum><text display-inline="yes-display-inline">within a timeframe specified by the
Secretary, not to be less than 45 days, when ordered by the Secretary (acting
through such offices), if the Secretary determines that new safety information
indicates that—</text>
<subitem commented="no" display-inline="no-display-inline" id="ID6614028349ef40e5bee74450f2fb7e23"><enum>(AA)</enum><text display-inline="yes-display-inline">the labeling of the drug should be changed;
or</text>
</subitem><subitem commented="no" display-inline="no-display-inline" id="ID5179b2b4df3246e38c3d63a35b0f61ad"><enum>(BB)</enum><text display-inline="yes-display-inline">an element under paragraph (4) or (5)
should be included in a strategy for the drug; or</text>
</subitem></item><item commented="no" display-inline="no-display-inline" id="ID749d7a972ba047a3b69130d35b3a21bd"><enum>(cc)</enum><text display-inline="yes-display-inline">within 90 days when ordered by the
Secretary (acting through such offices), if the Secretary determines that new
safety information indicates that an element under paragraph (6) should be
included in a strategy for the drug.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id0D70B7E235644CC2BCEE820395A23A2F"><enum>(iii)</enum><header display-inline="yes-display-inline">Content of letter</header><text display-inline="yes-display-inline">A letter under clause (ii)(II)(aa) shall
describe—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID6e4db099cd8e4cf98898d082ba05d930"><enum>(I)</enum><text display-inline="yes-display-inline">the data or information in the application
that warrants the proposal of a risk evaluation and mitigation strategy for the
drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID9cac1947888e4bb2befa44aaded3dcd7"><enum>(II)</enum><text display-inline="yes-display-inline">what elements under paragraphs (4), (5), or
(6) should be included in a strategy for the drug.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID662aadc2c2e7405991fa00b689972726"><enum>(iv)</enum><header display-inline="yes-display-inline">Content of order</header><text display-inline="yes-display-inline">An order under item (aa) or (bb) of clause
(ii)(II) shall describe—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID1d33842368ee4b6795949ed0a0cd1017"><enum>(I)</enum><text display-inline="yes-display-inline">the new safety information with respect to
the drug that warrants the proposal of a risk evaluation and mitigation
strategy for the drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID8c0b6ab98be4412fb62d30d08ad40efb"><enum>(II)</enum><text display-inline="yes-display-inline">whether and how the labeling of the drug
should be changed and what elements under paragraphs (4), (5), or (6) should be
included in a strategy for the drug.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDcf5b59d1d2a443c29a038135e72c77dc"><enum>(v)</enum><header display-inline="yes-display-inline">Content of proposal</header><text display-inline="yes-display-inline">A proposed risk evaluation and mitigation
strategy—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID8140f33a6cfc46a2a751e08576582115"><enum>(I)</enum><text display-inline="yes-display-inline">shall include a timetable as described
under paragraph (3)(B); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDf3539200a3b24912b06de7199d245eb3"><enum>(II)</enum><text display-inline="yes-display-inline">may also include additional elements as
provided for under paragraphs (4), (5), and (6).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8dc86c12239e4f84bc26f2e6a42ae916"><enum>(B)</enum><header display-inline="yes-display-inline">Assessment and modification of a risk
evaluation and mitigation strategy</header>
<clause commented="no" display-inline="no-display-inline" id="ID1fe422aee12d498da9ad705b0dd31fad"><enum>(i)</enum><header display-inline="yes-display-inline">Voluntary assessments</header><text display-inline="yes-display-inline">If a risk evaluation and mitigation
strategy for a drug is required, the applicant may submit to the Secretary an
assessment of, and propose a modification to, such approved strategy for the
drug at any time.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id41D0B07C25F945419A1242CE87660DE3"><enum>(ii)</enum><header display-inline="yes-display-inline">Required assessments</header><text display-inline="yes-display-inline">If a risk evaluation and mitigation
strategy for a drug is required, the applicant shall submit an assessment of,
and may propose a modification to, such approved strategy for the drug—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID571009b91e8e49b195205d8f040ed1f7"><enum>(I)</enum><text display-inline="yes-display-inline">when submitting an application, including a
supplemental application, for a new indication under subsection (b) or section
351 of the Public Health Service Act;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDafdf4bdb9ddb4e108d79c2f5c206922f"><enum>(II)</enum><text display-inline="yes-display-inline">when required by the strategy, as provided
for in the timetable under paragraph (3)(B);</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDb893f7ecf68340adb668d93a69c21723"><enum>(III)</enum><text display-inline="yes-display-inline">within a timeframe specified by the
Secretary, not to be less than 45 days, when ordered by the Secretary (acting
through the offices described in subparagraph (A)(ii)(I)), if the Secretary
determines that new safety information indicates that an element under
paragraph (3) or (4) should be modified or added to the strategy;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID552d28d59dfe488a9027237e4b8bbb26"><enum>(IV)</enum><text display-inline="yes-display-inline">within 90 days when ordered by the
Secretary (acting through such offices), if the Secretary determines that new
safety information indicates that an element under paragraph (6) should be
modified or added to the strategy; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDaa7bb7f979d44c6984986483d23fd830"><enum>(V)</enum><text display-inline="yes-display-inline">within 15 days when ordered by the
Secretary (acting through such offices), if the Secretary determines that there
may be a cause for action by the Secretary under subsection (e).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID3850a53011ca4d039dff5512dc438e4e"><enum>(iii)</enum><header display-inline="yes-display-inline">Content of order</header><text display-inline="yes-display-inline">An order under subclauses (III), (IV), or
(V) of clause (ii) shall describe—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID445944c8ac8c4712be7f2713f2b98136"><enum>(I)</enum><text display-inline="yes-display-inline">the new safety information with respect to
the drug that warrants an assessment of the approved risk evaluation and
mitigation strategy for the drug; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID37dc8327ebea4cb4bec77b9fb1ab94ca"><enum>(II)</enum><text display-inline="yes-display-inline">whether and how such strategy should be
modified because of such information.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDeeb2cfd03e5e4cee87302eb8249b7edc"><enum>(iv)</enum><header display-inline="yes-display-inline">Assessment</header><text display-inline="yes-display-inline">An assessment of the approved risk
evaluation and mitigation strategy for a drug shall include—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID63d735d0ac0e4b4b8575e4cd20ca0615"><enum>(I)</enum><text display-inline="yes-display-inline">a description of new safety information, if
any, with respect to the drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID90870a682460482db8c297fed2510087"><enum>(II)</enum><text display-inline="yes-display-inline">whether and how to modify such strategy
because of such information;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID45a3acade02e4262b3896a69a1558dbd"><enum>(III)</enum><text display-inline="yes-display-inline">with respect to any postapproval study
required under paragraph (4)(B) or otherwise undertaken by the applicant to
investigate a safety issue, the status of such study, including whether any
difficulties completing the study have been encountered;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDe78b353f4ea644989969b2aea5b6990c"><enum>(IV)</enum><text display-inline="yes-display-inline">with respect to any postapproval clinical
trial required under paragraph (4)(C) or otherwise undertaken by the applicant
to investigate a safety issue, 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 subsections (i) and (j) of section 402 of the Public Health Service Act;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID666035ac330948b4b8dbe4ecc47c1f75"><enum>(V)</enum><text display-inline="yes-display-inline">with respect to any goal under paragraph
(6) and considering input and evaluations, if applicable, under paragraph
(6)(E), an assessment of how well the elements to assure safe use are meeting
the goal of increasing safe access to drugs with known serious risks or whether
the goal or such elements should be modified.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDfe6f980041ca49ba9b6454ad55aa9420"><enum>(v)</enum><header display-inline="yes-display-inline">Modification</header><text display-inline="yes-display-inline">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)
or (B) of paragraph (3) or the addition, modification, or removal of any
element under paragraph (4), (5), or (6), such as—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID6c01aae6812741eea9b7ae905150bb37"><enum>(I)</enum><text display-inline="yes-display-inline">a labeling change, including the addition
of a boxed warning;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDd65ed8fc78f742f08d83cf29f992a0f9"><enum>(II)</enum><text display-inline="yes-display-inline">adding a postapproval study or clinical
trial requirement;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID5e6dc422eede43378c1ff904ae7b7ee3"><enum>(III)</enum><text display-inline="yes-display-inline">modifying a postapproval study or clinical
trial requirement (such as a change in trial design due to legitimate
difficulties recruiting participants);</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id5FF7B55C3CC046F5A0A1A0097CD943E1"><enum>(IV)</enum><text display-inline="yes-display-inline">adding, modifying, or removing an element
on advertising under subparagraph (D), (E), or (F) of paragraph (5);</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4d86898141304a7397d20ca6112e6e90"><enum>(V)</enum><text display-inline="yes-display-inline">adding, modifying, or removing an element
to assure safe use under paragraph (6); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDebf88ea72ace418ba06ad33cbbdb4d92"><enum>(VI)</enum><text display-inline="yes-display-inline">modifying the timetable for assessments of
the strategy under paragraph (3)(B), including to eliminate assessments.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4587ed59bb5a441687fe9ef2ce251d15"><enum>(C)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">The Secretary (acting through the offices
described in subparagraph (A)(ii)(I)) 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 commented="no" display-inline="no-display-inline" id="ID9464812f80b44514882bfe7e9e735c78"><enum>(D)</enum><header display-inline="yes-display-inline">Discussion</header><text display-inline="yes-display-inline">The Secretary (acting through the offices
described in subparagraph (A)(ii)(I)) 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 commented="no" display-inline="no-display-inline" id="ID8b1424e6503347baaed27c53bdede5ce"><enum>(i)</enum><text display-inline="yes-display-inline">if the proposed strategy or assessment is
submitted as part of an application (including a supplemental application)
under subparagraph (A)(i), (A)(ii)(II)(aa), or (B)(ii)(I), by the target date
for communication of feedback from the review team to the applicant regarding
proposed labeling and postmarketing study commitments, as set forth in the
letters described in section 735(a);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDa665dd3be01f4f878a8fade1a7bcd505"><enum>(ii)</enum><text display-inline="yes-display-inline">if the proposed strategy is submitted under
subparagraph (A)(ii)(II)(bb) or the assessment is submitted under subclause
(II) or (III) of subparagraph (B)(ii), not later than 20 days after such
submission;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID74899f827bb7445faa94ca1ddd0abbb3"><enum>(iii)</enum><text display-inline="yes-display-inline">if the proposed strategy is submitted under
subparagraph (A)(ii)(II)(cc) or 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 commented="no" display-inline="no-display-inline" id="ID339554957bff408485fb9663d7f61323"><enum>(iv)</enum><text display-inline="yes-display-inline">if the assessment is submitted under
subparagraph (B)(ii)(V), not later than 10 days after such submission.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID01fe9c1d15fd4140a38ec93fc1ad64e8"><enum>(E)</enum><header display-inline="yes-display-inline">Action</header>
<clause commented="no" display-inline="no-display-inline" id="id192DDFA12A8446F2B719740E5D7895F5"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Unless the applicant requests the dispute
resolution process as described under subparagraph (F) or (G), the Secretary
(acting through the offices described in subparagraph (A)(ii)(I)) shall approve
and include the risk evaluation and mitigation strategy for a drug, or any
modification to the strategy (including a timeframe for implementing such
modification), with—</text>
<subclause commented="no" display-inline="no-display-inline" id="id92D4936DEBF846A2B7BB372C9A9DEF5A"><enum>(I)</enum><text display-inline="yes-display-inline">the action letter on the application, if a
proposed strategy is submitted under subparagraph (A)(i) or (A)(ii)(II)(aa) or
an assessment of the strategy is submitted under subparagraph (B)(ii)(I);
or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idBC7EF546B9AF4107AE90348A9C9F8E80"><enum>(II)</enum><text display-inline="yes-display-inline">an order, which shall be made public,
issued not later than 50 days after the date discussions of such proposed
strategy or modification begin under subparagraph (D), if a proposed strategy
is submitted under item (bb) or (cc) of subparagraph (A)(ii)(II) or an
assessment of the strategy is submitted under subparagraph (B)(i) or under
subclause (II), (III), (IV), or (V) of subparagraph (B)(ii).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idBC2CBA3B0C7E4402BEF70F9938107EDE"><enum>(ii)</enum><header display-inline="yes-display-inline">Inaction</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDd5c595c274534c45b199679976045fc7"><enum>(F)</enum><header display-inline="yes-display-inline">Dispute resolution at initial
approval</header><text display-inline="yes-display-inline">If a proposed risk
evaluation and mitigation strategy is submitted under subparagraph (A)(i) or
(A)(ii)(II)(aa) in an application for initial approval of a drug and there is a
dispute about the strategy, the applicant shall use the major dispute
resolution procedures as set forth in the letters described in section
735(a).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID33803b9e0b324311afa8a9a2dc49fc31"><enum>(G)</enum><header display-inline="yes-display-inline">Dispute resolution in all other
cases</header>
<clause commented="no" display-inline="no-display-inline" id="ID2138d1a9eccd4336815fd76060aec096"><enum>(i)</enum><header display-inline="yes-display-inline">Request for review</header><text display-inline="yes-display-inline">In any case other than a submission under
subparagraph (A)(i) or (A)(ii)(II)(aa) in an application for initial approval
of a drug if there is a dispute about the strategy, not earlier than 15 days,
and not later than 35 days, after discussions under subparagraph (D) have
begun, the applicant shall request in writing that the dispute be reviewed by
the Drug Safety Oversight Board.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID703e7bb8896a4ade8e0760560eeb2201"><enum>(ii)</enum><header display-inline="yes-display-inline">Scheduling review</header><text display-inline="yes-display-inline">If the applicant requests review under
clause (i), the Secretary—</text>
<subclause commented="no" display-inline="no-display-inline" id="idD583FE338D63424F82DA61D81B8613E3"><enum>(I)</enum><item commented="no" display-inline="yes-display-inline" id="idA4443CF8FD9640B6AADDBAFC7D598B8F"><enum>(aa)</enum><text display-inline="yes-display-inline">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>
</item><item commented="no" display-inline="no-display-inline" id="id503B24CFB5174540825CE21C2F02D06F" indent="up1"><enum>(bb)</enum><text display-inline="yes-display-inline">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>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="IDf703b21385144f569b78ee979151323d"><enum>(II)</enum><text display-inline="yes-display-inline">shall give advance notice to the public
through the Federal Register and on the Internet website of the Food and Drug
Administration—</text>
<item commented="no" display-inline="no-display-inline" id="ID18de7473ef3b4e58ab113c347986df57"><enum>(aa)</enum><text display-inline="yes-display-inline">that the drug is to be discussed by the
Drug Safety Oversight Board; and</text>
</item><item commented="no" display-inline="no-display-inline" id="ID407ae2e3001443db8a278d47e9bbd428"><enum>(bb)</enum><text display-inline="yes-display-inline">of the date on which the Drug Safety
Oversight Board shall discuss such drug; and</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="idEADF9B76AE9D4C24B4CE3C64746BACA1"><enum>(III)</enum><text display-inline="yes-display-inline">shall apply section 301(j), section 552 of
title 5, and <external-xref legal-doc="usc" parsable-cite="usc/18/1905">section 1905</external-xref> of title 18, United States Code, to any request for
information about such review.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idEA6DE5D54C094A5285577C9F59BC59C3"><enum>(iii)</enum><header display-inline="yes-display-inline">Agreement after discussion or
administrative appeals</header>
<subclause commented="no" display-inline="no-display-inline" id="id94527125CADD4A7E85BC30FCB0E86801"><enum>(I)</enum><header display-inline="yes-display-inline">Further discussion or administrative
appeals</header><text display-inline="yes-display-inline">A request for review
under clause (i) shall not preclude—</text>
<item commented="no" display-inline="no-display-inline" id="idA231F5D4020D4744B8161C261D718F3B"><enum>(aa)</enum><text display-inline="yes-display-inline">further discussions to reach agreement on
the risk evaluation and mitigation strategy; or</text>
</item><item commented="no" display-inline="no-display-inline" id="idCAC2023A27584BB185985CF634277436"><enum>(bb)</enum><text display-inline="yes-display-inline">the use of administrative appeals within
the Food and Drug Administration to reach agreement on the strategy, including
the major dispute resolution procedures as set forth in the letters described
in section 735(a).</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="ID8f4b44a596c64f20ae218dda87b89a89"><enum>(II)</enum><header display-inline="yes-display-inline">Agreement terminates dispute
resolution</header><text display-inline="yes-display-inline">At any time before
a decision and order is issued under clause (vi), the Secretary (acting through
the offices described in subparagraph (A)(ii)(I)) 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 commented="no" display-inline="no-display-inline" id="IDb75c238a9cdb466e868e942e0ca20a0f"><enum>(iv)</enum><header display-inline="yes-display-inline">Meeting of the board</header><text display-inline="yes-display-inline">At the meeting of the Drug Safety Oversight
Board described in clause (ii), the Board shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID6b3308e48f46489d97d4aea2829b0431"><enum>(I)</enum><text display-inline="yes-display-inline">hear from both parties; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3a69c379bb244aa8bc436e1056f09cd5"><enum>(II)</enum><text display-inline="yes-display-inline">review the dispute.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID252b22b64b004a10bbbe5c7f240c8455"><enum>(v)</enum><header display-inline="yes-display-inline">Recommendation of the Board</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID29869ff4650a4172a8986861477fe929"><enum>(vi)</enum><header display-inline="yes-display-inline">Action by the secretary</header>
<subclause commented="no" display-inline="no-display-inline" id="id06C85BE95F6D4119A9DD58EBF9FEF015"><enum>(I)</enum><header display-inline="yes-display-inline">Action letter</header><text display-inline="yes-display-inline">With respect to a proposed risk evaluation
and mitigation strategy submitted under subparagraph (A)(i) or (A)(ii)(II)(aa)
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 commented="no" display-inline="no-display-inline" id="id2217915A81284298972BDD424E87B5B9"><enum>(aa)</enum><text display-inline="yes-display-inline">the action deadline for the action letter
on the application; or</text>
</item><item commented="no" display-inline="no-display-inline" id="id2BCF6E8BB71943ECB31A6468528BC114"><enum>(bb)</enum><text display-inline="yes-display-inline">7 days after receiving the recommendation
of the Drug Safety Oversight Board.</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="id38F1AF356DC44D0790F2E428A167DDF5"><enum>(II)</enum><header display-inline="yes-display-inline">Order</header><text display-inline="yes-display-inline">With respect to a proposed risk evaluation
and mitigation strategy submitted under item (bb) or (cc) of subparagraph
(A)(ii)(II) or 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 (with the
recommendation of the Drug Safety Oversight Board) 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 commented="no" display-inline="no-display-inline" id="id0E035F66705843E190582F36BED4EAAA"><enum>(vii)</enum><header display-inline="yes-display-inline">Inaction</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id10BE0C7DA51F4D76AA97F3EBEFB989FB"><enum>(viii)</enum><header display-inline="yes-display-inline">Effect on action deadline</header><text display-inline="yes-display-inline">With respect to the application or
supplemental application in which a proposed risk evaluation and mitigation
strategy is submitted under subparagraph (A)(i) or (A)(ii)(II)(aa) 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 for the action
letter on such application if the applicant requests the dispute resolution
process described in this subparagraph and if the Secretary—</text>
<subclause commented="no" display-inline="no-display-inline" id="id766D24994A104977B67A010C99D701A6"><enum>(I)</enum><text display-inline="yes-display-inline">has initiated the discussions described
under subparagraph (D) by the target date referred to in subparagraph (D)(i);
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id9BFC5D628D9F4A5AB81B7469A9B6BA45"><enum>(II)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id5928A0D1170348C88E72FADB53F9084D"><enum>(ix)</enum><header display-inline="yes-display-inline">Disqualification</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id7F742E43313D4E92BBE8403AE4FA3853"><enum>(x)</enum><header display-inline="yes-display-inline">Additional expertise</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id465FF774417442A29EB6E63D2362B4C4"><enum>(H)</enum><header display-inline="yes-display-inline">Use of advisory committees</header><text display-inline="yes-display-inline">The Secretary (acting through the offices
described in subparagraph (A)(ii)(I)) may convene a meeting of 1 or more
advisory committees of the Food and Drug Administration to—</text>
<clause commented="no" display-inline="no-display-inline" id="id408AF7C83EDC49CCB99A3463119610C9"><enum>(i)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="IDcf7defc0abce4ec1b4aed07ab8966260"><enum>(ii)</enum><text display-inline="yes-display-inline">review the risk evaluation and mitigation
strategy or strategies of a drug or group of drugs; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID71570f6e0fae45248fde5f424fa997fb"><enum>(iii)</enum><text display-inline="yes-display-inline">with the consent of the applicant, review a
dispute under subparagraph (G).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDebff1fffd8b045f7b5c64e6b89180716"><enum>(I)</enum><header display-inline="yes-display-inline">Process for addressing Drug Class
Effects</header>
<clause commented="no" display-inline="no-display-inline" id="ID07e35ea7bae84948aaf7c6e69d78e296"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">When a concern about a serious risk of a
drug may be related to the pharmacological class of the drug, the Secretary
(acting through the offices described in subparagraph (A)(ii)(I)) may defer
assessments of the approved risk evaluation and mitigation strategies for such
drugs until the Secretary has—</text>
<subclause commented="no" display-inline="no-display-inline" id="idDF1CCA82F3A6476B8B2E40734C6718A4"><enum>(I)</enum><text display-inline="yes-display-inline">convened, after appropriate public notice,
1 or more public meetings to consider possible responses to such concern;
or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3a3e3ca4a33b4c5991f63d2317ef81d4"><enum>(II)</enum><text display-inline="yes-display-inline">gathered additional information or data
about such concern.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID6da86c42506c48baae16babf9ec0a270"><enum>(ii)</enum><header display-inline="yes-display-inline">Public meetings</header><text display-inline="yes-display-inline">Such public meetings may include—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID8caab8566c124c76a7067f195132337f"><enum>(I)</enum><text display-inline="yes-display-inline">1 or more meetings of the applicants for
such drugs;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDd51d4e3cb4414004a153320cbbf28e69"><enum>(II)</enum><text display-inline="yes-display-inline">1 or more meetings of 1 or more advisory
committees of the Food and Drug Administration, as provided for under
subparagraph (H); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4da0c953a6204236a05077bab33f68ef"><enum>(III)</enum><text display-inline="yes-display-inline">1 or more workshops of scientific experts
and other stakeholders.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idD36ECBCE9B0B41F9BBAAFBDF41E077E3"><enum>(iii)</enum><header display-inline="yes-display-inline">Action</header><text display-inline="yes-display-inline">After considering the discussions from any
meetings under clause (ii), the Secretary may—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID0c53160064a44d67925d2f3f9364b924"><enum>(I)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID3b7e2fa77f1642e0b6e3b2b8fcf88ea9"><enum>(II)</enum><text display-inline="yes-display-inline">seek public comment about such action;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID8521715029ef499d9b1db0dc3584e32e"><enum>(III)</enum><text display-inline="yes-display-inline">after seeking such comment, issue an order
addressing such regulatory action.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID051540dd785c4debacbb3fcfd6e1ca29"><enum>(J)</enum><header display-inline="yes-display-inline">International Coordination</header><text display-inline="yes-display-inline">The Secretary (acting through the offices
described in subparagraph (A)(ii)(I)) may coordinate the timetable for
submission of assessments under paragraph (3)(B), a study under paragraph
(4)(B), or a clinical trial under paragraph (4)(C), 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 commented="no" display-inline="no-display-inline" id="id6665F78DD25542418C6C92CADA782B03"><enum>(K)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">Use of the processes described in
subparagraphs (I) and (J) shall not delay action on an application or a
supplement to an application for a drug.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC5CCFCFBF1BF42AC9A1FB6DF55A314A9"><enum>(L)</enum><header display-inline="yes-display-inline">No effect on labeling changes that do not
require preapproval</header><text display-inline="yes-display-inline">In the
case of a labeling change to which <external-xref legal-doc="usc" parsable-cite="usc/21/314">section 314.70</external-xref> 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 commented="no" display-inline="no-display-inline" id="id9FEA43ADFA8B43CBB312802AB309EA1E"><enum>(8)</enum><header display-inline="yes-display-inline">Drug safety oversight board</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id18B42AE4B53349DC93E851A7D0D45D57"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">There is established a Drug Safety
Oversight Board.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id49FE49AEACDD42C69CC7C3B7283B7A8B"><enum>(B)</enum><header display-inline="yes-display-inline">Composition; meetings</header><text display-inline="yes-display-inline">The Drug Safety Oversight Board
shall—</text>
<clause commented="no" display-inline="no-display-inline" id="IDb1beb4c468034b23a7b7a6b998c49ce7"><enum>(i)</enum><text display-inline="yes-display-inline">be composed of scientists and health care
practitioners appointed by the Secretary, each of whom is an employee of the
Federal Government;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID64b9f5e352fd4ec59cd6fc6e20832984"><enum>(ii)</enum><text display-inline="yes-display-inline">include representatives from offices
throughout the Food and Drug Administration (including the offices responsible
for postapproval safety of drugs);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID91c4c6f05b014572885533bfee09842b"><enum>(iii)</enum><text display-inline="yes-display-inline">include at least 1 representative each from
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 commented="no" display-inline="no-display-inline" id="IDde451bc69e424297aab7c328166ce722"><enum>(iv)</enum><text display-inline="yes-display-inline">meet at least monthly to provide oversight
and advice to the Secretary on the management of important drug safety
issues.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id95BB388697594DB6B29BF19B168A8745"><enum>(9)</enum><header display-inline="yes-display-inline">Civil monetary penalty</header><text display-inline="yes-display-inline">Notwithstanding any other provision of this
Act, an applicant (as such term is defined for purposes of this section) that
knowingly fails to comply with a requirement of an approved risk evaluation and
mitigation strategy under this subsection shall be subject to a civil money
penalty of $250,000 for the first 30-day period that the applicant is in
noncompliance, and such amount shall double for every 30-day period thereafter
that the requirement is not complied with, not to exceed
$2,000,000.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="ID897206f3cfd541469a3add8b66006f72" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Enforcement</header>
<subsection commented="no" display-inline="no-display-inline" id="ID53f1f2d2a0784ad2ae62060bbdb6176e"><enum>(a)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">Section 502 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id9FACF3812D3549C99CA3CD3B0E175D5C" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idB464A8F89CB04CEC9198087D0C0E451A"><enum>(x)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID3507fd0654b54216bab22734e7ab1f62"><enum>(1)</enum><text display-inline="yes-display-inline">make a labeling change required by such
strategy after the Secretary has approved such strategy or completed review of,
and acted on, an assessment of such strategy under paragraph (7) of such
section; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDbb2afe9219b64b8ba2ae0db0389077c2"><enum>(2)</enum><text display-inline="yes-display-inline">comply with a requirement of such strategy
with respect to advertising as provided for under subparagraph (D), (E), or (F)
of paragraph (5) of such
section.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id64E0131B4DC64C30A825BC99A032221F"><enum>(b)</enum><header display-inline="yes-display-inline">Civil penalties</header><text display-inline="yes-display-inline">Section 303(f) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idA37BD0DF12694CB79D68A3F3FA694DA8"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (3), (4), and
(5) as paragraphs (4), (5), and (6), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6B3C85A3D2F1489FA9E1C1A4BCE9CA48"><enum>(2)</enum><text display-inline="yes-display-inline">by inserting after paragraph (2) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idC0F09AE9D3B746708C124B01A75C42B7" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id9E5E77C97E9F42D681BD614A1D9A3B8E"><enum>(3)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="idA7B4383F61F647E7AE8D0CF9BFE9493E"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (2)(C), by striking
<quote>paragraph (3)(A)</quote> and inserting <quote>paragraph
(4)(A)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC2496A8CE26B41429C3F06F1DD3A2EBC"><enum>(4)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id079C9844573C4C4085CDEE9373FFA360"><enum>(5)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID161e8ad871344cd7be7a1c1c468b14cb" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Regulation of drugs that are biological
products</header><text display-inline="no-display-inline">Section 351 of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id8F12CDD2C0654828803E0F0D863935D7"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)(2), by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id8E5B8DA1814241C0805C0C73763AB579" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id10490212C59148498EF05291CC19B0E2" indent="up2"><enum>(D)</enum><header display-inline="yes-display-inline">Risk evaluation and mitigation
strategy</header><text display-inline="yes-display-inline">A person that
submits an application for a license for a drug under this paragraph may 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 commented="no" display-inline="no-display-inline" id="id4CF319E849AB427987C474E6D3CF59CE"><enum>(2)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID3c7c3f3b971146fb8b7a7662fbc11e6f" section-type="subsequent-section"><enum>205.</enum><header display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(e)</external-xref>) 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)(7)(B)(ii)(V).</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="ID6536b0accc704aac8968386ddbb1e35a" section-type="subsequent-section"><enum>206.</enum><header display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(2)</external-xref>) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idBF3C42BF78DB4D1E951C068F94B9E324" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id2E5F8ABF58234E399B3481579F93AB9C" indent="up2"><enum>(E)</enum><header display-inline="yes-display-inline">Risk evaluation and mitigation strategy
requirement</header>
<clause commented="no" display-inline="no-display-inline" id="idB21FECF3219E4DFBAD430A8F7562099C"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 approved risk evaluation and mitigation strategy
if required under subsection (o) for the applicable listed drug:</text>
<subclause commented="no" display-inline="no-display-inline" id="id542D4EC104AB40EDBF43C2D82B9658FD"><enum>(I)</enum><text display-inline="yes-display-inline">Labeling, as required under subsection
(o)(3)(A) for the applicable listed drug.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id769358E19A2847ED93B28A1A63B7C024"><enum>(II)</enum><text display-inline="yes-display-inline">A Medication Guide or patient package
insert, if required under subsection (o)(5)(B) for the applicable listed
drug.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id4BC0553C9073469F90DEE698106FFB3F"><enum>(III)</enum><text display-inline="yes-display-inline">Prereview of advertising, if required under
subsection (o)(5)(D) for the applicable listed drug.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id1F4E52E605234323B4DA0DCFB1464399"><enum>(IV)</enum><text display-inline="yes-display-inline">Specific disclosures in advertising, if
required under subsection (o)(5)(E) for the applicable listed drug.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id99C80233978142AC844455CCEA2B059A"><enum>(V)</enum><text display-inline="yes-display-inline">Elements to assure safe use, if required
under subsection (o)(6) for the applicable listed drug, except that such drug
may use a different, comparable aspect of such elements as are necessary to
assure safe use of such drug if—</text>
<item commented="no" display-inline="no-display-inline" id="id86E97949C1E444E2A65586C01024EAD1"><enum>(aa)</enum><text display-inline="yes-display-inline">the corresponding aspect of the elements to
assure safe 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" display-inline="no-display-inline" id="idE806706E6A5B479D8E0459CDE4FA21CD"><enum>(bb)</enum><text display-inline="yes-display-inline">the applicant certifies that it has sought
a license for use of such aspect of the elements to assure safe use for the
applicable listed drug.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="id22ED8850F56140C4BAC56EE91907F946"><enum>(ii)</enum><header display-inline="yes-display-inline">Action by Secretary</header><text display-inline="yes-display-inline">For an applicable listed drug for which a
drug is approved under this subsection, the Secretary—</text>
<subclause commented="no" display-inline="no-display-inline" id="id148C2CBD7AC64AB4BE50A55FC8A413EF"><enum>(I)</enum><text display-inline="yes-display-inline">shall undertake any communication plan to
health care providers required under section (o)(5)(C) for the applicable
listed drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id6F15C145AC1B4132A90B0986CEF63424"><enum>(II)</enum><text display-inline="yes-display-inline">shall conduct, or contract for, any
postapproval study required under subsection (o)(4)(B) for the applicable
listed drug;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idC4B3212D406B4F9EB75A7D2F6C3AC4CF"><enum>(III)</enum><text display-inline="yes-display-inline">shall inform the applicant for a drug
approved under this subsection if the approved risk evaluation and mitigation
strategy for the applicable listed drug is modified; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idCC71E9A017E3408EAA88A4EABD21972F"><enum>(IV)</enum><text display-inline="yes-display-inline">in order to minimize the burden on the
health care delivery system of different elements to assure safe use for the
drug approved under this subsection and the applicable listed drug, may seek to
negotiate a voluntary agreement with the owner of the patent, method, or
process for a license under which the applicant for such drug may use an aspect
of the elements to assure safe use, if required under subsection (o)(6) 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" display-inline="no-display-inline" id="id2FF9618AB6D94CC0976ACD0B9BE85FA7" section-type="subsequent-section"><enum>207.</enum><header display-inline="yes-display-inline">Resources</header>
<subsection commented="no" display-inline="no-display-inline" id="ID2f13c5d264a94a569ac03c1db17da01f"><enum>(a)</enum><header display-inline="yes-display-inline">User fees</header><text display-inline="yes-display-inline">Subparagraph (F) of section 735(d)(6) of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g(d)(6)</external-xref>), as amended by
section 103, is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDe8192147d64a40c2b154d068631876d7"><enum>(1)</enum><text display-inline="yes-display-inline">in clause (ii), by striking
<quote>systems); and</quote> and inserting <quote>systems);</quote></text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7d743d7f20b94a5f9b279150a51b7c42"><enum>(2)</enum><text display-inline="yes-display-inline">in clause (iii), by striking
<quote>bases).</quote> and inserting <quote>bases); and</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDba9f74c0e90545a59ccb5f1700b4352d"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2F98B2B6642146C08E40115D79E948D0" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="ID823021da23034af693888ce0e526e603"><enum>(iv)</enum><text display-inline="yes-display-inline">reviewing, implementing, and ensuring
compliance with risk evaluation and mitigation
strategies.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id21481C8ABFF04C6E9D4A03B62BD96223"><enum>(b)</enum><header display-inline="yes-display-inline">Additional fee revenues for drug
safety</header><text display-inline="yes-display-inline">Section 736 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h</external-xref>), as amended by section
103, is amended by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idE47AB812EC5242B8BB7A682C1D8F4E01"><enum>(1)</enum><text display-inline="yes-display-inline">striking the subsection designation and all
that follows through <quote>.—Except</quote> and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id19B9879A70594332B7569B412D411D9E" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id7161B48D823B432087CF2E520328949B"><enum>(b)</enum><header display-inline="yes-display-inline">Fee revenue amounts</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8C21D2D429C84780809FEF2BCC447DF0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB8212811F1724BB581B947761072938F"><enum>(2)</enum><text display-inline="yes-display-inline">adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9B82F5D325C74FA7BE08BB74998A7F37" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idCE2816E701144089A28C8F1474F3D795"><enum>(2)</enum><header display-inline="yes-display-inline">Additional fee revenues for drug
safety</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id889CF69525D44E36BB7EAE5986802891"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to subparagraph (C), in each of
fiscal years 2008 through 2012, paragraph (1) shall be applied by substituting
the amount determined under subparagraph (B) for
<quote>$392,783,000</quote>.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id49683229515A4B9AA2AAFB3DDA8FD7AB"><enum>(B)</enum><header display-inline="yes-display-inline">Amount determined</header><text display-inline="yes-display-inline">For any fiscal year 2008 through 2012, the
amount determined under this subparagraph is the sum of—</text>
<clause commented="no" display-inline="no-display-inline" id="idD7FA7C7403B848E4AE37F0C458DA9AB2"><enum>(i)</enum><text display-inline="yes-display-inline">$392,783,000; plus</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD5F62FD8390B47099A4FABDEF9A8EC16"><enum>(ii)</enum><text display-inline="yes-display-inline">the amount equal to—</text>
<subclause commented="no" display-inline="no-display-inline" id="id1D503D9AB7074177A480CEF4B7095448"><enum>(I)</enum><item commented="no" display-inline="yes-display-inline" id="id65511B324D954135BE098F97C1702093"><enum>(aa)</enum><text display-inline="yes-display-inline">for fiscal year 2008, $25,000,000;</text>
</item><item commented="no" display-inline="no-display-inline" id="idB6BD870DA96D42ADAB9C301AF78A459B" indent="up1"><enum>(bb)</enum><text display-inline="yes-display-inline">for fiscal year 2009, $35,000,000;</text>
</item><item commented="no" display-inline="no-display-inline" id="id4829791D06F84FE3AB6A3837AA733FAE" indent="up1"><enum>(cc)</enum><text display-inline="yes-display-inline">for fiscal year 2010, $45,000,000;</text>
</item><item commented="no" display-inline="no-display-inline" id="idA52BBD5BE06C407DA56519A28317EDC7" indent="up1"><enum>(dd)</enum><text display-inline="yes-display-inline">for fiscal year 2011, $55,000,000;
and</text>
</item><item commented="no" display-inline="no-display-inline" id="id36E69F743FCE4AB4A1BDEDA8E2981644" indent="up1"><enum>(ee)</enum><text display-inline="yes-display-inline">for fiscal year 2012, $65,000,000;
minus</text>
</item></subclause><subclause id="id430F8C85C5F5408BB66229C1F2C5CFC1" indent="up1"><enum>(II)</enum><text>the amount equal to one-fifth of the
excess amount in item (bb), provided that—</text>
<item id="id0B5C8CDDDAFD4AD98D08FA62FD46CDF3"><enum>(aa)</enum><text>the amount of the total appropriation
for the Food and Drug Administration for such fiscal year (excluding the amount
of fees appropriated for such fiscal year) exceeds the amount of the total
appropriation for the Food and Drug Administration for fiscal year 2007
(excluding the amount of fees appropriated for such fiscal year), adjusted as
provided under subsection (c)(1); and</text>
</item><item id="idE6445732C107442EB9EAD4F8CC07B595"><enum>(bb)</enum><text>the amount of the total
appropriations for the process of human drug review at the Food and Drug
Administration for such fiscal year (excluding the amount of fees appropriated
for such fiscal year) exceeds the amount of appropriations for the process of
human drug review at the Food and Drug Administration for fiscal year 2007
(excluding the amount of fees appropriated for such fiscal year), adjusted as
provided under subsection (c)(1).</text>
</item><continuation-text continuation-text-level="subclause">In making
the adjustment under subclause (II) for any fiscal year 2008 through 2012,
subsection (c)(1) shall be applied by substituting <quote>2007</quote> for
<quote>2008.</quote>
</continuation-text></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3A67D338BACD4361A58AFEC890199C6A"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">This paragraph shall not apply for any
fiscal year if the amount described under subparagraph (B)(ii) is less than
0.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id46E354EEDB364180B9D051D34C462C9E"><enum>(c)</enum><header display-inline="yes-display-inline">Strategic Plan for information
technology</header><text display-inline="yes-display-inline">Not later than 1
year after the date of enactment of this title, the Secretary of Health and
Human Services (referred to in this title 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" display-inline="no-display-inline" id="id5B8005D3A2344602BDE7849BA22B1167"><enum>(1)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id991AFA8190B240D183F3D99C591963F1"><enum>(A)</enum><text display-inline="yes-display-inline">comply with the requirements of this
subtitle (and the amendments made by this subtitle);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA4C69BF0724946E1A8B98E972E405129"><enum>(B)</enum><text display-inline="yes-display-inline">achieve interoperability within and among
the centers of the Food and Drug Administration and between the Food and Drug
Administration and product application sponsors;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBE9AC8E93A7243B6A2DB2B04D3B47B4F"><enum>(C)</enum><text display-inline="yes-display-inline">utilize electronic health records;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id882DF3A9280E41A9B290DCE882BF506B"><enum>(D)</enum><text display-inline="yes-display-inline">implement routine active surveillance under
section 505(k)(3) (including complementary approaches under subsection (c) of
such section) of the Federal Food, Drug, and Cosmetic Act, as added by section
201 of this Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idCB96FA4EE6854613819FBB70F3CCED92"><enum>(E)</enum><text display-inline="yes-display-inline">communicate drug safety information to
physicians and other health care providers;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id617F140DBF434003910C612E8D02AF84"><enum>(2)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id65F152CE9F4A42DBAC2FA4422DB73F0B"><enum>(3)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id73EC4845446C475D9252F68BFAC511B9"><enum>(4)</enum><text display-inline="yes-display-inline">an assessment of additional resources
needed to so enhance the information technology assets of the Food and Drug
Administration.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idC323683E97E74DCD92B7AA361513797F" section-type="subsequent-section"><enum>208.</enum><header display-inline="yes-display-inline">Safety labeling changes</header>
<subsection commented="no" display-inline="no-display-inline" id="id09316306D10C4A2D844A9209639E4B35"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by inserting
after section 506C the following:</text>
<quoted-block display-inline="no-display-inline" id="id5A4DA3B66CC74633980E904B58EA9314" style="OLC">
<section commented="no" display-inline="no-display-inline" id="ID9f0c78206c4d4bfba5dec4f461c1a71c" section-type="subsequent-section"><enum>506D.</enum><header display-inline="yes-display-inline">Safety labeling changes</header>
<subsection commented="no" display-inline="no-display-inline" id="IDa209c431b17245dba899e5231d842fb3"><enum>(a)</enum><header display-inline="yes-display-inline">New safety information</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDeff995c0ce414e87a4561064157ed602"><enum>(1)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">The holder of an approved application under
section 505 of this Act or a license under section 351 of the Public Health
Service Act (referred to in this section as a <quote>holder</quote>) shall
promptly notify the Secretary if the holder becomes aware of new safety
information that the holder believes should be included in the labeling of the
drug. The Secretary shall promptly notify the holder if the Secretary becomes
aware of new safety information that the Secretary believes should be included
in the labeling of the drug.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2f48c785e8584e04a034bdf9db197c59"><enum>(2)</enum><header display-inline="yes-display-inline">Discussion regarding labeling
changes</header><text display-inline="yes-display-inline">Following
notification pursuant to paragraph (1), the Secretary and holder shall initiate
discussions of the new safety information in order to reach agreement on
whether the labeling for the drug should be modified to reflect the new safety
information and, if so, on the contents of such labeling changes.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1e4cc32cc690484097c190047f8d0c49"><enum>(3)</enum><header display-inline="yes-display-inline">Supplement</header><text display-inline="yes-display-inline">If the Secretary determines that there is
reasonable scientific evidence that an adverse event is associated with use of
the drug, the Secretary may request the holder to submit a supplement to an
application under section 505 of this Act or to a license under section 351 of
the Public Health Service Act (referred to in this section as a
<quote>supplement</quote>) proposing changes to the approved labeling to
reflect the new safety information, including changes to boxed warnings,
contraindications, warnings, precautions, or adverse reactions (referred to in
this section as a <quote>safety labeling change</quote>). If the Secretary
determines that no safety labeling change is necessary or appropriate based
upon the new safety information, the Secretary shall notify the holder of this
determination in writing.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDa9aee6a1a59d40c79ca669a06d242a5d"><enum>(b)</enum><header display-inline="yes-display-inline">Labeling supplements</header>
<paragraph commented="no" display-inline="no-display-inline" id="id6231C2CEE8CA4533AB42E493507A6B42"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The holder shall submit a supplement
whenever the holder seeks, either at the holder's own initiative or at the
request of the Secretary, to make a safety labeling change.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7163F0F9C7CF44638C6CF4BCA2EE968B"><enum>(2)</enum><header display-inline="yes-display-inline">Nonaccelerated process</header><text display-inline="yes-display-inline">Unless the accelerated labeling review
process described in subsection (c) is initiated, any supplement proposing a
safety labeling change shall be reviewed and acted upon by the Secretary not
later than 30 days after the date the Secretary receives the supplement. Until
the Secretary acts on such a supplement proposing a safety labeling change, the
existing approved labeling shall remain in effect and be distributed by the
holder without change.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF625F9F3DE3F4A468F8F258C0C225592"><enum>(3)</enum><header display-inline="yes-display-inline">New safety information</header><text display-inline="yes-display-inline">Nothing in this section shall prohibit the
Secretary from informing health care professionals or the public about new
safety information prior to approval of a supplement proposing a safety
labeling change.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDebf3891663d94791ac255694e8fbdce6"><enum>(c)</enum><header display-inline="yes-display-inline">Accelerated labeling review
process</header><text display-inline="yes-display-inline">An accelerated
labeling review process shall be available to resolve disagreements in a timely
manner between the Secretary and a holder about the need for, or content of, a
safety labeling change, as follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDd9b8d7e0396044fdba44ebb205825076"><enum>(1)</enum><header display-inline="yes-display-inline">Request to initiate accelerated
process</header><text display-inline="yes-display-inline">The accelerated
labeling review process shall be initiated upon the written request of either
the Secretary or the holder. Such request may be made at any time after the
notification described in subsection (a)(1), including during the Secretary’s
review of a supplement proposing a safety labeling change.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0bb8ccd6be6b4d1298d8554cdbd9dcbc"><enum>(2)</enum><header display-inline="yes-display-inline">Scientific discussion and meetings</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id0128DFD658AE48BEA928D136A5BBF4B2"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Following initiation of the accelerated
labeling review process, the Secretary and holder shall immediately initiate
discussions to review and assess the new safety information and to reach
agreement on whether safety labeling changes are necessary and appropriate and,
if so, the content of such safety labeling changes.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDba4604824b54421b955ab7703fac4c9c"><enum>(B)</enum><header display-inline="yes-display-inline">Time period</header><text display-inline="yes-display-inline">The discussions under this paragraph shall
not extend for more than 45 calendar days after the initiation of the
accelerated labeling review process.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID135e9967e43e497e8b474f0c21f87aa4"><enum>(C)</enum><header display-inline="yes-display-inline">Dispute proceedings</header><text display-inline="yes-display-inline">If the Secretary and holder do not reach an
agreement regarding the safety labeling changes by not later than 25 calendar
days after the initiation of the accelerated labeling review process, the
dispute automatically shall be referred to the director of the drug evaluation
office responsible for the drug under consideration, who shall be required to
take an active role in such discussions.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDee44ecb841f64d5598b7c95b73e6dd64"><enum>(3)</enum><header display-inline="yes-display-inline">Request for safety labeling change and
failure to agree</header><text display-inline="yes-display-inline">If the
Secretary and holder fail to reach an agreement on appropriate safety labeling
changes by not later than 45 calendar days after the initiation of the
accelerated labeling review process—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id5A440D9695EE4D4EA5551783D07855B7"><enum>(A)</enum><text display-inline="yes-display-inline">on the next calendar day (other than a
weekend or Federal holiday) after such period, the Secretary shall—</text>
<clause commented="no" display-inline="no-display-inline" id="id74DE5F918D994195966371C75DC6F8AA"><enum>(i)</enum><text display-inline="yes-display-inline">request in writing that the holder make any
safety labeling change that the Secretary determines to be necessary and
appropriate based upon the new safety information; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id89B1A1AE8E2241D88C737A3F8CAE7681"><enum>(ii)</enum><text display-inline="yes-display-inline">notify the holder in writing that the
Secretary has determined that no safety labeling change is necessary or
appropriate; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa7a9ac941c334dd0bdfdcd5feb2f951b"><enum>(B)</enum><text display-inline="yes-display-inline">if the Secretary fails to act within the
specified time, or if the holder does not agree to make a safety labeling
change requested by the Secretary or does not agree with the Secretary’s
determination that no labeling change is necessary or appropriate, the
Secretary (on his own initiative or upon request by the holder) shall refer the
matter for expedited review to the Drug Safety Oversight Board.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb2468765e74f485291b79463b17a1d5d"><enum>(4)</enum><header display-inline="yes-display-inline">Action by the drug safety oversight
board</header><text display-inline="yes-display-inline">Not later than 45 days
after receiving a referral under paragraph (3)(B), the Drug Safety Oversight
Board shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDe20639d3f1694e93a3cc6fbaeb0d42d8"><enum>(A)</enum><text display-inline="yes-display-inline">review the new safety information;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0fdb8195c4074b9f8de4ac06332cbbc3"><enum>(B)</enum><text display-inline="yes-display-inline">review all written material submitted by
the Secretary and the holder;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID942d6a8f67374c36be99a0337e56f6df"><enum>(C)</enum><text display-inline="yes-display-inline">convene a meeting to hear oral
presentations and arguments from the Secretary and holder; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8fc82f21fed64f9c86d9e6b782171a1b"><enum>(D)</enum><text display-inline="yes-display-inline">make a written recommendation to the
Secretary—</text>
<clause commented="no" display-inline="no-display-inline" id="ID5905d90c4c964835a8ae9b8e2d8db6e7"><enum>(i)</enum><text display-inline="yes-display-inline">concerning appropriate safety labeling
changes, if any; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDdef4b1e84d244fe1bb0d91e9a3192f55"><enum>(ii)</enum><text display-inline="yes-display-inline">stating that no safety labeling changes are
necessary or appropriate based upon the new safety information.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4f45b9bd181a49638ef801f06ea4641e"><enum>(5)</enum><header display-inline="yes-display-inline">Consideration of recommendations</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID9b2adce992b949a68fa1f72d507fdd16"><enum>(A)</enum><header display-inline="yes-display-inline">Action by the Secretary</header><text display-inline="yes-display-inline">The Secretary shall consider the
recommendation of the Drug Safety Oversight Board made under paragraph (4)(D)
and, not later than 20 days after receiving the recommendation—</text>
<clause commented="no" display-inline="no-display-inline" id="idE53C5B00AED04A27A5038FB66C036B5E"><enum>(i)</enum><text display-inline="yes-display-inline">issue an order requiring the holder to make
any safety labeling change that the Secretary determines to be necessary and
appropriate; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idFF97EE12305845C7B7F33A0A8F295096"><enum>(ii)</enum><text display-inline="yes-display-inline">if the Secretary determines that no safety
labeling change is necessary or appropriate, the Secretary shall notify the
holder of this determination in writing.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd9989eb8b09c4885b53c2d205f0af198"><enum>(B)</enum><header display-inline="yes-display-inline">Failure
to act</header><text display-inline="yes-display-inline">If the Secretary fails
to act by not later than 20 days after receiving the recommendation of the Drug
Safety Oversight Board, the written recommendation of the Drug Safety Oversight
Board shall be considered the order of the Secretary under this
paragraph.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDed45b2baf0c84aeca9f5fcc0e3e64f62"><enum>(C)</enum><header display-inline="yes-display-inline">Nondelegation</header><text display-inline="yes-display-inline">The Secretary’s authority under this
paragraph shall not be redelegated to an individual below the level of the
Director of the Center for Drug Evaluation and Research, or the Director of the
Center for Biologics Evaluation and Research, of the Food and Drug
Administration.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDf8b4697034194369bfba237bda1b63e7"><enum>(6)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">If the holder, not later than 10 days after
receiving an order under subparagraph (A) or (B) of paragraph (5), does not
agree to make a safety labeling change ordered by the Secretary, the Secretary
may deem the drug that is the subject of the request to be misbranded.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID9129dafcc24f49dd949bf327b945209d"><enum>(d)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">Nothing in this section shall be construed
to change the standards in existence on the date of enactment of this section
for determining whether safety labeling changes are necessary or
appropriate.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id63F92B368CA744529B308016529EB274"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 502 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352 et seq.</external-xref>), as amended by section 203, is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id1AC1B7A397344C00AE0F35612F7076DE" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idB88E16DC3B6C4EA8ACBBF94C7CEAB83B"><enum>(y)</enum><text display-inline="yes-display-inline">If it is a drug and the holder does not
agree to make a safety labeling change ordered by the Secretary under section
506D(c) within 10 days after issuance of such an
order.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" display-inline="no-display-inline" id="idA75077BAB760474998B24A7CD3A60F0F" section-type="subsequent-section"><enum>209.</enum><header display-inline="yes-display-inline">Postmarket drug safety information for
patients and providers</header><text display-inline="no-display-inline">Section
505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>), as amended by
section 251, is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id14202E6730D4432B85357FC3D290F3D6" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id19D7B277E970459C97EE96DC4D2A1833"><enum>(r)</enum><header display-inline="yes-display-inline">Postmarket drug safety information for
patients and providers</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8AA635A30FFA424199D4B4D745973062"><enum>(1)</enum><header display-inline="yes-display-inline">Establishment</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the Enhancing Drug Safety and Innovation Act of 2007, the
Secretary shall improve the transparency of pharmaceutical data and allow
patients and health care providers better access to pharmaceutical data by
developing and maintaining an Internet website that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDfe01a987853244cf851c904c0f9b911f"><enum>(A)</enum><text display-inline="yes-display-inline">provides comprehensive drug safety
information for prescription drugs that are approved by the Secretary under
this section or licensed under section 351 of the Public Health Service Act;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf94dbf6b2427425f89184ef68f712311"><enum>(B)</enum><text display-inline="yes-display-inline">improves communication of drug safety
information to patients and providers.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc35a9318cd254434bc0e720d1e0f8590"><enum>(2)</enum><header display-inline="yes-display-inline">Internet website</header><text display-inline="yes-display-inline">The Secretary shall carry out paragraph (1)
by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID49b0f398ec8946c48cfd130877bb61ed"><enum>(A)</enum><text display-inline="yes-display-inline">developing and maintaining an accessible,
consolidated Internet website with easily searchable drug safety information,
including the information found on United States Government Internet websites,
such as the United States National Library of Medicine’s Daily Med and Medline
Plus websites, in addition to other such websites maintained by the
Secretary;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID441e4091377f43d796adf08d93b713d8"><enum>(B)</enum><text display-inline="yes-display-inline">ensuring that the information provided on
the Internet website is comprehensive and includes, when available and
appropriate—</text>
<clause commented="no" display-inline="no-display-inline" id="ID17e5a2b57646496aa7dc38d9abe1c8a3"><enum>(i)</enum><text display-inline="yes-display-inline">patient labeling and patient packaging
inserts;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID7633ab6180cf49fd843f1e7c831807b5"><enum>(ii)</enum><text display-inline="yes-display-inline">a link to a list of each drug, whether
approved under this section 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>
</clause><clause commented="no" display-inline="no-display-inline" id="ID9e7ed97cb9e5446698c90950b9f32e11"><enum>(iii)</enum><text display-inline="yes-display-inline">a link to the clinical trial registry data
bank provided for under subsections (i) and (j) of section 402 of the Public
Health Service Act;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4ba596d057fc4842880c71e85081597e"><enum>(iv)</enum><text display-inline="yes-display-inline">the most recent safety information and
alerts issued by the Food and Drug Administration for drugs approved by the
Secretary under this section, such as product recalls, warning letters, and
import alerts;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID737778f89dae4fd096cba91767ba4386"><enum>(v)</enum><text display-inline="yes-display-inline">publicly available information about
implemented RiskMAPs and risk evaluation and mitigation strategies under
subsection (o);</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID31035444ce7b42dbb8a95b3aab582f7c"><enum>(vi)</enum><text display-inline="yes-display-inline">guidance documents and regulations related
to drug safety; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDf8efa5c423574dbdb80fd0c4e047be68"><enum>(vii)</enum><text display-inline="yes-display-inline">other material determined appropriate by
the Secretary;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID24106062bc67484fa8a3d63065f69b41"><enum>(C)</enum><text display-inline="yes-display-inline">including links to non-Food and Drug
Administration Internet resources that provide access to relevant drug safety
information, such as medical journals and studies;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa2ec579ca1a84989ba6421185063a3e1"><enum>(D)</enum><text display-inline="yes-display-inline">providing access to summaries of the
assessed and aggregated data collected from the active surveillance
infrastructure under subsection (k)(3) to provide information of known and
serious side-effects for drugs approved by the Secretary under this section or
licensed under such section 351;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa385d2e3ba9a499a848af6666d1c6193"><enum>(E)</enum><text display-inline="yes-display-inline">enabling patients, providers, and drug
sponsors to submit adverse event reports through the Internet website;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd691676e23464e65b15d54690b897b54"><enum>(F)</enum><text display-inline="yes-display-inline">providing educational materials for
patients and providers about the appropriate means of disposing of expired,
damaged, or unusable medications; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0d77ba2515834f80a32259368dca231d"><enum>(G)</enum><text display-inline="yes-display-inline">supporting initiatives that the Secretary
determines to be useful to fulfill the purposes of the Internet website.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID248bffafb48e4879ac132ec3591726e2"><enum>(3)</enum><header display-inline="yes-display-inline">Posting of drug labeling</header><text display-inline="yes-display-inline">The Secretary shall post on the Internet
website established under paragraph (1) the approved professional labeling and
any required patient labeling of a drug approved under this section or licensed
under such section 351 not later than 21 days after the date the drug is
approved or licensed, including in a supplemental application with respect to a
labeling change.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID697badb14ec4484f8615e88f184c2f4a"><enum>(4)</enum><header display-inline="yes-display-inline">Private sector resources</header><text display-inline="yes-display-inline">To ensure development of the Internet
website by the date described in paragraph (1), the Secretary may, on a
temporary or permanent basis, implement systems or products developed by
private entities.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDfdd9665ad0004195a6e1659c2e604ecc"><enum>(5)</enum><header display-inline="yes-display-inline">Authority for contracts</header><text display-inline="yes-display-inline">The Secretary may enter into contracts with
public and private entities to fulfill the requirements of this
subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDef6a3f0dc9864015a12e7bcfa56688c6"><enum>(6)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">The Advisory Committee on Risk
Communication under section 566 shall, on a regular basis, perform a
comprehensive review and evaluation of the types of risk communication
information provided on the Internet website established under paragraph (1)
and, through other means, shall identify, clarify, and define the purposes and
types of information available to facilitate the efficient flow of information
to patients and providers, and shall recommend ways for the Food and Drug
Administration to work with outside entities to help facilitate the dispensing
of risk communication information to patients and
providers.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id140290422B57458793A603A092770CB5" section-type="subsequent-section"><enum>210.</enum><header display-inline="yes-display-inline">Action package for approval</header><text display-inline="no-display-inline">Section 505(l) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(l)</external-xref>) is amended by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id95A02E83E1214BB2BD38DC6B88647080"><enum>(1)</enum><text display-inline="yes-display-inline">redesignating paragraphs (1), (2), (3),
(4), and (5) as subparagraphs (A), (B), (C), (D), and (E), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD1AA8F3BA2C944A09D86F18F8BEEC749"><enum>(2)</enum><text display-inline="yes-display-inline">striking <quote>(l) Safety and</quote> and
inserting <quote>(l)(1) Safety and</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id670C560055744F7B9C4C2E97D26A4488"><enum>(3)</enum><text display-inline="yes-display-inline">adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id0357578ACE96402DBA54B906C1AA02D4" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idE73D295F3E394AB28D44E8EBD9AC8BCD" indent="up1"><enum>(2)</enum><header display-inline="yes-display-inline">Action package for approval</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id3CD4A266A72B4CACB461429DB13599F4"><enum>(A)</enum><header display-inline="yes-display-inline">Action
package</header><text display-inline="yes-display-inline">The Secretary shall
publish the action package for approval of an application under subsection (b)
or section 351 of the Public Health Service Act on the Internet website of the
Food and Drug Administration—</text>
<clause commented="no" display-inline="no-display-inline" id="idF4A23C80C11F4C7E88DB049A530F8EA9"><enum>(i)</enum><text display-inline="yes-display-inline">not later than 30 days after the date of
approval of such application for a drug no active ingredient (including any
ester or salt of the active ingredient) of which has been approved in any other
application under this section or section 351 of the Public Health Service Act;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0B4FF7DE0CD043E7A94F8B0BEC74DA9F"><enum>(ii)</enum><text display-inline="yes-display-inline">not later than 30 days after the third
request for such action package for approval received under section 552 of
title 5, United States Code, for any other drug.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAFF556EDB6E948AB98185C5224C237A9"><enum>(B)</enum><header display-inline="yes-display-inline">Immediate publication of summary
review</header><text display-inline="yes-display-inline">Notwithstanding
subparagraph (A), the Secretary shall publish, on the Internet website of the
Food and Drug Administration, the materials described in subparagraph (C)(iv)
not later than 48 hours after the date of approval of the drug, except where
such materials require redaction by the Secretary.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF005467FD7EA4B3FAE2E5A858E69689D"><enum>(C)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">An action package for approval of an
application under subparagraph (A) shall be dated and shall include the
following:</text>
<clause commented="no" display-inline="no-display-inline" id="id749E7C8B0F7C4C529E865508A3DC64C5"><enum>(i)</enum><text display-inline="yes-display-inline">Documents generated by the Food and Drug
Administration related to review of the application.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idC1CD1E310DF7422EAC4F37D0508D5498"><enum>(ii)</enum><text display-inline="yes-display-inline">Documents pertaining to the format and
content of the application generated during drug development.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id10DC2108712C42B39D3B7E521154C39E"><enum>(iii)</enum><text display-inline="yes-display-inline">Labeling submitted by the applicant.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id14A86CD63E5B4DB4A7A545798B6ACA6A"><enum>(iv)</enum><text display-inline="yes-display-inline">A summary review that documents conclusions
from all reviewing disciplines about the drug, noting any critical issues and
disagreements with the applicant and how they were resolved, recommendation for
action, and an explanation of any nonconcurrence with review
conclusions.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id402CE6A7F9994443AF9D3DC0D296E165"><enum>(v)</enum><text display-inline="yes-display-inline">If applicable, a separate review from a
supervisor who does not concur with the summary review.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id03BF9CEB4B5C4ED99992F339B51C553E"><enum>(vi)</enum><text display-inline="yes-display-inline">Identification by name of each officer or
employee of the Food and Drug Administration who—</text>
<subclause commented="no" display-inline="no-display-inline" id="id7647BC3CD3D347B3841BAF01C9613DE3"><enum>(I)</enum><text display-inline="yes-display-inline">participated in the decision to approve the
application; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idAED2DFAA7389418E91C3A98594FF8163"><enum>(II)</enum><text display-inline="yes-display-inline">consents to have his or her name included
in the package.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFF628C2DB36648F3A5ECC8987657C112"><enum>(D)</enum><header display-inline="yes-display-inline">Disagreements</header><text display-inline="yes-display-inline">A scientific review of an application is
considered the work of the reviewer and shall not be altered by management or
the reviewer once final. Disagreements by team leaders, division directors, or
office directors with any or all of the major conclusions of a reviewer shall
be document in a separate review or in an addendum to the review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2D63BB493A374AB0BADE5FF18D888BDE"><enum>(E)</enum><header display-inline="yes-display-inline">Confidential information</header><text display-inline="yes-display-inline">This paragraph does not authorize the
disclosure of any trade secret or confidential commercial or financial
information described in <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552(b)(4)</external-xref> of title 5, United States Code,
unless the Secretary declares an emergency under section 319 of the Public
Health Service Act and such disclosure is necessary to mitigate the effects of
such
emergency.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="idBBC014F30E154E25928D60B2E15BCA35" section-type="subsequent-section"><enum>211.</enum><header display-inline="yes-display-inline">Risk communication</header><text display-inline="no-display-inline">Subchapter E of chapter V of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb">21 U.S.C. 360bbb et seq.</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id649AF2B339BE4D3A9C54AC12EF74DED2" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id87612E32B53642A68025C2B2067C3794" section-type="subsequent-section"><enum>566.</enum><header display-inline="yes-display-inline">Risk communication</header>
<subsection commented="no" display-inline="no-display-inline" id="idD7D6123E2201419DB1B4FBEF80BB7584"><enum>(a)</enum><header display-inline="yes-display-inline">Advisory committee on risk
communication</header>
<paragraph commented="no" display-inline="no-display-inline" id="idA8A95B2E286546CF9E9018613B7884EA"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall establish an advisory
committee to be known as the <quote>Advisory Committee on Risk
Communication</quote> (referred to in this section as the
<quote>Committee</quote>).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA2F19BF3F14B4F8A9E586C6E7DE0E3C3"><enum>(2)</enum><header display-inline="yes-display-inline">Duties of Committee</header><text display-inline="yes-display-inline">The Committee shall advise the Commissioner
on methods to effectively communicate risks associated with the products
regulated by the Food and Drug Administration.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAA8E6B352D44417192C1E6DA79F1F115"><enum>(3)</enum><header display-inline="yes-display-inline">Members</header><text display-inline="yes-display-inline">The Secretary shall ensure that the
Committee is composed of experts on risk communication, experts on the risks
described in subsection (b), and representatives of patient, consumer, and
health professional organizations.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id83A227C0930344B58E9D9687F40A12AE"><enum>(4)</enum><header display-inline="yes-display-inline">Permanence of Committee</header><text display-inline="yes-display-inline">Section 14 of the Federal Advisory
Committee Act shall not apply to the Committee established under this
subsection.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id4F6738BA9202481FA0CDA985A798EA1E"><enum>(b)</enum><header display-inline="yes-display-inline">Partnerships for risk
communication</header>
<paragraph commented="no" display-inline="no-display-inline" id="idBCB61BB599B74FAD91CC35829EB987B9"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall partner with
professional medical societies, medical schools, academic medical centers, and
other stakeholders to develop robust and multi-faceted systems for
communication to health care providers about emerging postmarket drug
risks.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2930C19630004ADD85FC4994959DEB9A"><enum>(2)</enum><header display-inline="yes-display-inline">Partnerships</header><text display-inline="yes-display-inline">The systems developed under paragraph (1)
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID3708f8ef0ffb45d0a096efb717029095"><enum>(A)</enum><text display-inline="yes-display-inline">account for the diversity among physicians
in terms of practice, affinity for technology, and focus; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID41d1b1c2be5244f2bf7b0bddf93f1043"><enum>(B)</enum><text display-inline="yes-display-inline">include the use of existing communication
channels, including electronic communications, in place at the Food and Drug
Administration.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idE584FAA6FC914BC4B9F4EB3FABBD07F2" section-type="subsequent-section"><enum>212.</enum><header display-inline="yes-display-inline">Referral to advisory
committee</header><text display-inline="no-display-inline">Section 505 of the
Federal Food, Drug, and Cosmetic Act, as amended by section 202, is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id76A6B8E68B3749CC9E69A7DD1D846907" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id0F885801E7084159A4860D7F578C55A1"><enum>(p)</enum><header display-inline="yes-display-inline">Referral to advisory committee</header>
<paragraph commented="no" display-inline="no-display-inline" id="id93F3C123B7B649CCAA3B7DD088CD3DC5"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Prior to the approval of a drug no active
ingredient (including any ester or salt of the active ingredient) of which has
been approved in any other application under this section or section 351 of the
Public Health Service Act, the Secretary shall refer such drug to a Food and
Drug Administration advisory committee for review at a meeting of such advisory
committee.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAA65769A7BCC4C128876ED68DDBD8E71"><enum>(2)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Notwithstanding paragraph (1), an advisory
committee review of a drug described under such paragraph may occur within 1
year after approval of such a drug if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID8ad7dcdbf34946b3bc777a15de59236f"><enum>(A)</enum><text display-inline="yes-display-inline">the clinical trial that formed the primary
basis of the safety and efficacy determination was halted by a drug safety
monitoring board or an Institutional Review Board before its scheduled
completion due to early unanticipated therapeutic results; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7a18f405a97b4b33900ce5bb27383ba7"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary determines that it would be
beneficial to the public
health.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idB325846B884E4FE88D465AE40CF3486E" section-type="subsequent-section"><enum>213.</enum><header display-inline="yes-display-inline">Response to the institute of
medicine</header>
<subsection commented="no" display-inline="no-display-inline" id="id9F92E4B91D5048A0B46B42A93D2E1AB5"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this title, the Secretary shall issue a report responding to the
2006 report of the Institute of Medicine entitled <quote>The Future of Drug
Safety—Promoting and Protecting the Health of the Public</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idBEE55C41593749DC8631C491B0767F35"><enum>(b)</enum><header display-inline="yes-display-inline">Content of report</header><text display-inline="yes-display-inline">The report issued by the Secretary under
subsection (a) shall include—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDdc63f64f5b1c45de86aeb2dc554ad1aa"><enum>(1)</enum><text display-inline="yes-display-inline">an update on the implementation by the Food
and Drug Administration of its plan to respond to the Institute of Medicine
report described under such subsection; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1f02ab8e35ee49a9beb2ebbeb5d74f97"><enum>(2)</enum><text display-inline="yes-display-inline">an assessment of how the Food and Drug
Administration has implemented—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idE0B45245A57743F49F0B755F44EC19D4"><enum>(A)</enum><text display-inline="yes-display-inline">the recommendations described in such
Institute of Medicine report; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2E10D572B2354EDBBEB420F004F737AD"><enum>(B)</enum><text display-inline="yes-display-inline">the requirement under paragraph (7) of
section 505(o) of the Federal Food, Drug, and Cosmetic Act (as added by this
title), that the appropriate office responsible for reviewing a drug and the
office responsible for postapproval safety with respect to the drug act
together to assess, implement, and ensure compliance with the requirements of
such section 505(o).</text>
</subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="IDaaf265baba754d9abb4f81e31889c9d0" section-type="subsequent-section"><enum>214.</enum><header display-inline="yes-display-inline">Effective date and applicability</header>
<subsection commented="no" display-inline="no-display-inline" id="ID7c621b42a385458283ec5f267e194b13"><enum>(a)</enum><header display-inline="yes-display-inline">Effective dates</header>
<paragraph commented="no" display-inline="no-display-inline" id="id34CFC7444F3846C9822C157DD75ABE2E"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), this
subtitle shall take effect 180 days after the date of enactment of this
title.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0BA4EA9E33644373B45D268BB2105F19"><enum>(2)</enum><header display-inline="yes-display-inline">User fees</header><text display-inline="yes-display-inline">The amendments made by subsections (a)
through (c) of section 207 shall take effect on October 1, 2007.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDc6241ae44ce148a1a77e60d7c97a3fe5"><enum>(b)</enum><header display-inline="yes-display-inline">Drugs deemed To have risk evaluation and
mitigation strategies</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID6b1d7ced5fac4190928a58703f4a27ae"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A drug that was approved before the
effective date of this subtitle 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 subtitle) if there are in effect on
the effective date of this subtitle restrictions on distribution or use—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID894c33e4dfd245f2843ce65ce839c44c"><enum>(A)</enum><text display-inline="yes-display-inline">required under section 314.520 or section
601.42 of title 21, Code of Federal Regulations; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe5613c7f258f4a03bc85ec9ddb7598e0"><enum>(B)</enum><text display-inline="yes-display-inline">otherwise agreed to by the applicant and
the Secretary for such drug.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1e76e12b61e04f5e982060265390988c"><enum>(2)</enum><header display-inline="yes-display-inline">Risk evaluation and mitigation
strategy</header><text display-inline="yes-display-inline">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), (5), and (6) in effect for such drug on the effective date of
this subtitle.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID77a265cc77964a9c8b50e77ee5838f9a"><enum>(3)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">Not later than 30 days after the effective
date of this subtitle, the Secretary shall notify the applicant for each drug
described in paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4B1CF4224A6543258AC0608A457D2C78"><enum>(A)</enum><text display-inline="yes-display-inline">that such drug is deemed to have an
approved risk evaluation and mitigation strategy pursuant to such paragraph;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id68E9A4EE19F748798E55D3BDF03B3E0F"><enum>(B)</enum><text display-inline="yes-display-inline">of the date, which, unless a safety issue
with the drug arises, 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 (7)(B) of such section 505(o), except
with respect to the drug Mifeprex (mifepristone), such assessment shall be
submitted 6 months after the applicant is so notified.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBEA26F666E794486B49BCEFA4735949A"><enum>(4)</enum><header display-inline="yes-display-inline">Enforcement Only after Assessment and
Review</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id92D6E0B9DC034A4FA60FCAAD5FC4CE70"><enum>(c)</enum><header display-inline="yes-display-inline">No effect on veterinary
medicine</header><text display-inline="yes-display-inline">This subtitle, and
the amendments made by this subtitle, shall have no effect on the use of drugs
approved under section 505 of the Federal Food, Drug, and Cosmetic Act by, or
on the lawful written or oral order of, a licensed veterinarian within the
context of a veterinarian-client-patient relationship, as provided for under
section 512(a)(5) of such Act.</text>
</subsection></section></subtitle><subtitle commented="no" id="id98781C81C36246C3A14F53775792C35D" level-type="subsequent" style="OLC"><enum>B</enum><header display-inline="yes-display-inline">Reagan-Udall Foundation for the Food and
Drug Administration</header>
<section commented="no" display-inline="no-display-inline" id="ID0eb90637548f4e0a91127ac4f6071f6f" section-type="subsequent-section"><enum>221.</enum><header display-inline="yes-display-inline">The Reagan-Udall Foundation for the Food
and Drug Administration</header>
<subsection commented="no" display-inline="no-display-inline" id="idC84D76A7984C4147BE1741B3A9CE1054"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Chapter VII of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id7C2F98ABDEDE43F1A377231692B546F8" style="OLC">
<subchapter commented="no" id="id80E3B17EFC994A3DBE5907ED9050E52D" level-type="subsequent"><enum>I</enum><header display-inline="yes-display-inline">Reagan-Udall Foundation for the Food and
Drug Administration</header>
<section commented="no" display-inline="no-display-inline" id="ID5d2f8ef44f4d4a86b0dadee48ac45e2c" section-type="subsequent-section"><enum>770.</enum><header display-inline="yes-display-inline">Establishment and functions of the
Foundation</header>
<subsection commented="no" display-inline="no-display-inline" id="ID2fb32e47797d4a22a48315184e75a8fb"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A nonprofit corporation to be known as the
Reagan-Udall Foundation for the Food and Drug Administration (referred to in
this subchapter as the <quote>Foundation</quote>) shall be established in
accordance with this section. The Foundation shall be headed by an Executive
Director, appointed by the members of the Board of Directors under subsection
(e). The Foundation shall not be an agency or instrumentality of the United
States Government.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID9105c23306d84c3c88f2c965229080cd"><enum>(b)</enum><header display-inline="yes-display-inline">Purpose of Foundation</header><text display-inline="yes-display-inline">The purpose of the Foundation is to advance
the mission of the Food and Drug Administration to modernize medical,
veterinary, food, food ingredient, and cosmetic product development, accelerate
innovation, and enhance product safety.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID40aa674cff8241f3b731402f4bc30490"><enum>(c)</enum><header display-inline="yes-display-inline">Duties of the Foundation</header><text display-inline="yes-display-inline">The Foundation shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID756e180f62dc467ca597ecfbd1717315"><enum>(1)</enum><text display-inline="yes-display-inline">taking into consideration the Critical Path
reports and priorities published by the Food and Drug Administration, identify
unmet needs in the development, manufacture, and evaluation of the safety and
effectiveness, including postapproval, of devices, including diagnostics,
biologics, and drugs, and the safety of food, food ingredients, and
cosmetics;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID905d50c83866436eabea63bdff90a0b9"><enum>(2)</enum><text display-inline="yes-display-inline">establish goals and priorities in order to
meet the unmet needs identified in paragraph (1);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa9c553b5642e4a1ca09987f36d856c90"><enum>(3)</enum><text display-inline="yes-display-inline">in consultation with the Secretary,
identify existing and proposed Federal intramural and extramural research and
development programs relating to the goals and priorities established under
paragraph (2), coordinate Foundation activities with such programs, and
minimize Foundation duplication of existing efforts;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3A108B97B9EE4D0FACAB5981E9311E0E"><enum>(4)</enum><text display-inline="yes-display-inline">award grants to, or enter into contracts,
memoranda of understanding, or cooperative agreements with, scientists and
entities, which may include the Food and Drug Administration, university
consortia, public-private partnerships, institutions of higher education,
entities described in section 501(c)(3) of the Internal Revenue Code (and
exempt from tax under section 501(a) of such Code), and industry, to
efficiently and effectively advance the goals and priorities established under
paragraph (2);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id238ECAEF92F640B4A76E6A182AA0A18D"><enum>(5)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDefd9313360cd4cbf9053047a782c51a4"><enum>(6)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID7e558a6132b14301a6221a4604975ce8"><enum>(7)</enum><text display-inline="yes-display-inline">ensure that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idF89B6BE7BC414BE49725FF92B147AD5A"><enum>(A)</enum><text display-inline="yes-display-inline">action is taken as necessary to obtain
patents for inventions developed by the Foundation or with funds from the
Foundation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEA13757DE8F9453696BC0C020F6E84F2"><enum>(B)</enum><text display-inline="yes-display-inline">action is taken as necessary to enable the
licensing of inventions developed by the Foundation or with funds from the
Foundation; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id17AD56ED51A74FD28536FD4241D644C1"><enum>(C)</enum><text display-inline="yes-display-inline">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 Foundation to further the goals and priorities
established under paragraph (2);</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEED99915F39840D89FFE582E358BF304"><enum>(8)</enum><text display-inline="yes-display-inline">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 and meets the agency's
public health mission;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idCCB23BBEB3344277AC6650549F7B83DB"><enum>(9)</enum><text display-inline="yes-display-inline">conduct annual assessments of the unmet
needs identified in paragraph (1); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEC27189A240745768C53D66A856858D4"><enum>(10)</enum><text display-inline="yes-display-inline">carry out such other activities consistent
with the purposes of the Foundation as the Board determines appropriate.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0dad4278748d445fb72655b24a5c0430"><enum>(d)</enum><header display-inline="yes-display-inline">Board of directors</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID52ded8691a1b4f658bc2cc6176af5f93"><enum>(1)</enum><header display-inline="yes-display-inline">Establishment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID69abf14ee2a44fbbbeee21f3cc69486d"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Foundation 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 commented="no" display-inline="no-display-inline" id="IDb266b4ff751c4061a961e05198221e30"><enum>(B)</enum><header display-inline="yes-display-inline">Ex officio members</header><text display-inline="yes-display-inline">The ex officio members of the Board shall
be the following individuals or their designees:</text>
<clause commented="no" display-inline="no-display-inline" id="IDcf5e8a7d157b4310abb5ba174e83ea39"><enum>(i)</enum><text display-inline="yes-display-inline">The Commissioner.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDd9a0f5ffb2844926941432abae22b587"><enum>(ii)</enum><text display-inline="yes-display-inline">The Director of the National Institutes of
Health.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0FB401BBAFF64CFE88DE5F15C51DCE90"><enum>(iii)</enum><text display-inline="yes-display-inline">The Director of the Centers for Disease
Control and Prevention.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idCBA8B6BDE4584DB0B86A0ABC2D09CBE7"><enum>(iv)</enum><text display-inline="yes-display-inline">The Director of the Agency for Healthcare
Research and Quality.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID82ac93bda1424ee28a4e1305072a15ce"><enum>(C)</enum><header display-inline="yes-display-inline">Appointed members</header>
<clause commented="no" display-inline="no-display-inline" id="id012EC0326380401CA386A1AF84F7D6DB"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The ex officio members of the Board under
subparagraph (B) shall, by majority vote, appoint to the Board 12 individuals,
from a list of candidates to be provided by the National Academy of Sciences.
