1.This Act may be cited as
the Drug and Device Accountability Act
of 2009
.
2.Table of contents;
references in Act
(a)The table of
contents for this Act is as follows:
Sec. 1. Short
title.
Sec. 2. Table of contents; references in Act.
TITLE I—Ensuring the safety and quality of medical products and
their components
Subtitle A—Enhanced registration and inspection of drug and
device establishments
Sec. 101. Registration of drug and device
establishments.
Sec. 102. Registration of foreign drug and device
establishments.
Sec. 103. Registration of establishments for drug precursor
ingredients.
Sec. 104. Registration and licensing of drug
importers.
Sec. 105. Inspection of drug and device
establishments.
Sec. 106. Listing of drugs and devices; enhanced information
technology system for registration and listing; inactive
ingredients.
Sec. 107. Fees related to establishment
inspections.
Sec. 108. Electronic submission and certification of
registrations and listings.
Sec. 109. Technical and conforming amendments.
Sec. 110. Effective date.
Subtitle B—Ensuring identity and sourcing of drug
ingredients
Sec. 111. Compendial modernization.
Sec. 112. Testing of drug purity and identity.
Sec. 113. Manufacturer responsibility for source and quality of
drug ingredients.
Sec. 114. Current manufacturing science.
Sec. 115. Country of origin labeling.
Sec. 116. Effective date; implementation.
Subtitle C—Ensuring standards for imported drugs
Sec. 121. Good distribution and import practices.
Sec. 122. Standards for admission of imported drugs and drug
ingredients.
Sec. 123. Prohibition on use of drugs and drug ingredients not
declared as drugs on importation.
Sec. 124. Destruction of unsafe products refused
admission.
Sec. 125. Effective date.
Subtitle D—Enhanced response to unsafe drugs
Sec. 131. Administrative detention of drugs.
Sec. 132. Mandatory recall authority for drugs.
Sec. 133. Records and reports of drug defects and destruction
of defective drugs that cannot be reconditioned.
Sec. 134. Civil money penalties.
Subtitle E—Additional provisions related to medical
products
Sec. 141. Certification of information.
Sec. 142. Whistleblower protections.
Sec. 143. Study by the Institute of Medicine regarding the
review of medical devices.
TITLE II—General authorities to enhance food and drug
administration oversight of products from a global market
Sec. 201. Dedicated foreign inspectorate.
Sec. 202. Authority to exchange confidential information with
foreign government officials.
Sec. 203. Subpoena authority.
Sec. 204. Information reporting.
(b)Except as otherwise specified, amendments made by this Act to
a section or other provision of law are amendments to such section or other
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
<enum>I</enum><header>Ensuring the
safety and quality of medical products and their components</header>
<subtitle id="id3CB9CB47C8F5442E9BB32472AB0F6FBD"><enum>A</enum><header>Enhanced
registration and inspection of drug and device establishments</header>
<section id="idE5B4FFB174CE4921BFE46687848A2275"><enum>101.</enum><header>Registration
of drug and device establishments</header><text display-inline="no-display-inline">Section 510 (21 U.S.C. 360) is
amended—</text>
<paragraph id="id66C0835F84244A3F8E6C728A3BF35E82"><enum>(1)</enum><text>by striking
subsection (b) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id8C12EAB9619D49819254D4E025259133" style="OLC">
<subsection id="id225AEE1F176342C8AFB9B063B1A60C6A"><enum>(b)</enum><header>Registration of
domestic establishments</header><text>Any person who owns or operates any
establishment in any State engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or device shall—</text>
<paragraph id="id09DED1F0712E4262AC0B018807A91729"><enum>(1)</enum><text>upon first
engaging in any such activity, immediately submit a registration to the
Secretary that includes the name of such person, places of business of such
person, all such establishments, the D–U–N–S number of each such establishment,
an e-mail address for use in an emergency, and payment of any inspection fee
for each such establishment required under section 743;</text>
</paragraph><paragraph id="ID6f573a5c38f048b78690a985198cb43b"><enum>(2)</enum><text>thereafter
immediately submit a registration that includes the information and fee
described in paragraph (1) for any additional establishment owned or operated
by such person in any State in which such person begins the manufacture,
preparation, propagation, compounding, or processing of a drug or device;
and</text>
</paragraph><paragraph id="id18B6B3FBD0C7475FA8C15C22655A14FF"><enum>(3)</enum><text>thereafter—</text>
<subparagraph id="idA999A814368444218892F6A066BD81FD"><enum>(A)</enum><text>with respect to
such drugs, submit a registration described in paragraph (1) to the Secretary
on or before December 31 of each year; and</text>
</subparagraph><subparagraph id="id83D4423278C2459DBCC317F70BC48CC9"><enum>(B)</enum><text>with respect to
such devices, submit a registration described in paragraph (1) to the Secretary
during the period beginning on October 1 and ending on December 31 of each
year.</text>
</subparagraph></paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="idAAD711C45EAF43F886B33024151BFE6C"><enum>(2)</enum><text>by striking
subsections (c) and (d).</text>
</paragraph></section><section id="id3996BA85996241A6846DB564275D622C"><enum>102.</enum><header>Registration
of foreign drug and device establishments</header>
<subsection id="id1D5D99888FD74E439341E240A482C178"><enum>(a)</enum><header>Enforcement of
registration of foreign establishments</header><text>Section 502(o) (21 U.S.C.
352(o)) is amended by striking <quote>in any State</quote>.</text>
</subsection><subsection id="idCC8BA99FCAD54CA3AD709C5CE64773E7"><enum>(b)</enum><header>Registration of
foreign establishments</header><text>Section 510 (U.S.C. 360), as amended by
section 101, is further amended—</text>
<paragraph id="id1821BA55DDB34DDEA3A109665C694091"><enum>(1)</enum><text>by transferring
subsection (i) so as to appear after subsection (b); and</text>
</paragraph><paragraph id="id525892AF20774A0999B56BD7022ECCDF"><enum>(2)</enum><text>in subsection (i)
(as so transferred)—</text>
<subparagraph id="id08676CBD7E3C488F8B48A47BB41042AB"><enum>(A)</enum><text>by striking
<quote>(i) (1)</quote> and all that follows through <quote>of each
year.</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idA2B73D5639014876B8B063CA29928916" style="OLC">
<subsection id="idC1B3382218D04BDAA1F381ADA04D5530"><enum>(c)</enum><header>Registration of
foreign establishments</header>
<paragraph id="idF5BEBBC290924C36A97D4DF9BAA58D63"><enum>(1)</enum><header>In
general</header><text>Any person who owns or operates any establishment within
any foreign country engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or device that is imported or offered for
import into the United States shall—</text>
<subparagraph id="id4329A054522440E0B49F403092F09037"><enum>(A)</enum><text>upon first
engaging in any such activity, immediately submit a registration to the
Secretary that includes the name and place of business of such person, all such
establishments, the D–U–N–S number of each such establishment, an e-mail
address for use in an emergency, payment of any inspection fee for each such
establishment required under section 743, the name of the United States agent
of each such establishment, the name of each importer of such drug or device in
the United States that is known to each such establishment, and the name of
each person who imports or offers for import such drug or device to the United
States for purposes of importation;</text>
</subparagraph><subparagraph id="id4122D84C92184DBBBD72B52FE54422D1"><enum>(B)</enum><text>thereafter
immediately submit a registration that includes the information and fee
described in paragraph (1) for any additional establishment owned or operated
by such person within any foreign country in which such person begins the
manufacture, preparation, propagation, compounding, or processing of such a
drug or device; and</text>
</subparagraph><subparagraph id="id2F1B8F9C3D4E411CB1E7DE90AE62C48F"><enum>(C)</enum><text>thereafter—</text>
<clause id="idCA63331B034B4C259B7E702CB7FEF8D5"><enum>(i)</enum><text>with respect to
drugs, submit a registration described in subparagraph (A) to the Secretary on
or before December 31 of each year; and</text>
</clause><clause id="id3FF0F9C2BA264057892A8F5E79BE5AB0"><enum>(ii)</enum><text>with respect to
devices, submit a registration described in subparagraph (A) to the Secretary
during the period beginning on October 1 and ending on December 31 of each
year.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="idC1335A36E1754425B599452CC3BDFDC0"><enum>(B)</enum><text>by striking
paragraph (2);</text>
</subparagraph><subparagraph id="id0FF6A6DC18D64A40B91597DB67464026"><enum>(C)</enum><text>in paragraph (3),
by striking <quote>(3) The Secretary</quote> and inserting <quote>(2)
<header-in-text level="paragraph" style="OLC">Cooperative
arrangements</header-in-text>.—The Secretary</quote>; and</text>
</subparagraph><subparagraph id="id2C394D98903642AE8C2C49F3E7A9FA90"><enum>(D)</enum><text>by moving the
indentation of paragraph (2), as amended, 2 ems to the right.</text>
</subparagraph></paragraph></subsection></section><section id="id913BE7AA2DE144D0B3485B249726BCFE"><enum>103.</enum><header>Registration
of establishments for drug precursor ingredients</header>
<subsection id="id3385990E3A874527800949104B36289F"><enum>(a)</enum><header>Registration of
establishments that manufacture drug precursor
ingredients</header><text>Section 510(a) (21 U.S.C. 360(a)) is amended—</text>
<paragraph id="ID77a193908ec94856bf1534e49fd2fded"><enum>(1)</enum><text>in the matter
preceding paragraph (1), by striking <quote>As used</quote> and inserting
<quote><header-in-text level="subsection" style="OLC">Definitions</header-in-text>.—As used</quote>;</text>
</paragraph><paragraph id="ID60ae8ff4873d4206b6f19f4b0e1dd003"><enum>(2)</enum><text>by redesignating
paragraphs (1) and (2) as paragraphs (2) and (3), respectively; and</text>
</paragraph><paragraph id="ID42bf3d7fcad14eb193813bcf7bd6dbe5"><enum>(3)</enum><text>by inserting
after <quote>this section—</quote> the following:</text>
<quoted-block display-inline="no-display-inline" id="id218716032951452D973667F7226270AB" style="OLC">
<paragraph id="ID204a291c4a684a4893246e1a28f4631a"><enum>(1)</enum><text>the term
<quote>drug</quote> includes a precursor
ingredient;</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="id33D0725A118140458DD39285B0F3A1D3"><enum>(b)</enum><header>Definition of
precursor ingredient</header><text>Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9824E4FDE05E426FA9A9C8A4CF9C8D09" style="OLC">
<subsection id="idEC7608A4684B466C8D7F00DC2E119669"><enum>(rr)</enum><text>The term
<quote>precursor ingredient</quote>, with respect to an active ingredient of a
drug, means an article that is a material—</text>
<paragraph id="idB84660162A1A43E6A7AA27CC4DB09CC7"><enum>(1)</enum><text>of animal origin
from which such active ingredient is derived; or</text>
</paragraph><paragraph id="idF39EE989252943119262BABC823092E8"><enum>(2)</enum><text>used in the final
stage of synthesis or purification of such active ingredient, if so specified
by the Secretary by regulation or in an order approving a drug that bears or
contains such active
ingredient.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="IDc61872104e44448685efd3ac46920ac2"><enum>104.</enum><header>Registration
and licensing of drug importers</header><text display-inline="no-display-inline">Section 510 (21 U.S.C. 360), as amended by
section 102, is further amended by inserting after subsection (c) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idBDA2083317C6420280EC704BB00EB439" style="OLC">
<subsection id="IDea50adc8430e4d5eafc075fb6c1fe9a1"><enum>(d)</enum><header>Registration
and licensing of drug importers</header>
<paragraph id="idCEFC4F2A4F9C4D7D89ACAA0C65852411"><enum>(1)</enum><header>In
general</header><text>Any person who owns or operates any establishment engaged
in the importation, filing for importation, or brokering for importation of a
drug into the United States shall—</text>
<subparagraph id="id58F770C4B8B0438EA3E21F4746BC0E3E"><enum>(A)</enum><text>upon first
engaging in any such activity, immediately submit a registration to the
Secretary that includes the name of such person, places of business of such
person, all such establishments, the D–U–N–S number of each such establishment,
and an e-mail address for use in an emergency;</text>
</subparagraph><subparagraph id="IDee9db661b60a42b7acaa8325f523d295"><enum>(B)</enum><text>thereafter
immediately submit a registration that includes the information described in
subparagraph (A) for any additional establishment owned or operated by such
person in which such person begins any such activity; and</text>
</subparagraph><subparagraph id="IDf10fd63ea7f0434883b70331968365b3"><enum>(C)</enum><text>thereafter submit
a registration described in subparagraph (A) to the Secretary during the period
beginning on October 1 and ending on December 31 of each year.</text>
</subparagraph></paragraph><paragraph id="ID79370f6f8ca3404c8c75224031d8c64c"><enum>(2)</enum><header>Licensing</header>
<subparagraph id="IDf9d7c1aae7e34d11869c679ff22df7f7"><enum>(A)</enum><header>In
general</header><text>The Secretary may require any person engaged in the
importation, filing for importation, or brokering for importation of a drug
into the United States, before engaging in those activities, to obtain a
license to be issued by the Secretary.</text>
</subparagraph><subparagraph id="ID919e7903ac1f45468c291db4d2a55310"><enum>(B)</enum><header>Bond</header><text>The
Secretary may require as a condition of a license for a person under
subparagraph (A) that the person post a bond subject to forfeiture if the
person has, in connection with the importation, filing for importation, or
brokering for importation of a drug into the United States—</text>
<clause id="ID2746f193d1094e33be20ef87d5144e3a"><enum>(i)</enum><text>violated, or
caused the violation, of this Act; or</text>
</clause><clause id="IDabeae993b8cf484db23bc184a6a63294"><enum>(ii)</enum><text>made, or caused
to be made, a false or misleading statement.</text>
</clause></subparagraph><subparagraph id="idEC6B37A40239402DB459FE37BCE6D87D"><enum>(C)</enum><header>Amount of
bond</header><text>The Secretary shall ensure that the amount of any bond
required under subparagraph (B) for a person is sufficient to deter such person
from, in connection with the importation, filing for importation, or brokering
for importation of a drug into the United States—</text>
<clause id="id26AACB8D389B416593347BC36AC0BDA2"><enum>(i)</enum><text>violating, or
causing the violation of, this Act; or</text>
</clause><clause id="idEF8A4A273BB44666AC3024A25CBC2D50"><enum>(ii)</enum><text>making, or
causing to be made, a false or misleading statement.</text>
</clause></subparagraph><subparagraph id="ID238bfa6de64f435192f1294609db0d18"><enum>(D)</enum><header>Revocation</header><text>The
Secretary may revoke the license for a person under subparagraph (A) if the
Secretary finds that, in connection with the importation, filing for
importation, or brokering for importation of a drug into the United States,
such person has—</text>
<clause id="IDce9b64e3f1b04105be088010462e2c3d"><enum>(i)</enum><text>violated, or
caused the violation of, this Act; or</text>
</clause><clause id="ID3dedc8f36e1d45818401862dcf186788"><enum>(ii)</enum><text>made, or caused
to be made, a false or misleading
statement.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="IDc23e53900bac418f825f5405b6a9d9da"><enum>105.</enum><header>Inspection of
drug and device establishments</header>
<subsection id="ID3f46bd19cc424134bc83f9c457ec0b50"><enum>(a)</enum><header>Equal
inspection authority for domestic and foreign establishments; Refused
inspections</header><text>Section 510(h) (21 U.S.C. 360(h)) is amended
by—</text>
<paragraph id="ID74fbc320ab8e4309b57e62f81680192e"><enum>(1)</enum><text>striking
<quote>Every</quote> and inserting:
<header-in-text level="subsection" style="OLC">“Inspections.—</header-in-text></text>
<quoted-block display-inline="no-display-inline" id="id7B11DDF8D7E340B386223C14AB94EB82" style="OLC">
<paragraph id="idE342A2DFBCB1403EB55F94BF290E075B"><enum>(1)</enum><header>In
general</header><text>Every</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="ID60c241ad6689437bb850c34fcc927eb8"><enum>(2)</enum><text>striking
<quote>in any State</quote>; and</text>
</paragraph><paragraph id="ID56482f76ed4c47a5bb4717fe66e2921a"><enum>(3)</enum><text>striking
<quote>704 and every such establishment</quote> and
inserting</text>
<quoted-block display-inline="yes-display-inline" id="idD144185477A54D27B7CDB711DB8BFAB3" style="OLC">
<text>704.</text><paragraph id="ID042859dcac2d429db8a92702a4e4924f"><enum>(2)</enum><header>Refused
inspection</header><text>Any establishment described in paragraph (1) shall not