Of such appointed members—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDff89560da427400787ae3f68182c1db4"><enum>(I)</enum><text display-inline="yes-display-inline">4 shall be representatives of the general
pharmaceutical, device, food, cosmetic, and biotechnology industries;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDd7957b34f02946cf882f72d85c181f38"><enum>(II)</enum><text display-inline="yes-display-inline">3 shall be representatives of academic
research organizations;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDa53d6aebc9ab42b08afa939de34672d0"><enum>(III)</enum><text display-inline="yes-display-inline">2 shall be representatives of Government
agencies, including the Food and Drug Administration and the National
Institutes of Health;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id97D824FD4CBC4BC49DA8C9EED176E8E9"><enum>(IV)</enum><text display-inline="yes-display-inline">2 shall be representatives of patient or
consumer advocacy organizations; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idABB6A251F4B84FC694BB5A541F263A65"><enum>(V)</enum><text display-inline="yes-display-inline">1 shall be a representative of health care
providers.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idE33DB63558994B649B706E5BF169BCA4"><enum>(ii)</enum><header display-inline="yes-display-inline">Requirement</header><text display-inline="yes-display-inline">The ex officio members shall ensure the
Board membership includes individuals with expertise in areas including the
sciences of developing, manufacturing, and evaluating the safety and
effectiveness of devices, including diagnostics, biologics, and drugs, and the
safety of food, food ingredients, and cosmetics.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDBFD8DEED15004514A1531307916F5F2D"><enum>(D)</enum><header display-inline="yes-display-inline">Initial meeting</header>
<clause commented="no" display-inline="no-display-inline" id="id3AF6F977EE6140FEA0B321BA36B25F8A"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="id552C5BB8682D413FB9285ECA20E39F49"><enum>(I)</enum><text display-inline="yes-display-inline">incorporate the Foundation; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idD1EBA39F71C7466CA0224FED7D704BC7"><enum>(II)</enum><text display-inline="yes-display-inline">appoint the members of the Board in
accordance with subparagraph (C).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id637E6C4D630E4FABA3D3621516ACC671"><enum>(ii)</enum><header display-inline="yes-display-inline">Service of ex officio members</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID1388d4bc46c5469f820105fccd30ff67"><enum>(iii)</enum><header display-inline="yes-display-inline">Chair</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idC4054B128BBC460CA6E720977A0CA7C2"><enum>(2)</enum><header display-inline="yes-display-inline">Duties of board</header><text display-inline="yes-display-inline">The Board shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDae2c0409babc40fe87b17f002e79aaa7"><enum>(A)</enum><text display-inline="yes-display-inline">establish bylaws for the Foundation
that—</text>
<clause commented="no" display-inline="no-display-inline" id="ID8e766d265b5e47c88e861757c2e2ac79"><enum>(i)</enum><text display-inline="yes-display-inline">are published in the Federal Register and
available for public comment;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID95d1a7cdec1c464d9c65e1c2a5ce61b2"><enum>(ii)</enum><text display-inline="yes-display-inline">establish policies for the selection of the
officers, employees, agents, and contractors of the Foundation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID881b9b3947bf417e8cdbbaf2e5000115"><enum>(iii)</enum><text display-inline="yes-display-inline">establish policies, including ethical
standards, for the acceptance, solicitation, and disposition of donations and
grants to the Foundation and for the disposition of the assets of the
Foundation, including appropriate limits on the ability of donors to designate,
by stipulation or restriction, the use or recipient of donated funds;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID3ed870a73ae24df3901f76acabccc642"><enum>(iv)</enum><text display-inline="yes-display-inline">establish policies that would subject all
employees, fellows, and trainees of the Foundation to the conflict of interest
standards under <external-xref legal-doc="usc" parsable-cite="usc/18/208">section 208</external-xref> of title 18, United States Code;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID6c7aaf673f504d559bacfdac242b6abf"><enum>(v)</enum><text display-inline="yes-display-inline">establish licensing, distribution, and
publication policies that support the widest and least restrictive use by the
public of information and inventions developed by the Foundation or with
Foundation funds to carry out the duties described in paragraphs (6) and (7) of
subsection (c), and may include charging cost-based fees for published material
produced by the Foundation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDb39ece3ba068477ea9fc9ae6eb4238c4"><enum>(vi)</enum><text display-inline="yes-display-inline">specify principles for the review of
proposals and awarding of grants and contracts that include peer review and
that are consistent with those of the Foundation for the National Institutes of
Health, to the extent determined practicable and appropriate by the
Board;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDefa095c28e41402ca1bfb091bc93559f"><enum>(vii)</enum><text display-inline="yes-display-inline">specify a cap on administrative expenses
for recipients of a grant, contract, or cooperative agreement from the
Foundation;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDf13bdf22877d4c07bb5da535913426f1"><enum>(viii)</enum><text display-inline="yes-display-inline">establish policies for the execution of
memoranda of understanding and cooperative agreements between the Foundation
and other entities, including the Food and Drug Administration;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID62628c7a12724ff19b4b3ecb303693b0"><enum>(ix)</enum><text display-inline="yes-display-inline">establish policies for funding training
fellowships, whether at the Foundation, academic or scientific institutions, or
the Food and Drug Administration, for scientists, doctors, and other
professionals who are not employees of regulated industry, to foster greater
understanding of and expertise in new scientific tools, diagnostics,
manufacturing techniques, and potential barriers to translating basic research
into clinical and regulatory practice;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID9cb0db97cf8541e999cc42d3d1235604"><enum>(x)</enum><text display-inline="yes-display-inline">specify a process for annual Board review
of the operations of the Foundation; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDf948659e4dfd4de8804c08d75f183df8"><enum>(xi)</enum><text display-inline="yes-display-inline">establish specific duties of the Executive
Director;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDcebf87e921264edcadf31fdcc8cc2f9f"><enum>(B)</enum><text display-inline="yes-display-inline">prioritize and provide overall direction to
the activities of the Foundation;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID31049838f07d432480fdaf5e62704b7e"><enum>(C)</enum><text display-inline="yes-display-inline">evaluate the performance of the Executive
Director; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc2e7208a9a5943a3aef06b26e7f8f611"><enum>(D)</enum><text display-inline="yes-display-inline">carry out any other necessary activities
regarding the functioning of the Foundation.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID03792ecfbd614d188200cbc93a5fddd8"><enum>(3)</enum><header display-inline="yes-display-inline">Terms and vacancies</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID82d8d837a486404ea802bafcf04c23bf"><enum>(A)</enum><header display-inline="yes-display-inline">Term</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDe01afaff6cd04704bd70daaa235f977e"><enum>(B)</enum><header display-inline="yes-display-inline">Vacancy</header><text display-inline="yes-display-inline">Any vacancy in the membership of the
Board—</text>
<clause commented="no" display-inline="no-display-inline" id="id0744ECACD83C4419B593C6A6A9D671F3"><enum>(i)</enum><text display-inline="yes-display-inline">shall not affect the power of the remaining
members to execute the duties of the Board; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id18D5D463CD874501BA47272F4D508A39"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be filled by appointment by the
appointed members described in paragraph (1)(C) by majority vote.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID90148d3a007347459166701485656ba6"><enum>(C)</enum><header display-inline="yes-display-inline">Partial term</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID807df6efe585419eb7320200cf5835fd"><enum>(D)</enum><header display-inline="yes-display-inline">Serving past term</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="IDe43d5793a8a248a7b417e49b5c0e980a"><enum>(4)</enum><header display-inline="yes-display-inline">Compensation</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID79E30121D7474CF6A48C20F90B65442A"><enum>(e)</enum><header display-inline="yes-display-inline">Incorporation</header><text display-inline="yes-display-inline">The ex officio members of the Board shall
serve as incorporators and shall take whatever actions necessary to incorporate
the Foundation.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDE5356B78CDD5400EA370B59AB319AD3B"><enum>(f)</enum><header display-inline="yes-display-inline">Nonprofit status</header><text display-inline="yes-display-inline">The Foundation shall be considered to be a
corporation under <external-xref legal-doc="usc" parsable-cite="usc/26/501">section 501(c)</external-xref> of the Internal Revenue Code of 1986, and
shall be subject to the provisions of such section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID7ca1d1d90584491f9f2607ecd0e07811"><enum>(g)</enum><header display-inline="yes-display-inline">Executive Director</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID3af75d1ad3c74866863ff22d70631c79"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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 Foundation and shall
have such specific duties and responsibilities as the Board shall
prescribe.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID0226b8a095834702b8600bbc9aa28b4d"><enum>(2)</enum><header display-inline="yes-display-inline">Compensation</header><text display-inline="yes-display-inline">The compensation of the Executive Director
shall be fixed by the Board but shall not be greater than the compensation of
the Commissioner.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDef448985e1a547108899a9298a9a5b12"><enum>(h)</enum><header display-inline="yes-display-inline">Administrative powers</header><text display-inline="yes-display-inline">In carrying out this subchapter, the Board,
acting through the Executive Director, may—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id3D888A0767AD4E838710A012C8706E4B"><enum>(1)</enum><text display-inline="yes-display-inline">adopt, alter, and use a corporate seal,
which shall be judicially noticed;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe1fd682b49df4bfaa50750fc4298b815"><enum>(2)</enum><text display-inline="yes-display-inline">hire, promote, compensate, and discharge 1
or more officers, employees, and agents, as may be necessary, and define their
duties;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4666cb7a29634b36bc353370ab98d3d9"><enum>(3)</enum><text display-inline="yes-display-inline">prescribe the manner in which—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID72a75c99eaef4665af6589f041bf1f68"><enum>(A)</enum><text display-inline="yes-display-inline">real or personal property of the Foundation
is acquired, held, and transferred;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID59cd004ba5f1407ca9962e4067f1f1c6"><enum>(B)</enum><text display-inline="yes-display-inline">general operations of the Foundation are to
be conducted; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDbc019f4e2ffe49248f35346bef499045"><enum>(C)</enum><text display-inline="yes-display-inline">the privileges granted to the Board by law
are exercised and enjoyed;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID259b27e0422345658cf71f48b9d5b2ea"><enum>(4)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID9485fbbdc5cc4722915df3bd17613530"><enum>(5)</enum><text display-inline="yes-display-inline">enter into contracts with public and
private organizations for the writing, editing, printing, and publishing of
books and other material;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID43023703e4f34da49b2c129d1521cf86"><enum>(6)</enum><text display-inline="yes-display-inline">hold, administer, invest, and spend any
gift, devise, or bequest of real or personal property made to the Foundation
under subsection (i);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4fb7d725da8e47f8b61c6ee49716f12e"><enum>(7)</enum><text display-inline="yes-display-inline">enter into such other contracts, leases,
cooperative agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4035cc79a14241deab2215c14e25cbcb"><enum>(8)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="ID2d3be665883e46789485a006fc4e6b0b"><enum>(9)</enum><text display-inline="yes-display-inline">take such action as may be necessary to
obtain patents and licenses for devices and procedures developed by the
Foundation and its employees;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDbf48808a88354cff9ff2ae24c5a4d5dc"><enum>(10)</enum><text display-inline="yes-display-inline">sue and be sued in its corporate name, and
complain and defend in courts of competent jurisdiction;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID6e738c7e4ef24a6aaeb0c6f24203d54b"><enum>(11)</enum><text display-inline="yes-display-inline">appoint other groups of advisors as may be
determined necessary to carry out the functions of the Foundation; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc88976403bfe4e86b65096ade2076766"><enum>(12)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id0627B60CDFAB443A8086230630C41B80"><enum>(i)</enum><header display-inline="yes-display-inline">Acceptance of funds from other
sources</header><text display-inline="yes-display-inline">The Executive
Director may solicit and accept on behalf of the Foundation, any funds, gifts,
grants, devises, or bequests of real or personal property made to the
Foundation, including from private entities, for the purposes of carrying out
the duties of the Foundation.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idE51B58E0D90349DE9B3E50983C37CA8D"><enum>(j)</enum><header display-inline="yes-display-inline">Service of Federal employees</header><text display-inline="yes-display-inline">Federal Government employees may serve on
committees advisory to the Foundation and otherwise cooperate with and assist
the Foundation in carrying out its functions, so long as such employees do not
direct or control Foundation activities.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idAC7EF3F3E84749F093A59DB0BBFE6619"><enum>(k)</enum><header display-inline="yes-display-inline">Detail of government employees;
Fellowships</header>
<paragraph commented="no" display-inline="no-display-inline" id="id4CAF5DEF62F1490797C079124D6225FE"><enum>(1)</enum><header display-inline="yes-display-inline">Detail from Federal agencies</header><text display-inline="yes-display-inline">Federal Government employees may be
detailed from Federal agencies with or without reimbursement to those agencies
to the Foundation 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
Foundation.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id464B51E84B064BA690D7F63A3F08E18F"><enum>(2)</enum><header display-inline="yes-display-inline">Voluntary service; acceptance of Federal
employees</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id48521B46C55541B7975D4E540E087EBC"><enum>(A)</enum><header display-inline="yes-display-inline">Foundation</header><text display-inline="yes-display-inline">The Executive Director of the Foundation
may accept the services of employees detailed from Federal agencies with or
without reimbursement to those agencies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id25EA3BB63D5C49EE93852DCE01CADA57"><enum>(B)</enum><header display-inline="yes-display-inline">Food and Drug Administration</header><text display-inline="yes-display-inline">The Commissioner may accept the
uncompensated services of Foundation fellows or trainees. Such services shall
be considered to be undertaking an activity under contract with the Secretary
as described in section 708.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id7A0623E998CA404D97FB0BADF28A8AF0"><enum>(l)</enum><header display-inline="yes-display-inline">Annual reports</header>
<paragraph commented="no" display-inline="no-display-inline" id="idC472A69D59C740BC9E372B7DBEDAB874"><enum>(1)</enum><header display-inline="yes-display-inline">Reports to Foundation</header><text display-inline="yes-display-inline">Any recipient of a grant, contract,
fellowship, memorandum of understanding, or cooperative agreement from the
Foundation under this section shall submit to the Foundation a report on an
annual basis for the duration of such grant, contract, fellowship, memorandum
of understanding, or cooperative agreement, that describes the activities
carried out under such grant, contract, fellowship, memorandum of
understanding, or cooperative agreement.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD7A155A868494463A2C13B3727A4B67F"><enum>(2)</enum><header display-inline="yes-display-inline">Report to Congress and the
FDA</header><text display-inline="yes-display-inline">Beginning with fiscal
year 2009, the Executive Director shall submit to Congress and the Commissioner
an annual report that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID05b2fe973a094ac3acfebfba3e2f4679"><enum>(A)</enum><text display-inline="yes-display-inline">describes the activities of the Foundation
and the progress of the Foundation in furthering the goals and priorities
established under subsection (c)(2), including the practical impact of the
Foundation on regulated product development;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDbeaea64c76e346329f52675ead48f03a"><enum>(B)</enum><text display-inline="yes-display-inline">provides a specific accounting of the
source and use of all funds used by the Foundation to carry out such
activities; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7a4555db7e84467c9300101868c696ed"><enum>(C)</enum><text display-inline="yes-display-inline">provides information on how the results of
Foundation activities could be incorporated into the regulatory and product
review activities of the Food and Drug Administration.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id19F3189C5FB34F3CAB80812E4574EFE3"><enum>(m)</enum><header display-inline="yes-display-inline">Separation of funds</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id96E27B5F83314E49BFF51619E980B0DB"><enum>(n)</enum><header display-inline="yes-display-inline">Funding</header><text display-inline="yes-display-inline">From amounts appropriated to the Food and
Drug Administration for each fiscal year, the Commissioner shall transfer not
less than $500,000 and not more than $1,250,000, to the Foundation to carry out
subsections (a), (b), and (d) through
(m).</text>
</subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID41bd91d5d3384cf6a621522e9229198e"><enum>(b)</enum><header display-inline="yes-display-inline">Other Foundation provisions</header><text display-inline="yes-display-inline">Chapter VII (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>) (as
amended by subsection (a)) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id5B81EC0708B8400485DB92818AC2BD7B" style="OLC">
<section commented="no" display-inline="no-display-inline" id="IDd6b82541c38e4303a5556cd233d76382" section-type="subsequent-section"><enum>771.</enum><header display-inline="yes-display-inline">Location of Foundation</header><text display-inline="no-display-inline">The Foundation shall, if practicable, be
located not more than 20 miles from the District of Columbia.</text>
</section><section commented="no" display-inline="no-display-inline" id="id40A981DAA2324131B6FCFA3DDEE56E5A" section-type="subsequent-section"><enum>772.</enum><header display-inline="yes-display-inline">Activities of the Food and Drug
Administration</header>
<subsection commented="no" display-inline="no-display-inline" id="id788D96523AD044C4992A27288875FFF9"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Commissioner shall receive and assess
the report submitted to the Commissioner by the Executive Director of the
Foundation under section 770(l)(2).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id72D872A4B963442BADC21046A19C1935"><enum>(b)</enum><header display-inline="yes-display-inline">Report to Congress</header><text display-inline="yes-display-inline">Beginning with fiscal year 2009, the
Commissioner shall submit to Congress an annual report summarizing the
incorporation of the information provided by the Foundation in the report
described under section 770(l)(2) and by other recipients of grants, contracts,
memoranda of understanding, or cooperative agreements into regulatory and
product review activities of the Food and Drug Administration.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID70dc830b050f416d8fdc036b88f0080b"><enum>(c)</enum><header display-inline="yes-display-inline">Extramural grants</header><text display-inline="yes-display-inline">The provisions of this subchapter shall
have no effect on any grant, contract, memorandum of understanding, or
cooperative agreement between the Food and Drug Administration and any other
entity entered into before, on, or after the date of enactment of the Enhancing
Drug Safety and Innovation Act of
2007.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id9D5203DAB77941CF925FA15263A36DF2"><enum>(c)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 742(b) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379l">21 U.S.C. 379l(b)</external-xref>) is amended by adding at the end the
following: <quote>Any such fellowships and training programs under this section
or under section 770(d)(2)(A)(ix) may include provision by such scientists and
physicians of services on a voluntary and uncompensated basis, as the Secretary
determines appropriate. Such scientists and physicians shall be subject to all
legal and ethical requirements otherwise applicable to officers or employees of
the Department of Health and Human Services.</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="idF9C27D7AD46940E4B454166D7E57CA4F" section-type="subsequent-section"><enum>222.</enum><header display-inline="yes-display-inline">Office of the Chief Scientist</header><text display-inline="no-display-inline">Chapter IX of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/391">21 U.S.C. 391 et seq.</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id0745E9B2F86B42F0BD6F4CD7C83CCF54" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id08BD1E4EB23D4380AE534B42F11DE577" section-type="subsequent-section"><enum>910.</enum><header display-inline="yes-display-inline">Office of the chief scientist</header>
<subsection commented="no" display-inline="no-display-inline" id="IDde55def064f644e28b2a47e023b1e569"><enum>(a)</enum><header display-inline="yes-display-inline">Establishment; appointment</header><text display-inline="yes-display-inline">The Secretary shall establish within the
Office of the Commissioner an office to be known as the Office of the Chief
Scientist. The Secretary shall appoint a Chief Scientist to lead such
Office.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idF8C449AA78CA4AD68381B692C886E2F3"><enum>(b)</enum><header display-inline="yes-display-inline">Duties of the Office</header><text display-inline="yes-display-inline">The Office of the Chief Scientist
shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID983ab1b580b24719a31e0fe95552556a"><enum>(1)</enum><text display-inline="yes-display-inline">oversee, coordinate, and ensure quality and
regulatory focus of the intramural research programs of the Food and Drug
Administration;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDfd6854cd874546879fdcc7c5a1e7d2a1"><enum>(2)</enum><text display-inline="yes-display-inline">track and, to the extent necessary,
coordinate intramural research awards made by each center of the Administration
or science-based office within the Office of the Commissioner, and ensure that
there is no duplication of research efforts supported by the Reagan-Udall
Foundation for the Food and Drug Administration;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID106803f6f576454cb547ce326eba8458"><enum>(3)</enum><text display-inline="yes-display-inline">develop and advocate for a budget to
support intramural research;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID06bede8e8cea481bbb7e0d3410b398b0"><enum>(4)</enum><text display-inline="yes-display-inline">develop a peer review process by which
intramural research can be evaluated; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID42fa5f2d7fab4093955391a1508c6ede"><enum>(5)</enum><text display-inline="yes-display-inline">identify and solicit intramural research
proposals from across the Food and Drug Administration through an advisory
board composed of employees of the Administration that shall include—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID1f137beca793454bb4bc5b0e5e064d0b"><enum>(A)</enum><text display-inline="yes-display-inline">representatives of each of the centers and
the science-based offices within the Office of the Commissioner; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0fafd67b5af34270a6da352a0d9d3627"><enum>(B)</enum><text display-inline="yes-display-inline">experts on trial design, epidemiology,
demographics, pharmacovigilance, basic science, and public
health.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle commented="no" id="idF7C27CA90AA742ACAD3325323E2CCDE3" level-type="subsequent" style="OLC"><enum>C</enum><header display-inline="yes-display-inline">Clinical trials</header>
<section commented="no" display-inline="no-display-inline" id="idEFD8887C660743D6973B6DA383036069" section-type="subsequent-section"><enum>231.</enum><header display-inline="yes-display-inline">Expanded clinical trial registry data
bank</header>
<subsection commented="no" display-inline="no-display-inline" id="id4DAB89F9A38A4DEAABDB37F9F6834CFE"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 402 of the Public Health Service
Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282</external-xref>) is amended by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id13C99183BC5246E78F17AE454A634A1B"><enum>(1)</enum><text display-inline="yes-display-inline">redesignating subsections (j) and (k) as
subsections (k) and (l), respectively; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF280282EE967425D92EF10F2B362FF52"><enum>(2)</enum><text display-inline="yes-display-inline">inserting after subsection (i) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idC27E38658BCE4B4A8729A3EBEE4A8934" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id28846695FF3F4B2AB5350604E9337968"><enum>(j)</enum><header display-inline="yes-display-inline">Expanded clinical trial registry data
bank</header>
<paragraph commented="no" display-inline="no-display-inline" id="id925EA086AC5143B3B9B081049FF4B45F"><enum>(1)</enum><header display-inline="yes-display-inline">Definitions; requirement</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idC36800BC1DBF42FA8B1F834BAD681E9C"><enum>(A)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this subsection:</text>
<clause commented="no" display-inline="no-display-inline" id="id3B0413EF47FC4E23954E85887C0F7512"><enum>(i)</enum><header display-inline="yes-display-inline">applicable device clinical
trial</header><text display-inline="yes-display-inline">The term
<quote>applicable device clinical trial</quote> means—</text>
<subclause commented="no" display-inline="no-display-inline" id="idC965701BC36B4ADB914B71BACBF3E0ED"><enum>(I)</enum><text display-inline="yes-display-inline">a prospective study of health outcomes
comparing an intervention against a control in human subjects intended to
support an application under section 515 or 520(m), or a report under section
510(k), of the Federal Food, Drug, and Cosmetic Act (other than a limited study
to gather essential information used to refine the device or design a pivotal
trial and that is not intended to determine safety and effectiveness of a
device); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id22638216ADC4409CBFFC8D8B3C461F75"><enum>(II)</enum><text display-inline="yes-display-inline">a pediatric postmarket surveillance as
required under section 522 of the Federal Food, Drug, and Cosmetic Act.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id66BADF1D76BE4627B2196C25E35296E7"><enum>(ii)</enum><header display-inline="yes-display-inline">Applicable drug clinical trial</header>
<subclause commented="no" display-inline="no-display-inline" id="id02914691F7D74CD0AFBBA9FE5780E4E4"><enum>(I)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The term <term>applicable drug clinical
trial</term> means a controlled clinical investigation, other than a phase I
clinical investigation, of a product subject to section 505 of the Federal
Food, Drug, and Cosmetic Act or to section 351 of this Act.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idC9A5D2327FA54040BC2E132FDAD78B17"><enum>(II)</enum><header display-inline="yes-display-inline">Clinical investigation</header><text display-inline="yes-display-inline">For purposes of subclause (I), the term
<quote>clinical investigation</quote> has the meaning given that term in
<external-xref legal-doc="regulation" parsable-cite="cfr/21/312.3">section 312.3</external-xref> of title 21, Code of Federal Regulations.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id794A4CBE5179483FB38EF0A2AC579669"><enum>(III)</enum><header display-inline="yes-display-inline">Phase I</header><text display-inline="yes-display-inline">The term <term>phase I</term> has the
meaning given that term in <external-xref legal-doc="usc" parsable-cite="usc/21/312">section 312.21</external-xref> of title 21, Code of Federal
Regulations.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id0CB5AD83644345F1AAC0688A1F2EB0BE"><enum>(iii)</enum><header display-inline="yes-display-inline">Clinical trial information</header><text display-inline="yes-display-inline">The term <term>clinical trial
information</term> means those data elements that are necessary to complete an
entry in the clinical trial registry data bank under paragraph (2).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id155072CDA44B481684797E7022AE0446"><enum>(iv)</enum><header display-inline="yes-display-inline">Completion date</header><text display-inline="yes-display-inline">The term <term>completion date</term>
means, with respect to an applicable drug clinical trial or an applicable
device 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 commented="no" display-inline="no-display-inline" id="idCD1F0EEC0E0042889DD8739F8097DA46"><enum>(v)</enum><header display-inline="yes-display-inline">Device</header><text display-inline="yes-display-inline">The term <term>device</term> means a device
as defined in section 201(h) of the Federal Food, Drug, and Cosmetic
Act.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idEB9B054467654B419C9E2DA5968E1DD8"><enum>(vi)</enum><header display-inline="yes-display-inline">Drug</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id0B0613422E434FE2ACB6B35AF59A55AF"><enum>(vii)</enum><header display-inline="yes-display-inline">Responsible party</header><text display-inline="yes-display-inline">The term <term>responsible party</term>,
with respect to a clinical trial of a drug or device, means—</text>
<subclause commented="no" display-inline="no-display-inline" id="idBAB77DF336A149B989FC9C219211FCC9"><enum>(I)</enum><text display-inline="yes-display-inline">the sponsor of the clinical trial (as
defined in <external-xref legal-doc="regulation" parsable-cite="cfr/21/50.3">section 50.3</external-xref> of title 21, Code of Federal Regulations (or any
successor regulations)) or the principal investigator of such clinical trial if
so designated by such sponsor; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id8DF37A8E323349E3AAB4108DC54C38F5"><enum>(II)</enum><text display-inline="yes-display-inline">if no sponsor exists, the grantee,
contractor, or awardee for a trial funded by a Federal agency or the principal
investigator of such clinical trial if so designated by such grantee,
contractor, or awardee.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8DA86750221C4548B7A05B6C1B61FDAB"><enum>(B)</enum><header display-inline="yes-display-inline">Requirement</header><text display-inline="yes-display-inline">The Secretary shall develop a mechanism by
which—</text>
<clause commented="no" display-inline="no-display-inline" id="idF00F770241334AE2814D6934173DD65A"><enum>(i)</enum><text display-inline="yes-display-inline">the responsible party for each applicable
drug clinical trial and applicable device 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 commented="no" display-inline="no-display-inline" id="idA3AFEE956D854FEB8867A39A8CF64454"><enum>(ii)</enum><text display-inline="yes-display-inline">other Federal agencies may identify the
responsible party for an applicable drug clinical trial or applicable device
clinical trial.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id231FEAF54E584E4CA5D5A518E85251C9"><enum>(2)</enum><header display-inline="yes-display-inline">Expansion of clinical trial registry data
bank with respect to clinical trial information</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idA1139C39DB06401F94437A93D0B8478D"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header>
<clause commented="no" display-inline="no-display-inline" id="id2F7862720A9B4FEDA77885CF4B4DC749"><enum>(i)</enum><header display-inline="yes-display-inline">Expansion of data bank</header><text display-inline="yes-display-inline">To enhance patient enrollment and provide a
mechanism to track subsequent progress of clinical trials, the Secretary,
acting through the Director of NIH, shall expand, in accordance with this
subsection, the clinical trials registry of the data bank described under
subsection (i)(3)(A) (referred to in this subsection as the <quote>registry
data bank</quote>). The Director of NIH shall ensure that the registry data
bank is made publicly available through the Internet.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID9813901cbaef4468893e46009cd551c3"><enum>(ii)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of the Enhancing Drug Safety and Innovation Act of 2007, and after
notice and comment, the Secretary shall promulgate regulations to expand the
registry data bank to require the submission to the registry data bank of
clinical trial information for applicable drug clinical trials and applicable
device clinical trials that—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID62a60d3c4876463e98543d3e847a9615"><enum>(I)</enum><text display-inline="yes-display-inline">conforms to the International Clinical
Trials Registry Platform trial registration data set of the World Health
Organization;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id7D5C924C7EB14F71909F34741F1597A0"><enum>(II)</enum><text display-inline="yes-display-inline">includes the city, State, and zip code for
each clinical trial location, or a toll-free number through which such location
information may be accessed;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3eb6995274084a689785e61ca40e61cc"><enum>(III)</enum><text display-inline="yes-display-inline">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;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id2D793EC540C44505A7B4FE3D83688EF7"><enum>(IV)</enum><text display-inline="yes-display-inline">requires the inclusion of such other data
elements to the registry data bank as appropriate; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id630F96E72293442D91749BDECBFCC52D"><enum>(V)</enum><text display-inline="yes-display-inline">becomes effective 90 days after issuance of
the final rule.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id16FF02CA450646B59BE1233136D18074"><enum>(B)</enum><header display-inline="yes-display-inline">Format and structure</header>
<clause commented="no" display-inline="no-display-inline" id="idD49524E75F554DAA8420A8383F2C56F5"><enum>(i)</enum><header display-inline="yes-display-inline">Searchable categories</header><text display-inline="yes-display-inline">The Director of NIH shall ensure that the
public may search the entries in the registry data bank by 1 or more of the
following criteria:</text>
<subclause commented="no" display-inline="no-display-inline" id="id59D34172AD7243FDA93F0ECBCA3B5629"><enum>(I)</enum><text display-inline="yes-display-inline">The disease or condition being studied in
the clinical trial, using Medical Subject Headers (MeSH) descriptors.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idFF78867FAA544869B9BD0D288122CE2C"><enum>(II)</enum><text display-inline="yes-display-inline">The treatment being studied in the clinical
trial.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id6B5478EBC26D402CACD8D5B05085C7DC"><enum>(III)</enum><text display-inline="yes-display-inline">The location of the clinical trial.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id9C01FE454163498EB1CCCF41E6F9CC77"><enum>(IV)</enum><text display-inline="yes-display-inline">The age group studied in the clinical
trial, including pediatric subpopulations.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idF95C7BC4E9A342129C706CAC0AE053E3"><enum>(V)</enum><text display-inline="yes-display-inline">The study phase of the clinical
trial.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id263F2287F4C84319B3E64EE8267C6642"><enum>(VI)</enum><text display-inline="yes-display-inline">The source of support for the clinical
trial, which may be the National Institutes of Health or other Federal agency,
a private industry source, or a university or other organization.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id3D8B39C9659C4BF78857EA115BB7FCAD"><enum>(VII)</enum><text display-inline="yes-display-inline">The recruitment status of the clinical
trial.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id903FD636DDDC46B989EEB5CA087F770D"><enum>(VIII)</enum><text display-inline="yes-display-inline">The National Clinical Trial number or other
study identification for the clinical trial.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDa5036e66a8d24a61b193acd2b662a70e"><enum>(ii)</enum><header display-inline="yes-display-inline">Format</header><text display-inline="yes-display-inline">The Director of the NIH shall ensure that
the registry data bank is easily used by the public, and that entries are
easily compared.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id69BA85FCA1FF4A95948F15ABA003898E"><enum>(C)</enum><header display-inline="yes-display-inline">Data submission</header><text display-inline="yes-display-inline">The responsible party for an applicable
drug clinical trial shall submit to the Director of NIH for inclusion in the
registry data bank the clinical trial information described in subparagraph
(A)(ii).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFB516B4152EA4448BDB53B045D250824"><enum>(D)</enum><header display-inline="yes-display-inline">Truthful clinical trial
information</header>
<clause commented="no" display-inline="no-display-inline" id="idBF2E0A5D13AE43F5A15DC80347ABD166"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The clinical trial information submitted by
a responsible party under this paragraph shall not be false or misleading in
any particular.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id1EC0225865EB4EDDBF6C35B3F83F53F2"><enum>(ii)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">Clause (i) shall not have the effect of
requiring clinical trial information with respect to an applicable drug
clinical trial or an applicable device clinical trial to include information
from any source other than such clinical trial involved.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3842A65A51244FAD944564BE34AD478F"><enum>(E)</enum><header display-inline="yes-display-inline">Changes in clinical trial status</header>
<clause commented="no" display-inline="no-display-inline" id="IDb3839a7360524aedb507b457b0bfef32"><enum>(i)</enum><header display-inline="yes-display-inline">Enrollment</header><text display-inline="yes-display-inline">The responsible party for an applicable
drug clinical trial or an applicable device clinical trial shall update the
enrollment status not later than 30 days after the enrollment status of such
clinical trial changes.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA8A7E6614B8D423F800C96C0D6CEA8A0"><enum>(ii)</enum><header display-inline="yes-display-inline">Completion</header><text display-inline="yes-display-inline">The responsible party for an applicable
drug clinical trial or applicable device 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 commented="no" display-inline="no-display-inline" id="idAA6B2FD0213F4756A0DEEBC8D8FFCAEF"><enum>(F)</enum><header display-inline="yes-display-inline">Timing of submission</header><text display-inline="yes-display-inline">The clinical trial information for an
applicable drug clinical trial or an applicable device clinical trial required
to be submitted under this paragraph shall be submitted not later than 21 days
after the first patient is enrolled in such clinical trial.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA3BDB82680484E05A2E8B289B534C2B7"><enum>(G)</enum><header display-inline="yes-display-inline">Posting of data</header>
<clause commented="no" display-inline="no-display-inline" id="id7B25A94798AE455E86FD7C994096C262"><enum>(i)</enum><header display-inline="yes-display-inline">applicable drug clinical
trial</header><text display-inline="yes-display-inline">The Director of NIH
shall ensure that clinical trial information for an applicable drug clinical
trial submitted in accordance with this paragraph is posted publicly within 30
days of such submission.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id38466B758EF4444691D9C98F8498C81C"><enum>(ii)</enum><header display-inline="yes-display-inline">applicable device clinical
trial</header><text display-inline="yes-display-inline">The Director of NIH
shall ensure that clinical trial information for an applicable device clinical
trial submitted in accordance with this paragraph is posted publicly within 30
days of clearance under section 510(k) of the Federal Food, Drug, and Cosmetic
Act, or approval under section 515 or section 520(m) of such Act, as
applicable.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2994049D932F48F3B60519D73863F23D"><enum>(H)</enum><header display-inline="yes-display-inline">Voluntary submissions</header><text display-inline="yes-display-inline">A responsible party for a clinical trial
that is not an applicable drug clinical trial or an applicable device clinical
trial may submit clinical trial information to the registry data bank in
accordance with this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF2276BE39C83450799DFCD36A916E975"><enum>(3)</enum><header display-inline="yes-display-inline">Expansion of registry data bank to include
results of clinical trials</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idABD0DFBB0EB84742B0B010ABB63AD0A7"><enum>(A)</enum><header display-inline="yes-display-inline">Linking registry data bank to existing
results</header>
<clause commented="no" display-inline="no-display-inline" id="id3FCE7663E6224A38ABE9539FA659D47A"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning not later than 90 days after the
date of enactment of the Enhancing Drug Safety and Innovation Act of 2007, for
those clinical trials that form the primary basis of an efficacy claim or are
conducted after the drug involved is approved or after the device involved is
cleared or approved, the Secretary shall ensure that the registry data bank
includes links to results information for such clinical trial—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID98271e482b5d4718af3a617d07f6b151"><enum>(I)</enum><text display-inline="yes-display-inline">not earlier than 30 days after the date of
the approval of the drug involved or clearance or approval of the device
involved; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDdd1ec3f21026460194dff888b1990993"><enum>(II)</enum><text display-inline="yes-display-inline">not later than 30 days after such
information becomes publicly available, as applicable.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDb0169a9ace5f4b2eba5cebabaec4a171"><enum>(ii)</enum><header display-inline="yes-display-inline">Required information</header>
<subclause commented="no" display-inline="no-display-inline" id="id0B83F42218FA4AC58C75BAAD64A58017"><enum>(I)</enum><header display-inline="yes-display-inline">FDA information</header><text display-inline="yes-display-inline">The Secretary shall ensure that the
registry data bank includes links to the following information:</text>
<item commented="no" display-inline="no-display-inline" id="idB4CBAC6246484B75A8ECA5DB76987660"><enum>(aa)</enum><text display-inline="yes-display-inline">If an advisory committee considered at a
meeting an applicable drug clinical trial or an applicable device clinical
trial, any posted Food and Drug Administration summary document regarding such
applicable drug clinical trial or applicable clinical device trial.</text>
</item><item commented="no" display-inline="no-display-inline" id="id2A6A6A409A2F4462B47992A4E333ED2C"><enum>(bb)</enum><text display-inline="yes-display-inline">If an applicable drug clinical trial was
conducted under section 505A or 505B of the Federal Food, Drug, and Cosmetic
Act, a link to the posted Food and Drug Administration assessment of the
results of such trial.</text>
</item><item commented="no" display-inline="no-display-inline" id="idA3F7311BD82343F48ED2C1084E4DC2E8"><enum>(cc)</enum><text display-inline="yes-display-inline">Food and Drug Administration public health
advisories regarding the drug or device that is the subject of the applicable
drug clinical trial or applicable device clinical trial, respectively, if
any.</text>
</item><item commented="no" display-inline="no-display-inline" id="IDf939a0f3f1bc4cd9b13517df4d88eb2d"><enum>(dd)</enum><text display-inline="yes-display-inline">For an applicable drug clinical trial, the
Food and Drug Administration action package for approval document required
under section 505(l)(2) of the Food Drug and Cosmetic Act.</text>
</item><item commented="no" display-inline="no-display-inline" id="id47ADE86C23854D21B477FEA41252F5D6"><enum>(ee)</enum><text display-inline="yes-display-inline">For an applicable device clinical trial, in
the case of a premarket application, the detailed summary of information
respecting the safety and effectiveness of the device required under section
520(h)(1) of the Federal Food, Drug, and Cosmetic Act, or, in the case of a
report under section 510(k) of such Act, the section 510(k) summary of the
safety and effectiveness data required under <external-xref legal-doc="usc" parsable-cite="usc/21/807">section 807.95(d)</external-xref> of title 21,
Code of Federal Regulations (or any successor regulations).</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="id0A176BC25ED942A9A6D7D208551F6317"><enum>(II)</enum><header display-inline="yes-display-inline">NIH information</header><text display-inline="yes-display-inline">The Secretary shall ensure that the
registry data bank includes links to the following information:</text>
<item commented="no" display-inline="no-display-inline" id="id3B001538D2724D5C9C3147A63560C488"><enum>(aa)</enum><text display-inline="yes-display-inline">Medline citations to any publications
regarding each applicable drug clinical trial and applicable device clinical
trial.</text>
</item><item commented="no" display-inline="no-display-inline" id="id643C377D60514E769B7C2F0E07825397"><enum>(bb)</enum><text display-inline="yes-display-inline">The entry for the drug that is the subject
of an applicable drug clinical trial in the National Library of Medicine
database of structured product labels, if available.</text>
</item></subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDa5a70134a643466795d17ab6b21e8fb5"><enum>(iii)</enum><header display-inline="yes-display-inline">Results for existing data bank
entries</header><text display-inline="yes-display-inline">The Secretary may
include the links described in clause (ii) for data bank entries for clinical
trials submitted to the data bank prior to enactment of the Enhancing Drug
Safety and Innovation Act of 2007, as available.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id44FA50862BDB4CAEAA18102F9A1767FB"><enum>(B)</enum><header display-inline="yes-display-inline">Feasibility study</header><text display-inline="yes-display-inline">The Director of NIH shall—</text>
<clause commented="no" display-inline="no-display-inline" id="id298A328262974F74A7FAB539069124B6"><enum>(i)</enum><text display-inline="yes-display-inline">conduct a study to determine the best,
validated methods of making the results of clinical trials publicly available
after the approval of the drug that is the subject of an applicable drug
clinical trial; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id4EEDD14A5BA84875B4B6D883995B2809"><enum>(ii)</enum><text display-inline="yes-display-inline">not later than 18 months after initiating
such study, submit to the Secretary any findings and recommendations of such
study.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3e0fdf96bbf8406e92da0247c74f8731"><enum>(C)</enum><header display-inline="yes-display-inline">Negotiated rulemaking</header>
<clause commented="no" display-inline="no-display-inline" id="IDa83639257e7447d0b844b105bafdd8a2"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall establish a negotiated
rulemaking process pursuant to subchapter IV of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/5">chapter 5</external-xref> of title 5, United
States Code, to determine, for applicable drug clinical trials—</text>
<subclause commented="no" display-inline="no-display-inline" id="idC8AE719371694FEBBAA2BC8CA1D59D98"><enum>(I)</enum><text display-inline="yes-display-inline">how to ensure quality and validate methods
of expanding the registry data bank to include clinical trial results
information for trials not within the scope of this Act;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idED443E9C723D4BA7AE75805DFD5D4817"><enum>(II)</enum><text display-inline="yes-display-inline">the clinical trials of which the results
information is appropriate for adding to the expanded registry data bank;
and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idF086220A314A4222AD471CB87ABF37E4"><enum>(III)</enum><text display-inline="yes-display-inline">the appropriate timing of the posting of
such results information.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID077fed907af642ecac99d535a1cdbebc"><enum>(ii)</enum><header display-inline="yes-display-inline">Time requirement</header><text display-inline="yes-display-inline">The process described in paragraph (1)
shall be conducted in a timely manner to ensure that—</text>
<subclause commented="no" display-inline="no-display-inline" id="IDf00947724df64883804e5a7eb2dbb94a"><enum>(I)</enum><text display-inline="yes-display-inline">any recommendation for a proposed
rule—</text>
<item commented="no" display-inline="no-display-inline" id="IDa4c6bdcc319a43d4a9f2a02af35fe0f3"><enum>(aa)</enum><text display-inline="yes-display-inline">is provided to the Secretary not later than
21 months after the date of the enactment of the Enhancing Drug Safety and
Innovation Act of 2007; and</text>
</item><item commented="no" display-inline="no-display-inline" id="IDdc5fbe5dc021484085927270d526176a"><enum>(bb)</enum><text display-inline="yes-display-inline">includes an assessment of the benefits and
costs of the recommendation; and</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="IDc0f09ba3b4eb4c19a29ee450ea0ea87f"><enum>(II)</enum><text display-inline="yes-display-inline">a final rule is promulgated not later than
30 months after the date of the enactment of the Enhancing Drug Safety and
Innovation Act of 2007, taking into account the recommendations under subclause
(I) and the results of the feasibility study conducted under subparagraph
(B).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID735ca81d95c34294a17e8d26cfa82cda"><enum>(iii)</enum><header display-inline="yes-display-inline">Representation on negotiated rulemaking
committee</header><text display-inline="yes-display-inline">The negotiated
rulemaking committee established by the Secretary pursuant to clause (i) shall
include members representing—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID0990ea97147f424fbef96deebec22f90"><enum>(I)</enum><text display-inline="yes-display-inline">the Food and Drug Administration;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID9945486f9d72490cb0e453ba8bba2915"><enum>(II)</enum><text display-inline="yes-display-inline">the National Institutes of Health;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4d61eda136264f3fbd4be987b1dea9d1"><enum>(III)</enum><text display-inline="yes-display-inline">other Federal agencies as the Secretary
determines appropriate;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID9fea09436d584c23a6dd046ba8bbf875"><enum>(IV)</enum><text display-inline="yes-display-inline">patient advocacy and health care provider
groups;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id332FFF5B3CDF45E597CE454F0ED3873B"><enum>(V)</enum><text display-inline="yes-display-inline">the pharmaceutical industry;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDaafd24aae488441eadda7b9531845423"><enum>(VI)</enum><text display-inline="yes-display-inline">contract clinical research
organizations;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id53A709A0BACB48CFA29ADB18189460FD"><enum>(VII)</enum><text display-inline="yes-display-inline">the International Committee of Medical
Journal Editors; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDb4683175eece4e239f70bf3f0ee845f2"><enum>(VIII)</enum><text display-inline="yes-display-inline">other interested parties, including experts
in privacy protection, pediatrics, health information technology, health
literacy, communication, clinical trial design and implementation, and health
care ethics.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID5d49859737554554aaed38569e6c450d"><enum>(iv)</enum><header display-inline="yes-display-inline">Content of regulations</header><text display-inline="yes-display-inline">The regulations promulgated pursuant to
clause (i) shall establish—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID191496add07d4181a1b59bd57675499a"><enum>(I)</enum><text display-inline="yes-display-inline">procedures to determine which clinical
trials results information data elements shall be included in the registry data
bank, taking into account the needs of different populations of users of the
registry data bank;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID4552f2eeb17745d1956bcc14fff94eb7"><enum>(II)</enum><text display-inline="yes-display-inline">a standard format for the submission of
clinical trials results to the registry data bank;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID58bf6391f93b45489fcf0d5b4468c2fc"><enum>(III)</enum><text display-inline="yes-display-inline">a standard procedure for the submission of
clinical trial results information, including the timing of submission and the
timing of posting of results information, to the registry data bank, taking
into account the possible impacts on publication of manuscripts based on the
clinical trial;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID11981027b653418c9afe742667863603"><enum>(IV)</enum><text display-inline="yes-display-inline">a standard procedure for the verification
of clinical trial results information, including ensuring that free text data
elements are non-promotional; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDe48b4825ed344b8a80cc4ac4754c7da9"><enum>(V)</enum><text display-inline="yes-display-inline">an implementation plan for the prompt
inclusion of clinical trials results information in the registry data
bank.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDdf27f93ab0f7473a856a2a13044471b0"><enum>(D)</enum><header display-inline="yes-display-inline">Consideration of World Health Organization
data set</header><text display-inline="yes-display-inline">The Secretary shall
consider the status of the consensus data elements set for reporting clinical
trial results of the World Health Organization when promulgating the
regulations under subparagraph (C).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDA8F5DD363E04AFEB7B8E41DED5F63AF"><enum>(E)</enum><header display-inline="yes-display-inline">Truthful clinical trial
information</header>
<clause commented="no" display-inline="no-display-inline" id="id3104884D9F024C0AB658E712DE3D7626"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The clinical trial information submitted by
a responsible party under this paragraph shall not be false or misleading in
any particular.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF6C449E5CCA94593B0DD35F3DBE49929"><enum>(ii)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">Clause (i) shall not have the effect of
requiring clinical trial information with respect to an applicable drug
clinical trial or an applicable device clinical trial to include information
from any source other than such clinical trial involved.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID597137f497e24936a8b3efc063148880"><enum>(F)</enum><header display-inline="yes-display-inline">Waivers regarding certain clinical trial
results</header><text display-inline="yes-display-inline">The Secretary may
waive any applicable requirements of this paragraph for an applicable drug
clinical trial or an applicable device clinical trial, upon a written request
from the responsible person, if the Secretary determines that extraordinary
circumstances justify the waiver and that providing the waiver is in the public
interest, consistent with the protection of public health, or in the interest
of national security. Not later than 30 days after any part of a waiver is
granted, the Secretary shall notify, in writing, the appropriate committees of
Congress of the waiver and provide an explanation for why the waiver was
granted.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id75A0EA8895D6431F8099210CC340C57B"><enum>(4)</enum><header display-inline="yes-display-inline">Coordination and compliance</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idDA9BB20C98D04F17A46D39912AC67F27"><enum>(A)</enum><header display-inline="yes-display-inline">Clinical trials supported by grants from
Federal agencies</header>
<clause commented="no" display-inline="no-display-inline" id="idF3C68EC6BDD44093A006A8308877ABDA"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">No Federal agency may release funds under a
research grant to an awardee who has not complied with paragraph (2) for any
applicable drug clinical trial or applicable device clinical trial for which
such person is the responsible party.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idDCCB9E2BDD274E0E8736794FFA212A4E"><enum>(ii)</enum><header display-inline="yes-display-inline">Grants from certain Federal
agencies</header><text display-inline="yes-display-inline">If an applicable
drug clinical trial or applicable device clinical trial is funded in whole or
in part by a grant from the Food and Drug Administration, 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 paragraph (2).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id80B50D6E616441B983E0B24E72E1CA17"><enum>(iii)</enum><header display-inline="yes-display-inline">Verification by Federal
agencies</header><text display-inline="yes-display-inline">The heads of the
agencies referred to in clause (ii), as applicable, shall verify that the
clinical trial information for each applicable drug clinical trial or
applicable device clinical trial for which a grantee is the responsible party
has been submitted under paragraph (2) before releasing any remaining funding
for a grant or funding for a future grant to such grantee.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF4B19A834DC747F5987696A174A7002F"><enum>(iv)</enum><header display-inline="yes-display-inline">Notice and opportunity to
remedy</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id7D69550BF67E452B82554036D85C1992"><enum>(v)</enum><header display-inline="yes-display-inline">Consultation with other Federal
agencies</header><text display-inline="yes-display-inline">The Secretary
shall—</text>
<subclause commented="no" display-inline="no-display-inline" id="idEC6F2AF9CD2F415295CC8591C108CE55"><enum>(I)</enum><text display-inline="yes-display-inline">consult with other agencies that conduct
research involving human subjects in accordance with any section of part 46 of
title 45, Code of Federal Regulations (or any successor regulations), to
determine if any such research is an applicable drug clinical trial or an
applicable device clinical trial under paragraph (1); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id8C66775F01B0499A89B3186E677F1D97"><enum>(II)</enum><text display-inline="yes-display-inline">develop with such agencies procedures
comparable to those described in clauses (ii), (iii), and (iv) to ensure that
clinical trial information for such applicable drug clinical trials and
applicable device clinical trial is submitted under paragraph (2).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id79E24ED58A23473DAF0A635AE8C00EF7"><enum>(B)</enum><header display-inline="yes-display-inline">Certification to accompany drug, biological
product, and device submissions</header><text display-inline="yes-display-inline">At the time of submission of an application
under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of
such Act, section 520(m) of such Act, or section 351 of this Act, or submission
of a report under section 510(k) of such Act, such application or submission
shall be accompanied by a certification that all applicable requirements of
this subsection have been met. Where available, such certification shall
include the appropriate National Clinical Trial control numbers.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2037877168094091999f5c662f29dd5a"><enum>(C)</enum><header display-inline="yes-display-inline">Verification of submission prior to
posting</header><text display-inline="yes-display-inline">In the case of
clinical trial information that is submitted under paragraph (2), but is not
made publicly available pending regulatory approval or clearance, as
applicable, the Director of NIH shall respond to inquiries from other Federal
agencies and peer-reviewed scientific journals to confirm that such clinical
trial information has been submitted but has not yet been posted.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id02DE005A11CA444F9F11C9E65B164D71"><enum>(5)</enum><header display-inline="yes-display-inline">Limitation on disclosure of clinical trial
information</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDc7d5cc013e4b4514a1271c3750c41602"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Nothing in this subsection (or under
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United States Code) shall require the Secretary to
publicly disclose, from any record or source other than the registry data bank
expanded under this subsection, information described in subparagraph
(B).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD243B3048E8D46A096230F23AD8F63BF"><enum>(B)</enum><header display-inline="yes-display-inline">Information described</header><text display-inline="yes-display-inline">Information described in this subparagraph
is—</text>
<clause commented="no" display-inline="no-display-inline" id="IDde663418db1646108d4f7dd13243d4e1"><enum>(i)</enum><text display-inline="yes-display-inline">information submitted to the Director of
NIH under this subsection, or information of the same general nature as (or
integrally associated with) the information so submitted; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0548a05371af4c4da19cf5beb6c72e22"><enum>(ii)</enum><text display-inline="yes-display-inline">not otherwise publicly available, including
because it is protected from disclosure under <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United
States Code.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9F6ABBFCA3454532A06954CAEC55076F"><enum>(6)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">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>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6EBA36A477134E8F8151A689621A1360"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendments</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8A3DB40B0B9143E69597460858BD1DB9"><enum>(1)</enum><header display-inline="yes-display-inline">Prohibited acts</header><text display-inline="yes-display-inline">Section 301 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idB49F93FD81184734816734C1691AE534" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idEA542CC3FDE342DFB512A711D0132278"><enum>(jj)</enum><paragraph commented="no" display-inline="yes-display-inline" id="idDD0D825CCDCD4187B27FEE6E8638528E"><enum>(1)</enum><text display-inline="yes-display-inline">The failure to submit the certification
required by section 402(j)(4)(B) of the Public Health Service Act, or knowingly
submitting a false certification under such section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC83D827A9D2A43C9ABD8B46523071E79" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">The submission of clinical trial
information under subsection (i) or (j) of section 402 of the Public Health
Service Act that is promotional or false or misleading in any particular under
paragraph (2) or (3) of such subsection
(j).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2E03910128EC4467AF43DB79C1091CF2"><enum>(2)</enum><header display-inline="yes-display-inline">Civil money penalties</header><text display-inline="yes-display-inline">Section 303(f) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)</external-xref>), as amended by section 203, is further
amended by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id695FD88E571C41B8B8A3861B1808157E"><enum>(A)</enum><text display-inline="yes-display-inline">redesignating paragraphs (4), (5), and (6)
as paragraphs (5), (6), and (7), respectively;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1B4F6B7F3C6F4416A45A6983888257E2"><enum>(B)</enum><text display-inline="yes-display-inline">inserting after paragraph (3) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idFAE8D055AD244329B5F2EA95B6407586" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idB20DB7E57EFA4193A678387CAE34887D" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">Any person who violates section 301(jj)
shall be subject to a civil monetary penalty of not more than $10,000 for the
first violation, and not more than $20,000 for each subsequent
violation.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3CF037E788E94760B571413AF081608B"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2)(C), by striking
<quote>paragraph (4)(A)</quote> and inserting <quote>paragraph
(5)(A)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idADDC9094A10F469C975F0991F740ECDA"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (5), as so redesignated, by
striking <quote>paragraph (1), (2), or (3)</quote> each place it appears and
inserting <quote>paragraph (1), (2), (3), or (4)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEF4C5FDF8AD64283944224A95F940DC1"><enum>(E)</enum><text display-inline="yes-display-inline">in paragraph (7), as so redesignated, by
striking <quote>paragraph (5)</quote> each place it appears and inserting
<quote>paragraph (6)</quote>.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6989251F106D411E97D71C99BD87182D"><enum>(3)</enum><header display-inline="yes-display-inline">New drugs and devices</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id361DFE2DA9B44D238EBF02A29887EEC6"><enum>(A)</enum><header display-inline="yes-display-inline">Investigational new drugs</header><text display-inline="yes-display-inline">Section 505(i) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(i)</external-xref>) is amended 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 has been or will be submitted for
inclusion in the registry data bank pursuant to subsections (i) and (j) of
section 402 of the Public Health Service Act.</quote>.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0546724cc6674d95a5d83f534ae4d648"><enum>(B)</enum><header display-inline="yes-display-inline">New drug applications</header><text display-inline="yes-display-inline">Section 505(b) of the Federal, Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(b)</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idB987589FCF054ED8A1EB855F7BAC0FBB" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="IDba2c6fe5d7244238a4c8d29f087f6acd"><enum>(6)</enum><text display-inline="yes-display-inline">An application submitted under this
subsection shall be accompanied by the certification required under section
402(j)(4)(B) of the Public Health Service Act. Such certification shall not be
considered an element of such
application.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2900F765F5BF4DBE8EA096A146713504"><enum>(C)</enum><header display-inline="yes-display-inline">Device reports under section
<enum-in-header>510(k)</enum-in-header></header><text display-inline="yes-display-inline">Section 510(k) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(k)</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idDFD598E6A31847E2A3CD9797CF519A73" style="OLC">
<quoted-block-continuation-text commented="no" quoted-block-continuation-text-level="subsection">A notification submitted under this
subsection that contains clinical trial data for an applicable device clinical
trial (as defined in section 402(j)(1) of the Public Health Service Act) shall
be accompanied by the certification required under section 402(j)(4)(B) of such
Act. Such certification shall not be considered an element of such
notification.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id32ACDE40E8124AF5A3DA7FB860BACAC2"><enum>(D)</enum><header display-inline="yes-display-inline">Device premarket approval
application</header><text display-inline="yes-display-inline">Section 515(c) of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21 U.S.C. 360e(c)</external-xref>) is amended—</text>
<clause commented="no" display-inline="no-display-inline" id="idC556C34962244C749C0CC6B89E57FE67"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (F), by striking <quote>;
and</quote> and inserting a semicolon;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA3E42A518F5148FCA5053ECB66B18BF9"><enum>(ii)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (G) as
subparagraph (H); and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id375C4B91367E4E688D40291982729E1C"><enum>(iii)</enum><text display-inline="yes-display-inline">by inserting after subparagraph (F) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idEC1FE81D15814AA58A9C9CF8D9A29A03" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="idB367651FA93947A58FFABE7072D98656"><enum>(G)</enum><text display-inline="yes-display-inline">the certification required under section
402(j)(4)(B) of the Public Health Service Act (which shall not be considered an
element of such application);
and</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id805268DC7BBA4EBAA50C2E36484230F8"><enum>(E)</enum><header display-inline="yes-display-inline">Humanitarian device exemption</header><text display-inline="yes-display-inline">Section 520(m)(2) of the Federal Food,
Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21 U.S.C. 360e(c)</external-xref>) is amended in the first sentence in
the matter following subparagraph (C), by inserting at the end before the
period <quote>and such application shall include the certification required
under section 402(j)(4)(B) of the Public Health Service Act (which shall not be
considered an element of such application)</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idE04A38EDAFCB4256A0BDE9709EFADA5D"><enum>(c)</enum><header display-inline="yes-display-inline">Preemption</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDd45d10c0fa9a47d390e9545ed3640309"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID812d4e958ef94f33a24a2313ee5142fd"><enum>(2)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">The fact of submission of clinical trial
information, if submitted in compliance with subsection (i) and (j) of section
402 of the Public Health Service Act (as amended by this section), that relates
to a use of a drug or device not included in the official labeling of the
approved drug or device shall not be construed by the Secretary or in any
administrative or judicial proceeding, as evidence of a new intended use of the
drug or device that is different from the intended use of the drug or device
set forth in the official labeling of the drug or device. The availability of
clinical trial information through the data bank under such subsections (i) and
(j), if submitted in compliance with such subsections, shall not be considered
as labeling, adulteration, or misbranding of the drug or device under the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5367BAD9E6D04138AE65EA7C5182D720"><enum>(d)</enum><header display-inline="yes-display-inline">Transition rule; effective date of funding
restrictions</header>
<paragraph commented="no" display-inline="no-display-inline" id="idAA119C4D28FC481695FDA96BE7C8514E"><enum>(1)</enum><header display-inline="yes-display-inline">Transition rule for clinical trials
initiated prior to expansion of registry data bank</header><text display-inline="yes-display-inline">The
responsible party (as defined in paragraph (1) of section 402(j) of the Public
Health Service Act (as added by this section)) for an applicable drug clinical
trial or applicable device clinical trial (as defined under such paragraph (1))
that is initiated after the date of enactment of this subtitle and before the
effective date of the regulations promulgated under paragraph (2) of such
section 402(j), shall submit required clinical trial information under such
section not later than 120 days after such effective date.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id97B959FD06BD4AC7BA95EFC9A3AB4DA9"><enum>(2)</enum><header display-inline="yes-display-inline">Funding restrictions</header><text display-inline="yes-display-inline">Subparagraph (A) of paragraph (4) of such
section 402(j) shall take effect 210 days after the effective date of the
regulations promulgated under paragraph (2) of such section 402(j).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idE0E412E9125C42768C6C9891412ECDFB"><enum>(e)</enum><header display-inline="yes-display-inline">Effective date</header>
<paragraph commented="no" display-inline="no-display-inline" id="idA66498D1BCC64276971BA609F9180C01"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning 90 days after the date of
enactment of this title, the responsible party for an applicable drug clinical
trial or an applicable device clinical trial (as that term is defined in such
section 402(j)) that is initiated after the date of enactment of this title and
before the effective date of the regulations issued under subparagraph (A) of
paragraph (2) of such subsection, shall submit clinical trial information under
such paragraph (2).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBC7959A52E394F459DB2959E27E20BC7"><enum>(2)</enum><header display-inline="yes-display-inline">Rulemaking</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDf11c50e3b43d4c7cb3c55717fea68283"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B),
subsection (c)(1) shall become effective on the date on which the regulation
promulgated pursuant to section 402(j)(3)(C)(i) of the Public Health Service
Act, as added by this section, becomes effective.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID84decc7b6f40418dbc4a5e0379f57644"><enum>(B)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">Subsection (c)(1) shall apply with respect
to any clinical trial for which the registry data bank includes links to
results information, as provided for under section 402(j)(3)(A) of such Act, as
added by this section.</text>
</subparagraph></paragraph></subsection></section></subtitle><subtitle commented="no" id="idD4668B774EB440F9B30179F871B2FC27" level-type="subsequent" style="OLC"><enum>D</enum><header display-inline="yes-display-inline">Conflicts of interest</header>
<section commented="no" display-inline="no-display-inline" id="id72B6521E70E64C14B851988E2D188D01" section-type="subsequent-section"><enum>241.</enum><header display-inline="yes-display-inline">Conflicts of interest</header>
<subsection commented="no" display-inline="no-display-inline" id="id58C8D5A475FD452B95651B9E342FC112"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subchapter A of chapter VII of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>) is amended by inserting at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id662A3B04BF7E4911BC36A69F10E3A55E" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idB853998414564B63A21E0A7286930783" section-type="subsequent-section"><enum>712.</enum><header display-inline="yes-display-inline">Conflicts of interest</header>
<subsection commented="no" display-inline="no-display-inline" id="idF4EA597F8D984719B424CA9D402BB86F"><enum>(a)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this section:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id2F9771BD3FE14E9D9A41500D64D71F7F"><enum>(1)</enum><header display-inline="yes-display-inline">Advisory committee</header><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="idB808C1E204E24605AFF49835FC8BFE22"><enum>(2)</enum><header display-inline="yes-display-inline">Financial interest</header><text display-inline="yes-display-inline">The term <term>financial interest</term>
means a financial interest under <external-xref legal-doc="usc" parsable-cite="usc/18/208">section 208(a)</external-xref> of title 18, United States
Code.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6EF2F131D3604442B67C84669E34DBAC"><enum>(b)</enum><header display-inline="yes-display-inline">Appointments to advisory
committees</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID55ac02371a714ccaa8f0f1dbbc4cdf58"><enum>(1)</enum><header display-inline="yes-display-inline">Recruitment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idF7E47289752B42D6AD56C6F45F6E5156"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Given the importance of advisory committees
to the review process at the Food and Drug Administration, the Secretary shall
carry out informational and recruitment activities for purposes of recruiting
individuals to serve as advisory committee members. The Secretary shall seek
input from professional medical and scientific societies to determine the most
effective informational and recruitment activities. The Secretary shall also
take into account the advisory committees with the greatest number of
vacancies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD7595ED870E24060BF439EFBE0927ED2"><enum>(B)</enum><header display-inline="yes-display-inline">Recruitment activities</header><text display-inline="yes-display-inline">The recruitment activities under
subparagraph (A) may include—</text>
<clause commented="no" display-inline="no-display-inline" id="IDed5181e54ea1432f82115f2afde6822b"><enum>(i)</enum><text display-inline="yes-display-inline">advertising the process for becoming an
advisory committee member at medical and scientific society conferences;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID6baa118ce73344688c1b60a7254085fe"><enum>(ii)</enum><text display-inline="yes-display-inline">making widely available, including by using
existing electronic communications channels, the contact information for the
Food and Drug Administration point of contact regarding advisory committee
nominations; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDd0b039a888084cea8d199c61963445b0"><enum>(iii)</enum><text display-inline="yes-display-inline">developing a method through which an entity
receiving National Institutes of Health funding can identify a person who the
Food and Drug Administration can contact regarding the nomination of
individuals to serve on advisory committees.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id191D57CC03754689B9D7BBE7E9B34757"><enum>(2)</enum><header display-inline="yes-display-inline">Evaluation and criteria</header><text display-inline="yes-display-inline">When considering a term appointment to an
advisory committee, the Secretary shall review the expertise of the individual
and the financial disclosure report filed by the individual pursuant to the
Ethics in Government Act of 1978 for each individual under consideration for
the appointment, so as to reduce the likelihood that an appointed individual
will later 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
<external-xref legal-doc="usc" parsable-cite="usc/18/208">section 208(b)(3)</external-xref> of title 18, United States Code, or a waiver as referred to
in subsection (c)(3) of this section for service on the committee at a meeting
of the committee.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9151C8012A584D46BF4E8CEA8C3A60FD"><enum>(c)</enum><header display-inline="yes-display-inline">Granting and disclosure of waivers</header>
<paragraph commented="no" display-inline="no-display-inline" id="idD22094F817E24381B4FC0C8E19FEA903"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Prior to a meeting of an advisory committee
regarding a <quote>particular matter</quote> (as that term is used in section
208 of title 18, United States Code), each member of the committee who is a
full-time Government employee or special Government employee shall disclose to
the Secretary financial interests in accordance with subsection (b) of such
section 208.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE811B95C3F6F4704B623F1CD3FBF894F"><enum>(2)</enum><header display-inline="yes-display-inline">Financial interest of advisory committee
member or family member</header><text display-inline="yes-display-inline">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) has a financial interest that could be affected by the advice given to
the Secretary with respect to such matter, excluding interests exempted in
regulations issued by the Director of the Office of Government Ethics as too
remote or inconsequential to affect the integrity of the services of the
Government officers or employees to which such regulations apply.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1B0BCCD79BC24CFF9449F8ECF5F6AE30"><enum>(3)</enum><header display-inline="yes-display-inline">Waiver</header><text display-inline="yes-display-inline">The Secretary may grant a waiver of the
prohibition in paragraph (2) if such waiver is necessary to afford the advisory
committee essential expertise.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9e6cd60831b447c58ae2a6a2465de0e7"><enum>(4)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">The Secretary may not grant a waiver under
paragraph (3) for a member of an advisory committee when the member's own
scientific work is involved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id38B3F6744F7C48B8A811F28FA159099F"><enum>(5)</enum><header display-inline="yes-display-inline">Disclosure of waiver</header><text display-inline="yes-display-inline">Notwithstanding section 107(a)(2) of the
Ethics in Government Act (5 U.S.C. App.), the following shall apply:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idA25160108F644032946E673391028310"><enum>(A)</enum><header display-inline="yes-display-inline">15 or more days in advance</header><text display-inline="yes-display-inline">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 <external-xref legal-doc="usc" parsable-cite="usc/18/208">section 208(b)(1)</external-xref> 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 <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> 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 commented="no" display-inline="no-display-inline" id="IDe214b27eea4d4f809429752903f82741"><enum>(i)</enum><text display-inline="yes-display-inline">the type, nature, and magnitude of the
financial interests of the advisory committee member to which such
determination, certification, or waiver applies; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDb81950b933d74540aa59bb8c6830b8fb"><enum>(ii)</enum><text display-inline="yes-display-inline">the reasons of the Secretary for such
determination, certification, or waiver.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8480EDCA26E94EC188823C37072EB4EA"><enum>(B)</enum><header display-inline="yes-display-inline">Less than 30 days in advance</header><text display-inline="yes-display-inline">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 <external-xref legal-doc="usc" parsable-cite="usc/18/208">section 208(b)(3)</external-xref> 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 <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United
States Code, and <external-xref legal-doc="usc" parsable-cite="usc/5/552a">section 552a</external-xref> 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 practicable after the
Secretary makes such determination, certification, or waiver, but in no case
later than the date of such meeting.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id8D31AEA438FB42A88D72E58B932893AE"><enum>(d)</enum><header display-inline="yes-display-inline">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 <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United States Code, and section
552a of title 5, United States Code).</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID85a6ed47cbd24f24a1405e2a8e2c73dc"><enum>(e)</enum><header display-inline="yes-display-inline">Annual report</header><text display-inline="yes-display-inline">Not later than February 1 of each year, the
Secretary shall submit 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, a report that describes—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID4bac88193d4f43358dd48460254b2cc3"><enum>(1)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID47a112c0b626482190320eb427574a57"><enum>(2)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="idD3C5708D20AB48F0BFE35A826D7E9689"><enum>(3)</enum><text display-inline="yes-display-inline">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" display-inline="no-display-inline" id="ID4610e1367a774b3990ae49e220a350b9"><enum>(4)</enum><text display-inline="yes-display-inline">how the Secretary plans to reduce the
number of vacancies reported under paragraph (1) during the fiscal year
following such year, and mechanisms to encourage the nomination of individuals
for service on an advisory committee, including those who are classified by the
Food and Drug Administration as academicians or practitioners.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id64F631CD77C640CFAACA9FFAFDF6C92F"><enum>(f)</enum><header display-inline="yes-display-inline">Periodic review of guidance</header><text display-inline="yes-display-inline">Not less than once every 5 years, the
Secretary shall review guidance of the Food and Drug Administration regarding
conflict of interest waiver determinations with respect to advisory committees
and update such guidance as
necessary.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id91371780926447CEA546BA9103605D56"><enum>(b)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">Section 505(n) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(n)</external-xref>) is amended by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id7BD09CAD6410429C8BDC8314D297BF02"><enum>(1)</enum><text display-inline="yes-display-inline">striking paragraph (4); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id60839C62B8624A58B2894DCCE5FCD52A"><enum>(2)</enum><text display-inline="yes-display-inline">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>(c)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this section shall take effect on October 1, 2007.</text>
</subsection></section></subtitle><subtitle commented="no" id="idA1B3F4A73FE541BA8CE9D6E7C1A81875" level-type="subsequent" style="OLC"><enum>E</enum><header display-inline="yes-display-inline">Other drug safety provisions</header>
<section commented="no" display-inline="no-display-inline" id="id56292716C12049CBB8C92C7840FBAB1B" section-type="subsequent-section"><enum>251.</enum><header display-inline="yes-display-inline">Database for authorized generic
drugs</header><text display-inline="no-display-inline">Section 505 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>), as amended by this title,
is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id994E16C235D64EC98BD3707CE2C56084" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id2EE8E384D450497AB120788C8704FD56"><enum>(q)</enum><header display-inline="yes-display-inline">Database for authorized generic
drugs</header>
<paragraph commented="no" display-inline="no-display-inline" id="idB92806023C074E6E8315D10F3702C8A2"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idB737B3996A6F418BADC6A96BAE46E419"><enum>(A)</enum><header display-inline="yes-display-inline">Publication</header><text display-inline="yes-display-inline">The Commissioner shall—</text>
<clause commented="no" display-inline="no-display-inline" id="idA313110550294420B62695475B40951B"><enum>(i)</enum><text display-inline="yes-display-inline">not later than 9 months after the date of
enactment of the Enhancing Drug Safety and Innovation Act of 2007, publish a
complete list on the Internet website of the Food and Drug Administration of
all authorized generic drugs (including drug trade name, brand company
manufacturer, and the date the authorized generic drug entered the market);
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id68511313B22346358647A7C5C3A2BDCE"><enum>(ii)</enum><text display-inline="yes-display-inline">update the list quarterly to include each
authorized generic drug included in an annual report submitted to the Secretary
by the sponsor of a listed drug during the preceding 3-month period.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE79A8091A3994BB6BCD30AAF28441B37"><enum>(B)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">The Commissioner shall notify relevant
Federal agencies, including the Centers for Medicare & Medicaid Services
and the Federal Trade Commission, any time the Commissioner updates the
information described in subparagraph (A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3DE7DA965143472592A81191EA707BC0"><enum>(2)</enum><header display-inline="yes-display-inline">Inclusion</header><text display-inline="yes-display-inline">The Commissioner shall include in the list
described in paragraph (1) each authorized generic drug included in an annual
report submitted to the Secretary by the sponsor of a listed drug after January
1, 1999.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB1E8852B4D9F4064B1E1D09C5A7C2547"><enum>(3)</enum><header display-inline="yes-display-inline">Authorized generic drug</header><text display-inline="yes-display-inline">In this section, the term <term>authorized
generic drug</term> means a listed drug (as that term is used in subsection
(j)) that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID0df2d6fb27b24762969f72c7993eda94"><enum>(A)</enum><text display-inline="yes-display-inline">has been approved under subsection (c);
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID7e5125e03deb4f3eacc01b889d81d31b"><enum>(B)</enum><text display-inline="yes-display-inline">is marketed, sold, or distributed directly
or indirectly to retail class of trade under a different labeling, packaging
(other than repackaging as the listed drug in blister packs, unit doses, or
similar packaging for use in institutions), product code, labeler code, trade
name, or trade mark than the listed
drug.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id5D1B3A9E374B41B6BA3E1DE0F3B62D8E" section-type="subsequent-section"><enum>252.</enum><header display-inline="yes-display-inline">Medical marijuana</header><text display-inline="no-display-inline">The Secretary shall require that
State-legalized medical marijuana be subject to the full regulatory
requirements of the Food and Drug Administration, including a risk evaluation
and mitigation strategy and all other requirements and penalties of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) regarding safe and
effective reviews, approval, sale, marketing, and use of
pharmaceuticals.</text>
</section></subtitle><subtitle id="idEA87088916C2484AAC6E574ADA894F45"><enum>F</enum><header>Antibiotic access
and innovation</header>
<section id="id7C27A19C25C54E68B055C3ADA639F90B"><enum>261.</enum><header>Incentives for
the development of, and access to, certain antibiotics</header>
<subsection id="id835BDD51321641279B7DBB1D66957828"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 505 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>), as amended by this Act,
is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idEE97B1746453473D9B89DF0D3A6B29AC" style="OLC">
<subsection id="IDf6ea6aeeeefa4f628c5aaec959efe5af"><enum>(s)</enum><header>Antibiotic
drugs submitted before November 21, 1997</header>
<paragraph id="ID9cde8cecfb1a496f81bdb59004a883bf"><enum>(1)</enum><header>Antibiotic
drugs approved before November 21, 1997</header>
<subparagraph id="idAF7C7DD399AF4F56B43263ADAC0C784D"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any provision of the Food and Drug
Administration Modernization Act of 1997 or any other provision of law, a
sponsor of a drug that is the subject of an application described in
subparagraph (B)(i) shall be eligible for, with respect to the drug, the 3-year
exclusivity period referred to under clauses (iii) and (iv) of subsection
(c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as applicable.</text>
</subparagraph><subparagraph id="IDcd16d2a03b434a588fa5a36a8aefb8de"><enum>(B)</enum><header>Application;
antibiotic drug described</header>
<clause id="id9A8284FA4CFA476AA0F5FA1FAED8FE6A"><enum>(i)</enum><header>Application</header><text>An
application described in this clause is an application for marketing submitted
under this section after the date of enactment of this subsection in which the
drug that is the subject of the application contains an antibiotic drug
described in clause (ii).</text>
</clause><clause id="id2DF939C2E0DC4FBA8DC041066688A7DF"><enum>(ii)</enum><header>Antibiotic
drug</header><text>An antibiotic drug described in this clause is an antibiotic
drug that was the subject of an application approved by the Secretary under
section 507 of this Act (as in effect before November 21, 1997).</text>
</clause></subparagraph></paragraph><paragraph id="ID0253a1ba55c84ef9b8f2315bef6a235b"><enum>(2)</enum><header>Antibiotic
drugs submitted before November 21, 1997, but not approved</header>
<subparagraph id="idEF54F9D3A11140D0B2620F859212E609"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any provision of the Food and Drug
Administration Modernization Act of 1997 or any other provision of law, a
sponsor of a drug that is the subject of an application described in
subparagraph (B)(i) may elect to be eligible for, with respect to the
drug—</text>
<clause id="id72A92E3582F945869BFC473D119E3DAD"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="id01152BB604CF4F3FA060202301F3CE28"><enum>(I)</enum><text>the 3-year exclusivity
period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and
under clauses (iii) and (iv) of subsection (j)(5)(F), subject to the
requirements of such clauses, as applicable; and</text>
</subclause><subclause id="idA2561986962C4CF786388D3AC222EF58" indent="up1"><enum>(II)</enum><text>the 5-year exclusivity period referred
to under clause (ii) of subsection (c)(3)(E) and under clause (ii) of
subsection (j)(5)(F), subject to the requirements of such clauses, as
applicable; or</text>
</subclause></clause><clause id="id8D2BDE8C0DF84F4E960FF4E89D5631C4"><enum>(ii)</enum><text>a patent term
extension under <external-xref legal-doc="usc" parsable-cite="usc/35/156">section 156</external-xref> of title 35, United States Code, subject to the
requirements of such section.</text>
</clause></subparagraph><subparagraph id="idEF0D8190F3EE4F578D607AF0EC03F052"><enum>(B)</enum><header>Application;
antibiotic drug described</header>
<clause id="id8A4D1AAFC8F24F5D9DDEC78A238E9DBA"><enum>(i)</enum><header>Application</header><text>An
application described in this clause is an application for marketing submitted
under this section after the date of enactment of this subsection in which the
drug that is the subject of the application contains an antibiotic drug
described in clause (ii).</text>
</clause><clause id="idF000FD599AFE41E3ACEED34C35549AA1"><enum>(ii)</enum><header>Antibiotic
drug</header><text>An antibiotic drug described in this clause is an antibiotic
drug that was the subject of 1 or more applications received by the Secretary
under section 507 of this Act (as in effect before November 21, 1997), none of
which was approved by the Secretary under such section.</text>
</clause></subparagraph></paragraph><paragraph id="idA78BB62AFCAA497B98AFB5CB4AC008A4"><enum>(3)</enum><header>Limitations</header>
<subparagraph id="id4BE202ED584F4BB39435B538DEF619E3"><enum>(A)</enum><header>Exclusivities
and extensions</header><text>Paragraphs (1)(A) and (2)(A) shall not be
construed to entitle a drug that is the subject of an approved application
described in subparagraphs (1)(B)(i) or (2)(B)(i), as applicable, to any market
exclusivities or patent extensions other than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).</text>
</subparagraph><subparagraph id="id69F33FEDF8BD42138743131B544AD37A"><enum>(B)</enum><header>Conditions of
use</header><text>Paragraphs (1)(A) and (2)(A)(i) shall not apply to any
condition of use for which the drug referred to in subparagraph (1)(B)(i) or
(2)(B)(i), as applicable, was approved before the date of enactment of this
subsection.</text>
</subparagraph></paragraph><paragraph commented="no" id="idF3391B16D2114EC2902039819AD6EB1B"><enum>(4)</enum><header>Application of
certain provisions</header><text>Notwithstanding section 125, or any other
provision, of the Food and Drug Administration Modernization Act of 1997, or
any other provision of law, and subject to the limitations in paragraphs (1),
(2), and (3), the provisions of the Drug Price Competition and Patent Term
Restoration Act of 1984 shall apply to any drug subject to paragraph (1) or any
drug with respect to which an election is made under paragraph
(2)(A).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id4EC60A5D946C4C2E99559E3836BE7B0A"><enum>(b)</enum><header>Transition
rule</header><text>With respect to a patent issued on or before the date of
enactment of this Act, any patent information required to be filed with the
Secretary under subsection (b)(1) or (c)(2) of section 505 of the Federal Food,
Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) to be listed on a drug to which
subsection (s)(1) of such section 505 (as added by this section) applies shall
be filed with such Secretary not later than 60 days after the date of enactment
of this Act.</text>
</subsection></section><section id="ID71ca08be64024b93a386a68b69a0081a"><enum>262.</enum><header>Antibiotics as
orphan products</header>
<subsection id="idFD57C743BF044F47AED5817A91236E3E"><enum>(a)</enum><header>Public
meeting</header><text>The Commissioner of Food and Drugs shall convene a public
meeting and, if appropriate, issue guidance, regarding which serious and
life-threatening infectious diseases, such as diseases due to gram-negative
bacteria and other diseases due to antibiotic-resistant bacteria, potentially
qualify for available grants and contracts under subsection (a) of section 5 of
the Orphan Drug Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ee">21 U.S.C. 360ee(a)</external-xref>) or other incentives for
development.</text>
</subsection><subsection id="id68100FC47AA54C27B302893FFC4A0CBA"><enum>(b)</enum><header>Grants and
contracts for the development of orphan drugs</header><text>Subsection (c) of
section 5 of the Orphan Drug Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ee">21 U.S.C. 360ee(c)</external-xref>) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id227FA367FAF84F558211C9B9226E5839" style="OLC">
<subsection id="idBAD9F35A0713471596C3299DD6FFE9E1"><enum>(c)</enum><text>For grants and
contracts under subsection (a) there are authorized to be appropriated—</text>
<paragraph id="idD53EABD1F9FB4B2EB728E2C3F547A4AC"><enum>(1)</enum><text>such sums as
already have been appropriated for fiscal year 2007; and</text>
</paragraph><paragraph id="idC64143D9D1F64089B5ACFDCC7507BDDC"><enum>(2)</enum><text>$35,000,000 for
each of fiscal years 2008 through
2012.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="idD9842793254347E7B38FAF37E0E87BAD"><enum>263.</enum><header>Identification
of clinically susceptible concentrations of antimicrobials</header>
<subsection id="idB13F4F392A6A4CD7AA3C6EF5FAC352AA"><enum>(a)</enum><header>Definition</header><text>In
this section, the term <quote>clinically susceptible concentrations</quote>
means specific values which characterize bacteria as clinically susceptible,
intermediate, or resistant to the drug (or drugs) tested.</text>
</subsection><subsection id="idE66BE66AEF654D06ACB9407EE420CE4D"><enum>(b)</enum><header>Identification</header><text>The
Secretary of Health and Human Services (referred to in this section as the
<quote>Secretary</quote>), through the Commissioner of Food and Drugs, shall
identify and periodically update clinically susceptible concentrations.</text>
</subsection><subsection id="id0EE53A5CEC3E472AA1006AAC3FC28E3D"><enum>(c)</enum><header>Public
availability</header><text>The Secretary, through the Commissioner of Food and
Drugs, shall make such clinically susceptible concentrations publicly available
within 30 days of the date of identification and any update under this
section.</text>
</subsection><subsection id="id4A593532CF0C4D6EA572DC3CDBBACC93"><enum>(d)</enum><header>Effect</header><text>Nothing
in this section shall be construed to restrict, in any manner, the prescribing
of antibiotics by physicians, or to limit the practice of medicine, including
for diseases such as Lyme and tick-borne diseases.</text>
</subsection></section><section id="id902E1CD754524230BBAE2F7F4BDF6ECD"><enum>264.</enum><header>Exclusivity of
certain drugs containing single enantiomers</header><text display-inline="no-display-inline">Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S. C. 355), as amended by this subtitle, is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id23B5BC27629F4B0BBC0281EB7B7C0A8F" style="OLC">
<subsection id="idE5A48CBF2A794B94BCBC01AD2636E5D9"><enum>(t)</enum><header>Certain drugs
containing single enantiomers</header>
<paragraph id="id9A9BD55CF38441C9BBD7B9C9BBACE973"><enum>(1)</enum><header>In
general</header><text>For purposes of subsections (c)(3)(E)(ii) and
(j)(5)(F)(ii), if an application is submitted under subsection (b) for a
non-racemic drug containing as an active ingredient a single enantiomer that is
contained in a racemic drug approved in another application under subsection
(b), the applicant may, in the application for such non-racemic drug, elect to
have the single enantiomer not be considered the same active ingredient as that
contained in the approved racemic drug, if—</text>
<subparagraph id="idBCFA2356ABB1400286B68538C541D497"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="idC82114A47B5746008DE00E1A70E96F33"><enum>(i)</enum><text>the single enantiomer
has not been previously approved except in the approved racemic drug;
and</text>
</clause><clause id="id04D14CBD2EB14D6289CA07A1BF4272B5" indent="up1"><enum>(ii)</enum><text>the application submitted under
subsection (b) for such non-racemic drug—</text>
<subclause id="id66596451170B495D8F34E547A866BB01"><enum>(I)</enum><text>includes full reports of new clinical
investigations (other than bioavailability studies)—</text>
<item id="id0978756730334B1AB7FC50D9A63D4263"><enum>(aa)</enum><text>necessary for the approval of the
application under subsections (c) and (d); and</text>
</item><item id="id36556ED552A24171BA63D30D76AC3205"><enum>(bb)</enum><text>conducted or sponsored by the
applicant; and</text>
</item></subclause><subclause id="idB39E5C5848EE4F0C8B24D47379FC42FC"><enum>(II)</enum><text>does not rely on any investigations that
are part of an application submitted under subsection (b) for approval of the
approved racemic drug; and</text>
</subclause></clause></subparagraph><subparagraph id="id7C984E8390DA48AE838B24C2D4896E77"><enum>(B)</enum><text>the application
submitted under subsection (b) for such non-racemic drug is not submitted for
approval of a condition of use—</text>
<clause id="idFF7EB5D117D14FD6AF2FDBA80805A025"><enum>(i)</enum><text>in a therapeutic
category in which the approved racemic drug has been approved; or</text>
</clause><clause id="id3F41256F0F2D45C88A383214F575F483"><enum>(ii)</enum><text>for which any
other enantiomer of the racemic drug has been approved.</text>
</clause></subparagraph></paragraph><paragraph id="idCBCCE107BD104F61A7DE814F03F05203"><enum>(2)</enum><header>Limitation</header>
<subparagraph id="id22AA2F60F3994858A616B3DBA4E3EEA0"><enum>(A)</enum><header>No approval in
certain therapeutic categories</header><text>Until the date that is 10 years
after the date of approval of a non-racemic drug described in paragraph (1) and
with respect to which the applicant has made the election provided for by such
paragraph, the Secretary shall not approve such non-racemic drug for any
condition of use in the therapeutic category in which the racemic drug has been
approved.</text>
</subparagraph><subparagraph id="id65B9AA7E6F52422C84CE6C55185F6EDE"><enum>(B)</enum><header>Labeling</header><text>If
applicable, the labeling of a non-racemic drug described in paragraph (1) and
with respect to which the applicant has made the election provided for by such
paragraph shall include a statement that the non-racemic drug is not approved,
and has not been shown to be safe and effective, for any condition of use of
the racemic drug.</text>
</subparagraph></paragraph><paragraph id="idBF1D86ED298C4EC7A8272BBD7EE09A3F"><enum>(3)</enum><header>Definition</header>
<subparagraph id="idA2034326FB774987BE4EDDA1D5519F25"><enum>(A)</enum><header>In
general</header><text>For purposes of this subsection, the term
<term>therapeutic category</term> means a therapeutic category identified in
the list developed by the United States Pharmacopeia pursuant to section
1860D–4(b)(3)(C)(ii) of the Social Security Act and as in effect on the date of
enactment of this subsection.</text>
</subparagraph><subparagraph id="id56B933CE7A654186B1C5BD06244008A0"><enum>(B)</enum><header>Publication by
Secretary</header><text>The Secretary shall publish the list described in
subparagraph (A) and may amend such list by regulation.</text>
</subparagraph></paragraph><paragraph id="IDa31ba3e373f04eeb8fa299af47d9b435"><enum>(4)</enum><header>Availability</header><text>The
election referred to in paragraph (1) may be made only in an application that
is submitted to the Secretary after the date of enactment of this subsection
and before October 1,
2012.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id1E6681FAA1134CD7AFFE2CA330F42457"><enum>265.</enum><header>Report</header><text display-inline="no-display-inline">Not later than January 1, 2012, the
Comptroller General of the United States shall submit a report to the Committee
on Health, Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives that examines whether and
how this subtitle has—</text>
<paragraph id="idB1467309348A4467AF30A5E98DDAF4F4"><enum>(1)</enum><text>encouraged the
development of new antibiotics and other drugs; and</text>
</paragraph><paragraph id="idE0501589F6474C908513CB51C4E6B0BA"><enum>(2)</enum><text>prevented or
delayed timely generic drug entry into the market.</text>
</paragraph></section></subtitle><enum>III</enum><header display-inline="yes-display-inline">Medical devices</header>
<section commented="no" display-inline="no-display-inline" id="idB1C4248764C84E0EB5BA4A4CD0EE3760" section-type="subsequent-section"><enum>300.</enum><header display-inline="yes-display-inline">References</header><text display-inline="no-display-inline">Except as otherwise specified, whenever in
this title an amendment is expressed in terms of an amendment to a section or
other provision, the reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).</text>
</section><subtitle commented="no" id="id96E088DEDFB049ED9E8A55AC38B1658C" level-type="subsequent" style="OLC"><enum>A</enum><header display-inline="yes-display-inline">Device user fees</header>
<section commented="no" display-inline="no-display-inline" id="idBCA1AA93312C4BCFA75F9EFF22F35148" section-type="subsequent-section"><enum>301.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the
<quote>Medical Device User Fee Amendments of 2007</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="idF65B1116B03243B98EA93A3C24748A45" section-type="subsequent-section"><enum>302.</enum><header display-inline="yes-display-inline">Device fees</header><text display-inline="no-display-inline">Section 737 (<external-xref legal-doc="usc" parsable-cite="usc/21/379i">21 U.S.C. 379i</external-xref>) is
amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idD6BE0971F2C4424E86D1011533E68AB5"><enum>(1)</enum><text display-inline="yes-display-inline">by striking the section designation and all
that follows through <quote>For purposes of this subchapter</quote> and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id066355C671A84BE3A0EC29AE066F6836" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idCE3C105BBAD04111B2711A7533FBB7EF" section-type="subsequent-section"><enum>737.</enum><header display-inline="yes-display-inline">Device fees</header>
<subsection commented="no" display-inline="no-display-inline" id="id666AA3D8209C4E27B5F5670927DD9F69"><enum>(a)</enum><header display-inline="yes-display-inline">Purpose</header><text display-inline="yes-display-inline">It is the purpose of this part that the
fees authorized under this part be dedicated toward expediting the process for
the review of device applications and for assuring the safety and effectiveness
of devices, as set forth in the goals identified for purposes of this part in
the letters from the Secretary to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as set forth in the
Congressional Record.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id2307925025D44215BFC1B6C2FD6D3C69"><enum>(b)</enum><header display-inline="yes-display-inline">Reports</header>
<paragraph commented="no" display-inline="no-display-inline" id="id7EEA00B8E424409291102C4A9E9A0424"><enum>(1)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">For fiscal years 2008 through 2012, not
later than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives, a report
concerning the progress of the Food and Drug Administration in achieving the
goals identified in the letters described in subsection (a) during such fiscal
year and the future plans of the Food and Drug Administration for meeting the
goals. The report for a fiscal year shall include information on all previous
cohorts for which the Secretary has not given a complete response on all device
premarket applications, supplements, and premarket notifications in the
cohort.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID09ceba264e6243149e417ece3c668701"><enum>(2)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">For fiscal years 2008 through 2012, not
later than 120 days after the end of each fiscal year during which fees are
collected under this part, the Secretary shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives, a report on
the implementation of the authority for such fees during such fiscal year and
the use, by the Food and Drug Administration, of the fees collected during such
fiscal year for which the report is made.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEB3A95D3B42342A3BC8E1EB1B00F9638"><enum>(3)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">The Secretary shall make the reports
required under paragraphs (1) and (2) available to the public on the Internet
website of the Food and Drug Administration.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idDC13A9E9D0A841478442D299222F23B1"><enum>(c)</enum><header display-inline="yes-display-inline">Reauthorization</header>
<paragraph commented="no" display-inline="no-display-inline" id="id4616AC89149D4DEE92139C5ED4FA0354"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In developing recommendations to present to
Congress with respect to the goals, and plans for meeting the goals, for the
process for the review of device applications for the first 5 fiscal years
after fiscal year 2012, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDf67e696569714ce1b23607eaeef41599"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the
House of Representatives;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc24425797d4f4faeb31152caa3c0e12f"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor,
and Pensions of the Senate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6f208cdc6dda4cbe8140724e1af39035"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID91fad47d70f1431a9541a9b83718c126"><enum>(D)</enum><text display-inline="yes-display-inline">health care professionals;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4276bbe2a11b43cba12a7b68e95fc8b1"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer
advocacy groups; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID37357f49f0ef43c5bf553c2636500f5c"><enum>(F)</enum><text display-inline="yes-display-inline">the regulated industry.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEAA6CBFF08A64E359F364EFC14EBBE84"><enum>(2)</enum><header display-inline="yes-display-inline">Public review of
recommendations</header><text display-inline="yes-display-inline">After
negotiations with the regulated industry, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID9659da1e5ebc43c5906dbb1940eac529"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under
paragraph (1) to the Congressional committees specified in such
paragraph;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDab3b827325d74b8caeed88fb90298533"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal
Register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID364f4bcbbcb342d39a0de66b99785d62"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the
public to provide written comments on such recommendations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID09ea2cdcc52947319bb62fe953f7196d"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may
present its views on such recommendations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6916BE395FA14AD383A7C4104B06D142"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views
and comments, revise such recommendations as necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2DE445DB0FF2471FB12EDB34BCE90AEB"><enum>(3)</enum><header display-inline="yes-display-inline">Transmittal of
recommendations</header><text display-inline="yes-display-inline">Not later
than January 15, 2012, the Secretary shall transmit to Congress the revised
recommendations under paragraph (2), a summary of the views and comments
received under such paragraph, and any changes made to the recommendations in
response to such views and comments.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id42051E8169714C43B580C247A6092BE3"><enum>(d)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">For purposes of this
part:</text>
</subsection></section><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id047149B1700040D991335FD1F515B92D"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (5), (6), (7),
and (8), as paragraphs (7), (8), (9), and (11), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6F585298C2204B4088D0BBF16454A9E6"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id52FB64FEC7F34FF1881A90F9807E775F"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>or
an efficacy supplement,</quote> and inserting <quote>an efficacy supplement, or
a 30-day notice,</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0CA59C8BA82D402DB32F092DC1C90CA8"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id5F86DA136FD446149DDE41A0F20E51FB" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="idAB76E848F63F4457B5065E992586089F" indent="up1"><enum>(F)</enum><text display-inline="yes-display-inline">The term <term>30-day notice</term> means a
supplement to an approved premarket application or premarket report under
section 515 that is limited to a request to make modifications to manufacturing
procedures or methods of manufacture affecting the safety and effectiveness of
the
device.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id56254FE233D7429990BB08C842BC1E4A"><enum>(4)</enum><text display-inline="yes-display-inline">by inserting after paragraph (4) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idD04D815E17034669B7019CBB059E96B5" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID4283b20e4d3a4ac7b8d2400f1c28e5c7"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>request for classification
information</term> means a request made under section 513(g) for information
respecting the class in which a device has been classified or the requirements
applicable to a device.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb6b1501e0ca34850b57f934b89e16646"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>annual fee for periodic
reporting concerning a class III device</term> means the fee associated with
reports imposed by a premarket application approval order (as described in
<external-xref legal-doc="regulation" parsable-cite="cfr/21/814.82">section 814.82(a)(7)</external-xref> of title 21, Code of Federal Regulations), usually
referred to as <quote>annual
reports.</quote></text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7C06940546B54508A96C10DD2BC26168"><enum>(5)</enum><text display-inline="yes-display-inline">in paragraph (9), as redesignated by
paragraph (2)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id97CCA259566A4B23A25CDF9382580AE1"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>April of</quote> and
inserting <quote>October of </quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF37C17B271EA4F5A89B492D400E783D4"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>April 2002</quote> and
inserting <quote>October 2001</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id22DF181C47FB4A3685BA371D60432B42"><enum>(6)</enum><text display-inline="yes-display-inline">by inserting after paragraph (9), as
redesignated by paragraph (2), the following:</text>
<quoted-block display-inline="no-display-inline" id="id43A0F4A3833446D2841DDF40193B01FC" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idBA8FD341E0A7405680483976533335C8"><enum>(10)</enum><text display-inline="yes-display-inline">The term <term>person</term> includes an
affiliate of such person.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBEA1F5A1D18646C0884414723BE653B8"><enum>(7)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id8C4AFE4F1BE74FC29677983FE2954067" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID8f63d2da37714208b1d5554f0ab7152e"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>establishment subject to a
registration fee</term> means an establishment required to register with the
Secretary under section 510 at which any of the following types of activities
are conducted:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDa2d911a1ef5740818925036f71dab618"><enum>(A)</enum><header display-inline="yes-display-inline">Manufacturer</header><text display-inline="yes-display-inline">An establishment that makes by any means
any article that is a device including an establishment that sterilizes or
otherwise makes such article for or on behalf of a specification developer or
any other person.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID8bedc6da0ad147968e31dfda7d23ea09"><enum>(B)</enum><header display-inline="yes-display-inline">Single-use device reprocessor</header><text display-inline="yes-display-inline">An establishment that performs
manufacturing operations on a single-use device that has previously been used
on a patient.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID1f2d00fff3a24efeb534b745e18c9023"><enum>(C)</enum><header display-inline="yes-display-inline">Specification developer</header><text display-inline="yes-display-inline">An establishment that develops
specifications for a device that is distributed under the establishment’s name
but that performs no manufacturing, including establishments that, in addition
to developing specifications, arrange for the manufacturing of devices labeled
with another establishment’s name by a contract manufacturer.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID478e5e9d94cf470faa7c17a6c9a1d0b7"><enum>(13)</enum><text display-inline="yes-display-inline">The term <term>establishment registration
fee</term> means a fee assessed under section 738(a)(3) for the registration of
an establishment subject to a registration fee.</text>
</paragraph><subsection commented="no" display-inline="no-display-inline" id="id811A6C4FB66D461180B465CC5096A498"><enum>(e)</enum><header display-inline="yes-display-inline">Sunset</header><text display-inline="yes-display-inline">This part shall cease to be effective on
October 1, 2012, except that subsection (b) with respect to reports shall cease
to be effective January 31,
2013.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id3B5ECE3D92104E82A6BFE6C69494F4CA" section-type="subsequent-section"><enum>303.</enum><header display-inline="yes-display-inline">Authority to assess and use device
fees</header><text display-inline="no-display-inline">Section 738 (21 U.S.C.
379j) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id85669DF79B5B45EFB5A98D5E096067AD"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id26E8DBF271564EF3A1C4B7A116995AD7"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="id3ABEE5E9B46F4FBCA19064101A10849C"><enum>(i)</enum><text display-inline="yes-display-inline">in the header, by inserting
<quote><header-in-text level="paragraph" style="OLC">, and annual fee for
periodic reporting concerning a class III device</header-in-text></quote> after
<quote><header-in-text level="subparagraph" style="OLC">fee</header-in-text></quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF2303B37CA5C451CA1A5D7443234A416"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<subclause commented="no" display-inline="no-display-inline" id="idE77C92EEF55A4AFCB00C38B0E9D9B89A"><enum>(I)</enum><text display-inline="yes-display-inline">in clause (iii), by inserting <quote>75
percent of</quote> after <quote>a fee equal to</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id7E3557DB06C1493F824F913C2C80B0CE"><enum>(II)</enum><text display-inline="yes-display-inline">in clause (iv), by striking
<quote>21.5</quote> and inserting <quote>15</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id3EDB1AEAAC8C47FABD7BEF0B448F0231"><enum>(III)</enum><text display-inline="yes-display-inline">in clause (v), by striking
<quote>7.2</quote> and inserting <quote>7</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idD5A975497AB44AD580C4DAA50CF91FAF"><enum>(IV)</enum><text display-inline="yes-display-inline">by redesignating clauses (vi) and (vii) as
clauses (vii) and (viii), respectively;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id54D6D61B9A44447C8DE24C61132E1DC2"><enum>(V)</enum><text display-inline="yes-display-inline">by inserting after clause (v) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id42EC629923E44AAE92DD2DF2CFECE5F6" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="id74DD00D354FC4E558C0650DD8CD2A2B1"><enum>(vi)</enum><text display-inline="yes-display-inline">For a 30-day notice, a fee equal to 1.6
percent of the fee that applies under clause
(i).</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idE06BE7A60E534813AE7392CBDAA92CFA"><enum>(VI)</enum><text display-inline="yes-display-inline">in clause (viii), as redesignated by
subclause (IV)—</text>
<item commented="no" display-inline="no-display-inline" id="idBB1D6C6AFFFD467AA75E4EC4D0A069F5"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>1.42</quote> and
inserting <quote>1.84</quote>; and</text>
</item><item commented="no" display-inline="no-display-inline" id="id1EF501F23CA74542BE70C943A7020171"><enum>(bb)</enum><text display-inline="yes-display-inline">by striking <quote>, subject to any
adjustment under subsection (e)(2)(C)(ii)</quote>; and</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="idC27C66EBB19D4A03B90FB25DD3677E8E"><enum>(VII)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9B1F55B318F347F9849A8AA0B011F3F6" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="ID96ac5d2b86b346a98705a6aa5162af15"><enum>(ix)</enum><text display-inline="yes-display-inline">For a request for classification
information, a fee equal to 1.35 percent of the fee that applies under clause
(i).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDe083dcacbfb0421994b046cff749948f"><enum>(x)</enum><text display-inline="yes-display-inline">For periodic reporting concerning a class
III device, the annual fee shall be equal to 3.5 percent of the fee that
applies under clause
(i).</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id21C3E236C9264CC885E5F89872E3771D"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (C)—</text>
<subclause commented="no" display-inline="no-display-inline" id="idC73516E57D4A4C1F9CE20DC073216759"><enum>(I)</enum><text display-inline="yes-display-inline">in the first sentence—</text>
<item commented="no" display-inline="no-display-inline" id="idE4791D66EECB488187B463841E1FF417"><enum>(aa)</enum><text display-inline="yes-display-inline">by striking <quote>or</quote>; and</text>
</item><item commented="no" display-inline="no-display-inline" id="idFE5D31EE6B1B4272B0E87BD1380F8540"><enum>(bb)</enum><text display-inline="yes-display-inline">by striking <quote>except that</quote> and
all that follows through the period and inserting <quote>, 30-day notice,
request for classification information, or periodic report concerning a class
III device.</quote>; and</text>
</item></subclause><subclause commented="no" display-inline="no-display-inline" id="id20D709D45B454738B892ECCB9CAF3F29"><enum>(II)</enum><text display-inline="yes-display-inline">by striking the third sentence; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id77A33CD303664787A1922B56C56C4B3B"><enum>(iv)</enum><text display-inline="yes-display-inline">in subparagraph (D)—</text>
<subclause commented="no" display-inline="no-display-inline" id="id1DC7D54B38CC41E9B0ABEA21417FCD35"><enum>(I)</enum><text display-inline="yes-display-inline">in clause (iii), by striking the last two
sentences; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id3D31A1544B564C8D95400C3B2815D9D7"><enum>(II)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id453B6ED83E1042F7ACCC00FC6FB10CAC" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="id6B854E2A72AD464C8E751D44ABADD3F2"><enum>(iv)</enum><header display-inline="yes-display-inline">Modular application withdrawn before first
action</header><text display-inline="yes-display-inline">The Secretary shall
refund 75 percent of the application fee paid for a modular application
submitted under section 515(c)(4) that is withdrawn before a second module is
submitted and before a first action on the first module. If the modular
application is withdrawn after a second or subsequent module is submitted but
before any first action, the Secretary may return a portion of the fee. The
amount of refund, if any, shall be based on the level of effort already
expended on the review of the modules submitted.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5E2F65BF7F254560A4A3B316B385A8E9"><enum>(v)</enum><header display-inline="yes-display-inline">Sole discretion to refund</header><text display-inline="yes-display-inline">The Secretary shall have sole discretion to
refund a fee or portion of the fee under this subparagraph. A determination by
the Secretary concerning a refund under this paragraph shall not be
reviewable.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBD69A90DAE09430AA2A6C22BB5E6A9E7"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id799A525C719B4C3DA3971D69360CAE8E" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idA4DC62BEE10741C4B5466A58F3046021"><enum>(3)</enum><header display-inline="yes-display-inline">Annual establishment registration
fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID7bf2eda4194d4ca08c4852db8f11d563"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in subparagraph (B),
each establishment subject to a registration fee shall be subject to a fee for
each initial or annual registration beginning with its registration for fiscal
year 2008.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc770bd1f0723491587a2fd1ea4b95fc4"><enum>(B)</enum><header display-inline="yes-display-inline">Exception for federal or state government
establishment</header><text display-inline="yes-display-inline">No fee shall be
required under subparagraph (A) for an establishment operated by a Federal or
State government entity unless a device manufactured by the establishment is to
be distributed commercially.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID9de69231f8c54bce8fc8f98b10ea3dc1"><enum>(C)</enum><header display-inline="yes-display-inline">Payment</header><text display-inline="yes-display-inline">The annual establishment registration fee
shall be due once each fiscal year, upon the initial registration of the
establishment or upon the annual registration under section
510.</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC28FEE81CCB34BD4A58B555DB5D12E0D"><enum>(2)</enum><text display-inline="yes-display-inline">by striking subsection (b) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id66FA6115AA734D499B705822C77DE98F" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id81EFF6247B324E478C35455E3A4B685E"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header><text display-inline="yes-display-inline">Except as provided in subsections (c), (d),
and (e), the fees under subsection (a) shall be based on the following fee
amounts:</text>
<table align-to-level="section" blank-lines-after="0" blank-lines-before="1" frame="all" line-rules="all-gen" rule-weights="4.4.4.4.4.0" subformat="S6211" table-type="6-Generic:-1-text,-5-num">
<tgroup cols="6" fnote-size="0" grid-typeface="1.1" thead-tbody-ldg-size="10.10.12" ttitle-size="0"><colspec align="left" coldef="txt-no-ldr" colname="col1" colsep="1" colwidth="93" min-data-value="60" rowsep="1"></colspec><colspec align="right" coldef="fig" colname="col2" colsep="1" colwidth="74" min-data-value="8"></colspec><colspec align="right" coldef="fig" colname="col3" colsep="1" colwidth="74" min-data-value="8"></colspec><colspec align="right" coldef="fig" colname="col4" colsep="1" colwidth="74" min-data-value="8"></colspec><colspec align="right" coldef="fig" colname="col5" colsep="1" colwidth="74" min-data-value="8"></colspec><colspec align="right" coldef="fig" colname="col6" colsep="1" colwidth="74" min-data-value="8"></colspec>
<thead>
<row><entry align="center" colname="col1" rowsep="1">Fee
Type</entry><entry align="center" colname="col2" rowsep="1">Fiscal Year
2008</entry><entry align="center" colname="col3" rowsep="1">Fiscal Year
2009</entry><entry align="center" colname="col4" rowsep="1">Fiscal Year
2010</entry><entry align="center" colname="col5" rowsep="1">Fiscal Year
2011</entry><entry align="center" colname="col6" rowsep="1">Fiscal Year
2012</entry>
</row>
</thead>
<tbody>
<row><entry align="left" colname="col1" leader-modify="clr-ldr" rowsep="1" rowsep-modify="bold" stub-definition="txt-clr" stub-hierarchy="1">Premarket Application</entry><entry align="right" colname="col2" leader-modify="force-ldr" rowsep="1" rowsep-modify="bold">$185,000</entry><entry align="right" colname="col3" leader-modify="force-ldr" rowsep="1" rowsep-modify="bold">$200,725</entry><entry align="right" colname="col4" leader-modify="force-ldr" rowsep="1" rowsep-modify="bold">$217,787</entry><entry align="right" colname="col5" leader-modify="force-ldr" rowsep="1" rowsep-modify="bold">$236,298</entry><entry align="right" colname="col6" leader-modify="force-ldr" rowsep="1" rowsep-modify="bold">$256,384</entry>
</row>
<row><entry align="left" colname="col1" leader-modify="clr-ldr" rowsep="0" stub-definition="txt-clr" stub-hierarchy="1">Establishment
Registration Fee</entry><entry align="right" colname="col2" leader-modify="force-ldr" rowsep="1">$1,706</entry><entry align="right" colname="col3" leader-modify="force-ldr" rowsep="1">$1,851</entry><entry align="right" colname="col4" leader-modify="force-ldr" rowsep="1">$2,008</entry><entry align="right" colname="col5" leader-modify="force-ldr" rowsep="1">$2,179</entry><entry align="right" colname="col6" leader-modify="force-ldr" rowsep="1">$2,364</entry>
</row>
</tbody>
</tgroup></table>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idF1F958B5A938421BABC6A0255B321844"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (c)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1D039EBB8FE946E58BEC3CFA60708125"><enum>(A)</enum><text display-inline="yes-display-inline">in the heading, by striking <quote>Annual
Fee Setting.—</quote> and inserting <quote><header-in-text level="subsection" style="OLC">Annual Fee Setting.—</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idEE91A6758CAE42C7A27896CCDDD1B24E"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking the second
sentence;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE822481A541E4FDDA2487D7D22095BF4"><enum>(C)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (2) and (3) as
paragraphs (3) and (4), respectively;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3A1960BE4F0F4B268F1E0E6F0D3C1B9B"><enum>(D)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id9F0D86A1369240919347A30B3554A7B7" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idFA35B374036146BBA6C0C333C5135AFA"><enum>(2)</enum><header display-inline="yes-display-inline">Adjustment of annual establishment
registration fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID160c9837497e4f5fa9cb3b1541b17d21"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">When setting the fees for fiscal year 2010,
the Secretary may increase the establishment registration fee specified in
subsection (b) only if the Secretary estimates that the number of
establishments submitting fees for fiscal year 2009 is less than 12,250. The
percent increase shall be the percent by which the estimate of establishments
submitting fees in fiscal year 2009 is less than 12,750, but in no case shall
the percent increase be more than 8.5 percent over the amount for such fee
specified in subsection (b) for fiscal year 2010. If the Secretary makes any
adjustment to the establishment registration fee for fiscal year 2010, then the
establishment registration fee for fiscal years 2011 and 2012 under subsection
(b) shall be adjusted as follows: the fee for fiscal year 2011 shall be equal
to the adjusted fee for fiscal year 2010, increased by 8.5 percent, and the fee
for fiscal year 2012 shall be equal to the adjusted fee for fiscal year 2011,
increased by 8.5 percent.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe13e8319cf6b478797b1339d777b9d9a"><enum>(B)</enum><header display-inline="yes-display-inline">Publication in the federal
register</header><text display-inline="yes-display-inline">The Secretary shall
publish any determination with respect to any establishment registration fee
adjustment made under subparagraph (A), and the rationale for such
determination, in the Federal Register.</text>
</subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2B30A8DE582A4A6AA32C8A396E088663"><enum>(E)</enum><text display-inline="yes-display-inline">in paragraph (4)(A), as so
redesignated—</text>
<clause commented="no" display-inline="no-display-inline" id="id553BEC130D1D46128DBC5401048EAD98"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>For fiscal years 2006
and 2007, the</quote> and inserting <quote>The</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id42E2370F19B242338DB82E4E3CA85479"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>of fiscal year
2008</quote> and inserting <quote>of the next fiscal year</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id05A81A9C916E4FF39F90FB3816985B0A"><enum>(4)</enum><text display-inline="yes-display-inline">in subsection (d)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idE55BA149D199452BA81D91CB31CFA808"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>,
partners, and parent firms</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idADC09EAC0FDC41018AE84549C6378222"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="id39135EB1957541A98F4066F3BF07C17A"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>,
partners, and parent firms</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5CF19433B0064CEAB3B1D03470FE0620"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (B)—</text>
<subclause commented="no" display-inline="no-display-inline" id="idA78F154CEA1C4BEDA2BBEAE8DECDB663"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>An applicant
shall</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id3DBF64D85D99472686E235F2B975CE71" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="idCED80BF0B1F9422985FABED59F3001E8"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An applicant
shall</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id4CA283B3EB6247E997F2C77210B825B6"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>The applicant shall
support</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idA122067D6F6C46D090C854A6E5291129" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="id812D28D55C614166B836658A1633B9A5"><enum>(ii)</enum><header display-inline="yes-display-inline">Firms submitting tax returns to the united
states internal revenue service</header><text display-inline="yes-display-inline">The applicant shall
support</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idE0CFCC40242246F7BC4463D31AA8FC93"><enum>(III)</enum><text display-inline="yes-display-inline">by striking <quote>, partners, and parent
firms</quote> both places the term appears;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id75CF4E2E3846404EB50F028297A3287D"><enum>(IV)</enum><text display-inline="yes-display-inline">by striking <quote>partners, or parent
firms, the</quote> and inserting <quote>the</quote>;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id60057D6D7DC344A0AC1CAF7AA67D0567"><enum>(V)</enum><text display-inline="yes-display-inline">by striking <quote>, partners, or parent
firms, respectively</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id7665D62EE2C64D7380B0220CE8F62B01"><enum>(VI)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id67DE368AE8FE463BA1B1A3C1C9428657" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="idEF63B0352B974A929C9E9A86B4A9E313"><enum>(iii)</enum><header display-inline="yes-display-inline">Firms not submitting tax returns to the
united states internal revenue service</header><text display-inline="yes-display-inline">The applicant shall support its claim that
it meets the definition under subparagraph (A) by submission of the
following:</text>
<subclause commented="no" display-inline="no-display-inline" id="ID7e2d375cb562461fb92e0c5f6f5e5e8f"><enum>(I)</enum><text display-inline="yes-display-inline">A signed certification, in such form as the
Secretary may direct through a notice published in the Federal Register, that
the applicant meets the criteria for a small business.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID49f8d287e7664a4a95fc1abb278fe6bc"><enum>(II)</enum><text display-inline="yes-display-inline">A certification, in English, from the
national taxing authority of the country in which it is headquartered. Such
certification shall provide the applicant's gross receipts and sales for the
most recent year, in both the local currency and in United States dollars, the
exchange rate used in making this conversion to dollars, and the dates during
which these receipts and sales were collected, and it shall bear the official
seal of the national taxing authority.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDfa6a5308c0004d789d681c64e480dbf5"><enum>(III)</enum><text display-inline="yes-display-inline">Identical certifications shall be provided
for each of the applicant's affiliates.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDc15ca94ce20e4ae0bacad5b35e9e7eb3"><enum>(IV)</enum><text display-inline="yes-display-inline">A statement signed by the head of the
applicant or its chief financial officer that it has submitted certifications
for all of its affiliates, or that it had no affiliates, whichever is
applicable.</text>
</subclause></clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id745C87A51F8F47DBB87EA12BABFA17A9"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (C)—</text>
<subclause commented="no" display-inline="no-display-inline" id="id8D49AAA6D3EC4DB794FBF8F869B6A060"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>reduced rate of </quote>
and inserting <quote>reduced rate of—</quote>; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id88F592618259461ABA5869C678A3C407"><enum>(II)</enum><text display-inline="yes-display-inline">by striking <quote>38 percent</quote> and
all that follows through the period and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idA664B53D31624D22ADE3918D0D8236A1" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="id574125D119194D97BDEF907CC456C136"><enum>(i)</enum><text display-inline="yes-display-inline">25 percent of the fee established under
such subsection for a premarket application, a premarket report, a supplement,
or a periodic report concerning a class III device; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID1557956160a840a8a622f979ae346f14"><enum>(ii)</enum><text display-inline="yes-display-inline">50 percent of the fee established under
such subsection for a 30-day notice or a request for classification
information.</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEBE67D8F62174B378634338790E04A28"><enum>(5)</enum><text display-inline="yes-display-inline">in subsection (e)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id87586D97971D40368AC52464C3F2C80B"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking
<quote>2004</quote> and inserting <quote>2008</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC0F43DDE9BB44E9499E91154EC88EF2C"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="idFC5FDE0117994B1D86C28B1DEE2DE16B"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>,
partners, and parent firms</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idB502471A2E5C4B5C86B26EB1939F3473"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking subparagraph (B) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id37C1F398DB9044F3914E6492F4BD0D79" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id8BFBE77FB1DA4F59AA2712C7F164C013"><enum>(B)</enum><header display-inline="yes-display-inline">Evidence of qualification</header>
<clause commented="no" display-inline="no-display-inline" id="ID50a3a2d46e2a463cbc0ec7dc8307411a"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An applicant shall pay the higher fees
established by the Secretary each year unless the applicant submits evidence
that it qualifies for the lower fee rate.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDdc8eef741b6b474cb8b271b890fc331b"><enum>(ii)</enum><header display-inline="yes-display-inline">Firms submitting tax returns to the united
states internal revenue service</header><text display-inline="yes-display-inline">The applicant shall support its claim that
it meets the definition under subparagraph (A) by submission of a copy of its
most recent Federal income tax return for a taxable year, and a copy of such
returns of its affiliates, which show an amount of gross sales or receipts that
is less than the maximum established in subparagraph (A). The applicant, and
each of such affiliates, shall certify that the information provided is a true
and accurate copy of the actual tax forms they submitted to the Internal
Revenue Service. If no tax forms are submitted for affiliates, the applicant
shall certify that the applicant has no affiliates.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDf4390dbf0f8e40d0a9f04675915dae33"><enum>(iii)</enum><header display-inline="yes-display-inline">Firms not submitting tax returns to the
united states internal revenue service</header><text display-inline="yes-display-inline">The applicant shall support its claim that
it meets the definition under subparagraph (A) by submission of the
following:</text>
<subclause commented="no" display-inline="no-display-inline" id="IDd9edc624c0094de894e17a600b4f7ff2"><enum>(I)</enum><text display-inline="yes-display-inline">A signed certification, in such form as the
Secretary may direct through a notice published in the Federal Register, that
the applicant meets the criteria for a small business.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID01ec6181e7dd4e9bbd50b476b66d2524"><enum>(II)</enum><text display-inline="yes-display-inline">A certification, in English, from the
national taxing authority of the country in which it is headquartered. Such
certification shall provide the applicant's gross receipts and sales for the
most recent year, in both the local currency and in United States dollars, and
the exchange rate used in making such conversion to dollars, and the dates
during which such receipts and sales were collected, and it shall bear the
official seal of the national taxing authority.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3eb4bcca86444113b481e50826ddeab0"><enum>(III)</enum><text display-inline="yes-display-inline">Identical certifications shall be provided
for each of the applicant's affiliates.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDd239c2960c0e4c59bca7f1863279fd33"><enum>(IV)</enum><text display-inline="yes-display-inline">A statement signed by the head of the
applicant or its chief financial officer that it has submitted certifications
for all of its affiliates, or that it had no affiliates, whichever is
applicable.</text>
</subclause></clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="id31228C0DB8A3414FA26909DF31E21C04"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking subparagraph (C) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id684853D8CBD3413F9D50919629BF6E8D" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="idB9312BDEF98C4DB4997A53768F15AED6"><enum>(C)</enum><header display-inline="yes-display-inline">Reduced fees</header><text display-inline="yes-display-inline">For fiscal year 2008 and each subsequent
fiscal year, where the Secretary finds that the applicant involved meets the
definition under subparagraph (A), the fee for a premarket notification
submission may be paid at 50 percent of the fee that applies under subsection
(a)(2)(A)(viii) and as established under subsection
(c)(1).</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2D31B7E4F3CA44A1AFAB81B3FECE8287"><enum>(6)</enum><text display-inline="yes-display-inline">by striking subsection (f) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="idE7669C48D35A421C961C348FF27BC10C" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idF5B344E85A6F4AE7B1F33D6BDA67F5D5"><enum>(f)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID39f8629d6e1242e4ad469f5eb8442e55"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A premarket application, premarket report,
supplement, or premarket notification submission, 30-day notice, request for
classification information, or periodic report concerning a class III device
submitted by a person subject to fees under paragraphs (2) and (3) of
subsection (a) shall be considered incomplete and shall not be accepted by the
Secretary until all fees owed by such person have been paid.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3c17825699c94f4993c9743c7e6f4fec"><enum>(2)</enum><header display-inline="yes-display-inline">Registration information</header><text display-inline="yes-display-inline">Registration information submitted by an
establishment subject to a registration fee under subsection (a)(3) shall be
considered incomplete and shall not be accepted by the Secretary until the
registration fee owed for the establishment has been paid. Until the fee is
paid and the registration is complete, the establishment shall be deemed to
have failed to register in accordance with section
510.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id976C9C04C1E14FACAE1BF2C38B4296AB"><enum>(7)</enum><text display-inline="yes-display-inline">in subsection (g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6263D33FDAB943DDA104A837E12BBB1A"><enum>(A)</enum><text display-inline="yes-display-inline">by striking paragraph (1) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="idE3F0B09B3ED343FF85D690452244A369" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idC7641C4147C845E089B62BCB350527A8"><enum>(1)</enum><header display-inline="yes-display-inline">Performance goals; termination of
program</header><text display-inline="yes-display-inline">With respect to the
amount that, under the salaries and expenses account of the Food and Drug
Administration, is appropriated for a fiscal year for devices and radiological
products, fees may not be assessed under subsection (a) for the fiscal year,
and the Secretary is not expected to meet any performance goals identified for
the fiscal year, if—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID125360bb1f674ad28b8bee01641f8aa9"><enum>(A)</enum><text display-inline="yes-display-inline">the amount so appropriated for the fiscal
year, excluding the amount of fees appropriated for the fiscal year, is more
than 1 percent less than $205,720,000 multiplied by the adjustment factor
applicable to such fiscal year; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID58f282daf43446c6b341b0878d063cfe"><enum>(B)</enum><text display-inline="yes-display-inline">fees were not assessed under subsection (a)
for the previous fiscal year.</text>
</subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id95CB1D2783EB4AEDA5137FE5E1876075"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>and
premarket notification submissions, and</quote> and inserting <quote>premarket
notification submissions, 30-day notices, requests for classification
information, periodic reports concerning a class III device, and establishment
registrations</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idEB8F41CD95EB4E668AD03A421F2B3BD2"><enum>(8)</enum><text display-inline="yes-display-inline">in subsection (h), by striking paragraphs
(3) and (4) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id472ECC2C00A34924B8EB62B0961C194D" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="IDef5f4d622a91455fba167f932b7c400d"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated for fees under this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDc54558e6b051459382a41f80a8378134"><enum>(A)</enum><text display-inline="yes-display-inline">$48,431,000 for fiscal year 2008;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc6ec336437c043f4a834b8c11747a36f"><enum>(B)</enum><text display-inline="yes-display-inline">$52,547,000 for fiscal year 2009;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb5b15322142941978c2d6841065e9052"><enum>(C)</enum><text display-inline="yes-display-inline">$57,014,000 for fiscal year 2010;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0c7b8f4c17c140e1a7da30aabb751ab2"><enum>(D)</enum><text display-inline="yes-display-inline">$61,860,000 for fiscal year 2011;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID079a88ff12ee49839e2166c0553c78e8"><enum>(E)</enum><text display-inline="yes-display-inline">$67,118,000 for fiscal year 2012.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID51b8aaedc96f43208f4fd4b0f9766df3"><enum>(4)</enum><header display-inline="yes-display-inline">Offset</header><text display-inline="yes-display-inline">If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, added to the amount estimated to be
collected for fiscal year 2011 (which estimate shall be based upon the amount
of fees received by the Secretary through June 30, 2011), exceeds the amount of
fees specified in aggregate in paragraph (3) for such 4 fiscal years, the
aggregate amount in excess shall be credited to the appropriation account of
the Food and Drug Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be authorized to be
collected under this section pursuant to appropriation Acts for fiscal year
2012.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id28BF69C61E314F3AB4744B9AD86BBCBC" section-type="subsequent-section"><enum>304.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">Notwithstanding section
107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law
107–250), and notwithstanding the amendments made by this subtitle, part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in
effect on the day before the date of enactment of this subtitle, shall continue
to be in effect with respect to premarket applications, premarket reports,
premarket notification submissions, and supplements (as defined in such part as
of such day) that on or after October 1, 2002, but before October 1, 2007, were
accepted by the Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a fiscal year prior
to fiscal year 2008.</text>
</section><section commented="no" display-inline="no-display-inline" id="id10CC86E8947A433DB9BFDD42BFAA9C98" section-type="subsequent-section"><enum>305.</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="no-display-inline">The amendments made by
this subtitle shall take effect on October 1, 2007.</text>
</section></subtitle><subtitle commented="no" id="idEC2FF8B1B1A14D06ACD2FA7C79D32C1C" level-type="subsequent" style="OLC"><enum>B</enum><header display-inline="yes-display-inline">Amendments regarding regulation of medical
devices</header>
<section commented="no" display-inline="no-display-inline" id="ID0f37327089f04625887cc8e0d5869e73" section-type="subsequent-section"><enum>311.</enum><header display-inline="yes-display-inline">Inspections by accredited
persons</header><text display-inline="no-display-inline">Section 704(g) (21
U.S.C. 374(g)) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDda7d9251b04943de86e887b4c787a648"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by striking <quote>Not
later than one year after the date of enactment of this subsection, the
Secretary</quote> and inserting <quote>The Secretary</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6C14688A28364090A28D8912719888B6"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2), by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idA946515AA0C048D19B031EE5053F648E"><enum>(A)</enum><text display-inline="yes-display-inline">striking <quote>Not later than 180 days
after the date of enactment of this subsection, the</quote> and inserting
<quote>The Secretary</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3BC8E9F2D0D946B7A2BA75B7074BF150"><enum>(B)</enum><text display-inline="yes-display-inline">striking the fifth sentence;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa3ffba97c6d34cd4b9be96a06be538a7"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (3), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id3409D18D26A94BE893070FD943BE2932" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="IDaf7df8f4b547401997ee3459ad1aac69"><enum>(F)</enum><text display-inline="yes-display-inline">Such person shall notify the Secretary of
any withdrawal, suspension, restriction, or expiration of certificate of
conformance with the quality systems standard referred to in paragraph (7) for
any device establishment that such person inspects under this subsection not
later than 30 days after such withdrawal, suspension, restriction, or
expiration.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID106f113ea1cc4debb5e88bcebf8eabab"><enum>(G)</enum><text display-inline="yes-display-inline">Such person may conduct audits to establish
conformance with the quality systems standard referred to in paragraph
(7).</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1a26d95adbf242b88ca0ca2a9f59d651"><enum>(4)</enum><text display-inline="yes-display-inline">by amending paragraph (6) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id387DD21308F34450A8D14627F160259F" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idAC14A1A5C2FB4B91A7F746320E55C266" indent="up1"><enum>(6)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id731D8AC0E886465D82AA8D8B8F43604B"><enum>(A)</enum><text display-inline="yes-display-inline">Subject to subparagraphs (B) and (C), a
device establishment is eligible for inspection by persons accredited under
paragraph (2) if the following conditions are met:</text>
<clause commented="no" display-inline="no-display-inline" id="idABDE3DE0B9854D0F9B9C4082B1AEF880" indent="up1"><enum>(i)</enum><text display-inline="yes-display-inline">The Secretary classified the results of the
most recent inspection of the establishment as <quote>no action
indicated</quote> or <quote>voluntary action indicated</quote>.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id60CFD582B3C84E8691AC44DAC9BB59D2" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">With respect to inspections of the
establishment to be conducted by an accredited person, the owner or operator of
the establishment submits to the Secretary a notice that—</text>
<subclause commented="no" display-inline="no-display-inline" id="idA21E835010E743E081E3918CB51428D9"><enum>(I)</enum><text display-inline="yes-display-inline">provides the date of the last inspection of
the establishment by the Secretary and the classification of that
inspection;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idD38D9D4AF122458E89AB8275610905AA"><enum>(II)</enum><text display-inline="yes-display-inline">states the intention of the owner or
operator to use an accredited person to conduct inspections of the
establishment;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id67807555C9E84460B202EE4E925E87AB"><enum>(III)</enum><text display-inline="yes-display-inline">identifies the particular accredited person
the owner or operator intends to select to conduct such inspections; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id243975784D984E00BBD6439A9A69783C"><enum>(IV)</enum><text display-inline="yes-display-inline">includes a certification that, with respect
to the devices that are manufactured, prepared, propagated, compounded, or
processed in the establishment—</text>
<item commented="no" display-inline="no-display-inline" id="id50AB351FC8484D8BB26FE5F99757B450"><enum>(aa)</enum><text display-inline="yes-display-inline">at least 1 of such devices is marketed in
the United States; and</text>
</item><item commented="no" display-inline="no-display-inline" id="idFF206912A1FF4142B0FEF851E8D1742C"><enum>(bb)</enum><text display-inline="yes-display-inline">at least 1 of such devices is marketed, or
is intended to be marketed, in 1 or more foreign countries, 1 of which
countries certifies, accredits, or otherwise recognizes the person accredited
under paragraph (2) and identified under subclause (III) as a person authorized
to conduct inspections of device establishments.</text>
</item></subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4039C07F01D14D77B70547CCFDBD7BCA" indent="up1"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id5F08225867F048599A96281F02C1466B"><enum>(i)</enum><text display-inline="yes-display-inline">Except with respect to the requirement of
subparagraph (A)(i), a device establishment is deemed to have clearance to
participate in the program and to use the accredited person identified in the
notice under subparagraph (A)(ii) for inspections of the establishment unless
the Secretary, not later than 30 days after receiving such notice, issues a
response that—</text>
<subclause commented="no" display-inline="no-display-inline" id="id8910EE220D984FE988E1638D33B4F0FD" indent="up1"><enum>(I)</enum><text display-inline="yes-display-inline">denies clearance to participate as provided
under subparagraph (C); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idE82FAE439A9E4B44ABA26566900E5A54" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">makes a request under clause (ii).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idA9A06EC93E414FB2B82D313D67C69B5D" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">The Secretary may request from the owner or
operator of a device establishment in response to the notice under subparagraph
(A)(ii) with respect to the establishment, or from the particular accredited
person identified in such notice—</text>
<subclause commented="no" display-inline="no-display-inline" id="id422DF9755011455DA78F47E59CE3287D"><enum>(I)</enum><text display-inline="yes-display-inline">compliance data for the establishment in
accordance with clause (iii)(I); or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id2306807B17164391AB6720EB56AB1980"><enum>(II)</enum><text display-inline="yes-display-inline">information concerning the relationship
between the owner or operator of the establishment and the accredited person
identified in such notice in accordance with clause (iii)(II).</text>
<continuation-text commented="no" continuation-text-level="subclause">The owner or operator of the
establishment, or such accredited person, as the case may be, shall respond to
such a request not later than 60 days after receiving such request.</continuation-text></subclause></clause><clause commented="no" display-inline="no-display-inline" id="idA9F42CEEAEF742DF9266B099BF9C8144" indent="up1"><enum>(iii)</enum><subclause commented="no" display-inline="yes-display-inline" id="idC49DC22B345645B2A264FE2D44384A3D"><enum>(I)</enum><text display-inline="yes-display-inline">The compliance data to be submitted by the
owner or operation of a device establishment in response to a request under
clause (ii)(I) are data describing whether the quality controls of the
establishment have been sufficient for ensuring consistent compliance with
current good manufacturing practice within the meaning of section 501(h) and
with other applicable provisions of this Act. Such data shall include complete
reports of inspectional findings regarding good manufacturing practice or other
quality control audits that, during the preceding 2-year period, were conducted
at the establishment by persons other than the owner or operator of the
establishment, together with all other compliance data the Secretary deems
necessary. Data under the preceding sentence shall demonstrate to the Secretary
whether the establishment has facilitated consistent compliance by promptly
correcting any compliance problems identified in such inspections.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idBAC4894A16A349D789739E208C6D0BE1" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">A request to an accredited person under
clause (ii)(II) may not seek any information that is not required to be
maintained by such person in records under subsection (f)(1).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id905828FCEC67450694278AD012FF9E9D" indent="up1"><enum>(iv)</enum><text display-inline="yes-display-inline">A device establishment is deemed to have
clearance to participate in the program and to use the accredited person
identified in the notice under subparagraph (A)(ii) for inspections of the
establishment unless the Secretary, not later than 60 days after receiving the
information requested under clause (ii), issues a response that denies
clearance to participate as provided under subparagraph (C).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2C950599F7A94A32954093EBDA0C2BAC" indent="up1"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="idE90F4F67021441CDACD72E6B2A6BC3D5"><enum>(i)</enum><text display-inline="yes-display-inline">The Secretary may deny clearance to a
device establishment if the Secretary has evidence that the certification under
subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or
operator of the establishment a statement summarizing such evidence.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idC9A6B8F1B7354CC8B186EC9B3FB99AB0" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">The Secretary may deny clearance to a
device establishment if the Secretary determines that the establishment has
failed to demonstrate consistent compliance for purposes of subparagraph
(B)(iii)(I) and the Secretary provides to the owner or operator of the
establishment a statement of the reasons for such determination.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id9408DBBCC2CD4E339777540520DA0A81" indent="up1"><enum>(iii)</enum><subclause commented="no" display-inline="yes-display-inline" id="id1A7455047694456CA211A4BB8CA55C56"><enum>(I)</enum><text display-inline="yes-display-inline">The Secretary may reject the selection of
the accredited person identified in the notice under subparagraph (A)(ii) if
the Secretary provides to the owner or operator of the establishment a
statement of the reasons for such rejection. Reasons for the rejection may
include that the establishment or the accredited person, as the case may be,
has failed to fully respond to the request, or that the Secretary has concerns
regarding the relationship between the establishment and such accredited
person.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idE73B5FF3ED5F494DB13880A2CC465DC5" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">If the Secretary rejects the selection of
an accredited person by the owner or operator of a device establishment, the
owner or operator may make an additional selection of an accredited person by
submitting to the Secretary a notice that identifies the additional selection.
Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause,
apply to the selection of an accredited person through a notice under the
preceding sentence in the same manner and to the same extent as such provisions
apply to a selection of an accredited person through a notice under
subparagraph (A)(ii).</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="id2432917DE893482AA2E41CC6DC9FE985" indent="up1"><enum>(iv)</enum><text display-inline="yes-display-inline">In the case of a device establishment that
is denied clearance under clause (i) or (ii) or with respect to which the
selection of the accredited person is rejected under clause (iii), the
Secretary shall designate a person to review the statement of reasons, or
statement summarizing such evidence, as the case may be, of the Secretary under
such clause if, during the 30-day period beginning on the date on which the
owner or operator of the establishment receives such statement, the owner or
operator requests the review. The review shall commence not later than 30 days
after the owner or operator requests the review, unless the Secretary and the
owner or operator otherwise
agree.</text>
</clause></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB7C03A7871E344A7A9A21D8E85F9CB55"><enum>(5)</enum><text display-inline="yes-display-inline">in paragraph (7)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDc7e8b2a367be48969040a3e90525636a"><enum>(A)</enum><text display-inline="yes-display-inline">by amending subparagraph (A) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id9F2F2A4C27AE4E60A2E7AB813F57602D" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ID837dd1f31e0446cd9b0d682472caea3c"><enum>(A)</enum><text display-inline="yes-display-inline">Persons accredited under paragraph (2) to
conduct inspections shall record in writing their inspection observations and
shall present the observations to the device establishment's designated
representative and describe each observation. Additionally, such accredited
person shall prepare an inspection report in a form and manner designated by
the Secretary to conduct inspections, taking into consideration the goals of
international harmonization of quality systems standards. Any official
classification of the inspection shall be determined by the
Secretary.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf39e4e0d09de4c6ebbe02cb0b0701a38"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id1B74E0B0E1BB4E17AC91B4B53D8E53E0" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ID8d0ceb13e46c486d979d0974a8562c1b"><enum>(F)</enum><text display-inline="yes-display-inline">For the purpose of setting risk-based
inspectional priorities, the Secretary shall accept voluntary submissions of
reports of audits assessing conformance with appropriate quality systems
standards set by the International Organization for Standardization (ISO) and
identified by the Secretary in public notice. If the owner or operator of an
establishment elects to submit audit reports under this subparagraph, the owner
or operator shall submit all such audit reports with respect to the
establishment during the preceding 2-year
periods.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id32C019B486BF4B4AA925A28848C2C830"><enum>(6)</enum><text display-inline="yes-display-inline">in paragraphs (10)(C)(iii), by striking
<quote>based</quote> and inserting <quote>base</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="IDc75938d372dc4e24857d083aa1835a9f" section-type="subsequent-section"><enum>312.</enum><header display-inline="yes-display-inline">Extension of authority for third party
review of premarket notification</header><text display-inline="no-display-inline">Section 523(c) (<external-xref legal-doc="usc" parsable-cite="usc/21/360m">21 U.S.C. 360m(c)</external-xref>) is
amended by striking <quote>2007</quote> and inserting
<quote>2012</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="ID99b6f0288ecb454e96b78119c11e76aa" section-type="subsequent-section"><enum>313.</enum><header display-inline="yes-display-inline">Registration</header>
<subsection commented="no" display-inline="no-display-inline" id="IDaffb7f62935b471d872e729924de0be5"><enum>(a)</enum><header display-inline="yes-display-inline">Annual registration of producers of drugs
and devices</header><text display-inline="yes-display-inline">Section 510(b)
(<external-xref legal-doc="usc" parsable-cite="usc/21/359">21 U.S.C. 359(b)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDe16a59511d5142e8a997d20628becd5c"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating the existing text as
paragraph (1), and indenting and relocating it appropriately;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa765379ab6d145da8b313f05b443b970"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (1), as so redesignated, by
striking <quote>or a device or devices</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDf6cbaa6ef5c641fab7e8223816577333"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following new
paragraph:</text>
<quoted-block display-inline="no-display-inline" id="idEDB9E2F3C5D140C7BBB856D6353A2267" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="IDfc7dabd5670d49e5b7d46b1e4998c053"><enum>(2)</enum><text display-inline="yes-display-inline">Between October 1 and December 31 of each
year every person who owns or operates any establishment in any State engaged
in the manufacture, preparation, propagation, compounding, or processing of a
device or devices shall register with the Secretary his name, places of
business, and all such
establishments.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID7dc981ad3b224c3992d4ca2023d91665"><enum>(b)</enum><header display-inline="yes-display-inline">Registration of foreign
establishments</header><text display-inline="yes-display-inline">Section
510(i)(1) (<external-xref legal-doc="usc" parsable-cite="usc/21/359">21 U.S.C. 359(i)(1)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID57057bd1f6a941f2851a045f45303b4a"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating the existing text as
subparagraph (A), and indenting and relocating it appropriately;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID75aa5e5e2fbd43129ef9ab3a71b3d7da"><enum>(2)</enum><text display-inline="yes-display-inline">in subparagraph (A), as so
redesignated—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDfde5610832a347689d2c2036a9a17148"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>processing of a drug or
a device that is imported</quote> and inserting <quote>processing of a drug
that is imported</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID28208194f6754b5993cacd00333c0eef"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>or device</quote> each
place it appears; and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDe0ea865446924973991b31286163a64c"><enum>(3)</enum><text display-inline="yes-display-inline">by adding after such subparagraph (A) the
following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="idDCF9BBC391974469B21310FB1046C54E" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ID7a2897feea3e44c58379c5c710840293"><enum>(B)</enum><text display-inline="yes-display-inline">Between October 1 and December 31 of each
year, any establishment within any foreign country engaged in the manufacture,
preparation, propagation, compounding, or processing of a device that is
imported or offered for import into the United States shall, through electronic
means in accordance with the criteria of the Secretary, register with the
Secretary the name and place of business of the establishment, the name of the
United States agent for the establishment, the name of each importer of such
device in the United States that is known to the establishment, and the name of
each person who imports or offers for import such device to the United States
for purposes of
importation.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="IDb31f8ae9114e426d9c309c3532b20791" section-type="subsequent-section"><enum>314.</enum><header display-inline="yes-display-inline">Filing of lists of drugs and devices
manufactured prepared, propagated and compounded by registrants; statements;
accompanying disclosures</header><text display-inline="no-display-inline">Section 510(j)(2) (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(j)(2)</external-xref> is
amended, in the matter preceding subparagraph (A), to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idD56BC950BFC44C669266D1533DB8952C" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="IDfaef1b6df740456aa95de2bc6f051e73"><enum>(2)</enum><text display-inline="yes-display-inline">Each person who registers with the
Secretary under this section shall report to the Secretary (i) with regard to
drugs, once during the month of June of each year and once during the month of
December of each year, and (ii) with regard to devices, once each year between
October 1 and December 31, the following
information:</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="IDe96a54d5ae1d449b8fcd2f574578f5f8" section-type="subsequent-section"><enum>315.</enum><header display-inline="yes-display-inline">Electronic registration and
listing</header><text display-inline="no-display-inline">Section 510(p) (21
U.S.C. 360(p)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idDA83B740D04445F5AADBFE6C57877CD9" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="IDdd1bf3a4a40d4b4c8f8419263bcc0402"><enum>(p)</enum><paragraph commented="no" display-inline="yes-display-inline" id="idEC6579A3A9524179B50E596678BE193F"><enum>(1)</enum><text display-inline="yes-display-inline">With regard to any establishment engaged in
the manufacture, preparation, propagation, compounding, or processing of a
drug, registrations under subsections (b), (c), (d), and (i) of this section
(including the submission of updated information) shall be submitted to the
Secretary by electronic means, upon a finding by the Secretary that the
electronic receipt of such registrations is feasible, unless the Secretary
grants a request for waiver of such requirement because use of electronic means
is not reasonable for the person requesting such waiver.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDdd48c49a5d45492d8ed00a85f068c809" indent="up1"><enum>(2)</enum><text display-inline="yes-display-inline">With regard to any establishment engaged in
the manufacture, preparation, propagation, compounding, or processing of a
device, the registration and listing information required by this section shall
be submitted to the Secretary by electronic means, unless the Secretary grants
a waiver because electronic registration and listing is not reasonable for the
person requesting such
waiver.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><enum>IV</enum><header display-inline="yes-display-inline">Pediatric Medical Products</header>
<subtitle commented="no" id="id9A8967D28B4E4D2DB369EB31B851E2D2" level-type="subsequent" style="OLC"><enum>A</enum><header display-inline="yes-display-inline">Best pharmaceuticals for children</header>
<section commented="no" display-inline="no-display-inline" id="idA8A323456E3C436F974BE1605C3CFFC0" section-type="subsequent-section"><enum>401.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the
<quote><short-title>Best Pharmaceuticals for Children
Amendments of 2007</short-title></quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="IDf42aa039057741c6bf2780987d3e9fab" section-type="subsequent-section"><enum>402.</enum><header display-inline="yes-display-inline">Pediatric studies of drugs</header>
<subsection commented="no" display-inline="no-display-inline" id="idF92956A00C6C47349E5800B5CA2863F0"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 505A of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idE2FB53D57913416DB4D52D4D08376BF7"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a), by inserting before the
period at the end the following: <quote>, and, at the discretion of the
Secretary, may include preclinical studies</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id12D47BF5CB9246CF9637ADB31B69276B"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2690768B4786422F9528365075CE63B1"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)(i), by striking
<quote>(D)</quote> both places it appears and inserting
<quote>(E)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1587E3D5AEF442A98129DC822F87AECF"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)(ii), by striking
<quote>(D)</quote> and inserting <quote>(E)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2A230ADA31CB4778892FD829234E74BA"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>(1)(A)(i)</quote> and
inserting <quote>(A)(i)(I)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idAF1E5E837696403C82DFB30CEE8CDE81"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>(ii) the</quote> and
inserting <quote>(II) the</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF0E1FD6E758D4CBEB14D24725C47D589"><enum>(E)</enum><text display-inline="yes-display-inline">by striking <quote>(B) if the drug is
designated</quote> and inserting <quote>(ii) if the drug is
designated</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF868503F7B244956B9BF4C427DD01349"><enum>(F)</enum><text display-inline="yes-display-inline">by striking <quote>(2)(A)</quote> and
inserting <quote>(B)(i)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD046593A2A7F4E908C87448F3023F484"><enum>(G)</enum><text display-inline="yes-display-inline">by striking <quote>(i) a listed
patent</quote> and inserting <quote>(I) a listed patent</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id93240496CF58408D8A6410542984606E"><enum>(H)</enum><text display-inline="yes-display-inline">by striking <quote>(ii) a listed
patent</quote> and inserting <quote>(II) a listed patent</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id882E446A229C48889EC4005798BCE097"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>(B) if the drug is the
subject</quote> and inserting <quote>(ii) if the drug is the
subject</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id97F9FB1C5EB140E9B97254EA98E41DEF"><enum>(J)</enum><text display-inline="yes-display-inline">by striking <quote>If</quote> and all that
follows through <quote>subsection (d)(3)</quote> and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id096E151B5DDC48FCA047CC34D24856A1" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id96F31ECD5AD34B8EBD6A3CC1060BD17B"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), if,
prior to approval of an application that is submitted under section 505(b)(1),
the Secretary determines that information relating to the use of a new drug in
the pediatric population may produce health benefits in that population, the
Secretary makes a written request for pediatric studies (which shall include a
timeframe for completing such studies), the applicant agrees to the request,
such studies are completed using appropriate formulations for each age group
for which the study is requested within any such timeframe, and the reports
thereof are submitted and accepted in accordance with subsection (d)(3), and if
the Secretary determines that labeling changes are appropriate, such changes
are made within the timeframe requested by the
Secretary—</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7537C5CF06594F128D38022B092067CE"><enum>(K)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id210500FF27AE4191BB1D2F175B6C72EE" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id85A7D591FB9D49AEB1AA1CCAFAA2E090"><enum>(2)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The Secretary shall not extend a period
referred to in paragraph (1)(A) or in paragraph (1)(B) if the determination
made under subsection (d)(3) is made less than 9 months prior to the expiration
of such
period.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idFC4A1DCD3DD64464821BC3E9A13097E1"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (c)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6821585771CE4546B3A5F849C949EE5E"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)(i), by striking
<quote>(D)</quote> both places it appears and inserting
<quote>(E)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id968F5906011C4904BEFCB125EED07DF5"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)(A)(ii), by striking
<quote>(D)</quote> and inserting <quote>(E)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31D585793CA448DAA3BB451781AD5988"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>(1)(A)(i)</quote> and
inserting <quote>(A)(i)(I)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id51558D0C7FC9493C82FE508875ECD9F1"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote>(ii) the</quote> and
inserting <quote>(II) the</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id129E9778F59B43FCA2B7F4E57A3C5B8B"><enum>(E)</enum><text display-inline="yes-display-inline">by striking <quote>(B) if the drug is
designated</quote> and inserting <quote>(ii) if the drug is
designated</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3BB7FF046B3E4345A7DA94404BE2963B"><enum>(F)</enum><text display-inline="yes-display-inline">by striking <quote>(2)(A)</quote> and
inserting <quote>(B)(i)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id55F965304E2A4A95AF9BB48B2E873D3E"><enum>(G)</enum><text display-inline="yes-display-inline">by striking <quote>(i) a listed
patent</quote> and inserting <quote>(I) a listed patent</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id19F36F01188844CAB8BD006091EB218A"><enum>(H)</enum><text display-inline="yes-display-inline">by striking <quote>(ii) a listed
patent</quote> and inserting <quote>(II) a listed patent</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBC44AD9EC5FF4D5F85F810D4B1CC2E71"><enum>(I)</enum><text display-inline="yes-display-inline">by striking <quote>(B) if the drug is the
subject</quote> and inserting <quote>(ii) if the drug is the
subject</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD33CF1A249C9452A8C9AA65E139F115C"><enum>(J)</enum><text display-inline="yes-display-inline">by striking <quote>If</quote> and all that
follows through <quote>subsection (d)(3)</quote> and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id3AD2B5B4A41D444B888990A41382DEFC" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idD737CAD432A4469B8B84C31AFAE10D07"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Except as provided in paragraph (2), if the
Secretary determines that information relating to the use of an approved drug
in the pediatric population may produce health benefits in that population and
makes a written request to the holder of an approved application under section
505(b)(1) for pediatric studies (which shall include a timeframe for completing
such studies), the holder agrees to the request, such studies are completed
using appropriate formulations for each age group for which the study is
requested within any such timeframe, and the reports thereof are submitted and
accepted in accordance with subsection (d)(3), and if the Secretary determines
that labeling changes are appropriate, such changes are made within the
timeframe requested by the Secretary—</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD8FEDBE1172F461EA9CB1A588E15F2C1"><enum>(K)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idC4AC01AC219E41ABAE93ABCD90B09152" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id5FC50C7AD6DE49BD88472D705E91590A"><enum>(2)</enum><header display-inline="yes-display-inline">Exception</header><text display-inline="yes-display-inline">The Secretary shall not extend a period
referred to in paragraph (1)(A) or in paragraph (1)(B) if the determination
made under subsection (d)(3) is made less than 9 months prior to the expiration
of such
period.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA0FF08CDE1DA44C59FE12AA931B6266E"><enum>(4)</enum><text display-inline="yes-display-inline">by striking subsection (d) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id6CEE84E7C26A48339D2F09E57ADE5D26" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID7a491341702740d18cabc78f616b4119"><enum>(d)</enum><header display-inline="yes-display-inline">Conduct of pediatric studies</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID908502178aa8423ebf42e6ebcdbaafc1"><enum>(1)</enum><header display-inline="yes-display-inline">Request for studies</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id4C5C472021224C189B85F47967A6DE89"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary may, after consultation with
the sponsor of an application for an investigational new drug under section
505(i), the sponsor of an application for a new drug under section 505(b)(1),
or the holder of an approved application for a drug under section 505(b)(1),
issue to the sponsor or holder a written request for the conduct of pediatric
studies for such drug. In issuing such request, the Secretary shall take into
account adequate representation of children of ethnic and racial minorities.