be considered duly registered under this section if an inspection of such
establishment by the Secretary is refused, delayed, or limited by—</text>
<subparagraph id="IDd564f8ca2ae0403db33696d0f9338ecd"><enum>(A)</enum><text>the person who
owns or operates such establishment, or any agent or employee of such person;
or</text>
</subparagraph><subparagraph id="IDb4c4305e8174482896506972e69f5484"><enum>(B)</enum><text>any agent of a
governmental authority in the foreign country within which such establishment
is located.</text>
</subparagraph></paragraph><paragraph id="idECFEC1CBB61540B4952F96AD53079EE8"><enum>(3)</enum><header>Biennial
inspection schedule</header><text>Except as provided in paragraph (4), and
except for establishments that manufacture, prepare, propagate, compound, or
process only inactive ingredients, every establishment described in paragraph
(1).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="ID968f361cadfb46aaba45ef14753ccd37"><enum>(b)</enum><header>Providing for
risk-based inspections of establishments</header>
<paragraph id="idE517F1F131CF4C8D95BD429A70A524B4"><enum>(1)</enum><header>In
general</header><text>Section 510(h) (21 U.S.C. 360(h)), as amended by
subsection (a), is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idB62365EEB7874F93818C0BA04806876A" style="OLC">
<paragraph id="IDea4a0dd75b624de183e2ee031540afc2"><enum>(4)</enum><header>Risk-based
inspection schedule</header>
<subparagraph id="ID5e6b6ac80f1944c7a68dd24fb88ecb70"><enum>(A)</enum><header>In
general</header><text>The Secretary may by regulation provide for an inspection
schedule for establishments described in paragraph (3) (including those
establishments that manufacture, prepare, propagate, compound, or process only
inactive ingredients) different from that required by such paragraph.</text>
</subparagraph><subparagraph id="ID82dce79be2d3400786af1cb98d7dfd75"><enum>(B)</enum><header>Inspection
frequency and risk-based factors</header><text>In providing for an inspection
schedule under subparagraph (A), the Secretary—</text>
<clause id="ID21511a43788e4e3486520e6fb745ef21"><enum>(i)</enum><text>may require
inspections of an establishment more frequently than once in every successive
2-year period;</text>
</clause><clause id="IDf3c6a28d630b43bf9a658e209049fd6c"><enum>(ii)</enum><text>shall require
inspections of an establishment at least once in every successive 5-year
period; and</text>
</clause><clause id="ID005e1618a34b4ed9b07d49287f7ab838"><enum>(iii)</enum><text>shall
consider—</text>
<subclause id="ID3236bae409304cf2800e4ee36195f31a"><enum>(I)</enum><text>the risks
presented by the drug or drugs, or the device or devices, manufactured,
prepared, propagated, compounded, or processed by an establishment (including
whether the drug is a finished dosage form, an active ingredient, a precursor
ingredient, or an inactive ingredient; the route of administration of the drug;
whether the device is intended to be implanted, permanently implantable, life
sustaining, or life supporting; and the use or uses for which the drug or
device is approved or cleared under this Act or licensed under section 351 of
the Public Health Service Act);</text>
</subclause><subclause id="IDb22d29209cb34899abbe25d7000c2d3f"><enum>(II)</enum><text>whether or not
an establishment is within a foreign country with a governmental authority
responsible for drugs or devices, as applicable, deemed adequate by the
Secretary;</text>
</subclause><subclause id="ID3344843f687048db87b5728ab5b3d9bd"><enum>(III)</enum><text>whether or not,
and the frequency with which, an establishment is subject to inspection by a
governmental authority responsible for drugs or devices, as applicable, deemed
adequate by the Secretary; and</text>
</subclause><subclause id="IDb16d5ac4ab844a01a8f74913a8ce8e88"><enum>(IV)</enum><text>such other
factors as the Secretary determines are relevant to determining an inspection
schedule for establishments.</text>
</subclause></clause></subparagraph><subparagraph id="IDcb9e54cb443d4050883656343abf0cc7"><enum>(C)</enum><header>Risk-based
factors for modifying frequency of inspections of an
establishment</header><text>The Secretary may inspect an establishment at a
frequency different than that required by the inspection schedule under
subparagraph (A) by considering—</text>
<clause id="IDe3bec434b0c3496094e777f26d74ed67"><enum>(i)</enum><text>the history of
any safety problems with any drug or device manufactured, prepared, propagated,
compounded, or processed by the establishment;</text>
</clause><clause id="IDa69ffb621cf647f1bc417bd17067ef70"><enum>(ii)</enum><text>the record of
inspections by the Secretary of the establishment;</text>
</clause><clause id="ID90928f6d3f02488195f652a8bb6432dd"><enum>(iii)</enum><text>with respect to
a drug that is not a finished dosage form, the record of inspections by a
governmental authority responsible for drugs deemed adequate by the
Secretary;</text>
</clause><clause id="IDa712dafbb0454d9ab51eeb663134d279"><enum>(iv)</enum><text>with respect to
a drug that is an inactive ingredient, a quality certification by a private
entity, if the Secretary has agreed to accept such a certification; and</text>
</clause><clause id="IDa8803c98c05a467b8a7ac0734ac5349b"><enum>(v)</enum><text>such other
factors as the Secretary determines are relevant to assessing the risk
presented by the drug or drugs, or the device or devices, manufactured,
prepared, propagated, compounded, or processed by the
establishment.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="id6864ABA360D64780AC8F88CCEDCC1338"><enum>(2)</enum><header>Implementation</header><text>The
Secretary of Health and Human Services may issue a proposed rule to provide for
a risk-based inspection schedule as described in section 510(h)(4) of the
Federal Food, Drug, and Cosmetic Act, as amended by this Act, no earlier than
March 31, 2011.</text>
</paragraph></subsection><subsection id="ID13ba77c6dfe545748fe2c33866221148"><enum>(c)</enum><header>Annual report
on inspections of establishments</header><text>Section 510(h) (21 U.S.C.
360(h)), as amended by subsection (b), is further amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id46EADB8FE4DC49D696D2B5F373A471E4" style="OLC">
<paragraph id="ID76a5c94bdf1c495caf33d500ebdfe26a"><enum>(5)</enum><header>Annual report
on inspections of establishments</header><text>Not later than February 1 of
each year, the Secretary shall submit a report to the Congress about—</text>
<subparagraph id="ID4428f0d8b9554cd2bfef428d9929620a"><enum>(A)</enum><text>the
appropriations used to inspect establishments registered pursuant to this
section in the previous fiscal year;</text>
</subparagraph><subparagraph id="id271B44BDA3A944EDB7CDB328B4D21BED"><enum>(B)</enum><text>the number of
domestic and foreign establishments registered with the Secretary under this
section during the previous calendar year;</text>
</subparagraph><subparagraph id="IDc9c3d221d7bf4624b7952f3bd0ad223f"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="id0B3D37AF3752451E9E6676470CD8BA01"><enum>(i)</enum><text>the number of domestic
and foreign establishments registered pursuant to this section that the
Secretary inspected in the previous fiscal year; and</text>
</clause><clause id="idD720427058964B22B4F87FDEB45048C3" indent="up1"><enum>(ii)</enum><text>if the Secretary has provided for
a schedule under paragraph (4)(A) with different frequencies of inspection for
different classes of establishments, the numbers and identities for each such
class;</text>
</clause></subparagraph><subparagraph id="IDba8a7d3c79ca491187677fc1b018f8f0"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="id312C77AEB37E4A6B87E82EE58DE8F2EB"><enum>(i)</enum><text>the number of domestic
and foreign establishments registered pursuant to this section that the
Secretary did not inspect in the previous fiscal year; and</text>
</clause><clause id="id9A394FA985D34175A88E9EDA37840BA2" indent="up1"><enum>(ii)</enum><text>if the Secretary has provided for
a schedule under paragraph (4)(A) with expected frequencies of inspection for
different classes of establishments, the numbers for each such class;</text>
</clause></subparagraph><subparagraph id="ID57d8cb9b1b404fe7a207f72ee9ffce9f"><enum>(E)</enum><text>information on
the performance in the previous fiscal year of the foreign inspectorate
established under section 704(h) including—</text>
<clause id="id45C8979685C14F82A818A48E0E293F83"><enum>(i)</enum><text>the number of
inspections conducted with and without personnel who are fluent in the language
used in the establishment under inspection;</text>
</clause><clause id="ID781551f24a624b5793a964df1a7d2bf8"><enum>(ii)</enum><text>the number of
personnel in such inspectorate;</text>
</clause><clause id="ID5e2b8911f2e841bda27c5e689f06c1ea"><enum>(iii)</enum><text>the countries
in which such personnel conduct inspections;</text>
</clause><clause id="IDd134fbb4b7214f5484a58f8e94e709ed"><enum>(iv)</enum><text>the offices in
foreign countries where such personnel are permanently stationed;</text>
</clause><clause id="ID6a7b29ea3d744408bfea78ade7f7ba94"><enum>(v)</enum><text>the number of
personnel conducting inspections in each country who are fluent in the language
or languages used in the establishments of that country; and</text>
</clause><clause id="ID974d69b8fdba4af78459f89316814697"><enum>(vi)</enum><text>the number of
personnel who are permanently stationed in each in-country office who are
fluent in the language or languages used in the establishments of that country;
and</text>
</clause></subparagraph><subparagraph id="IDaf691437d5544dedaf3a2fe08b4c3fc8"><enum>(F)</enum><text>other information
deemed relevant by the Secretary.</text>
</subparagraph></paragraph><paragraph id="idD99A9CB2EFD94B1BA38EEE58C1D6B879"><enum>(6)</enum><header>Public
availability of annual reports</header><text>The Secretary shall make the
report required under paragraph (5) available to the public on the Internet Web
site of the Food and Drug
Administration.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="ID91efb273b67f4be9908e571a1e77ad1b"><enum>106.</enum><header>Listing of
drugs and devices; enhanced information technology system for registration and
listing; inactive ingredients</header>
<subsection id="idC7975FB860904C6D802B2C4C97267A10"><enum>(a)</enum><header>Listing of
drugs and devices</header><text display-inline="yes-display-inline">Section
510(j) (21 U.S.C. 360(j)) is amended—</text>
<paragraph id="id4BBD4E5F79D146139E7385568CC8281C"><enum>(1)</enum><text>by striking
<quote>(j)(1) Every person who registers with the Secretary under subsection
(b), (c), (d), or (i)</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id8447060F4C594971BEF49AA3080CDF31" style="OLC">
<subsection id="idCEE5FDC249ED41F7855F03C6A9167204"><enum>(i)</enum><header>Submission of
list of drugs and devices</header>
<paragraph id="idA813EB6D6BA74CB1B5E0B072267F9C08"><enum>(1)</enum><header>In
general</header><text>Every person who registers with the Secretary under
subsection (b) or
(c)</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id9233AE113DEB4165AF461AAA5E443C83"><enum>(2)</enum><text>in paragraph
(1)—</text>
<subparagraph id="IDaa1dabfe68134ac0a9223ef18bc73cbf"><enum>(A)</enum><text>in subparagraph
(B)(i), by inserting <quote>in the case of a drug, the authority under this Act
that does not require such drug to be subject to section 505 and section
512,</quote> after <quote>labeling for such drug or device,</quote>;</text>
</subparagraph><subparagraph id="ID45382711553d4b74b52b4901284cd0f6"><enum>(B)</enum><text>in subparagraph
(B)(ii), by inserting <quote>, in the case of a drug, the authority under this
Act that does not require such drug to be subject to section 505 and section
512,</quote> after <quote>insert for such drug or device</quote>;</text>
</subparagraph><subparagraph id="idDCA0AE02240545FD9A82E4DE714F23D5"><enum>(C)</enum><text>by moving the
indentation of subparagraphs (A) through (D) 2 ems to the right; and</text>
</subparagraph><subparagraph id="idCE3458CEC02D4F41AB39E2E6A22274AA"><enum>(D)</enum><text>in subparagraph
(B), by moving the indentation of clauses (i) and (ii) 2 ems to the
right;</text>
</subparagraph></paragraph><paragraph id="id5849E4D0F228406EAAB3312707933D8A"><enum>(3)</enum><text>in paragraph
(2)—</text>
<subparagraph id="id45C2B38215484D1E820D9C8C2BE3069F"><enum>(A)</enum><text>by striking
<quote>(2) Each person who registers with the Secretary under this
section</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id4C0F97BAAD2447F5BA3EBA49D772C919" style="OLC">
<paragraph id="id31DF3C9A52C44F5F90F916286F15F28D"><enum>(2)</enum><header>Report to
Secretary</header><text>Every person who registers with the Secretary under
subsection (b) or (c)</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id218ACA9E505844F4BC038BA15B28640D"><enum>(B)</enum><text>by moving the
indentation of subparagraphs (A) through (D) 2 ems to the right;</text>
</subparagraph></paragraph><paragraph id="idA7D28CE74E564BB483259F1A8F954D18"><enum>(4)</enum><text>in paragraph (3),
by striking <quote>(3) The Secretary</quote> and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="idB9373A87CBD042DBAFBCCFDDF7775FC9" style="OLC">
<paragraph id="id795FFCD8D4BC4CC4B98D8CC473EE38D8"><enum>(3)</enum><header>Additional
list</header><text>The Secretary</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id5DD3CD4E6ADA4843BAB13FA0C44758DC"><enum>(5)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2A7966E701654196A9D6F31FB0B54A53" style="OLC">
<paragraph id="id83CFCFC5A4684821A6D9BC6854504864"><enum>(4)</enum><header>Submission for
finished dosage form</header><text>Every person who files a list under
paragraph (1) or reports a list under paragraph (2) shall submit with such
list, for any drug that is a finished dosage form, the identity of each
establishment engaged in the manufacture, preparation, propagation,
compounding, or processing of—</text>
<subparagraph id="IDcf9087d083e24ac5ab734e034f492425"><enum>(A)</enum><text>the finished
dosage form;</text>
</subparagraph><subparagraph id="ID55251c841d564d36a085dfeacc75e6e8"><enum>(B)</enum><text>any active
ingredient of the drug;</text>
</subparagraph><subparagraph id="ID50b721f135ab4f6e8c05d567a547ca7e"><enum>(C)</enum><text>any inactive
ingredient of the drug; or</text>
</subparagraph><subparagraph id="IDaf53311e5f154aafab0fff772bd4b3a6"><enum>(D)</enum><text>any precursor
ingredient of any such active
ingredient.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="ID0004de7635dc455babdb1f4557a1f1a8"><enum>(b)</enum><header>Enhanced
information technology system for registration and
listing</header><text>Section 510(j) (21 U.S.C. 360(j)), as amended by
subsection (a), is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id5300ECAB773C476CB3EF12B06CD1D276" style="OLC">
<paragraph id="id4593D8F35FCB49B5ACA792F9F62D9AF6"><enum>(5)</enum><header>Electronic
submission and maintenance of information</header><text>Not later than October
1, 2010, the Secretary shall establish and maintain—</text>
<subparagraph id="IDdc61cd48ba3c40189387e48eef641f02"><enum>(A)</enum><text>an Internet-based
portal through which information to register establishments under subsection
(b), (c), and (d) and to list drugs and devices under this subsection shall be
submitted to the Secretary; and</text>
</subparagraph><subparagraph id="ID45b128bdd357489cb961b388166a8440"><enum>(B)</enum><text>an electronic
database (which shall not be subject to inspection under subsection (f))
populated with the information submitted under subparagraph (A) that—</text>
<clause id="ID2d9e4fca250f488eb9bab18cb4eaffb8"><enum>(i)</enum><text>includes
appropriate links between registered establishments and between such
establishments and listed drugs and devices sufficient to enable the Secretary
to track and assess the establishments and articles involved in the
manufacture, preparation, propagation, compounding, or processing of each drug
that is a finished dosage form or an active ingredient and each device;</text>
</clause><clause id="ID1dfcac4075f4485a848a067fa4ecaa63"><enum>(ii)</enum><text>includes the
date of each inspection by the Secretary (with the Secretary’s report on and
assessment of the inspection) for each such establishment and such other
information on the inspectional record and compliance history of the
establishment as the Secretary deems necessary and appropriate to assess the
compliance history of the establishment and, if applicable, apply the
inspection schedule under subsection (h)(4) to such establishment; and</text>
</clause><clause id="ID3f36428a0047478daa7f4eb8d5b8ebe4"><enum>(iii)</enum><text>is
interoperable and communicates with other relevant databases within the Food
and Drug Administration (including a database for submission of information
under section
801(p)).</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID704d97b4459143ada52d000bdb1df719"><enum>(c)</enum><header>Drugs that are
not approved under Section 505 or 512</header><text>Section 510(f) (21 U.S.C.