Such request to conduct pediatric studies shall be in writing and shall include
a timeframe for such studies and a request to the sponsor or holder to propose
pediatric labeling resulting from such studies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8D16B7612644440D81F83921DDDD8EF8"><enum>(B)</enum><header display-inline="yes-display-inline">Single written request</header><text display-inline="yes-display-inline">A single written request—</text>
<clause commented="no" display-inline="no-display-inline" id="id4762F12B89AB401CB89A272F615DCF46"><enum>(i)</enum><text display-inline="yes-display-inline">may relate to more than 1 use of a drug;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id4FD7903A035641F593EFF96186FFAB40"><enum>(ii)</enum><text display-inline="yes-display-inline">may include uses that are both approved and
unapproved.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID34ce03b8a0734f63a1608e6d893218be"><enum>(2)</enum><header display-inline="yes-display-inline">Written request for pediatric
studies</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID09be4e16562f4289ae2e78900bc4ad3b"><enum>(A)</enum><header display-inline="yes-display-inline">Request and response</header>
<clause commented="no" display-inline="no-display-inline" id="id478DF4C6FAEA4745897CC8165BC794FF"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the Secretary makes a written request
for pediatric studies (including neonates, as appropriate) under subsection (b)
or (c), the applicant or holder, not later than 180 days after receiving the
written request, shall respond to the Secretary as to the intention of the
applicant or holder to act on the request by—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID8a8b073d062147f39ded5b94bfe84c14"><enum>(I)</enum><text display-inline="yes-display-inline">indicating when the pediatric studies will
be initiated, if the applicant or holder agrees to the request; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDaaabd4abac1c4577b87c6abd8a85f8d5"><enum>(II)</enum><text display-inline="yes-display-inline">indicating that the applicant or holder
does not agree to the request and the reasons for declining the request.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idD9B0ECD568F0495FA5BB1505D1597C50"><enum>(ii)</enum><header display-inline="yes-display-inline">Disagree with request</header><text display-inline="yes-display-inline">If, on or after the date of enactment of
the <short-title>Best Pharmaceuticals for Children
Amendments of 2007</short-title>, the applicant or holder does not agree to the
request on the grounds that it is not possible to develop the appropriate
pediatric formulation, the applicant or holder shall submit to the Secretary
the reasons such pediatric formulation cannot be developed.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb45ca0a174ca45599619be3ba6c5011a"><enum>(B)</enum><header display-inline="yes-display-inline">Adverse event reports</header><text display-inline="yes-display-inline">An applicant or holder that, on or after
the date of enactment of the <short-title>Best
Pharmaceuticals for Children Amendments of 2007</short-title>, agrees to the
request for such studies shall provide the Secretary, at the same time as
submission of the reports of such studies, with all postmarket adverse event
reports regarding the drug that is the subject of such studies and are
available prior to submission of such reports.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7c8f7530f7904ae3aeccd05dafe7e9a6"><enum>(3)</enum><header display-inline="yes-display-inline">Meeting the studies
requirement</header><text display-inline="yes-display-inline">Not later than
180 days after the submission of the reports of the studies, the Secretary
shall accept or reject such reports and so notify the sponsor or holder. The
Secretary’s only responsibility in accepting or rejecting the reports shall be
to determine, within the 180 days, whether the studies fairly respond to the
written request, have been conducted in accordance with commonly accepted
scientific principles and protocols, and have been reported in accordance with
the requirements of the Secretary for filing.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7996e34410bd4567a671885dc844f550"><enum>(4)</enum><header display-inline="yes-display-inline">Effect of subsection</header><text display-inline="yes-display-inline">Nothing in this subsection alters or amends
section 301(j) of this Act or <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5 or section 1905 of title
18, United States
Code.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id035A280E54504A8D93894AEDA7B336F1"><enum>(5)</enum><text display-inline="yes-display-inline">by striking subsections (e) and (f) and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idB412DB570DAA4A87989119C3CB0B9036" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idA9FD315E4D3C4ABA95108CECE3F8F48C"><enum>(e)</enum><header display-inline="yes-display-inline">Notice of determinations on studies
requirement</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID157fa421807041e3b18e8e9e7c7b3bc5"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall publish a notice of any
determination, made on or after the date of enactment of the
<short-title>Best Pharmaceuticals for Children Amendments
of 2007</short-title>, that the requirements of subsection (d) have been met
and that submissions and approvals under subsection (b)(2) or (j) of section
505 for a drug will be subject to the provisions of this section. Such notice
shall be published not later than 30 days after the date of the Secretary’s
determination regarding market exclusivity and shall include a copy of the
written request made under subsection (b) or (c).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5e9354cca6db40deb098e0ed83ea9ce5"><enum>(2)</enum><header display-inline="yes-display-inline">Identification of certain
drugs</header><text display-inline="yes-display-inline">The Secretary shall
publish a notice identifying any drug for which, on or after the date of
enactment of the <short-title>Best Pharmaceuticals for
Children Amendments of 2007</short-title>, a pediatric formulation was
developed, studied, and found to be safe and effective in the pediatric
population (or specified subpopulation) if the pediatric formulation for such
drug is not introduced onto the market within 1 year of the date that the
Secretary publishes the notice described in paragraph (1). Such notice
identifying such drug shall be published not later than 30 days after the date
of the expiration of such 1 year period.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDaee63f9abb3545cc9367491cc8480262"><enum>(f)</enum><header display-inline="yes-display-inline">Internal review of written requests and
pediatric studies</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDe3fceabe4df740bfb587236fb54c2b3d"><enum>(1)</enum><header display-inline="yes-display-inline">Internal review</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id5837861192B24E0399C4EE74FD8E0EA7"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall create an internal
review committee to review all written requests issued and all reports
submitted on or after the date of enactment of the
<short-title>Best Pharmaceuticals for Children Amendments
of 2007</short-title>, in accordance with paragraphs (2) and (3).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD8D403CA9C9D4F31A97639D139637958"><enum>(B)</enum><header display-inline="yes-display-inline">Members</header><text display-inline="yes-display-inline">The committee under subparagraph (A) shall
include individuals, each of whom is an employee of the Food and Drug
Administration, with the following expertise:</text>
<clause commented="no" display-inline="no-display-inline" id="idB2007243F8794493BF5584106980D8DF"><enum>(i)</enum><text display-inline="yes-display-inline">Pediatrics.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idBC7867326DC44CD695AC6FE0B09669A6"><enum>(ii)</enum><text display-inline="yes-display-inline">Biopharmacology.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idBDB2BA2CA3A64AECB36A687757078D10"><enum>(iii)</enum><text display-inline="yes-display-inline">Statistics.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id25A34724F5904CBAAC19B24C83ED40D7"><enum>(iv)</enum><text display-inline="yes-display-inline">Drugs and drug formulations.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id026D4D62FDC34001B4FFF104387B90EF"><enum>(v)</enum><text display-inline="yes-display-inline">Legal issues.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idDD8A49C710704C66B9AE16930C1CD13E"><enum>(vi)</enum><text display-inline="yes-display-inline">Appropriate expertise, such as expertise in
child and adolescent psychiatry, pertaining to the pediatric product under
review.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id80F154D7AFC34063BEB1FFB1917C1071"><enum>(vii)</enum><text display-inline="yes-display-inline">One or more experts from the Office of
Pediatric Therapeutics, which may include an expert in pediatric ethics.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id617A886DF7EF4202B9172D0D4BB965B2"><enum>(viii)</enum><text display-inline="yes-display-inline">Other individuals as designated by the
Secretary.</text>
</clause></subparagraph><subparagraph id="ID8bb36afd98a94adea28a5c6681028c58"><enum>(C)</enum><header>Action by
committee</header><text>The committee established under this paragraph may
perform a function under this section using appropriate members of the
committee under subparagraph (B) and need not convene all members of the
committee under subparagraph (B) in order to perform a function under this
section.</text>
</subparagraph><subparagraph id="ID55c0b3a03b8b410e91494b9861a7a31e"><enum>(D)</enum><header>Documentation
of committee action</header><text>The committee established under this
paragraph shall document for each function under paragraphs (2) and (3), which
members of the committee participated in such function.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1ef486423b8f4b62a3ec46ad2bc9018e"><enum>(2)</enum><header display-inline="yes-display-inline">Review of written requests</header><text display-inline="yes-display-inline">All written requests under this section
shall be reviewed and approved by the committee established under paragraph (1)
prior to being issued.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID163f20e81cfb472e8bfd722348677355"><enum>(3)</enum><header display-inline="yes-display-inline">Review of pediatric studies</header><text display-inline="yes-display-inline">The committee established under paragraph
(1) shall review all studies conducted pursuant to this section to make a
recommendation to the Secretary whether to accept or reject such reports under
subsection (d)(3).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDee9ab4fe20c2498196d7fb06933403d2"><enum>(4)</enum><header display-inline="yes-display-inline">Tracking pediatric studies and labeling
changes</header><text display-inline="yes-display-inline">The committee
established under paragraph (1) shall be responsible for tracking and making
available to the public, in an easily accessible manner, including through
posting on the website of the Food and Drug Administration—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID81cc2f2c52494104993a816edbfd60c2"><enum>(A)</enum><text display-inline="yes-display-inline">the number of studies conducted under this
section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6a5ea3d2c95740179a47d49f58736098"><enum>(B)</enum><text display-inline="yes-display-inline">the specific drugs and drug uses, including
labeled and off-labeled indications, studied under this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID96d10d88ac7543f09cbd201dd9d4dc21"><enum>(C)</enum><text display-inline="yes-display-inline">the types of studies conducted under this
section, including trial design, the number of pediatric patients studied, and
the number of centers and countries involved;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDef2e5f294087453b928865fcb0f59fd1"><enum>(D)</enum><text display-inline="yes-display-inline">the number of pediatric formulations
developed and the number of pediatric formulations not developed and the
reasons such formulations were not developed;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDe051bf70a1574f5eac75e57040aac933"><enum>(E)</enum><text display-inline="yes-display-inline">the labeling changes made as a result of
studies conducted under this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6b6b81d9e9544623b0f29486c8c651eb"><enum>(F)</enum><text display-inline="yes-display-inline">an annual summary of labeling changes made
as a result of studies conducted under this section for distribution pursuant
to subsection (k)(2);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id03C3C7D2657D40A7B33C00774006CFAD"><enum>(G)</enum><text display-inline="yes-display-inline">information regarding reports submitted on
or after the date of enactment of the <short-title>Best
Pharmaceuticals for Children Amendments of 2007</short-title>; and</text>
</subparagraph><subparagraph id="ID539c0a5e915e42b88ba79306354f9df9"><enum>(H)</enum><text>the number of
times the committee established under paragraph (1) made a recommendation to
the Secretary under paragraph (3), the number of times the Secretary did not
follow such a recommendation to accept reports under subsection (d)(3), and the
number of times the Secretary did not follow such a recommendation to reject
such reports under section (d)(3).</text>
</subparagraph></paragraph><paragraph id="ID667b3b7c6389469d944005056011a2dd"><enum>(5)</enum><header>Committee</header><text>The
committee established under paragraph (1) is the committee established under
section
505B(f)(1).</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8E964459C7454F8F91DFADE5076DF824"><enum>(6)</enum><text display-inline="yes-display-inline">in subsection (g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idD4D5313B83E54818B8B203D9374904E9"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="id536BD3CC2DAB441F94A220668D6AEA50"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>(c)(1)(A)(ii)</quote>
and inserting <quote>(c)(1)(A)(i)(II)</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id04AD0540386F49F99115ACD704166CC7"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>(c)(2)</quote> and
inserting <quote>(c)(1)(B)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1069C9349FA243ABAEDA33529CCB1E03"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking
<quote>(c)(1)(B)</quote> and inserting <quote>(c)(1)(A)(ii)</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC8D734BBE2464F1D936921A9B32F2629"><enum>(C)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (1) and (2) as
subparagraphs (A) and (B), respectively;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id04535B1546CB409EB406C7B6BF5A26C6"><enum>(D)</enum><text display-inline="yes-display-inline">by striking <quote><header-in-text level="subsection" style="OLC">Limitations.</header-in-text>—A drug</quote> and
inserting</text>
<quoted-block display-inline="yes-display-inline" id="idEA8B428F028D4BA9B04889EE461A82ED" style="OLC">
<text><header-in-text level="subsection" style="OLC">Limitations.</header-in-text>—</text><paragraph commented="no" display-inline="no-display-inline" id="id5FCF62EF860F482F92CDB9B0BF118450"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding subsection (c)(2), a
drug</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id155BB6FF098842B8B43A0EB38D009E3E"><enum>(E)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idB7F5ED791CE04042891F6E518C6D2AA4" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID851fdb0fe815407faec0365af49aa163"><enum>(2)</enum><header display-inline="yes-display-inline">Exclusivity adjustment</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDa7cc6cc98e5f45a9a1b1f82e8f6a62b8"><enum>(A)</enum><header display-inline="yes-display-inline">Adjustment</header>
<clause commented="no" display-inline="no-display-inline" id="idE50E6471D470483CB07CAB79579A5603"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">With respect to any drug, if the
organization designated under subparagraph (B) notifies the Secretary that the
combined annual gross sales for all drugs with the same active moiety exceeded
$1,000,000,000 in any calendar year prior to the time the sponsor or holder
agrees to the initial written request pursuant to subsection (d)(2), then each
period of market exclusivity deemed or extended under subsection (b) or (c)
shall be reduced by 3 months for such drug.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id354257CBE86246C986FEBECE75C621AA"><enum>(ii)</enum><header display-inline="yes-display-inline">Determination</header><text display-inline="yes-display-inline">The determination under clause (i) of the
combined annual gross sales shall be determined—</text>
<subclause commented="no" display-inline="no-display-inline" id="id7839567FE05D4CB3A4A36C5860958BFC"><enum>(I)</enum><text display-inline="yes-display-inline">taking into account only those sales within
the United States; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id93B5533099B544789C06E7184F3FF52C"><enum>(II)</enum><text display-inline="yes-display-inline">taking into account only the sales of all
drugs with the same active moiety of the sponsor or holder and its
affiliates.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc115d08ccc7140aa855cd2acd997d2e6"><enum>(B)</enum><header display-inline="yes-display-inline">Designation</header><text display-inline="yes-display-inline">The Secretary shall designate an
organization other than the Food and Drug Administration to evaluate whether
the combined annual gross sales for all drugs with the same active moiety
exceeded $1,000,000,000 in a calendar year as described in subparagraph (A).
Prior to designating such organization, the Secretary shall determine that such
organization is independent and is qualified to evaluate the sales of
pharmaceutical products. The Secretary shall re-evaluate the designation of
such organization once every 3 years.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc408d768c8ee4134abef4ba2d9f49db8"><enum>(C)</enum><header display-inline="yes-display-inline">Notification</header><text display-inline="yes-display-inline">Once a year at a time designated by the
Secretary, the organization designated under subparagraph (B) shall notify the
Food and Drug Administration of all drugs with the same active moiety with
combined annual gross sales that exceed $1,000,000,000 during the previous
calendar
year.</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4252E79DCDEE4029843338FF1B575469"><enum>(7)</enum><text display-inline="yes-display-inline">in subsection (i)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id73B06D216FD24882AB4314F1BC14E9A2"><enum>(A)</enum><text display-inline="yes-display-inline">in the heading, by striking
<quote><header-in-text level="subsection" style="OLC">Supplements</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">Changes</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7972788B2F45405D9DEBA88C559F9DA6"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="id6AD3AF9F72474B43BA49961E3F473F9B"><enum>(i)</enum><text display-inline="yes-display-inline">in the heading, by inserting
<quote><header-in-text level="paragraph" style="OLC">applications
and</header-in-text></quote> after <quote><header-in-text level="paragraph" style="OLC">pediatric</header-in-text></quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3CC027CCF40649D980FF6C0AEA19851A"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>application or</quote>
after <quote>Any</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id3A8AD98B01574D9AB2691050EA17C43F"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>change pursuant to a
report on a pediatric study under</quote> and inserting <quote>change as a
result of any pediatric study conducted pursuant to</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA60537A84E544869AE76F773235E0718"><enum>(iv)</enum><text display-inline="yes-display-inline">by inserting <quote>application or</quote>
after <quote>to be a priority</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idB9D9DF0F3A7D4AE69F44BCC0CB87B9B5"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2)(A), by—</text>
<clause commented="no" display-inline="no-display-inline" id="id533146ED20AD4A1A8F81B6C11612AC0A"><enum>(i)</enum><text display-inline="yes-display-inline">striking <quote>If the Commissioner</quote>
and inserting <quote>If, on or after the date of enactment of the
<short-title>Best Pharmaceuticals for Children Amendments
of 2007</short-title>, the Commissioner</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id37D4122BDB574BA08934EF74A665DDE8"><enum>(ii)</enum><text display-inline="yes-display-inline">striking <quote>an application with</quote>
and all that follows through <quote>on appropriate</quote> and inserting
<quote>the sponsor and the Commissioner have been unable to reach agreement on
appropriate</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD0AAE1E38B3E42F08C8EF10655D474C0"><enum>(8)</enum><text display-inline="yes-display-inline">by striking subsection (m);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC458E7B77B2D4EC587C57557F78D7BDB"><enum>(9)</enum><text display-inline="yes-display-inline">by redesignating subsections (j), (k), (l),
and (n), as subsections (k), (m), (o), and (p), respectively;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7DB6E190854C41FEA21C4893603C217B"><enum>(10)</enum><text display-inline="yes-display-inline">by inserting after subsection (i) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id810EADCC1024489C87C6A5356C328272" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID7ddc97bc561240488a84a0d4b95c6f07"><enum>(j)</enum><header display-inline="yes-display-inline">Other labeling changes</header><text display-inline="yes-display-inline">If, on or after the date of enactment of
the <short-title>Best Pharmaceuticals for Children
Amendments of 2007</short-title>, the Secretary determines that a pediatric
study conducted under this section does or does not demonstrate that the drug
that is the subject of the study is safe and effective, including whether such
study results are inconclusive, in pediatric populations or subpopulations, the
Secretary shall order the labeling of such product to include information about
the results of the study and a statement of the Secretary’s
determination.</text>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idBF1B9F6E0AB346F288A688A0449A2D2A"><enum>(11)</enum><text display-inline="yes-display-inline">in subsection (k), as redesignated by
paragraph (9)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idBAAC12B5858742DB9EF02EFE4B70B9D0"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="idC9026E4B7A9541758596512730ED2F73"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>a summary of the medical
and</quote> and inserting <quote>the medical, statistical, and</quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idB96B179745354B7CB532AE36C9EC28A9"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>for the
supplement</quote> and all that follows through the period and inserting
<quote>under subsection (b) or (c).</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id209C5FEF86A34575821F43B9E6A3A2C9"><enum>(B)</enum><text display-inline="yes-display-inline">by redesignating paragraph (2) as paragraph
(3); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9FA3630A901C4440A1E0B4F274F43713"><enum>(C)</enum><text display-inline="yes-display-inline">by inserting after paragraph (1) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id3D8A6F319BAE4FB0818C6FA2FEDE5350" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="IDb935727a447f4ada8dbfda7352f7a47d"><enum>(2)</enum><header display-inline="yes-display-inline">Dissemination of information regarding
labeling changes</header><text display-inline="yes-display-inline">Beginning on
the date of enactment of the <short-title>Best
Pharmaceuticals for Children Amendments of 2007</short-title>, the Secretary
shall require that the sponsors of the studies that result in labeling changes
that are reflected in the annual summary developed pursuant to subsection
(f)(4)(F) distribute, at least annually (or more frequently if the Secretary
determines that it would be beneficial to the public health), such information
to physicians and other health care
providers.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idAE82AF32C4BC43159EBE207CAB7BA1F8"><enum>(12)</enum><text display-inline="yes-display-inline">by inserting after subsection (k), as
redesignated by paragraph (9), the following:</text>
<quoted-block display-inline="no-display-inline" id="id4669859C2FA74BEABE185ECA96D13E7D" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID3c76275fd9b148148d85dc5d724fabf6"><enum>(l)</enum><header display-inline="yes-display-inline">Adverse event reporting</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID6c229193be0848cba0e1d28224c28e10"><enum>(1)</enum><header display-inline="yes-display-inline">Reporting in year one</header><text display-inline="yes-display-inline">Beginning on the date of enactment of the
<short-title>Best Pharmaceuticals for Children Amendments
of 2007</short-title>, during the 1-year period beginning on the date a
labeling change is made pursuant to subsection (i), the Secretary shall ensure
that all adverse event reports that have been received for such drug
(regardless of when such report was received) are referred to the Office of
Pediatric Therapeutics established under section 6 of the Best Pharmaceuticals
for Children Act (<external-xref legal-doc="public-law" parsable-cite="pl/107/109">Public Law 107–109</external-xref>). In considering such reports, the
Director of such Office shall provide for the review of the report by the
Pediatric Advisory Committee, including obtaining any recommendations of such
Committee regarding whether the Secretary should take action under this section
in response to such reports.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID442f8a01720f44bf9f2421b9fd3d751f"><enum>(2)</enum><header display-inline="yes-display-inline">Reporting in subsequent years</header><text display-inline="yes-display-inline">Following the 1-year period described in
paragraph (1), the Secretary shall, as appropriate, refer to the Office of
Pediatric Therapeutics all pediatric adverse event reports for a drug for which
a pediatric study was conducted under this section. In considering such
reports, the Director of such Office may provide for the review of such reports
by the Pediatric Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take action in response
to such reports.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id48165BF32D9848549584FC7180489A80"><enum>(3)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">The requirements of this subsection shall
supplement, not supplant, other review of such adverse event reports by the
Secretary.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1A7D7556CA0847CFB8E812F33E4C92B7"><enum>(13)</enum><text display-inline="yes-display-inline">by inserting after subsection (m), as
redesignated by paragraph (9), the following:</text>
<quoted-block display-inline="no-display-inline" id="id9FEDB0B5C14A42389C5C96B244C54D30" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="IDd0d4b1b488544c438b6a21fc0d8d4d10"><enum>(n)</enum><header display-inline="yes-display-inline">Referral if pediatric studies not
completed</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDada1bf8e5c364184b0c0535e90a16df0"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Beginning on the date of enactment of the
<short-title>Best Pharmaceuticals for Children Amendments
of 2007</short-title>, if pediatric studies of a drug have not been completed
under subsection (d) and if the Secretary, through the committee established
under subsection (f), determines that there is a continuing need for
information relating to the use of the drug in the pediatric population
(including neonates, as appropriate), the Secretary shall carry out the
following:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idAD9B696CA626490E9D43E2D3F055737A"><enum>(A)</enum><text display-inline="yes-display-inline">For a drug for which a listed patent has
not expired, make a determination regarding whether an assessment shall be
required to be submitted under section 505B. Prior to making such
determination, the Secretary may take not more than 60 days to certify whether
the Foundation for the National Institutes of Health has sufficient funding at
the time of such certification to initiate 1 or more of the pediatric studies
of such drug referred to in the sentence preceding this paragraph and fund 1 or
more of such studies in their entirety. Only if the Secretary makes such
certification in the affirmative, the Secretary shall refer such pediatric
study or studies to the Foundation for the National Institutes of Health for
the conduct of such study or studies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDc9d6afbd841b4fcabfc5d5c42fdf9359"><enum>(B)</enum><text display-inline="yes-display-inline">For a drug that has no listed patents or
has 1 or more listed patents that have expired, the Secretary shall refer the
drug for inclusion on the list established under section 409I of the Public
Health Service Act for the conduct of studies.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDd21f7f98f2964e94bf0040b371f409ae"><enum>(2)</enum><header display-inline="yes-display-inline">Public notice</header><text display-inline="yes-display-inline">The Secretary shall give the public notice
of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID345d8b79b9754d0fb83b2513fd7992f8"><enum>(A)</enum><text display-inline="yes-display-inline">a decision under paragraph (1)(A) not to
require an assessment under section 505B and the basis for such decision;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID84748401d5cb4986987fbbe8a23d9c00"><enum>(B)</enum><text display-inline="yes-display-inline">any referral under paragraph (1)(B) of a
drug for inclusion on the list established under section 409I of the Public
Health Service Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5040f1bdbd6e4a9cbac536a293417057"><enum>(3)</enum><header display-inline="yes-display-inline">Effect of subsection</header><text display-inline="yes-display-inline">Nothing in this subsection alters or amends
section 301(j) of this Act or <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5 or section 1905 of title
18, United States Code.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB8F151A2167D400899DCD783C7C35D1F"><enum>(14)</enum><text display-inline="yes-display-inline">in subsection (p), as redesignated by
paragraph (9)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idAA998E30154A4032A8758940F4725987"><enum>(A)</enum><text display-inline="yes-display-inline">striking <quote>6-month period</quote> and
inserting <quote>3-month or 6-month period</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8971215B93EC4DE6A612A0B987BBDBCD"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>subsection (a)</quote>
and inserting <quote>subsection (b)</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4AB37DD05D8645AEA638067C522B26A4"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>2007</quote> both places
it appears and inserting <quote>2012</quote>.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9C2CCC0D33404B12B1D626113A9D8C2A"><enum>(b)</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="yes-display-inline">Except as otherwise
provided in the amendments made by subsection (a), such amendments shall apply
to written requests under section 505A of the Federal Food, Drug, and Cosmetic
Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>) made after the date of enactment of this subtitle.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="IDc3bd6fb8fd2048cfb9f826265cb8a1b6" section-type="subsequent-section"><enum>403.</enum><header display-inline="yes-display-inline">Program for pediatric studies of
drugs</header><text display-inline="no-display-inline">Section 409I of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idD429767B903645429EA543C42005AD41"><enum>(1)</enum><text display-inline="yes-display-inline">by striking subsections (a) and (b) and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id6505F6096046486DA82DF001F0BA45C0" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="IDdf596a5ce4034dc9ac6d5f601cfd43b0"><enum>(a)</enum><header display-inline="yes-display-inline">List of priority issues in pediatric
therapeutics</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDa9f939c3ad4443e7bce0b0e2d7b8fc92"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of the Best Pharmaceuticals for Children Amendments of 2007, the
Secretary, acting through the Director of the National Institutes of Health and
in consultation with the Commissioner of Food and Drugs and experts in
pediatric research, shall develop and publish a priority list of needs in
pediatric therapeutics, including drugs or indications that require study. The
list shall be revised every 3 years.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9cdfb1d972a040c8be488ba0fd7f8188"><enum>(2)</enum><header display-inline="yes-display-inline">Consideration of available
information</header><text display-inline="yes-display-inline">In developing and
prioritizing the list under paragraph (1), the Secretary shall consider—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID085587c223e048d7bf365022cd65ae4c"><enum>(A)</enum><text display-inline="yes-display-inline">therapeutic gaps in pediatrics that may
include developmental pharmacology, pharmacogenetic determinants of drug
response, metabolism of drugs and biologics in children, and pediatric clinical
trials;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd1203dc9ce4c4c74812c318008248646"><enum>(B)</enum><text display-inline="yes-display-inline">particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of therapeutics, including
drugs and biologics, may be beneficial in pediatric populations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID042db892155b474eb4fcb9f7b47a6346"><enum>(C)</enum><text display-inline="yes-display-inline">the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including research networks and
trained pediatric investigators.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID0616fa4847524413b0895989edcf7b54"><enum>(b)</enum><header display-inline="yes-display-inline">Pediatric studies and
research</header><text display-inline="yes-display-inline">The Secretary,
acting through the National Institutes of Health, shall award funds to entities
that have the expertise to conduct pediatric clinical trials or other research
(including qualified universities, hospitals, laboratories, contract research
organizations, practice groups, federally funded programs such as pediatric
pharmacology research units, other public or private institutions, or
individuals) to enable the entities to conduct the drug studies or other
research on the issues described in subsection (a). The Secretary may use
contracts, grants, or other appropriate funding mechanisms to award funds under
this
subsection.</text>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB26F366AFDDD452086C8B15E2D74C501"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (c)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4ADC6CBC3BEC40BB90FD70EB8806FDFC"><enum>(A)</enum><text display-inline="yes-display-inline">in the heading, by striking
<quote><header-in-text level="subsection" style="OLC">contracts</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">proposed pediatric study
requests</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7A8824A756304A468439715537E35B48"><enum>(B)</enum><text display-inline="yes-display-inline">by striking paragraphs (4) and (12);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id86995D9B8FEF405FAF1CE235532E6CEC"><enum>(C)</enum><text display-inline="yes-display-inline">by redesignating paragraphs (1), (2), and
(3), as paragraphs (2), (3), and (4);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4A04F46762674333A6C8096055D22AA3"><enum>(D)</enum><text display-inline="yes-display-inline">by inserting before paragraph (2), as
redesignated by subparagraph (C), the following:</text>
<quoted-block display-inline="no-display-inline" id="id06085947D84848D09C048F99018EE5AE" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID6e95a752241b4c5aaa8e924aa454614a"><enum>(1)</enum><header display-inline="yes-display-inline">Submission of proposed pediatric study
request</header><text display-inline="yes-display-inline">The Director of the
National Institutes of Health shall, as appropriate, submit proposed pediatric
study requests for consideration by the Commissioner of Food and Drugs for
pediatric studies of a specific pediatric indication identified under
subsection (a). Such a proposed pediatric study request shall be made in a
manner equivalent to a written request made under subsection (b) or (c) of
section 505A of the Federal Food, Drug, and Cosmetic Act, including with
respect to the information provided on the pediatric studies to be conducted
pursuant to the request. The Director of the National Institutes of Health may
submit a proposed pediatric study request for a drug for which—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDf8a9351ac8bd40f6a3ec6c6c66ce68ea"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="id910AB46B08B443BAB6DF38AD3734FB10"><enum>(i)</enum><text display-inline="yes-display-inline">there is an approved application under
section 505(j) of the Federal Food, Drug, and Cosmetic Act; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idF979FD210E3F42A3AC48516083AB4CD6" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">there is a submitted application that could
be approved under the criteria of section 505(j) of the Federal Food, Drug, and
Cosmetic Act;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4CB11051EC3943E8B94C4ECE1923092B"><enum>(B)</enum><text display-inline="yes-display-inline">there is no patent protection or market
exclusivity protection for at least 1 form of the drug under the Federal Food,
Drug, and Cosmetic Act; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idBFDE2F25325B4AF79AFB2CDD4785E6FC"><enum>(C)</enum><text display-inline="yes-display-inline">additional studies are needed to assess the
safety and effectiveness of the use of the drug in the pediatric
population.</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3BD87991F0D84D9690EC5BC57BFABA02"><enum>(E)</enum><text display-inline="yes-display-inline">in paragraph (2), as redesignated by
subparagraph (C)—</text>
<clause commented="no" display-inline="no-display-inline" id="idB991F829348441BF8350726EEDAE525A"><enum>(i)</enum><text display-inline="yes-display-inline">by inserting <quote>based on the proposed
pediatric study request for the indication or indications submitted pursuant to
paragraph (1)</quote> after <quote>issue a written request</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id72EBD10FE589440E9DD1E6CC317CF074"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>in the list described in
subsection (a)(1)(A) (except clause (iv))</quote> and inserting <quote>under
subsection (a)</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id54533F5FE4C340AD9A3E1208271FF81F"><enum>(iii)</enum><text display-inline="yes-display-inline">by inserting <quote>and using appropriate
formulations for each age group for which the study is requested</quote> before
the period at the end;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idACDA5B048826486985618CBAAF0FCFC9"><enum>(F)</enum><text display-inline="yes-display-inline">in paragraph (3), as redesignated by
subparagraph (C)—</text>
<clause commented="no" display-inline="no-display-inline" id="idE25E3631C9D84AC5BC8AD0174604E3AD"><enum>(i)</enum><text display-inline="yes-display-inline">in the heading, by striking
<quote><header-in-text level="paragraph" style="OLC">contract</header-in-text></quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id05AFCCC219F4412BB97FE517A2E2A9B3"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph (1)</quote>
and inserting <quote>paragraph (2)</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5340DEB4E0044E43953BC4E08D8260E8"><enum>(iii)</enum><text display-inline="yes-display-inline">by striking <quote>or if a referral
described in subsection (a)(1)(A)(iv) is made,</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0061955AE16248EAA79BCCA7F3500505"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking <quote>for contract
proposals</quote> and inserting <quote>for proposals</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id24256D8A6F8341EEBC3C31A665189191"><enum>(v)</enum><text display-inline="yes-display-inline">by inserting <quote>in accordance with
subsection (b)</quote> before the period at the end;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id27ECD9EE8EC64FEAAFB59115BD71E9F2"><enum>(G)</enum><text display-inline="yes-display-inline">in paragraph (4), as redesignated by
subparagraph (C)—</text>
<clause commented="no" display-inline="no-display-inline" id="idE353D037316D408E88B0C4963C0CC19F"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>contract</quote>;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id02FD0F50B61745B5AAAFCFDD7A374C52"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>paragraph (2)</quote>
and inserting <quote>paragraph (3)</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9472E779E596485586BBEC05D80DF426"><enum>(H)</enum><text display-inline="yes-display-inline">in paragraph (5)—</text>
<clause commented="no" display-inline="no-display-inline" id="id3EBA3101A7704BCFA6775FEE43716BAE"><enum>(i)</enum><text display-inline="yes-display-inline">by striking the heading and inserting
<quote><header-in-text level="paragraph" style="OLC">Contracts, grants, or
other funding mechanisms</header-in-text></quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id2AF227680FB34583946DC93F5F8A6602"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking <quote>A contract</quote> and
all that follows through <quote>is submitted</quote> and inserting <quote>A
contract, grant, or other funding may be awarded under this section only if a
proposal is submitted</quote>;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2A6FC3B1E4B743A18EE0A17FCB7F92E8"><enum>(I)</enum><text display-inline="yes-display-inline">in paragraph (6)(A)—</text>
<clause commented="no" display-inline="no-display-inline" id="id36DB88930FE74ACCB5595AF994EFFD9F"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>a contract
awarded</quote> and inserting <quote>an award</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id9B577CA1EAE64BC497866FC400C89694"><enum>(ii)</enum><text display-inline="yes-display-inline">by inserting <quote>, including a written
request if issued</quote> after <quote>with the study</quote>; and</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA74B0D44FF214FEDBBE0987BB6252942"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after subsection (c) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idD5C172D62192467A863524E5696AFD56" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID4b17b7f6a28b42198ecf4a4d58bba7db"><enum>(d)</enum><header display-inline="yes-display-inline">Dissemination of pediatric
information</header><text display-inline="yes-display-inline">Not later than 1
year after the date of enactment of the Best Pharmaceuticals for Children
Amendments of 2007, the Secretary, acting through the Director of the National
Institutes of Health, shall study the feasibility of establishing a compilation
of information on pediatric drug use and report the findings to
Congress.</text>
</subsection><after-quoted-block></after-quoted-block></quoted-block>
<quoted-block display-inline="no-display-inline" id="id5F0D7AD7EBF2450097FE1DAE79E5F585" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID90b73f333adb4028bb0aeaca415bf45a"><enum>(e)</enum><header display-inline="yes-display-inline">Authorization of appropriations</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDcf60479d15d04c14903a4d5e000bf52d"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">There are authorized to be appropriated to
carry out this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDbb54425a1e46467fa18de4e595021b80"><enum>(A)</enum><text display-inline="yes-display-inline">$200,000,000 for fiscal year 2008;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf9e7d41d00fb4fd49186bc90eabc3365"><enum>(B)</enum><text display-inline="yes-display-inline">such sums as are necessary for each of the
4 succeeding fiscal years.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDf69e4bc6e544428d9edbbb05eb58b98d"><enum>(2)</enum><header display-inline="yes-display-inline">Availability</header><text display-inline="yes-display-inline">Any amount appropriated under paragraph (1)
shall remain available to carry out this section until
expended.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id989A5F8C4AF44DA3A549983E81E5A6EE" section-type="subsequent-section"><enum>404.</enum><header display-inline="yes-display-inline">Reports and studies</header>
<subsection commented="no" display-inline="no-display-inline" id="idD4C868631BD54DA29BC2612C7F56DC2C"><enum>(a)</enum><header display-inline="yes-display-inline">GAO Report</header><text display-inline="yes-display-inline">Not later than January 31, 2011, the
Comptroller General of the United States, in consultation with the Secretary of
Health and Human Services, shall submit to Congress a report that addresses the
effectiveness of section 505A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) in ensuring that medicines used by children are tested and
properly labeled, including—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID3ec9fdbe643b4fbfaa2fb677bcb91b2e"><enum>(1)</enum><text display-inline="yes-display-inline">the number and importance of drugs for
children that are being tested as a result of the amendments made by this
subtitle and the importance for children, health care providers, parents, and
others of labeling changes made as a result of such testing;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID3752fb8dfe9b415f95a3bd25fbc0f799"><enum>(2)</enum><text display-inline="yes-display-inline">the number and importance of drugs for
children that are not being tested for their use notwithstanding the provisions
of this subtitle and the amendments made by this subtitle, and possible reasons
for the lack of testing, including whether the number of written requests
declined by sponsors or holders of drugs subject to section 505A(g)(2) of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a(g)(2)</external-xref>), has increased or
decreased as a result of the amendments made by this subtitle;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDde283e9cbd6f47caaf377a1cb06cc37b"><enum>(3)</enum><text display-inline="yes-display-inline">the number of drugs for which testing is
being done and labeling changes required, including the date labeling changes
are made and which labeling changes required the use of the dispute resolution
process established pursuant to the amendments made by this subtitle, together
with a description of the outcomes of such process, including a description of
the disputes and the recommendations of the Pediatric Advisory
Committee;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID9c7641f477894cf083d82ce0e32f7d29"><enum>(4)</enum><text display-inline="yes-display-inline">any recommendations for modifications to
the programs established under section 505A of the Federal Food, Drug and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>) and section 409I of the Public Health Service Act
(<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m</external-xref>) that the Secretary determines to be appropriate, including a
detailed rationale for each recommendation; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDc5cd61b3ef934c6783b611eedf9c3e81"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id46C647F084A143578E8DE6C31C79BA34"><enum>(A)</enum><text display-inline="yes-display-inline">the efforts made by the Secretary to
increase the number of studies conducted in the neonate population; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id24F6F167C9154DC98CCD2B89B8884B51" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">the results of those efforts, including
efforts made to encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other information to
make the conduct of the studies ethical and safe.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id52A1C4016286445C8708B3F5DD0DC17A"><enum>(b)</enum><header display-inline="yes-display-inline">IOM study</header><text display-inline="yes-display-inline">Not later than 3 years after the date of
enactment of this subtitle, the Secretary of Health and Human Services shall
enter into a contract with the Institute of Medicine to conduct a study and
report to Congress regarding the written requests made and the studies
conducted pursuant to section 505A of the Federal Food, Drug, and Cosmetic Act.
The Institute of Medicine may devise an appropriate mechanism to review a
representative sample of requests made and studies conducted pursuant to such
section in order to conduct such study. Such study shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idF55A76423DC34F50B2FC2C2897CEA7FD"><enum>(1)</enum><text display-inline="yes-display-inline">review such representative written requests
issued by the Secretary since 1997 under subsections (b) and (c) of such
section 505A;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id129E05A74FF544D587CF3BA816FAF77C"><enum>(2)</enum><text display-inline="yes-display-inline">review and assess such representative
pediatric studies conducted under such subsections (b) and (c) since 1997 and
labeling changes made as a result of such studies; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id80C2D3B3D5C847679C99A281FAC6E5AA"><enum>(3)</enum><text display-inline="yes-display-inline">review the use of extrapolation for
pediatric subpopulations, the use of alternative endpoints for pediatric
populations, neonatal assessment tools, and ethical issues in pediatric
clinical trials.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idB40D3490B8134B3FBF4892C3220C8FDA" section-type="subsequent-section"><enum>405.</enum><header display-inline="yes-display-inline">Training of pediatric
pharmacologists</header>
<subsection commented="no" display-inline="no-display-inline" id="idD5792EAAEA234B66AC125DC06824E978"><enum>(a)</enum><header display-inline="yes-display-inline">Investment in tomorrow's pediatric
researchers</header><text display-inline="yes-display-inline">Section 452G(2)
of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/285g-10">42 U.S.C. 285g–10(2)</external-xref>) is amended by adding
before the period at the end the following: <quote>, including pediatric
pharmacological research</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idB47753BF07284FEFA006A2007D4A6728"><enum>(b)</enum><header display-inline="yes-display-inline">Pediatric research loan repayment
program</header><text display-inline="yes-display-inline">Section 487F(a)(1) of
the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/288-6">42 U.S.C. 288–6(a)(1)</external-xref>) is amended by inserting
<quote>including pediatric pharmacological research,</quote> after
<quote>pediatric research,</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id25E0B9485B5F4718BB905D14E75705AE" section-type="subsequent-section"><enum>406.</enum><header display-inline="yes-display-inline">Foundation for the National Institutes of
Health</header><text display-inline="no-display-inline">Section 499(c)(1)(C) of
the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/290b">42 U.S.C. 290b(c)(1)(C)</external-xref>) is amended by striking
<quote>and studies listed by the Secretary pursuant to section 409I(a)(1)(A) of
the is Act and referred under section 505A(d)(4)(C) of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 355(a)(d)(4)(C)</quote> and inserting <quote>and
studies for which the Secretary issues a certification under section
505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(n)(1)(A))</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="idBEC89FD8B04441CC88F345E0B4C48626" section-type="subsequent-section"><enum>407.</enum><header display-inline="yes-display-inline">Continuation of operation of
committee</header><text display-inline="no-display-inline">Section 14 of the
Best Pharmaceuticals for Children Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m</external-xref> note) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id1EB3D1E0FE8B40B790170B8844AAABE3" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id7D5ACBBD9F434B80865B307733C6E948"><enum>(d)</enum><header display-inline="yes-display-inline">Continuation of operation of
committee</header><text display-inline="yes-display-inline">Notwithstanding
<external-xref legal-doc="usc-act" parsable-cite="usc-act/Federal Advisory Committee Act /14">section 14</external-xref> of the Federal Advisory Committee Act (5 U.S.C. App.), the advisory
committee shall continue to operate during the 5-year period beginning on the
date of enactment of the Best Pharmaceuticals for Children Amendments of
2007.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="ID8C4C83A77F29440F80B5309CFC07F92E" section-type="subsequent-section"><enum>408.</enum><header display-inline="yes-display-inline">Pediatric Subcommittee of the Oncologic
Drugs Advisory Committee</header><text display-inline="no-display-inline">Section 15 of the Best Pharmaceuticals for
Children Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m</external-xref> note) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id0D0FE1B4FB1F4A2381AE26AC764E0075"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idF12D5367CCD04CAAA95D15B0CA61E140"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause commented="no" display-inline="no-display-inline" id="id78B6750F2E3140BD99B4228E725A2678"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking
<quote>and</quote> after the semicolon;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idC762C6F2C03642CCB046EE9C2F8F657C"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking the period
at the end and inserting <quote>; and</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id33B303BF17E3485D811BEFA40F21541A"><enum>(iii)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id18F0E2F8B11B440FBE36448BE7B2093C" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="id80937AD88C414DA98CE6AFC2E3154C45"><enum>(D)</enum><text display-inline="yes-display-inline">provide recommendations to the internal
review committee created under section 505A(f) of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a(f)</external-xref>) regarding the implementation of amendments to
sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a and 355c) with respect to the treatment of pediatric
cancers.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD52AC302A6B4428BB570B36EB3FFE907"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id45FD2720704545FB954AAF3F4583D98A" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id7D6F8F5E5F9A404697BE2346AF39C635"><enum>(3)</enum><header display-inline="yes-display-inline">Continuation of operation of
subcommittee</header><text display-inline="yes-display-inline">Notwithstanding
<external-xref legal-doc="usc-act" parsable-cite="usc-act/Federal Advisory Committee Act /14">section 14</external-xref> of the Federal Advisory Committee Act (5 U.S.C. App.), the
Subcommittee shall continue to operate during the 5-year period beginning on
the date of enactment of the Best Pharmaceuticals for Children Amendments of
2007.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB9C0B21BDAE84B5A881BD99E1E686493"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (d), by striking
<quote>2003</quote> and inserting <quote>2009</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="idA42410FDE8AD4A2687C9FF66465711C4" section-type="subsequent-section"><enum>409.</enum><header display-inline="yes-display-inline">Effective date and limitation for rule
relating to toll-free number for adverse events on labeling for human drug
products</header>
<subsection commented="no" display-inline="no-display-inline" id="id159C98BB366B481CB6EF7EE754407E3E"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Notwithstanding subchapter II of chapter 5,
and chapter 7, of title 5, United States Code (commonly known as the
<quote>Administrative Procedure Act</quote>) and any other provision of law,
the proposed rule issued by the Commissioner of Food and Drugs entitled
<quote>Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug
Products</quote>, 69 Fed. Reg. 21778, (April 22, 2004) shall take effect on
January 1, 2008, unless such Commissioner issues the final rule before such
date.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id2FD7F6F444664AF48EB35682E821F5B6"><enum>(b)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">The proposed rule that takes effect under
subsection (a), or the final rule described under subsection (a), shall,
notwithstanding section 17(a) of the Best Pharmaceuticals for Children Act (21
U.S.C. 355b(a)), not apply to a drug—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idA15C929B2061448DA3ED5E6B407A8AF0"><enum>(1)</enum><text display-inline="yes-display-inline">for which an application is approved under
section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC026D162D4F743CFBA9C7EB1C66223AE"><enum>(2)</enum><text display-inline="yes-display-inline">that is not described under section
503(b)(1) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(b)(1)</external-xref>); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8A6BFD0006054886B503B3DA17B04B7A"><enum>(3)</enum><text display-inline="yes-display-inline">the packaging of which includes a toll-free
number through which consumers can report complaints to the manufacturer or
distributor of the drug.</text>
</paragraph></subsection></section></subtitle><subtitle commented="no" id="idDD955B43B08D4EBFA9EEA7817747F9C0" level-type="subsequent" style="OLC"><enum>B</enum><header display-inline="yes-display-inline">Pediatric research improvement</header>
<section commented="no" display-inline="no-display-inline" id="id57F573E1E8394ED9980B0E78353DE5F0" section-type="subsequent-section"><enum>411.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the
<quote><short-title>Pediatric Research Improvement
Act</short-title></quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="ID411a30649cdb41249efe957e03540d6f" section-type="subsequent-section"><enum>412.</enum><header display-inline="yes-display-inline">Pediatric formulations, extrapolations, and
deferrals</header><text display-inline="no-display-inline">Section 505B(a) of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id16CE2BDFC0324920B5FD404B86F8A4AF"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (4)(C), by adding at the end
the following: <quote>An applicant seeking either a partial or full waiver on
this ground shall submit to the Secretary documentation detailing why a
pediatric formulation cannot be developed, and, if the waiver is granted, the
applicant’s submission shall promptly be made available to the public in an
easily accessible manner, including through posting on the website of the Food
and Drug Administration</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA1A2BBACA9144FF08C0390EE4216454D"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(B), by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="idDA1243E10C274986858D72D21BE5FB65" style="OLC">
<clause commented="no" display-inline="no-display-inline" id="ID61fd79d55818420bac95bf56b3086f4f"><enum>(iii)</enum><header display-inline="yes-display-inline">Information on extrapolation</header><text display-inline="yes-display-inline">A brief documentation of the scientific
data supporting the conclusion under clauses (i) and (ii) shall be included in
any pertinent reviews for the application under section 505 or section 351 of
the Public Health Service Act.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idDD8EAD67F5DA4339B194968C92E11A79"><enum>(3)</enum><text display-inline="yes-display-inline">by striking paragraph (3) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id9E83E1BAB934449989C9F6B4B7FFDA2E" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID4e83b9085a6e467ab8f7d30fdd9f29a9"><enum>(3)</enum><header display-inline="yes-display-inline">Deferral</header>
<subparagraph commented="no" display-inline="no-display-inline" id="IDec0b274c6a404e3489a184fa296d4bc3"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">On the initiative of the Secretary or at
the request of the applicant, the Secretary may defer submission of some or all
assessments required under paragraph (1) until a specified date after approval
of the drug or issuance of the license for a biological product if—</text>
<clause commented="no" display-inline="no-display-inline" id="IDc9fcbde802d84069a23616ce715e5feb"><enum>(i)</enum><text display-inline="yes-display-inline">the Secretary finds that—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID355612ebd0b943ea8890ec4929e37707"><enum>(I)</enum><text display-inline="yes-display-inline">the drug or biological product is ready for
approval for use in adults before pediatric studies are complete;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDb5f149cedb94448298e796096e3839ea"><enum>(II)</enum><text display-inline="yes-display-inline">pediatric studies should be delayed until
additional safety or effectiveness data have been collected; or</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID2989bdcaa20247b8b6da9b38796eedf2"><enum>(III)</enum><text display-inline="yes-display-inline">there is another appropriate reason for
deferral; and</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="IDe17ea041a9d640d886787f340a23a8ab"><enum>(ii)</enum><text display-inline="yes-display-inline">the applicant submits to the
Secretary—</text>
<subclause commented="no" display-inline="no-display-inline" id="ID612b9a54071d4f1c91f14b8334282015"><enum>(I)</enum><text display-inline="yes-display-inline">certification of the grounds for deferring
the assessments;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID84a1ef4168eb4931a3842e91f178ef90"><enum>(II)</enum><text display-inline="yes-display-inline">a description of the planned or ongoing
studies;</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDa405c25b3f6a4c9aaf7bdf067ff60dac"><enum>(III)</enum><text display-inline="yes-display-inline">evidence that the studies are being
conducted or will be conducted with due diligence and at the earliest possible
time; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id030C816B26AA43228FE391FD080B2A8B"><enum>(IV)</enum><text display-inline="yes-display-inline">a timeline for the completion of such
studies.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3ef725ace5a14c169bf8e952b5012a5f"><enum>(B)</enum><header display-inline="yes-display-inline">Annual review</header>
<clause commented="no" display-inline="no-display-inline" id="id274B0D1029F044B1BD849D4F34133F69"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">On an annual basis following the approval
of a deferral under subparagraph (A), the applicant shall submit to the
Secretary the following information:</text>
<subclause commented="no" display-inline="no-display-inline" id="ID19a309ba317c411f85bbe25302472cee"><enum>(I)</enum><text display-inline="yes-display-inline">Information detailing the progress made in
conducting pediatric studies.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDdb5b909f9fd44800b6d0390f8b4604da"><enum>(II)</enum><text display-inline="yes-display-inline">If no progress has been made in conducting
such studies, evidence and documentation that such studies will be conducted
with due diligence and at the earliest possible time.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="idE6F828B39BEE48BBB45238EC9D914DB3"><enum>(ii)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">The information submitted through the
annual review under clause (i) shall promptly be made available to the public
in an easily accessible manner, including through the website of the Food and
Drug
Administration.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="ID6a5cea2298b642ffa5be2c4231eb1281" section-type="subsequent-section"><enum>413.</enum><header display-inline="yes-display-inline">Improving availability of pediatric data
for already marketed products</header><text display-inline="no-display-inline">Section 505B(b) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(b)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id1A068D1754B04804BC4D4C80D8DC3D42"><enum>(1)</enum><text display-inline="yes-display-inline">by striking paragraph (1) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id947C657A0CBE4B76937D0969ACAB7DC4" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="IDe9e30ed9d4c1463f905192d64233f0d1"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">After providing notice in the form of a
written request under section 505A that was declined by the sponsor or holder,
or a letter referencing such declined written request, and an opportunity for
written response and a meeting, which may include an advisory committee
meeting, the Secretary may (by order in the form of a letter) require the
sponsor or holder of an approved application for a drug under section 505 or
the holder of a license for a biological product under section 351 of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>) to submit by a specified date the
assessments described in subsection (a)(2) and the written request, as
appropriate, for the labeled indication or indications, if the Secretary finds
that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID4dcdafc130ac4ec79715863c9eb32e07"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="idBCCD55CD67E04E71AC2B55A9C04FC62D"><enum>(i)</enum><text display-inline="yes-display-inline">the drug or biological product is used for
a substantial number of pediatric patients for the labeled indications;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idE2FAC829030B4585962288A57A48F74F" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">adequate pediatric labeling could confer a
benefit on pediatric patients;</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID398b1fbb78234008802951e7725cdbdf"><enum>(B)</enum><text display-inline="yes-display-inline">there is reason to believe that the drug or
biological product would represent a meaningful therapeutic benefit over
existing therapies for pediatric patients for 1 or more of the claimed
indications; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id937687286864458494CE67537EA3BD2D"><enum>(C)</enum><text display-inline="yes-display-inline">the absence of adequate pediatric labeling
could pose a risk to pediatric
patients.</text>
</subparagraph></paragraph><after-quoted-block>;
</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC91AF04407D84A8D88FA631C59759016"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)(C), by adding at the end
the following: <quote>An applicant seeking either a partial or full waiver
shall submit to the Secretary documentation detailing why a pediatric
formulation cannot be developed, and, if the waiver is granted, the applicant’s
submission shall promptly be made available to the public in an easily
accessible manner, including through posting on the website of the Food and
Drug Administration.</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2EDF0E08D7BE47E9BBAC5CA0CEF6E1CF"><enum>(3)</enum><text display-inline="yes-display-inline">by striking paragraph (3) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id60ABCBE57C434E2EBC20FF5274564909" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id14DBCC84893042BEA1AE0FD35579444E"><enum>(3)</enum><header display-inline="yes-display-inline">Effect of subsection</header><text display-inline="yes-display-inline">Nothing in this subsection alters or amends
section 301(j) of this Act or <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5 or section 1905 of title
18, United States
Code.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="ID56c6f4b2f4704d0da32c6b5acd951e37" section-type="subsequent-section"><enum>414.</enum><header display-inline="yes-display-inline">Sunset; review of pediatric assessments;
adverse event reporting; labeling changes; and pediatric
assessments</header><text display-inline="no-display-inline">Section 505B of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idD3733641F28246248445EE9290D4237C"><enum>(1)</enum><text display-inline="yes-display-inline">redesignating subsection (h) as subsection
(j);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id25D595B7A5FF402C965853CDC0B506F5"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (j), as so redesignated, by
striking <quote>505A(n)</quote> and inserting <quote>505A(p)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID884b3b53ed4e43d2ae1e240881bac735"><enum>(3)</enum><text display-inline="yes-display-inline">by redesignating subsection (f) as
subsection (k);</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID23d371d4904242e6b858b44489a70b14"><enum>(4)</enum><text display-inline="yes-display-inline">by redesignating subsection (g) as
subsection (l); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1aa2204dd8614b8e93bbd737e5dd59d1"><enum>(5)</enum><text display-inline="yes-display-inline">by inserting after subsection (e) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id94B86A19C99E4442B74B3E7FBE172895" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="ID79d93f83505542e09ff45167542b7de8"><enum>(f)</enum><header display-inline="yes-display-inline">Review of pediatric assessment requests,
pediatric assessments, deferrals, and waivers</header>
<paragraph commented="no" display-inline="no-display-inline" id="IDe3d7e6830ae4486ab6076f6ef5a4e14a"><enum>(1)</enum><header display-inline="yes-display-inline">Review</header><text display-inline="yes-display-inline">The Secretary shall create an internal
committee to review all pediatric assessment requests issued under this
section, all pediatric assessments conducted under this section, and all
deferral and waiver requests made pursuant to this section. Such internal
committee shall include individuals, each of whom is an employee of the Food
and Drug Administration, with the following expertise:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID2095748ce2a545c1881f2f486de7b1c1"><enum>(A)</enum><text display-inline="yes-display-inline">Pediatrics.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf42b28a1ee484a218ccbc6e772a4e664"><enum>(B)</enum><text display-inline="yes-display-inline">Biopharmacology.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID97d5d8a1dd4a44ec8fa6dc0a59b3d762"><enum>(C)</enum><text display-inline="yes-display-inline">Statistics.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDcd20a2e449854ddc8b3a5e482e540ad3"><enum>(D)</enum><text display-inline="yes-display-inline">Drugs and drug formulations.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID600033e0052b4955af7c210bf8e3803e"><enum>(E)</enum><text display-inline="yes-display-inline">Pediatric ethics.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID4b1c7877ec334ce7806e5463252e2e4d"><enum>(F)</enum><text display-inline="yes-display-inline">Legal issues.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID52322c702980454c84787764ca7fb111"><enum>(G)</enum><text display-inline="yes-display-inline">Appropriate expertise, such as expertise in
child and adolescent psychiatry, pertaining to the pediatric product under
review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID2f0f72b5ec394d3aba2de7a00abace48"><enum>(H)</enum><text display-inline="yes-display-inline">1 or more experts from the Office of
Pediatric Therapeutics.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID787d05e7a5c246b2b8d8f2c13d5e7e1c"><enum>(I)</enum><text display-inline="yes-display-inline">Other individuals as designated by the
Secretary.</text>
</subparagraph></paragraph><paragraph id="ID92e668218d4f43c1b87263b8314f312f"><enum>(2)</enum><header>Action by the
committee</header><text>The committee established under paragraph (1) may
perform a function under this section using appropriate members of the
committee under paragraph (1) and need not convene all members of the committee
under paragraph (1) in order to perform a function under this section.</text>
</paragraph><paragraph id="IDfb7f8adefc994eaa8a5bc9e8abe46a46"><enum>(3)</enum><header>Documentation
of committee action</header><text>For each drug or biological product, the
committee established under this paragraph shall document for each function
under paragraph (4) or (5), which members of the committee participated in such
function.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID02d1861831ef4bb6bdcab922613a5c5e"><enum>(4)</enum><header display-inline="yes-display-inline">Review of requests for pediatric
assessments, deferrals, and waivers</header><text display-inline="yes-display-inline">All written requests for a pediatric
assessment issued pursuant to this section and all requests for deferrals and
waivers from the requirement to conduct a pediatric assessment under this
section shall be reviewed and approved by the committee established under
paragraph (1).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDac0001538b6448d7ac7ca057f99ed0ee"><enum>(5)</enum><header display-inline="yes-display-inline">Review of assessments</header><text display-inline="yes-display-inline">The committee established under paragraph
(1) shall review all assessments conducted under this section to determine
whether such assessments meet the requirements of this section.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDbc6a71a4d04c46dca10dbf82a9d59570"><enum>(6)</enum><header display-inline="yes-display-inline">Tracking of assessments and labeling
changes</header><text display-inline="yes-display-inline">The committee
established under paragraph (1) is responsible for tracking and making public
in an easily accessible manner, including through posting on the website of the
Food and Drug Administration—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="IDc0b376e3d51446b0b08476769d7ecf31"><enum>(A)</enum><text display-inline="yes-display-inline">the number of assessments conducted under
this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDdca7ea31a88d49f58635c847d07e2937"><enum>(B)</enum><text display-inline="yes-display-inline">the specific drugs and drug uses assessed
under this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID978ebac4379a489f8c7012542e7c30ef"><enum>(C)</enum><text display-inline="yes-display-inline">the types of assessments conducted under
this section, including trial design, the number of pediatric patients studied,
and the number of centers and countries involved;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf551b27b68ab4f2b902a9b55bbcef062"><enum>(D)</enum><text display-inline="yes-display-inline">the total number of deferrals requested and
granted under this section, and, if granted, the reasons for such deferrals,
the timeline for completion, and the number completed and pending by the
specified date, as outlined in subsection (a)(3);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0b7fb4a1fb024d988ecc3800d2d348ac"><enum>(E)</enum><text display-inline="yes-display-inline">the number of waivers requested and granted
under this section, and, if granted, the reasons for the waivers;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDd41757207fb44701862376de5228bc7f"><enum>(F)</enum><text display-inline="yes-display-inline">the number of pediatric formulations
developed and the number of pediatric formulations not developed and the
reasons any such formulations were not developed;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDa2de25bbbb4b4b36bda40fb57528a956"><enum>(G)</enum><text display-inline="yes-display-inline">the labeling changes made as a result of
assessments conducted under this section;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID26653d7877f14ded83c16ab1b7bc5181"><enum>(H)</enum><text display-inline="yes-display-inline">an annual summary of labeling changes made
as a result of assessments conducted under this section for distribution
pursuant to subsection (i)(2); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDb5e6c3de6a184e9ebe837a290a9939b8"><enum>(I)</enum><text display-inline="yes-display-inline">an annual summary of the information
submitted pursuant to subsection (a)(3)(B).</text>
</subparagraph></paragraph><paragraph id="ID4367a098e8ad4d38a5374148ea30fa13"><enum>(7)</enum><header>Committee</header><text>The
committee established under paragraph (1) is the committee established under
section 505A(f)(1).</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID8b4b9afc96ea48e58ef6147f88d1165a"><enum>(g)</enum><header display-inline="yes-display-inline">Labeling changes</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID74caa95304874c928895b0262b04c372"><enum>(1)</enum><header display-inline="yes-display-inline">Priority status for pediatric
supplement</header><text display-inline="yes-display-inline">Any supplement to
an application under section 505 and section 351 of the Public Health Service
Act proposing a labeling change as a result of any pediatric assessments
conducted pursuant to this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID88f12a9642d741a793ccc6ca9e48775d"><enum>(A)</enum><text display-inline="yes-display-inline">shall be considered a priority supplement;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID0640401978314960bcff7fd0aa4b35b1"><enum>(B)</enum><text display-inline="yes-display-inline">shall be subject to the performance goals
established by the Commissioner for priority drugs.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID8bd170eaa8674d39ac4fa27c4f5bdf06"><enum>(2)</enum><header display-inline="yes-display-inline">Dispute resolution</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ID40bd9c24ce7440b39fb1b7f02de06aa5"><enum>(A)</enum><header display-inline="yes-display-inline">Request for labeling change and failure To
agree</header><text display-inline="yes-display-inline">If the Commissioner
determines that a sponsor and the Commissioner have been unable to reach
agreement on appropriate changes to the labeling for the drug that is the
subject of the application or supplement, not later than 180 days after the
date of the submission of the application or supplement—</text>
<clause commented="no" display-inline="no-display-inline" id="ID5f0b1c4c14e540ecabda4bde0f83f10f"><enum>(i)</enum><text display-inline="yes-display-inline">the Commissioner shall request that the
sponsor make any labeling change that the Commissioner determines to be
appropriate; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4a74bb46b060450a8b8066c5076444bc"><enum>(ii)</enum><text display-inline="yes-display-inline">if the sponsor does not agree to make a
labeling change requested by the Commissioner, the Commissioner shall refer the
matter to the Pediatric Advisory Committee.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID670297c0280f41c28df31e2c7e5bc727"><enum>(B)</enum><header display-inline="yes-display-inline">Action by the pediatric advisory
committee</header><text display-inline="yes-display-inline">Not later than 90
days after receiving a referral under subparagraph (A)(ii), the Pediatric
Advisory Committee shall—</text>
<clause commented="no" display-inline="no-display-inline" id="ID48e2540f8394459b93dc7cb609eb933b"><enum>(i)</enum><text display-inline="yes-display-inline">review the pediatric study reports;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID13da4a0d01b644cc9a049d2d6fec6900"><enum>(ii)</enum><text display-inline="yes-display-inline">make a recommendation to the Commissioner
concerning appropriate labeling changes, if any.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDf1f261bc9bb24c3fba94c3655fd1360c"><enum>(C)</enum><header display-inline="yes-display-inline">Consideration of
recommendations</header><text display-inline="yes-display-inline">The
Commissioner shall consider the recommendations of the Pediatric Advisory
Committee and, if appropriate, not later than 30 days after receiving the
recommendation, make a request to the sponsor of the application or supplement
to make any labeling changes that the Commissioner determines to be
appropriate.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID07f470c9954047ba9cc832a88e10bb24"><enum>(D)</enum><header display-inline="yes-display-inline">Misbranding</header><text display-inline="yes-display-inline">If the sponsor, within 30 days after
receiving a request under subparagraph (C), does not agree to make a labeling
change requested by the Commissioner, the Commissioner may deem the drug that
is the subject of the application or supplement to be misbranded.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID34bfb1c9d9164be0bc79584ebc7ed503"><enum>(E)</enum><header display-inline="yes-display-inline">No effect on authority</header><text display-inline="yes-display-inline">Nothing in this subsection limits the
authority of the United States to bring an enforcement action under this Act
when a drug lacks appropriate pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement action referred to in
the preceding sentence) shall preclude, delay, or serve as the basis to stay
the other course of action.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID79133a64c5cb4a16b7ea461d33762833"><enum>(3)</enum><header display-inline="yes-display-inline">Other labeling changes</header><text display-inline="yes-display-inline">If the Secretary makes a determination that
a pediatric assessment conducted under this section does or does not
demonstrate that the drug that is the subject of such assessment is safe and
effective, including whether such assessment results are inconclusive, in
pediatric populations or subpopulations, the Secretary shall order the labeling
of such product to include information about the results of the assessment and
a statement of the Secretary's determination.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID79f9a1d04ae44a5ca1caee13ba44afa9"><enum>(h)</enum><header display-inline="yes-display-inline">Dissemination of pediatric
information</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID63c9cabe9c7244f1b480671c729c4fd8"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
submission of a pediatric assessment under this section, the Secretary shall
make available to the public in an easily accessible manner the medical,
statistical, and clinical pharmacology reviews of such pediatric assessments
and shall post such assessments on the website of the Food and Drug
Administration.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDcef56dd15d37465ea1cac4e4ed202fdb"><enum>(2)</enum><header display-inline="yes-display-inline">Dissemination of information regarding
labeling changes</header><text display-inline="yes-display-inline">The
Secretary shall require that the sponsors of the assessments that result in
labeling changes that are reflected in the annual summary developed pursuant to
subsection (f)(4)(H) distribute such information to physicians and other health
care providers.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDfe7562fea0344aa2b658cc7fe38e845e"><enum>(3)</enum><header display-inline="yes-display-inline">Effect of subsection</header><text display-inline="yes-display-inline">Nothing in this subsection shall alter or
amend section 301(j) of this Act or <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United States Code,
or <external-xref legal-doc="usc" parsable-cite="usc/18/1905">section 1905</external-xref> of title 18, United States Code.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID29ccb40d8e124cc49430560c1ec22efc"><enum>(i)</enum><header display-inline="yes-display-inline">Adverse event reporting</header>
<paragraph commented="no" display-inline="no-display-inline" id="ID5335984ea0574aefa498596cff054549"><enum>(1)</enum><header display-inline="yes-display-inline">Reporting in year 1</header><text display-inline="yes-display-inline">During the 1-year period beginning on the
date a labeling change is made pursuant to subsection (g), the Secretary shall
ensure that all adverse event reports that have been received for such drug
(regardless of when such report was received) are referred to the Office of
Pediatric Therapeutics. In considering such reports, the Director of such
Office shall provide for the review of the report by the Pediatric Advisory
Committee, including obtaining any recommendations of such committee regarding
whether the Secretary should take action under this Act in response to such
report.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID2de2ac8fa5de47b490f52fbc9ad43105"><enum>(2)</enum><header display-inline="yes-display-inline">Reporting in subsequent years</header><text display-inline="yes-display-inline">Following the 1-year period described in
paragraph (1), the Secretary shall, as appropriate, refer to the Office of
Pediatric Therapeutics with all pediatric adverse event reports for a drug for
which a pediatric study was conducted under this section. In considering such
reports, the Director of such Office may provide for the review of such reports
by the Pediatric Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take action in response
to such report.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id24387F18B76E4DE2887075AAD82DED19"><enum>(3)</enum><header display-inline="yes-display-inline">Effect</header><text display-inline="yes-display-inline">The requirements of this subsection shall
supplement, not supplant, other review of such adverse event reports by the
Secretary.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="idE357E83481A9420FADF65818B01BA5F2" section-type="subsequent-section"><enum>415.</enum><header display-inline="yes-display-inline">Meaningful therapeutic
benefit</header><text display-inline="no-display-inline">Section 505B(c) of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id754AE87542E244B2884AA85EF963F9DE"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>estimates</quote> and
inserting <quote>determines</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB6351E24CC0C4B918EDEDD72FFB33A90"><enum>(2)</enum><text display-inline="yes-display-inline">by striking <quote>would</quote> and
inserting <quote>could</quote>.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="idAE2FA9D5626744839B817F31B52E5347" section-type="subsequent-section"><enum>416.</enum><header display-inline="yes-display-inline">Reports</header>
<subsection commented="no" display-inline="no-display-inline" id="id4A67B4E7124A48B2AFF06F9E380D8BBC"><enum>(a)</enum><header display-inline="yes-display-inline">Institute of Medicine study</header>
<paragraph commented="no" display-inline="no-display-inline" id="id639B4FFF4335405BAF51C5DAB4116E86"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 3 years after the date of
enactment of this subtitle, the Secretary shall contract with the Institute of
Medicine to conduct a study and report to Congress regarding the pediatric
studies conducted pursuant to section 505B of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c</external-xref>) since 1997.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id08B9BE6845844E4A83A5C6A6E8C9E2B2"><enum>(2)</enum><header display-inline="yes-display-inline">Content of study</header><text display-inline="yes-display-inline">The study under paragraph (1) shall review
and assess—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id06666218587447DC9E260F9F168B1472"><enum>(A)</enum><text display-inline="yes-display-inline">pediatric studies conducted pursuant to
section 505B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c</external-xref>) since
1997 and labeling changes made as a result of such studies; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idFEA973AE82F3498DAEF4FF0F9D620046"><enum>(B)</enum><text display-inline="yes-display-inline">the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for pediatric populations,
neonatal assessment tools, number and type of pediatric adverse events, and
ethical issues in pediatric clinical trials.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2E9CD628A6DF40DDBC3146E7FBBFEDB0"><enum>(3)</enum><header display-inline="yes-display-inline">Representative sample</header><text display-inline="yes-display-inline">The Institute of Medicine may devise an
appropriate mechanism to review a representative sample of studies conducted
pursuant to section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c) from each review division within the Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research in order to make
the required assessment.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idBA0F4DE84A6244DC84E0B3670CAD770E"><enum>(b)</enum><header display-inline="yes-display-inline">GAO report</header><text display-inline="yes-display-inline">Not later than September 1, 2010, the
Comptroller General of the United States, in consultation with the Secretary of
Health and Human Services, shall submit to Congress a report that addresses the
effectiveness of section 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a) in ensuring that medicines used by children are tested and
properly labeled, including—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID6c51606d0a5d438d8530399bd50bb1c4"><enum>(1)</enum><text display-inline="yes-display-inline">the number and importance of drugs for
children that are being tested as a result of this provision and the importance
for children, health care providers, parents, and others of labeling changes
made as a result of such testing;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb91b4777c4fc4fd484e295f18d0ad799"><enum>(2)</enum><text display-inline="yes-display-inline">the number and importance of drugs for
children that are not being tested for their use notwithstanding the provisions
of such section 505B, and possible reasons for the lack of testing; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDa51ccc061524412b865da0fc8e940731"><enum>(3)</enum><text display-inline="yes-display-inline">the number of drugs for which testing is
being done and labeling changes required, including the date labeling changes
are made and which labeling changes required the use of the dispute resolution
process established under such section 505B, together with a description of the
outcomes of such process, including a description of the disputes and the
recommendations of the Pediatric Advisory Committee.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id0F4D21AFC3BC46D5AA6AFDA39D8ADE39" section-type="subsequent-section"><enum>417.</enum><header display-inline="yes-display-inline">Technical corrections</header><text display-inline="no-display-inline">Section 505B(a)(2)(B)(ii) of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c(a)(2)(B)(ii)</external-xref>) is amended by
striking <quote>one</quote> and inserting <quote>1</quote>.</text>
</section></subtitle><subtitle commented="no" id="id66774CAD335740CF971E0F3CB1A62E0C" level-type="subsequent" style="OLC"><enum>C</enum><header display-inline="yes-display-inline">Pediatric medical devices</header>
<section commented="no" display-inline="no-display-inline" id="id1678E42238134DB8A19E5EB4A6B08CEB" section-type="subsequent-section"><enum>421.</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the
<quote><short-title>Pediatric Medical Device Safety and
Improvement Act of 2007</short-title></quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="idECF63D0CA6A34D01A33B895C57FEB77E" section-type="subsequent-section"><enum>422.</enum><header display-inline="yes-display-inline">Tracking pediatric device
approvals</header><text display-inline="no-display-inline">Chapter V of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by inserting after section 515 the
following:</text>
<quoted-block display-inline="no-display-inline" id="idDB13099306E54DDEA18262DBAA52B0C3" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id6132F65AFF9241839C85255875472621" section-type="subsequent-section"><enum>515A.</enum><header display-inline="yes-display-inline">Pediatric uses of devices</header>
<subsection commented="no" display-inline="no-display-inline" id="id9F51F4B6F13B44FEB6D167703ADAD57E"><enum>(a)</enum><header display-inline="yes-display-inline">New devices</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5EF71DFA6251454A87485339B5A418B6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">A person that submits to the Secretary an
application under section 520(m), or an application (or supplement to an
application) or a product development protocol under section 515, shall include
in the application or protocol the information described in paragraph
(2).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDF54C4ABBF3D8424FB9827069ECD18232"><enum>(2)</enum><header display-inline="yes-display-inline">Required information</header><text display-inline="yes-display-inline">The application or protocol described in
paragraph (1) shall include, with respect to the device for which approval is
sought and if readily available—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id43476ECB08A6481AA5EBC93A6DA18463"><enum>(A)</enum><text display-inline="yes-display-inline">a description of any pediatric
subpopulations that suffer from the disease or condition that the device is
intended to treat, diagnose, or cure; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id61A35C61B04B4A279EA18FC69CC0A244"><enum>(B)</enum><text display-inline="yes-display-inline">the number of affected pediatric
patients.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1C2AC02A545A4DAEAFFB0B6F727B9180"><enum>(3)</enum><header display-inline="yes-display-inline">Annual report</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
enactment of this section, and annually thereafter, the Secretary shall submit
to the Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a report
that includes—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id5395250D3E4043D7A999DCCA1F144065"><enum>(A)</enum><text display-inline="yes-display-inline">the number of devices approved in the year
preceding the year in which the report is submitted, for which there is a
pediatric subpopulation that suffers from the disease or condition that the
device is intended to treat, diagnose, or cure;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7BBF33D7D60543D7B641A51785730D56"><enum>(B)</enum><text display-inline="yes-display-inline">the number of devices approved in the year
preceding the year in which the report is submitted, labeled for use in
pediatric patients;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id54895EA64AB74F0E8A1FBBA8214A1378"><enum>(C)</enum><text display-inline="yes-display-inline">the number of pediatric devices approved in
the year preceding the year in which the report is submitted, exempted from a
fee pursuant to section 738(a)(2)(B)(v); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE34FBE6083DE4D709F9D822CF9D7F35F"><enum>(D)</enum><text display-inline="yes-display-inline">the review time for each device described
in subparagraphs (A), (B), and (C).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idB9183C47E02F4D8FAD8C7B36CE5C8A43"><enum>(b)</enum><header display-inline="yes-display-inline">Determination of pediatric effectiveness
based on similar course of disease or condition or similar effect of device on
adults</header>
<paragraph commented="no" display-inline="no-display-inline" id="id74B77C52E2A04BA9B7879F8199CF2AB6"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">If the course of the disease or condition
and the effects of the device are sufficiently similar in adults and pediatric
patients, the Secretary may conclude that adult data may be used to support a
determination of a reasonable assurance of effectiveness in pediatric
populations, as appropriate.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8B14214A59884E15A634F049163DCE4E"><enum>(2)</enum><header display-inline="yes-display-inline">Extrapolation between
subpopulations</header><text display-inline="yes-display-inline">A study may
not be needed in each pediatric subpopulation if data from one subpopulation
can be extrapolated to another subpopulation.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idBA5A940CCB594015B3FFA8E350F8D780"><enum>(c)</enum><header display-inline="yes-display-inline">Pediatric subpopulation</header><text display-inline="yes-display-inline">In this section, the term <term>pediatric
subpopulation</term> has the meaning given the term in section
520(m)(6)(E)(ii).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id9CF36A6EF51D4F07A251F6C3153B9F6B" section-type="subsequent-section"><enum>423.</enum><header display-inline="yes-display-inline">Modification to humanitarian device
exemption</header>
<subsection commented="no" display-inline="no-display-inline" id="IDC31BFCA706704446A8EDC84C89D6B006"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 520(m) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C. 360j(m)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDE1CA92F10B6D4F4884D8AE1EA5AD1809"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking
<quote>No</quote> and inserting <quote>Except as provided in paragraph (6),
no</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID8FBBA62012E9463BAA21C221A3F29B31"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (5)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ID791CFD7DAC7F41228FB6C1DC216487B1"><enum>(A)</enum><text display-inline="yes-display-inline">by inserting <quote>, if the Secretary has
reason to believe that the requirements of paragraph (6) are no longer
met,</quote> after <quote>public health</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3474E443A3034BACAB5737837D1C6278"><enum>(B)</enum><text display-inline="yes-display-inline">by adding at the end the following:
<quote>If the person granted an exemption under paragraph (2) fails to
demonstrate continued compliance with the requirements of this subsection, the
Secretary may suspend or withdraw the exemption from the effectiveness
requirements of sections 514 and 515 for a humanitarian device only after
providing notice and an opportunity for an informal hearing.</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0246A290019A40E482DFD7F327C1ED2C"><enum>(3)</enum><text display-inline="yes-display-inline">by striking paragraph (6) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="idC5C6650512F941DBB6CAE124B198C04F" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="ID0C4B03106D904943939249D27907B5CB" indent="up1"><enum>(6)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idB4971BDAFDB34CAC84C863D035810EA4"><enum>(A)</enum><text display-inline="yes-display-inline">Except as provided in subparagraph (D), the
prohibition in paragraph (3) shall not apply with respect to a person granted
an exemption under paragraph (2) if each of the following conditions
apply:</text>
<clause commented="no" display-inline="no-display-inline" id="ID24F457901D7D4944B269AD8348EBFE1A" indent="up1"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="id07AD07249DD048A995B499EC97713A26"><enum>(I)</enum><text display-inline="yes-display-inline">The device with respect to which the
exemption is granted is intended for the treatment or diagnosis of a disease or
condition that occurs in pediatric patients or in a pediatric subpopulation,
and such device is labeled for use in pediatric patients or in a pediatric
subpopulation in which the disease or condition occurs.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idA58641203E2B4B4DB453CE05129BCFA3" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">The device was not previously approved
under this subsection for the pediatric patients or the pediatric subpopulation
described in subclause (I) prior to the date of enactment of the
<short-title>Pediatric Medical Device Safety and
Improvement Act of 2007</short-title>.</text>
</subclause></clause><clause commented="no" display-inline="no-display-inline" id="ID3347D5F672A746B99DFACACD091F6D50" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">During any calendar year, the number of
such devices distributed during that year does not exceed the annual
distribution number specified by the Secretary when the Secretary grants such
exemption. The annual distribution number shall be based on the number of
individuals affected by the disease or condition that such device is intended
to treat, diagnose, or cure, and of that number, the number of individuals
likely to use the device, and the number of devices reasonably necessary to
treat such individuals. In no case shall the annual distribution number exceed
the number identified in paragraph (2)(A).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID495B526124B14B2CA39362BA9CA6357E" indent="up1"><enum>(iii)</enum><text display-inline="yes-display-inline">Such person immediately notifies the
Secretary if the number of such devices distributed during any calendar year
exceeds the annual distribution number referred to in clause (ii).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="IDC4218158F19641A49F438C121B5FF438" indent="up1"><enum>(iv)</enum><text display-inline="yes-display-inline">The request for such exemption is submitted
on or before October 1, 2012.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idF8122E5405464E36BF28EFBF84344B26" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">The Secretary may inspect the records
relating to the number of devices distributed during any calendar year of a
person granted an exemption under paragraph (2) for which the prohibition in
paragraph (3) does not apply.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1DA8041DC25546BF82FFDB9DEBCC212E" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">A
person may petition the Secretary to modify the annual distribution number
specified by the Secretary under subparagraph (A)(ii) with respect to a device
if additional information on the number of individuals affected by the disease
or condition arises, and the Secretary may modify such number but in no case
shall the annual distribution number exceed the number identified in paragraph
(2)(A).</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id636D958D7397424D8DDC5216576FEDA3" indent="up1"><enum>(D)</enum><text display-inline="yes-display-inline">If a person notifies the Secretary, or the
Secretary determines through an inspection under subparagraph (B), that the
number of devices distributed during any calendar year exceeds the annual
distribution number, as required under subparagraph (A)(iii), and modified
under subparagraph (C), if applicable, then the prohibition in paragraph (3)
shall apply with respect to such person for such device for any sales of such
device after such notification.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="IDF56CD18B2F6F46818728F31CE35C607B" indent="up1"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="idBFB4D1E8B8F84E3C8F4D9D37AFE9953B"><enum>(i)</enum><text display-inline="yes-display-inline">In this subsection, the term
<term>pediatric patients</term> means patients who are 21 years of age or
younger at the time of the diagnosis or treatment.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID4F678B4DE62E4E63AF0890FA9B0E7A02" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">In this subsection, the term
<term>pediatric subpopulation</term> means 1 of the following
populations:</text>
<subclause commented="no" display-inline="no-display-inline" id="IDBC69458809314E12A22908D22E22E53C"><enum>(I)</enum><text display-inline="yes-display-inline">Neonates.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID3F09F05AD1DD41CBAFC4692DC2B79F78"><enum>(II)</enum><text display-inline="yes-display-inline">Infants.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="ID9BF6AE36EF07462EAFD3C30C5C9773E4"><enum>(III)</enum><text display-inline="yes-display-inline">Children.</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="IDE5D67012D7D54059A0CFE95E086B6896"><enum>(IV)</enum><text display-inline="yes-display-inline">Adolescents.</text>
</subclause></clause></subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC3C4164841DB47948706DFB7E7C46E73"><enum>(4)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idCF61E522CE5441F2850D8E4D5DA82B63" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id5EEA3A4438E74B8898734E2E4D9A3E0F" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">The Secretary shall refer any report of an
adverse event regarding a device for which the prohibition under paragraph (3)
does not apply pursuant to paragraph (6)(A) that the Secretary receives to the
Office of Pediatric Therapeutics, established under section 6 of the Best
Pharmaceuticals for Children Act (<external-xref legal-doc="public-law" parsable-cite="pl/107/109">Public Law 107–109</external-xref>)). In considering the
report, the Director of the Office of Pediatric Therapeutics, in consultation
with experts in the Center for Devices and Radiological Health, shall provide
for periodic review of the report by the Pediatric Advisory Committee,
including obtaining any recommendations of such committee regarding whether the
Secretary should take action under this Act in response to the
report.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id78E9BBE0EBAB47CE82ACD2C76C7A04C8"><enum>(b)</enum><header display-inline="yes-display-inline">Report</header><text display-inline="yes-display-inline">Not later than January 1, 2012, the
Comptroller General of the United States shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report on the impact of
allowing persons granted an exemption under section 520(m)(2) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C. 360j(m)(2)</external-xref>) with respect to a device to profit from such device
pursuant to section 520(m)(6) of such<act-name parsable-cite="FFDCA">
Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C. 360j(m)(6)</external-xref>) (as amended by subsection (a)),
including—</text>
<paragraph commented="no" display-inline="no-display-inline" id="ID2cc05929f1fe4cf68d739cc81adf0eda"><enum>(1)</enum><text display-inline="yes-display-inline">an assessment of whether such section
520(m)(6) (as amended by subsection (a)) has increased the availability of
pediatric devices for conditions that occur in small numbers of children,
including any increase or decrease in the number of—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6265D3DA4EDA440A97DC38995B3BBE7B"><enum>(A)</enum><text display-inline="yes-display-inline">exemptions granted under such section
520(m)(2) for pediatric devices; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id18A00073F8F14BD2B5B7D3712F70ACAD"><enum>(B)</enum><text display-inline="yes-display-inline">applications approved under section 515 of
such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21 U.S.C. 360e</external-xref>) for devices intended to treat, diagnose, or cure
conditions that occur in pediatric patients or for devices labeled for use in a
pediatric population;</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDae6ca6bf4ff1482ebb612a2acdf2b261"><enum>(2)</enum><text display-inline="yes-display-inline">the conditions or diseases the pediatric
devices were intended to treat or diagnose and the estimated size of the
pediatric patient population for each condition or disease;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDcea5652fad564895afb92b820cb9fbc1"><enum>(3)</enum><text display-inline="yes-display-inline">the costs of the pediatric devices, based
on a survey of children's hospitals;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID33e2f25743e34be9a1a7fa0ddbefc7e1"><enum>(4)</enum><text display-inline="yes-display-inline">the extent to which the costs of such
devices are covered by health insurance;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4c5824f4471a402698ce53fff725269f"><enum>(5)</enum><text display-inline="yes-display-inline">the impact, if any, of allowing profit on
access to such devices for patients;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID4da1db67a83d403a80b4c5b4fb414109"><enum>(6)</enum><text display-inline="yes-display-inline">the profits made by manufacturers for each
device that receives an exemption;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb332b4e97e2d45ccbf6e8fb911c1c86b"><enum>(7)</enum><text display-inline="yes-display-inline">an estimate of the extent of the use of the
pediatric devices by both adults and pediatric populations for a condition or
disease other than the condition or disease on the label of such
devices;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID17c0a0beee3e4e29ad02cc57dc62906e"><enum>(8)</enum><text display-inline="yes-display-inline">recommendations of the Comptroller General
of the United States regarding the effectiveness of such section 520(m)(6) (as
amended by subsection (a)) and whether any modifications to such section
520(m)(6) (as amended by subsection (a)) should be made;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID762e61765c0c43a4a5ee96eebfdba6f7"><enum>(9)</enum><text display-inline="yes-display-inline">existing obstacles to pediatric device
development; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1ebe4ccd8ef94b96bd54ede5f48106ad"><enum>(10)</enum><text display-inline="yes-display-inline">an evaluation of the demonstration grants
described in section 425, which shall include an evaluation of the number of
pediatric medical devices—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id891602E7C3014C3BA5AE8864BFDE8034"><enum>(A)</enum><text display-inline="yes-display-inline">that have been or are being studied in
children; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3BEF050A01A3416C9CEA5E5176386730"><enum>(B)</enum><text display-inline="yes-display-inline">that have been submitted to the Food and
Drug Administration for approval, clearance, or review under such section
520(m) (as amended by this Act) and any regulatory actions taken.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id2D069FA2327F43CCBDB7CA243C0ED44A"><enum>(c)</enum><header display-inline="yes-display-inline">Guidance</header><text display-inline="yes-display-inline">Not later than 180 days after the date of
enactment of this subtitle, the Commissioner of Food and Drugs shall issue
guidance for institutional review committees on how to evaluate requests for
approval for devices for which a humanitarian device exemption under section
520(m)(2) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and
Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C. 360j(m)(2)</external-xref>) has been granted.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id5FB5FB6B02A746FFB62D26F47B76C504" section-type="subsequent-section"><enum>424.</enum><header display-inline="yes-display-inline">Contact point for available
funding</header><text display-inline="no-display-inline">Section 402(b) of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282(b)</external-xref>) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id2175D27F7886427F973162FEF4A941B3"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (21), by striking
<quote>and</quote> after the semicolon at the end;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD4E8464F87A24B73AD761BEF98BBFF33"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (22), by striking the period
at the end and inserting <quote>; and</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id457490E4496445C99CC718DAA2BF98B3"><enum>(3)</enum><text display-inline="yes-display-inline">by inserting after paragraph (22) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id08735262E5064AE181D93CF46372D6CE" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="id6EFF836701D84CE6A36878FB22A37CCF"><enum>(23)</enum><text display-inline="yes-display-inline">shall designate a contact point or office
to help innovators and physicians identify sources of funding available for
pediatric medical device
development.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id246CA5E1A9C64974A2D4B45A3530DCA7" section-type="subsequent-section"><enum>425.</enum><header display-inline="yes-display-inline">Demonstration grants for improving
pediatric device availability</header>
<subsection commented="no" display-inline="no-display-inline" id="ID5eef1660da574037b1b94784b87e6d48"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="id72FA2AE532BF44FEA08507A9993B7D4C"><enum>(1)</enum><header display-inline="yes-display-inline">Request for proposals</header><text display-inline="yes-display-inline">Not later than 90 days after the date of
enactment of this subtitle, the Secretary of Health and Human Services shall
issue a request for proposals for 1 or more grants or contracts to nonprofit
consortia for demonstration projects to promote pediatric device
development.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB11D28ED03D34EE19B7127454613549F"><enum>(2)</enum><header display-inline="yes-display-inline">Determination on grants or
contracts</header><text display-inline="yes-display-inline">Not later than 180
days after the date the Secretary of Health and Human Services issues a request
for proposals under paragraph (1), the Secretary shall make a determination on
the grants or contracts under this section.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idDD3B943446FD401C981538A356B0D32E"><enum>(b)</enum><header display-inline="yes-display-inline">Application</header><text display-inline="yes-display-inline">A nonprofit consortium that desires to
receive a grant or contract under this section shall submit an application to
the Secretary of Health and Human Services at such time, in such manner, and
containing such information as the Secretary may require.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idD8465695D912486FB172234D3954A68F"><enum>(c)</enum><header display-inline="yes-display-inline">Use of funds</header><text display-inline="yes-display-inline">A nonprofit consortium that receives a
grant or contract under this section shall facilitate the development,
production, and distribution of pediatric medical devices by—</text>
<paragraph commented="no" display-inline="no-display-inline" id="IDe93a3abc40994a6d9b5c1edee05c285f"><enum>(1)</enum><text display-inline="yes-display-inline">encouraging innovation and connecting
qualified individuals with pediatric device ideas with potential
manufacturers;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5306262adde844c1899a48b8d3984fab"><enum>(2)</enum><text display-inline="yes-display-inline">mentoring and managing pediatric device
projects through the development process, including product identification,
prototype design, device development, and marketing;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDb8603eb33e444d8ebdbc86603abe3290"><enum>(3)</enum><text display-inline="yes-display-inline">connecting innovators and physicians to
existing Federal and non-Federal resources, including resources from the Food
and Drug Administration, the National Institutes of Health, the Small Business
Administration, the Department of Energy, the Department of Education, the
National Science Foundation, the Department of Veterans Affairs, the Agency for
Healthcare Research and Quality, and the National Institute of Standards and
Technology;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID5cf8a80ea3234e1bb68ecb7cef63d798"><enum>(4)</enum><text display-inline="yes-display-inline">assessing the scientific and medical merit
of proposed pediatric device projects; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD13229C6C8174A10A722C4D7737EDC64"><enum>(5)</enum><text display-inline="yes-display-inline">providing assistance and advice as needed
on business development, personnel training, prototype development, postmarket
needs, and other activities consistent with the purposes of this
section.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID5f549993dcc04c11a3778cdd33f084ad"><enum>(d)</enum><header display-inline="yes-display-inline">Coordination</header>
<paragraph commented="no" display-inline="no-display-inline" id="id78A6BACC35F5452B85FA186862FB77E5"><enum>(1)</enum><header display-inline="yes-display-inline">National institutes of health</header><text display-inline="yes-display-inline">Each consortium that receives a grant or
contract under this section shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id51CA7A52E658429D91EA4F473FAC5E75"><enum>(A)</enum><text display-inline="yes-display-inline">coordinate with the National Institutes of
Health's pediatric device contact point or office, designated under section
424; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id74722C1B5C1745B5B4C93FF64C4F3694"><enum>(B)</enum><text display-inline="yes-display-inline">provide to the National Institutes of
Health any identified pediatric device needs that the consortium lacks
sufficient capacity to address or those needs in which the consortium has been
unable to stimulate manufacturer interest.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID7c24896a01aa4a43bc012d8d9e0b7fdd"><enum>(2)</enum><header display-inline="yes-display-inline">Food and drug administration</header><text display-inline="yes-display-inline">Each consortium that receives a grant or
contract under this section shall coordinate with the Commissioner of Food and
Drugs and device companies to facilitate the application for approval or
clearance of devices labeled for pediatric use.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA40EE4EE872C42CD86F1122F70EBFC24"><enum>(3)</enum><header display-inline="yes-display-inline">Effectiveness and outcomes</header><text display-inline="yes-display-inline">Each consortium that receives a grant or
contract under this section shall annually report to the Secretary of Health
and Human Services on—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id9F9BEE7B3F7344C3B92EE8B462C622E8"><enum>(A)</enum><text display-inline="yes-display-inline">the effectiveness of activities conducted
under subsection (c);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idC527510846A64E47B79EFAE6227B4471"><enum>(B)</enum><text display-inline="yes-display-inline">the impact of activities conducted under
subsection (c) on pediatric device development; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0D7006C30C4E49ACBFA658FAEA240E58"><enum>(C)</enum><text display-inline="yes-display-inline">the status of pediatric device development
that has been facilitated by the consortium.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idF7C55A61EED043EFB3441D3F1CE7B233"><enum>(e)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated to carry out this section $6,000,000 for each of
fiscal years 2008 through 2012.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id0040E41DDE31445D99D3B0B8C57E9BCF" section-type="subsequent-section"><enum>426.</enum><header display-inline="yes-display-inline">Amendments to Office of Pediatric
Therapeutics and Pediatric Advisory Committee</header>
<subsection commented="no" display-inline="no-display-inline" id="idB4442E16A9CF40A5BC9C8D2EBF6E25F2"><enum>(a)</enum><header display-inline="yes-display-inline">In general</header>
<paragraph commented="no" display-inline="no-display-inline" id="idEB9D54AB0D934F24B99FF12C76693FE5"><enum>(1)</enum><header display-inline="yes-display-inline">Office of pediatric
therapeutics</header><text display-inline="yes-display-inline">Section 6(b) of
the Best Pharmaceuticals for Children Act (<external-xref legal-doc="usc" parsable-cite="usc/21/393a">21 U.S.C. 393a(b)</external-xref>) is amended by
inserting <quote>, including increasing pediatric access to medical
devices</quote> after <quote>pediatric issues</quote>.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA05C81C8794B41E89AC6E17952433BA0"><enum>(2)</enum><header display-inline="yes-display-inline">Plan for pediatric medical device
research</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id3FE11B509DD743FC866B3243242A4239"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Not later than 270 days after the date of
enactment of this subtitle, the Office of Pediatric Therapeutics, in
collaboration with the Director of the National Institutes of Health and the
Director of the Agency for Healthcare Research and Quality, shall submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives a plan for
expanding pediatric medical device research and development. In developing such
plan, the Commissioner of Food and Drugs shall consult with individuals and
organizations with appropriate expertise in pediatric medical devices.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID23cb19c28b744ca98c0b381900d6c07e"><enum>(B)</enum><header display-inline="yes-display-inline">Contents</header><text display-inline="yes-display-inline">The plan under subparagraph (A) shall
include—</text>
<clause commented="no" display-inline="no-display-inline" id="ID0ef1bbe306144975931cc4ed3f788a22"><enum>(i)</enum><text display-inline="yes-display-inline">the current status of federally funded
pediatric medical device research;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID70f787c5e1874ff3a9359e4a8f81a2d4"><enum>(ii)</enum><text display-inline="yes-display-inline">any gaps in such research, which may
include a survey of pediatric medical providers regarding unmet pediatric
medical device needs, as needed; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ID0d8d1eaf82e540b9aaa179fc9621b0d0"><enum>(iii)</enum><text display-inline="yes-display-inline">a research agenda for improving pediatric
medical device development and Food and Drug Administration clearance or
approval of pediatric medical devices, and for evaluating the short- and
long-term safety and effectiveness of pediatric medical devices.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id6415A7537D9C45A79FE850CE16939749"><enum>(b)</enum><header display-inline="yes-display-inline">Pediatric Advisory Committee</header><text display-inline="yes-display-inline">Section 14 of the Best Pharmaceuticals for
Children Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m</external-xref> note) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idD86F85FE81AA4E84ACDF651FDCB8B3F7"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a), by inserting
<quote>(including drugs and biological products) and medical devices</quote>
after <quote>therapeutics</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0B23623BBF9D471D9293A710D28A6F01"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id3602595698554372B1B57CC93B5C6751"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting
<quote>(including drugs and biological products) and medical devices</quote>
after <quote>therapeutics</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idD1F6184D18274C3EA77525932C494A1D"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<clause commented="no" display-inline="no-display-inline" id="idCE42E5E87E5B4CE88A881023F17EEDED"><enum>(i)</enum><text display-inline="yes-display-inline">in subparagraph (A), by striking <quote>and
505B</quote> and inserting <quote>505B, 510(k), 515, and 520(m)</quote>;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idC6B02235707D4CD197691D44FD3958FD"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking subparagraph (B) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="id745459DA5F684613904743DE0B7D5B1D" style="OLC">
<subparagraph commented="no" display-inline="no-display-inline" id="ID5cfdbc91242245d7ab35b9ff4338b178"><enum>(B)</enum><text display-inline="yes-display-inline">identification of research priorities
related to therapeutics (including drugs and biological products) and medical
devices for pediatric populations and the need for additional diagnostics and
treatments for specific pediatric diseases or conditions;
and</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause commented="no" display-inline="no-display-inline" id="id30CEF33D49EE4E7CAF0DDDE8485550C6"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (C), by inserting
<quote>(including drugs and biological products) and medical devices</quote>
after <quote>therapeutics</quote>.</text>
</clause></subparagraph></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id73057B29560644EE95CD25C00DC1FD87" section-type="subsequent-section"><enum>427.</enum><header display-inline="yes-display-inline">Postmarket Surveillance</header>
<subsection commented="no" display-inline="no-display-inline" id="id50FA67FD2D6A4BA486B2A41C9FF3C88A"><enum>(a)</enum><header display-inline="yes-display-inline">Postmarket surveillance</header><text display-inline="yes-display-inline">Section 522 of the Federal<act-name parsable-cite="FFDCA"> Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/360l">21 U.S.C. 360l</external-xref>)
is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id7D00521BF6AD433DAECA5E24DD95E406"><enum>(1)</enum><text display-inline="yes-display-inline">by striking subsection (a) and inserting
the following:</text>
<quoted-block display-inline="no-display-inline" id="idDCF7290B59FC49E58264CFB6D7CE07BF" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="idBDB14CAD5CCE4231A43F56679D2E6A47"><enum>(a)</enum><header display-inline="yes-display-inline">Postmarket surveillance</header>
<paragraph commented="no" display-inline="no-display-inline" id="id1142F084DFA94B0C9AFC3A8C9FDA65FB"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idB776F59066E44C3499FC84C790707AD0"><enum>(A)</enum><header display-inline="yes-display-inline">Conduct</header><text display-inline="yes-display-inline">The Secretary may by order require a
manufacturer to conduct postmarket surveillance for any device of the
manufacturer that is a class II or class III device—</text>
<clause commented="no" display-inline="no-display-inline" id="id933764F1325D4FB8A57821BC8674EAFA"><enum>(i)</enum><text display-inline="yes-display-inline">the failure of which would be reasonably
likely to have serious adverse health consequences;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idA5B49A0F23004F9784A63420A2A077B3"><enum>(ii)</enum><text display-inline="yes-display-inline">that is expected to have significant use in
pediatric populations; or</text>
</clause><clause id="idBF2F9E7A36DC418491FF1B83200B7DB2"><enum>(iii)</enum><text>that is
intended to be—</text>
<subclause id="id1D757BE9B1864082B82EF44D670D12FB"><enum>(I)</enum><text>implanted in the
human body for more than 1 year; or</text>
</subclause><subclause id="idCE0DEB5D6F4B4B3C97CEB075FABA7508"><enum>(II)</enum><text>a
life-sustaining or life-supporting device used outside a device user
facility.</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID6fe247f15bb847a88811cfacd3feecfd"><enum>(B)</enum><header display-inline="yes-display-inline">Condition</header><text display-inline="yes-display-inline">The Secretary may order a postmarket
surveillance under subparagraph (A) as a condition to approval or clearance of
a device described in subparagraph (A)(ii).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDfeae3c9b9cb643ebaf86adbeb8d237f1"><enum>(2)</enum><header display-inline="yes-display-inline">Rule of construction</header><text display-inline="yes-display-inline">The provisions of paragraph (1) shall have
no effect on authorities otherwise provided under the Act or regulations issued
under this Act.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idE3067ABD56AE4DA48A91EEBF78BA975E"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id565DC2E0C30D43649EEE47B17D6C3EBB"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>(b)
<header-in-text level="subsection" style="OLC">surveillance
approval</header-in-text>.—Each</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idC2A41147A716427D9EDF5362B9EF3758" style="OLC">
<subsection commented="no" display-inline="no-display-inline" id="id671AD43C011C4DBEB02040782CADD134"><enum>(b)</enum><header display-inline="yes-display-inline">Surveillance approval</header>
<paragraph commented="no" display-inline="no-display-inline" id="idF39C31333FAA4252B3F100571F18C4F4"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id53F679A108B547F69BA0F16EEB6E730D"><enum>(B)</enum><text display-inline="yes-display-inline">by striking <quote>The Secretary, in
consultation</quote> and inserting <quote>Except as provided in paragraph (2),
the Secretary, in consultation</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id45F7C84EB16B4E3A90AC293FDA6E82D3"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>Any
determination</quote> and inserting <quote>Except as provided in paragraph (2),
any determination</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id513CB9DC4BCB458BAF686C57D8472C73"><enum>(D)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id17910B7EDACC4B839A4245EF186BE43C" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idBDC4486E2007477DAFA16416D7087B46"><enum>(2)</enum><header display-inline="yes-display-inline">Longer surveillances for pediatric
devices</header><text display-inline="yes-display-inline">The Secretary may by
order require a prospective surveillance period of more than 36 months with
respect to a device that is expected to have significant use in pediatric
populations if such period of more than 36 months is necessary in order to
assess the impact of the device on growth and development, or the effects of
growth, development, activity level, or other factors on the safety of the
device.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection></section></subtitle><enum>V</enum><header display-inline="yes-display-inline">Other provisions</header>
<section commented="no" display-inline="no-display-inline" id="id5CD4DAF8DA50423FB043B84C4088941C" section-type="subsequent-section"><enum>501.</enum><header display-inline="yes-display-inline">Policy on the review and clearance of
scientific articles published by FDA employees</header><text display-inline="no-display-inline">Subchapter A of chapter VII of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>), as amended by section
241, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2916AC3AF0E04457A7E899BD05352845" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id90239B3BDEE64C4387FCBCA9B31F7D92" section-type="subsequent-section"><enum>713.</enum><header display-inline="yes-display-inline">Policy on the review and clearance of
scientific articles published by FDA employees</header>
<subsection commented="no" display-inline="no-display-inline" id="id4DD1C564EF7C4A5FAD662A376167004B"><enum>(a)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In this section, the term
<quote>article</quote> means a paper, poster, abstract, book, book chapter, or
other published writing.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id973BA22E124249A489F91A4BB8846BB6"><enum>(b)</enum><header display-inline="yes-display-inline">Policies</header><text display-inline="yes-display-inline">The Secretary, through the Commissioner of
Food and Drugs, shall establish and make publicly available clear written
policies to implement this section and govern the timely submission, review,
clearance, and disclaimer requirements for articles.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id19CA0A8E1FAD4933A58F5EA89B3FC423"><enum>(c)</enum><header display-inline="yes-display-inline">Timing of submission for
review</header><text display-inline="yes-display-inline">If an officer or
employee, including a Staff Fellow and a contractor who performs staff work, of
the Food and Drug Administration is required by the policies established under
subsection (b) to submit an article to the supervisor of such officer or
employee, or to some other official of the Food and Drug Administration, for
review and clearance before such officer or employee may seek to publish or
present such an article at a conference, such officer or employee shall submit
such article for such review and clearance not less than 30 days before
submitting the article for publication or presentation.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ID288d4169811448feaabf10a5a4ca4c07"><enum>(d)</enum><header display-inline="yes-display-inline">Timing for review and
clearance</header><text display-inline="yes-display-inline">The supervisor or
other reviewing official shall review such article and provide written
clearance, or written clearance on the condition of specified changes being
made, to such officer or employee not later than 30 days after such officer or
employee submitted such article for review.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="IDe6982ea30c4f452b8f3c17557131e5e5"><enum>(e)</enum><header display-inline="yes-display-inline">Non-timely review</header><text display-inline="yes-display-inline">If, 31 days after such submission under
subsection (c), the supervisor or other reviewing official has not cleared or
has not reviewed such article and provided written clearance, such officer or
employee may consider such article not to have been cleared and may submit the
article for publication or presentation with an appropriate disclaimer as
specified in the policies established under subsection
(b).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id7E3E1019CED54F99A40F32558F8AF391" section-type="subsequent-section"><enum>502.</enum><header display-inline="yes-display-inline">Technical amendments</header><text display-inline="no-display-inline">The Public Health Service Act (42 U.S.C. 201
et seq.) is amended—</text>
<paragraph commented="no" display-inline="no-display-inline" id="idB2F67BBA60294F2E9539682781B92AC9"><enum>(1)</enum><text display-inline="yes-display-inline">in section 319C–2(j)(3)(B), by striking
<quote>section 319C–1(h)</quote> and inserting <quote>section
319C–1(i)</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3CD17EAB204A43BCA7E9F8B65C299745"><enum>(2)</enum><text display-inline="yes-display-inline">in section 402(b)(4), by inserting
<quote>minority and other</quote> after <quote>reducing</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1960BF4E2B5043CBB67F00579F122969"><enum>(3)</enum><text display-inline="yes-display-inline">in section 403(a)(4)(C)(iv)(III), by
inserting <quote>and post doctoral training funded through
investigator-initiated research grant awards</quote> before the semicolon;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id952DB35F7B254CDEA582A9685A41AA22"><enum>(4)</enum><text display-inline="yes-display-inline">in section 403C(a)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idD31C09C4428A46C4880C8EC2B91B271A"><enum>(A)</enum><text display-inline="yes-display-inline">in the matter preceding paragraph (1), by
inserting <quote>graduate students supported by NIH for</quote> after
<quote>with respect to</quote>;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6583356E97D5447F94AD3CC90B09AE97"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting
<quote>such</quote> after <quote>percentage of</quote>; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id64E51EE55358469B8D1A40D639509A65"><enum>(C)</enum><text display-inline="yes-display-inline">in paragraph (2), by inserting <quote>(not
including any leaves of absence)</quote> after <quote>average
time</quote>.</text>
</subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="id91BE8669E34B47DF8B34951B492614FE" section-type="subsequent-section"><enum>503.</enum><header display-inline="yes-display-inline">Severability clause</header><text display-inline="no-display-inline">If any provision of this Act, an amendment
made this Act, or the application of such provision or amendment to any person
or circumstance is held to be unconstitutional, the remainder of this Act, the
amendments made by this Act, and the application of the provisions of such to
any person or circumstances shall not be affected thereby.</text>
</section><section id="idD179DA65026946EEBC5520656ABC8D9C"><enum>504.</enum><header>Sense of the
senate with respect to follow-on biologics</header>
<subsection id="IDf25af8049d9f4b978a79d1d62c2737bb"><enum>(a)</enum><header>Findings</header><text>The
Senate finds the following:</text>
<paragraph id="ID48c3bc03688842bba4c66d7c32b58988"><enum>(1)</enum><text>The Food and Drug
Administration has stated that it requires legislative authority to review
follow-on biologics.</text>
</paragraph><paragraph id="ID09182fe740f64ed69dce45d0198751fe"><enum>(2)</enum><text>Business,
consumer, and government purchasers require competition and choice to ensure
more affordable prescription drug options.</text>
</paragraph><paragraph id="IDbf0ee4551bf44583ac0b372e8d0773a5"><enum>(3)</enum><text>Well-constructed
policies that balance the needs of innovation and affordability have broad
bipartisan support.</text>
</paragraph></subsection><subsection id="IDbdb8a5bd5987454c868ef12f224068f7"><enum>(b)</enum><header>Sense of the
senate</header><text>It is the sense of the Senate that legislation should be
enacted to—</text>
<paragraph id="IDc8f5047836974bd9ae85ad847c968f04"><enum>(1)</enum><text>provide the Food
and Drug Administration with the authority and flexibility to approve
biopharmaceuticals subject to an abbreviated approval pathway;</text>
</paragraph><paragraph id="ID5167830b280c473684d51503a9fb92d0"><enum>(2)</enum><text>ensure that
patient safety remains paramount in the system;</text>
</paragraph><paragraph id="ID6d1358f6a7784c1391a5f58a2523b377"><enum>(3)</enum><text>establish a
regulatory pathway that is efficient, effective, and scientifically-grounded
and that also includes measures to ensure timely resolution of patent disputes;
and</text>
</paragraph><paragraph id="IDdfb24cff716b4fbaacfeba28cf63272c"><enum>(4)</enum><text>provide
appropriate incentives to facilitate the research and development of innovative
biopharmaceuticals.</text>
</paragraph></subsection></section><section id="id8E216093A92A4B9F92ACEAB5CA0FE261"><enum>505.</enum><header>Priority
review to encourage treatments for tropical diseases</header><text display-inline="no-display-inline">Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7A9BAB02451C4BB3B59D1B5E60FD7926" style="OLC">
<section id="idD06551843DB64EB08F0E6945DB47B317"><enum>524.</enum><header>Priority
review to encourage treatments for tropical diseases</header>
<subsection id="id687E11C09A3F46F79E3CCB68472BF47C"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="idB4EDCEE8CA544142B2E258D5903790EC"><enum>(1)</enum><header>AIDS</header><text>The
term <term>AIDS</term> means the acquired immune deficiency syndrome.</text>
</paragraph><paragraph id="ID8ab831367fbd41f79f61b0b9145c5a3a"><enum>(2)</enum><header>AIDS
drug</header><text>The term <term>AIDS drug</term> means a drug indicated for
treating HIV.</text>
</paragraph><paragraph id="id68E91BA779AC4BFFA72EA9276EAD63E2"><enum>(3)</enum><header>HIV</header><text>The
term <term>HIV</term> means the human immunodeficiency virus, the pathogen that
causes AIDS.</text>
</paragraph><paragraph id="IDa6b0b0cf21b74c7fbdcdb512b62a5983"><enum>(4)</enum><header>Neglected or
tropical disease</header><text>The term <term>neglected or tropical
disease</term> means—</text>
<subparagraph id="id1E6A91745C734381835622974F086788"><enum>(A)</enum><text>HIV, malaria,
tuberculosis, and related diseases; or</text>
</subparagraph><subparagraph id="id2B1B55BD82774DE2BB3A04F2F88953C5"><enum>(B)</enum><text>any other
infectious disease that disproportionately affects poor and marginalized
populations, including those diseases targeted by the Special Programme for
Research and Training in Tropical Diseases cosponsored by the United Nations
Development Program, UNICEF, the World Bank, and the World Health
Organization.</text>
</subparagraph></paragraph><paragraph id="id096655D256284CD3A86D4E43ACDFC4F9"><enum>(5)</enum><header>Priority
review</header><text>The term <term>priority review</term>, with respect to a
new drug application described in paragraph (6), means review and action by the
Secretary on such application not later than 180 days after receipt by the
Secretary of such application, pursuant to the Manual of Policies and
Procedures of the Food and Drug Administration.</text>
</paragraph><paragraph id="id621C6FC8BE884629A5ECE1AF6C7E26F2"><enum>(6)</enum><header>Priority review
voucher</header><text>The term <term>priority review voucher</term> means a
voucher issued by the Secretary to the sponsor of a tropical disease product
that entitles such sponsor, or a person described under subsection (b)(2), to
priority review of a new drug application submitted under section 505(b)(1)
after the date of approval of the tropical disease product.</text>
</paragraph><paragraph id="ID7cc79d2a24614edf9701ca85f5200805"><enum>(7)</enum><header>Tropical
disease product</header><text>The term <term>tropical disease product</term>
means a product that—</text>
<subparagraph id="idF802EEA745EF4493857DE9170625AD71"><enum>(A)</enum><text>is a new drug,
antibiotic drug, biological product, vaccine, device, diagnostic, or other tool
for treatment of a neglected or tropical disease; and</text>
</subparagraph><subparagraph id="id691440E174C149BAAF48E3A5E1024EEA"><enum>(B)</enum><text>is approved by
the Secretary for use in the treatment of a neglected or tropical
disease.</text>
</subparagraph></paragraph></subsection><subsection id="id9865ED1254634369864C476065836D49"><enum>(b)</enum><header>Priority review
voucher</header>
<paragraph id="id90E964B8FCA240ADADFC17CAA80D6490"><enum>(1)</enum><header>In
general</header><text>The Secretary shall award a priority review voucher to
the sponsor of a tropical disease product upon approval by the Secretary of
such tropical disease product.</text>
</paragraph><paragraph commented="no" id="idB291802EE2DF4B1D80FB1C4C85FF80BD"><enum>(2)</enum><header>Transferability</header><text>The
sponsor of a tropical disease product that receives a priority review voucher
under this section may transfer (including by sale) the entitlement to such
voucher to a sponsor of a new drug for which an application under section
505(b)(1) will be submitted after the date of the approval of the tropical
disease product.</text>
</paragraph><paragraph id="id5CFCD3765C8B47018D8AAB761DF586FC"><enum>(3)</enum><header>Limitation</header><text>A
sponsor of a tropical disease product may not receive a priority review voucher
under this section if the tropical disease product was approved by the
Secretary prior to the date of enactment of this section.</text>
</paragraph></subsection><subsection commented="no" id="idC245F25B292E4DA3982EB99705117367"><enum>(c)</enum><header>Priority review
user fee</header>
<paragraph commented="no" id="idA91340DF9D5E47C78F4A5376837B3DD1"><enum>(1)</enum><header>In
general</header><text>The Secretary shall establish a user fee program under
which a sponsor of a drug that is the subject of a priority review voucher
shall pay to the Secretary a fee determined under paragraph (2). Such fee shall
be in addition to any fee required to be submitted by the sponsor under chapter
VII.</text>
</paragraph><paragraph commented="no" id="id326CE40BA3D943C687BD2067FA233464"><enum>(2)</enum><header>Fee
amount</header><text>The amount of the priority review user fee shall be
determined each fiscal year by the Secretary and based on the anticipated costs
to the Secretary of implementing this section.</text>
</paragraph><paragraph commented="no" id="id9B2B05A06BB54EE09B18A1003781AFD1"><enum>(3)</enum><header>Annual fee
setting</header><text>The Secretary shall establish, before the beginning of
each fiscal year beginning after September 30, 2007, for that fiscal year, the
amount of the priority review user fee.</text>
</paragraph><paragraph commented="no" id="idDFD0F66188AE491386F57E0638D0151C"><enum>(4)</enum><header>Payment</header>
<subparagraph commented="no" id="id11B1D25E2D434022A3960EB2E5B7B644"><enum>(A)</enum><header>In
general</header><text>The fee required by this subsection shall be due upon the
filing of the new drug application under section 505(b)(1) for which the
voucher is used.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idE6980701474E4AE18BCC1228C8358E4E"><enum>(B)</enum><header>Complete
application</header><text>An application described under subparagraph (A) for
which the sponsor requests the use of a priority review voucher shall be
considered incomplete if the fee required by this subsection is not included in
such application.</text>
</subparagraph></paragraph><paragraph id="ID4c734ea45dfd453f9293ab7c26a1ce52"><enum>(5)</enum><header>Offsetting
collections</header><text>Fees collected pursuant to this subsection for any
fiscal year—</text>
<subparagraph id="IDe76b3de99d504eb49754790e516945e4"><enum>(A)</enum><text>shall be
deposited and credited as offsetting collections to the account providing
appropriations to the Food and Drug Administration; and</text>
</subparagraph><subparagraph id="id97806D2AAC844B22873EC0D2B220E86C"><enum>(B)</enum><text>shall not be
collected for any fiscal year except to the extent provided in advance in
appropriation
Acts.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id85A0BFE0622D49DC9E5AA49D8216FB68"><enum>506.</enum><header>Citizens
petitions and petitions for stay of agency action</header><text display-inline="no-display-inline">Section 505 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>), as amended by this Act, is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id49BDA7824BAD40A6BC238CD02BED34AC" style="OLC">
<subsection id="idFA570E8A5EBF4AB2969C07ADB2702268"><enum>(s)</enum><header>Citizen
petitions and petitions for stay of agency action</header>
<paragraph id="id7A0D91904224454095C91C841627E073"><enum>(1)</enum><header>In
general</header>
<subparagraph id="idDE6691539D724EBE97708BE5F8EA8AFF"><enum>(A)</enum><header>No delay of
consideration or approval</header>
<clause id="id56DEE33DEC5C4311AA7EAFD12B06EA6B"><enum>(i)</enum><header>In
general</header><text>With respect to a pending application submitted under
subsection (b)(2) or (j), if a petition is submitted to the Secretary that
seeks to have the Secretary take, or refrain from taking, any form of action
relating to the approval of the application, including a delay in the effective
date of the application, clauses (ii) and (iii) shall apply.</text>
</clause><clause id="IDb51155f383494a61871d0dd090418903"><enum>(ii)</enum><header>No delay of
consideration or approval</header><text>Except as provided in clause (iii), the
receipt and consideration of a petition described in clause (i) shall not delay
consideration or approval of an application submitted under subsection (b)(2)
or (j).</text>
</clause><clause id="ID15706828723e4bd38891b50ed61b81cd"><enum>(iii)</enum><header>No delay of
approval without determination</header><text>The Secretary shall not delay
approval of an application submitted under subsection (b)(2) or (j) while a
petition described in clause (i) is reviewed and considered unless the
Secretary determines, not later than 25 business days after the submission of
the petition, that a delay is necessary to protect the public health.</text>
</clause></subparagraph><subparagraph id="id1456DF633E18444DA28A13C586880F4E"><enum>(B)</enum><header>Determination
of delay</header><text>With respect to a determination by the Secretary under
subparagraph (A)(iii) that a delay is necessary to protect the public health
the following shall apply:</text>
<clause commented="no" id="idE0F34B1C41684997BBA373071E9FB8E3"><enum>(i)</enum><text>Not later than 5
days after making such determination, the Secretary shall publish on the
Internet website of the Food and Drug Administration a detailed statement
providing the reasons underlying the determination. The detailed statement
shall include a summary of the petition and comments and supplements, the
specific substantive issues that the petition raises which need to be
considered prior to approving a pending application submitted under subsection
(b)(2) or (j), and any clarifications and additional data that is needed by the
Secretary to promptly review the petition.</text>
</clause><clause id="ID9f8b4f93d44843b6a2a69a5076f50e24"><enum>(ii)</enum><text>Not later than
10 days after making such determination, the Secretary shall provide notice to
the sponsor of the pending application submitted under subsection (b)(2) or (j)
and provide an opportunity for a meeting with appropriate staff as determined
by the Commissioner to discuss the determination.</text>
</clause></subparagraph></paragraph><paragraph id="IDe13f0d3f7b3743f1ae16abdabf0f8071"><enum>(2)</enum><header>Timing of final
agency action on petitions</header>
<subparagraph id="id83A47021AE224709A76C7385D6F89958"><enum>(A)</enum><header>In
general</header><text>Notwithstanding a determination made by the Secretary
under paragraph (1)(A)(iii), the Secretary shall take final agency action with
respect to a petition not later than 180 days of submission of that petition
unless the Secretary determines, prior to the date that is 180 days after the
date of submission of the petition, that a delay is necessary to protect the
public health.</text>
</subparagraph><subparagraph commented="no" id="IDc4eceeffc384434f837931da2387734e"><enum>(B)</enum><header>Determination
of delay</header><text>With respect to a determination by the Secretary under
subparagraph (A) that a delay is necessary to protect the public health the
following shall apply:</text>
<clause commented="no" id="ID36d3a7c6d5a24b7f9935d350a6076dc8"><enum>(i)</enum><text>Not later than 5
days after making the determination under subparagraph (A), the Secretary shall
publish on the Internet website of the Food and Drug Administration a detailed
statement providing the reasons underlying the determination. The detailed
statement should include the state of the review of the petition, the specific
outstanding issues that still need to be resolved, a proposed timeframe to
resolve the issues, and any additional information that has been requested by
the Secretary of the petitioner or needed by the Secretary in order to resolve
the petition and not further delay an application filed under subsection (b)(2)
or (j).</text>
</clause><clause commented="no" id="IDbb2edb738f60406584bd012ecae4af84"><enum>(ii)</enum><text>Not later than
10 days after making the determination under subparagraph (A), the Secretary
shall provide notice to the sponsor of the pending application submitted under
subsection (b)(2) or (j) and provide an opportunity for a meeting with
appropriate staff as determined by the Commissioner to discuss the
determination.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="ID85f584683f1f444182e6ebea4c30a33b"><enum>(3)</enum><header>Verifications</header>
<subparagraph commented="no" id="id539C0F5514DB4EE39610C6994B96821D"><enum>(A)</enum><header>Petitions for
review</header><text>The Secretary shall not accept a petition for review
unless it is signed and contains the following verification: <quote>I certify
that, to my best knowledge and belief: (a) this petition includes all
information and views upon which the petition relies; (b) this petition
includes representative data and/or information known to the petitioner which
are unfavorable to the petition; and (c) information upon which I have based
the action requested herein first became known to the party on whose behalf
this petition is filed on or about __________. I received or expect to receive
payments, including cash and other forms of consideration, from the following
persons or organizations to file this petition:________. I verify under penalty
of perjury that the foregoing is true and correct.</quote>, with the date of
the filing of such petition and the signature of the petitioner inserted in the
first and second blank space, respectively.</text>
</subparagraph><subparagraph commented="no" id="IDd54d917148a04b4a97353bfd65db126b"><enum>(B)</enum><header>Supplemental
information</header><text>The Secretary shall not accept for review any
supplemental information or comments on a petition unless the party submitting
such information or comments does so in written form and that the subject
document is signed and contains the following verification: ‘I certify that, to
my best knowledge and belief: (a) I have not intentionally delayed submission
of this document or its contents; and (b) the information upon which I have
based the action requested herein first became known to me on or about
__________. I received or expect to receive payments, including cash and other
forms of consideration, from the following persons or organizations to submit
this information or its contents: _____. I verify under penalty of perjury that
the foregoing is true and correct.’, with the date of the submission of such
document and the signature of the petitioner inserted in the first and second
blank space, respectively.</text>
</subparagraph></paragraph><paragraph commented="no" id="ID67578a928a274027ba7587c1ad9fb6c9"><enum>(4)</enum><header>Annual report
on delays in approvals per petition</header><text>The Secretary shall annually
submit to the Congress a report that specifies—</text>
<subparagraph commented="no" id="idD8F461C5FA52459590B485A19E5BD19A"><enum>(A)</enum><text>the number of
applications under subsection (b)(2) and (j) that were approved during the
preceding 1-year period;</text>
</subparagraph><subparagraph commented="no" id="id0C596951C80647F0AA54DA5BA71CDD63"><enum>(B)</enum><text>the number of
petitions that were submitted during such period;</text>
</subparagraph><subparagraph commented="no" id="idC51C930AFA354082B545B208C071F2D4"><enum>(C)</enum><text>the number of
applications whose effective dates were delayed by petitions during such period
and the number of days by which the applications were so delayed; and</text>
</subparagraph><subparagraph commented="no" id="idE506DDF5C2694AE8B50866502C0FA1AA"><enum>(D)</enum><text>the number of
petitions that were filed under this subsection that were deemed by the
Secretary under paragraph (1)(A)(iii) to require delaying an application under
subsection (b)(2) or (j) and the number of days by which the applications were
so delayed.</text>
</subparagraph></paragraph><paragraph commented="no" id="IDab1dd7221b934d79858cce620fafb18a"><enum>(5)</enum><header>Exception</header><text>This
subsection does not apply to a petition that is made by the sponsor of the
application under subsection (b)(2) or (j) and that seeks only to have the
Secretary take or refrain from taking any form of action with respect to that
application.</text>
</paragraph><paragraph commented="no" id="ID85486341a66048c9ae5fdff93ab51793"><enum>(6)</enum><header>Report by
Inspector General</header><text>The Office of Inspector General of the
Department of Health and Human Services shall issue a report not later than 2
years after the date of enactment of this subsection evaluating evidence of the
compliance of the Food and Drug Administration with the requirement that the
consideration by the Secretary of petitions that do not raise public health
concerns remain separate and apart from the review and approval of an
application submitted under subsection (b)(2) or (j).</text>
</paragraph><paragraph commented="no" id="ID5330b3c79f6945d5ab96e08dfd37004d"><enum>(7)</enum><header>Definition</header><text>For
purposes of this subsection, the term <term>petition</term> includes any
request for an action described in paragraph (1)(A)(i) to the Secretary,
without regard to whether the request is characterized as a
petition.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idA2BA7BB4529146B9A4ECFF6494D30DC5"><enum>507.</enum><header>Publication of
annual reports</header>
<subsection id="id279ECCA63D0541B596FF520C067E03DF"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Commissioner on
Food and Drugs shall annually submit to Congress and publish on the Internet
website of the Food and Drug Administration, a report concerning the results of
the Administration's pesticide residue monitoring program, that
includes—</text>
<paragraph id="id8C5FE0D07F044352B172B4BB583EC7E9"><enum>(1)</enum><text display-inline="yes-display-inline">information and analysis similar to that
contained in the report entitled <quote>Food and Drug Administration Pesticide
Program Residue Monitoring 2003</quote> as released in June of 2005;</text>
</paragraph><paragraph id="idEDDEE47E5E8E4C84BBFF1CF28F6056D5"><enum>(2)</enum><text>based on an
analysis of previous samples, an identification of products or countries (for
imports) that require special attention and additional study based on a
comparison with equivalent products manufactured, distributed, or sold in the
United States (including details on the plans for such additional studies),
including in the initial report (and subsequent reports as determined
necessary) the results and analysis of the Ginseng Dietary Supplements Special
Survey as described on page 13 of the report entitled <quote>Food and Drug
Administration Pesticide Program Residue Monitoring 2003</quote>;</text>
</paragraph><paragraph id="IDeb2706b47e114400becd6c5189fb7745"><enum>(3)</enum><text>information on
the relative number of interstate and imported shipments of each tested
commodity that were sampled, including recommendations on whether sampling is
statistically significant, provides confidence intervals or other related
statistical information, and whether the number of samples should be increased
and the details of any plans to provide for such increase; and</text>
</paragraph><paragraph id="ID18214f5d31b5414e903ceda700dc4bd7"><enum>(4)</enum><text>a description of
whether certain commodities are being improperly imported as another commodity,
including a description of additional steps that are being planned to prevent
such smuggling.</text>
</paragraph></subsection><subsection id="id0E1860AB907547CE957247BD1B1CA0D6"><enum>(b)</enum><header>Initial
reports</header><text>Annual reports under subsection (a) for fiscal years 2004
through 2006 may be combined into a single report, by not later than June 1,
2008, for purposes of publication under subsection (a). Thereafter such reports
shall be completed by June 1 of each year for the data collected for the year
that was 2-years prior to the year in which the report is published.</text>
</subsection><subsection id="ID3e4033936ee245a6bd35d126f9d5d7e3"><enum>(c)</enum><header>Memorandum of
understanding</header><text>The Commissioner of Food and Drugs, the
Administrator of the Food Safety and Inspection Service, the Department of
Commerce, and the head of the Agricultural Marketing Service shall enter into a
memorandum of understanding to permit inclusion of data in the reports under
subsection (a) relating to testing carried out by the Food Safety and
Inspection Service and the Agricultural Marketing Service on meat, poultry,
eggs, and certain raw agricultural products, respectively.</text>
</subsection></section><section id="IDC4CD583214D347BDA1C177335D05EB14" section-type="subsequent-section"><enum>508.</enum><header><act-name parsable-cite="HSA">Head Start Act</act-name> amendment imposing parental
consent requirement for nonemergency intrusive physical
examinations</header><text display-inline="no-display-inline">The
<act-name parsable-cite="HSA">Head Start Act</act-name> (42 U.S.C. 9831 et
seq.) is amended by adding at the end the following:</text>
<quoted-block act-name="Head Start Act" id="ID62673C9E7876440F91B70000B84987FB">
<section id="ID1DA29668C4DE4E8F90CE4F7DB617C800"><enum>657A.</enum><header>Parental
consent requirement for nonemergency intrusive physical examinations</header>
<subsection id="ID74B03EF595FA4BAFBB14FBE2AFFA4611"><enum>(a)</enum><header>In
general</header><text>A Head Start agency shall obtain written parental consent
before administration of any nonemergency intrusive physical examination of a
child in connection with participation in a program under this
subchapter.</text>
</subsection><subsection id="ID52A5864830324509B2F9EEBBC3CEFF45"><enum>(b)</enum><header>Definition</header><text>The
term <term>nonemergency intrusive physical examination</term> means, with
respect to a child, a physical examination that—</text>
<paragraph id="IDCEF1234B6ACE40ABA79DDB367891293E"><enum>(1)</enum><text>is not
immediately necessary to protect the health or safety of the child involved or
the health or safety of another individual; and</text>
</paragraph><paragraph id="ID164D01C842EF4FD98D00B37D5CD26500"><enum>(2)</enum><text>requires incision
or is otherwise invasive, or involves exposure of private body parts.</text>
</paragraph></subsection><subsection id="id8B2BCB56B2F146E7A74C5B39E70115D9"><enum>(c)</enum><header>Rule of
construction</header><text>Nothing in this section shall be construed to
prohibit agencies from using established methods, for handling cases of
suspected or known child abuse and neglect, that are in compliance with
applicable Federal, State, or tribal
law.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idF0C34328EE634D48A6C098F2EE8D8AAB"><enum>509.</enum><header>Safety of food
additives</header><text display-inline="no-display-inline">Not later than 90
days after the date of enactment of this Act, the Food and Drug Administration
shall issue a report on the question of whether substances used to preserve the
appearance of fresh meat may create any health risks, or mislead
consumers.</text>
</section><section commented="no" id="idA81DBFF2D1E6454BB421140E206E582B"><enum>510.</enum><header>Improving
genetic test safety and quality</header><text display-inline="no-display-inline">Not later than 30 days after the date of
enactment of this Act, the Secretary shall enter into a contract with the
Institute of Medicine to conduct a study to assess the overall safety and
quality of genetic tests and prepare a report that includes recommendations to
improve Federal oversight and regulation of genetic tests. Such study shall
take into consideration relevant reports by the Secretary's Advisory Committee
on Genetic Testing and other groups and shall be completed not later than 1
year after the date on which the Secretary entered into such contract.</text>
</section><section id="id133CFA78920A47FC884FF9C119F365C3"><enum>511.</enum><header>Orphan disease
treatment in children</header>
<subsection id="id28CCD8C4FB354866B0277C4573032C3E"><enum>(a)</enum><header>Finding</header><text>The
Senate finds that parents of children suffering from rare genetic diseases
known as orphan diseases face multiple obstacles in obtaining safe and
effective treatment for their children due mainly to the fact that many Food
and Drug Administration-approved drugs used in the treatment of orphan diseases
in children may not be approved for pediatric indications.</text>
</subsection><subsection id="id76B4BA3B735B40E79BA78808024E365C"><enum>(b)</enum><header>Sense of the
Senate</header><text>It is the sense of the Senate that the Food and Drug
Administration should enter into a contract with the Institute of Medicine for
the conduct of a study concerning measures that may be taken to improve the
likelihood that Food and Drug Administration-approved drugs that are safe and
effective in treating children with orphan diseases are made available and
affordable for pediatric indications.</text>
</subsection></section><section id="idE0D8AED446494BD881051AB382A87D84"><enum>512.</enum><header>Color
certification reports</header><text display-inline="no-display-inline">Section
721 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379e">21 U.S.C. 379e</external-xref>) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id0101BC999283470D920E62F8E9EB8F69" style="OLC">
<subsection id="id9159B295FA9A4668B44AB473268982EC"><enum>(g)</enum><header>Color
certification reports</header><text>Not later than—</text>
<paragraph id="IDbb86fed45c7b4feeb235f3d8e87b042e"><enum>(1)</enum><text>90 days after the
close of a fiscal year in which color certification fees are collected, the
Secretary shall submit to Congress a performance report for such fiscal year on
the number of batches of color additives approved, the average turn around time
for approval, and quantifiable goals for improving laboratory efficiencies;
and</text>
</paragraph><paragraph id="IDd5971fc368034478b11d77f981b810de"><enum>(2)</enum><text>120 days after
the close of a fiscal year in which color certification fees are collected, the
Secretary shall submit to Congress a financial report for such fiscal year that
includes all fees and expenses of the color certification program, the balance
remaining in the fund at the end of the fiscal year, and anticipated costs
during the next fiscal year for equipment needs and laboratory improvements of
such
program.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idA9DC6CE71BAE4A52BD6D82A2CE16BDBF"><enum>513.</enum><header>Prohibition on
importation from a foreign food facility that denies access to food
inspectors</header><text display-inline="no-display-inline">Notwithstanding any
other provision of law, no food product may be imported into the United States
that is the product of a foreign facility registered under section 415 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/350d">21 U.S.C. 350d</external-xref>) that refuses to permit
United States inspectors, upon request, to inspect such facility or that unduly
delays access to United States inspectors.</text>
</section><section id="idE6E3296F9170419FA1C244CEFE834DAE"><enum>514.</enum><header>Counterfeit-resistant
technologies</header><text display-inline="no-display-inline">Notwithstanding
any other provision of this Act, the requirement that the Secretary of Health
and Human Services certify that the implementation of the title of this Act
relating to the Importation of Prescription Drugs will pose no additional risk
to the public's health and safety and will result in a significant reduction in
the cost of covered products to the American consumer shall not apply to the
requirement that the Secretary require that the packaging of any prescription
drug incorporates—</text>
<paragraph id="id13525574C0C34C509DE30B0852008F43"><enum>(1)</enum><text>not later than 18
months after the date of enactment of this Act, a standardized numerical
identifier (which, to the extent practicable, shall be harmonized with
international consensus standards for such an identifier) unique to each
package of such drug, applied at the point of manufacturing and repackaging (in
which case the numerical identifier shall be linked to the numerical identifier
applied at the point of manufacturing); and</text>
</paragraph><paragraph id="idBFD1B6AF36C346F3B6ADB6ED16697790"><enum>(2)</enum><text>not later than 24
months after the date of enactment of this Act for the 50 prescription drugs
with the highest dollar volume of sales in the United States, based on the
calendar year that ends of December 31, 2007, and, not later than 30 months
after the date of enactment of this Act for all other prescription
drugs—</text>
<subparagraph id="id3E767433416A4CB1AFBDE93997278E4E"><enum>(A)</enum><text>overt optically
variable counterfeit-resistant technologies that—</text>
<clause id="id506831FC1AE14EEDBB6B7E4E4B81F87B"><enum>(i)</enum><text>are
visible to the naked eye, providing for visual identification of product
authenticity without the need for readers, microscopes, lighting devices, or
scanners;</text>
</clause><clause id="idDBFA47346C1E48A6A78E1FEFFDFC99C3"><enum>(ii)</enum><text>are similar to
that used by the Bureau of Engraving and Printing to secure United States
currency;</text>
</clause><clause id="id4EABC46CFA484175A8E509B95752D4A2"><enum>(iii)</enum><text>are
manufactured and distributed in a highly secure, tightly controlled
environment; and</text>
</clause><clause id="id352F5196240D43EC812117A930AB7094"><enum>(iv)</enum><text>incorporate
additional layers of nonvisible convert security features up to and including
forensic capability; or</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id96FC85458DC0422D8E68C7A552FB6FDD"><enum>(B)</enum><text>technologies that
have a function of security comparable to that described in subparagraph (A),
as determined by the Secretary.</text>
</subparagraph></paragraph></section><section id="id299542B152AB4E65B49C74BD2BB4C2B6"><enum>515.</enum><header>Enhanced
aquaculture and seafood inspection</header>
<subsection id="idD8DDFC0C55CF4FE08724B90B6D518A90"><enum>(a)</enum><header>Findings</header><text display-inline="yes-display-inline">Congress finds the following:</text>
<paragraph id="IDe20aa5b23f37405c838ef71ea2f07d21"><enum>(1)</enum><text>In 2007, there
has been an overwhelming increase in the volume of aquaculture and seafood that
has been found to contain substances that are not approved for use in food in
the United States.</text>
</paragraph><paragraph id="id82BF6129940D4B0DA111BD9D8AC8B6A1"><enum>(2)</enum><text>As of May 2007,
inspection programs are not able to satisfactorily accomplish the goals of
ensuring the food safety of the United States.</text>
</paragraph><paragraph id="id20E59A3978B64FCA8B018222191A3325"><enum>(3)</enum><text>To protect the
health and safety of consumers in the United States, the ability of the
Secretary of Health and Human Services to perform inspection functions must be
enhanced.</text>
</paragraph></subsection><subsection id="id92782B38D0AF4EF392E9450058141068"><enum>(b)</enum><header>Heightened
inspections</header><text>The Secretary of Health and Human Services (referred
to in this section as the <quote>Secretary</quote>) is authorized to, by
regulation, enhance, as necessary, the inspection regime of the Food and Drug
Administration for aquaculture and seafood, consistent with obligations of the
United States under international agreements and United States law.</text>
</subsection><subsection id="id73CE23F43EAC4E38B4A587307916B48C"><enum>(c)</enum><header>Report to
Congress</header><text>Not later than 90 days after the date of enactment of
this Act, the Secretary shall submit to Congress a report that—</text>
<paragraph id="idFCEA4355AF4D4D70937EB0E2344F6845"><enum>(1)</enum><text>describes the
specifics of the aquaculture and seafood inspection program;</text>
</paragraph><paragraph id="id1442646E37EC424AB5057C54B86BC19F"><enum>(2)</enum><text>describes the
feasibility of developing a traceability system for all catfish and seafood
products, both domestic and imported, for the purpose of identifying the
processing plant of origin of such products; and</text>
</paragraph><paragraph id="idF91A1718E8534773B5BF16CC6D7213ED"><enum>(3)</enum><text>provides for an
assessment of the risks associated with particular contaminants and banned
substances.</text>
</paragraph></subsection><subsection id="idE4F28A64006846A6BAFA6BCE6634489A"><enum>(d)</enum><header>Partnerships
with States</header><text>Upon the request by any State, the Secretary may
enter into partnership agreements, as soon as practicable after the request is
made, to implement inspection programs regarding the importation of aquaculture
and seafood.</text>
</subsection><subsection id="idE549D7D8DC854FF4BDC909BCACA67895"><enum>(e)</enum><header>Authorization
of appropriations</header><text>There are authorized to be appropriated such
sums as may be necessary to carry out this section.</text>
</subsection></section><section id="id7926E0A94D244B4B93727B0368A58EE3"><enum>516.</enum><header>Sense of the
Senate regarding certain patent infringements</header>
<subsection id="idADEC4AE1096048AD992CEAFD97661661"><enum>(a)</enum><header>Findings</header><text>The
Senate makes the following findings:</text>
<paragraph id="id07A52642B8A243348DC6BA54DF6ECD75"><enum>(1)</enum><text>Innovation in
developing life-saving prescription drugs saves millions of lives around the
world each year.</text>
</paragraph><paragraph id="ID5e6a3486e1394cfbb6363cf1cbb04f04"><enum>(2)</enum><text>The responsible
protection of intellectual property is vital to the continued development of
new and life-saving drugs and future growth of the United States
economy.</text>
</paragraph><paragraph id="ID1055074941324312a98f5d30d908f4bd"><enum>(3)</enum><text>In order to
maintain the global competitiveness of the United States, the United States
Trade Representative’s Office of Intellectual Property and Innovation develops
and implements trade policy in support of vital American innovations, including
innovation in the pharmaceutical and medical technology industries.</text>
</paragraph><paragraph id="IDa873e956771744169aa9623576c1c16a"><enum>(4)</enum><text>The United States
Trade Representative also provides trade policy leadership and expertise across
the full range of interagency initiatives to enhance protection and enforcement
of intellectual property rights.</text>
</paragraph><paragraph id="ID9cfd2a774ea84f5ba4d9218a86b64078"><enum>(5)</enum><text>Strong and fair
intellectual property protection, including patent, copyright, trademark, and
data protection plays an integral role in fostering economic growth and
development and ensuring patient access to the most effective medicines around
the world.</text>
</paragraph><paragraph id="IDd86e9d543447448c8c31c7657a8adba2"><enum>(6)</enum><text>There are
concerns that certain countries have engaged in unfair price manipulation and
abuse of compulsory licensing. Americans bear the majority of research and
development costs for the world, which could undermine the value of existing
United States pharmaceutical patents and could impede access to important
therapies.</text>
</paragraph><paragraph id="ID3adf99a8de494db9b994cdd5db15ed49"><enum>(7)</enum><text>There is a
growing global threat of counterfeit medicines and increased need for the
United States Trade Representative and other United States agencies to use
available trade policy measures to strengthen laws and enforcement abroad to
prevent harm to United States patients and patients around the world.</text>
</paragraph></subsection><subsection id="ID5b7501ac16f342f19bd132a77ded52ce"><enum>(b)</enum><header>Sense of the
Senate</header><text>It is the sense of the Senate that—</text>
<paragraph id="idA6E59AF0FCCB4CA887B92331567086DF"><enum>(1)</enum><text>the United States
Trade Representative should use all the tools at the disposal of the Trade
Representative to address violations and other concerns with intellectual
property, including through—</text>
<subparagraph id="IDab845091a7624ad294f7eaf47843f470"><enum>(A)</enum><text>bilateral
engagement with United States trading partners;</text>
</subparagraph><subparagraph id="IDa3fbaf22dc834df293a81494311f6e24"><enum>(B)</enum><text>transparency and
balance of the annual <quote>Special 301</quote> review and reviews of
compliance with the intellectual property requirements of countries with
respect to which the United States grants trade preferences;</text>
</subparagraph><subparagraph id="IDe4cf259f7d9f45b2835e553b958dcf67"><enum>(C)</enum><text>negotiation of
responsible and fair intellectual property provisions as part of bilateral and
regional trade agreements; and</text>
</subparagraph><subparagraph id="ID7054f6217c8d444f8188a4c153a782a6"><enum>(D)</enum><text>multilateral
engagement through the World Trade Organization (WTO); and</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDacc4b4dfe54f413e990496622716ca90"><enum>(2)</enum><text>the United States
Trade Representative should develop and submit to Congress a strategic plan to
address the problem of countries that infringe upon American pharmaceutical
intellectual property rights and the problem of countries that engage in price
manipulation.</text>
</paragraph></subsection></section><section id="id32BDFD3B6A324379810E389D8746C7BF"><enum>517.</enum><header>Consultation
regarding genetically engineered seafood products</header><text display-inline="no-display-inline">The Commissioner of Food and Drugs shall
consult with the Assistant Administrator of the National Marine Fisheries
Service of the National Oceanic and Atmospheric Administration to produce a
report on any environmental risks associated with genetically engineered
seafood products, including the impact on wild fish stocks.</text>
</section><section id="id886C5307F6EF4B8A80268675AFF0A67D"><enum>518.</enum><header>Report on the
marketing of certain crustaceans</header><text display-inline="no-display-inline">Not later than 30 days after the date of
enactment of this Act, the Secretary of Health and Human Services, in
consultation with the Secretary of Commerce, shall submit to the Health,
Education, Labor, and Pensions Committee and the Committee on Commerce,
Science, and Transportation of the Senate, a report on the differences between
taxonomy of species of lobster in the subfamily Nephropinae, and species of
langostino, specifically from the infraorder<italic></italic> Caridea or
Anomura. This report shall also describe the differences in consumer perception
of such species, including such factors as taste, quality, and value of the
species.</text>
</section><section id="id1A2AB4CC185243FC893AE7A3DAAE08DE"><enum>519.</enum><header>Civil
penalties; direct-to-consumer advertisement</header>
<subsection id="id1FB7A503B43340DD94B09E735D7FF6E3"><enum>(a)</enum><header>Civil
penalties</header><text display-inline="yes-display-inline">Section 303 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>) is amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id1FDCB80E0F5A45F3B192529B447B708F" style="OLC">
<subsection id="id0A71B821E1344FF194DA8450E0BE57D6"><enum>(g)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id74E8B0BE56774C7E82EE3763AD5D50A4"><enum>(1)</enum><text>Any applicant (as such
term is used in section 505(o)) who disseminates a direct-to-consumer
advertisement for a prescription drug that is false or misleading and a
violation of section 502(n) shall be liable to the United States for a civil
penalty in an amount not to exceed $150,000 for the first such violation in any
3-year period, and not to exceed $300,000 for each subsequent violation
committed after the applicant has been penalized under this paragraph any time
in the preceding 3-year period. For the purposes of this paragraph, repeated
dissemination of the same or similar advertisement prior to the receipt of the
written notice referred to in paragraph (2) for such advertisements shall be
considered as 1 violation.</text>
</paragraph><paragraph id="idB5C7EFABDADE4C73B04842CFBF5A3CF6" indent="up1"><enum>(2)</enum><text>A civil penalty under paragraph (1)
shall be assessed by the Secretary by an order made on the record after
providing written notice to the applicant to be assessed a civil penalty and an
opportunity for a hearing in accordance with this paragraph and section 554 of
title 5, United States Code. If upon receipt of the written notice, the
applicant to be assessed a civil penalty objects and requests a hearing, then
in the course of any investigation related to such hearing, the Secretary may
issue subpoenas requiring the attendance and testimony of witnesses and the
production of evidence that relates to the matter under investigation,
including information pertaining to the factors described in paragraph
(3).</text>
</paragraph><paragraph id="id8D963EACBDC6492AB9DF0A9704ACC047" indent="up1"><enum>(3)</enum><text>Upon the request of the applicant to
be assessed a civil penalty, the Secretary, in determining the amount of a
civil penalty, shall take into account the nature, circumstances, extent, and
gravity of the violation or violations, including the following factors:</text>
<subparagraph id="idD39D1E615ED44334855DE461E8F09ED6"><enum>(A)</enum><text>Whether the applicant submitted the
advertisement or a similar advertisement for review under section 736A.</text>
</subparagraph><subparagraph id="id9DB42F092D2D48C69A0FD2891714556A"><enum>(B)</enum><text>Whether the applicant submitted the
advertisement for prereview if required under section 505(o)(5)(D).</text>
</subparagraph><subparagraph id="idF149A94CDD6947B08915FD6C52063364"><enum>(C)</enum><text>Whether, after submission of the
advertisement as described in subparagraph (A) or (B), the applicant
disseminated the advertisement before the end of the 45-day comment
period.</text>
</subparagraph><subparagraph id="id79EF04DACDB34BFF8FF325AE687B7511"><enum>(D)</enum><text>Whether the applicant failed to
incorporate any comments made by the Secretary with regard to the advertisement
or a similar advertisement into the advertisement prior to its
dissemination.</text>
</subparagraph><subparagraph id="id66F392C36BFF4A83BA2BCB0842CAC351"><enum>(E)</enum><text>Whether the applicant ceased
distribution of the advertisement upon receipt of the written notice referred
to in paragraph (2) for such advertisement.</text>
</subparagraph><subparagraph id="id43165695B546401D9AB53082F9FA4B0B"><enum>(F)</enum><text>Whether the applicant had the
advertisement reviewed by qualified medical, regulatory, and legal reviewers
prior to its dissemination.</text>
</subparagraph><subparagraph id="id7C484D373EE54D2492CCEA848AB66040"><enum>(G)</enum><text>Whether the violations were
material.</text>
</subparagraph><subparagraph id="id44229598C8CB466F9D5370246F686E65"><enum>(H)</enum><text>Whether the applicant who created the
advertisement acted in good faith.</text>
</subparagraph><subparagraph id="id8F65E47BD7E449CEACE25243AB0B72D4"><enum>(I)</enum><text>Whether the applicant who created the
advertisement has been assessed a civil penalty under this provision within the
previous 1-year period.</text>
</subparagraph><subparagraph id="id91E6262521D845C690EA825757D4F610"><enum>(J)</enum><text>The scope and extent of any voluntary,
subsequent remedial action by the applicant.</text>
</subparagraph><subparagraph id="id7FE5629836724EC2B61DAE0A1190D06F"><enum>(K)</enum><text>Such other matters, as justice may
require.</text>
</subparagraph></paragraph><paragraph id="id88B3D56CCA734B7ABEDADD6CB60A2583" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idC2BB019A3D084395BBAB736B6D0AA795"><enum>(A)</enum><text>Subject to subparagraph
(B), no applicant shall be required to pay a civil penalty under paragraph (1)
if the applicant submitted the advertisement to the Secretary and disseminated
such advertisement after incorporating any comment received from the
Secretary.</text>
</subparagraph><subparagraph id="id1096D25CAE234C408759C3C2A872BD79" indent="up1"><enum>(B)</enum><text>The Secretary may retract or modify
any prior comments the Secretary has provided to an advertisement submitted to
the Secretary based on new information or changed circumstances, so long as the
Secretary provides written notice to the applicant of the new views of the
Secretary on the advertisement and provides a reasonable time for modification
or correction of the advertisement prior to seeking any civil penalty under
paragraph (1).</text>
</subparagraph></paragraph><paragraph id="idADF2694639A84684A73FB2757EC79F90" indent="up1"><enum>(5)</enum><text>The Secretary may compromise, modify,
remit, with or without conditions, any civil penalty which may be assessed
under paragraph (1). The amount of such penalty, when finally determined, or
the amount charged upon in compromise, may be deducted from any sums owned by
the United States to the applicant charged.</text>
</paragraph><paragraph id="idF5013511AA1E4DC8BB145E5EE95F18A1" indent="up1"><enum>(6)</enum><text>Any applicant who requested, in
accordance with paragraph (2), a hearing with respect to the assessment of a
civil penalty and who is aggrieved by an order assessing a civil penalty, may
file a petition for de novo judicial review of such order with the United
States Court of Appeals for the District of Columbia Circuit or for any other
circuit in which such applicant resides or transacts business. Such a petition
may only be filed within the 60-day period beginning on the date the order
making such assessments was issued.</text>
</paragraph><paragraph id="id92464F0E8DCD454195B2A30918139862" indent="up1"><enum>(7)</enum><text>If any applicant fails to pay an
assessment of a civil penalty—</text>
<subparagraph id="idEE2EE0057E0E42E7A9FC116D2D2F895B"><enum>(A)</enum><text>after the order making the assessment
becomes final, and if such applicant does not file a petition for judicial
review of the order in accordance with paragraph (6); or</text>
</subparagraph><subparagraph id="idDE658B3FACA24776B798C5351C273A6B"><enum>(B)</enum><text>after a court in an action brought
under paragraph (6) has entered a final judgment in favor of the
Secretary,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the
Attorney General shall recover the amount assessed (plus interest at currently
prevailing rates from the date of the expiration of the 60-day period referred
to in paragraph (6) or date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United States. In such
an action, the validity, amount, and appropriateness of such penalty shall not
be subject to
review.</continuation-text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="idD262509792EF431DACCB3ECBBB1D4F73"><enum>(b)</enum><header>Direct-to-consumer
advertisement</header>
<paragraph id="idFE153689373742509A59F78904D53C66"><enum>(1)</enum><header>In
general</header><text>Section 502(n) of the Federal Food, Drug, and Cosmetic
Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352(n)</external-xref>) is amended by inserting after the first sentence the
following: <quote>In the case of an advertisement for a prescription drug
presented directly to consumers in television or radio format that states the
name of the drug and its conditions of use, the major statement relating to
side effects, contraindications, and effectiveness referred to in the previous
sentence shall be stated in a clear and conspicuous (neutral)
manner.</quote>.</text>
</paragraph><paragraph id="id3C6AF218E9BE4472903412C6936E19B1"><enum>(2)</enum><header>Regulations to
determine neutral manner</header><text>The Secretary of Health and Human
Services shall by regulation establish standards for determining whether a
major statement, relating to side effects, contraindications, and effectiveness
of a drug, described in section 502(n) of the Federal Food, Drug, and Cosmetic
Act (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352(n)</external-xref>) (as amended by paragraph (1)) is presented in the manner
required under such section.</text>
</paragraph></subsection></section><section id="idF0839648C9BF4A18AEFF1AF47C8B5F7F"><enum>520.</enum><header>Report by the
Food and Drug Administration regarding labeling information on the relationship
between the use of indoor tanning devices and development of skin cancer or
other skin damage</header>
<subsection id="ID8a7f6eafd0064066857b5f8cd7f87560"><enum>(a)</enum><header>In
general</header><text>The Secretary of Health and Human Services (referred to
in this section as the <quote>Secretary</quote>), acting through the
Commissioner of Food and Drugs, shall determine—</text>
<paragraph id="ID5f763028cd8e4065b17b7015f8e5202c"><enum>(1)</enum><text>whether the
labeling requirements for indoor tanning devices, including the positioning
requirements, provide sufficient information to consumers regarding the risks
that the use of such devices pose for the development of irreversible damage to
the eyes and skin, including skin cancer; and</text>
</paragraph><paragraph id="IDa837ad0e9450423d9c18b92b3c6845f1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id81093A74CFF6466AA54C1C369C6A8BEB"><enum>(A)</enum><text>whether modifying the
warning label required on tanning beds to read, “Ultraviolet radiation can
cause skin cancer”, or any other additional warning, would communicate the
risks of indoor tanning more effectively; or</text>
</subparagraph><subparagraph id="idDA1D733F07CC467282145978D8BE75A0" indent="up1"><enum>(B)</enum><text>whether there is no warning that would
be capable of adequately communicating such risks.</text>
</subparagraph></paragraph></subsection><subsection id="id0506B4D26B5340C7AF66C96B322D18A7"><enum>(b)</enum><header>Consumer
testing</header><text>In making the determinations under subsection (a), the
Secretary shall conduct appropriate consumer testing, using the best available
methods for determining consumer understanding of label warnings.</text>
</subsection><subsection id="id81089601F0B241A981A0C0C21A367D56"><enum>(c)</enum><header>Public
hearings; public comment</header><text>The Secretary shall hold public hearings
and solicit comments from the public in making the determinations under
subsection (a).</text>
</subsection><subsection id="id079CC29CFAE24DAC82DDC734455FC485"><enum>(d)</enum><header>Report</header><text>Not
later than 1 year after the date of the enactment of this Act, the Secretary
shall submit to the Congress a report that provides the determinations under
subsection (a). In addition, the Secretary shall include in the report the
measures being implemented by the Secretary to significantly reduce the risks
associated with indoor tanning devices.</text>
</subsection></section><enum>VI</enum><header>Food
safety</header>
<section id="idC06330579EE049F8836EC12ABCE74BA4"><enum>601.</enum><header>Findings</header>
<subsection id="IDb8f00f1416e54fd38cbec57aa623afab"><enum>(a)</enum><header>Findings</header><text>Congress
finds that—</text>
<paragraph id="ID8df45597594746bdacd4b0afd4188754"><enum>(1)</enum><text>the safety and
integrity of the United States food supply is vital to the public health, to
public confidence in the food supply, and to the success of the food sector of
the Nation's economy;</text>
</paragraph><paragraph id="IDcda93e00bb3849f3a46541441e58aafa"><enum>(2)</enum><text>illnesses and
deaths of individuals and companion animals caused by contaminated food—</text>
<subparagraph id="IDf3f22150e52d4482a514357a7cff63c0"><enum>(A)</enum><text>have contributed
to a loss of public confidence in food safety; and</text>
</subparagraph><subparagraph id="IDdca0fd771425402883d5f813fc84727c"><enum>(B)</enum><text>have caused
significant economic losses to manufacturers and producers not responsible for
contaminated food items;</text>
</subparagraph></paragraph><paragraph id="IDf16b7c2187184bdda90cb3f62cf599bb"><enum>(3)</enum><text>the task of
preserving the safety of the food supply of the United States faces tremendous
pressures with regard to—</text>
<subparagraph id="ID4f2ac6db5b7148c6ab1c6ce4c03376aa"><enum>(A)</enum><text>emerging
pathogens and other contaminants and the ability to detect all forms of
contamination; and</text>
</subparagraph><subparagraph id="ID8d8e67220f2642908d41be7c87f9bc5a"><enum>(B)</enum><text>an increasing
volume of imported food from a wide variety of countries; and</text>
</subparagraph><subparagraph id="idA1D743947D774D80A653F05DBD475F50"><enum>(C)</enum><text>a shortage of
adequate resources for monitoring and inspection;</text>
</subparagraph></paragraph><paragraph id="ID26e8af7b2d7348c9bef7e9875e50afe7"><enum>(4)</enum><text>the United States
is increasing the amount of food that it imports such that—</text>
<subparagraph id="IDae2e54bcccec472f832c3737ac8e5263"><enum>(A)</enum><text>from 2003 to the
present, the value of food imports has increased from $45,600,000,000 to
$64,000,000,000; and</text>
</subparagraph><subparagraph id="IDe9d3234f9ff04e52b7a7c11aa02c9871"><enum>(B)</enum><text>imported food
accounts for 13 percent of the average Americans diet including 31 percent of
fruits, juices, and nuts, 9.5 percent of red meat and 78.6 percent of fish and
shellfish; and</text>
</subparagraph></paragraph><paragraph id="ID1c7aff38bf8a48488acfdb6c9d150a69"><enum>(5)</enum><text>the number of
full time equivalent Food and Drug Administration employees conducting
inspections has decreased from 2003 to 2007.</text>
</paragraph></subsection></section><section id="idD1FD022676D749C4997F18E9DEB61939"><enum>602.</enum><header>Ensuring the
safety of pet food</header>
<subsection id="id3989621EAE1443029C05BA86510E5BBF"><enum>(a)</enum><header>Processing and
ingredient standards</header><text>Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human Services (referred to
in this title as the <quote>Secretary</quote>), in consultation with the
Association of American Feed Control Officials, and other relevant stakeholder
groups, including veterinary medical associations, animal health organizations,
and pet food manufacturers, shall by regulation establish—</text>