360(f)) is amended—</text>
<paragraph id="idDD251ACF31A74899BCB7630B8936F0E9"><enum>(1)</enum><text>by striking
<quote>(f) The Secretary</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idCD41581B20064543A797684279120D68" style="OLC">
<subsection id="idA8D985F7C38A47178233C5E9D09DD911"><enum>(f)</enum><header>Inspection by
public of registration</header>
<paragraph id="id7F81E65A9C294039B3338DD3FBB7AD5C"><enum>(1)</enum><header>In
general</header><text>The
Secretary</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id629A9F1D6D9E4F158293C233432C41E4"><enum>(2)</enum><text>by striking
<quote>subsection (j)</quote> and inserting <quote>subsection (i)</quote>;
and</text>
</paragraph><paragraph id="IDb990ccc07f9a4fbb8304323f3cc2ee62"><enum>(3)</enum><text>by inserting at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idFBFDE1C0156C4FD5AB840ADD09672A77" style="OLC">
<paragraph id="ID7415af54717f4204ac3543f58712a506"><enum>(2)</enum><header>List of drugs
that are not approved under Section 505 or 512</header><text>The Secretary
shall make available to the public on the Internet Web site of the Food and
Drug Administration a list that includes, for each drug described in subsection
(i)(1)(B)—</text>
<subparagraph id="ID1c530222ba6f4e9eb72cb1faa70bc2a7"><enum>(A)</enum><text>the drug;</text>
</subparagraph><subparagraph id="ID16e6a968cb5d44c0bd8cad0764e851c5"><enum>(B)</enum><text>the person who
listed such drug; and</text>
</subparagraph><subparagraph id="ID41598c38718d4a7d8a6d77d3ec943ae9"><enum>(C)</enum><text>the authority
under this Act that does not require such drug to be subject to section 505 and
section 512, as provided by such person in such
list.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="ID06fb1e49f37d4936877b2ae3e6c6e9dd"><enum>(d)</enum><header>Inactive
ingredients</header>
<paragraph id="ID9dd9c143be574d9c9540a31e21a0df53"><enum>(1)</enum><header>Assessment of
establishments that manufacture drug inactive ingredients</header><text>Not
later than March 31, 2011, the Secretary of Health and Human Services (referred
to in this subsection as the <quote>Secretary</quote>) shall—</text>
<subparagraph id="ID85cbf4d144c041b4a3176d01e1bd19df"><enum>(A)</enum><text>use the
information populating the electronic database referred to in section 510(j)(5)
of the Federal, Food, Drug, and Cosmetic Act, as added by subsection (b), to
identify the establishments that manufacture, prepare, propagate, compound, or
process an active ingredient of any drug listed in such database; and</text>
</subparagraph><subparagraph id="ID950d5e9ccea64045b622ff7482b852ab"><enum>(B)</enum><text>complete an
assessment as to whether the exemption from registration in subsection (e) of
section 207.10 of title 21, Code of Federal Regulations, should be eliminated
or modified.</text>
</subparagraph></paragraph><paragraph id="ID35d210f735dc4eee9d7f4078a15ec7a6"><enum>(2)</enum><header>Regulation to
eliminate or modify the exemption from registration for establishments that
manufacture drug inactive ingredients</header><text>In the regulation provided
for under section 105(b)(2), the Secretary may propose to eliminate or modify
the exemption referred to in paragraph (1)(B), as the Secretary deems
appropriate, after having completed the assessment under such paragraph.</text>
</paragraph></subsection></section><section id="IDf20a361322294efcb0fa7d271a026783"><enum>107.</enum><header>Fees related
to establishment inspections</header><text display-inline="no-display-inline">Subchapter C of chapter VII (21 U.S.C. 379f
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idDFF3AC3A1C4D43D6B6671F073B4EF02A" style="OLC">
<part id="id3BC3599998E24E17B949FCF904DBE387"><enum>6</enum><header>Fees related to
establishment inspections</header>
<section id="id0467736ED9DD4FC38D03665E6F1EF618"><enum>743.</enum><header>Authority to
assess and use fees</header>
<subsection id="IDba386be70edc4b8bb1854c132f730572"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="idFDD40CE1A27C4E198E3F04A88035B1E6"><enum>(1)</enum><header>Affiliate</header><text>The
term <quote>affiliate</quote> means a business entity that has a relationship
with a second business entity if, directly or indirectly—</text>
<subparagraph id="IDc1b1716e6b6b4e16ad64e94268dc8057"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="IDf2788362756d4e5bbbba740369f50901"><enum>(B)</enum><text>a third business
entity controls, or has the power to control, both of the business
entities.</text>
</subparagraph></paragraph><paragraph id="ID769ef7209099430c86a4f67004d8dcdf"><enum>(2)</enum><header>Device
establishment</header><text>The term <quote>device establishment</quote>
means—</text>
<subparagraph id="IDbdd37bd6b2e846f7be449185571adb61"><enum>(A)</enum><text>an establishment
in any State that is—</text>
<clause id="IDa1910fa3e9f5416a85f454ef993d1289"><enum>(i)</enum><text>engaged in the
manufacture, preparation, propagation, compounding, or processing of a device
classified in class II or class III; and</text>
</clause><clause id="ID05e24c43e23342f5823856d7e35d7b9a"><enum>(ii)</enum><text>subject to
inspection under subsection (h)(3) or (h)(4) of section 510, as applicable;
or</text>
</clause></subparagraph><subparagraph id="IDa70d5403c07040f6becbac735f66ed35"><enum>(B)</enum><text>an establishment
within any foreign country that is—</text>
<clause id="IDfe948e431e604d7fa51a8a15d0cba26a"><enum>(i)</enum><text>engaged in the
manufacture, preparation, propagation, compounding, or processing of a device
classified in class II or class III that is imported or offered for import into
the United States; and</text>
</clause><clause id="IDac948e246c1846d5819a2a3d7d7a6522"><enum>(ii)</enum><text>subject to
inspection under subsection (h)(3) or (h)(4) of section 510, as
applicable.</text>
</clause></subparagraph></paragraph><paragraph id="IDc90500df1f404558938700a114c74843"><enum>(3)</enum><header>Device
registration and inspection activities</header><text>The term <quote>device
registration and inspection activities</quote> means the following activities
of the Secretary:</text>
<subparagraph id="IDf991eea38dc544b3a1b911fc4216e684"><enum>(A)</enum><text>The registration
of device establishments under subsections (b) and (c) of section 510.</text>
</subparagraph><subparagraph id="IDf8be19756b504051bec7ebd93145836e"><enum>(B)</enum><text>The listing of
devices under section 510(i), including the activities for devices described in
section 510(i)(5).</text>
</subparagraph><subparagraph id="IDd053936581d442609379e673aaa6d15a"><enum>(C)</enum><text>The inspection of
device establishments under section 510(h)(3) or, if applicable, section
510(h)(4).</text>
</subparagraph><subparagraph id="ID165a137e477343dbbd3b87c4d1156509"><enum>(D)</enum><text>The review of
inspection reports from such inspections.</text>
</subparagraph><subparagraph id="ID8e24dca48478446cbfc0db60b7787b82"><enum>(E)</enum><text>Any action under
this Act pursuant to such registration, listing, inspections, or
reviews.</text>
</subparagraph></paragraph><paragraph id="ID7a99e67d9e5c4c72a30818cd340d3cea"><enum>(4)</enum><header>Drug
establishment</header><text>The term <quote>drug establishment</quote>
means—</text>
<subparagraph id="ID5def667005b245f9959e9cb52b01501c"><enum>(A)</enum><text>an establishment
in any State that is—</text>
<clause id="IDe7d7f45a0707476d989c8db45ddad29a"><enum>(i)</enum><text>engaged in the
manufacture, preparation, propagation, compounding, or processing of a drug;
and</text>
</clause><clause id="IDfefdca6fd1a94286ba8010bba1abb1f8"><enum>(ii)</enum><text>subject to
inspection under subsection (h)(3) or (h)(4) of section 510, as applicable;
or</text>
</clause></subparagraph><subparagraph id="ID4d2e59f138174527bce01a77d57deeeb"><enum>(B)</enum><text>an establishment
within any foreign country that is—</text>
<clause id="IDc525c8c6edb94035b35aa33c7db15d2c"><enum>(i)</enum><text>engaged in the
manufacture, preparation, propagation, compounding, or processing of a drug;
and</text>
</clause><clause id="ID442c7fe59c8047a5914cbcad96819334"><enum>(ii)</enum><text>subject to
inspection under subsection (h)(3) or (h)(4) of section 510, as
applicable.</text>
</clause></subparagraph></paragraph><paragraph id="ID184d9f82e03141a98edf511ddb8e90b2"><enum>(5)</enum><header>Drug
registration and inspection activities</header><text>The term <quote>drug
registration and inspection activities</quote> means the following activities
of the Secretary:</text>
<subparagraph id="ID481bb61e4dbd4d658e66ff7c5d62d8ff"><enum>(A)</enum><text>The registration
of drug establishments under subsections (b) and (c) of section 510.</text>
</subparagraph><subparagraph id="ID1ba7d8f4096c42a18f836e0bd564905b"><enum>(B)</enum><text>The listing of
drugs under section 510(i), including the activities for drugs described in
section 510(i)(5).</text>
</subparagraph><subparagraph id="ID593c3d5f7f134ce2923571f8fb7a50df"><enum>(C)</enum><text>The inspection of
drug establishments under section 510(h)(3) or, if applicable, section
510(h)(4).</text>
</subparagraph><subparagraph id="ID56e9d9a3932b47cfba5acbc76e16d309"><enum>(D)</enum><text>The review of
inspection reports from such inspections.</text>
</subparagraph><subparagraph id="IDafebe0d93b4e4efc85618d07cc2edcf4"><enum>(E)</enum><text>Any action under
this Act pursuant to such registration, listing, inspections, or
reviews.</text>
</subparagraph></paragraph><paragraph id="ID0bde759acddf4b9ba1316b53cea296ae"><enum>(6)</enum><header>Person</header><text>The
term <quote>person</quote> includes an affiliate thereof.</text>
</paragraph></subsection><subsection id="ID202e16f9188346deb4b52914d2e7c735"><enum>(b)</enum><header>Types of
fees</header>
<paragraph id="IDb0e00f5f981044728ed9011431346040"><enum>(1)</enum><header>Drug inspection
fees</header><text>Beginning in fiscal year 2010, the Secretary shall collect
drug inspection fees in accordance with this section as follows:</text>
<subparagraph id="ID55b70632e5d34a46a335981efbdf622a"><enum>(A)</enum><header>In
general</header><text>Except as provided under subparagraphs (B), (C), and (D),
each person that during a fiscal year registers a drug establishment under
subsection (b) or (c) of section 510 shall be subject to a drug inspection fee
established under subsection (c)(1).</text>
</subparagraph><subparagraph id="ID1edc6b53a2d34d2898e5fc02f22bf4f5"><enum>(B)</enum><header>Reduction for
positron emission tomography drugs</header><text>The drug inspection fee for a
drug establishment engaged solely in the manufacture, preparation, propagation,
compounding, or processing of 1 or more drugs to which section 736(a)(2)(C)(i)
applies shall be one-sixth of the drug inspection fee otherwise applicable to
such establishment under subsection (c)(1).</text>
</subparagraph><subparagraph id="ID97f8cd310dad4c9faf6f77f8fd945c17"><enum>(C)</enum><header>Exemption for
certain positron emission tomography drugs and certain orphan
drugs</header><text>A drug establishment engaged solely in the manufacture,
preparation, propagation, compounding, or processing of 1 or more drugs to
which section 736(a)(2)(C)(ii) or section 736(k) applies shall not be assessed
a drug inspection fee.</text>
</subparagraph><subparagraph id="IDbb1d6fada1e040b0b20654fecf09c76e"><enum>(D)</enum><header>Waiver or
reduction</header><text>The Secretary shall grant a waiver from or reduction of
the drug inspection fee as provided for under section 736(d).</text>
</subparagraph></paragraph><paragraph id="IDa0b9c4fe9e394ef79ec4fc0f236de244"><enum>(2)</enum><header>Device
inspection fees</header><text>Beginning in fiscal year 2010, the Secretary
shall collect device inspection fees in accordance with this section as
follows:</text>
<subparagraph id="ID401a692e1ead413b87efe06b1579d465"><enum>(A)</enum><header>In
general</header><text>Except as provided under subparagraphs (B) and (C), each
person that during a fiscal year registers a device establishment under
subsection (b) or (c) of section 510 shall pay a device inspection fee
established under subsection (c)(2).</text>
</subparagraph><subparagraph id="ID7dd8fd3e91274e28b66eabe0622d58bb"><enum>(B)</enum><header>Reduction for
small businesses</header><text>The device inspection fee for a device
establishment owned or operated by an entity that qualifies as a small business
under section 738(d)(2) shall be one-fourth of the device inspection fee
otherwise applicable to such establishment under subsection (c)(2).</text>
</subparagraph><subparagraph id="IDbb07f9152ca44802ae3e068bdba388e4"><enum>(C)</enum><header>Exemption for
certain State or Federal government establishments</header><text>A device
establishment operated by a State or Federal Government entity shall not be
assessed a device inspection fee unless a device classified in class II or
class III manufactured by the establishment is to be distributed
commercially.</text>
</subparagraph></paragraph></subsection><subsection id="ID12c0b19d47e647ec854169e019e8f38b"><enum>(c)</enum><header>Fee
amounts</header>
<paragraph id="IDe10d0fa24295418eac0157b8158c82d5"><enum>(1)</enum><header>Drug inspection
fee amounts</header>
<subparagraph id="IDac1611ab9cb149a882e4fc8e185eca05"><enum>(A)</enum><header>In
general</header><text>Beginning with fiscal year 2010, the Secretary shall, not
later than 30 days after the amount has been appropriated for a fiscal year in
an appropriations Act as described in subsection (e)(1), establish for such
fiscal year, and publish in the Federal Register, drug inspection fees, based
on the amount provided for in advance in appropriations Acts for such fees as
described in subsection (e)(1), considering—</text>
<clause id="id71495ADE2EB24CC4B68434692A338DA0"><enum>(i)</enum><text>the requirement
described under subparagraph (C);</text>
</clause><clause id="ID0c1a26ca8e3543d6933a0a4de49b4746"><enum>(ii)</enum><text>the reductions
required under subparagraphs (B) and (D) of subsection (b)(1); and</text>
</clause><clause id="IDc64c48f04eca4957a3b4d5f628cf382f"><enum>(iii)</enum><text>the number of
drug establishments subject to such a fee, considering subparagraphs (C) and
(D) of subsection (b)(1).</text>
</clause></subparagraph><subparagraph id="ID230a6b1e242a42a2bfc210ec7313dbce"><enum>(B)</enum><header>Foreign drug
establishment</header><text>For a foreign drug establishment, the drug
inspection fee shall be—</text>
<clause id="ID6f337ddc57274bfbb396b8779d67a049"><enum>(i)</enum><text>the applicable
drug inspection fee under subparagraph (A), plus</text>
</clause><clause id="ID677bc11cbd0d4ab9942129c288c0c8c0"><enum>(ii)</enum><text>the pro rata
costs, if any, of—</text>
<subclause id="idF9E13B56CCCD4207874F8688EE50F183"><enum>(I)</enum><text>travel to and
within, and lodging in, the country in which the establishment is located for
the individual or individuals who conduct the inspection of the establishment;
and</text>
</subclause><subclause id="ID240398d096684b42bb4354771d9e2d0b"><enum>(II)</enum><text>a translator for
the inspection of the establishment.</text>
</subclause></clause></subparagraph><subparagraph id="IDddebb50746ec4f92a8d402f6352546a1"><enum>(C)</enum><header>Proportional
fees</header>
<clause id="id97F7FFFA5FA84934972420375AC1A1D4"><enum>(i)</enum><header>Inspections
more frequent than every 2 years</header><text>The drug inspection fee for a
drug establishment that under the inspection schedule provided for under
section 510(h)(4) is to be inspected more frequently than once in every 2-year
period shall be more than the drug inspection fee for a drug establishment that
under such schedule is to be inspected once in every 2-year period, in
proportion to the factor by which such drug establishment to be is inspected
more frequently than once in every 2-year period.</text>
</clause><clause id="id8C39D9D4D0234549A900C9F062C5F95C"><enum>(ii)</enum><header>Inspections
less frequent than every 2 years</header><text>The drug inspection fee for a
drug establishment that under the inspection schedule provided for under
section 510(h)(4) is to be inspected less frequently than once in every 2-year
period shall be less than the drug inspection fee for a drug establishment that
under such schedule is to be inspected once in every 2-year period, in
proportion to the factor by which such establishment is to be inspected less
frequently than once in every 2-year period.</text>
</clause></subparagraph></paragraph><paragraph id="ID76bd856c1a2d46eeb8dd925428f10b9d"><enum>(2)</enum><header>Device
inspection fee amounts</header>
<subparagraph id="ID60c4f5e2b61f42829cfd0a06e1732b65"><enum>(A)</enum><header>In
general</header><text>Beginning with fiscal year 2010, the Secretary shall, not
later than 30 days after the amount has been appropriated for a fiscal year in
an appropriations Act as described in subsection (e)(2) establish for such
fiscal year, and publish in the Federal Register device inspection fees, based
on the amount provided for in advance in appropriations Acts for such fees as
described in subsection (e)(2) and considering—</text>
<clause id="id8E049C8F4B3A497D95D9A25D3094FB69"><enum>(i)</enum><text>the requirement
described under subparagraph (C);</text>
</clause><clause id="IDf998c971c06e48a1b0fa730ade498fa0"><enum>(ii)</enum><text>the reduction
required under subsection (b)(2)(B); and</text>
</clause><clause id="IDa5e74d3a667c492eb23f024b29c74ece"><enum>(iii)</enum><text>the number of
device establishments subject to such a fee, considering subsection
(b)(2)(C).</text>
</clause></subparagraph><subparagraph id="ID2efefe3a9cc94ab5a963e90f9eef8dfa"><enum>(B)</enum><header>Foreign device
establishment</header><text>For a foreign device establishment, the device
inspection fee shall be—</text>
<clause id="IDcd108df80a8a4098bd7b8ff564e78e1f"><enum>(i)</enum><text>the applicable
device inspection fee under subparagraph (A), plus</text>
</clause><clause id="IDf3774443eb544d56942227d7d1732aba"><enum>(ii)</enum><text>the pro rata
costs, if any, of—</text>
<subclause id="idEE1178EE048D4BD9A35CDF500BE7D519"><enum>(I)</enum><text>travel to and
within, and lodging in, the country in which the establishment is located for
the individual or individuals who conduct the inspection of the establishment;
and</text>
</subclause><subclause id="ID99b3e19055aa4410b5bf83f9950131a5"><enum>(II)</enum><text>a translator for
the inspection of the establishment.</text>
</subclause></clause></subparagraph><subparagraph id="id04F296AC7D6D4D07A1AC6F7A06E3AD5A"><enum>(C)</enum><header>Proportional
fees</header>
<clause id="id7CB91ADDF710450D8F54582C263F3178"><enum>(i)</enum><header>Inspections
more frequent than every 2 years</header><text>The device inspection fee for a
device establishment that under the inspection schedule provided for under
section 510(h)(4) is to be inspected more frequently than once in every 2-year
period shall be more than the device inspection fee for a device establishment
that under such schedule is to be inspected once in every 2-year period, in
proportion to the factor by which such device establishment is to be inspected
more frequently than once in every 2-year period.</text>
</clause><clause id="idE4241C111954477F9281017BABB3C1D6"><enum>(ii)</enum><header>Inspections
less frequent than every 2 years</header><text>The device inspection fee for a
device establishment that under the inspection schedule provided for under
section 510(h)(4) is to be inspected less frequently than once in every 2-year
period shall be less than the device inspection fee for a device establishment
that under such schedule is to be inspected once in every 2-year period, in
proportion to the factor by which such establishment is to be inspected less
frequently than once in every 2-year period.</text>
</clause></subparagraph></paragraph></subsection><subsection id="ID5bc72893f2864b55ba11380574dbc524"><enum>(d)</enum><header>Effect of
failure To pay fees</header>
<paragraph id="IDc326ed898adb4fb1887fca2f5b70fba0"><enum>(1)</enum><header>Drug inspection
fee</header><text>An establishment subject to a drug inspection fee under
subsection (b) shall be considered not to be registered under section 510 until
all fees under this section owed by the person required to register such
establishment have been paid.</text>
</paragraph><paragraph id="ID41f0e8bc68154a86b0dfdeec8b5feb92"><enum>(2)</enum><header>Device
inspection fee</header><text>An establishment subject to a device inspection
fee under subsection (b) shall be considered not to be registered under section
510 until all fees under this section owed by the person required to register
such establishment have been paid.</text>
</paragraph></subsection><subsection id="ID58be81c8273c4e36abe5146506b9698d"><enum>(e)</enum><header>Crediting and
availability of fees</header>
<paragraph id="ID684fd62a44ac48e9ba075a319a9658da"><enum>(1)</enum><header>Drug inspection
fees</header><text>Drug inspection fees authorized under subsection (b) 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 drug registration and inspection activities.</text>
</paragraph><paragraph id="IDa23f695151d34bd28bbb9dca35ba09c0"><enum>(2)</enum><header>Device
inspection fees</header><text>Device inspection fees authorized under
subsection (b) 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 device
registration and inspection activities.</text>
</paragraph><paragraph id="ID4abe4fd35ff64f849c687e344c2ace3f"><enum>(3)</enum><header>Authorization
of appropriations</header>
<subparagraph id="ID4b7b00420192477fa080903fe351d9d5"><enum>(A)</enum><header>Drug inspection
fees</header><text>Beginning in fiscal year 2010, there is authorized to be
appropriated for each fiscal year for drug inspection fees under this section
such sums as may be necessary to carry out drug inspection activities for such
fiscal year, except that such sums may be no greater than the lesser of—</text>
<clause id="ID205810009a464424a2844e19b2fbfae1"><enum>(i)</enum><text>the amount
appropriated (excluding fees) for such activities for such fiscal year;
or</text>
</clause><clause id="ID821fda183a5a48c59baecf69a3693e07"><enum>(ii)</enum><text>the difference
between the amount necessary to carry out such activities for such fiscal year
(as provided in the report required by subsection (h)(2)(A)) and the amount
appropriated (excluding fees) for such activities for such fiscal year.</text>
</clause></subparagraph><subparagraph id="ID0d6569866e914ce9b9319ece062a53af"><enum>(B)</enum><header>Device
inspection fees</header><text>Beginning in fiscal year 2010, there is
authorized to be appropriated for each fiscal year for device inspection fees
under this section such sums as may be necessary to carry out device
registration and inspection activities for such fiscal year, except that such
sums may be no greater than the lesser of—</text>
<clause id="IDfd236b734ced49588c540a0fc9930e7b"><enum>(i)</enum><text>the amount
appropriated (excluding fees) for such activities for such fiscal year;
or</text>
</clause><clause id="ID32504c4422564d02b598f207e1330dd9"><enum>(ii)</enum><text>the difference
between the amount necessary to carry out such activities for such fiscal year
(as provided in the report required by subsection (h)(2)(B)) and the amount
appropriated (excluding fees) for such activities for such fiscal year.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="IDD48B38247D32408982CF15E546F0E8DE"><enum>(f)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">If the Secretary does not assess fees under
subsection (b) during any portion of a fiscal year and if at a later date in
such fiscal year the Secretary may assess such fees, the Secretary may assess
and collect such fees, without any modification in the rate, at any time in
such fiscal year notwithstanding the provisions of subsections (b) and (c) of
section 510 relating to the date fees are to be paid.</text>
</subsection><subsection id="ID93d935c632a54988bc61d28d67416001"><enum>(g)</enum><header>Collection of
unpaid fees</header><text>In any case where the Secretary does not receive
payment of a fee required to be paid under subsection (b) 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 chapter 37 of title 31, United States Code.</text>
</subsection><subsection id="ID55ba196b7f2a4875b464e228cdcfea22"><enum>(h)</enum><header>Reports</header>
<paragraph id="ID3775a327c9884ace98ef2366f4a85380"><enum>(1)</enum><header>Performance
reports</header><text>Beginning for fiscal year 2010, not later than 120 days
after the end of each fiscal year for which fees are collected under this
section, the Secretary shall prepare and 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—</text>
<subparagraph id="IDcc65215040674054af003bfd8b20475c"><enum>(A)</enum><text>a report
concerning the performance of the Food and Drug Administration with respect to
drug registration and inspection activities during such fiscal year; and</text>
</subparagraph><subparagraph id="ID6e633d46527246a68f7b50814c85dad5"><enum>(B)</enum><text>a report
concerning the performance of the Food and Drug Administration with respect to
device registration and inspection activities during such fiscal year.</text>
</subparagraph></paragraph><paragraph id="ID17788efb11e14d4487dc5013dc6d9b62"><enum>(2)</enum><header>Fiscal
report</header><text>Beginning for fiscal year 2010, not later than 120 days
after the end of each fiscal year for which fees are collected under this
section, the Secretary shall prepare and 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—</text>
<subparagraph id="id9CFE9C24C18B478BB9669F3A0681238B"><enum>(A)</enum><text>a report
on—</text>
<clause id="id28FF572BE0034B699241DE33C63ABDC9"><enum>(i)</enum><text>the
implementation of the authority for drug establishment fees during such fiscal
year;</text>
</clause><clause id="id77D441F5CF4E4081BA868C09969CB7F7"><enum>(ii)</enum><text>the use, by the
Food and Drug Administration, of such fees collected for such fiscal year;
and</text>
</clause><clause id="ID74849c9458434904ae7daf2bb4dc2fb4"><enum>(iii)</enum><text>the amount
necessary to carry out drug registration and inspection activities for the
subsequent fiscal year (with a detailed explanation of the methodology used to
determine such amount); and</text>
</clause></subparagraph><subparagraph id="IDeb9b3a67d6064563a069fa1977c82c87"><enum>(B)</enum><text>a report
on—</text>
<clause id="ID6cda3455ce414d74924a3b5ab38b14af"><enum>(i)</enum><text>the
implementation of the authority for device establishment fees during such
fiscal year;</text>
</clause><clause id="IDe22bd56fb4e94354aaa7d67a17895b82"><enum>(ii)</enum><text>the use, by the
Food and Drug Administration, of such fees collected for such fiscal year;
and</text>
</clause><clause id="ID4df84bd94c9f4218be2995c67eb97a07"><enum>(iii)</enum><text>the amount
necessary to carry out device registration and inspection activities for the
subsequent fiscal year (with a detailed explanation of the methodology used to
determine such amount).</text>
</clause></subparagraph></paragraph><paragraph id="ID3d4e9a2734644467b3a223666a786dfc"><enum>(3)</enum><header>Public
availability</header><text>The Secretary shall make the reports required under
paragraphs (1) and (2) available to the public on the Internet Web site of the
Food and Drug
Administration.</text>
</paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idF6BD6D5C654F4FD2913ADA6917237D50"><enum>108.</enum><header>Electronic
submission and certification of registrations and listings</header><text display-inline="no-display-inline">Section 510 (21 U.S.C. 360), as amended by
section 106, is further amended by—</text>
<paragraph id="ID055a37eba08d4a16a03be3ee9760fed4"><enum>(1)</enum><text>inserting after
subsection (i) the following:</text>
<quoted-block display-inline="no-display-inline" id="idD8BE520B887E4C01B915843D60BA0C90" style="OLC">
<subsection id="id871DB519C76046F680C70C2939D954A7"><enum>(j)</enum><header>Electronic
submission and certification</header><text>Registrations and listings under
this section (including the submission of updated information) shall be
submitted and certified to the Secretary through the electronic portal
described in subsection (i)(5)(A) (or by other electronic means until the
Secretary establishes such portal) 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>
</subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="IDa7668b165f154b3593eabf240246b2d3"><enum>(2)</enum><text>striking
subsection (p).</text>
</paragraph></section><section id="id3DF6E1F2EAEA43A3A50717A97F4CAB34"><enum>109.</enum><header>Technical and
conforming amendments</header>
<subsection id="id0FD2CC0F7EFE4AA39011E14A7D01F7B1"><enum>(a)</enum><header>Section
510</header>
<paragraph id="idF6EA8A6E1DB6405AB847CEA30EBC4E52"><enum>(1)</enum><header>Listing
numbers</header><text>Section 510(e) (21 U.S.C. 360(e)) is amended—</text>
<subparagraph id="id1FA0C9C63E7B4DFCA7698D395DBD71E8"><enum>(A)</enum><text>by striking
<quote>(e) The Secretary</quote> and all that follows through <quote>Any
number</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idB7A088A33F924D5DAF6E3CA536075F41" style="OLC">
<subsection id="idA498C5ACA74F470BB6F6D864DC6799A1"><enum>(e)</enum><header>Listing