<paragraph id="id8F6F1A06BB3F4076B07B378ACEEB9FE9"><enum>(1)</enum><text>processing and
ingredient standards with respect to pet food, animal waste, and ingredient
definitions; and</text>
</paragraph><paragraph id="id3F2A1D97EBBE49BDB1118DEF7A26609E"><enum>(2)</enum><text>updated standards
for the labeling of pet food that includes nutritional information and
ingredient information.</text>
</paragraph></subsection><subsection id="idE00DA30BCA694F2686D27EDD89F0FADF"><enum>(b)</enum><header>Early warning
surveillance systems and notification during pet food recalls</header><text>Not
later than 180 days after the date of enactment of this Act, the Secretary
shall by regulation establish an early warning and surveillance system to
identify adulteration of the pet food supply and outbreaks of illness
associated with pet food. In establishing such system, the Secretary
shall—</text>
<paragraph id="id889DF9DEDC644817B20E746D3E9BAB31"><enum>(1)</enum><text>use surveillance
and monitoring mechanisms similar to, or in coordination with, those mechanisms
used by the Centers for Disease Control and Prevention to monitor human health,
such as the Foodborne Diseases Active Surveillance Network (FoodNet) and
PulseNet;</text>
</paragraph><paragraph id="id4F052B3FC80342FD84DF7F69D6CF32DF"><enum>(2)</enum><text>consult with
relevant professional associations and private sector veterinary hospitals;
and</text>
</paragraph><paragraph id="ID4ccc4d6e282a4e8b95662bc671dffae2"><enum>(3)</enum><text>work with the
Health Alert Network and other notification networks to inform veterinarians
and relevant stakeholders during any recall of pet food.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idCBCE5E2B8E4D4E10AB874D4B14A0C3CD"><enum>603.</enum><header>Ensuring
efficient and effective communications during a recall</header><text display-inline="no-display-inline">The Secretary shall, during an ongoing
recall of human or pet food—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id91B9955166964FB1A204185221CDFC36"><enum>(1)</enum><text>work with
companies, relevant professional associations, and other organizations to
collect and aggregate information pertaining to the recall;</text>
</paragraph><paragraph id="ID3661a13482504df4bc3089835ff24c75"><enum>(2)</enum><text>use existing
networks of communication including electronic forms of information
dissemination to enhance the quality and speed of communication with the
public; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4F07FACBD7304BCF8BDB10170CA1F576"><enum>(3)</enum><text>post information
regarding recalled products on the Internet website of the Food and Drug
Administration in a consolidated, searchable form that is easily accessed and
understood by the public.</text>
</paragraph></section><section id="ID241496984f43470c9aa6b896aea32c1a"><enum>604.</enum><header>State and
Federal Cooperation</header>
<subsection id="id8292FAEB344D494A858A3A70ECDAC132"><enum>(a)</enum><header>In
general</header><text>The Secretary shall work with the States in undertaking
activities and programs that assist in improving the safety of fresh and
processed produce so that State food safety programs involving the safety of
fresh and processed produce and activities conducted by the Secretaries
function in a coordinated and cost-effective manner. With the assistance
provided under subsection (b), the Secretary shall encourage States to—</text>
<paragraph id="ID1d0ea85da0e941009e60146e39c4df62"><enum>(1)</enum><text>establish,
continue, or strengthen State food safety programs, especially with respect to
the regulation of retail commercial food establishments; and</text>
</paragraph><paragraph id="IDf1b1f32dd2ca4b609502f474353a92af"><enum>(2)</enum><text>establish
procedures and requirements for ensuring that processed produce under the
jurisdiction of the State food safety programs is not unsafe for human
consumption.</text>
</paragraph></subsection><subsection id="IDe98216309f73478a96fd3441a14ab1c7"><enum>(b)</enum><header>Assistance</header><text>The
Secretary may provide to a State, for planning, developing, and implementing
such a food safety program—</text>
<paragraph id="ID69b0273e07104497b93a985c6b6e1802"><enum>(1)</enum><text>advisory
assistance;</text>
</paragraph><paragraph id="IDeca8021416974ee0bf7f141bda0acb0a"><enum>(2)</enum><text>technical
assistance, training, and laboratory assistance (including necessary materials
and equipment); and</text>
</paragraph><paragraph id="ID8e4b7c6a37e84f86ad4ae550d710b94e"><enum>(3)</enum><text>financial and
other assistance.</text>
</paragraph></subsection><subsection id="IDe3058dc23bdd481d8cde9b0253aa039c"><enum>(c)</enum><header>Service
agreements</header><text>The Secretary may, under an agreement entered into
with a Federal, State, or local agency, use, on a reimbursable basis or
otherwise, the personnel, services, and facilities of the agency to carry out
the responsibilities of the agency under this section. An agreement entered
into with a State agency under this subsection may provide for training of
State employees.</text>
</subsection></section><section id="IDe1e5af57d8244c98bcf1a172969b238b"><enum>605.</enum><header>Adulterated
food registry</header>
<subsection id="id854212256DF141D3ABF80F4529845DDA"><enum>(a)</enum><header>Findings</header><text>Congress
makes the following findings:</text>
<paragraph id="ID34a5a20a3e354c41a70c3b7a60385c84"><enum>(1)</enum><text>In 1994, Congress
passed the Dietary Supplement Health and Education Act (P.L. 103–417) to
provide the Food and Drug Administration with the legal framework to ensure
that dietary supplements are safe and properly labeled foods.</text>
</paragraph><paragraph id="ID14f3fb3ef22342f0ab3f0004156f2eb3"><enum>(2)</enum><text>In 2006, Congress
passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act
(P.L. 109–462) to establish a mandatory reporting system of serious adverse
events for non-prescription drugs and dietary supplements sold and consumed in
the United States.</text>
</paragraph><paragraph id="ID8d69de238b5d4c10975bbefd6a37f31e"><enum>(3)</enum><text>The adverse event
reporting system created under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act will serve as the early warning system for any
potential public health issues associated with the use of these food
products.</text>
</paragraph><paragraph id="IDcd6656c2769641e285bb6370dd61af4d"><enum>(4)</enum><text>A reliable
mechanism to track patterns of adulteration in food would support efforts by
the Food and Drug Administration to effectively target limited inspection
resources to protect the public health.</text>
</paragraph></subsection><subsection id="ID0b860acc364b4f0a905a0cc8250cf483"><enum>(b)</enum><header>In
general</header><text>Chapter IV of the Federal Food, Drug, and Cosmetic Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/341">21 U.S.C. 341 et seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id58F34D476FCC4D578AE6F32127D59384" style="OLC">
<section id="ID5c85e5f73b404678ab8f5a5c19f01ccb"><enum>417.</enum><header>Adulterated
food registry</header>
<subsection id="IDbb316589d1744bd6b052d853e48014b8"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="ID25de6cd3a2b144b9ae617cca8248f763"><enum>(1)</enum><header>Importer</header><text>The
term <quote>importer</quote>, with respect to an article of food, means the
person who submitted the notice with respect to such article of food under
section 801(m).</text>
</paragraph><paragraph id="IDd9e98260dfa941478f38666101014fcb"><enum>(2)</enum><header>Responsible
party</header><text>The term <quote>responsible party</quote>, with respect to
an article of food, means any registered food facility under section 415(a),
including those responsible for the manufacturing, processing, packaging or
holding of such food for consumption in the United States.</text>
</paragraph><paragraph id="IDeb2f26afaac04cbe923ae50d1b440205"><enum>(3)</enum><header>Reportable
adulterated food</header><text>The term <quote>reportable adulterated
food</quote> for purposes of this section means a food that is adulterated
or—</text>
<subparagraph id="ID83e5835df5e14d9dae05e4e2366453cc"><enum>(A)</enum><text>presents a
situation in which there is a reasonable probability that the use of, or
exposure to, a violative product will cause serious adverse health consequences
or death as defined in section 7.3(m)(1) of title, Code of Federal Regulations
(or any successor regulations); or</text>
</subparagraph><subparagraph id="IDb218a63072154ea588e1ba2447d802ee"><enum>(B)</enum><text>meets the
threshold established in section 304(h).</text>
</subparagraph></paragraph></subsection><subsection id="ID4390e0adac024d30b772ef418d384b92"><enum>(b)</enum><header>Establishment</header>
<paragraph id="idC645397099404485AC8B578471551CFE"><enum>(1)</enum><header>In
general</header><text>Not later than 180 days after the date of enactment of
this section, the Secretary shall establish within the Food and Drug
Administration an Adulterated Food Registry to which instances of reportable
adulterated food may be submitted by the Food and Drug Administration after
receipt of reports of adulteration, via an electronic portal, from—</text>
<subparagraph id="ID8516c173a0db4613bb4e9d4e3926f875"><enum>(A)</enum><text>Federal, State,
and local public health officials;</text>
</subparagraph><subparagraph id="ID90cd848673404b05bf434185a64fe458"><enum>(B)</enum><text>an
importer;</text>
</subparagraph><subparagraph id="IDad56029c42564de48a9f2f7dc86dbe6b"><enum>(C)</enum><text>a responsible
party; or</text>
</subparagraph><subparagraph id="ID34013fa3f64342e5b10200ac267e663a"><enum>(D)</enum><text>a consumer or
other individual.</text>
</subparagraph></paragraph><paragraph id="id9DB2B69EF16E4163894F138C759966F9"><enum>(2)</enum><header>Review by
Secretary</header><text>The Secretary shall review and determine the validity
of the information submitted under paragraph (1) for the purposes of
identifying adulterated food, submitting entries to the Adulterated Food
Registry, acting under subsection (c), and exercising other existing food
safety authorities under the Act to protect the public health.</text>
</paragraph></subsection><subsection id="ID16b0882eb9d941daad7ef169c0f55751"><enum>(c)</enum><header>Issuance of an
alert by the Secretary</header>
<paragraph id="ID841c346196b442d9a7c9df2178be9d1b"><enum>(1)</enum><header>In
general</header><text>The Secretary shall issue an alert with respect to an
adulterated food if the Adulterated Food Registry shows that the food—</text>
<subparagraph id="IDfb1d6e37c68e4bbdb1451a649c8d9c2a"><enum>(A)</enum><text>has been
associated with repeated and separate outbreaks of illness or has been
repeatedly determined to be adulterated; or</text>
</subparagraph><subparagraph id="id3A16D0D22F0741B386ACD2E76B06517C"><enum>(B)</enum><text>is a reportable
adulterated food.</text>
</subparagraph></paragraph><paragraph id="ID7101be1b0d374c16aa4c803f0bb61190"><enum>(2)</enum><header>Scope of
alert</header><text>An alert under paragraph (1) may apply to a particular food
or to food from a particular producer, manufacturer, shipper, growing area, or
country, to the extent that elements in subparagraph (A) or (B) of paragraph
(1) are associated with the particular food, producer, manufacturer, shipper,
growing area, or country.</text>
</paragraph></subsection><subsection id="IDe853c630a2e64ceeb377324f709b73d3"><enum>(d)</enum><header>Submission by a
consumer or other individual</header><text>A consumer or other individual may
submit a report to the Food and Drug Administration using the electronic portal
data elements described in subsection (e). Such reports shall be evaluated by
the Secretary as specified in subsection (b)(2).</text>
</subsection><subsection id="ID40d6045d9fca4ac29048fd9ad979a81b"><enum>(e)</enum><header>Notification
and reporting of adulteration</header>
<paragraph id="ID7065cc660fd2412fa49afa33115bcf1b"><enum>(1)</enum><header>Determination
by responsible party or importer</header><text>If a responsible party or
importer determines that an article of food it produced, processed,
manufactured, distributed, or otherwise handled is a reportable adulterated
food, the responsible party shall provide the notifications described under
paragraph (2).</text>
</paragraph><paragraph id="IDee14497be32e43fc962adcaa09e3e954"><enum>(2)</enum><header>Notification of
adulteration</header>
<subparagraph id="IDeea4e18fa6004a8e9cd632c8a1182442"><enum>(A)</enum><header>In
general</header><text>Not later than 5 days after a responsible party or
importer receives a notification, the responsible party or importer, as
applicable, shall review whether the food referenced in the report described in
paragraph (1) is a reportable adulterated food.</text>
</subparagraph><subparagraph id="ID6f23e048b7a44c9687693a2ca704f800"><enum>(B)</enum><header>Notification</header><text>If
a determination is made by such responsible party or importer that the food is
a reportable adulterated food, such responsible party or importer shall, no
later than 2 days after such determination is made, notify other responsible
parties directly linked in the supply chain to which and from which the article
of reportable adulterated food was transferred.</text>
</subparagraph></paragraph><paragraph id="IDe05eb20fde424af3a6f7dd8eb3f2e08e"><enum>(3)</enum><header>Submission of
reports to the food and drug administration by a responsible party or
importer</header><text>The responsible party or importer, as applicable, shall
submit a report to the Food and Drug Administration through the electronic
portal using the data elements described in subsection (f) not later than 2
days after a responsible party or importer—</text>
<subparagraph id="IDd9d55e965d3f479d8b599affed821eff"><enum>(A)</enum><text>makes a
notification under paragraph (2)(B); or</text>
</subparagraph><subparagraph id="IDac4ba239a8df4cb78294710dcf983231"><enum>(B)</enum><text>determines that
an article of food it produced, processed, manufactured, distributed, imported,
or otherwise handled is a reportable adulterated food, except that if such
adulteration was initiated with such responsible party or importer, was
detected prior to any transfer of such article of food, and was destroyed, no
report is necessary.</text>
</subparagraph></paragraph></subsection><subsection id="IDe0721cde986e409d9bbf5479376f0033"><enum>(f)</enum><header>Data elements
in the registry</header><text>A report submitted to the Food and Drug
Administration electronic portal under subsection (e) shall include the
following data elements:</text>
<paragraph id="IDc7b872554c0f4fd1b9799951ec139547"><enum>(1)</enum><text>Contact
information for the individual or entity submitting the report.</text>
</paragraph><paragraph id="ID96f459d264404b61985c8931942a8d75"><enum>(2)</enum><text>The date on which
an article of food was determined to be adulterated or suspected of being
adulterated.</text>
</paragraph><paragraph id="ID0158b7cd3e194388a3b0b8c0c1094f75"><enum>(3)</enum><text>A description of
the article of food including the quantity or amount.</text>
</paragraph><paragraph id="ID7943cfd297eb46459d85b82f65e590ff"><enum>(4)</enum><text>The extent and
nature of the adulteration.</text>
</paragraph><paragraph id="IDfef810647d164866bea85bbeda748c9f"><enum>(5)</enum><text>The disposition
of the article.</text>
</paragraph><paragraph id="ID4d1410ec4be540e39db90f26a223893d"><enum>(6)</enum><text>Product
information typically found on packaging including product codes, use by dates,
and names of manufactures or distributors.</text>
</paragraph><paragraph id="ID8f5973cbe2644a64a42e4111759a3fe3"><enum>(7)</enum><text>Information about
the place of purchase or process by which the consumer or other individual
acquired the article of adulterated food.</text>
</paragraph><paragraph id="ID0ddcef3a727c43448ec123cc14066cbe"><enum>(8)</enum><text>In the case of a
responsible party or an importer, the elements required for the registration of
food facilities under section 415(a).</text>
</paragraph><paragraph id="IDf89819b958f94d92b6a98cc6cc3bc972"><enum>(9)</enum><text>The contact
information for parties directly linked in the supply chain and notified under
subsection (e)(2).</text>
</paragraph><paragraph id="IDd234121c4a8a4b938fd05f42ffb9c91f"><enum>(10)</enum><text>In the case of
an importer, the elements required for the prior notice of imported food
shipments under section 801(m).</text>
</paragraph></subsection><subsection id="IDa99e8d04c4084d02bdac4f79104ca09b"><enum>(g)</enum><header>Maintenance and
inspection of records</header><text>The responsible person or importer shall
maintain records related to each report received, notification made, and report
submitted to the Food and Drug Administration under this section and permit
inspection of such records as provided for in section 414. Such records shall
also be made available during an inspection under section 704.</text>
</subsection><subsection id="IDa16af0d9d5834b11b3fba44b05f970d4"><enum>(h)</enum><header>Request for
information</header><text><external-xref legal-doc="usc" parsable-cite="usc/5/552">Section 552</external-xref> of title 5, United States Code, shall
apply to any request for information regarding a record in the Adulterated Food
Registry.</text>
</subsection><subsection id="IDc9dee3b7a5cd455b8e472c50acd9af44"><enum>(i)</enum><header>Homeland
security notification</header><text>If, after receiving a report under
subsection (e), the Secretary suspects such food may have been deliberately
adulterated, the Secretary shall immediately notify the Secretary of Homeland
Security. The Secretary shall make the data in the Adulterated Imported Food
Registry available to the Secretary of Homeland
Security.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID68bcbe1812f64fe7baeb728964b1b546"><enum>(c)</enum><header>Definition</header><text>Section
201(ff) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321(ff)</external-xref>) is
amended by striking <quote>section 201(g)</quote> and inserting <quote>sections
201(g) and 417</quote>.</text>
</subsection><subsection id="ID789c9c1baa3d453aac5d512a8fde502c"><enum>(d)</enum><header>Prohibited
Acts</header><text>Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331), as amended by this Act, is further amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id286F1CE51CF6488E990F4D308AF90FB1" style="OLC">
<subsection id="IDfce51a4998a64357bd754ca268c7d76f"><enum>(kk)</enum><text display-inline="yes-display-inline">The failure to provide a report as required
under section 417(e)(3).</text>
</subsection><subsection id="ID4be9f542c0ca43d3addcf9b48078748e"><enum>(ll)</enum><text>The
falsification a report as required under section
417(e)(3).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="IDb58108dfae504a87b75ea5e18f7e6979"><enum>(e)</enum><header>Suspected food
adulteration regulations</header><text>The Secretary shall, within 180 days of
enactment of this Act, promulgate regulations that establish standards and
thresholds by which importers and responsible parties shall be required and
consumers may be able to, under section 417 of the Federal Food, Drug, and
Cosmetic Act (as added by this section)—</text>
<paragraph id="IDd592285a1a5a4fef844ca5cd0e4d292a"><enum>(1)</enum><text>report instances
of suspected reportable adulteration of food to the Food and Drug
Administration for possible inclusion in the Adulterated Food Registry after
evaluation of such report; and</text>
</paragraph><paragraph id="ID10a96fd8907f4304856432b24d43b99d"><enum>(2)</enum><text>notify, in
keeping with subsection (e)(2) of such section 417, other responsible parties
directly linked in the supply chain, including establishments as defined in
section 415(b) of such Act.</text>
</paragraph></subsection><subsection id="ID4aa988e36a5a44798f10fda0702ffdeb"><enum>(f)</enum><header>Effective
date</header><text>The requirements of section 417(e) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a), shall become effective 180
days after the date of enactment of this Act.</text>
</subsection></section><section id="idEB2CDCC9C10648E796B6C32E0BFB1225"><enum>606.</enum><header>Sense of the
Senate</header><text display-inline="no-display-inline">It is the sense of the
Senate that—</text>
<paragraph id="IDc60d4ce37cc64ee5b210eda25273aa5b"><enum>(1)</enum><text>it is vital for
Congress to provide the Food and Drug Administration with additional resources,
authorities, and direction with respect to ensuring the safety of the food
supply of the United States;</text>
</paragraph><paragraph id="IDd300cdfc8edc474fb3b1b1b60acf3ab2"><enum>(2)</enum><text>additional
inspectors are required to improve the Food and Drug Administration’s ability
to safeguard the food supply of the United States;</text>
</paragraph><paragraph id="ID9f2d19424a7a424184f44759c529b80d"><enum>(3)</enum><text>because of the
increasing volume of international trade in food products the Secretary of
Health and Human Services should make it a priority to enter into agreements
with the trading partners of the United States with respect to food safety;
and</text>
</paragraph><paragraph id="ID30a4fbe641a5425788bbb0af8b08868e"><enum>(4)</enum><text>the Senate should
work to develop a comprehensive response to the issue of food safety.</text>
</paragraph></section><section id="idFE4FEBAAF72E44E890B352C57D810D81"><enum>607.</enum><header>Annual report
to Congress</header><text display-inline="no-display-inline">The Secretary
shall, on an annual basis, 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 report that includes, with respect to the preceding
1-year period—</text>
<paragraph id="ID1dc6ebdfd90c4d2399a51f9e2a9ce27a"><enum>(1)</enum><text>the number and
amount of food products regulated by the Food and Drug Administration imported
into the United States, aggregated by country and type of food;</text>
</paragraph><paragraph id="ID634e3791a67b4e608e16026022cdc300"><enum>(2)</enum><text>a listing of the
number of Food and Drug Administration inspectors of imported food products
referenced in paragraph (1) and the number of Food and Drug Administration
inspections performed on such products; and</text>
</paragraph><paragraph id="id5C3387742A7A4BA08CCE0997B13B5C0A"><enum>(3)</enum><text>aggregated data
on the findings of such inspections, including data related to violations of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/201">21 U.S.C. 201 et seq.</external-xref>), and
enforcement actions used to follow-up on such findings and violations.</text>
</paragraph></section><section id="ID3e3dd954eaa249269325bca3d1bcb475"><enum>608.</enum><header>Rule of
construction</header><text display-inline="no-display-inline">Nothing in this
title (or an amendment made by this title) shall be construed to affect—</text>
<paragraph id="ID9c5e6364a3004a5890de9f717ae2d2e1"><enum>(1)</enum><text>the regulation of
dietary supplements under the Dietary Supplement Health and Education Act;
or</text>
</paragraph><paragraph id="IDbf6f8acfd4e44e62afa48cb9fc66c5f3"><enum>(2)</enum><text>the adverse event
reporting system for dietary supplements created under the Dietary Supplement
and Nonprescription Drug Consumer Protection Act.</text>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="ID4b74d9da51ad45f0b66c4a953ce497be" section-type="subsequent-section"><enum>609.</enum><header>Authorization of
appropriations</header><text display-inline="no-display-inline">There are
authorized to be appropriated to carry out this title (and the amendments made
by this title) such sums as may be necessary.</text>
</section><enum>VII</enum><header>Domestic Pet
Turtle Market Access</header>
<section id="idE42CE1B76B20495590CAFBFAB38DB8E3"><enum>701.</enum><header>Short
title</header><text display-inline="no-display-inline">This title may be cited
as the <quote><short-title>Domestic Pet Turtle Market
Access Act of 2007</short-title></quote>.</text>
</section><section id="id50E74715F9D04C6898F4451CC75AF0F7"><enum>702.</enum><header>Findings</header><text display-inline="no-display-inline">Congress makes the following
findings:</text>
<paragraph id="IDae18255406a443c498384ccbcddc5dbc"><enum>(1)</enum><text>Pet turtles less
than 10.2 centimeters in diameter have been banned for sale in the United
States by the Food and Drug Administration since 1975 due to health
concerns.</text>
</paragraph><paragraph id="idF0C8F38DC582439A8ABAD7A22E766F96"><enum>(2)</enum><text>The Food and Drug
Administration does not ban the sale of iguanas or other lizards, snakes,
frogs, or other amphibians or reptiles that are sold as pets in the United
States that also carry salmonella bacteria. The Food and Drug Administration
also does not require that these animals be treated for salmonella bacteria
before being sold as pets.</text>
</paragraph><paragraph id="idCA69EE9332074ADD8DA70C3F327C7681"><enum>(3)</enum><text>The technology to
treat turtles for salmonella, and make them safe for sale, has greatly advanced
since 1975. Treatments exist that can nearly eradicate salmonella from turtles,
and individuals are more aware of the causes of salmonella, how to treat
salmonella poisoning, and the seriousness associated with salmonella
poisoning.</text>
</paragraph><paragraph id="IDeb392194edc248078a9ce18004a39446"><enum>(4)</enum><text>University
research has shown that these turtles can be treated in such a way that they
can be raised, shipped, and distributed without having a recolonization of
salmonella.</text>
</paragraph><paragraph id="id1272790F3DEE409DAE2D67537AFFC95E"><enum>(5)</enum><text>University
research has also shown that pet owners can be equipped with a treatment
regiment that allows the turtle to be maintained safe from salmonella.</text>
</paragraph><paragraph id="ID7b86742db0bf4c6180dab8daa64662a1"><enum>(6)</enum><text>The Food and Drug
Administration should allow the sale of turtles less than 10.2 centimeters in
diameter as pets as long as the sellers are required to use proven methods to
treat these turtles for salmonella.</text>
</paragraph></section><section id="id6A9AF3426D8B4FF490676A3D29DA7376"><enum>703.</enum><header>Sale of baby
turtles</header><text display-inline="no-display-inline">Notwithstanding any
other provision of law, the Food and Drug Administration shall not restrict the
sale by a turtle farmer, wholesaler, or commercial retail seller of a turtle
that is less than 10.2 centimeters in diameter as a pet if—</text>
<paragraph id="ID8242956a015f48109cd5b2d3938cba7c"><enum>(1)</enum><text>the State or
territory in which such farmer is located has developed a regulatory process by
which pet turtle farmers are required to have a State license to breed, hatch,
propagate, raise, grow, receive, ship, transport, export, or sell pet turtles
or pet turtle eggs;</text>
</paragraph><paragraph id="ID70e9dc23994d414498aeab8ded6590a8"><enum>(2)</enum><text>such State or
territory requires certification of sanitization that is signed by a
veterinarian who is licensed in the State or territory, and approved by the
State or territory agency in charge of regulating the sale of pet
turtles;</text>
</paragraph><paragraph id="IDb39f28b1c77e4fe4b5cac7e156cd69cf"><enum>(3)</enum><text>the certification
of sanitization requires each turtle to be sanitized or treated for diseases,
including salmonella, and is dependant upon using the Siebeling method, or
other such proven non-antibiotic method, to make the turtle salmonella-free;
and</text>
</paragraph><paragraph id="ID8cafae7964ff4d9d8ea5ae6b5e1b20a4"><enum>(4)</enum><text>the turtle farmer
or commercial retail seller includes, with the sale of such a turtle, a
disclosure to the buyer that includes—</text>
<subparagraph commented="no" id="idD7E381CB3DA0484296B8E83FD4236B6D"><enum>(A)</enum><text>information
regarding—</text>
<clause commented="no" id="idF5FA82BB6D35406CA071C64EBEDC7F7A"><enum>(i)</enum><text>the possibility
that salmonella can re-colonize in turtles;</text>
</clause><clause commented="no" id="id2E4115F7B4684CB38E6CE0BA1136D355"><enum>(ii)</enum><text>the dangers,
including possible severe illness or death, especially for at-risk people who
may be susceptible to salmonella poisoning, such as children, pregnant women,
and others who may have weak immune systems, that could result if the turtle is
not properly handled and safely maintained;</text>
</clause><clause commented="no" id="ID329cadf09ffa45efb64ceba59da66e15"><enum>(iii)</enum><text>the proper
handling of the turtle, including an explanation of proper hygiene such as
handwashing after handling a turtle; and</text>
</clause><clause commented="no" id="idB6822E71396F4033B394B34D008CA533"><enum>(iv)</enum><text>the proven
methods of treatment that, if properly applied, keep the turtle safe from
salmonella;</text>
</clause></subparagraph><subparagraph commented="no" id="IDcea79e447123445f8293880ad501a393"><enum>(B)</enum><text>a detailed
explanation of how to properly treat the turtle to keep it safe from
salmonella, using the proven methods of treatment referred to under
subparagraph (A), and how the buyer can continue to purchase the tools,
treatments, or any other required item to continually treat the turtle;
and</text>
</subparagraph><subparagraph commented="no" id="IDb9713ac299c1493982056051aed7ea93"><enum>(C)</enum><text>a statement that
buyers of pet turtles should not abandon the turtle or abandon it outside, as
the turtle may become an invasive species to the local community, but should
instead return them to a commercial retail pet seller or other organization
that would accept turtles no longer wanted as pets.</text>
</subparagraph></paragraph></section><section commented="no" display-inline="no-display-inline" id="id7B0AD5EA5C5C4C6F8492612C105A94C7" section-type="subsequent-section"><enum>704.</enum><header>FDA review of State
protections</header><text display-inline="no-display-inline">The Commissioner
of Food and Drugs may, after providing an opportunity for the affected State to
respond, restrict the sale of a turtle only if the Secretary of Health and
Human Services determines that the actual implementation of State health
protections described in this title are insufficient to protect consumers
against infectious diseases acquired from such turtle at the time of sale.</text>
</section><enum>VIII</enum><header>Importation of
prescription drugs</header>
<section id="id4450EC90C0AB457F92AB0C4D500DC0DD"><enum>801.</enum><header>Short
title</header><text display-inline="no-display-inline">This title may be cited
as the <quote><short-title>Pharmaceutical Market Access
and Drug Safety Act of 2007</short-title></quote>.</text>
</section><section id="ID230B31B779614C0C87FA6B4C37E1558B"><enum>802.</enum><header>Findings</header><text display-inline="no-display-inline">Congress finds that—</text>
<paragraph id="ID98A2C1C6485248E78275B5ED1CCC89A1"><enum>(1)</enum><text>Americans
unjustly pay up to 5 times more to fill their prescriptions than consumers in
other countries;</text>
</paragraph><paragraph id="ID1AFF2990C236420599F67B5394FD65DE"><enum>(2)</enum><text>the United States
is the largest market for pharmaceuticals in the world, yet American consumers
pay the highest prices for brand pharmaceuticals in the world;</text>
</paragraph><paragraph id="ID3440E3170FA0494FA492E42B8154A4CD"><enum>(3)</enum><text>a prescription
drug is neither safe nor effective to an individual who cannot afford
it;</text>
</paragraph><paragraph id="ID8F0173BEBB7A49C3B4F500FC547A3207"><enum>(4)</enum><text>allowing and
structuring the importation of prescription drugs to ensure access to safe and
affordable drugs approved by the Food and Drug Administration will provide a
level of safety to American consumers that they do not currently enjoy;</text>
</paragraph><paragraph id="IDF835BAB80174402DB5E5E6CCACA2D346"><enum>(5)</enum><text>American spend
more than $200,000,000,000 on prescription drugs every year;</text>
</paragraph><paragraph id="IDC7086A94D8044CB0B4C931B29FA0E1DA"><enum>(6)</enum><text>the Congressional
Budget Office has found that the cost of prescription drugs are between 35 to
55 percent less in other highly-developed countries than in the United States;
and</text>
</paragraph><paragraph id="idFE3997FB94D14CFC8129F39B4A371421"><enum>(7)</enum><text>promoting
competitive market pricing would both contribute to health care savings and
allow greater access to therapy, improving health and saving lives.</text>
</paragraph></section><section id="ID51BD1EE543A14136BE750D073F24105F"><enum>803.</enum><header>Repeal of
certain section regarding importation of prescription drugs</header><text display-inline="no-display-inline">Chapter VIII of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381 et seq.</external-xref>) is amended by striking section 804.</text>
</section><section id="ID8133A9E06F5443CCAFE1BB9FB1A21BCE"><enum>804.</enum><header>Importation of
prescription drugs; waiver of certain import restrictions</header>
<subsection id="ID20946A7BB45D43178EF677C97B78ABC0"><enum>(a)</enum><header>In
general</header><text>Chapter VIII of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 381 et seq.), as amended by section 803, is further amended by inserting
after section 803 the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="ID309446E36072489FB648C1EE5CC19866">
<section id="ID3FD2A6B5BDB642FD98D4C2002635E80F"><enum>804.</enum><header>Commercial and
personal importation of prescription drugs</header>
<subsection id="ID881B858AD51946A18FA7DDDA42DAEC50"><enum>(a)</enum><header>Importation of
prescription drugs</header>
<paragraph id="ID79355180348245FF997A0ADAAAF2DCCB"><enum>(1)</enum><header>In
general</header><text>In the case of qualifying drugs imported or offered for
import into the United States from registered exporters or by registered
importers—</text>
<subparagraph id="IDC201D8DC88CE41BABDDC906CA8F36A92"><enum>(A)</enum><text>the limitation on
importation that is established in section 801(d)(1) is waived; and</text>
</subparagraph><subparagraph id="IDB6C0EBC0397C4665B230C989F169CD6E"><enum>(B)</enum><text>the standards
referred to in section 801(a) regarding admission of the drugs are subject to
subsection (g) of this section (including with respect to qualifying drugs to
which section 801(d)(1) does not apply).</text>
</subparagraph></paragraph><paragraph id="IDE7FF5EBAE04B450D83C6AAC5D058F925"><enum>(2)</enum><header>Importers</header><text>A
qualifying drug may not be imported under paragraph (1) unless—</text>
<subparagraph id="IDB171D5E38B824ED1B982F78FDE2EF019"><enum>(A)</enum><text>the drug is
imported by a pharmacy, group of pharmacies, or a wholesaler that is a
registered importer; or</text>
</subparagraph><subparagraph id="IDDABAFD006C5F4016AC6D83830A5DAFCC"><enum>(B)</enum><text>the drug is
imported by an individual for personal use or for the use of a family member of
the individual (not for resale) from a registered exporter.</text>
</subparagraph></paragraph><paragraph id="ID8FEFA46C12D84EE4B9105B11395450D3"><enum>(3)</enum><header>Rule of
construction</header><text>This section shall apply only with respect to a drug
that is imported or offered for import into the United States—</text>
<subparagraph id="IDACB94C3FF50E42749162AF5AE1F7877E"><enum>(A)</enum><text>by a registered
importer; or</text>
</subparagraph><subparagraph id="IDB4E2AC45F61A49D09D50802A85BF2797"><enum>(B)</enum><text>from a registered
exporter to an individual.</text>
</subparagraph></paragraph><paragraph id="IDB0D6A53632F548909272F3B665C4FEEC"><enum>(4)</enum><header>Definitions</header>
<subparagraph id="ID858201A51B1940FB9543C57C62EE412C"><enum>(A)</enum><header>Registered
exporter; registered importer</header><text>For purposes of this
section:</text>
<clause id="ID893DEFD0FE234312A242D19241F14171"><enum>(i)</enum><text>The term
<term>registered exporter</term> means an exporter for which a registration
under subsection (b) has been approved and is in effect.</text>
</clause><clause id="ID2C1E3E4A012E4FABB6FAA83D437CB37B"><enum>(ii)</enum><text>The term
<term>registered importer</term> means a pharmacy, group of pharmacies, or a
wholesaler for which a registration under subsection (b) has been approved and
is in effect.</text>
</clause><clause id="IDBEE4424B2C0D4989A2CD205BBE2EE90A"><enum>(iii)</enum><text>The term
<term>registration condition</term> means a condition that must exist for a
registration under subsection (b) to be approved.</text>
</clause></subparagraph><subparagraph id="ID9E8DE32A1BD544C4B52F4417DD627E32"><enum>(B)</enum><header>Qualifying
drug</header><text>For purposes of this section, the term <term>qualifying
drug</term> means a drug for which there is a corresponding U.S. label
drug.</text>
</subparagraph><subparagraph id="ID19E2E6CF2E1648F18EECCBD053AFE28A"><enum>(C)</enum><header>U.S. label
drug</header><text>For purposes of this section, the term <term>U.S. label
drug</term> means a prescription drug that—</text>
<clause id="IDC7E130E398BD43EFA083105102B6A177"><enum>(i)</enum><text>with respect to a
qualifying drug, has the same active ingredient or ingredients, route of
administration, dosage form, and strength as the qualifying drug;</text>
</clause><clause id="IDE1F3C7ECAB994644A969002A45AA8877"><enum>(ii)</enum><text>with respect to
the qualifying drug, is manufactured by or for the person that manufactures the
qualifying drug;</text>
</clause><clause id="IDE49CE5A8E2F7486D9ECECAFE42EC31AA"><enum>(iii)</enum><text>is approved
under section 505(c); and</text>
</clause><clause id="ID258F11149F5244D1B5FA9DFA4C34F5B8"><enum>(iv)</enum><text>is not—</text>
<subclause id="ID03CCC564E88445A28D12F22D65993568"><enum>(I)</enum><text>a controlled
substance, as defined in section 102 of the <act-name parsable-cite="CSA">Controlled Substances Act</act-name> (21 U.S.C.
802);</text>
</subclause><subclause id="ID2DDA6860F8154EB9B6B66D8944998AFE"><enum>(II)</enum><text>a biological
product, as defined in section 351 of the <act-name parsable-cite="PHSA">Public
Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>), including—</text>
<item id="IDBF8519AC331A402ABA18A4010512C031"><enum>(aa)</enum><text>a
therapeutic DNA plasmid product;</text>
</item><item id="ID8FE24C2EC46B4E58B26D41EF0DFA21DC"><enum>(bb)</enum><text>a
therapeutic synthetic peptide product;</text>
</item><item id="IDA0809459B3354C83B6540B66C4693365"><enum>(cc)</enum><text>a
monoclonal antibody product for in vivo use; and</text>
</item><item id="ID3FCBEA59C8EF4025A17CB647562250AB"><enum>(dd)</enum><text>a
therapeutic recombinant DNA-derived product;</text>
</item></subclause><subclause id="IDD3C30CC6C6EF450A87C33542399907F6"><enum>(III)</enum><text>an infused
drug, including a peritoneal dialysis solution;</text>
</subclause><subclause id="ID36B689FDB35846A0BD5D91E33E3A78C7"><enum>(IV)</enum><text>an injected
drug;</text>
</subclause><subclause id="IDEE29E53ED700470BAD541DCE361FFF20"><enum>(V)</enum><text>a drug that is
inhaled during surgery;</text>
</subclause><subclause id="ID2DD2A9AD9DAA4E6FBCB1B6F5E6684EE2"><enum>(VI)</enum><text>a drug that is
the listed drug referred to in 2 or more abbreviated new drug applications
under which the drug is commercially marketed; or</text>
</subclause><subclause id="idCB357FDBD66A4607922168DB1DAC61BB"><enum>(VII)</enum><text>a sterile
opthlamic drug intended for topical use on or in the eye.</text>
</subclause></clause></subparagraph><subparagraph id="ID19731B1FAC1C472B8E1F0E9CD93F0E53"><enum>(D)</enum><header>Other
definitions</header><text>For purposes of this section:</text>
<clause id="ID58FBEB9356E54A3894E061C6A87AD1B5"><enum>(i)</enum><subclause commented="no" display-inline="yes-display-inline" id="ID85059805A6334E6FB6D9D3BB54DCF45C"><enum>(I)</enum><text>The term
<term>exporter</term> means a person that is in the business of exporting a
drug to individuals in the United States from Canada or from a permitted
country designated by the Secretary under subclause (II), or that, pursuant to
submitting a registration under subsection (b), seeks to be in such
business.</text>
</subclause><subclause id="IDE0BF09E14C6F4F8B8FC21638D1E0990C" indent="up1"><enum>(II)</enum><text>The Secretary shall designate a
permitted country under subparagraph (E) (other than Canada) as a country from
which an exporter may export a drug to individuals in the United States if the
Secretary determines that—</text>
<item id="ID90D6740774184214BDBC5FF7E2152987"><enum>(aa)</enum><text>the country has statutory or
regulatory standards that are equivalent to the standards in the United States
and Canada with respect to—</text>
<subitem id="ID0C2562905BF94D4EB570440FCBD6A7BC"><enum>(AA)</enum><text>the training of pharmacists;</text>
</subitem><subitem id="ID15096425D14048FE8B214A2A8821B2B0"><enum>(BB)</enum><text>the practice of pharmacy; and</text>
</subitem><subitem id="IDCA8F0730F95D4960ACDD68C07960D215"><enum>(CC)</enum><text>the protection of the privacy of personal
medical information; and</text>
</subitem></item><item id="id7C952F05D9DA4D82990E06D5430BD917"><enum>(bb)</enum><text>the importation of drugs to
individuals in the United States from the country will not adversely affect
public health.</text>
</item></subclause></clause><clause id="idDDD2E1CFD8984DB2B9013BABF198B681"><enum>(ii)</enum><text>The term
<term>importer</term> means a pharmacy, a group of pharmacies, or a wholesaler
that is in the business of importing a drug into the United States or that,
pursuant to submitting a registration under subsection (b), seeks to be in such
business.</text>
</clause><clause id="idEB20E2D62E3E4AFFAC0B10D2D9FE8213"><enum>(iii)</enum><text>The term
<term>pharmacist</term> means a person licensed by a State to practice
pharmacy, including the dispensing and selling of prescription drugs.</text>
</clause><clause id="idDFFF8CCEF4F64891AF80BE2030F1BCB3"><enum>(iv)</enum><text>The term
<term>pharmacy</term> means a person that—</text>
<subclause id="ID5B5ECB5D375045159EAFEF080AAEF446"><enum>(I)</enum><text>is licensed by a
State to engage in the business of selling prescription drugs at retail;
and</text>
</subclause><subclause id="ID88C41EDDE52C43BAA27D297D45A9DA70"><enum>(II)</enum><text>employs 1 or
more pharmacists.</text>
</subclause></clause><clause id="IDF6FB45F3D5084737B69DF30874263E7B"><enum>(v)</enum><text>The term
<term>prescription drug</term> means a drug that is described in section
503(b)(1).</text>
</clause><clause id="IDB4431F3A5F61490E9EEB2B9FAAD459BC"><enum>(vi)</enum><text>The term
<term>wholesaler</term>—</text>
<subclause id="ID97F59B8634664470940F8BA83645B94A"><enum>(I)</enum><text>means a person
licensed as a wholesaler or distributor of prescription drugs in the United
States under section 503(e)(2)(A); and</text>
</subclause><subclause id="ID4CC355F268AE43A5875F18D0DAC00620"><enum>(II)</enum><text>does not include
a person authorized to import drugs under section 801(d)(1).</text>
</subclause></clause></subparagraph><subparagraph id="IDA767207BBAF14864AC6A2BA6317FFE7D"><enum>(E)</enum><header>Permitted
country</header><text>The term <term>permitted country</term> means—</text>
<clause id="ID36914DEB996440E592DCD08ECC6714B6"><enum>(i)</enum><text>Australia;</text>
</clause><clause id="ID469D2E7463EF4228A58AF0BF93ADC145"><enum>(ii)</enum><text>Canada;</text>
</clause><clause id="IDD4223DE21C9B4C1E9D4E601AEBCC460E"><enum>(iii)</enum><text>a member
country of the European Union, but does not include a member country with
respect to which—</text>
<subclause id="ID278D2B43EC4A4CABB2665855CF2BFD99"><enum>(I)</enum><text>the country’s
Annex to the Treaty of Accession to the European Union 2003 includes a
transitional measure for the regulation of human pharmaceutical products that
has not expired; or</text>
</subclause><subclause id="ID46726B3412854D07AA53BA634E75A35E"><enum>(II)</enum><text>the Secretary
determines that the requirements described in subclauses (I) and (II) of clause
(vii) will not be met by the date on which such transitional measure for the
regulation of human pharmaceutical products expires;</text>
</subclause></clause><clause id="ID2617C267A37844EE94D773E78AB46024"><enum>(iv)</enum><text>Japan;</text>
</clause><clause id="ID452CBD3E84CB4E00836625CF133350B5"><enum>(v)</enum><text>New
Zealand;</text>
</clause><clause id="ID283CD2B337B44EE7BA727A6B7ED95491"><enum>(vi)</enum><text>Switzerland;
and</text>
</clause><clause id="ID56B4E8FF030C4848A2E292642AF1A8D4"><enum>(vii)</enum><text>a country in
which the Secretary determines the following requirements are met:</text>
<subclause id="ID3A831FEFE0A2470588B4DAF9D55B0C6C"><enum>(I)</enum><text>The country has
statutory or regulatory requirements—</text>
<item id="ID476B2151E0024D459B9A2360B9BCB106"><enum>(aa)</enum><text>that require the
review of drugs for safety and effectiveness by an entity of the government of
the country;</text>
</item><item id="ID748B820DD70B4EB1AEDCCBC9E7BBF958"><enum>(bb)</enum><text>that authorize
the approval of only those drugs that have been determined to be safe and
effective by experts employed by or acting on behalf of such entity and
qualified by scientific training and experience to evaluate the safety and
effectiveness of drugs on the basis of adequate and well-controlled
investigations, including clinical investigations, conducted by experts
qualified by scientific training and experience to evaluate the safety and
effectiveness of drugs;</text>
</item><item id="ID68A7635E565D4A95AFC488DCEF9A49CD"><enum>(cc)</enum><text>that require the
methods used in, and the facilities and controls used for the manufacture,
processing, and packing of drugs in the country to be adequate to preserve
their identity, quality, purity, and strength;</text>
</item><item id="ID846EE50A422D4E03921244C24E22F56E"><enum>(dd)</enum><text>for the
reporting of adverse reactions to drugs and procedures to withdraw approval and
remove drugs found not to be safe or effective; and</text>
</item><item id="ID914D438D8A824277B0F39033A9B05716"><enum>(ee)</enum><text>that require the
labeling and promotion of drugs to be in accordance with the approval of the
drug.</text>
</item></subclause><subclause id="ID2791C3E748EE4BF1A04B4F823BE62C76"><enum>(II)</enum><text>The valid
marketing authorization system in the country is equivalent to the systems in
the countries described in clauses (i) through (vi).</text>
</subclause><subclause id="ID988031F9794C4352889BFD74149942F9"><enum>(III)</enum><text>The importation
of drugs to the United States from the country will not adversely affect public
health.</text>
</subclause></clause></subparagraph></paragraph></subsection><subsection id="IDDEED9BE8E20140078F866A04713D9A57"><enum>(b)</enum><header>Registration of
importers and exporters</header>
<paragraph id="IDC2995010890549E086E503D8116DA8AD"><enum>(1)</enum><header>Registration of
importers and exporters</header><text>A registration condition is that the
importer or exporter involved (referred to in this subsection as a
<quote>registrant</quote>) submits to the Secretary a registration containing
the following:</text>
<subparagraph id="IDDF41F9429FAC4A8C99105B436B67C85D"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="ID8A269BBDB6F8479B886F346C702DE66C"><enum>(i)</enum><text>In the case of an
exporter, the name of the exporter and an identification of all places of
business of the exporter that relate to qualifying drugs, including each
warehouse or other facility owned or controlled by, or operated for, the
exporter.</text>
</clause><clause id="ID5178FCC4E93143F3B0E5362E52CDEC19" indent="up1"><enum>(ii)</enum><text>In the case of an importer, the
name of the importer and an identification of the places of business of the
importer at which the importer initially receives a qualifying drug after
importation (which shall not exceed 3 places of business except by permission
of the Secretary).</text>
</clause></subparagraph><subparagraph id="ID5304B4F2E8ED4A7BA0C61D1C399254E2"><enum>(B)</enum><text>Such information
as the Secretary determines to be necessary to demonstrate that the registrant
is in compliance with registration conditions under—</text>
<clause id="ID0BF216B083474C4A90F4E23E8FA6ACE3"><enum>(i)</enum><text>in the case of an
importer, subsections (c), (d), (e), (g), and (j) (relating to the sources of
imported qualifying drugs; the inspection of facilities of the importer; the
payment of fees; compliance with the standards referred to in section 801(a);
and maintenance of records and samples); or</text>
</clause><clause id="ID0998A6B72DF44978A1A8B64CFFAE3623"><enum>(ii)</enum><text>in the case of
an exporter, subsections (c), (d), (f), (g), (h), (i), and (j) (relating to the
sources of exported qualifying drugs; the inspection of facilities of the
exporter and the marking of compliant shipments; the payment of fees; and
compliance with the standards referred to in section 801(a); being licensed as
a pharmacist; conditions for individual importation; and maintenance of records
and samples).</text>
</clause></subparagraph><subparagraph id="IDB1A1FE3B9BCF41C990080F4FC00EFF9C"><enum>(C)</enum><text>An agreement by
the registrant that the registrant will not under subsection (a) import or
export any drug that is not a qualifying drug.</text>
</subparagraph><subparagraph id="ID3188DBFFCF1B4B28A5D7A2778761549F"><enum>(D)</enum><text>An agreement by
the registrant to—</text>
<clause id="ID8938E3D2FB594796B1B45719CB68B5BB"><enum>(i)</enum><text>notify the
Secretary of a recall or withdrawal of a qualifying drug distributed in a
permitted country that the registrant has exported or imported, or intends to
export or import, to the United States under subsection (a);</text>
</clause><clause id="ID79FEA187A24C4237B099A43D2B31179C"><enum>(ii)</enum><text>provide for the
return to the registrant of such drug; and</text>
</clause><clause id="ID97A936DAC33E4374892B064B334D7C2E"><enum>(iii)</enum><text>cease, or not
begin, the exportation or importation of such drug unless the Secretary has
notified the registrant that exportation or importation of such drug may
proceed.</text>
</clause></subparagraph><subparagraph id="IDDAC4E39836B34DBA9661F94B05D1D4FB"><enum>(E)</enum><text>An agreement by
the registrant to ensure and monitor compliance with each registration
condition, to promptly correct any noncompliance with such a condition, and to
promptly report to the Secretary any such noncompliance.</text>
</subparagraph><subparagraph id="ID780BF82E848449D1B27BF4FE9AC4D93B"><enum>(F)</enum><text>A plan describing
the manner in which the registrant will comply with the agreement under
subparagraph (E).</text>
</subparagraph><subparagraph id="IDF17C8E97D67948D1989B55052A6AE268"><enum>(G)</enum><text>An agreement by
the registrant to enforce a contract under subsection (c)(3)(B) against a party
in the chain of custody of a qualifying drug with respect to the authority of
the Secretary under clauses (ii) and (iii) of that subsection.</text>
</subparagraph><subparagraph id="ID7FAED45267FF4A679945B39799BB29A0"><enum>(H)</enum><text>An agreement by
the registrant to notify the Secretary not more than 30 days before the
registrant intends to make the change, of—</text>
<clause id="ID1B696A92BABC4B8FBF59185423F553A7"><enum>(i)</enum><text>any change that
the registrant intends to make regarding information provided under
subparagraph (A) or (B); and</text>
</clause><clause id="ID4C77072B161E4773902346EAB5333AC4"><enum>(ii)</enum><text>any change that
the registrant intends to make in the compliance plan under subparagraph
(F).</text>
</clause></subparagraph><subparagraph id="ID664394E29D204B6185509F06ED7B465E"><enum>(I)</enum><text>In the case of an
exporter—</text>
<clause id="ID1EE881BEB8C94C62AF493CAC50E95644"><enum>(i)</enum><text>An agreement by
the exporter that a qualifying drug will not under subsection (a) be exported
to any individual not authorized pursuant to subsection (a)(2)(B) to be an
importer of such drug.</text>
</clause><clause id="ID82C7B36BECEC4E91B7FDC0BE4B29F41F"><enum>(ii)</enum><text>An agreement to
post a bond, payable to the Treasury of the United States that is equal in
value to the lesser of—</text>
<subclause id="ID48BCD6945A0A4BE9AB943634F99B7F32"><enum>(I)</enum><text>the value of
drugs exported by the exporter to the United States in a typical 4-week period
over the course of a year under this section; or</text>
</subclause><subclause id="ID8F3625274D9A45C09FEF8158F6325E9D"><enum>(II)</enum><text>$1,000,000;</text>
</subclause></clause><clause id="ID57273DE8CF7043688D569DD34F0C9803"><enum>(iii)</enum><text>An agreement by
the exporter to comply with applicable provisions of Canadian law, or the law
of the permitted country designated under subsection (a)(4)(D)(i)(II) in which
the exporter is located, that protect the privacy of personal information with
respect to each individual importing a prescription drug from the exporter
under subsection (a)(2)(B).</text>
</clause><clause id="ID79D5B6C14503443E955D8B21BD53C1EB"><enum>(iv)</enum><text>An agreement by
the exporter to report to the Secretary—</text>
<subclause id="ID9B2FB5A3F8C144709D4AA288B25421DE"><enum>(I)</enum><text>not later than
August 1 of each fiscal year, the total price and the total volume of drugs
exported to the United States by the exporter during the 6-month period from
January 1 through June 30 of that year; and</text>
</subclause><subclause id="IDC32F6C9EED8F47A1A9F088AFEEA3403F"><enum>(II)</enum><text>not later than
January 1 of each fiscal year, the total price and the total volume of drugs
exported to the United States by the exporter during the previous fiscal
year.</text>
</subclause></clause></subparagraph><subparagraph id="ID3F674C3A45D14668BE79226B21B51FB5"><enum>(J)</enum><text>In the case of an
importer, an agreement by the importer to report to the Secretary—</text>
<clause id="IDA3B7FA1526E741A5B9280384A7229D97"><enum>(i)</enum><text>not later than
August 1 of each fiscal year, the total price and the total volume of drugs
imported to the United States by the importer during the 6-month period from
January 1 through June 30 of that fiscal year; and</text>
</clause><clause id="ID5BBB67BC1F624033875061031DE3D65F"><enum>(ii)</enum><text>not later than
January 1 of each fiscal year, the total price and the total volume of drugs
imported to the United States by the importer during the previous fiscal
year.</text>
</clause></subparagraph><subparagraph id="ID7EF9203B5CF7404E98EBAD41ABC21FC4"><enum>(K)</enum><text>Such other
provisions as the Secretary may require by regulation to protect the public
health while permitting—</text>
<clause id="ID3B4A88668C114EB382B910F5FD7164C0"><enum>(i)</enum><text>the importation
by pharmacies, groups of pharmacies, and wholesalers as registered importers of
qualifying drugs under subsection (a); and</text>
</clause><clause id="IDFA7DD09767A94485AD8C6B38EB38A8F7"><enum>(ii)</enum><text>importation by
individuals of qualifying drugs under subsection (a).</text>
</clause></subparagraph></paragraph><paragraph id="IDAE8BE023AEC1420A9401D6CDBB56F12F"><enum>(2)</enum><header>Approval or
disapproval of registration</header>
<subparagraph id="ID393F8774EEDD42BF936B86CAD0D71B50"><enum>(A)</enum><header>In
general</header><text>Not later than 90 days after the date on which a
registrant submits to the Secretary a registration under paragraph (1), the
Secretary shall notify the registrant whether the registration is approved or
is disapproved. The Secretary shall disapprove a registration if there is
reason to believe that the registrant is not in compliance with one or more
registration conditions, and shall notify the registrant of such reason. In the
case of a disapproved registration, the Secretary shall subsequently notify the
registrant that the registration is approved if the Secretary determines that
the registrant is in compliance with such conditions.</text>
</subparagraph><subparagraph id="ID326804DD032240B8B9A16840897C2873"><enum>(B)</enum><header>Changes in
registration information</header><text>Not later than 30 days after receiving a
notice under paragraph (1)(H) from a registrant, the Secretary shall determine
whether the change involved affects the approval of the registration of the
registrant under paragraph (1), and shall inform the registrant of the
determination.</text>
</subparagraph></paragraph><paragraph id="IDED5E554523074F40B269D804C9520E86"><enum>(3)</enum><header>Publication of
contact information for registered exporters</header><text>Through the Internet
website of the Food and Drug Administration and a toll-free telephone number,
the Secretary shall make readily available to the public a list of registered
exporters, including contact information for the exporters. Promptly after the
approval of a registration submitted under paragraph (1), the Secretary shall
update the Internet website and the information provided through the toll-free
telephone number accordingly.</text>
</paragraph><paragraph id="ID46FC7FD831534D28A1CBD1EA9388227F"><enum>(4)</enum><header>Suspension and
termination</header>
<subparagraph id="IDDA4A4389CD6C4D98A83710B495C07DB8"><enum>(A)</enum><header>Suspension</header><text>With
respect to the effectiveness of a registration submitted under paragraph
(1):</text>
<clause id="IDA9E1DC8DEF6440F8893A348D6C601E7F"><enum>(i)</enum><text>Subject to clause
(ii), the Secretary may suspend the registration if the Secretary determines,
after notice and opportunity for a hearing, that the registrant has failed to
maintain substantial compliance with a registration condition.</text>
</clause><clause id="ID8CA2EC99450E4602A4471098C833B515"><enum>(ii)</enum><text>If the Secretary
determines that, under color of the registration, the exporter has exported a
drug or the importer has imported a drug that is not a qualifying drug, or a
drug that does not comply with subsection (g)(2)(A) or (g)(4), or has exported
a qualifying drug to an individual in violation of subsection (i)(2)(F), the
Secretary shall immediately suspend the registration. A suspension under the
preceding sentence is not subject to the provision by the Secretary of prior
notice, and the Secretary shall provide to the registrant an opportunity for a
hearing not later than 10 days after the date on which the registration is
suspended.</text>
</clause><clause id="ID926BC44A62D04EF5BD65752A15F75299"><enum>(iii)</enum><text>The Secretary
may reinstate the registration, whether suspended under clause (i) or (ii), if
the Secretary determines that the registrant has demonstrated that further
violations of registration conditions will not occur.</text>
</clause></subparagraph><subparagraph id="ID7723CD07D71742F59649585BB6384996"><enum>(B)</enum><header>Termination</header><text>The
Secretary, after notice and opportunity for a hearing, may terminate the
registration under paragraph (1) of a registrant if the Secretary determines
that the registrant has engaged in a pattern or practice of violating 1 or more
registration conditions, or if on 1 or more occasions the Secretary has under
subparagraph (A)(ii) suspended the registration of the registrant. The
Secretary may make the termination permanent, or for a fixed period of not less
than 1 year. During the period in which the registration is terminated, any
registration submitted under paragraph (1) by the registrant, or a person that
is a partner in the export or import enterprise, or a principal officer in such
enterprise, and any registration prepared with the assistance of the registrant
or such a person, has no legal effect under this section.</text>
</subparagraph></paragraph><paragraph id="IDAA16FA5685AC4C13B3BC290F3A2D3106"><enum>(5)</enum><header>Default of
bond</header><text>A bond required to be posted by an exporter under paragraph
(1)(I)(ii) shall be defaulted and paid to the Treasury of the United States if,
after opportunity for an informal hearing, the Secretary determines that the
exporter has—</text>
<subparagraph id="IDC0C32B5FCD9B4623AE5B16B62DCA44DC"><enum>(A)</enum><text>exported a drug
to the United States that is not a qualifying drug or that is not in compliance
with subsection (g)(2)(A), (g)(4), or (i); or</text>
</subparagraph><subparagraph id="ID4C8556A7786247EF9A07DE0B6037B3C3"><enum>(B)</enum><text>failed to permit
the Secretary to conduct an inspection described under subsection (d).</text>
</subparagraph></paragraph></subsection><subsection id="ID956F61D10A294AB3943116675721DB60"><enum>(c)</enum><header>Sources of
qualifying drugs</header><text>A registration condition is that the exporter or
importer involved agrees that a qualifying drug will under subsection (a) be
exported or imported into the United States only if there is compliance with
the following:</text>
<paragraph id="IDB1B2DC24547B4D4DAEC8DE4A8C665D1F"><enum>(1)</enum><text>The drug was
manufactured in an establishment—</text>
<subparagraph id="IDC9FD4BBBB32040DF919C7207E6D7DFC4"><enum>(A)</enum><text>required to
register under subsection (h) or (i) of section 510; and</text>
</subparagraph><subparagraph id="IDDBD1B68C534E47999F456FF8D02F9380"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="ID5FC497A0BFFC4AF99049A6424A35E994"><enum>(i)</enum><text>inspected by the
Secretary; or</text>
</clause><clause id="IDA6E95B6F9B254C3E9BD79BB1202CD4AA" indent="up1"><enum>(ii)</enum><text>for which the Secretary has
elected to rely on a satisfactory report of a good manufacturing practice
inspection of the establishment from a permitted country whose regulatory
system the Secretary recognizes as equivalent under a mutual recognition
agreement, as provided for under section 510(i)(3), section 803, or part 26 of
title 21, Code of Federal Regulations (or any corresponding successor rule or
regulation).</text>
</clause></subparagraph></paragraph><paragraph id="ID359D01319E334C1598CA68175A69B767"><enum>(2)</enum><text>The establishment
is located in any country, and the establishment manufactured the drug for
distribution in the United States or for distribution in 1 or more of the
permitted countries (without regard to whether in addition the drug is
manufactured for distribution in a foreign country that is not a permitted
country).</text>
</paragraph><paragraph id="ID6779AC11BA7949168F6C6E547FC56659"><enum>(3)</enum><text>The exporter or
importer obtained the drug—</text>
<subparagraph id="ID11900CF89A174368A92F9BEA3F94E0D1"><enum>(A)</enum><text>directly from the
establishment; or</text>
</subparagraph><subparagraph id="ID85A42D4FB09A452881CD2055067A8056"><enum>(B)</enum><text>directly from an
entity that, by contract with the exporter or importer—</text>
<clause id="ID05E86D1DEFEB4595A1EBA074937F4E02"><enum>(i)</enum><text>provides to the
exporter or importer a statement (in such form and containing such information
as the Secretary may require) that, for the chain of custody from the
establishment, identifies each prior sale, purchase, or trade of the drug
(including the date of the transaction and the names and addresses of all
parties to the transaction);</text>
</clause><clause id="ID9543F1BC415D4FD9828886D983B731FE"><enum>(ii)</enum><text>agrees to permit
the Secretary to inspect such statements and related records to determine their
accuracy;</text>
</clause><clause id="ID499A8323C8684DD095CF457CDBB03DDA"><enum>(iii)</enum><text>agrees, with
respect to the qualifying drugs involved, to permit the Secretary to inspect
warehouses and other facilities, including records, of the entity for purposes
of determining whether the facilities are in compliance with any standards
under this Act that are applicable to facilities of that type in the United
States; and</text>
</clause><clause id="ID56D56EC07D6149889A9BC5060195FA11"><enum>(iv)</enum><text>has ensured,
through such contractual relationships as may be necessary, that the Secretary
has the same authority regarding other parties in the chain of custody from the
establishment that the Secretary has under clauses (ii) and (iii) regarding
such entity.</text>
</clause></subparagraph></paragraph><paragraph id="ID92E6B7F1F69C441998550637C6A72DCC"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="ID084B45D9C7BD43F886A02EEB7673D087"><enum>(A)</enum><text>The foreign country
from which the importer will import the drug is a permitted country; or</text>
</subparagraph><subparagraph id="ID5AB77E01B492496798325CD141F691A9" indent="up1"><enum>(B)</enum><text>The foreign country from which the
exporter will export the drug is the permitted country in which the exporter is
located.</text>
</subparagraph></paragraph><paragraph id="ID84CC9F3E6A6C4A2CBB111A102DE10D86"><enum>(5)</enum><text>During any period
in which the drug was not in the control of the manufacturer of the drug, the
drug did not enter any country that is not a permitted country.</text>
</paragraph><paragraph id="ID33938E414EE24CB6B8E644182CDF1D26"><enum>(6)</enum><text>The exporter or
importer retains a sample of each lot of the drug for testing by the
Secretary.</text>
</paragraph></subsection><subsection id="ID4B7E17B2EE59434EB0302AC25D9FB270"><enum>(d)</enum><header>Inspection of
facilities; marking of shipments</header>
<paragraph id="ID25C16B841C4543E7983087865895A09F"><enum>(1)</enum><header>Inspection of
facilities</header><text>A registration condition is that, for the purpose of
assisting the Secretary in determining whether the exporter involved is in
compliance with all other registration conditions—</text>
<subparagraph id="ID1D255406840D46AC8DD8AFC76263C398"><enum>(A)</enum><text>the exporter
agrees to permit the Secretary—</text>
<clause id="IDBA700837CFCF43D4AFB902F3751B12A2"><enum>(i)</enum><text>to conduct onsite
inspections, including monitoring on a day-to-day basis, of places of business
of the exporter that relate to qualifying drugs, including each warehouse or
other facility owned or controlled by, or operated for, the exporter;</text>
</clause><clause id="ID2DA7EE1F2E6941E8A7928D506CDB2BAD"><enum>(ii)</enum><text>to have access,
including on a day-to-day basis, to—</text>
<subclause id="ID4FAD5410EBCB4EE1BE9B3A1F543AD9DC"><enum>(I)</enum><text>records of the
exporter that relate to the export of such drugs, including financial records;
and</text>
</subclause><subclause id="ID3A4D764FDFAA4DBA8271696FFE510AB0"><enum>(II)</enum><text>samples of such
drugs;</text>
</subclause></clause><clause id="IDA9DCB9ECD8B04C67BC0197F84B874BA7"><enum>(iii)</enum><text>to carry out
the duties described in paragraph (3); and</text>
</clause><clause id="IDC6C852BF6D1745A1805D77183B4E9378"><enum>(iv)</enum><text>to carry out any
other functions determined by the Secretary to be necessary regarding the
compliance of the exporter; and</text>
</clause></subparagraph><subparagraph id="IDF92FC68A13F14C32A81B1E54509B9E7A"><enum>(B)</enum><text>the Secretary has
assigned 1 or more employees of the Secretary to carry out the functions
described in this subsection for the Secretary randomly, but not less than 12
times annually, on the premises of places of businesses referred to in
subparagraph (A)(i), and such an assignment remains in effect on a continuous
basis.</text>
</subparagraph></paragraph><paragraph id="ID6F644BF664D14E41B84436E3621BC361"><enum>(2)</enum><header>Marking of
compliant shipments</header><text>A registration condition is that the exporter
involved agrees to affix to each shipping container of qualifying drugs
exported under subsection (a) such markings as the Secretary determines to be
necessary to identify the shipment as being in compliance with all registration
conditions. Markings under the preceding sentence shall—</text>
<subparagraph id="ID6507BF0DF3B24F148266628270CF1617"><enum>(A)</enum><text>be designed to
prevent affixation of the markings to any shipping container that is not
authorized to bear the markings; and</text>
</subparagraph><subparagraph id="ID64D32AD92EA3404F8BBA4C1E44C025BD"><enum>(B)</enum><text>include
anticounterfeiting or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies.</text>
</subparagraph></paragraph><paragraph id="ID6E8E77BFDEB34381A209540B7592F3B1"><enum>(3)</enum><header>Certain duties
relating to exporters</header><text>Duties of the Secretary with respect to an
exporter include the following:</text>
<subparagraph id="ID6B85CAB01E9548C5A4138B9C1D9D4F84"><enum>(A)</enum><text>Inspecting,
randomly, but not less than 12 times annually, the places of business of the
exporter at which qualifying drugs are stored and from which qualifying drugs
are shipped.</text>
</subparagraph><subparagraph id="ID7210C98EB7DF47DB93E6DE6F3D629B94"><enum>(B)</enum><text>During the
inspections under subparagraph (A), verifying the chain of custody of a
statistically significant sample of qualifying drugs from the establishment in
which the drug was manufactured to the exporter, which shall be accomplished or
supplemented by the use of anticounterfeiting or track-and-trace technologies,
taking into account the economic and technical feasibility of those
technologies, except that a drug that lacks such technologies from the point of
manufacture shall not for that reason be excluded from importation by an
exporter.</text>
</subparagraph><subparagraph id="IDD86636B3486A43DBB9EF6003CF92EA2C"><enum>(C)</enum><text>Randomly
reviewing records of exports to individuals for the purpose of determining
whether the drugs are being imported by the individuals in accordance with the
conditions under subsection (i). Such reviews shall be conducted in a manner
that will result in a statistically significant determination of compliance
with all such conditions.</text>
</subparagraph><subparagraph id="ID539FE8C7CD3144F7BDAADA16A8F82EEC"><enum>(D)</enum><text>Monitoring the
affixing of markings under paragraph (2).</text>
</subparagraph><subparagraph id="ID593E5BE0ECBB4F4DA87BC46BB5CF1472"><enum>(E)</enum><text>Inspecting as the
Secretary determines is necessary the warehouses and other facilities,
including records, of other parties in the chain of custody of qualifying
drugs.</text>
</subparagraph><subparagraph id="ID8D6DE468E81748CBAE2FC53BDC3749E2"><enum>(F)</enum><text>Determining
whether the exporter is in compliance with all other registration
conditions.</text>
</subparagraph></paragraph><paragraph id="ID7705EBCBFAB9467D90F9CD7BEB9BEFE8"><enum>(4)</enum><header>Prior notice of
shipments</header><text>A registration condition is that, not less than 8 hours
and not more than 5 days in advance of the time of the importation of a
shipment of qualifying drugs, the importer involved agrees to submit to the
Secretary a notice with respect to the shipment of drugs to be imported or
offered for import into the United States under subsection (a). A notice under
the preceding sentence shall include—</text>
<subparagraph id="ID0A78C13F47844F278CA371696A788190"><enum>(A)</enum><text>the name and
complete contact information of the person submitting the notice;</text>
</subparagraph><subparagraph id="ID0C0D2052B47542AF9F3C6AC0CA287D93"><enum>(B)</enum><text>the name and
complete contact information of the importer involved;</text>
</subparagraph><subparagraph id="ID0EFA2723D17B417F858ABB9E64BB1C72"><enum>(C)</enum><text>the identity of
the drug, including the established name of the drug, the quantity of the drug,
and the lot number assigned by the manufacturer;</text>
</subparagraph><subparagraph id="ID1440C2C5672C44198AD12E9E929403E3"><enum>(D)</enum><text>the identity of
the manufacturer of the drug, including the identity of the establishment at
which the drug was manufactured;</text>
</subparagraph><subparagraph id="IDAEF00B3DB79940C3ADD210A501227943"><enum>(E)</enum><text>the country from
which the drug is shipped;</text>
</subparagraph><subparagraph id="ID793A31A99BDE42728F1159AABCD2E6E3"><enum>(F)</enum><text>the name and
complete contact information for the shipper of the drug;</text>
</subparagraph><subparagraph id="ID1841AE62183B4FFB8976F0F8DFB301D4"><enum>(G)</enum><text>anticipated
arrival information, including the port of arrival and crossing location within
that port, and the date and time;</text>
</subparagraph><subparagraph id="IDF5B8BF52E7CE4F408E4A5C8831964D1D"><enum>(H)</enum><text>a summary of the
chain of custody of the drug from the establishment in which the drug was
manufactured to the importer;</text>
</subparagraph><subparagraph id="ID7C0CFA0FCECB41978B829B30D798F4E5"><enum>(I)</enum><text>a declaration as
to whether the Secretary has ordered that importation of the drug from the
permitted country cease under subsection (g)(2)(C) or (D); and</text>
</subparagraph><subparagraph id="IDAA063C40EC8D49A88CB6943058CD3ED4"><enum>(J)</enum><text>such other
information as the Secretary may require by regulation.</text>
</subparagraph></paragraph><paragraph id="IDD625FBD2045F4527B83F4DC52FBB3B8F"><enum>(5)</enum><header>Marking of
compliant shipments</header><text>A registration condition is that the importer
involved agrees, before wholesale distribution (as defined in section 503(e))
of a qualifying drug that has been imported under subsection (a), to affix to
each container of such drug such markings or other technology as the Secretary
determines necessary to identify the shipment as being in compliance with all
registration conditions, except that the markings or other technology shall not
be required on a drug that bears comparable, compatible markings or technology
from the manufacturer of the drug. Markings or other technology under the
preceding sentence shall—</text>
<subparagraph id="IDF02B8B0B73D94171B09EC61B908ED7C3"><enum>(A)</enum><text>be designed to
prevent affixation of the markings or other technology to any container that is
not authorized to bear the markings; and</text>
</subparagraph><subparagraph id="ID038179724CCD48E4B73B06E3CACA5A8A"><enum>(B)</enum><text>shall include
anticounterfeiting or track-and-trace technologies, taking into account the
economic and technical feasibility of such technologies.</text>
</subparagraph></paragraph><paragraph id="IDEFF60D8A49804F41B002BC17EF1D5D35"><enum>(6)</enum><header>Certain duties
relating to importers</header><text>Duties of the Secretary with respect to an
importer include the following:</text>
<subparagraph id="ID458512CF6B674F6F97F36CF3CBD0603D"><enum>(A)</enum><text>Inspecting,
randomly, but not less than 12 times annually, the places of business of the
importer at which a qualifying drug is initially received after
importation.</text>
</subparagraph><subparagraph id="IDE5718A0C93AC4E0899FEA155B0235489"><enum>(B)</enum><text>During the
inspections under subparagraph (A), verifying the chain of custody of a
statistically significant sample of qualifying drugs from the establishment in
which the drug was manufactured to the importer, which shall be accomplished or
supplemented by the use of anticounterfeiting or track-and-trace technologies,
taking into account the economic and technical feasibility of those
technologies, except that a drug that lacks such technologies from the point of
manufacture shall not for that reason be excluded from importation by an
importer.</text>
</subparagraph><subparagraph id="ID3DE9E22F108C4331910D34A5F17FF0F7"><enum>(C)</enum><text>Reviewing notices
under paragraph (4).</text>
</subparagraph><subparagraph id="ID8D505DA584884CBB8F4D6749B4C92C41"><enum>(D)</enum><text>Inspecting as the
Secretary determines is necessary the warehouses and other facilities,
including records of other parties in the chain of custody of qualifying
drugs.</text>
</subparagraph><subparagraph id="ID5FA577FC2C6746B2AAB3FBDC4138284F"><enum>(E)</enum><text>Determining
whether the importer is in compliance with all other registration
conditions.</text>
</subparagraph></paragraph></subsection><subsection id="ID997C87182793416EAB3179B6BBB4F4A6"><enum>(e)</enum><header>Importer
fees</header>
<paragraph id="IDF3AF1A58A9AC4A8CB0DE0621D6C04D7F"><enum>(1)</enum><header>Registration
fee</header><text>A registration condition is that the importer involved pays
to the Secretary a fee of $10,000 due on the date on which the importer first
submits the registration to the Secretary under subsection (b).</text>
</paragraph><paragraph id="IDBEE7EBFBBFC3416C9123C5E54B052CE8"><enum>(2)</enum><header>Inspection
fee</header><text>A registration condition is that the importer involved pays a
fee to the Secretary in accordance with this subsection. Such fee shall be paid
not later than October 1 and April 1 of each fiscal year in the amount provided
for under paragraph (3).</text>
</paragraph><paragraph id="ID995318B86A7F42598A1B9E21E90E1C78"><enum>(3)</enum><header>Amount of
inspection fee</header>
<subparagraph id="ID0A8543A9A8D040ACAA68DC80E8254ACC"><enum>(A)</enum><header>Aggregate total
of fees</header><text>Not later than 30 days before the start of each fiscal
year, the Secretary, in consultation with the Secretary of Homeland Security
and the Secretary of the Treasury, shall establish an aggregate total of fees
to be collected under paragraph (2) for importers for that fiscal year that is
sufficient, and not more than necessary, to pay the costs for that fiscal year
of administering this section with respect to registered importers, including
the costs associated with—</text>
<clause id="IDFEE802E7101647339EB6C58AAA958FFA"><enum>(i)</enum><text>inspecting the
facilities of registered importers, and of other entities in the chain of
custody of a qualifying drug as necessary, under subsection (d)(6);</text>
</clause><clause id="IDF602388C898E4E249C213A87E52DBB52"><enum>(ii)</enum><text>developing,
implementing, and operating under such subsection an electronic system for
submission and review of the notices required under subsection (d)(4) with
respect to shipments of qualifying drugs under subsection (a) to assess
compliance with all registration conditions when such shipments are offered for
import into the United States; and</text>
</clause><clause id="ID0E7C09082F574B729B465AAD7D277754"><enum>(iii)</enum><text>inspecting such
shipments as necessary, when offered for import into the United States to
determine if such a shipment should be refused admission under subsection
(g)(5).</text>
</clause></subparagraph><subparagraph id="IDA8AC6917D25D4AA882FB1F18A7075975"><enum>(B)</enum><header>Limitation</header><text>Subject
to subparagraph (C), the aggregate total of fees collected under paragraph (2)
for a fiscal year shall not exceed 2.5 percent of the total price of qualifying
drugs imported during that fiscal year into the United States by registered
importers under subsection (a).</text>
</subparagraph><subparagraph id="ID6DCD360C31924A429D338868FCA8D669"><enum>(C)</enum><header>Total price of
drugs</header>
<clause id="IDC8FD30AD971348759EF1324BBF08C468"><enum>(i)</enum><header>Estimate</header><text>For
the purposes of complying with the limitation described in subparagraph (B)
when establishing under subparagraph (A) the aggregate total of fees to be
collected under paragraph (2) for a fiscal year, the Secretary shall estimate
the total price of qualifying drugs imported into the United States by
registered importers during that fiscal year by adding the total price of
qualifying drugs imported by each registered importer during the 6-month period
from January 1 through June 30 of the previous fiscal year, as reported to the
Secretary by each registered importer under subsection (b)(1)(J).</text>
</clause><clause id="IDBB9CFCC52DEF493B82214F75BA95BF46"><enum>(ii)</enum><header>Calculation</header><text>Not
later than March 1 of the fiscal year that follows the fiscal year for which
the estimate under clause (i) is made, the Secretary shall calculate the total
price of qualifying drugs imported into the United States by registered
importers during that fiscal year by adding the total price of qualifying drugs
imported by each registered importer during that fiscal year, as reported to
the Secretary by each registered importer under subsection (b)(1)(J).</text>
</clause><clause id="IDBCB2AE0977904F049FC794DA9C4D6413"><enum>(iii)</enum><header>Adjustment</header><text>If
the total price of qualifying drugs imported into the United States by
registered importers during a fiscal year as calculated under clause (ii) is
less than the aggregate total of fees collected under paragraph (2) for that
fiscal year, the Secretary shall provide for a pro-rata reduction in the fee
due from each registered importer on April 1 of the subsequent fiscal year so
that the limitation described in subparagraph (B) is observed.</text>
</clause></subparagraph><subparagraph id="ID2C446A18968A4EE09421815E08A1D0B1"><enum>(D)</enum><header>Individual
importer fee</header><text>Subject to the limitation described in subparagraph
(B), the fee under paragraph (2) to be paid on October 1 and April 1 by an
importer shall be an amount that is proportional to a reasonable estimate by
the Secretary of the semiannual share of the importer of the volume of
qualifying drugs imported by importers under subsection (a).</text>
</subparagraph></paragraph><paragraph id="IDC81FF58464F941A8BEFBE0F83978AE8D"><enum>(4)</enum><header>Use of
fees</header>
<subparagraph id="IDBE754EC830BA46CF8FFEE350032239E8"><enum>(A)</enum><header>In
general</header><text>Subject to appropriations Acts, fees collected by the
Secretary under paragraphs (1) and (2) shall be credited to the appropriation
account for salaries and expenses of the Food and Drug Administration until
expended (without fiscal year limitation), and the Secretary may, in
consultation with the Secretary of Homeland Security and the Secretary of the
Treasury, transfer some proportion of such fees to the appropriation account
for salaries and expenses of the Bureau of Customs and Border Protection until
expended (without fiscal year limitation).</text>
</subparagraph><subparagraph id="IDF65248550EDB4A6B8FFBCDA8A6800EE0"><enum>(B)</enum><header>Sole
purpose</header><text>Fees collected by the Secretary under paragraphs (1) and
(2) are only available to the Secretary and, if transferred, to the Secretary
of Homeland Security, and are for the sole purpose of paying the costs referred
to in paragraph (3)(A).</text>
</subparagraph></paragraph><paragraph id="ID860AC212830B482DB12B644E299E4361"><enum>(5)</enum><header>Collection of
fees</header><text>In any case where the Secretary does not receive payment of
a fee assessed under paragraph (1) or (2) within 30 days after it is due, such
fee shall be treated as a claim of the United States Government subject to
subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
</paragraph></subsection><subsection id="ID0786B1EF14994477B5413BBCAE9EAAB8"><enum>(f)</enum><header>Exporter
fees</header>
<paragraph id="ID767C26CC4A7E4925B8AA4473CA0D1740"><enum>(1)</enum><header>Registration
fee</header><text>A registration condition is that the exporter involved pays
to the Secretary a fee of $10,000 due on the date on which the exporter first
submits that registration to the Secretary under subsection (b).</text>
</paragraph><paragraph id="ID3905B8730136434BBFB7360483337AEB"><enum>(2)</enum><header>Inspection
fee</header><text>A registration condition is that the exporter involved pays a
fee to the Secretary in accordance with this subsection. Such fee shall be paid
not later than October 1 and April 1 of each fiscal year in the amount provided
for under paragraph (3).</text>
</paragraph><paragraph id="ID678767416B004C93A0939FD007EF9617"><enum>(3)</enum><header>Amount of
inspection fee</header>
<subparagraph id="ID5C6D335A50A64C0D9965C9921D18DFEB"><enum>(A)</enum><header>Aggregate total
of fees</header><text>Not later than 30 days before the start of each fiscal
year, the Secretary, in consultation with the Secretary of Homeland Security
and the Secretary of the Treasury, shall establish an aggregate total of fees
to be collected under paragraph (2) for exporters for that fiscal year that is
sufficient, and not more than necessary, to pay the costs for that fiscal year
of administering this section with respect to registered exporters, including
the costs associated with—</text>
<clause id="ID7857B7A7F7D840739714D5D65FE0051B"><enum>(i)</enum><text>inspecting the
facilities of registered exporters, and of other entities in the chain of
custody of a qualifying drug as necessary, under subsection (d)(3);</text>
</clause><clause id="ID10E2F1BE655A48B29F749529B36A9C06"><enum>(ii)</enum><text>developing,
implementing, and operating under such subsection a system to screen marks on
shipments of qualifying drugs under subsection (a) that indicate compliance
with all registration conditions, when such shipments are offered for import
into the United States; and</text>
</clause><clause id="IDB7D7001954BF4175B6565A1641C494D1"><enum>(iii)</enum><text>screening such
markings, and inspecting such shipments as necessary, when offered for import
into the United States to determine if such a shipment should be refused
admission under subsection (g)(5).</text>
</clause></subparagraph><subparagraph id="ID5DDAC6157FB44770ADFAFB10926A9E8C"><enum>(B)</enum><header>Limitation</header><text>Subject
to subparagraph (C), the aggregate total of fees collected under paragraph (2)
for a fiscal year shall not exceed 2.5 percent of the total price of qualifying
drugs imported during that fiscal year into the United States by registered
exporters under subsection (a).</text>
</subparagraph><subparagraph id="ID82666CF994884C90B9357308B420A533"><enum>(C)</enum><header>Total price of
drugs</header>
<clause id="ID4CE13ED2BF3741D7AC34CFF92AA67A61"><enum>(i)</enum><header>Estimate</header><text>For
the purposes of complying with the limitation described in subparagraph (B)
when establishing under subparagraph (A) the aggregate total of fees to be
collected under paragraph (2) for a fiscal year, the Secretary shall estimate
the total price of qualifying drugs imported into the United States by
registered exporters during that fiscal year by adding the total price of
qualifying drugs exported by each registered exporter during the 6-month period
from January 1 through June 30 of the previous fiscal year, as reported to the
Secretary by each registered exporter under subsection (b)(1)(I)(iv).</text>
</clause><clause id="IDC26A5D5C48A344FCB2B2A4BE7E0931CA"><enum>(ii)</enum><header>Calculation</header><text>Not
later than March 1 of the fiscal year that follows the fiscal year for which
the estimate under clause (i) is made, the Secretary shall calculate the total
price of qualifying drugs imported into the United States by registered
exporters during that fiscal year by adding the total price of qualifying drugs
exported by each registered exporter during that fiscal year, as reported to
the Secretary by each registered exporter under subsection
(b)(1)(I)(iv).</text>
</clause><clause id="ID3584D1977E704D6EA5C2A96E928B9DBF"><enum>(iii)</enum><header>Adjustment</header><text>If
the total price of qualifying drugs imported into the United States by
registered exporters during a fiscal year as calculated under clause (ii) is
less than the aggregate total of fees collected under paragraph (2) for that
fiscal year, the Secretary shall provide for a pro-rata reduction in the fee
due from each registered exporter on April 1 of the subsequent fiscal year so
that the limitation described in subparagraph (B) is observed.</text>
</clause></subparagraph><subparagraph id="IDC45DF0D815834A019E686FFA483F565C"><enum>(D)</enum><header>Individual
exporter fee</header><text>Subject to the limitation described in subparagraph
(B), the fee under paragraph (2) to be paid on October 1 and April 1 by an
exporter shall be an amount that is proportional to a reasonable estimate by
the Secretary of the semiannual share of the exporter of the volume of
qualifying drugs exported by exporters under subsection (a).</text>
</subparagraph></paragraph><paragraph id="IDF4FAD563095A40DBB0C4C209909228AF"><enum>(4)</enum><header>Use of
fees</header>
<subparagraph id="ID729A24E666384C8980B652A866208802"><enum>(A)</enum><header>In
general</header><text>Subject to appropriations Acts, fees collected by the
Secretary under paragraphs (1) and (2) shall be credited to the appropriation
account for salaries and expenses of the Food and Drug Administration until
expended (without fiscal year limitation), and the Secretary may, in
consultation with the Secretary of Homeland Security and the Secretary of the
Treasury, transfer some proportion of such fees to the appropriation account
for salaries and expenses of the Bureau of Customs and Border Protection until
expended (without fiscal year limitation).</text>
</subparagraph><subparagraph id="ID77A345ADF32C4B9EAC8751A0FE747CA4"><enum>(B)</enum><header>Sole
purpose</header><text>Fees collected by the Secretary under paragraphs (1) and
(2) are only available to the Secretary and, if transferred, to the Secretary
of Homeland Security, and are for the sole purpose of paying the costs referred
to in paragraph (3)(A).</text>
</subparagraph></paragraph><paragraph id="IDD6A63CE1A9D04E75B99D0EAD52D9E8B8"><enum>(5)</enum><header>Collection of
fees</header><text>In any case where the Secretary does not receive payment of
a fee assessed under paragraph (1) or (2) within 30 days after it is due, such
fee shall be treated as a claim of the United States Government subject to
subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
</paragraph></subsection><subsection id="ID4B01F0B6133B4FD9A9049AC5C985F282"><enum>(g)</enum><header>Compliance with
Section <enum-in-header>801(a)</enum-in-header></header>
<paragraph id="IDEB89B825C9E949F680B8564B16AFFAF3"><enum>(1)</enum><header>In
general</header><text>A registration condition is that each qualifying drug
exported under subsection (a) by the registered exporter involved or imported
under subsection (a) by the registered importer involved is in compliance with
the standards referred to in section 801(a) regarding admission of the drug
into the United States, subject to paragraphs (2), (3), and (4).</text>
</paragraph><paragraph id="ID71975237FC234658B7EC0591B957846C"><enum>(2)</enum><header>Section
<enum-in-header>505</enum-in-header>; approval status</header>
<subparagraph id="ID2B9CE27998CB4A9FA6CB792DF36CA75A"><enum>(A)</enum><header>In
general</header><text>A qualifying drug that is imported or offered for import
under subsection (a) shall comply with the conditions established in the
approved application under section 505(b) for the U.S. label drug as described
under this subsection.</text>
</subparagraph><subparagraph id="ID7ED196AAE245487098C8D144B4EE4EA0"><enum>(B)</enum><header>Notice by
manufacturer; general provisions</header>
<clause id="IDD1910B654A174288AEA28ED4440AF3AF"><enum>(i)</enum><header>In
general</header><text>The person that manufactures a qualifying drug that is,
or will be, introduced for commercial distribution in a permitted country shall
in accordance with this paragraph submit to the Secretary a notice that—</text>
<subclause id="IDDE0738D7576548F98EA191E81AB8FE42"><enum>(I)</enum><text>includes each
difference in the qualifying drug from a condition established in the approved
application for the U.S. label drug beyond—</text>
<item id="IDD2B776D833FB4D3BAAFA997C2EA5FF7B"><enum>(aa)</enum><text>the variations
provided for in the application; and</text>
</item><item id="ID54ADA72D867E49B1BC7CE38BEA2EF21D"><enum>(bb)</enum><text>any difference
in labeling (except ingredient labeling); or</text>
</item></subclause><subclause id="IDA2DF23B0F525484A818D7D223EA5200D"><enum>(II)</enum><text>states that
there is no difference in the qualifying drug from a condition established in
the approved application for the U.S. label drug beyond—</text>
<item id="IDAF28774A9A1A47AA9ABDE3BD74F08420"><enum>(aa)</enum><text>the variations
provided for in the application; and</text>
</item><item id="IDC32CEFCFD91640F7A4E7156B91AE1235"><enum>(bb)</enum><text>any difference
in labeling (except ingredient labeling).</text>
</item></subclause></clause><clause id="IDDB1EDB0A7DBF4343BDC456CF6FD247A9"><enum>(ii)</enum><header>Information in
notice</header><text>A notice under clause (i)(I) shall include the information
that the Secretary may require under section 506A, any additional information
the Secretary may require (which may include data on bioequivalence if such
data are not required under section 506A), and, with respect to the permitted
country that approved the qualifying drug for commercial distribution, or with
respect to which such approval is sought, include the following:</text>
<subclause id="IDA8F4215AA87446AFA021531C34FA44A5"><enum>(I)</enum><text>The date on which
the qualifying drug with such difference was, or will be, introduced for
commercial distribution in the permitted country.</text>
</subclause><subclause id="IDC8902493E4A44453B498F15F8EFE5A85"><enum>(II)</enum><text>Information
demonstrating that the person submitting the notice has also notified the
government of the permitted country in writing that the person is submitting to
the Secretary a notice under clause (i)(I), which notice describes the
difference in the qualifying drug from a condition established in the approved
application for the U.S. label drug.</text>
</subclause><subclause id="IDB359B9FCEB93439E980A9E274774E037"><enum>(III)</enum><text>The information
that the person submitted or will submit to the government of the permitted
country for purposes of obtaining approval for commercial distribution of the
drug in the country which, if in a language other than English, shall be
accompanied by an English translation verified to be complete and accurate,
with the name, address, and a brief statement of the qualifications of the
person that made the translation.</text>
</subclause></clause><clause id="IDA0F7658E98444A26A9433F9B8E02E0E1"><enum>(iii)</enum><header>Certifications</header><text>The
chief executive officer and the chief medical officer of the manufacturer
involved shall each certify in the notice under clause (i) that—</text>
<subclause id="ID64D4B0BADA204706856E68CF6A830E17"><enum>(I)</enum><text>the information
provided in the notice is complete and true; and</text>
</subclause><subclause id="IDD4E573E542B74222AF43A733315559BA"><enum>(II)</enum><text>a copy of the
notice has been provided to the Federal Trade Commission and to the State
attorneys general.</text>
</subclause></clause><clause id="ID670E778EF21D4D90AF1872FB40415EBE"><enum>(iv)</enum><header>Fee</header><text>If
a notice submitted under clause (i) includes a difference that would, under
section 506A, require the submission of a supplemental application if made as a
change to the U.S. label drug, the person that submits the notice shall pay to
the Secretary a fee in the same amount as would apply if the person were paying
a fee pursuant to section 736(a)(1)(A)(ii). Subject to appropriations Acts,
fees collected by the Secretary under the preceding sentence are available only
to the Secretary and are for the sole purpose of paying the costs of reviewing
notices submitted under clause (i).</text>
</clause><clause id="ID48FDF50CCA374BF9B0BDB0055566DAC4"><enum>(v)</enum><header>Timing of
submission of notices</header>
<subclause id="ID13B0F03898294D27922DAAB3F687297B"><enum>(I)</enum><header>Prior approval
notices</header><text>A notice under clause (i) to which subparagraph (C)
applies shall be submitted to the Secretary not later than 120 days before the
qualifying drug with the difference is introduced for commercial distribution
in a permitted country, unless the country requires that distribution of the
qualifying drug with the difference begin less than 120 days after the country
requires the difference.</text>
</subclause><subclause id="ID6BD2516C15114BD692DA807ED4692021"><enum>(II)</enum><header>Other approval
notices</header><text>A notice under clause (i) to which subparagraph (D)
applies shall be submitted to the Secretary not later than the day on which the
qualifying drug with the difference is introduced for commercial distribution
in a permitted country.</text>
</subclause><subclause id="IDC24668F2D85140509BC15B94545AD775"><enum>(III)</enum><header>Other
notices</header><text>A notice under clause (i) to which subparagraph (E)
applies shall be submitted to the Secretary on the date that the qualifying
drug is first introduced for commercial distribution in a permitted country and
annually thereafter.</text>
</subclause></clause><clause id="ID74FD1F83A56F4E529C08BE537D9BDFB0"><enum>(vi)</enum><header>Review by
Secretary</header>
<subclause id="ID9B9CE452560646E590E986E250FFDE12"><enum>(I)</enum><header>In
general</header><text>In this paragraph, the difference in a qualifying drug
that is submitted in a notice under clause (i) from the U.S. label drug shall
be treated by the Secretary as if it were a manufacturing change to the U.S.