number</header><text>The Secretary may assign a listing number to each drug or
class of drugs listed under subsection (i). Any
number</text>
</subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id103DD86FA23F4658806DA553D0CA01E4"><enum>(B)</enum><text>by striking
<quote>subsection (j)</quote> and inserting <quote>subsection
(i)</quote>.</text>
</subparagraph></paragraph><paragraph id="id35C040B89017485FA0CB5CA95D99C658"><enum>(2)</enum><header>Exemptions</header><text>Section
510(g) (21 U.S.C. 360(g)) is amended by striking <quote>(g) The
foregoing</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idD13C6A16166644B88EE38D3FCBEB5306" style="OLC">
<subsection id="id1317C449FFBA4FEBA1BFFE53A63D1BE0"><enum>(g)</enum><header>Exemptions</header><text>The
foregoing</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="id91F9D6C6752346DC84DA0DF330471B9F"><enum>(3)</enum><header>Device
reports</header><text>Section 510(k) (21 U.S.C. 360(k)) is amended by striking
<quote>(k) Each person</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idCDCC8584E9CB41598DE5913A989CC7E0" style="OLC">
<subsection id="idBDEE973C1A6A4699BB815259E63A747D"><enum>(k)</enum><header>Device
reports</header><text>Each
person</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="idF9DE649A192A47B1A8DA5577DB8BCD39"><enum>(4)</enum><header>No report
required</header><text>Section 510(l) (21 U.S.C. 360(l)) is amended by striking
<quote>(l) A report</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idBEC25AF5AD6A465593DC4EE865EB68C7" style="OLC">
<subsection id="idEF2B46F1E2E44B078ECD8F8CCD06D610"><enum>(l)</enum><header>No report
required</header><text>A
report</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="idAF137D1277EB470CB23BE46D2EDC37BB"><enum>(5)</enum><header>Exemptions for
Class II devices</header><text>Section 510(m) (21 U.S.C. 360(m)) is
amended—</text>
<subparagraph id="id289116B1EE194B6D82B7EC516F9728B4"><enum>(A)</enum><text>by striking
<quote>(m)(1) Not later than</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id5710104DA5DD445F936972517AD1ABE1" style="OLC">
<subsection id="idCFB3254F17434CCA834642833469BE43"><enum>(m)</enum><header>Exemptions for
Class II devices</header>
<paragraph id="id2251778943FB4BDAA450826B72295757"><enum>(1)</enum><header>List of
exempted devices</header><text>Not later
than</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id604A0C708C58461BB32419A25D048A08"><enum>(B)</enum><text>by striking
<quote>(2) Beginning</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id840916202D304E22BB935CC970EF7E90" style="OLC">
<paragraph id="idD48254A451F14707B75EB65E9813C104"><enum>(2)</enum><header>Other exempted
devices</header><text>Beginning</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id832807CE52D74CDB93ABF182A318FDBB"><enum>(6)</enum><header>Review of
report</header><text>Section 510(n) (21 U.S.C. 360(n)) is amended by striking
<quote>(n) The Secretary</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idA327CBCACCCD4FEF941498CEE77E4A04" style="OLC">
<subsection id="id6BD0C609878C40CEB504B6A93CFCBE71"><enum>(n)</enum><header>Review of
report</header><text>The
Secretary</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="idFB63AACED11545DD9DE663411C70F355"><enum>(7)</enum><header>Reprocessed
single-use devices</header><text>Section 510(o) (21 U.S.C. 360(o)) is
amended—</text>
<subparagraph id="idC34984D0E62F43F2818F22DD7C095F96"><enum>(A)</enum><text>by striking
<quote>(o)(1) With respect to</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id9436B57C649B4F8D994CF1D501426C57" style="OLC">
<subsection id="id8D0C3E4BDB2C4AF09B06F4BC501D0250"><enum>(o)</enum><header>Reprocessed
single-use devices</header>
<paragraph id="idC9D18E18FB7B4910929A4D1704184559"><enum>(1)</enum><header>Reprocessed
single-use devices for which reports are required</header><text>With respect
to</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="idEBFE5F6F86E648BD95A0AA7088B92092"><enum>(B)</enum><text>in paragraph (1),
by moving the indentation of subparagraphs (A) through (D) 2 ems to the
right;</text>
</subparagraph><subparagraph id="id1F906C1CF9324DEFA80688CA3110D495"><enum>(C)</enum><text>by striking
<quote>(2) With respect to</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idFF484029EDA44D12B2678A93050D86FE" style="OLC">
<paragraph id="id886025B2E5514589A1F50F7C3A90A692"><enum>(2)</enum><header>Critical and
semicritical Reprocessed single-use devices</header><text>With respect
to</text>
</paragraph><after-quoted-block>; and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id90B868DB6ED5443A89EEB9242E994AAC"><enum>(D)</enum><text>in paragraph (2),
by moving the indentation of subparagraphs (A) through (E) 2 ems to the
right.</text>
</subparagraph></paragraph></subsection><subsection id="id57BD0ED3266544759C4D8BC2ED71C851"><enum>(b)</enum><header>Other
provisions</header><text>The Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) is amended—</text>
<paragraph id="idE3DB0CC5D9E24C6C939FCFB4C1919C52"><enum>(1)</enum><text>by striking
<quote>510(i)</quote> each place it appears and inserting
<quote>510(c)</quote>;</text>
</paragraph><paragraph id="id82200B93F7E046FAB556EE0894AFDBE5"><enum>(2)</enum><text>in section
301(p)—</text>
<subparagraph commented="no" id="id588CE9DCEAF447A6A2287493739AEE31"><enum>(A)</enum><text>by striking
<quote>510(j)</quote> and inserting <quote>510(i)</quote>; and</text>
</subparagraph><subparagraph commented="no" id="idA06806467C094B9FBFFCF044CC0CBF7D"><enum>(B)</enum><text>by striking
<quote>510(j)(2)</quote> and inserting <quote>510(i)(2)</quote>;</text>
</subparagraph></paragraph><paragraph id="id02C07BBB9A0B464BBC843AFB5C41DCD1"><enum>(3)</enum><text>in section
502(o), by striking <quote>510(j)</quote> and inserting <quote>510(i)</quote>;
and</text>
</paragraph><paragraph id="id4FB6C1A968234AC4948CC03E490C058D"><enum>(4)</enum><text>in section
801(a), by striking <quote>subsection (i) of section 510</quote> and inserting
<quote>subsection (c) of section 510</quote>.</text>
</paragraph></subsection></section><section id="id82C3F8CD1F104B25B046B488499EF602"><enum>110.</enum><header>Effective
date</header><text display-inline="no-display-inline">Except as otherwise
provided in this subtitle, this subtitle, and the amendments made by this
subtitle, shall take effect on October 1, 2009.</text>
</section></subtitle><subtitle id="id485C76082B844F919D95A977C2F50766"><enum>B</enum><header>Ensuring identity
and sourcing of drug ingredients</header>
<section id="idB60F03EB7B144F74AF385C94E1F0324D"><enum>111.</enum><header>Compendial
modernization</header>
<subsection id="IDe675ffa20c7a4ffebeec630d9d3a5128"><enum>(a)</enum><header>In
general</header><text>Section 501(b) (21 U.S.C. 351(b)) is amended by—</text>
<paragraph id="ID4fbbcc686222423781dbfa5f9a70b2cb"><enum>(1)</enum><text>inserting
<quote>or of the appropriate body charged with the revision of such
compendium</quote> after <quote>are, in the judgment of the
Secretary</quote>;</text>
</paragraph><paragraph id="ID97452dc1f11e42a8a01e6c8203df93ff"><enum>(2)</enum><text>inserting
<quote>(1)</quote> after <quote>insufficient for the making of such
determination,</quote>;</text>
</paragraph><paragraph id="ID198748090f8346d8a1e39161810e95d2"><enum>(3)</enum><text>striking
<quote>attention of the appropriate body charged with the revision of such
compendium</quote> and inserting <quote>attention of such body</quote>;
and</text>
</paragraph><paragraph id="ID67ab168e51264ad1994913ad1c3b1752"><enum>(4)</enum><text>inserting
<quote>, or (2) such body shall bring such fact to the attention of the
Secretary, and the Secretary shall work with such body to develop approaches
that will allow such body to establish sufficient standards</quote> after
<quote>purity shall be made</quote>.</text>
</paragraph></subsection><subsection id="IDfc36f01e952c44909708270ee6cea788"><enum>(b)</enum><header>Rulemaking</header><text>Section
701(e)(1) (21 U.S.C. 371(e)(1)) is amended in the first sentence by deleting
<quote>501(b),</quote>.</text>
</subsection><subsection id="IDbd64fa778f0e4fa789b3b98e8669435e"><enum>(c)</enum><header>Assessment</header><text>The
Secretary of Health and Human Services, in consultation with the United States
Pharmacopeia, other drug regulatory agencies, academic experts, and industry,
shall periodically assess the tests and methods of assay for drugs found in
official compendia to—</text>
<paragraph id="IDdf629b90fd3445509887d1b4b3462609"><enum>(1)</enum><text>identify,
considering current scientific methods, which tests and methods of assay are no
longer scientifically sound and appropriate and of sufficient analytical
precision and specificity for their purpose; and</text>
</paragraph><paragraph id="ID37e4ce665e2949b7a26257c23b01d700"><enum>(2)</enum><text>prioritize which
such tests and methods of assay should be revised, considering—</text>
<subparagraph id="ID5f072929274e4de981790598b3bd3c7c"><enum>(A)</enum><text>the risks posed
by a drug if its strength differs, or its quality or purity falls below, the
compendia standards for such drug; and</text>
</subparagraph><subparagraph id="IDa31261ee02184015b73854b8cf2ba973"><enum>(B)</enum><text>whether such
tests and methods of assay are sufficient to distinguish such drug from
contaminants or adulterants reasonably likely to be present in or on such
drug.</text>
</subparagraph></paragraph></subsection></section><section id="id7CF1F4C873964B07AEE73C4BC3216EED"><enum>112.</enum><header>Testing of
drug purity and identity</header><text display-inline="no-display-inline">Section 501 (21 U.S.C. 351) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idEBCAD64E499B4C5DAC102507C99FB0A2" style="OLC">
<subsection id="ID881e139aff66419d92c5d4caa8cd6354"><enum>(j)</enum><text>If it is a drug
and it bears or contains an article, unless the manufacturer of such drug
verifies the purity and identity of such article using scientifically sound and
appropriate methods of sufficient analytical precision and specificity to
detect and quantify the article separate from—</text>
<paragraph id="id15C1E94EAAC54B9D9E39743C4B53F74E"><enum>(1)</enum><text>impurities;
and</text>
</paragraph><paragraph id="id567F5B898451467EBC7BF33A71FAB1ED"><enum>(2)</enum><text>contaminants and
adulterants reasonably likely to be present in or on such
article.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id5EDCFA243B584B32BDDAB87F39647A74"><enum>113.</enum><header>Manufacturer
responsibility for source and quality of drug ingredients</header><text display-inline="no-display-inline">Section 501 (21 U.S.C. 351), as amended by
section 112, is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id08E1B8E2228B41E5919192D802555C6A" style="OLC">
<subsection id="ID8d7c7cd2e9aa4623ae20e2cc67abc556"><enum>(k)</enum><text>If it is a drug
and the manufacturer or importer fails to establish and maintain for a period
of time determined by the Secretary documentation adequate to—</text>
<paragraph id="ID8d53b6bfc02a4f98a78e8b4aa80e600c"><enum>(1)</enum><text>identify each
establishment that manufactured, processed, packed, or held each article that
is a component of the drug or a precursor ingredient of such a component;
and</text>
</paragraph><paragraph id="ID6b3d3828ee7146c58ba485c9778de075"><enum>(2)</enum><text>establish,
including through appropriate and periodic audits of the establishments
described in paragraph (1), that the drug and each such article is not
adulterated under this section or misbranded under section
502.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id1004EC7BFEA8473F9B4AA65191B05F5A"><enum>114.</enum><header>Current
manufacturing science</header><text display-inline="no-display-inline">Section
501(a) (21 U.S.C. 351(a)) is amended by striking <quote>; or (3)</quote> and
inserting the following: <quote>or (D) if it is manufactured in a manner that
is inconsistent with current manufacturing technologies, including quality
risk-management practices, in-process controls, and relation of quality
standards to clinical performance of the drug or device, as determined by the
Secretary; or (3)</quote>.</text>
</section><section id="ID0efe7195a21a462491b0d2dd264016fd"><enum>115.</enum><header>Country of
origin labeling</header><text display-inline="no-display-inline">Section 502
(21 U.S.C. 352) is amended by inserting after subsection (c) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id95C7D1BFBF3845A28AC395C11B9F44D9" style="OLC">
<subsection commented="no" id="ID124fc9247f6a4971b738e5ac4a32f2e8"><enum>(d)</enum><text>If it is a drug
in final dosage form or device for use on or by patients unless the Internet
Web site of the manufacturer or distributor of the drug or device (whichever is
identified on the label of the drug or device) lists, for each lot of such drug
or device, the identity of—</text>
<paragraph commented="no" id="IDaf6fb2e2c8cc4731b68a7fad78ea5b8a"><enum>(1)</enum><text>the country of
manufacture of the drug or device; and</text>
</paragraph><paragraph commented="no" id="ID59e83d75d2214892927959bcac2ce041"><enum>(2)</enum><text>if it is a drug,
the country of manufacture of each active ingredient of the
drug.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idB02DC32A6FD44FFEABEFD7D9F0B91201"><enum>116.</enum><header>Effective
date; implementation</header>
<subsection id="id330A37FE41E344F49017F0A3B8C3D39C"><enum>(a)</enum><header>Effective
date</header><text display-inline="yes-display-inline">Sections 112, 113, 114,
and 115, and the amendments made by such sections, shall take effect on the
date that is 2 years after the date of enactment of this Act.</text>
</subsection><subsection id="ID91812040406244a89e32d443dc2a8665"><enum>(b)</enum><header>Implementation</header><text>Not
later than 18 months after the date of enactment of this Act, the Secretary of
Health and Human Services shall issue a guidance for industry about how a drug
may comply with the requirements of subsections (a)(2)(D), (j), and (k) of
section 501 of the Federal Food, Drug, and Cosmetic Act (as added by this
subtitle) and section 501(a)(2)(B) of such Act (21 U.S.C. 351(a)(2)(B)).</text>
</subsection></section></subtitle><subtitle id="id571E71FE7B154F4EB7689DF50ED19813"><enum>C</enum><header>Ensuring
standards for imported drugs</header>
<section id="id1C6F1AF00C614F8789DB9512722D8A1C"><enum>121.</enum><header>Good
distribution and import practices</header>
<subsection id="id45F95EE1024C4A2B9EA937A5F0D8F800"><enum>(a)</enum><header>Good
distribution and import practices</header><text>Section 501(a) (21 U.S.C.
351(a)), as amended by section 114, is further amended by striking <quote>; or
(3)</quote> and inserting <quote>or (E) if it is a drug and it is not
distributed, shipped, warehoused, brokered, imported, or conveyed in conformity
with current good distribution and import practices to assure the identity,
strength, quality, and purity of the drug; or (3)</quote>.</text>
</subsection><subsection id="id135D73FFB36244A09E125DF74EF529C8"><enum>(b)</enum><header>Inspection of
importers and distributors of drugs</header><text>Section 704 (21 U.S.C. 374)
is amended—</text>
<paragraph id="id5010ACAF7DD6485583EC713B588FFB38"><enum>(1)</enum><text>in subsection
(a)—</text>
<subparagraph id="idB31CB6FB92D74FFEAE82C75E69B65132"><enum>(A)</enum><text>in paragraph
(1)(A), by inserting <quote>(and in the case of drugs, distributed, shipped,
warehoused, or conveyed),</quote> after <quote>or held,</quote>; and</text>
</subparagraph><subparagraph id="id4194E67DFDF448538F278E05576C12C7"><enum>(B)</enum><text>in the third
sentence—</text>
<clause id="id0129E3FB357649D4B756246362D63220"><enum>(i)</enum><text>by
inserting <quote>(and in the case of drugs, distributed, shipped, warehoused,
or conveyed),</quote> after <quote>packed, or held,</quote>; and</text>
</clause><clause id="idE3D81A44503E4805BBE927AD282C0755"><enum>(ii)</enum><text>by
inserting <quote>, (and in the case of drugs, distributed, shipped, warehoused,
or conveyed),</quote> after <quote>transported, or held</quote>; and</text>
</clause></subparagraph></paragraph><paragraph id="idFD84CAF2B6644BB382DBAE9AA11C3778"><enum>(2)</enum><text>in subsection
(e), by striking <quote>519 or</quote> and inserting <quote>502(a)(2)(E), 519,
or</quote>.</text>
</paragraph></subsection></section><section id="idA1D22A7EC1B64FC8898B6B75C14E264A"><enum>122.</enum><header>Standards for
admission of imported drugs and drug ingredients</header>
<subsection id="id72A2C1C2FB9A4D3C911F59EE3E5027C2"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 801 (21
U.S.C. 381) is amended—</text>
<paragraph id="IDb825945ea2dd43cda0f6fae5218efa17"><enum>(1)</enum><text>in subsection
(o), by striking <quote>drug or</quote>; and</text>
</paragraph><paragraph id="ID11701596f70a4624bb3566322d8f16bd"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE8FC6D02F5D84AE0AA3B97D5B59364AE" style="OLC">
<subsection id="ID7cbf27fae2574bc18497b9996d083a76"><enum>(p)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id9EE749E1C53D4C678EB9A90BCE4EA0AD"><enum>(1)</enum><text>Except as provided in
paragraph (2), a drug, or an article that appears to be a drug, in finished
dosage form, an article that is intended to be a component of a drug, or an
article that is intended to be a precursor ingredient of such a component that
is being imported or offered for import into the United States shall be refused
admission unless the person importing or offering for import such drug or
article provides to the Secretary, at the time of being imported or offered for
import (and through an electronic portal as provided by the Secretary)—</text>
<subparagraph id="id00C9011E93614362BCDAA997E616216A" indent="up1"><enum>(A)</enum><text>all information submitted to U.S.
Customs and Border Protection in the entry declaration for such drug or such
article;</text>
</subparagraph><subparagraph id="idF4CBEA15662049D2B8019D6A403D3A80" indent="up1"><enum>(B)</enum><text>for a drug, or an article that appears
to be a drug, in finished dosage form—</text>
<clause id="idB92E8A0C564141758B39CBDB1155C0BD"><enum>(i)</enum><text>the listing number under section
510(e) of such drug;</text>
</clause><clause id="id308D58D8989E482DB660D6C4FDB6E617"><enum>(ii)</enum><text>the D–U–N–S number of each
establishment in which such drug was manufactured, prepared, propagated,
compounded, or processed;</text>
</clause><clause id="idF72A8CE19EAF4A0CBD16FB15CB62B903"><enum>(iii)</enum><text>the new drug application number,
the biologics license application number, the abbreviated new drug application
number, the number of the investigational new drug exemption for the drug, or
the drug monograph number, as applicable;</text>
</clause><clause id="id5C360380BB904C099BDD908018E3BF7F"><enum>(iv)</enum><text>the label required by the new drug
application, the biologics license application number, abbreviated new drug
application, investigational new drug exemption, or drug monograph, as
applicable; and</text>
</clause><clause id="id28899AFD67F545AF96F4F4DBCDB674AA"><enum>(v)</enum><text>the record of inspections by the
Secretary;</text>
</clause></subparagraph><subparagraph id="id063A6727F7B746319905251CCB3A83E8" indent="up1"><enum>(C)</enum><text>for an article that is an active
ingredient of a drug, or an article that is a precursor ingredient of an active
ingredient—</text>
<clause id="idE6A2F9A7725849628AC6C9821C7BFDC8"><enum>(i)</enum><text>the listing number under section
510(e) of such article;</text>
</clause><clause id="idA0185603BB094F2EA154D49168638418"><enum>(ii)</enum><text>the D–U–N–S number of each
establishment in which such article was manufactured, prepared, propagated,
compounded, or processed;</text>
</clause><clause id="id9AA1EF70D12E4E459D277D0866188C66"><enum>(iii)</enum><text>the new drug application number,
the biologics license application number, the abbreviated new drug application
number, the number of the investigational new drug exemption for the drug, or
the drug monograph number, as applicable, of the finished dosage form for which
such article is intended;</text>
</clause><clause id="idE0AD38DFC95F45BD83368928B62E6EA9"><enum>(iv)</enum><text>the label under a regulatory
exemption from section 502(f)(1); and</text>
</clause><clause id="idE0942100EBD34BA2AD8B97242B291D5B"><enum>(v)</enum><text>the record of inspections by the
Secretary or by a governmental authority responsible for drugs deemed adequate
by the Secretary; and</text>
</clause></subparagraph><subparagraph id="idBC26B53838CF4EBE8FB6F7EA4CD2E199" indent="up1"><enum>(D)</enum><text>for an article (other than an active
ingredient) that is intended to be a component of a drug, or an article that is
a precursor ingredient of any such component—</text>
<clause id="id188C63418B234D84B0669A626C9AB68F"><enum>(i)</enum><text>the listing number under section
510(e) of such article;</text>
</clause><clause id="idC1516FCF22CA4FC89636BAE89D1234E5"><enum>(ii)</enum><text>the D–U–N–S number of each
establishment in which such article was manufactured, prepared, propagated,
compounded, or processed;</text>
</clause><clause id="id899AB356056A4866A5C90296534258FD"><enum>(iii)</enum><text>the new drug application number,
the biologics license application number, the abbreviated new drug application
number, the number of the investigational new drug exemption for the drug, or
the drug monograph number, as applicable, of the finished dosage form for which
such article is intended; and</text>
</clause><clause id="idF0401037A4A04019ADAF6B368FEF7729"><enum>(iv)</enum><subclause commented="no" display-inline="yes-display-inline" id="id53AE79E2352A4981B0393E381B201BD1"><enum>(I)</enum><text>the record of
inspections by the Secretary or by a governmental authority responsible for
drugs deemed adequate by the Secretary;</text>
</subclause><subclause id="id5D74AB1C5D9942D7BD94940BD04D3700" indent="up1"><enum>(II)</enum><text>a quality certification by a
private entity, if the Secretary has agreed to accept such a certification;
and</text>
</subclause><subclause id="idE43DEBA3E50E4255A58FF9CB4F8CD908" indent="up1"><enum>(III)</enum><text>other evidence of quality that
the Secretary has deemed acceptable by regulation.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="idC41C9DA871794C8983410B62367FBEB0" indent="up1"><enum>(2)</enum><text>Paragraph (1) shall not apply
to—</text>
<subparagraph id="id7AA7753E5D81445ABF79E8D05BCB1FF5"><enum>(A)</enum><text>a drug to which subsection (g)
applies; or</text>
</subparagraph><subparagraph id="id07C3D8CA66DC471F935A0B6C2EB3D29B"><enum>(B)</enum><text>an article that—</text>
<clause id="idCE732DE7B0274CB19042C0D2F984611E"><enum>(i)</enum><text>is intended to be subject to
further manufacturing for export as a drug, a device, or a component of a drug
or a device; and</text>
</clause><clause id="id52A478CEF3ED4475AE5F5C3D863A74B7"><enum>(ii)</enum><text>is not deemed to be adulterated or
misbranded under subsection
(e)(1).</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="ID5bc7fdfe508f41119e542d05e0ff85b4"><enum>(b)</enum><header>Implementation</header><text>Not
later than 2 years after the date of enactment of this Act, the Secretary of
Health and Human Services shall provide for an electronic portal for submission
of the information required to be submitted under section 801(p) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a).</text>
</subsection></section><section id="id887C686AA4764506A90C0AC5713FF4D5"><enum>123.</enum><header>Prohibition on
use of drugs and drug ingredients not declared as drugs on
importation</header><text display-inline="no-display-inline">Section 502 (21
U.S.C. 352) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idC4439C39656F47FC86793A8BE217B9C2" style="OLC">
<subsection id="ID209ccbb9f7614c50b5dd8211628bfb32"><enum>(aa)</enum><text>If it is a drug
and it is, bears, or contains an article that, when imported or offered for
import into the United States is intended to be a drug or a component of a
drug, unless—</text>
<paragraph id="idCDEFB91F34374957822F3EB52872FEEF"><enum>(1)</enum><text>the label of such
article, when so imported or offered for import, contains the statement
<quote>for drug use</quote>; and</text>
</paragraph><paragraph id="id1E3299103A294B27ABC05DB548B7341A"><enum>(2)</enum><text>the article is
declared when so imported or offered for import as <quote>for drug
use</quote>.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id9E220DD44DD6498F840270640293E701"><enum>124.</enum><header>Destruction of
unsafe products refused admission</header><text display-inline="no-display-inline">Section 801(a) (21 U.S.C. 381(a)) is amended
by striking the sixth sentence and inserting the following: <quote>The
Secretary of the Treasury shall cause the destruction of any such article
refused admission (1) if the Secretary of Health and Human Services informs the
Secretary of the Treasury that such article appears to pose a risk of injury or
death; or (2) if such article is not exported, under regulations prescribed by
the Secretary of the Treasury, within 90 days of the date of notice of such
refusal or within such additional time as may be permitted pursuant to such
regulations. The preceding sentence shall not apply to drugs to which
subsection (g) applies.</quote>.</text>
</section><section id="id3CF4160CF4234BD4BAF3F6EFEA92F75C"><enum>125.</enum><header>Effective
date</header><text display-inline="no-display-inline">This subtitle, and the
amendments made by this subtitle, shall take effect on the date that is 30 days
after the date of enactment of this Act.</text>
</section></subtitle><subtitle id="idFA74E701798542378D5BA7CA7DD1F6C4"><enum>D</enum><header>Enhanced response
to unsafe drugs</header>
<section id="idE217A816AED042C4ADA8E54D46A138C1"><enum>131.</enum><header>Administrative
detention of drugs</header>
<subsection id="id0D440DF5E43B4AE5BA879B599CB17635"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 304(g) (21
U.S.C. 334(g)) is amended—</text>
<paragraph id="id556EC51F5F3B41FF8C71C3CF7DA95F20"><enum>(1)</enum><text>in paragraph
(1)—</text>
<subparagraph id="idBB0F7A3B50184A0686C662B6117B7B77"><enum>(A)</enum><text>by inserting
<quote>drug or</quote> before <quote>device</quote> each place it appears;
and</text>
</subparagraph><subparagraph id="idFCB82C04E03F4D6A9C4910DD3CE43285"><enum>(B)</enum><text>by inserting
<quote>, or, in the case of a drug, which the officer or employee making the
inspection has reason to believe is in violation of section 505,</quote> after
<quote>or misbranded</quote>; and</text>
</subparagraph></paragraph><paragraph id="id40CA5C3F050B4B89BEA349726B97A315"><enum>(2)</enum><text>in paragraph (2),
by inserting <quote>drug or</quote> before <quote>device</quote> each place it
appears.</text>
</paragraph></subsection><subsection id="idC561415E959B4F97A4302FBEDB705417"><enum>(b)</enum><header>Technical
amendments</header><text>Section 304(g)(1) (21 U.S.C. 334(g)(1)), as amended by
subsection (a), is further amended by—</text>
<paragraph id="idAE3A057C4B8540B79994BC87E517F636"><enum>(1)</enum><text>striking
<quote>(1) If</quote> and inserting <quote>(1)(A) If</quote>;</text>
</paragraph><paragraph id="idC823ACA42A5049BFA615ACE5F08733E7"><enum>(2)</enum><text>striking
<quote>thirty days. Regulations</quote> and inserting the following: “thirty
days.</text>
<quoted-block display-inline="no-display-inline" id="id52752D56B03C4DF693CED9BC87F4D4C9" style="OLC">
<subparagraph id="id7ADDA0B106B5451AA261A69C429A3308" indent="up2"><enum>(B)</enum><text>Regulations</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id7E18DA68AAFE4F61A603AFC225D41325"><enum>(3)</enum><text>striking
<quote>such order. A detention</quote> and inserting the following: “such
order.</text>
<quoted-block display-inline="no-display-inline" id="id0874A82C8E484C049C1DA9F094D11F24" style="OLC">
<subparagraph id="id2BD9E7FE70E540328FE873F27C958932" indent="up2"><enum>(C)</enum><text>A
detention</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id6A28006A34B149C582A5D9C18C9F8EBC"><enum>(4)</enum><text>striking
<quote>as detained. Any person</quote> and inserting the following: “as
detained.</text>
<quoted-block display-inline="no-display-inline" id="id01A21DF6CC144724A76655A574C12B25" style="OLC">
<subparagraph id="id21D83CEDB52B488BBEAAE8064DBC8CA7" indent="up2"><enum>(D)</enum><text>Any
person</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="idC898F912BB8347B0A6EB796BD4F4C4AC"><enum>(c)</enum><header>Regulations</header><text>Until
the date that the Secretary of Health and Human Services issues a final