label drug under section 506A.</text>
</subclause><subclause id="IDB2843EED62B247F283D53189DBB16EB9"><enum>(II)</enum><header>Standard of
review</header><text>Except as provided in subclause (III), the Secretary shall
review and approve or disapprove the difference in a notice submitted under
clause (i), if required under section 506A, using the safe and effective
standard for approving or disapproving a manufacturing change under section
506A.</text>
</subclause><subclause id="ID627FE5B2604F42A8AED0F7693FADAF35"><enum>(III)</enum><header>Bioequivalence</header><text>If
the Secretary would approve the difference in a notice submitted under clause
(i) using the safe and effective standard under section 506A and if the
Secretary determines that the qualifying drug is not bioequivalent to the U.S.
label drug, the Secretary shall—</text>
<item id="IDC56BAEC220A148C89B48669714459AD6"><enum>(aa)</enum><text>include in the
labeling provided under paragraph (3) a prominent advisory that the qualifying
drug is safe and effective but is not bioequivalent to the U.S. label drug if
the Secretary determines that such an advisory is necessary for health care
practitioners and patients to use the qualifying drug safely and effectively;
or</text>
</item><item id="ID348296E252DD403EBDBBB185B2B98699"><enum>(bb)</enum><text>decline to
approve the difference if the Secretary determines that the availability of
both the qualifying drug and the U.S. label drug would pose a threat to the
public health.</text>
</item></subclause><subclause id="ID62E52D3C501B44F785B9572641C2CE6D"><enum>(IV)</enum><header>Review by the
Secretary</header><text>The Secretary shall review and approve or disapprove
the difference in a notice submitted under clause (i), if required under
section 506A, not later than 120 days after the date on which the notice is
submitted.</text>
</subclause><subclause id="ID90E0056566264282A05DEF9953F5C2D7"><enum>(V)</enum><header>Establishment
inspection</header><text>If review of such difference would require an
inspection of the establishment in which the qualifying drug is
manufactured—</text>
<item id="ID38770BAE9E3B4226BB3938CF8654538A"><enum>(aa)</enum><text>such inspection
by the Secretary shall be authorized; and</text>
</item><item id="IDF7A2CFBFA8A14015BD60FF3A70DCA230"><enum>(bb)</enum><text>the Secretary
may rely on a satisfactory report of a good manufacturing practice inspection
of the establishment from a permitted country whose regulatory system the
Secretary recognizes as equivalent under a mutual recognition agreement, as
provided under section 510(i)(3), section 803, or part 26 of title 21, Code of
Federal Regulations (or any corresponding successor rule or regulation).</text>
</item></subclause></clause><clause id="ID646653EA1A7B409293D0D0955DA18D21"><enum>(vii)</enum><header>Publication
of information on notices</header>
<subclause id="ID2100A5EB0A4D4840A1636F28E59F6DD7"><enum>(I)</enum><header>In
general</header><text>Through the Internet website of the Food and Drug
Administration and a toll-free telephone number, the Secretary shall readily
make available to the public a list of notices submitted under clause
(i).</text>
</subclause><subclause id="IDFE61E463AD834A058226BC37D779B80A"><enum>(II)</enum><header>Contents</header><text>The
list under subclause (I) shall include the date on which a notice is submitted
and whether—</text>
<item id="IDD6D4AF41901649E8A950E2C67BCA994B"><enum>(aa)</enum><text>a
notice is under review;</text>
</item><item id="ID5C72435E29A043CD8C8275BB90D7B0C5"><enum>(bb)</enum><text>the Secretary
has ordered that importation of the qualifying drug from a permitted country
cease; or</text>
</item><item id="ID7EF7F5B5D11B4D66B60760DE8DACDA97"><enum>(cc)</enum><text>the importation
of the drug is permitted under subsection (a).</text>
</item></subclause><subclause id="ID190EA990B4F24A20A42FDD7E36E7CF0D"><enum>(III)</enum><header>Update</header><text>The
Secretary shall promptly update the Internet website with any changes to the
list.</text>
</subclause></clause></subparagraph><subparagraph id="ID5AE492B48E2E4AC78D827E8E2161B073"><enum>(C)</enum><header>Notice; drug
difference requiring prior approval</header><text>In the case of a notice under
subparagraph (B)(i) that includes a difference that would, under section
506A(c) or (d)(3)(B)(i), require the approval of a supplemental application
before the difference could be made to the U.S. label drug the following shall
occur:</text>
<clause id="IDC50AE691ABB8474291DB25D283CA20C2"><enum>(i)</enum><text>Promptly after
the notice is submitted, the Secretary shall notify registered exporters,
registered importers, the Federal Trade Commission, and the State attorneys
general that the notice has been submitted with respect to the qualifying drug
involved.</text>
</clause><clause id="ID9F5D28B5AB714190B9A208F9AFC1571D"><enum>(ii)</enum><text>If the Secretary
has not made a determination whether such a supplemental application regarding
the U.S. label drug would be approved or disapproved by the date on which the
qualifying drug involved is to be introduced for commercial distribution in a
permitted country, the Secretary shall—</text>
<subclause id="IDC075E61F59834A63BCBA1E58574D2FDA"><enum>(I)</enum><text>order that the
importation of the qualifying drug involved from the permitted country not
begin until the Secretary completes review of the notice; and</text>
</subclause><subclause id="ID5C1BBE681640411284A7168A8CB2488A"><enum>(II)</enum><text>promptly notify
registered exporters, registered importers, the Federal Trade Commission, and
the State attorneys general of the order.</text>
</subclause></clause><clause id="IDCBBBEB571604425195756F17FD6E49E9"><enum>(iii)</enum><text>If the
Secretary determines that such a supplemental application regarding the U.S.
label drug would not be approved, the Secretary shall—</text>
<subclause id="ID5105D525C60C49AF8C7AC6E6CF920173"><enum>(I)</enum><text>order that the
importation of the qualifying drug involved from the permitted country cease,
or provide that an order under clause (ii), if any, remains in effect;</text>
</subclause><subclause id="ID8DA5CE99DC9C4CEBB1DC13B55620632A"><enum>(II)</enum><text>notify the
permitted country that approved the qualifying drug for commercial distribution
of the determination; and</text>
</subclause><subclause id="IDA47F8E1EEBEA4E4C89E664C718269CED"><enum>(III)</enum><text>promptly notify
registered exporters, registered importers, the Federal Trade Commission, and
the State attorneys general of the determination.</text>
</subclause></clause><clause id="IDF3DDB8D4AD5944B78D58B199BC4B34A0"><enum>(iv)</enum><text>If the Secretary
determines that such a supplemental application regarding the U.S. label drug
would be approved, the Secretary shall—</text>
<subclause id="IDD339AEB4359D4A1B9B59EE8C8D8561A4"><enum>(I)</enum><text>vacate the order
under clause (ii), if any;</text>
</subclause><subclause id="ID8A4F2D2194EC434CBE7CF084C2A73195"><enum>(II)</enum><text>consider the
difference to be a variation provided for in the approved application for the
U.S. label drug;</text>
</subclause><subclause id="ID3F7F474806D34FAC8510AFE7A3E7DA25"><enum>(III)</enum><text>permit
importation of the qualifying drug under subsection (a); and</text>
</subclause><subclause id="ID1DC50E8F10C44798B61C2861A83F0474"><enum>(IV)</enum><text>promptly notify
registered exporters, registered importers, the Federal Trade Commission, and
the State attorneys general of the determination.</text>
</subclause></clause></subparagraph><subparagraph id="ID9BFE4E6384DA4BE1B3489CE98754F040"><enum>(D)</enum><header>Notice; drug
difference not requiring prior approval</header><text>In the case of a notice
under subparagraph (B)(i) that includes a difference that would, under section
506A(d)(3)(B)(ii), not require the approval of a supplemental application
before the difference could be made to the U.S. label drug the following shall
occur:</text>
<clause id="IDFE2833DDBFA24C9EB380BA81047CC0DA"><enum>(i)</enum><text>During the period
in which the notice is being reviewed by the Secretary, the authority under
this subsection to import the qualifying drug involved continues in
effect.</text>
</clause><clause id="ID14FFB0C3CE5848EDB0AAE5180FA11BF8"><enum>(ii)</enum><text>If the Secretary
determines that such a supplemental application regarding the U.S. label drug
would not be approved, the Secretary shall—</text>
<subclause id="ID1EFE1D2582FE4631AA0926A2E533FB92"><enum>(I)</enum><text>order that the
importation of the qualifying drug involved from the permitted country
cease;</text>
</subclause><subclause id="IDD6DCFD02F70547C78159648005B223EB"><enum>(II)</enum><text>notify the
permitted country that approved the qualifying drug for commercial distribution
of the determination; and</text>
</subclause><subclause id="ID8719373C714C4539930D96FE77C4A2B0"><enum>(III)</enum><text>promptly notify
registered exporters, registered importers, the Federal Trade Commission, and
the State attorneys general of the determination.</text>
</subclause></clause><clause id="IDA11E5673FDBF4D2B96F10B1A84142777"><enum>(iii)</enum><text>If the
Secretary determines that such a supplemental application regarding the U.S.
label drug would be approved, the difference shall be considered to be a
variation provided for in the approved application for the U.S. label
drug.</text>
</clause></subparagraph><subparagraph id="IDBC3092283D244765A3B20EDD8999E015"><enum>(E)</enum><header>Notice; drug
difference not requiring approval; no difference</header><text>In the case of a
notice under subparagraph (B)(i) that includes a difference for which, under
section 506A(d)(1)(A), a supplemental application would not be required for the
difference to be made to the U.S. label drug, or that states that there is no
difference, the Secretary—</text>
<clause id="ID9A4A097FC7F34ACE832492837A022F76"><enum>(i)</enum><text>shall consider
such difference to be a variation provided for in the approved application for
the U.S. label drug;</text>
</clause><clause id="IDBBB56D14505A47579FADF571A81DF5A2"><enum>(ii)</enum><text>may not order
that the importation of the qualifying drug involved cease; and</text>
</clause><clause id="ID852D386BD3F342D4ADF8B7B0DD201CBA"><enum>(iii)</enum><text>shall promptly
notify registered exporters and registered importers.</text>
</clause></subparagraph><subparagraph id="ID4F8DE68A8BBD45EA81A15A57CEB7661A"><enum>(F)</enum><header>Differences in
active ingredient, route of administration, dosage form, or strength</header>
<clause id="IDB5870115C87B40FABA6C3F10290BB262"><enum>(i)</enum><header>In
general</header><text>A person who manufactures a drug approved under section
505(b) shall submit an application under section 505(b) for approval of another
drug that is manufactured for distribution in a permitted country by or for the
person that manufactures the drug approved under section 505(b) if—</text>
<subclause id="ID82341C169FBF4E569AC2DF45B4162679"><enum>(I)</enum><text>there is no
qualifying drug in commercial distribution in permitted countries whose
combined population represents at least 50 percent of the total population of
all permitted countries with the same active ingredient or ingredients, route
of administration, dosage form, and strength as the drug approved under section
505(b); and</text>
</subclause><subclause id="ID14B4647439B84D988C6D413315FECBC2"><enum>(II)</enum><text>each active
ingredient of the other drug is related to an active ingredient of the drug
approved under section 505(b), as defined in clause (v).</text>
</subclause></clause><clause id="ID6E0262940A27423EB3A26F63522BF924"><enum>(ii)</enum><header>Application
under Section <enum-in-header>505(b)</enum-in-header></header><text>The
application under section 505(b) required under clause (i) shall—</text>
<subclause id="IDE4BB0F69B77F4CE49EBC0F79C40C4AD7"><enum>(I)</enum><text>request approval
of the other drug for the indication or indications for which the drug approved
under section 505(b) is labeled;</text>
</subclause><subclause id="IDB62D9B34F96540059CFBD6C5E08B8BAB"><enum>(II)</enum><text>include the
information that the person submitted to the government of the permitted
country for purposes of obtaining approval for commercial distribution of the
other drug in that country, which if in a language other than English, shall be
accompanied by an English translation verified to be complete and accurate,
with the name, address, and a brief statement of the qualifications of the
person that made the translation;</text>
</subclause><subclause id="ID7635E1B2E24248A8852AD700862D236C"><enum>(III)</enum><text>include a right
of reference to the application for the drug approved under section 505(b);
and</text>
</subclause><subclause id="IDBD76D607BE914FEDAD0FE034FF8D90BA"><enum>(IV)</enum><text>include such
additional information as the Secretary may require.</text>
</subclause></clause><clause id="ID95622C3AAB6646E587BEE3E856486035"><enum>(iii)</enum><header>Timing of
submission of application</header><text>An application under section 505(b)
required under clause (i) shall be submitted to the Secretary not later than
the day on which the information referred to in clause (ii)(II) is submitted to
the government of the permitted country.</text>
</clause><clause id="ID41E2BCF3CC1A4EBCB0E073D9F230522A"><enum>(iv)</enum><header>Notice of
decision on application</header><text>The Secretary shall promptly notify
registered exporters, registered importers, the Federal Trade Commission, and
the State attorneys general of a determination to approve or to disapprove an
application under section 505(b) required under clause (i).</text>
</clause><clause id="ID15FFA49487594572BECF80ED389FFE5C"><enum>(v)</enum><header>Related active
ingredients</header><text>For purposes of clause (i)(II), 2 active ingredients
are related if they are—</text>
<subclause id="IDC732886DF5B2480385A96330801F3647"><enum>(I)</enum><text>the same;
or</text>
</subclause><subclause id="IDA32F64090F9646FCAFE5D26E541D3322"><enum>(II)</enum><text>different salts,
esters, or complexes of the same moiety.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="IDAF699952774247BEAAA31973C6CC41EB"><enum>(3)</enum><header>Section 502;
labeling</header>
<subparagraph id="ID0FDBF00F89D74B8C86E92BAB5A3D6854"><enum>(A)</enum><header>Importation by
registered importer</header>
<clause id="ID3F0FA1D90FE34D6C90CD96EAE5B6EBBB"><enum>(i)</enum><header>In
general</header><text>In the case of a qualifying drug that is imported or
offered for import by a registered importer, such drug shall be considered to
be in compliance with section 502 and the labeling requirements under the
approved application for the U.S. label drug if the qualifying drug
bears—</text>
<subclause id="ID6039A0BBF4F74AC8BBB55CB48DAC8706"><enum>(I)</enum><text>a copy of the
labeling approved for the U.S. label drug under section 505, without regard to
whether the copy bears any trademark involved;</text>
</subclause><subclause id="IDED528DB9750C4A30A2428974865B9C4C"><enum>(II)</enum><text>the name of the
manufacturer and location of the manufacturer;</text>
</subclause><subclause id="ID601AE86D14E14F438B59AE42AAAAC747"><enum>(III)</enum><text>the lot number
assigned by the manufacturer;</text>
</subclause><subclause id="IDF8A92A8D64FF47AEB81253776CE0CA83"><enum>(IV)</enum><text>the name,
location, and registration number of the importer; and</text>
</subclause><subclause id="ID6451FF62C61D44E9A7977C83DEB23B70"><enum>(V)</enum><text>the National Drug
Code number assigned to the qualifying drug by the Secretary.</text>
</subclause></clause><clause id="ID25CB57E07F5041D79F03B867E267F207"><enum>(ii)</enum><header>Request for
copy of the labeling</header><text>The Secretary shall provide such copy to the
registered importer involved, upon request of the importer.</text>
</clause><clause id="ID8DB38A1162B345219DB5D451A827FCCF"><enum>(iii)</enum><header>Requested
labeling</header><text>The labeling provided by the Secretary under clause (ii)
shall—</text>
<subclause id="ID3CEA7DB6B0E84BABA14F1F99EF7514BF"><enum>(I)</enum><text>include the
established name, as defined in section 502(e)(3), for each active ingredient
in the qualifying drug;</text>
</subclause><subclause id="ID86D14056889342BE9851032621040505"><enum>(II)</enum><text>not include the
proprietary name of the U.S. label drug or any active ingredient
thereof;</text>
</subclause><subclause id="ID17CAF0AE62C446A6822F4BEBAE6720B6"><enum>(III)</enum><text>if required
under paragraph (2)(B)(vi)(III), a prominent advisory that the qualifying drug
is safe and effective but not bioequivalent to the U.S. label drug; and</text>
</subclause><subclause id="ID393580A9468B4092BCE0145440593BC4"><enum>(IV)</enum><text>if the inactive
ingredients of the qualifying drug are different from the inactive ingredients
for the U.S. label drug, include—</text>
<item id="IDD6A06A42EC6740D2A3145BBE1B82576F"><enum>(aa)</enum><text>a
prominent notice that the ingredients of the qualifying drug differ from the
ingredients of the U.S. label drug and that the qualifying drug must be
dispensed with an advisory to people with allergies about this difference and a
list of ingredients; and</text>
</item><item id="IDA1C31699099943879AE1D99F15FCC095"><enum>(bb)</enum><text>a
list of the ingredients of the qualifying drug as would be required under
section 502(e).</text>
</item></subclause></clause></subparagraph><subparagraph id="ID39036F5D2F584539BBF43534800444D5"><enum>(B)</enum><header>Importation by
individual</header>
<clause id="IDC2801F2D1CCF44D2A8F1654789081C5F"><enum>(i)</enum><header>In
general</header><text>In the case of a qualifying drug that is imported or
offered for import by a registered exporter to an individual, such drug shall
be considered to be in compliance with section 502 and the labeling
requirements under the approved application for the U.S. label drug if the
packaging and labeling of the qualifying drug complies with all applicable
regulations promulgated under sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (<external-xref legal-doc="usc" parsable-cite="usc/15/1471">15 U.S.C. 1471 et seq.</external-xref>) and the labeling of the
qualifying drug includes—</text>
<subclause id="ID6770405009E54834A6304149571236DB"><enum>(I)</enum><text>directions for
use by the consumer;</text>
</subclause><subclause id="IDD0DC07D368E34DE8B33831281F25C2B9"><enum>(II)</enum><text>the lot number
assigned by the manufacturer;</text>
</subclause><subclause id="ID96756545D8F64ADDA2BBEEF73E17208C"><enum>(III)</enum><text>the name and
registration number of the exporter;</text>
</subclause><subclause id="ID99149BCB2567482590FD9E89E31F4477"><enum>(IV)</enum><text>if required
under paragraph (2)(B)(vi)(III), a prominent advisory that the drug is safe and
effective but not bioequivalent to the U.S. label drug;</text>
</subclause><subclause id="ID4DA12763CCA24E3A8D2F074DE8ED86EE"><enum>(V)</enum><text>if the inactive
ingredients of the drug are different from the inactive ingredients for the
U.S. label drug—</text>
<item id="IDF7615B4281A44B1C9B88C8BF46E9F412"><enum>(aa)</enum><text>a
prominent advisory that persons with an allergy should check the ingredient
list of the drug because the ingredients of the drug differ from the
ingredients of the U.S. label drug; and</text>
</item><item id="ID3F2ACEA680D24DEA8BC008DB97AF75F0"><enum>(bb)</enum><text>a
list of the ingredients of the drug as would be required under section 502(e);
and</text>
</item></subclause><subclause id="ID402D04C1801C47BEB3EA0FFE494424A1"><enum>(VI)</enum><text>a copy of any
special labeling that would be required by the Secretary had the U.S. label
drug been dispensed by a pharmacist in the United States, without regard to
whether the special labeling bears any trademark involved.</text>
</subclause></clause><clause id="id83CD825CBA3E40449EB7F8F91E1C2541"><enum>(ii)</enum><header>Packaging</header><text>A
qualifying drug offered for import to an individual by an exporter under this
section that is packaged in a unit-of-use container (as those items are defined
in the United States Pharmacopeia and National Formulary) shall not be
repackaged, provided that—</text>
<subclause id="idCECAF43D34A2434297046FC7C91D9C1F"><enum>(I)</enum><text>the packaging
complies with all applicable regulations under sections 3 and 4 of the Poison
Prevention Packaging Act of 1970 (<external-xref legal-doc="usc" parsable-cite="usc/15/1471">15 U.S.C. 1471 et seq.</external-xref>); or</text>
</subclause><subclause id="id3CD9BE683DEB40EFBA827F66C8DE69C8"><enum>(II)</enum><text>the consumer
consents to waive the requirements of such Act, after being informed that the
packaging does not comply with such Act and that the exporter will provide the
drug in packaging that is compliant at no additional cost.</text>
</subclause></clause><clause id="ID45BBE2A6BC3A4D11B5DA86744F79EBBC"><enum>(iii)</enum><header>Request for
copy of special labeling and ingredient list</header><text>The Secretary shall
provide to the registered exporter involved a copy of the special labeling, the
advisory, and the ingredient list described under clause (i), upon request of
the exporter.</text>
</clause><clause id="ID8AD60E1DD8BE4C1F85AC67ED418F7BA6"><enum>(iv)</enum><header>Requested
labeling and ingredient list</header><text>The labeling and ingredient list
provided by the Secretary under clause (iii) shall—</text>
<subclause id="ID748994FF6701464D92CFE8E6EC665551"><enum>(I)</enum><text>include the
established name, as defined in section 502(e)(3), for each active ingredient
in the drug; and</text>
</subclause><subclause id="ID90DF311B5C4043E3A7DF977154B57A6D"><enum>(II)</enum><text>not include the
proprietary name of the U.S. label drug or any active ingredient
thereof.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="ID4E8D43110F5C401B90DFB7FE435E6D99"><enum>(4)</enum><header>Section 501;
adulteration</header><text>A qualifying drug that is imported or offered for
import under subsection (a) shall be considered to be in compliance with
section 501 if the drug is in compliance with subsection (c).</text>
</paragraph><paragraph id="IDE9F3A61F1A1B472387D564E13E377FD9"><enum>(5)</enum><header>Standards for
refusing admission</header><text>A drug exported under subsection (a) from a
registered exporter or imported by a registered importer may be refused
admission into the United States if 1 or more of the following applies:</text>
<subparagraph id="ID3F5ED036D53140FA94B65EE999EC67B5"><enum>(A)</enum><text>The drug is not a
qualifying drug.</text>
</subparagraph><subparagraph id="IDB337968453FB41FDA7C3BA85ED53440D"><enum>(B)</enum><text>A notice for the
drug required under paragraph (2)(B) has not been submitted to the
Secretary.</text>
</subparagraph><subparagraph id="ID9A44DE3B87ED4534A5CC8DA6C35B4300"><enum>(C)</enum><text>The Secretary has
ordered that importation of the drug from the permitted country cease under
paragraph (2) (C) or (D).</text>
</subparagraph><subparagraph id="IDEB55EC812D1145EC87883A8D5FABB444"><enum>(D)</enum><text>The drug does not
comply with paragraph (3) or (4).</text>
</subparagraph><subparagraph id="IDF5D938A7BF3545BA8A48CBE4640A1159"><enum>(E)</enum><text>The shipping
container appears damaged in a way that may affect the strength, quality, or
purity of the drug.</text>
</subparagraph><subparagraph id="IDFE69C81BF6CD4DF5A48BF5F65E2FF9E7"><enum>(F)</enum><text>The Secretary
becomes aware that—</text>
<clause id="ID8480697E986E4AC1967992BF6B76355A"><enum>(i)</enum><text>the drug may be
counterfeit;</text>
</clause><clause id="IDFF9C3BD2E82842D4BD26FCD853046B07"><enum>(ii)</enum><text>the drug may
have been prepared, packed, or held under insanitary conditions; or</text>
</clause><clause id="ID1689C0944ED7404499DB31D03F1DB0BF"><enum>(iii)</enum><text>the methods
used in, or the facilities or controls used for, the manufacturing, processing,
packing, or holding of the drug do not conform to good manufacturing
practice.</text>
</clause></subparagraph><subparagraph id="ID5F10B866F279436591C0B82A17969ED1"><enum>(G)</enum><text>The Secretary has
obtained an injunction under section 302 that prohibits the distribution of the
drug in interstate commerce.</text>
</subparagraph><subparagraph id="ID8F7BD432EB8A46B0812C45999AC82D98"><enum>(H)</enum><text>The Secretary has
under section 505(e) withdrawn approval of the drug.</text>
</subparagraph><subparagraph id="IDD2561153CF984870A8C68EF80EF77AFB"><enum>(I)</enum><text>The manufacturer
of the drug has instituted a recall of the drug.</text>
</subparagraph><subparagraph id="IDEF2380120FE244E5AFEA0AA75FD399CB"><enum>(J)</enum><text>If the drug is
imported or offered for import by a registered importer without submission of a
notice in accordance with subsection (d)(4).</text>
</subparagraph><subparagraph id="ID7736510443F846F387C0B85575817D2E"><enum>(K)</enum><text>If the drug is
imported or offered for import from a registered exporter to an individual and
1 or more of the following applies:</text>
<clause id="IDF025BF2CFF6B4D32B43513B7F2531E59"><enum>(i)</enum><text>The shipping
container for such drug does not bear the markings required under subsection
(d)(2).</text>
</clause><clause id="ID1172931698034F098B5B5AD5E6CAE820"><enum>(ii)</enum><text>The markings on
the shipping container appear to be counterfeit.</text>
</clause><clause id="IDDFA6441B35544C6CB65364604A468D54"><enum>(iii)</enum><text>The shipping
container or markings appear to have been tampered with.</text>
</clause></subparagraph></paragraph></subsection><subsection id="ID706620D78CCA45D7AD81759177D48D31"><enum>(h)</enum><header>Exporter
licensure in permitted country</header><text>A registration condition is that
the exporter involved agrees that a qualifying drug will be exported to an
individual only if the Secretary has verified that—</text>
<paragraph id="ID278203F6729B45A281CD8250759E026F"><enum>(1)</enum><text>the exporter is
authorized under the law of the permitted country in which the exporter is
located to dispense prescription drugs; and</text>
</paragraph><paragraph id="ID7FA007CE7F534E5FBBDF8C88D6758F0B"><enum>(2)</enum><text>the exporter
employs persons that are licensed under the law of the permitted country in
which the exporter is located to dispense prescription drugs in sufficient
number to dispense safely the drugs exported by the exporter to individuals,
and the exporter assigns to those persons responsibility for dispensing such
drugs to individuals.</text>
</paragraph></subsection><subsection id="ID4370C533001C44A0A21107C476691F00"><enum>(i)</enum><header>Individuals;
conditions for importation</header>
<paragraph id="IDA2B7BE0CE8D1474DB24F1B0389E997EB"><enum>(1)</enum><header>In
general</header><text>For purposes of subsection (a)(2)(B), the importation of
a qualifying drug by an individual is in accordance with this subsection if the
following conditions are met:</text>
<subparagraph id="IDC17E053C06534219883A351D26671D51"><enum>(A)</enum><text>The drug is
accompanied by a copy of a prescription for the drug, which
prescription—</text>
<clause id="ID3BEB937CBB484E52AEB79AE71D1D14FD"><enum>(i)</enum><text>is valid under
applicable Federal and State laws; and</text>
</clause><clause id="IDDE238F39A4684891B57BBF8D8CF43F98"><enum>(ii)</enum><text>was issued by a
practitioner who, under the law of a State of which the individual is a
resident, or in which the individual receives care from the practitioner who
issues the prescription, is authorized to administer prescription drugs.</text>
</clause></subparagraph><subparagraph id="ID2B256310D16646F79DC681CECC5C0E77"><enum>(B)</enum><text>The drug is
accompanied by a copy of the documentation that was required under the law or
regulations of the permitted country in which the exporter is located, as a
condition of dispensing the drug to the individual.</text>
</subparagraph><subparagraph id="ID88AED1674BD444E18F7DF4A96A2168DC"><enum>(C)</enum><text>The copies
referred to in subparagraphs (A)(i) and (B) are marked in a manner
sufficient—</text>
<clause id="IDA1AEBB9CBF1B48A98664E7D22DD2CDF9"><enum>(i)</enum><text>to indicate that
the prescription, and the equivalent document in the permitted country in which
the exporter is located, have been filled; and</text>
</clause><clause id="ID498CAD1D28314C3AB6980AB90DBFC710"><enum>(ii)</enum><text>to prevent a
duplicative filling by another pharmacist.</text>
</clause></subparagraph><subparagraph id="IDC732ABDBA18E49FD9E4DBA3983E07189"><enum>(D)</enum><text>The individual
has provided to the registered exporter a complete list of all drugs used by
the individual for review by the individuals who dispense the drug.</text>
</subparagraph><subparagraph id="ID575D19830C1247B19EE077C65838C236"><enum>(E)</enum><text>The quantity of
the drug does not exceed a 90-day supply.</text>
</subparagraph><subparagraph id="ID6F2B143AE3A0446788FA67E7E5D46960"><enum>(F)</enum><text>The drug is not
an ineligible subpart H drug. For purposes of this section, a prescription drug
is an <quote>ineligible subpart H drug</quote> if the drug was approved by the
Secretary under subpart H of part 314 of title 21, Code of Federal Regulations
(relating to accelerated approval), with restrictions under section 520 of such
part to assure safe use, and the Secretary has published in the Federal
Register a notice that the Secretary has determined that good cause exists to
prohibit the drug from being imported pursuant to this subsection.</text>
</subparagraph></paragraph><paragraph id="IDBC3643903FC946B4852030BE2FBC9BDE"><enum>(2)</enum><header>Notice
regarding drug refused admission</header><text>If a registered exporter ships a
drug to an individual pursuant to subsection (a)(2)(B) and the drug is refused
admission to the United States, a written notice shall be sent to the
individual and to the exporter that informs the individual and the exporter of
such refusal and the reason for the refusal.</text>
</paragraph></subsection><subsection id="ID374357AB2D644223807B8608FB3400F4"><enum>(j)</enum><header>Maintenance of
records and samples</header>
<paragraph id="ID155A077A507C4BA1A65BA9AD0D0AF7A8"><enum>(1)</enum><header>In
general</header><text>A registration condition is that the importer or exporter
involved shall—</text>
<subparagraph id="IDC0AFCF0A91B84E478088DAAA5502732B"><enum>(A)</enum><text>maintain records
required under this section for not less than 2 years; and</text>
</subparagraph><subparagraph id="ID6E6A87EC77B647078170C61EF6C2EDC7"><enum>(B)</enum><text>maintain samples
of each lot of a qualifying drug required under this section for not more than
2 years.</text>
</subparagraph></paragraph><paragraph id="ID2643B41B2B00470582A869A28D59B9D1"><enum>(2)</enum><header>Place of record
maintenance</header><text>The records described under paragraph (1) shall be
maintained—</text>
<subparagraph id="ID906CF4403E0F49D58D9DB5182D951CB8"><enum>(A)</enum><text>in the case of an
importer, at the place of business of the importer at which the importer
initially receives the qualifying drug after importation; or</text>
</subparagraph><subparagraph id="IDFFA6F6B311184F64822D8257B8541D54"><enum>(B)</enum><text>in the case of an
exporter, at the facility from which the exporter ships the qualifying drug to
the United States.</text>
</subparagraph></paragraph></subsection><subsection id="ID656055BCE25D429BAB9B17CCDA3FB718"><enum>(k)</enum><header>Drug
recalls</header>
<paragraph id="ID5BF189DB205D4EDBB6793A02E38D5CA6"><enum>(1)</enum><header>Manufacturers</header><text>A
person that manufactures a qualifying drug imported from a permitted country
under this section shall promptly inform the Secretary—</text>
<subparagraph id="IDF07B208BD7224FD0AAE3BCB8488DC8E8"><enum>(A)</enum><text>if the drug is
recalled or withdrawn from the market in a permitted country;</text>
</subparagraph><subparagraph id="IDA1FBD7C989B04D848086545E7D88AD78"><enum>(B)</enum><text>how the drug may
be identified, including lot number; and</text>
</subparagraph><subparagraph id="IDF3EFCA5430C64A9082170193116E7738"><enum>(C)</enum><text>the reason for
the recall or withdrawal.</text>
</subparagraph></paragraph><paragraph id="ID3D1F033FC8D8418597AA49125F77EB41"><enum>(2)</enum><header>Secretary</header><text>With
respect to each permitted country, the Secretary shall—</text>
<subparagraph id="IDCDAD20BC91BE42E6BD198BD2102BBE1E"><enum>(A)</enum><text>enter into an
agreement with the government of the country to receive information about
recalls and withdrawals of qualifying drugs in the country; or</text>
</subparagraph><subparagraph id="ID29C253675A744D639AC1EEE43D8A276C"><enum>(B)</enum><text>monitor recalls
and withdrawals of qualifying drugs in the country using any information that
is available to the public in any media.</text>
</subparagraph></paragraph><paragraph id="ID528FE626B5824D859527BE15B38146DB"><enum>(3)</enum><header>Notice</header><text>The
Secretary may notify, as appropriate, registered exporters, registered
importers, wholesalers, pharmacies, or the public of a recall or withdrawal of
a qualifying drug in a permitted country.</text>
</paragraph></subsection><subsection id="IDF1F1041E48FA4D6FB31F61B39D6DBFD9"><enum>(l)</enum><header>Drug labeling
and packaging</header>
<paragraph id="idC6CD60002E8645A593E5AF7D8F4F7CEA"><enum>(1)</enum><header>In
general</header><text>When a qualifying drug that is imported into the United
States by an importer under subsection (a) is dispensed by a pharmacist to an
individual, the pharmacist shall provide that the packaging and labeling of the
drug complies with all applicable regulations promulgated under sections 3 and
4 of the Poison Prevention Packaging Act of 1970 (<external-xref legal-doc="usc" parsable-cite="usc/15/1471">15 U.S.C. 1471 et seq.</external-xref>) and
shall include with any other labeling provided to the individual the
following:</text>
<subparagraph id="IDFA326C1613EB430C893D1B69D4643271"><enum>(A)</enum><text>The lot number
assigned by the manufacturer.</text>
</subparagraph><subparagraph id="IDB5C12C14A05840D09BE4F2ED93C03314"><enum>(B)</enum><text>The name and
registration number of the importer.</text>
</subparagraph><subparagraph id="id6FC64810E8E84E7E87B4E0B91EADE119"><enum>(C)</enum><text>If required under
paragraph (2)(B)(vi)(III) of subsection (g), a prominent advisory that the drug
is safe and effective but not bioequivalent to the U.S. label drug.</text>
</subparagraph><subparagraph id="IDB23757324E44403780B2C0A00BAAE3C3"><enum>(D)</enum><text>If the inactive
ingredients of the drug are different from the inactive ingredients for the
U.S. label drug—</text>
<clause id="IDEBD71C768CBD4B05A581F3FCEF0055B3"><enum>(i)</enum><text>a
prominent advisory that persons with allergies should check the ingredient list
of the drug because the ingredients of the drug differ from the ingredients of
the U.S. label drug; and</text>
</clause><clause id="ID911A0221859340EBB49E8D851F1C0DB8"><enum>(ii)</enum><text>a list of the
ingredients of the drug as would be required under section 502(e).</text>
</clause></subparagraph></paragraph><paragraph id="idF3ECB940DCB34D07965666B9EA6094A1"><enum>(2)</enum><header>Packaging</header><text>A
qualifying drug that is packaged in a unit-of-use container (as those terms are
defined in the United States Pharmacopeia and National Formulary) shall not be
repackaged, provided that—</text>
<subparagraph id="id0CE6FDA8B0F446FB816AB48542494E07"><enum>(A)</enum><text>the packaging
complies with all applicable regulations under sections 3 and 4 of the Poison
Prevention Packaging Act of 1970 (<external-xref legal-doc="usc" parsable-cite="usc/15/1471">15 U.S.C. 1471 et seq.</external-xref>); or</text>
</subparagraph><subparagraph id="id42B6E6BB9FC047F3A9F3717B5E8B85D9"><enum>(B)</enum><text>the consumer
consents to waive the requirements of such Act, after being informed that the
packaging does not comply with such Act and that the pharmacist will provide
the drug in packaging that is compliant at no additional cost.</text>
</subparagraph></paragraph></subsection><subsection id="ID920D46F3EFD7474087F9E86ED5728EA6"><enum>(m)</enum><header>Charitable
contributions</header><text>Notwithstanding any other provision of this
section, this section does not authorize the importation into the United States
of a qualifying drug donated or otherwise supplied for free or at nominal cost
by the manufacturer of the drug to a charitable or humanitarian organization,
including the United Nations and affiliates, or to a government of a foreign
country.</text>
</subsection><subsection id="IDC89CF2CE7F6E4FA59AE471F3C953A713"><enum>(n)</enum><header>Unfair and
discriminatory Acts and practices</header>
<paragraph id="IDB3CA6A3CA1324605804361AA3725424B"><enum>(1)</enum><header>In
general</header><text>It is unlawful for a manufacturer, directly or indirectly
(including by being a party to a licensing agreement or other agreement),
to—</text>
<subparagraph id="IDE958D16B60084DB993A6263425CA54D9"><enum>(A)</enum><text>discriminate by
charging a higher price for a prescription drug sold to a registered exporter
or other person in a permitted country that exports a qualifying drug to the
United States under this section than the price that is charged, inclusive of
rebates or other incentives to the permitted country or other person, to
another person that is in the same country and that does not export a
qualifying drug into the United States under this section;</text>
</subparagraph><subparagraph id="ID60E154D1EAA04C2CA7DCC779BEFFA89D"><enum>(B)</enum><text>discriminate by
charging a higher price for a prescription drug sold to a registered importer
or other person that distributes, sells, or uses a qualifying drug imported
into the United States under this section than the price that is charged to
another person in the United States that does not import a qualifying drug
under this section, or that does not distribute, sell, or use such a
drug;</text>
</subparagraph><subparagraph id="ID2C8D01C1EB4E4CAD8DFDD4A524031766"><enum>(C)</enum><text>discriminate by
denying, restricting, or delaying supplies of a prescription drug to a
registered exporter or other person in a permitted country that exports a
qualifying drug to the United States under this section or to a registered
importer or other person that distributes, sells, or uses a qualifying drug
imported into the United States under this section;</text>
</subparagraph><subparagraph id="ID4590EE89528B4D3F9EB5C16E7B2853D4"><enum>(D)</enum><text>discriminate by
publicly, privately, or otherwise refusing to do business with a registered
exporter or other person in a permitted country that exports a qualifying drug
to the United States under this section or with a registered importer or other
person that distributes, sells, or uses a qualifying drug imported into the
United States under this section;</text>
</subparagraph><subparagraph id="IDD4F17F7EF0ED4044A6C2AF150CFB3B00"><enum>(E)</enum><text>knowingly fail to
submit a notice under subsection (g)(2)(B)(i), knowingly fail to submit such a
notice on or before the date specified in subsection (g)(2)(B)(v) or as
otherwise required under subsection (e) (3), (4), and (5) of section 4 of the
<short-title>Pharmaceutical Market Access and Drug Safety
Act of 2007</short-title>, knowingly submit such a notice that makes a
materially false, fictitious, or fraudulent statement, or knowingly fail to
provide promptly any information requested by the Secretary to review such a
notice;</text>
</subparagraph><subparagraph id="ID510394677272452A8548A2A1027CF9E3"><enum>(F)</enum><text>knowingly fail to
submit an application required under subsection (g)(2)(F), knowingly fail to
submit such an application on or before the date specified in subsection
(g)(2)(F)(ii), knowingly submit such an application that makes a materially
false, fictitious, or fraudulent statement, or knowingly fail to provide
promptly any information requested by the Secretary to review such an
application;</text>
</subparagraph><subparagraph id="IDB72736FB8C5141CA8378452796225867"><enum>(G)</enum><text>cause there to be
a difference (including a difference in active ingredient, route of
administration, dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that manufactures the drug)
between a prescription drug for distribution in the United States and the drug
for distribution in a permitted country;</text>
</subparagraph><subparagraph id="ID717FF36B9C534E599A54FA958849E70A"><enum>(H)</enum><text>refuse to allow
an inspection authorized under this section of an establishment that
manufactures a qualifying drug that is, or will be, introduced for commercial
distribution in a permitted country;</text>
</subparagraph><subparagraph id="ID7E5BE94FD72C41AAB80A95CD7934DEBD"><enum>(I)</enum><text>fail to conform
to the methods used in, or the facilities used for, the manufacturing,
processing, packing, or holding of a qualifying drug that is, or will be,
introduced for commercial distribution in a permitted country to good
manufacturing practice under this Act;</text>
</subparagraph><subparagraph id="IDB7DAC2D35065497C8C473EFF152867B1"><enum>(J)</enum><text>become a party to
a licensing agreement or other agreement related to a qualifying drug that
fails to provide for compliance with all requirements of this section with
respect to such drug;</text>
</subparagraph><subparagraph id="ID91909B39A61B4BCBAB57BB871CDF28A3"><enum>(K)</enum><text>enter into a
contract that restricts, prohibits, or delays the importation of a qualifying
drug under this section;</text>
</subparagraph><subparagraph id="IDCA3B51F9F9B3434CAD12EE3959E5439E"><enum>(L)</enum><text>engage in any
other action to restrict, prohibit, or delay the importation of a qualifying
drug under this section; or</text>
</subparagraph><subparagraph id="ID869F1D4ED73C4FB7B9DE0CD35B9E54B3"><enum>(M)</enum><text>engage in any
other action that the Federal Trade Commission determines to discriminate
against a person that engages or attempts to engage in the importation of a
qualifying drug under this section.</text>
</subparagraph></paragraph><paragraph id="idE41453FEF9D24168BC917CE240F92527"><enum>(2)</enum><header>Referral of
potential violations</header><text>The Secretary shall promptly refer to the
Federal Trade Commission each potential violation of subparagraph (E), (F),
(G), (H), or (I) of paragraph (1) that becomes known to the Secretary.</text>
</paragraph><paragraph id="IDBB09ECA47A2A4EBCBC39AF03FBECE180"><enum>(3)</enum><header>Affirmative
defense</header>
<subparagraph id="IDB0C81C9BCBB74A3686C3126A4E8F13BA"><enum>(A)</enum><header>Discrimination</header><text>It
shall be an affirmative defense to a charge that a manufacturer has
discriminated under subparagraph (A), (B), (C), (D), or (M) of paragraph (1)
that the higher price charged for a prescription drug sold to a person, the
denial, restriction, or delay of supplies of a prescription drug to a person,
the refusal to do business with a person, or other discriminatory activity
against a person, is not based, in whole or in part, on—</text>
<clause id="IDB71416640BA34FD0829EA7E2B471D501"><enum>(i)</enum><text>the person
exporting or importing a qualifying drug into the United States under this
section; or</text>
</clause><clause id="ID58BA3F8BD1194594861F146988CCC21F"><enum>(ii)</enum><text>the person
distributing, selling, or using a qualifying drug imported into the United
States under this section.</text>
</clause></subparagraph><subparagraph id="ID3E78C67B77944F55AED321FF01E77C73"><enum>(B)</enum><header>Drug
differences</header><text>It shall be an affirmative defense to a charge that a
manufacturer has caused there to be a difference described in subparagraph (G)
of paragraph (1) that—</text>
<clause id="ID06F34B3182D345AF88C73FFCEC5FA653"><enum>(i)</enum><text>the difference
was required by the country in which the drug is distributed;</text>
</clause><clause id="IDDF5D98EDB58148EB9101D641A48295E9"><enum>(ii)</enum><text>the Secretary
has determined that the difference was necessary to improve the safety or
effectiveness of the drug;</text>
</clause><clause id="IDCF68B0C276D84B7E950AAE0B857C47DE"><enum>(iii)</enum><text>the person
manufacturing the drug for distribution in the United States has given notice
to the Secretary under subsection (g)(2)(B)(i) that the drug for distribution
in the United States is not different from a drug for distribution in permitted
countries whose combined population represents at least 50 percent of the total
population of all permitted countries; or</text>
</clause><clause id="ID5DF5CAFA8C124BFFACF1AA1539C5F2A3"><enum>(iv)</enum><text>the difference
was not caused, in whole or in part, for the purpose of restricting importation
of the drug into the United States under this section.</text>
</clause></subparagraph></paragraph><paragraph id="IDA45D7E781B2A4A3E97CAF5ABE3FF535F"><enum>(4)</enum><header>Effect of
subsection</header>
<subparagraph id="ID5098697F5DAD467FA212B66C5F9AB540"><enum>(A)</enum><header>Sales in other
countries</header><text>This subsection applies only to the sale or
distribution of a prescription drug in a country if the manufacturer of the
drug chooses to sell or distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a drug to
distribute or sell the drug in a country.</text>
</subparagraph><subparagraph id="IDC22B229E7D2A49EF95835487629CDABD"><enum>(B)</enum><header>Discounts to
insurers, health plans, pharmacy benefit managers, and covered
entities</header><text>Nothing in this subsection shall be construed to—</text>
<clause id="IDE4A0EFBECF344265AF8E4E82E81AF1BC"><enum>(i)</enum><text>prevent or
restrict a manufacturer of a prescription drug from providing discounts to an
insurer, health plan, pharmacy benefit manager in the United States, or covered
entity in the drug discount program under section 340B of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
256b) in return for inclusion of the drug on a formulary;</text>
</clause><clause id="IDC85CB29B17E54FB79B96997D8E205737"><enum>(ii)</enum><text>require that
such discounts be made available to other purchasers of the prescription drug;
or</text>
</clause><clause id="IDBB760B21F9654CA7B5CD14002FEFDDB9"><enum>(iii)</enum><text>prevent or
restrict any other measures taken by an insurer, health plan, or pharmacy
benefit manager to encourage consumption of such prescription drug.</text>
</clause></subparagraph><subparagraph id="ID9C09698E7BD746C4B3A6D047E3A05FFF"><enum>(C)</enum><header>Charitable
contributions</header><text>Nothing in this subsection shall be construed
to—</text>
<clause id="IDB6E285B6BAB94BDE9B320C0E60D2D851"><enum>(i)</enum><text>prevent a
manufacturer from donating a prescription drug, or supplying a prescription
drug at nominal cost, to a charitable or humanitarian organization, including
the United Nations and affiliates, or to a government of a foreign country;
or</text>
</clause><clause id="IDDE101AB8E2F240C2B7A497BD0BBE1043"><enum>(ii)</enum><text>apply to such
donations or supplying of a prescription drug.</text>
</clause></subparagraph></paragraph><paragraph id="ID82F1EABEF6C1424E82A69F95B398EB20"><enum>(5)</enum><header>Enforcement</header>
<subparagraph id="IDAA2D22C6C4C449CD9DC36845A7DE8E3C"><enum>(A)</enum><header>Unfair or
deceptive Act or practice</header><text>A violation of this subsection shall be
treated as a violation of a rule defining an unfair or deceptive act or
practice prescribed under section 18(a)(1)(B) of the
<act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (15
U.S.C. 57a(a)(1)(B)).</text>
</subparagraph><subparagraph id="ID7A5BAD682B434F7C90EB46715C90E58F"><enum>(B)</enum><header>Actions by the
commission</header><text>The Federal Trade Commission—</text>
<clause id="ID3FE652BA253A4DD48F952531A75E136B"><enum>(i)</enum><text>shall enforce
this subsection in the same manner, by the same means, and with the same
jurisdiction, powers, and duties as though all applicable terms and provisions
of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/15/41">15 U.S.C. 41 et seq.</external-xref>) were incorporated into and made a part of this section;
and</text>
</clause><clause id="ID32AB20F57001458CBB6776A91F8947C6"><enum>(ii)</enum><text>may seek
monetary relief threefold the damages sustained, in addition to any other
remedy available to the Federal Trade Commission under the
<act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (15
U.S.C. 41 et seq.).</text>
</clause></subparagraph></paragraph><paragraph id="ID33D4AD83FF7848C79784C6AD0FEDA4A2"><enum>(6)</enum><header>Actions by
States</header>
<subparagraph id="IDEF27844036D340299495F733AFA261AF"><enum>(A)</enum><header>In
general</header>
<clause id="IDF014B2DAD84E451DBD5813ACAA7DD6E9"><enum>(i)</enum><header>Civil
actions</header><text>In any case in which the attorney general of a State has
reason to believe that an interest of the residents of that State have been
adversely affected by any manufacturer that violates paragraph (1), the
attorney general of a State may bring a civil action on behalf of the residents
of the State, and persons doing business in the State, in a district court of
the United States of appropriate jurisdiction to—</text>
<subclause id="IDC6B1BAABBC004B6498F0CC54FBCF9D27"><enum>(I)</enum><text>enjoin that
practice;</text>
</subclause><subclause id="ID4405808ACF044324B08F53D43B848029"><enum>(II)</enum><text>enforce
compliance with this subsection;</text>
</subclause><subclause id="IDF1897699C1FB4DDA9D7AC7D1D2DE9745"><enum>(III)</enum><text>obtain damages,
restitution, or other compensation on behalf of residents of the State and
persons doing business in the State, including threefold the damages; or</text>
</subclause><subclause id="IDC648902245BB488A80075BEB333FA872"><enum>(IV)</enum><text>obtain such
other relief as the court may consider to be appropriate.</text>
</subclause></clause><clause id="ID135C7ECC7CA2459B8B89610F3296298E"><enum>(ii)</enum><header>Notice</header>
<subclause id="ID4E2C21B6246A4616A3DDA99008D3730C"><enum>(I)</enum><header>In
general</header><text>Before filing an action under clause (i), the attorney
general of the State involved shall provide to the Federal Trade
Commission—</text>
<item id="IDE339C0C4EEC2409CB5B907AD12A3A9E5"><enum>(aa)</enum><text>written notice
of that action; and</text>
</item><item id="ID1EC3740BB0E440669A97E5DB3C54C278"><enum>(bb)</enum><text>a
copy of the complaint for that action.</text>
</item></subclause><subclause id="IDABD7005DB88147378AC15011576E0BCF"><enum>(II)</enum><header>Exemption</header><text>Subclause
(I) shall not apply with respect to the filing of an action by an attorney
general of a State under this paragraph, if the attorney general determines
that it is not feasible to provide the notice described in that subclause
before filing of the action. In such case, the attorney general of a State
shall provide notice and a copy of the complaint to the Federal Trade
Commission at the same time as the attorney general files the action.</text>
</subclause></clause></subparagraph><subparagraph id="IDCA96844ED8404271AE80F10AE990BE92"><enum>(B)</enum><header>Intervention</header>
<clause id="ID9957A7B122694A7EA8A5A1195C86CFD0"><enum>(i)</enum><header>In
general</header><text>On receiving notice under subparagraph (A)(ii), the
Federal Trade Commission shall have the right to intervene in the action that
is the subject of the notice.</text>
</clause><clause id="IDE2C8E8F327FA4F6C881496F60C84E22D"><enum>(ii)</enum><header>Effect of
intervention</header><text>If the Federal Trade Commission intervenes in an
action under subparagraph (A), it shall have the right—</text>
<subclause id="ID4E423DB407524E97BEC21EF8EA627A80"><enum>(I)</enum><text>to be heard with
respect to any matter that arises in that action; and</text>
</subclause><subclause id="ID893B9F8B4B9940A2B8A04947F7B5CBF2"><enum>(II)</enum><text>to file a
petition for appeal.</text>
</subclause></clause></subparagraph><subparagraph id="ID5C021B8B65F3478D8E7646A806CF90D7"><enum>(C)</enum><header>Construction</header><text>For
purposes of bringing any civil action under subparagraph (A), nothing in this
subsection shall be construed to prevent an attorney general of a State from
exercising the powers conferred on the attorney general by the laws of that
State to—</text>
<clause id="IDD646FA371C1D4ABDA782446E4804F6F5"><enum>(i)</enum><text>conduct
investigations;</text>
</clause><clause id="IDD0DFD4F5B2B742DBBD546094DF7B0FDB"><enum>(ii)</enum><text>administer oaths
or affirmations; or</text>
</clause><clause id="ID99639AEC2E0A44BA95084E0B95E870D7"><enum>(iii)</enum><text>compel the
attendance of witnesses or the production of documentary and other
evidence.</text>
</clause></subparagraph><subparagraph id="ID7D2CB49845224C4982B6FCF744CC344C"><enum>(D)</enum><header>Actions by the
commission</header><text>In any case in which an action is instituted by or on
behalf of the Federal Trade Commission for a violation of paragraph (1), a
State may not, during the pendency of that action, institute an action under
subparagraph (A) for the same violation against any defendant named in the
complaint in that action.</text>
</subparagraph><subparagraph id="ID3B6EC79C8EAA4133BA49446733366031"><enum>(E)</enum><header>Venue</header><text>Any
action brought under subparagraph (A) may be brought in the district court of
the United States that meets applicable requirements relating to venue under
<external-xref legal-doc="usc" parsable-cite="usc/28/1391">section 1391</external-xref> of title 28, United States Code.</text>
</subparagraph><subparagraph id="IDEC9AACEB130C45928A408BE8306D8AFE"><enum>(F)</enum><header>Service of
process</header><text>In an action brought under subparagraph (A), process may
be served in any district in which the defendant—</text>
<clause id="ID80BAA594FC814D4A99CA8C567C614C61"><enum>(i)</enum><text>is an inhabitant;
or</text>
</clause><clause id="ID012701F5B9AD4014A4559B49FB0E9F32"><enum>(ii)</enum><text>may be
found.</text>
</clause></subparagraph><subparagraph id="ID70DFC4D863934A56A2B29D9489664166"><enum>(G)</enum><header>Measurement of
damages</header><text>In any action under this paragraph to enforce a cause of
action under this subsection in which there has been a determination that a
defendant has violated a provision of this subsection, damages may be proved
and assessed in the aggregate by statistical or sampling methods, by the
computation of illegal overcharges or by such other reasonable system of
estimating aggregate damages as the court in its discretion may permit without
the necessity of separately proving the individual claim of, or amount of
damage to, persons on whose behalf the suit was brought.</text>
</subparagraph><subparagraph id="ID0DA10338DCD94E4D824B935775569726"><enum>(H)</enum><header>Exclusion on
duplicative relief</header><text>The district court shall exclude from the
amount of monetary relief awarded in an action under this paragraph brought by
the attorney general of a State any amount of monetary relief which duplicates
amounts which have been awarded for the same injury.</text>
</subparagraph></paragraph><paragraph id="ID373AA165AB8F45569DEDF35FFEA736DD"><enum>(7)</enum><header>Effect on
antitrust laws</header><text>Nothing in this subsection shall be construed to
modify, impair, or supersede the operation of the antitrust laws. For the
purpose of this subsection, the term <term>antitrust laws</term> has the
meaning given it in the first section of the <act-name parsable-cite="CLAY">Clayton Act</act-name>, except that it includes section 5
of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name>
to the extent that such section 5 applies to unfair methods of
competition.</text>
</paragraph><paragraph id="ID5A9D61CC585148AA8FD48DE32F6FC272"><enum>(8)</enum><header>Manufacturer</header><text>In
this subsection, the term <term>manufacturer</term> means any entity, including
any affiliate or licensee of that entity, that is engaged in—</text>
<subparagraph id="ID4C817B4F38CB4AFDB5A487449524179C"><enum>(A)</enum><text>the production,
preparation, propagation, compounding, conversion, or processing of a
prescription drug, either directly or indirectly by extraction from substances
of natural origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis; or</text>
</subparagraph><subparagraph id="ID6C32E9FADF884F5F89E021EB9B2D407D"><enum>(B)</enum><text>the packaging,
repackaging, labeling, relabeling, or distribution of a prescription
drug.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="IDEDE7F8F368EE491582030D423C66B8C5"><enum>(b)</enum><header>Prohibited
Acts</header><text>The <act-name parsable-cite="FFDCA">Federal Food, Drug, and
Cosmetic Act</act-name> is amended—</text>
<paragraph id="ID8517332672D940D48C2C0F374BE13907"><enum>(1)</enum><text>in section 301
(<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>), by striking paragraph (aa) and inserting the following:</text>
<quoted-block id="ID2DC7C4537E034C92B7D5F2A739C0199C">
<item id="IDC02E1C98F59B480D8B0EAD3FD4A6A363" indent="up5"><enum>(aa)</enum><subitem commented="no" display-inline="yes-display-inline" id="ID1EBFEBB8737544F895611900503EAF6F"><enum>(1)</enum><text>The sale or trade by a
pharmacist, or by a business organization of which the pharmacist is a part, of
a qualifying drug that under section 804(a)(2)(A) was imported by the
pharmacist, other than—</text>
</subitem></item><subparagraph id="ID48B29A840F6E41B1A71CF1858EF1D5AC" indent="up1"><enum>(A)</enum><text>a sale at retail made pursuant to
dispensing the drug to a customer of the pharmacist or organization; or</text>
</subparagraph><subparagraph id="ID15045D8D16FF4C0D8169D5A150E8E949" indent="up1"><enum>(B)</enum><text>a sale or trade of the drug to a
pharmacy or a wholesaler registered to import drugs under section 804.</text>
</subparagraph><paragraph id="ID6B77EAA336844D9D80081838369C9C7B" indent="up1"><enum>(2)</enum><text>The sale or trade by an individual of
a qualifying drug that under section 804(a)(2)(B) was imported by the
individual.</text>
</paragraph><paragraph id="IDAEB21822D32544FFB29D8C0156E0A111" indent="up1"><enum>(3)</enum><text>The making of a materially false,
fictitious, or fraudulent statement or representation, or a material omission,
in a notice under clause (i) of section 804(g)(2)(B) or in an application
required under section 804(g)(2)(F), or the failure to submit such a notice or
application.</text>
</paragraph><paragraph id="IDDA6FC943B7CD40EB89291F7B2F3441B6" indent="up1"><enum>(4)</enum><text>The importation of a drug in
violation of a registration condition or other requirement under section 804,
the falsification of any record required to be maintained, or provided to the
Secretary, under such section, or the violation of any registration condition
or other requirement under such
section.</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="ID47418579B52D422BB0D288784D6B2F96"><enum>(2)</enum><text>in section 303(a)
(<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(a)</external-xref>), by striking paragraph (6) and inserting the
following:</text>
<quoted-block id="ID6EA58B3CC6F5441FADB870C5BECD6B36">
<paragraph id="ID84C090A527C745A18F6FB4AC41738106" indent="up1"><enum>(6)</enum><text>Notwithstanding subsection (a), any
person that knowingly violates section 301(i) (2) or (3) or section 301(aa)(4)
shall be imprisoned not more than 10 years, or fined in accordance with title
18, United States Code, or
both.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="ID45372B47605F48B690D9B39CF7A042FA"><enum>(c)</enum><header>Amendment of
certain provisions</header>
<paragraph id="ID24F2163DEF3345F78DEB16E054643ECD"><enum>(1)</enum><header>In
general</header><text>Section 801 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 381) is amended by striking subsection (g) and inserting the
following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="IDFDC783AECA364CB987B528B0EC1BAB43">
<subsection id="ID4D620477605448C6BC81E55FA606F64D"><enum>(g)</enum><text>With respect to a
prescription drug that is imported or offered for import into the United States
by an individual who is not in the business of such importation, that is not
shipped by a registered exporter under section 804, and that is refused
admission under subsection (a), the Secretary shall notify the individual
that—</text>
<paragraph id="IDC60D06484E524693A83D9A299D4C6BC9"><enum>(1)</enum><text>the drug has been
refused admission because the drug was not a lawful import under section
804;</text>
</paragraph><paragraph id="ID3A9E20D47D404BD4B68A86C697F6B7EE"><enum>(2)</enum><text>the drug is not
otherwise subject to a waiver of the requirements of subsection (a);</text>
</paragraph><paragraph id="ID052740FFB7574D02AFF09822DD7D84D2"><enum>(3)</enum><text>the individual
may under section 804 lawfully import certain prescription drugs from exporters
registered with the Secretary under section 804; and</text>
</paragraph><paragraph id="ID45E3FA1806424CCB836A752CB4FC1E75"><enum>(4)</enum><text>the individual
can find information about such importation, including a list of registered
exporters, on the Internet website of the Food and Drug Administration or
through a toll-free telephone number required under section
804.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="ID21949B394C5D4B6CA5B0F47564F36E3B"><enum>(2)</enum><header>Establishment
registration</header><text>Section 510(i) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(i)</external-xref>) is amended in paragraph (1) by inserting after <quote>import
into the United States</quote> the following: <quote>, including a drug that
is, or may be, imported or offered for import into the United States under
section 804,</quote>.</text>
</paragraph><paragraph id="ID28B5EEADAF4D4E29A052479C33A2CE10"><enum>(3)</enum><header>Effective
date</header><text>The amendments made by this subsection shall take effect on
the date that is 90 days after the date of enactment of this title.</text>
</paragraph></subsection><subsection id="ID26EF669298534FB6840FF726772662DB"><enum>(d)</enum><header>Exhaustion</header>
<paragraph id="ID6D092A8CC58C44F89B16F069982FE79B"><enum>(1)</enum><header>In
general</header><text><external-xref legal-doc="usc" parsable-cite="usc/35/271">Section 271</external-xref> of title 35, United States Code, is
amended—</text>
<subparagraph id="ID6CE34D4D5C464284A9722251EFB0BC8E"><enum>(A)</enum><text>by redesignating
subsections (h) and (i) as (i) and (j), respectively; and</text>
</subparagraph><subparagraph id="IDE288553774834F328F912B6FC4DF187E"><enum>(B)</enum><text>by inserting
after subsection (g) the following:</text>
<quoted-block id="ID3432FF7B985B45E98CA8010DAB3F6042">
<subsection id="ID69CA5CA37DB24441BFE2837B7148ABB2"><enum>(h)</enum><text>It shall not be
an act of infringement to use, offer to sell, or sell within the United States
or to import into the United States any patented invention under section 804 of
the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name> that was first sold abroad by or under authority of the owner or
licensee of such
patent.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="IDBEEFD143DCD44C628C8E164BFE4CBAB1"><enum>(2)</enum><header>Rule of
construction</header><text>Nothing in the amendment made by paragraph (1) shall
be construed to affect the ability of a patent owner or licensee to enforce
their patent, subject to such amendment.</text>
</paragraph></subsection><subsection id="ID417999FF678B4258AD37096A8F9FE06D"><enum>(e)</enum><header>Effect of
Section <enum-in-header>804</enum-in-header></header>
<paragraph id="ID49A11BFFB3104785A6B5C3CC5F50AAF0"><enum>(1)</enum><header>In
general</header><text>Section 804 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as added
by subsection (a), shall permit the importation of qualifying drugs (as defined
in such section 804) into the United States without regard to the status of the
issuance of implementing regulations—</text>
<subparagraph id="ID02A5B28522F449B29A2DF1BA21FDC5FA"><enum>(A)</enum><text>from exporters
registered under such section 804 on the date that is 90 days after the date of
enactment of this title; and</text>
</subparagraph><subparagraph id="ID03ECF5B2E10D429C9621E8379BCF02ED"><enum>(B)</enum><text>from permitted
countries, as defined in such section 804, by importers registered under such
section 804 on the date that is 1 year after the date of enactment of this
title.</text>
</subparagraph></paragraph><paragraph id="IDD4E9B81D04AB4F5085C2B865E82E88B3"><enum>(2)</enum><header>Review of
registration by certain exporters</header>
<subparagraph id="ID009CE89C347E49ACB30B49BBD103CD06"><enum>(A)</enum><header>Review
priority</header><text>In the review of registrations submitted under
subsection (b) of such section 804, registrations submitted by entities in
Canada that are significant exporters of prescription drugs to individuals in
the United States as of the date of enactment of this title will have priority
during the 90 day period that begins on such date of enactment.</text>
</subparagraph><subparagraph id="IDBAF2352920914405868300A60490F119"><enum>(B)</enum><header>Period for
review</header><text>During such 90-day period, the reference in subsection
(b)(2)(A) of such section 804 to 90 days (relating to approval or disapproval
of registrations) is, as applied to such entities, deemed to be 30 days.</text>
</subparagraph><subparagraph id="ID72F1AC71474B4C01B142C358F3C700D5"><enum>(C)</enum><header>Limitation</header><text>That
an exporter in Canada exports, or has exported, prescription drugs to
individuals in the United States on or before the date that is 90 days after
the date of enactment of this title shall not serve as a basis, in whole or in
part, for disapproving a registration under such section 804 from the
exporter.</text>
</subparagraph><subparagraph id="IDB33AD014A5CE4F05A4FD36AC83A71432"><enum>(D)</enum><header>First year
limit on number of exporters</header><text>During the 1-year period beginning
on the date of enactment of this title, the Secretary of Health and Human
Services (referred to in this section as the <quote>Secretary</quote>) may
limit the number of registered exporters under such section 804 to not less
than 50, so long as the Secretary gives priority to those exporters with
demonstrated ability to process a high volume of shipments of drugs to
individuals in the United States.</text>
</subparagraph><subparagraph id="ID534F529B739E49FE9B9F70E5A8EF4739"><enum>(E)</enum><header>Second year
limit on number of exporters</header><text>During the 1-year period beginning
on the date that is 1 year after the date of enactment of this title, the
Secretary may limit the number of registered exporters under such section 804
to not less than 100, so long as the Secretary gives priority to those
exporters with demonstrated ability to process a high volume of shipments of
drugs to individuals in the United States.</text>
</subparagraph><subparagraph id="ID6BA04586A2464F54BA04C749E7C80797"><enum>(F)</enum><header>Further limit
on number of exporters</header><text>During any 1-year period beginning on a
date that is 2 or more years after the date of enactment of this title, the
Secretary may limit the number of registered exporters under such section 804
to not less than 25 more than the number of such exporters during the previous
1-year period, so long as the Secretary gives priority to those exporters with
demonstrated ability to process a high volume of shipments of drugs to
individuals in the United States.</text>
</subparagraph></paragraph><paragraph id="ID67E5D3E1CA0840248838EDA75074E507"><enum>(3)</enum><header>Limits on
number of importers</header>
<subparagraph id="IDDE06E13595B34EDD84E86FA49122D549"><enum>(A)</enum><header>First year
limit on number of importers</header><text>During the 1-year period beginning
on the date that is 1 year after the date of enactment of this title, the
Secretary may limit the number of registered importers under such section 804
to not less than 100 (of which at least a significant number shall be groups of
pharmacies, to the extent feasible given the applications submitted by such
groups), so long as the Secretary gives priority to those importers with
demonstrated ability to process a high volume of shipments of drugs imported
into the United States.</text>
</subparagraph><subparagraph id="IDFA7975178DC9474B8843C74F9BB41EAF"><enum>(B)</enum><header>Second year
limit on number of importers</header><text>During the 1-year period beginning
on the date that is 2 years after the date of enactment of this title, the
Secretary may limit the number of registered importers under such section 804
to not less than 200 (of which at least a significant number shall be groups of
pharmacies, to the extent feasible given the applications submitted by such
groups), so long as the Secretary gives priority to those importers with
demonstrated ability to process a high volume of shipments of drugs into the
United States.</text>
</subparagraph><subparagraph id="ID892D488FB680419C98CB155A632386C4"><enum>(C)</enum><header>Further limit
on number of importers</header><text>During any 1-year period beginning on a
date that is 3 or more years after the date of enactment of this title, the
Secretary may limit the number of registered importers under such section 804
to not less than 50 more (of which at least a significant number shall be
groups of pharmacies, to the extent feasible given the applications submitted
by such groups) than the number of such importers during the previous 1-year
period, so long as the Secretary gives priority to those importers with
demonstrated ability to process a high volume of shipments of drugs to the