regulation to implement the amendments to section 304(g) of the Federal Food,
Drug, and Cosmetic Act (as made by subsection (a)), the regulations on
administrative detention in section 800.55 of title 21, Code of Federal
Regulations, shall apply to any administrative detention of a drug under such
section 304(g).</text>
</subsection></section><section id="ID2f2a60e5c5a540d59a6dac93daefe669"><enum>132.</enum><header>Mandatory
recall authority for drugs</header>
<subsection id="idAFBD0F198F5546B6AC39B22099A8366D"><enum>(a)</enum><header>In
general</header><text>Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 506C the following:</text>
<quoted-block display-inline="no-display-inline" id="id26271493D1DC493C812C7E8B8E11D8FD" style="OLC">
<section id="idF612EE5F14484A5699F9710235BA1859"><enum>507.</enum><header>Mandatory
recall authority for drugs</header>
<subsection id="id4B8BD1062B154908ACC438B21232F05C"><enum>(a)</enum><header>Order To cease
distribution; notification; process</header>
<paragraph id="id0613332E70F74497BF632FC158AEDB24"><enum>(1)</enum><header>Order To cease
distribution; notification</header><text>If the Secretary finds that there is a
reasonable probability that a drug intended for human use would cause serious,
adverse health consequences or death, the Secretary shall issue an order
requiring the appropriate person (including the manufacturers, importers,
distributors, or retailers of the drug)—</text>
<subparagraph id="id1F9632E20B5D43BB86A64B3710819CA7"><enum>(A)</enum><text>to immediately
cease distribution of such drug; and</text>
</subparagraph><subparagraph id="idAA668CF5E12D4AEE9B94785BBFF3F040"><enum>(B)</enum><text>to immediately
notify health professionals and hospitals and other health care facilities of
the order and to instruct such professionals and facilities to cease use of
such drug.</text>
</subparagraph></paragraph><paragraph id="id9819F95282DE47F1A32912D33C6623C7"><enum>(2)</enum><header>Process</header><text>The
order under paragraph (1) shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than 10 days after
the date of the issuance of the order, on the actions required by the order and
on whether the order should be amended to require a recall of such drug. If,
after providing an opportunity for such a hearing, the Secretary determines
that inadequate grounds exist to support the actions required by the order, the
Secretary shall vacate the order.</text>
</paragraph></subsection><subsection id="idD82EB1FB86AC4FD3901A0F13EA6CA3D5"><enum>(b)</enum><header>Order To
recall</header>
<paragraph id="id7A27DF70D31E4F5BA40B0FE371829D4B"><enum>(1)</enum><header>In
general</header><text>If, after providing an opportunity for an informal
hearing under subsection (a), the Secretary determines that the order should be
amended to include a recall of the drug with respect to which the order was
issued, the Secretary shall, except as provided in paragraph (2), amend the
order to require a recall. The Secretary shall specify a timetable in which the
drug recall will occur and shall require periodic reports to the Secretary
describing the progress of the recall.</text>
</paragraph><paragraph id="id1ECFBEEEF2A542ABA4D9E7856AB9876B"><enum>(2)</enum><header>Amended
order</header><text>An amended order under paragraph (1)—</text>
<subparagraph id="idAD0D3C2FD7AB4580ADC9D59A50613846"><enum>(A)</enum><text>shall—</text>
<clause id="id834299F1937340259A97A8219958E1A3"><enum>(i)</enum><text>not include
recall of a drug from individuals; and</text>
</clause><clause id="id59DFA316BF444ECC981864DA73E4A602"><enum>(ii)</enum><text>not include
recall of a drug from hospitals and other health care facilities if the
Secretary determines that the risk of recalling such drug from the facilities
presents a greater health risk than the health risk of not recalling the drug
from use; and</text>
</clause></subparagraph><subparagraph id="id3276D61B51594ACAA98969A252A49D70"><enum>(B)</enum><text>shall provide for
notice to individuals subject to the risks associated with the use of such
drug.</text>
</subparagraph></paragraph><paragraph id="id541472145FE648B4BA3292B60A173A7B"><enum>(3)</enum><header>Assistance</header><text>In
providing the notice required by paragraph (2), the Secretary may use the
assistance of health professionals who prescribed or used such a drug for
individuals. If a significant number of such individuals cannot be identified,
the Secretary shall notify such individuals pursuant to section
705(b).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="id9D0E1D4C9AA248E2BA3398C061BAE709"><enum>(b)</enum><header>Regulations</header><text>Until
the date that the Secretary of Health and Human Services issues a final
regulation to implement section 507 of the Federal Food, Drug, and Cosmetic Act
(as added by subsection (a)), the regulations on medical device recall
authority in part 810 of title 21, Code of Federal Regulations, shall apply to
any recall of a drug under such section 507.</text>
</subsection></section><section commented="no" id="idB0E45277AD724787A299F4177F5EDD76"><enum>133.</enum><header>Records and
reports of drug defects and destruction of defective drugs that cannot be
reconditioned</header>
<subsection commented="no" id="id9399449241444DFF9E5741C0CFA233CA"><enum>(a)</enum><header>In
general</header><text>Section 503 (21 U.S.C. 353) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idFBC6B99F41934A8EAB16988E20B94BEB" style="OLC">
<subsection commented="no" id="idA2ACAFBDED0E461E87925DB972EC5740"><enum>(h)</enum><header>Drug
defects</header>
<paragraph commented="no" id="id251E56661B1844C39B59B7B5EEF9CAB4"><enum>(1)</enum><header>Records</header><text>The
manufacturer of a drug shall make and maintain records about any defect of the
drug.</text>
</paragraph><paragraph commented="no" id="id2FD4DD0B83004E45887DBA4303FB3AF0"><enum>(2)</enum><header>Reports</header><text>The
manufacturer of a drug shall submit reports to the Secretary about any defect
of the drug that the Secretary specifies in guidance in accordance with a
schedule specified by the Secretary in such guidance.</text>
</paragraph><paragraph id="ID8fdc47033544499aacf614d30df69c69"><enum>(3)</enum><header>Investigation
and corrective action</header><text>The manufacturer of a drug shall—</text>
<subparagraph id="ID24fbf53b08b64d3f82fc62d74ecee38a"><enum>(A)</enum><text>investigate the
cause of any defect of the drug; and</text>
</subparagraph><subparagraph id="IDb31b18e185994115906e21a53da7d675"><enum>(B)</enum><text>take appropriate
corrective action.</text>
</subparagraph></paragraph><paragraph commented="no" id="idA81FCB3E9B514ABA99240C6E1C117F7F"><enum>(4)</enum><header>Destruction</header><text>If
a drug may cause injury or death because of a defect, the manufacturer shall,
after the investigation of the defect required under paragraph (3), destroy the
drug and shall not recondition the drug.</text>
</paragraph><paragraph commented="no" id="id901A67973CD04C62A21F9BD6C801D874"><enum>(5)</enum><header>Defect</header><text>For
purposes of this subsection, a defect of a drug shall include—</text>
<subparagraph id="ID5dbb0708d4fb46b4879261f4d519dc0a"><enum>(A)</enum><text>microbiological
or other contamination;</text>
</subparagraph><subparagraph id="IDde68e26781994aaaaef752c5ffb14c9f"><enum>(B)</enum><text>significant
chemical, physical, or other change or deterioration;</text>
</subparagraph><subparagraph id="id8441A52940E64F678DBC60EA2BCCE5B2"><enum>(C)</enum><text>any deviation
from purity or identity identified under section 501(j); and</text>
</subparagraph><subparagraph id="ID268fe9e5bff4478da7ee1b5fac0593a6"><enum>(D)</enum><text>any failure of 1
or more batches of the drug to meet a specification established for
it.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="id972BD276CF904C9DA1F59B1846F5DA63"><enum>(b)</enum><header>Prohibited
acts</header><text>Section 301 (21 U.S.C. 331) is amended—</text>
<paragraph commented="no" id="id03A8034ED7AB495B8982F326F5D38631"><enum>(1)</enum><text>in subsection
(d), by striking <quote>505</quote> and inserting <quote>503(h), 505</quote>;
and</text>
</paragraph><paragraph commented="no" id="idCA5CBDA624974E3FA79A01DE6D8EB214"><enum>(2)</enum><text>in subsection
(e), by striking <quote>504</quote> and inserting <quote>503(h),
504</quote>.</text>
</paragraph></subsection><subsection id="id0F878650D3AC4CF48DD984BE6FFFF168"><enum>(c)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The amendments made by
this section shall take effect on the date that is 180 days after the date of
enactment of this Act.</text>
</subsection></section><section commented="no" id="ID3835ca32ca0c42799780085253b1f8cc"><enum>134.</enum><header>Civil money
penalties</header>
<subsection commented="no" id="ID99c113cb33c84f47ad0e1c070671b39f"><enum>(a)</enum><header>In
general</header><text>Section 303(f) (21 U.S.C. 333(f)) is amended—</text>
<paragraph id="id5D5D8A9CB4A642D3B9C07AB0FE2AA6A3"><enum>(1)</enum><text>by redesignating
paragraphs (5), (6), and (7) as paragraphs (6), (7), and (8),
respectively;</text>
</paragraph><paragraph id="id6D52A52EB8704DD1A2596D8DC43F267E"><enum>(2)</enum><text>in paragraph (4),
by striking <quote>or 505–1</quote> each place it appears and inserting
<quote>505–1, 505A, or 523A</quote>;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD46666EC9AC34590B51B5C7B62F767D5"><enum>(3)</enum><text>by inserting
after paragraph (4) the following:</text>
<quoted-block display-inline="no-display-inline" id="id581736F036A84E78A7172698D62F3641" style="OLC">
<paragraph commented="no" id="ID102276cad7c741bf82807c6eb8fc22f2"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id6B200E46C259426FB5FA166B363B7680"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="id900BAC0C6DA642B99313D7F4DEB44BB9"><enum>(i)</enum><text>Any manufacturer,
distributor, importer, broker, or filer that violates a requirement of this Act
that relates to drugs for human use (except a requirement referred to in
paragraph (4) or subsection (g)) shall be liable to the United States for a
civil penalty not to exceed $100,000 per violation.</text>
</clause><clause commented="no" id="idF48E10EF18C547CF912323D403B3A602" indent="up2"><enum>(ii)</enum><text>Each day during which a violation
continues shall be considered a separate violation under clause (i).</text>
</clause></subparagraph><subparagraph commented="no" id="id01E300179CE04C9CAFFCB8AB12551263" indent="up1"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="idBBA937B90DEB43D7AD26041905A533D0"><enum>(i)</enum><text>Any manufacturer,
distributor, importer, broker, or filer that knowingly reports or enters false
or misleading data on documents related to the importation of a drug shall be
liable to the United States for a civil penalty not to exceed $150,000.</text>
</clause><clause commented="no" id="id071129378D0D462EBA64AE2AD9A2773C" indent="up1"><enum>(ii)</enum><text>Each act of reporting or entering
false data shall be considered a separate violation under clause
(i).</text>
</clause></subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id4543FA31B51C4181BDCA4A5762639BC1"><enum>(4)</enum><text>in paragraph (6),
as so redesignated, by striking <quote>, or (4)</quote> each place it appears
and inserting <quote>(4), or (5)</quote>;</text>
</paragraph><paragraph id="id777B6C5C672B4F2AA8E17DC021034DD0"><enum>(5)</enum><text>in paragraph (7),
as so redesignated, by striking <quote>(5)(A)</quote> and inserting
<quote>(6)(A)</quote>; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8AFB2A7F08F340028003E153CF9F6884"><enum>(6)</enum><text>in paragraph (8),
as so redesignated, by striking <quote>paragraph (6)</quote> each place it
appears and inserting <quote>paragraph (7)</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id2C468B96DB7144ADAF3A1DD47D911DDC"><enum>(b)</enum><header>Applicability</header><text>Section
303(f)(5), as amended by subsection (a), shall apply to violations described in
such section that occur after the date of enactment of this Act.</text>
</subsection></section></subtitle><subtitle id="id94C2349123DA4C1AB4C1C6C69838F9E7"><enum>E</enum><header>Additional
provisions related to medical products</header>
<section id="id2666CAF310F24D14B716AA9213BEA507"><enum>141.</enum><header>Certification
of information</header>
<subsection id="id56A3C35A4AA04937B86200717C7B8603"><enum>(a)</enum><header>Drugs</header><text display-inline="yes-display-inline">Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 505D the following:</text>
<quoted-block display-inline="no-display-inline" id="id034CDF7AB7474C32A212D9B80BDB6DA5" style="OLC">
<section id="id7D11F87D8EC14600A63C402A3E19296F"><enum>505E.</enum><header>Certification
of drug information</header>
<subsection id="ID9134268505df427885f3bb0b0a01abaf"><enum>(a)</enum><header>Certification</header>
<paragraph id="idF5BF06601D6B4EEB9ED689012384B88A"><enum>(1)</enum><header>In
general</header><text>A submission, when submitted to the Secretary, shall
include a certification, in writing (which may be in electronic form) and under
penalty of perjury, by the responsible person that—</text>
<subparagraph id="IDf6ccc891f2444328bbbac3768be83f9a"><enum>(A)</enum><text>such person has
actual knowledge of the requirements under this Act and, if applicable, such
section 351, with respect to the drug that is the subject of such
submission;</text>
</subparagraph><subparagraph id="IDa134cb76ae7844e8bed053b6cb17fb41"><enum>(B)</enum><text>such person has
actual knowledge of the information related to such drug;</text>
</subparagraph><subparagraph id="ID3dee4e9a73bf4a31992ddba49852e643"><enum>(C)</enum><text>such person has
actual knowledge of the information in such submission (and, if such submission
is an annual report, in any submission of any other information with respect to
such application or report for which a certification under this paragraph is
not otherwise required);</text>
</subparagraph><subparagraph id="ID0c6ecdc0d005449a963394d027865cff"><enum>(D)</enum><text>the information