United States.</text>
</subparagraph></paragraph><paragraph id="ID4F62EF3A20FB40DFB4643AC65342A2C5"><enum>(4)</enum><header>Notices for
drugs for import from Canada</header><text>The notice with respect to a
qualifying drug introduced for commercial distribution in Canada as of the date
of enactment of this title that is required under subsection (g)(2)(B)(i) of
such section 804 shall be submitted to the Secretary not later than 30 days
after the date of enactment of this title if—</text>
<subparagraph id="IDEF13C53B8E1047BCBD93533511BCB4FD"><enum>(A)</enum><text>the U.S. label
drug (as defined in such section 804) for the qualifying drug is 1 of the 100
prescription drugs with the highest dollar volume of sales in the United States
based on the 12 calendar month period most recently completed before the date
of enactment of this Act; or</text>
</subparagraph><subparagraph id="ID3C8C43800AC447FE896329240D18FB39"><enum>(B)</enum><text>the notice is a
notice under subsection (g)(2)(B)(i)(II) of such section 804.</text>
</subparagraph></paragraph><paragraph id="ID4815DC1199EB403EB13E50D7218F80C5"><enum>(5)</enum><header>Notice for
drugs for import from other countries</header><text>The notice with respect to
a qualifying drug introduced for commercial distribution in a permitted country
other than Canada as of the date of enactment of this title that is required
under subsection (g)(2)(B)(i) of such section 804 shall be submitted to the
Secretary not later than 180 days after the date of enactment of this title
if—</text>
<subparagraph id="ID7F7130B12F0B4B9B8393B108DEAC5E10"><enum>(A)</enum><text>the U.S. label
drug for the qualifying drug is 1 of the 100 prescription drugs with the
highest dollar volume of sales in the United States based on the 12 calendar
month period that is first completed on the date that is 120 days after the
date of enactment of this title; or</text>
</subparagraph><subparagraph id="IDF4B30B0F84104910B8B8C1130CDC05E3"><enum>(B)</enum><text>the notice is a
notice under subsection (g)(2)(B)(i)(II) of such section 804.</text>
</subparagraph></paragraph><paragraph id="ID4FFA2B73DA3E4E8096BD7F9243F9D225"><enum>(6)</enum><header>Notice for
other drugs for import</header>
<subparagraph id="ID8E7F30F07DA948DC896EC68F63F4FD0D"><enum>(A)</enum><header>Guidance on
submission dates</header><text>The Secretary shall by guidance establish a
series of submission dates for the notices under subsection (g)(2)(B)(i) of
such section 804 with respect to qualifying drugs introduced for commercial
distribution as of the date of enactment of this title and that are not
required to be submitted under paragraph (4) or (5).</text>
</subparagraph><subparagraph id="IDCA721A23AD6F453098F44F075D1D74A3"><enum>(B)</enum><header>Consistent and
efficient use of resources</header><text>The Secretary shall establish the
dates described under subparagraph (A) so that such notices described under
subparagraph (A) are submitted and reviewed at a rate that allows consistent
and efficient use of the resources and staff available to the Secretary for
such reviews. The Secretary may condition the requirement to submit such a
notice, and the review of such a notice, on the submission by a registered
exporter or a registered importer to the Secretary of a notice that such
exporter or importer intends to import such qualifying drug to the United
States under such section 804.</text>
</subparagraph><subparagraph id="ID0889A45A3CD44F7297F5C83F7354BBBA"><enum>(C)</enum><header>Priority for
drugs with higher sales</header><text>The Secretary shall establish the dates
described under subparagraph (A) so that the Secretary reviews the notices
described under such subparagraph with respect to qualifying drugs with higher
dollar volume of sales in the United States before the notices with respect to
drugs with lower sales in the United States.</text>
</subparagraph></paragraph><paragraph id="IDAE0626285C49465C8BCE91CAB1D2E00F"><enum>(7)</enum><header>Notices for
drugs approved after effective date</header><text>The notice required under
subsection (g)(2)(B)(i) of such section 804 for a qualifying drug first
introduced for commercial distribution in a permitted country (as defined in
such section 804) after the date of enactment of this title shall be submitted
to and reviewed by the Secretary as provided under subsection (g)(2)(B) of such
section 804, without regard to paragraph (4), (5), or (6).</text>
</paragraph><paragraph id="ID35DAC34EBB82449F9FECDBE6158CD7B5"><enum>(8)</enum><header>Report</header><text>Beginning
with the first full fiscal year after the date of enactment of this title, not
later than 90 days after the end of each fiscal year during which the Secretary
reviews a notice referred to in paragraph (4), (5), or (6), the Secretary shall
submit a report to Congress concerning the progress of the Food and Drug
Administration in reviewing the notices referred to in paragraphs (4), (5), and
(6).</text>
</paragraph><paragraph id="IDFBC0C33A4ABE49769A1BCADF1BB43114"><enum>(9)</enum><header>User
fees</header>
<subparagraph id="ID0795003A788341DCA2A41720E9A64D5E"><enum>(A)</enum><header>Exporters</header><text>When
establishing an aggregate total of fees to be collected from exporters under
subsection (f)(2) of such section 804, the Secretary shall, under subsection
(f)(3)(C)(i) of such section 804, estimate the total price of drugs imported
under subsection (a) of such section 804 into the United States by registered
exporters during the first fiscal year in which this title takes effect to be
an amount equal to the amount which bears the same ratio to $1,000,000,000 as
the number of days in such fiscal year during which this title is effective
bears to 365.</text>
</subparagraph><subparagraph id="ID561929F729D744BD98C06F8FF66B949B"><enum>(B)</enum><header>Importers</header><text>When
establishing an aggregate total of fees to be collected from importers under
subsection (e)(2) of such section 804, the Secretary shall, under subsection
(e)(3)(C)(i) of such section 804, estimate the total price of drugs imported
under subsection (a) of such section 804 into the United States by registered
importers during—</text>
<clause id="ID92A5655173FD4A3DB6F4B25BDA5792D5"><enum>(i)</enum><text>the
first fiscal year in which this title takes effect to be an amount equal to the
amount which bears the same ratio to $1,000,000,000 as the number of days in
such fiscal year during which this title is effective bears to 365; and</text>
</clause><clause id="IDAB9CD7FED5DE43969340AA9543EB4FB5"><enum>(ii)</enum><text>the second
fiscal year in which this title is in effect to be $3,000,000,000.</text>
</clause></subparagraph><subparagraph id="ID157876643BED43DA991DFC929E9DC221"><enum>(C)</enum><header>Second year
adjustment</header>
<clause id="ID6955351C625C4255B8E3EE0844AFAD81"><enum>(i)</enum><header>Reports</header><text>Not
later than February 20 of the second fiscal year in which this title is in
effect, registered importers shall report to the Secretary the total price and
the total volume of drugs imported to the United States by the importer during
the 4-month period from October 1 through January 31 of such fiscal
year.</text>
</clause><clause id="ID610A61F86A9F4D71BDA6F9A2D14FB93B"><enum>(ii)</enum><header>Reestimate</header><text>Notwithstanding
subsection (e)(3)(C)(ii) of such section 804 or subparagraph (B), the Secretary
shall reestimate the total price of qualifying drugs imported under subsection
(a) of such section 804 into the United States by registered importers during
the second fiscal year in which this title is in effect. Such reestimate shall
be equal to—</text>
<subclause id="ID5C2880F089BD4BB7916CCA5CB81452EC"><enum>(I)</enum><text>the total price
of qualifying drugs imported by each importer as reported under clause (i);
multiplied by</text>
</subclause><subclause id="ID9072CECAD0AE480382DED84214575C43"><enum>(II)</enum><text>3.</text>
</subclause></clause><clause id="IDD42A783BD1ED4C1EA70D9765D49D7E67"><enum>(iii)</enum><header>Adjustment</header><text>The
Secretary shall adjust the fee due on April 1 of the second fiscal year in
which this title is in effect, from each importer so that the aggregate total
of fees collected under subsection (e)(2) for such fiscal year does not exceed
the total price of qualifying drugs imported under subsection (a) of such
section 804 into the United States by registered importers during such fiscal
year as reestimated under clause (ii).</text>
</clause></subparagraph><subparagraph id="idC6BC8E2AAF0144D19053E48819BAC5D1"><enum>(D)</enum><header>Failure to pay
fees</header><text>Notwithstanding any other provision of this section, the
Secretary may prohibit a registered importer or exporter that is required to
pay user fees under subsection (e) or (f) of such section 804 and that fails to
pay such fees within 30 days after the date on which it is due, from importing
or offering for importation a qualifying drug under such section 804 until such
fee is paid.</text>
</subparagraph><subparagraph id="ID2AE96FFFF25440FD8FA6435191457D74"><enum>(E)</enum><header>Annual
report</header>
<clause id="ID514B74DD411D48E088932F76FB0DAB49"><enum>(i)</enum><header>Food and Drug
Administration</header><text>Not later than 180 days after the end of each
fiscal year during which fees are collected under subsection (e), (f), or
(g)(2)(B)(iv) of such section 804, the Secretary shall prepare and submit to
the House of Representatives and the Senate a report on the implementation of
the authority for such fees during such fiscal year and the use, by the Food
and Drug Administration, of the fees collected for the fiscal year for which
the report is made and credited to the Food and Drug Administration.</text>
</clause><clause id="ID598830ADA3F04BD8905016380BF39782"><enum>(ii)</enum><header>Customs and
border control</header><text>Not later than 180 days after the end of each
fiscal year during which fees are collected under subsection (e) or (f) of such
section 804, the Secretary of Homeland Security, in consultation with the
Secretary of the Treasury, shall prepare and submit to the House of
Representatives and the Senate a report on the use, by the Bureau of Customs
and Border Protection, of the fees, if any, transferred by the Secretary to the
Bureau of Customs and Border Protection for the fiscal year for which the
report is made.</text>
</clause></subparagraph></paragraph><paragraph id="id14AA613477564352BCB8C036B5E46286"><enum>(10)</enum><header>Special rule
regarding importation by individuals</header>
<subparagraph id="id9EAC0237A3A44BB9BA0F20E9C34F5848"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any provision of this title (or an
amendment made by this title), the Secretary shall expedite the designation of
any additional countries from which an individual may import a qualifying drug
into the United States under such section 804 if any action implemented by the
Government of Canada has the effect of limiting or prohibiting the importation
of qualifying drugs into the United States from Canada.</text>
</subparagraph><subparagraph id="idFCD960C7A6F843D88CBA38FA989DF126"><enum>(B)</enum><header>Timing and
criteria</header><text>The Secretary shall designate such additional countries
under subparagraph (A)—</text>
<clause id="id958740709CAA462B828DE71FF2D79779"><enum>(i)</enum><text>not
later than 6 months after the date of the action by the Government of Canada
described under such subparagraph; and</text>
</clause><clause id="idCA53D36A6B514145942F400CE1FC9FE8"><enum>(ii)</enum><text>using the
criteria described under subsection (a)(4)(D)(i)(II) of such section
804.</text>
</clause></subparagraph></paragraph></subsection><subsection id="IDF551245FCA1D4798BC30096506C9FEEA"><enum>(f)</enum><header>Implementation
of Section <enum-in-header>804</enum-in-header></header>
<paragraph id="ID7DE21F5828524BE2977B0CDA625F6D25"><enum>(1)</enum><header>Interim
rule</header><text>The Secretary may promulgate an interim rule for
implementing section 804 of the <act-name parsable-cite="FFDCA">Federal Food,
Drug, and Cosmetic Act</act-name>, as added by subsection (a) of this
section.</text>
</paragraph><paragraph id="ID945809C415FD48C4A18AE67AE3322F50"><enum>(2)</enum><header>No notice of
proposed rulemaking</header><text>The interim rule described under paragraph
(1) may be developed and promulgated by the Secretary without providing general
notice of proposed rulemaking.</text>
</paragraph><paragraph id="IDF1FA44FC556B4EA79FA9B6EFD27FA95D"><enum>(3)</enum><header>Final
rule</header><text>Not later than 1 year after the date on which the Secretary
promulgates an interim rule under paragraph (1), the Secretary shall, in
accordance with procedures under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section 553</external-xref> of title 5, United States Code,
promulgate a final rule for implementing such section 804, which may
incorporate by reference provisions of the interim rule provided for under
paragraph (1), to the extent that such provisions are not modified.</text>
</paragraph></subsection><subsection id="IDD159A99A7A684C06AA6C5485C8096FD0"><enum>(g)</enum><header>Consumer
education</header><text>The Secretary shall carry out activities that educate
consumers—</text>
<paragraph id="IDBD80008964204A7BBDF5179D331512AD"><enum>(1)</enum><text>with regard to
the availability of qualifying drugs for import for personal use from an
exporter registered with and approved by the Food and Drug Administration under
section 804 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and
Cosmetic Act</act-name>, as added by this section, including information on how
to verify whether an exporter is registered and approved by use of the Internet
website of the Food and Drug Administration and the toll-free telephone number
required by this title;</text>
</paragraph><paragraph id="IDF49EE0D2AA1B4AAA978778C0AC627FF4"><enum>(2)</enum><text>that drugs that
consumers attempt to import from an exporter that is not registered with and
approved by the Food and Drug Administration can be seized by the United States
Customs Service and destroyed, and that such drugs may be counterfeit,
unapproved, unsafe, or ineffective;</text>
</paragraph><paragraph id="idD92E88BF2C86463A994A77DF9DB99A1A"><enum>(3)</enum><text>with regard to
the suspension and termination of any registration of a registered importer or
exporter under such section 804; and</text>
</paragraph><paragraph id="ID5A6343A483A2440E911F1E0629191DE2"><enum>(4)</enum><text>with regard to
the availability at domestic retail pharmacies of qualifying drugs imported
under such section 804 by domestic wholesalers and pharmacies registered with
and approved by the Food and Drug Administration.</text>
</paragraph></subsection><subsection id="ID0CE3BCE5AB644AFABD53B45594D5C977"><enum>(h)</enum><header>Effect on
administration practices</header><text>Notwithstanding any provision of this
title (and the amendments made by this title), the practices and policies of
the Food and Drug Administration and Bureau of Customs and Border Protection,
in effect on January 1, 2004, with respect to the importation of prescription
drugs into the United States by an individual, on the person of such
individual, for personal use, shall remain in effect.</text>
</subsection><subsection id="id81FC2F8343A6427996C56C8F16215E5F"><enum>(i)</enum><header>Report to
Congress</header><text>The Federal Trade Commission shall, on an annual basis,
submit to Congress a report that describes any action taken during the period
for which the report is being prepared to enforce the provisions of section
804(n) of the Federal Food, Drug, and Cosmetic Act (as added by this title),
including any pending investigations or civil actions under such
section.</text>
</subsection></section><section id="ID811EBDFE2365427EB22EA69F8AFF79A5"><enum>805.</enum><header>Disposition of
certain drugs denied admission into United States</header>
<subsection id="IDEB5C9ECFDF49462EBF5E1456E1128D41"><enum>(a)</enum><header>In
general</header><text>Chapter VIII of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 381 et seq.), as amended by section 804, is further amended by adding at
the end the following section:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="ID0C5DF90289494C79814A05091048BB29">
<section id="ID662BB921E5974A619ECB4EF0F6A79CAD"><enum>805.</enum><header>Disposition of
certain drugs denied admission</header>
<subsection id="ID4DA088F7111A4A8EB793126FF9BBE8BA"><enum>(a)</enum><header>In
general</header><text>The Secretary of Homeland Security shall deliver to the
Secretary a shipment of drugs that is imported or offered for import into the
United States if—</text>
<paragraph id="IDF0E930946366473C941DEBEF1B5EF79E"><enum>(1)</enum><text>the shipment has
a declared value of less than $10,000; and</text>
</paragraph><paragraph id="IDC08AE3A669D6405DA89975CCA3896DE1"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="IDB152C24466224BB5A187DC285402C2C4"><enum>(A)</enum><text>the shipping container
for such drugs does not bear the markings required under section 804(d)(2);
or</text>
</subparagraph><subparagraph id="ID67F9C8D0D98D43BB8EB701C3427856DA" indent="up1"><enum>(B)</enum><text>the Secretary has requested delivery
of such shipment of drugs.</text>
</subparagraph></paragraph></subsection><subsection id="IDC18CBA9B7B0E4A7DAE70A9792277DDF2"><enum>(b)</enum><header>No bond or
export</header><text>Section 801(b) does not authorize the delivery to the
owner or consignee of drugs delivered to the Secretary under subsection (a)
pursuant to the execution of a bond, and such drugs may not be exported.</text>
</subsection><subsection id="ID4942D589D2EA412984913C504E12AD0E"><enum>(c)</enum><header>Destruction of
violative shipment</header><text>The Secretary shall destroy a shipment of
drugs delivered by the Secretary of Homeland Security to the Secretary under
subsection (a) if—</text>
<paragraph id="IDC555262C17C24B71BD1E1CE0BB34DBF9"><enum>(1)</enum><text>in the case of
drugs that are imported or offered for import from a registered exporter under
section 804, the drugs are in violation of any standard described in section
804(g)(5); or</text>
</paragraph><paragraph id="ID05AE7AD558904919AA9DC1610E3CBDBE"><enum>(2)</enum><text>in the case of
drugs that are not imported or offered for import from a registered exporter
under section 804, the drugs are in violation of a standard referred to in
section 801(a) or 801(d)(1).</text>
</paragraph></subsection><subsection id="ID7C26B2FBD320415A9BBCBD61C6DD76A9"><enum>(d)</enum><header>Certain
procedures</header>
<paragraph id="ID007F297FC4894BA4AEEB331EAC6FF74C"><enum>(1)</enum><header>In
general</header><text>The delivery and destruction of drugs under this section
may be carried out without notice to the importer, owner, or consignee of the
drugs except as required by section 801(g) or section 804(i)(2). The issuance
of receipts for the drugs, and recordkeeping activities regarding the drugs,
may be carried out on a summary basis.</text>
</paragraph><paragraph id="IDD029DA00489843C3BD3AA1C93520094F"><enum>(2)</enum><header>Objective of
procedures</header><text>Procedures promulgated under paragraph (1) shall be
designed toward the objective of ensuring that, with respect to efficiently
utilizing Federal resources available for carrying out this section, a
substantial majority of shipments of drugs subject to described in subsection
(c) are identified and destroyed.</text>
</paragraph></subsection><subsection id="ID829BE754C57B4D3CB3B141AFAF66533E"><enum>(e)</enum><header>Evidence
exception</header><text>Drugs may not be destroyed under subsection (c) to the
extent that the Attorney General of the United States determines that the drugs
should be preserved as evidence or potential evidence with respect to an
offense against the United States.</text>
</subsection><subsection id="IDCD492B638CE94555B264A0BF4FCEE7A6"><enum>(f)</enum><header>Rule of
construction</header><text>This section may not be construed as having any
legal effect on applicable law with respect to a shipment of drugs that is
imported or offered for import into the United States and has a declared value
equal to or greater than
$10,000.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID4AE645B8549E44DAB163A7B14B7B2EE0"><enum>(b)</enum><header>Procedures</header><text>Procedures
for carrying out section 805 of the <act-name parsable-cite="FFDCA">Federal
Food, Drug, and Cosmetic Act</act-name>, as added by subsection (a), shall be
established not later than 90 days after the date of the enactment of this
title.</text>
</subsection><subsection id="ID33D676839A8A4DB1B1FD634F8A766962"><enum>(c)</enum><header>Effective
date</header><text>The amendments made by this section shall take effect on the
date that is 90 days after the date of enactment of this title.</text>
</subsection></section><section id="ID7A4967C5D3FB43449E3CD4845982CB86"><enum>806.</enum><header>Wholesale
distribution of drugs; statements regarding prior sale, purchase, or
trade</header>
<subsection id="ID35D9D803AE2C44DEB9C5219FBA320F48"><enum>(a)</enum><header>Striking of
exemptions; applicability to registered exporters</header><text>Section 503(e)
of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/353">21 U.S.C. 353(e)</external-xref>) is amended—</text>
<paragraph id="IDBE72EF25A50A4B4C9601D9C807996652"><enum>(1)</enum><text>in paragraph
(1)—</text>
<subparagraph id="ID3AEA8987D166492AA795F75F14BAA69B"><enum>(A)</enum><text>by striking
<quote>and who is not the manufacturer or an authorized distributor of record
of such drug</quote>;</text>
</subparagraph><subparagraph id="ID15DF4AA624AE4E74AD6BECA1F6FFAC52"><enum>(B)</enum><text>by striking
<quote>to an authorized distributor of record or</quote>; and</text>
</subparagraph><subparagraph id="ID3C9FCB86C8CB484888EF32E707B39011"><enum>(C)</enum><text>by striking
subparagraph (B) and inserting the following:</text>
<quoted-block id="IDE916BDE28D85422A8A0D9301C0F41A0C">
<subparagraph id="ID2619AA1209714D2FBD8C641C79B1747C" indent="up2"><enum>(B)</enum><text>The fact that a drug subject to
subsection (b) is exported from the United States does not with respect to such
drug exempt any person that is engaged in the business of the wholesale
distribution of the drug from providing the statement described in subparagraph
(A) to the person that receives the drug pursuant to the export of the
drug.</text>
</subparagraph><subparagraph id="IDCA1A4D5C0DCB4BE1B45E4BF850BD2B9D" indent="up2"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="ID787615C4A53E4BA0B92B967A49FF83DB"><enum>(i)</enum><text>The Secretary shall by
regulation establish requirements that supersede subparagraph (A) (referred to
in this subparagraph as <quote>alternative requirements</quote>) to identify
the chain of custody of a drug subject to subsection (b) from the manufacturer
of the drug throughout the wholesale distribution of the drug to a pharmacist
who intends to sell the drug at retail if the Secretary determines that the
alternative requirements, which may include standardized anti-counterfeiting or
track-and-trace technologies, will identify such chain of custody or the
identity of the discrete package of the drug from which the drug is dispensed
with equal or greater certainty to the requirements of subparagraph (A), and
that the alternative requirements are economically and technically
feasible.</text>
</clause><clause id="ID05A2F9041C55456396960A3CC75E83F4" indent="up1"><enum>(ii)</enum><text>When the Secretary promulgates a
final rule to establish such alternative requirements, the final rule in
addition shall, with respect to the registration condition established in
clause (i) of section 804(c)(3)(B), establish a condition equivalent to the
alternative requirements, and such equivalent condition may be met in lieu of
the registration condition established in such clause
(i).</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="ID6CC6C6E463544E0E9C79A2E5DD80D396"><enum>(2)</enum><text>in paragraph
(2)(A), by adding at the end the following: <quote>The preceding sentence may
not be construed as having any applicability with respect to a registered
exporter under section 804.</quote>; and</text>
</paragraph><paragraph id="ID1D6442BB7C5E4A92A476A888588D7E15"><enum>(3)</enum><text>in paragraph (3),
by striking <quote>and subsection (d)—</quote> in the matter preceding
subparagraph (A) and all that follows through <quote>the term <term>wholesale
distribution</term> means</quote> in subparagraph (B) and inserting the
following: <quote>and subsection (d), the term <term>wholesale
distribution</term> means</quote>.</text>
</paragraph></subsection><subsection id="IDBCE645B1C21D443EBD65BBDC97F405AF"><enum>(b)</enum><header>Conforming
amendment</header><text>Section 503(d) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 353(d)) is amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="IDF3F342344FE348528F749B33A4DEFD7D">
<paragraph id="ID532A423F419D4F2CAF7A106AFCFAB657" indent="up1"><enum>(4)</enum><text>Each manufacturer of a drug subject
to subsection (b) shall maintain at its corporate offices a current list of the
authorized distributors of record of such drug.</text>
</paragraph><paragraph id="ID6724042EDC9442E5A443327CB952A8B4" indent="up1"><enum>(5)</enum><text>For purposes of this subsection, the
term <term>authorized distributors of record</term> means those distributors
with whom a manufacturer has established an ongoing relationship to distribute
such manufacturer’s
products.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID04252AEDE39045CCBB324E8F3C71213E"><enum>(c)</enum><header>Effective
date</header>
<paragraph id="ID888606AC2BF340ED93013C869CDF0391"><enum>(1)</enum><header>In
general</header><text>The amendments made by paragraphs (1) and (3) of
subsection (a) and by subsection (b) shall take effect on January 1,
2010.</text>
</paragraph><paragraph id="ID197FEE8D61E74EEFA7165A1F7D86E25D"><enum>(2)</enum><header>Drugs imported
by registered importers under Section
<enum-in-header>804</enum-in-header></header><text>Notwithstanding paragraph
(1), the amendments made by paragraphs (1) and (3) of subsection (a) and by
subsection (b) shall take effect on the date that is 90 days after the date of
enactment of this title with respect to qualifying drugs imported under section
804 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>, as added by section 804.</text>
</paragraph><paragraph id="IDFAB50F6BA18E4B22B21FA461EEE5EC6D"><enum>(3)</enum><header>Effect with
respect to registered exporters</header><text>The amendment made by subsection
(a)(2) shall take effect on the date that is 90 days after the date of
enactment of this title.</text>
</paragraph><paragraph id="IDBDBE97C9A12342CEA21C541F64ABFB19"><enum>(4)</enum><header>Alternative
requirements</header><text>The Secretary shall issue regulations to establish
the alternative requirements, referred to in the amendment made by subsection
(a)(1), that take effect not later than January 1, 2010.</text>
</paragraph><paragraph id="ID828B7916ED094663BA494886B44F1BF5"><enum>(5)</enum><header>Intermediate
requirements</header><text>The Secretary shall by regulation require the use of
standardized anti-counterfeiting or track-and-trace technologies on
prescription drugs at the case and pallet level effective not later than 1 year
after the date of enactment of this title.</text>
</paragraph><paragraph id="id6D3F599452F64540A121721FF1A62CC1"><enum>(6)</enum><header>Additional
requirements</header>
<subparagraph id="idDF6098E18DE540048B9973F94D449F4E"><enum>(A)</enum><header>In
general</header><text>Notwithstanding any other provision of this section, the
Secretary shall, not later than 18 months after the date of enactment of this
title, require that the packaging of any prescription drug incorporates—</text>
<clause id="id860A8883E244474F830AE8978DEDC839"><enum>(i)</enum><text>a
standardized numerical identifier unique to each package of such drug, applied
at the point of manufacturing and repackaging (in which case the numerical
identifier shall be linked to the numerical identifier applied at the point of
manufacturing); and</text>
</clause><clause id="idAF2AB634C5C14E4DB5E72B4D24D53995"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="idC739E8AEDA8C465CB662AEA4A139697B"><enum>(I)</enum><text>overt optically
variable counterfeit-resistant technologies that—</text>
<item id="id3C91EAD645FF4AB69ED9B7B713AFAC59" indent="up1"><enum>(aa)</enum><text>are visible to the naked eye,
providing for visual identification of product authenticity without the need
for readers, microscopes, lighting devices, or scanners;</text>
</item><item id="idEDA54D2A5CDA426095E2DA1797573C30" indent="up1"><enum>(bb)</enum><text>are similar to that used by the
Bureau of Engraving and Printing to secure United States currency;</text>
</item><item id="idFA8A20D9CE9C4AC991F0DD3C6E92A609" indent="up1"><enum>(cc)</enum><text>are manufactured and distributed in a
highly secure, tightly controlled environment; and</text>
</item><item id="id290C167948A2456DA4DFA3309B80B3D8" indent="up1"><enum>(dd)</enum><text>incorporate additional layers of
nonvisible convert security features up to and including forensic capability,
as described in subparagraph (B); or</text>
</item></subclause><subclause id="id499E2482B2114B07ADBEB04BC59EE7F7" indent="up1"><enum>(II)</enum><text>technologies that have a function of
security comparable to that described in subclause (I), as determined by the
Secretary.</text>
</subclause></clause></subparagraph><subparagraph id="idD06735EA2BDD43C4BDC9D3ED6843AAA4"><enum>(B)</enum><header>Standards for
packaging</header><text>For the purpose of making it more difficult to
counterfeit the packaging of drugs subject to this paragraph, the manufacturers
of such drugs shall incorporate the technologies described in subparagraph (A)
into at least 1 additional element of the physical packaging of the drugs,
including blister packs, shrink wrap, package labels, package seals, bottles,
and boxes.</text>
</subparagraph></paragraph></subsection></section><section id="IDD470091DFC3C4DBA8FE507D014677D9D"><enum>807.</enum><header>Internet sales
of prescription drugs</header>
<subsection id="ID579473DD5D6B402B93B4D44B464591EE"><enum>(a)</enum><header>In
general</header><text>Chapter V of the <act-name parsable-cite="FFDCA">Federal
Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>) is amended by
inserting after section 503A the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="IDCBC4A75CBC3B47D7B3FC33CCCC49C64A">
<section id="IDB96FED5EB177430292D0A2BBA43FEDB4"><enum>503B.</enum><header>Internet
sales of prescription drugs</header>
<subsection id="ID92F8798D49FC45089F300B55C830C35E"><enum>(a)</enum><header>Requirements
regarding information on Internet site</header>
<paragraph id="ID8C4DE8E9974546C6931436C7171C0A8A"><enum>(1)</enum><header>In
general</header><text>A person may not dispense a prescription drug pursuant to
a sale of the drug by such person if—</text>
<subparagraph id="ID59E8871D704C47A6AF151115B4BB32B9"><enum>(A)</enum><text>the purchaser of
the drug submitted the purchase order for the drug, or conducted any other part
of the sales transaction for the drug, through an Internet site;</text>
</subparagraph><subparagraph id="IDAC16A1B55EB944BE914573AC9827DC09"><enum>(B)</enum><text>the person
dispenses the drug to the purchaser by mailing or shipping the drug to the
purchaser; and</text>
</subparagraph><subparagraph id="IDFE231A7E217E46DDA857F15FF56CED53"><enum>(C)</enum><text>such site, or any
other Internet site used by such person for purposes of sales of a prescription
drug, fails to meet each of the requirements specified in paragraph (2), other
than a site or pages on a site that—</text>
<clause id="IDA444076479BA4CE4BA4E5FC7EC0A5CAF"><enum>(i)</enum><text>are not intended
to be accessed by purchasers or prospective purchasers; or</text>
</clause><clause id="ID2FE483ED8AC2489891E85E8C22345EB2"><enum>(ii)</enum><text>provide an
Internet information location tool within the meaning of section 231(e)(5) of
the <act-name parsable-cite="CA34">Communications Act of 1934</act-name> (47
U.S.C. 231(e)(5)).</text>
</clause></subparagraph></paragraph><paragraph id="ID9CDBA0FB4B1543219E9109699B626954"><enum>(2)</enum><header>Requirements</header><text>With
respect to an Internet site, the requirements referred to in subparagraph (C)
of paragraph (1) for a person to whom such paragraph applies are as
follows:</text>
<subparagraph id="IDCCD3E56B22E5402D8678887C09517CA1"><enum>(A)</enum><text>Each page of the
site shall include either the following information or a link to a page that
provides the following information:</text>
<clause id="ID7CD5BF1F1E334A2CA1A141A30C928A42"><enum>(i)</enum><text>The name of such
person.</text>
</clause><clause id="ID14C0C75C09724FB285D9F9E7D8B5A9D0"><enum>(ii)</enum><text>Each State in
which the person is authorized by law to dispense prescription drugs.</text>
</clause><clause id="ID39656903D7964F2FBE18A2E7DDD39715"><enum>(iii)</enum><text>The address and
telephone number of each place of business of the person with respect to sales
of prescription drugs through the Internet, other than a place of business that
does not mail or ship prescription drugs to purchasers.</text>
</clause><clause id="ID3FE6F7D07DD44E68A7724EF3925B086B"><enum>(iv)</enum><text>The name of each
individual who serves as a pharmacist for prescription drugs that are mailed or
shipped pursuant to the site, and each State in which the individual is
authorized by law to dispense prescription drugs.</text>
</clause><clause id="IDF3353C8CCA8E47FA98140CABCC9E6B51"><enum>(v)</enum><text>If the person
provides for medical consultations through the site for purposes of providing
prescriptions, the name of each individual who provides such consultations;
each State in which the individual is licensed or otherwise authorized by law
to provide such consultations or practice medicine; and the type or types of
health professions for which the individual holds such licenses or other
authorizations.</text>
</clause></subparagraph><subparagraph id="ID8C586A6D51CE4567B7150F2671798867"><enum>(B)</enum><text>A link to which
paragraph (1) applies shall be displayed in a clear and prominent place and
manner, and shall include in the caption for the link the words
<quote>licensing and contact information</quote>.</text>
</subparagraph></paragraph></subsection><subsection id="ID216ECC955F594320ADB282CE35E5AE21"><enum>(b)</enum><header>Internet sales
without appropriate medical relationships</header>
<paragraph id="ID32B9DC1A11C24A2AB17A3F373FC0269B"><enum>(1)</enum><header>In
general</header><text>Except as provided in paragraph (2), a person may not
dispense a prescription drug, or sell such a drug, if—</text>
<subparagraph id="ID79018EAF2B9849D5A3644C4F57DCFEB3"><enum>(A)</enum><text>for purposes of
such dispensing or sale, the purchaser communicated with the person through the
Internet;</text>
</subparagraph><subparagraph id="IDEB2AE0C4AABB46709B5BDEF6F2770D34"><enum>(B)</enum><text>the patient for
whom the drug was dispensed or purchased did not, when such communications
began, have a prescription for the drug that is valid in the United
States;</text>
</subparagraph><subparagraph id="ID52B377F9B9034339897B3D4DD91C2FFB"><enum>(C)</enum><text>pursuant to such
communications, the person provided for the involvement of a practitioner, or
an individual represented by the person as a practitioner, and the practitioner
or such individual issued a prescription for the drug that was
purchased;</text>
</subparagraph><subparagraph id="IDBB12293497154684AE3F1AA31E5F541B"><enum>(D)</enum><text>the person knew,
or had reason to know, that the practitioner or the individual referred to in
subparagraph (C) did not, when issuing the prescription, have a qualifying
medical relationship with the patient; and</text>
</subparagraph><subparagraph id="IDE3AAAACFC7394B579B3B2FB37CD0BBCF"><enum>(E)</enum><text>the person
received payment for the dispensing or sale of the drug.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">For
purposes of subparagraph (E), payment is received if money or other valuable
consideration is received.</continuation-text></paragraph><paragraph id="IDFEC54C81E86B446EAE2B83A7F84B698C"><enum>(2)</enum><header>Exceptions</header><text>Paragraph
(1) does not apply to—</text>
<subparagraph id="IDF360BEFC44CF4236AD882B8952746611"><enum>(A)</enum><text>the dispensing or
selling of a prescription drug pursuant to telemedicine practices sponsored
by—</text>
<clause id="IDA054798B8DF049469092061CE61B88A0"><enum>(i)</enum><text>a
hospital that has in effect a provider agreement under title XVIII of the
<act-name parsable-cite="SSA">Social Security Act</act-name> (relating to the
Medicare program); or</text>
</clause><clause id="IDE168CD9098F74EC9856BFCA2E673D080"><enum>(ii)</enum><text>a group practice
that has not fewer than 100 physicians who have in effect provider agreements
under such title; or</text>
</clause></subparagraph><subparagraph id="ID99D0ADBE7D8D49B097C7B8CB37C677D1"><enum>(B)</enum><text>the dispensing or
selling of a prescription drug pursuant to practices that promote the public
health, as determined by the Secretary by regulation.</text>
</subparagraph></paragraph><paragraph id="ID05173D41893F48AFAEEE7E8AFCA3FAA7"><enum>(3)</enum><header>Qualifying
medical relationship</header>
<subparagraph id="IDA5377D8C480942FBB570DBEBB40D150F"><enum>(A)</enum><header>In
general</header><text>With respect to issuing a prescription for a drug for a
patient, a practitioner has a qualifying medical relationship with the patient
for purposes of this section if—</text>
<clause id="ID40591F110C2040A0AD64D878F1197113"><enum>(i)</enum><text>at least one
in-person medical evaluation of the patient has been conducted by the
practitioner; or</text>
</clause><clause id="ID38C77D43615F4362B6F256EC0213B1CE"><enum>(ii)</enum><text>the practitioner
conducts a medical evaluation of the patient as a covering practitioner.</text>
</clause></subparagraph><subparagraph id="ID7740DFDEB87041A79A5FD093FEBFF2CF"><enum>(B)</enum><header>In-person
medical evaluation</header><text>A medical evaluation by a practitioner is an
in-person medical evaluation for purposes of this section if the practitioner
is in the physical presence of the patient as part of conducting the
evaluation, without regard to whether portions of the evaluation are conducted
by other health professionals.</text>
</subparagraph><subparagraph id="ID5FC15C5F5EE241F095068B3386E368F2"><enum>(C)</enum><header>Covering
practitioner</header><text>With respect to a patient, a practitioner is a
covering practitioner for purposes of this section if the practitioner conducts
a medical evaluation of the patient at the request of a practitioner who has
conducted at least one in-person medical evaluation of the patient and is
temporarily unavailable to conduct the evaluation of the patient. A
practitioner is a covering practitioner without regard to whether the
practitioner has conducted any in-person medical evaluation of the patient
involved.</text>
</subparagraph></paragraph><paragraph id="ID4D458285760B47C38C00BDAEEF8B98A8"><enum>(4)</enum><header>Rules of
construction</header>
<subparagraph id="IDF401C9CE40124BF9A8B4BBCAF85D683C"><enum>(A)</enum><header>Individuals
represented as practitioners</header><text>A person who is not a practitioner
(as defined in subsection (e)(1)) lacks legal capacity under this section to
have a qualifying medical relationship with any patient.</text>
</subparagraph><subparagraph id="ID444B70FC98554B15B4D1B1E623C2CA54"><enum>(B)</enum><header>Standard
practice of pharmacy</header><text>Paragraph (1) may not be construed as
prohibiting any conduct that is a standard practice in the practice of
pharmacy.</text>
</subparagraph><subparagraph id="IDE83BAFBB806B4B248A3D0889C6C2F994"><enum>(C)</enum><header>Applicability
of requirements</header><text>Paragraph (3) may not be construed as having any
applicability beyond this section, and does not affect any State law, or
interpretation of State law, concerning the practice of medicine.</text>
</subparagraph></paragraph></subsection><subsection id="ID2752852352464FC4989CBFFCA4A20635"><enum>(c)</enum><header>Actions by
States</header>
<paragraph id="ID870C4E220C8545ACB7468F9CB961D11C"><enum>(1)</enum><header>In
general</header><text>Whenever an attorney general of any State has reason to
believe that the interests of the residents of that State have been or are
being threatened or adversely affected because any person has engaged or is
engaging in a pattern or practice that violates section 301(l), the State may
bring a civil action on behalf of its residents in an appropriate district
court of the United States to enjoin such practice, to enforce compliance with
such section (including a nationwide injunction), to obtain damages,
restitution, or other compensation on behalf of residents of such State, to
obtain reasonable attorneys fees and costs if the State prevails in the civil
action, or to obtain such further and other relief as the court may deem
appropriate.</text>
</paragraph><paragraph id="IDCECD7D8C5FCD4047890EAF52A6CB30F5"><enum>(2)</enum><header>Notice</header><text>The
State shall serve prior written notice of any civil action under paragraph (1)
or (5)(B) upon the Secretary and provide the Secretary with a copy of its
complaint, except that if it is not feasible for the State to provide such
prior notice, the State shall serve such notice immediately upon instituting
such action. Upon receiving a notice respecting a civil action, the Secretary
shall have the right—</text>
<subparagraph id="ID235974EEC89F4D8C9F7C9A1ED8DC3752"><enum>(A)</enum><text>to intervene in
such action;</text>
</subparagraph><subparagraph id="ID0CB02F6A5CE84D9FB2BCEB05FC346B2D"><enum>(B)</enum><text>upon so
intervening, to be heard on all matters arising therein; and</text>
</subparagraph><subparagraph id="ID2A81E43F0E00491792A47F5DB211E979"><enum>(C)</enum><text>to file petitions
for appeal.</text>
</subparagraph></paragraph><paragraph id="ID3CFE585166FD49DD8D7ED2D9F7B0149C"><enum>(3)</enum><header>Construction</header><text>For
purposes of bringing any civil action under paragraph (1), nothing in this
chapter shall prevent an attorney general of a State from exercising the powers
conferred on the attorney general by the laws of such State to conduct
investigations or to administer oaths or affirmations or to compel the
attendance of witnesses or the production of documentary and other
evidence.</text>
</paragraph><paragraph id="ID0EF563B33220472080205BB9D5A564EA"><enum>(4)</enum><header>Venue; service
of process</header><text>Any civil action brought under paragraph (1) in a
district court of the United States may be brought in the district in which the
defendant is found, is an inhabitant, or transacts business or wherever venue
is proper under <external-xref legal-doc="usc" parsable-cite="usc/28/1391">section 1391</external-xref> of title 28, United States Code. Process in such
an action may be served in any district in which the defendant is an inhabitant
or in which the defendant may be found.</text>
</paragraph><paragraph id="ID5075AA51547C4481BCF241CFCD8030B2"><enum>(5)</enum><header>Actions by
other State officials</header>
<subparagraph id="IDD790D111D37C41C0B3EE3D5CFA06C41C"><enum>(A)</enum><text>Nothing contained
in this section shall prohibit an authorized State official from proceeding in
State court on the basis of an alleged violation of any civil or criminal
statute of such State.</text>
</subparagraph><subparagraph id="ID1EC13719BC7E48559593B1B7209A3711"><enum>(B)</enum><text>In addition to
actions brought by an attorney general of a State under paragraph (1), such an
action may be brought by officers of such State who are authorized by the State
to bring actions in such State on behalf of its residents.</text>
</subparagraph></paragraph></subsection><subsection id="ID32024C443A5044689C5413A3731AD41C"><enum>(d)</enum><header>Effect of
Section</header><text>This section shall not apply to a person that is a
registered exporter under section 804.</text>
</subsection><subsection id="IDE6B40A3647AA432C9CE5A137016B3758"><enum>(e)</enum><header>General
definitions</header><text>For purposes of this section:</text>
<paragraph id="ID37D641A6527341C18D0A6545AA8E2674"><enum>(1)</enum><text>The term
<term>practitioner</term> means a practitioner referred to in section 503(b)(1)
with respect to issuing a written or oral prescription.</text>
</paragraph><paragraph id="ID1E568E2D2C1342A58024B2341417F91C"><enum>(2)</enum><text>The term
<term>prescription drug</term> means a drug that is described in section
503(b)(1).</text>
</paragraph><paragraph id="ID605D30F2238E42EE9020E2D2A6EE1CE5"><enum>(3)</enum><text>The term
<term>qualifying medical relationship</term>, with respect to a practitioner
and a patient, has the meaning indicated for such term in subsection
(b).</text>
</paragraph></subsection><subsection id="ID3934E0912E7549C1A6AC9A4351658F80"><enum>(f)</enum><header>Internet-Related
definitions</header>
<paragraph id="IDA2D2217FA408431DA87E0344F57595BA"><enum>(1)</enum><header>In
general</header><text>For purposes of this section:</text>
<subparagraph id="ID46A4EBFB9A5D420ABF9144A4B94F0FDD"><enum>(A)</enum><text>The term
<term>Internet</term> means collectively the myriad of computer and
telecommunications facilities, including equipment and operating software,
which comprise the interconnected world-wide network of networks that employ
the transmission control protocol/internet protocol, or any predecessor or
successor protocols to such protocol, to communicate information of all kinds
by wire or radio.</text>
</subparagraph><subparagraph id="ID847B096313784178BAE8093476026A75"><enum>(B)</enum><text>The term
<term>link</term>, with respect to the Internet, means one or more letters,
words, numbers, symbols, or graphic items that appear on a page of an Internet
site for the purpose of serving, when activated, as a method for executing an
electronic command—</text>
<clause id="IDB04607F041E14C719EDAB4A3DF4059EB"><enum>(i)</enum><text>to move from
viewing one portion of a page on such site to another portion of the
page;</text>
</clause><clause id="IDD6B8A78BF7BC456A8C649E009B27EF44"><enum>(ii)</enum><text>to move from
viewing one page on such site to another page on such site; or</text>
</clause><clause id="ID575C90F28D1B4593B0F9481AA2E53DA9"><enum>(iii)</enum><text>to move from
viewing a page on one Internet site to a page on another Internet site.</text>
</clause></subparagraph><subparagraph id="ID0EF4542EE9814E94970C02AE91866CDD"><enum>(C)</enum><text>The term
<term>page</term>, with respect to the Internet, means a document or other file
accessed at an Internet site.</text>
</subparagraph><subparagraph id="IDE3BC817B65B14CB1B52B5B26BBAFCC41"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="IDE4B1DF4EDA2E4FC39A2542A9067FDF85"><enum>(i)</enum><text>The terms
<term>site</term> and <term>address</term>, with respect to the Internet, mean
a specific location on the Internet that is determined by Internet Protocol
numbers. Such term includes the domain name, if any.</text>
</clause><clause id="IDD7230825A42D4502A024115BAF428A10" indent="up1"><enum>(ii)</enum><text>The term <term>domain name</term>
means a method of representing an Internet address without direct reference to
the Internet Protocol numbers for the address, including methods that use
designations such as <quote>.com</quote>, <quote>.edu</quote>,
<quote>.gov</quote>, <quote>.net</quote>, or <quote>.org</quote>.</text>
</clause><clause id="ID1F247C4E995A4A509BC2040ED79A346C" indent="up1"><enum>(iii)</enum><text>The term <term>Internet Protocol
numbers</term> includes any successor protocol for determining a specific
location on the Internet.</text>
</clause></subparagraph></paragraph><paragraph id="IDEBA52DCCE0BF460FBBB0C2225069FC66"><enum>(2)</enum><header>Authority of
Secretary</header><text>The Secretary may by regulation modify any definition
under paragraph (1) to take into account changes in technology.</text>
</paragraph></subsection><subsection id="ID63A3C413DBBC435183E1CF4AFD711CA6"><enum>(g)</enum><header>Interactive
computer service; advertising</header><text>No provider of an interactive
computer service, as defined in section 230(f)(2) of the
<act-name parsable-cite="CA34">Communications Act of 1934</act-name> (47 U.S.C.
230(f)(2)), or of advertising services shall be liable under this section for
dispensing or selling prescription drugs in violation of this section on
account of another person’s selling or dispensing such drugs, provided that the
provider of the interactive computer service or of advertising services does
not own or exercise corporate control over such
person.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID75E2989C7FF3423DA2E10CE00106B6DB"><enum>(b)</enum><header>Inclusion as
prohibited Act</header><text>Section 301 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21
U.S.C. 331) is amended by inserting after paragraph (k) the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="ID5B5A00A4EE0246C4B475877499C96820">
<subsection id="IDE14728FDD32649AB885E5AF7151800DF"><enum>(l)</enum><text>The dispensing or
selling of a prescription drug in violation of section
503B.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID9521E240389E43079A2F5B1ED0430124"><enum>(c)</enum><header>Internet sales
of prescription drugs; consideration by Secretary of practices and procedures
for certification of legitimate businesses</header><text>In carrying out
section 503B of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and
Cosmetic Act</act-name> (as added by subsection (a) of this section), the
Secretary of Health and Human Services shall take into consideration the
practices and procedures of public or private entities that certify that
businesses selling prescription drugs through Internet sites are legitimate
businesses, including practices and procedures regarding disclosure formats and
verification programs.</text>
</subsection><subsection id="IDA5E095FA5B514E878DFB6FEB0E74663D"><enum>(d)</enum><header>Reports
regarding Internet-Related violations of Federal and State laws on dispensing
of drugs</header>
<paragraph id="IDB7BDBD3D8ACD452B8E87F0D76407A07E"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services (referred to
in this subsection as the <quote>Secretary</quote>) shall, pursuant to the
submission of an application meeting the criteria of the Secretary, make an
award of a grant or contract to the National Clearinghouse on Internet
Prescribing (operated by the Federation of State Medical Boards) for the
purpose of—</text>
<subparagraph id="ID34D51C5504144450B5BBD5C8B984F76E"><enum>(A)</enum><text>identifying
Internet sites that appear to be in violation of Federal or State laws
concerning the dispensing of drugs;</text>
</subparagraph><subparagraph id="IDB812BE4375C947BAB5FCB2076124C78A"><enum>(B)</enum><text>reporting such
sites to State medical licensing boards and State pharmacy licensing boards,
and to the Attorney General and the Secretary, for further investigation;
and</text>
</subparagraph><subparagraph id="ID61FF604DB2104CE1A29ACF2173D8A0CF"><enum>(C)</enum><text>submitting, for
each fiscal year for which the award under this subsection is made, a report to
the Secretary describing investigations undertaken with respect to violations
described in subparagraph (A).</text>
</subparagraph></paragraph><paragraph id="ID008E2AD0E3994BAF84C30FDFC32A10BF"><enum>(2)</enum><header>Authorization
of appropriations</header><text>For the purpose of carrying out paragraph (1),
there is authorized to be appropriated $100,000 for each of the first 3 fiscal
years in which this section is in effect.</text>
</paragraph></subsection><subsection id="ID5824C73110844473B6DB7894D6441949"><enum>(e)</enum><header>Effective
date</header><text>The amendments made by subsections (a) and (b) take effect
90 days after the date of enactment of this title, without regard to whether a
final rule to implement such amendments has been promulgated by the Secretary
of Health and Human Services under section 701(a) of the
<act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name>. The preceding sentence may not be construed as affecting the
authority of such Secretary to promulgate such a final rule.</text>
</subsection></section><section id="id43FAA6C1FD744106AB715B3487097A12"><enum>808.</enum><header>Prohibiting
payments to unregistered foreign pharmacies</header>
<subsection id="idEE116BDBA3844D248613DF1688EEB544"><enum>(a)</enum><header>In
general</header><text>Section 303 of the Federal Food, Drug, and Cosmetic Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id160872B2B9134C6EA5C651682C76E75C" style="OLC">
<subsection id="ID91a04745e0b44893ac6e4bc8a5b4b12c"><enum>(g)</enum><header>Restricted
transactions</header>
<paragraph id="id2A4D2FC9B53B4574863E8C384852B35C"><enum>(1)</enum><header>In
general</header><text>The introduction of restricted transactions into a
payment system or the completion of restricted transactions using a payment
system is prohibited.</text>
</paragraph><paragraph id="id5B12D2A5567945F09DCF23D209338856"><enum>(2)</enum><header>Payment
system</header>
<subparagraph id="id911D0F81E85F473A8C4C8F1E430BF223"><enum>(A)</enum><header>In
general</header><text>The term <quote>payment system</quote> means a system
used by a person described in subparagraph (B) to effect a credit transaction,
electronic fund transfer, or money transmitting service that may be used in
connection with, or to facilitate, a restricted transaction, and
includes—</text>
<clause id="idA197921812CD4EC5A84877A4A252B500"><enum>(i)</enum><text>a
credit card system;</text>
</clause><clause id="idBBE490B2F672480E9F7D8CAA5B331329"><enum>(ii)</enum><text>an
international, national, regional, or local network used to effect a credit
transaction, an electronic fund transfer, or a money transmitting service;
and</text>
</clause><clause id="id79F4F18E831441FA842E79F3BC0CD142"><enum>(iii)</enum><text>any other
system that is centrally managed and is primarily engaged in the transmission
and settlement of credit transactions, electronic fund transfers, or money
transmitting services.</text>
</clause></subparagraph><subparagraph id="id76FB7B1986F84CE2886185652603C99D"><enum>(B)</enum><header>Persons
described</header><text>A person referred to in subparagraph (A) is—</text>
<clause id="id0FE382D1DE15478DAE7D6958DDF982B6"><enum>(i)</enum><text>a
creditor;</text>
</clause><clause id="id336E87C14BE8450AB4DF533AE18FCF82"><enum>(ii)</enum><text>a credit card
issuer;</text>
</clause><clause id="id17A2F5FDBA684D35B32DB2C233E46CF2"><enum>(iii)</enum><text>a financial
institution;</text>
</clause><clause id="id60891DB46CC143579C0DAE4E711DE5B0"><enum>(iv)</enum><text>an operator of a
terminal at which an electronic fund transfer may be initiated;</text>
</clause><clause id="id1A5D5F59FBD44225BF0281CF6DC6DCC5"><enum>(v)</enum><text>a
money transmitting business; or</text>
</clause><clause id="idD9A04D4EA41E4D16B603CDB78C184792"><enum>(vi)</enum><text>a participant in
an international, national, regional, or local network used to effect a credit
transaction, electronic fund transfer, or money transmitting service.</text>
</clause></subparagraph></paragraph><paragraph id="idC7FEA1B46E27423DA8579DA698A3FEE8"><enum>(3)</enum><header>Restricted
transaction</header><text>The term <quote>restricted transaction</quote> means
a transaction or transmittal, on behalf of an individual who places an unlawful
drug importation request to any person engaged in the operation of an
unregistered foreign pharmacy, of—</text>
<subparagraph id="idB1B0DCB1D19842FBAEA7FA2FB5FDFC12"><enum>(A)</enum><text>credit, or the
proceeds of credit, extended to or on behalf of the individual for the purpose
of the unlawful drug importation request (including credit extended through the
use of a credit card);</text>
</subparagraph><subparagraph id="id6B503EB8866941799E77F5F93C78F897"><enum>(B)</enum><text>an electronic
fund transfer or funds transmitted by or through a money transmitting business,
or the proceeds of an electronic fund transfer or money transmitting service,
from or on behalf of the individual for the purpose of the unlawful drug
importation request;</text>
</subparagraph><subparagraph id="id723E5DCB899A4D27ABBFF8914B6A3050"><enum>(C)</enum><text>a check, draft,
or similar instrument which is drawn by or on behalf of the individual for the
purpose of the unlawful drug importation request and is drawn on or payable at
or through any financial institution; or</text>
</subparagraph><subparagraph id="id9131F4FC14984B908CD1C99B2F997705"><enum>(D)</enum><text>the proceeds of
any other form of financial transaction (identified by the Board by regulation)
that involves a financial institution as a payor or financial intermediary on
behalf of or for the benefit of the individual for the purpose of the unlawful
drug importation request.</text>
</subparagraph></paragraph><paragraph id="idC55DAA5D555041308A0471A9CD79209B"><enum>(4)</enum><header>Unlawful drug
importation request</header><text>The term <quote>unlawful drug importation
request</quote> means the request, or transmittal of a request, made to an
unregistered foreign pharmacy for a prescription drug by mail (including a
private carrier), facsimile, phone, or electronic mail, or by a means that
involves the use, in whole or in part, of the Internet.</text>
</paragraph><paragraph id="id87807FE7C02040439DEB1C49B52E2597"><enum>(5)</enum><header>Unregistered
foreign pharmacy</header><text>The term <quote>unregistered foreign
pharmacy</quote> means a person in a country other than the United States that
is not a registered exporter under section 804.</text>
</paragraph><paragraph id="id610EE588535D4206969343065AA9D1CA"><enum>(6)</enum><header>Other
definitions</header>
<subparagraph id="idA7E03FA874EF4E44BF3B44064EAF185C"><enum>(A)</enum><header>Credit;
creditor; credit card</header><text>The terms <quote>credit</quote>,
‘creditor’, and <quote>credit card</quote> have the meanings given the terms in
section 103 of the Truth in Lending Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1602">15 U.S.C. 1602</external-xref>).</text>
</subparagraph><subparagraph id="idB683910E34B2425FA9DE575D75F4F4B1"><enum>(B)</enum><header>Access device;
electronic fund transfer</header><text>The terms <quote>access device</quote>
and <quote>electronic fund transfer</quote>—</text>
<clause id="id5D8744E547094B69846201AA7C1F6242"><enum>(i)</enum><text>have the meaning
given the term in section 903 of the Electronic Fund Transfer Act (15 U.S.C.
1693a); and</text>
</clause><clause id="id11A2DBC70B9A436B8536654D2543B9E8"><enum>(ii)</enum><text>the term
<quote>electronic fund transfer</quote> also includes any fund transfer covered
under Article 4A of the Uniform Commercial Code, as in effect in any
State.</text>
</clause></subparagraph><subparagraph id="id3BCAFF2BB286430EBA7A85618B432F33"><enum>(C)</enum><header>Financial
institution</header><text>The term <quote>financial institution</quote>—</text>
<clause id="id1D0AD0355E3048ECA01C054A0D803818"><enum>(i)</enum><text>has the meaning
given the term in section 903 of the Electronic Transfer Fund Act (15 U.S.C.
1693a); and</text>
</clause><clause id="idEE524280F6D94E2C83457182A9BF2FEA"><enum>(ii)</enum><text>includes a
financial institution (as defined in section 509 of the Gramm-Leach-Bliley Act
(<external-xref legal-doc="usc" parsable-cite="usc/15/6809">15 U.S.C. 6809</external-xref>)).</text>
</clause></subparagraph><subparagraph id="idF80DE3BEA4814B84A8CA323F22B66AC1"><enum>(D)</enum><header>Money
transmitting business; money transmitting service</header><text>The terms
<quote>money transmitting business</quote> and <quote>money transmitting
service</quote> have the meaning given the terms in section 5330(d) of title
31, United States Code.</text>
</subparagraph><subparagraph id="idB6187FF36A414264931F0850123ABCC2"><enum>(E)</enum><header>Board</header><text>The
term <quote>Board</quote> means the Board of Governors of the Federal Reserve
System.</text>
</subparagraph></paragraph><paragraph id="id651518061B1D4B308F2F2491CA2384EB"><enum>(7)</enum><header>Policies and
procedures required to prevent restricted transactions</header>
<subparagraph id="id852FA52BB12349098750F71751F59AF8"><enum>(A)</enum><header>Regulations</header><text>The
Board shall promulgate regulations requiring—</text>
<clause id="id9706DCCF28E14C05BCE3C7A27CCC6FA8"><enum>(i)</enum><text>an operator of a
credit card system;</text>
</clause><clause id="id3296FA4B964940E6BA3D0771D3DF5623"><enum>(ii)</enum><text>an operator of
an international, national, regional, or local network used to effect a credit
transaction, an electronic fund transfer, or a money transmitting
service;</text>
</clause><clause id="id7C84CFE0E7C04922A9525D2AB533F284"><enum>(iii)</enum><text>an operator of
any other payment system that is centrally managed and is primarily engaged in
the transmission and settlement of credit transactions, electronic transfers or
money transmitting services where at least one party to the transaction or
transfer is an individual; and</text>
</clause><clause id="idA411595A11644FD7ABDAFA5F87ED5151"><enum>(iv)</enum><text>any other person
described in paragraph (2)(B) and specified by the Board in such
regulations,</text>
</clause><continuation-text continuation-text-level="subparagraph">to
establish policies and procedures that are reasonably designed to prevent the
introduction of a restricted transaction into a payment system or the
completion of a restricted transaction using a payment system</continuation-text></subparagraph><subparagraph id="id64C6991E28EE4529B19E766588CEE394"><enum>(B)</enum><header>Requirements
for policies and procedures</header><text>In promulgating regulations under
subparagraph (A), the Board shall—</text>
<clause id="id13DA5B64A91C4A8899401D016CA1901D"><enum>(i)</enum><text>identify types of
policies and procedures, including nonexclusive examples, that shall be
considered to be reasonably designed to prevent the introduction of restricted
transactions into a payment system or the completion of restricted transactions
using a payment system; and</text>
</clause><clause id="id43AE51DC440344FF9804C412CEB11498"><enum>(ii)</enum><text>to the extent
practicable, permit any payment system, or person described in paragraph
(2)(B), as applicable, to choose among alternative means of preventing the
introduction or completion of restricted transactions.</text>
</clause></subparagraph><subparagraph id="id8B741CB062E94DE2BE063EFF64E7D7A0"><enum>(C)</enum><header>No liability
for blocking or refusing to honor restricted transaction</header>
<clause id="idDA0994CE2F8242949EA8BE6441E88311"><enum>(i)</enum><header>In
general</header><text>A payment system, or a person described in paragraph
(2)(B) that is subject to a regulation issued under this subsection, and any
participant in such payment system that prevents or otherwise refuses to honor
transactions in an effort to implement the policies and procedures required
under this subsection or to otherwise comply with this subsection shall not be
liable to any party for such action.</text>
</clause><clause id="idE4E5D24D2BB849FE853CF7D16592299F"><enum>(ii)</enum><header>Compliance</header><text>A
person described in paragraph (2)(B) meets the requirements of this subsection
if the person relies on and complies with the policies and procedures of a
payment system of which the person is a member or in which the person is a
participant, and such policies and procedures of the payment system comply with
the requirements of the regulations promulgated under subparagraph (A).</text>
</clause></subparagraph><subparagraph id="idB20188344AD94D858C93E973AB69310B"><enum>(D)</enum><header>Enforcement</header>
<clause id="idBDC1F7767966487AB9101BBED85EB65C"><enum>(i)</enum><header>In
general</header><text>This section shall be enforced by the Federal functional
regulators and the Federal Trade Commission under applicable law in the manner
provided in section 505(a) of the Gramm-Leach-Bliley Act (15 U.S.C.
6805(a)).</text>
</clause><clause id="id27D1813E8A5A46B49538001FECE22CBB"><enum>(ii)</enum><header>Factors to be
considered</header><text>In considering any enforcement action under this
subsection against a payment system or person described in paragraph (2)(B),
the Federal functional regulators and the Federal Trade Commission shall
consider the following factors:</text>
<subclause id="id1D831976ACDE4721A5787C703058660C"><enum>(I)</enum><text>The extent to
which the payment system or person knowingly permits restricted
transactions.</text>
</subclause><subclause id="idDA767204412849B3977082F23B75252A"><enum>(II)</enum><text>The history of
the payment system or person in connection with permitting restricted
transactions.</text>
</subclause><subclause id="id0E5370923EB04158A91717E565DEF359"><enum>(III)</enum><text>The extent to
which the payment system or person has established and is maintaining policies
and procedures in compliance with regulations prescribed under this
subsection.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="idF0A93997E8AA461FAE2D3B96F9E72464"><enum>(8)</enum><header>Transactions
permitted</header><text>A payment system, or a person described in paragraph
(2)(B) that is subject to a regulation issued under this subsection, is
authorized to engage in transactions with foreign pharmacies in connection with
investigating violations or potential violations of any rule or requirement
adopted by the payment system or person in connection with complying with
paragraph (7). A payment system, or such a person, and its agents and employees
shall not be found to be in violation of, or liable under, any Federal, State
or other law by virtue of engaging in any such transaction.</text>
</paragraph><paragraph id="idA2D5430BF0EF493B8501C7218AD700BB"><enum>(9)</enum><header>Relation to
State laws</header><text>No requirement, prohibition, or liability may be
imposed on a payment system, or a person described in paragraph (2)(B) that is
subject to a regulation issued under this subsection, under the laws of any
state with respect to any payment transaction by an individual because the
payment transaction involves a payment to a foreign pharmacy.</text>
</paragraph><paragraph id="idD4A4C21354D948DA9D7B6DBFE5CDA867"><enum>(10)</enum><header>Timing of
requirements</header><text>A payment system, or a person described in paragraph
(2)(B) that is subject to a regulation issued under this subsection, must adopt
policies and procedures reasonably designed to comply with any regulations
required under paragraph (7) within 60 days after such regulations are issued
in final
form.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id5B6FE23C26314981B6CC328FB4E95B59"><enum>(b)</enum><header>Effective
date</header><text>The amendment made by this section shall take effect on the
day that is 90 days after the date of enactment of this Act.</text>
</subsection><subsection id="id3A93F9C8FF82427A9853828DA232724C"><enum>(c)</enum><header>Implementation</header><text>The
Board of Governors of the Federal Reserve System shall promulgate regulations
as required by subsection (g)(7) of section 303 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333</external-xref>), as added by subsection (a), not later than 90
days after the date of enactment of this title.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="ID44323B23202841D0BF0C3B3D465583C8" section-type="subsequent-section"><enum>809.</enum><header>Importation
exemption under Controlled Substances Import and Export Act</header><text display-inline="no-display-inline">Section 1006(a)(2) of the Controlled
Substances Import and Export Act (<external-xref legal-doc="usc" parsable-cite="usc/21/956">21 U.S.C. 956(a)(2)</external-xref>) is amended by striking
<quote>not import the controlled substance into the United States in an amount
that exceeds 50 dosage units of the controlled substance.</quote> and inserting
<quote>import into the United States not more than 10 dosage units combined of
all such controlled substances.</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="id77EFAF8A4FF14D8CBF48E6E32F743B00" section-type="subsequent-section"><enum>810.</enum><header>Severability</header><text display-inline="no-display-inline">If any provision of this title, an amendment
by this title, or the application of such provision or amendment to any person
or circumstance is held to be unconstitutional, the remainder of this title,
the amendments made by this title, and the application of the provisions of
such to any person or circumstance shall not affected thereby.</text>
</section><section id="idEA60AFB23694437FA704433AE90E013F"><enum>811.</enum><header>Protection of
health and safety</header><text display-inline="no-display-inline">This title,
and the amendments made by this title, shall become effective only if the
Secretary of Health and Human Services certifies to Congress that the
implementation of this title (and amendments) will—</text>
<paragraph id="ID150045801a25413ebba42cf1b14b4f65"><enum>(1)</enum><text>pose no
additional risk to the public's health and safety; and</text>
</paragraph><paragraph id="ID9e206c719491400187460fba1b42021d"><enum>(2)</enum><text>result in a
significant reduction in the cost of covered products to the American
consumer.</text>
</paragraph></section>
Passed the Senate May 9, 2007.
Secretary.