in such submission (and, if such submission is an annual report, in any
submission of any other information with respect to such application or report
for which a certification under this paragraph is not otherwise required)
complies with such requirements;</text>
</subparagraph><subparagraph id="IDffc88766ffd04911a52c7858dc72bcc3"><enum>(E)</enum><text>the information
in such submission (and, if such submission is an annual report, in any
submission of any other information with respect to such application or report
for which a certification under this paragraph is not otherwise required) is
not false or misleading; and</text>
</subparagraph><subparagraph id="ID0b4c5cbdfcec4c4281f9efaa265ef02a"><enum>(F)</enum><text>full reports of
all clinical trials and postmarket studies (whether conducted within or outside
the United States) related to the safety or effectiveness of the drug under
review that were funded by the sponsor of such submission, or the full reports
of which the sponsor of such submission had access, have been submitted to the
Food and Drug Administration.</text>
</subparagraph></paragraph><paragraph id="id93CFAAF478CB4C1E9C9D887C17C0574C"><enum>(2)</enum><header>Definitions</header><text>In
this section:</text>
<subparagraph id="ID22d013c53d65432bbdcd5f796e8aac95"><enum>(A)</enum><header>Responsible
person</header><text>The term <term>responsible person</term> means, with
respect to a submission, a senior officer or director of the sponsor of such
submission with knowledge of, and management responsibility for, such
submission.</text>
</subparagraph><subparagraph id="idA79AAAEF6A0041D08D55D8F9E0BD477C"><enum>(B)</enum><header>Submission</header><text>The
term <term>submission</term> means—</text>
<clause id="id7D455C6A6AA74E9DABB3BF720418DDE5"><enum>(i)</enum><text>new drug
application under section 505(b);</text>
</clause><clause id="id286B2E6934BA4C6BB4DDA4972D4CA748"><enum>(ii)</enum><text>an abbreviated
new drug application under section 505(j);</text>
</clause><clause id="idF83AF5040CC640CC8DC443D7E52A971E"><enum>(iii)</enum><text>a biologics
license application under section 351 of the Public Health Service Act;</text>
</clause><clause id="idFB5C5DC166444F70BB25BBF525EA14CB"><enum>(iv)</enum><text>an application
for an investigational new drug exemption under section 505(i);</text>
</clause><clause id="id39D8A61004604CC9BFBDAA97E5F3D9A0"><enum>(v)</enum><text>a
new animal drug application under section 512(b);</text>
</clause><clause id="id214235428B8F4DFC99D8D06321E47DDC"><enum>(vi)</enum><text>an abbreviated
new animal drug application under section 512(b);</text>
</clause><clause id="id96501E952727407AA73BFAAD79D00C6C"><enum>(vii)</enum><text>an application
under section 571;</text>
</clause><clause id="idC6719398EB21449B969873351F322FF2"><enum>(viii)</enum><text>a request
under section 572;</text>
</clause><clause id="id4E3ED87C1BCF411B8EEA98AB8816EE62"><enum>(ix)</enum><text>or a major
amendment, supplement, or an annual report submitted to the Secretary with
respect to any application or request described in clauses (i) through
(viii);</text>
</clause><clause id="id617A9CF34F434321B1195B1FAFA49D5D"><enum>(x)</enum><text>a
record or report related to the safety or effectiveness of a drug subject to
section 505 or such section 351, to an adverse event under section 505(k) or
760, or to a postapproval study or postapproval clinical trial under section
505(o); or</text>
</clause><clause id="id99750BD07AD84018A76E7F88A9B5FB33"><enum>(xi)</enum><text>a list under
section 510(i) including a drug.</text>
</clause></subparagraph></paragraph></subsection><subsection id="id1E86B99E75774A43AC79A6A8AA62885C"><enum>(b)</enum><header>Inspections</header>
<paragraph id="id35505B621D2149D78434BBBE5A1ACEF9"><enum>(1)</enum><header>In
general</header><text>If the Secretary determines, after notice and opportunity
for an informal hearing, that a sponsor described in subsection (a)(2) knew or
should have known that the information in a submission described in subsection
(a)(1) did not comply with the requirements of this Act or was false or
misleading, the Secretary may provide that any factory, warehouse,
establishment, or consulting laboratory related to such noncompliance or such
false or misleading information shall be inspected periodically by officers or
employees duly designated by the Secretary for a period of time determined by
the Secretary, not to exceed 5 years.</text>
</paragraph><paragraph id="id27803915C1984C6B92B87CB0D6E4443F"><enum>(2)</enum><header>Costs</header><text>The
Secretary shall assess the costs of such inspections to such
sponsor.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id729E71C72C914435943CBAA62FC0EE7C"><enum>(b)</enum><header>Devices</header><text>Chapter
V (21 U.S.C. 351 et seq.) is amended by inserting after section 523 the
following:</text>
<quoted-block display-inline="no-display-inline" id="idE37D26382F6444B4AD4C63ADA42A4F66" style="OLC">
<section id="idEF60060826C0477CB5BF676BCFF69FD2"><enum>523A.</enum><header>Certification
of device information</header>
<subsection id="id0164AD79901E4F9CBAD9CE3797757014"><enum>(a)</enum><header>Certification</header>
<paragraph id="idBF9B3FC574A54A0E941887FE7724E9A9"><enum>(1)</enum><header>Certification
by sponsor</header><text>A submission, when submitted to the Secretary, shall
include a certification, in writing and under penalty of perjury, by the
responsible person that—</text>
<subparagraph id="IDf453a7773f6345d0a7dff7cc9d84e639"><enum>(A)</enum><text>such person has
actual knowledge of the requirements under this Act with respect to the device
that is the subject of such submission;</text>
</subparagraph><subparagraph id="ID64d6832f8f9943f38f1db41e92bb5f7f"><enum>(B)</enum><text>such person has
actual knowledge of the information related to such device;</text>
</subparagraph><subparagraph id="ID61f96ac2b635463fa9012a19dc59b0a6"><enum>(C)</enum><text>such person has
actual knowledge of the information in such submission (and, if such submission
is an annual report, in any submission of any other information with respect to
such application or report for which a certification under this paragraph is
not otherwise required);</text>
</subparagraph><subparagraph id="IDa1b47142b5d7495a9c726f341bc66d1e"><enum>(D)</enum><text>the information
in such submission (and, if such submission is an annual report, in any
submission of any other information with respect to such application or report
for which a certification under this paragraph is not otherwise required)
complies with such requirements;</text>
</subparagraph><subparagraph id="ID1fc87b0e375c479fb06c9e79c3b1cd66"><enum>(E)</enum><text>the information
in such submission (and, if such submission is an annual report, in any
submission of any other information with respect to such application or report
for which a certification under this paragraph is not otherwise required) is
not false or misleading; and</text>
</subparagraph><subparagraph id="IDd3cbefe8c18e43479ac11d20c8628aa7"><enum>(F)</enum><text>full reports of
all clinical trials and postmarket studies (whether conducted within or outside
the United States) related to the safety or effectiveness of the device under
review that were funded by the sponsor of such submission, or the full reports
of which the sponsor of such submission had access, have been submitted to the
Food and Drug Administration.</text>
</subparagraph></paragraph><paragraph id="idB55A1C61EE174661945C2C260117FAC4"><enum>(2)</enum><header>Definitions</header><text>In
this section:</text>
<subparagraph id="IDeff59cd0898f418985bb0227370123c5"><enum>(A)</enum><header>Responsible
person</header><text>The term <term>responsible person</term> means, with
respect to a submission, a senior officer or director of the sponsor of such
submission with knowledge of, and management responsibility for, such
submission.</text>
</subparagraph><subparagraph id="id3CE6639E40AD4973B032F640CE5724D8"><enum>(B)</enum><header>Submission</header><text>The
term <term>submission</term> means—</text>
<clause id="idBAF38F22C61D4AD3AF6943B6B5A3B18B"><enum>(i)</enum><text>an application or
report for premarket approval under section 515;</text>
</clause><clause id="id7CC456F9504A4A098D1E00A9CE7A4E93"><enum>(ii)</enum><text>an application
for an investigational device exemption under section 520(g);</text>
</clause><clause id="id6F0AE405E5FA4FC98D00940EA64885A4"><enum>(iii)</enum><text>a report under
section 510(k);</text>
</clause><clause id="id19A67F761EB34F03AAAB544C1F16FC38"><enum>(iv)</enum><text>an application
for a humanitarian device exemption under section 520(m);</text>
</clause><clause id="idCB1D739EEE8E442C8FF73D2C18642DF1"><enum>(v)</enum><text>a
major amendment, supplement, or an annual report submitted to the Secretary
with respect to any application or report described in clauses (i) through
(iv);</text>
</clause><clause id="id973BE71CCD1F457391E9892E69F54450"><enum>(vi)</enum><text>a record or
report related to an adverse event, a report, or postmarket surveillance under
section 519 or 522; or</text>
</clause><clause id="idB9597353491B4E39915779370A9D3B21"><enum>(vii)</enum><text>a list under
section 510(i) including a device,</text>
</clause></subparagraph></paragraph></subsection><subsection id="id033968BF931A4A8D81C2D03582E54D3B"><enum>(b)</enum><header>Inspections</header>
<paragraph id="ID6396fb82d8cb4a4194c6242a8e904b39"><enum>(1)</enum><header>In
general</header><text>If the Secretary determines, after notice and opportunity
for an informal hearing, that a sponsor described in subsection (a)(2) knew or
should have known that the information in a submission described in subsection
(a)(1) did not comply with the requirements of this Act or was false or
misleading, the Secretary may provide that any factory, warehouse,
establishment, or consulting laboratory related to such noncompliance or such
false or misleading information shall be inspected periodically by officers or
employees duly designated by the Secretary for a period of time determined by
the Secretary, not to exceed 5 years.</text>
</paragraph><paragraph id="ID549ff18d7aa24d848d5a6df6ee853080"><enum>(2)</enum><header>Costs</header><text>The
Secretary shall assess the costs of such inspections to such
sponsor.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id0A3BB48B72E949ECAEB9664716103671"><enum>(c)</enum><header>Criminal
penalties</header><text>Chapter 47 of title 18, United States Code, is amended
by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idAD5567EE2090478689EF345669B9A865" style="USC">
<section id="idF6B546E2B40743CE822ED0D45187199F"><enum>1041.</enum><header>Certifications
related to drug and device information</header>
<subsection id="id7E7F7C4061094A3DAAB8E17BAB3FCF00"><enum>(a)</enum><text>If a responsible
person—</text>
<paragraph id="idE66D6A3C7E484D558E40EAFE180DD3C7"><enum>(1)</enum><text>certifies any
submission as set forth in section 505E or 523A of the Federal Food, Drug, and
Cosmetic Act knowing that a component of such certification is false or
misleading, then—</text>
<subparagraph id="idE420798F90534C909610C0C2D70FB5C3"><enum>(A)</enum><text>the sponsor of
such submission shall be fined not more than $1,000,000; and</text>
</subparagraph><subparagraph id="idA935127D0D4D437BA91CAE788D96FDAC"><enum>(B)</enum><text>such responsible
person shall be fined not more than $1,000,000, imprisoned for not more than 10
years, or both; or</text>
</subparagraph></paragraph><paragraph id="id2E473FDA30CA4036984AFE48D2BD59F5"><enum>(2)</enum><text>willfully
certifies any submission as set forth in section 505E or 523A of the Federal
Food, Drug, and Cosmetic Act knowing that a component of such certification is
false or misleading, then—</text>
<subparagraph id="idDDD6DB70F1214A1EAA8FE10624956CD3"><enum>(A)</enum><text>the sponsor of
such submission shall be fined not more than $5,000,000; and</text>
</subparagraph><subparagraph id="id26DD409952354F16BCE40E320A2317F7"><enum>(B)</enum><text>such responsible
person shall be fined not more than $5,000,000, imprisoned not more than 20
years, or both.</text>
</subparagraph></paragraph></subsection><subsection id="idEA302D683AA24E6CADF015331693A634"><enum>(b)</enum><text>In this
section:</text>
<paragraph id="idDC4847EF29344915A2F847EE38FD9C47"><enum>(1)</enum><text>The term
<term>responsible person</term>—</text>
<subparagraph id="id61823BA665D3458E9E955F8CEAA2198D"><enum>(A)</enum><text>with respect to a
submission related to a drug, has the meaning given that term in section
505E(a)(2) of the Federal Food, Drug, and Cosmetic Act; and</text>
</subparagraph><subparagraph id="idBD525D305DA645FF88F9E6A2C40BED30"><enum>(B)</enum><text>with respect to a
submission related to device, has the meaning given that term in section
523A(a)(2) of such Act.</text>
</subparagraph></paragraph><paragraph id="idBEDBD8586CB74C868E6E8A6071E912A3"><enum>(2)</enum><text>The term
<term>submission</term> means—</text>
<subparagraph id="id830F5A74D2AC4DBF8C2B8DD82A3BBE69"><enum>(A)</enum><text>with respect to a
drug—</text>
<clause id="id331F8AEFCF7C486F9262DAECF7AEBC83"><enum>(i)</enum><text>a
new drug application under section 505(b) of the Federal Food, Drug, and
Cosmetic Act;</text>
</clause><clause id="idFA433A5DC1784335AD634B30D8102F8B"><enum>(ii)</enum><text>an abbreviated
new drug application under section 505(j) of such Act;</text>
</clause><clause id="idEC18A364B2C84206B53254EB0031466E"><enum>(iii)</enum><text>a biologics
license application under section 351 of the Public Health Service Act;</text>
</clause><clause id="idCF027C8A4A0E4D2AA5218A56ED14C599"><enum>(iv)</enum><text>an application
for an investigational new drug exemption under section 505(i) of the Federal
Food, Drug, and Cosmetic Act;</text>
</clause><clause id="id3B5C26B21DF14E61A825FE8EBE7F714B"><enum>(v)</enum><text>a
new animal drug application under section 512(b) of the Federal Food, Drug, and
Cosmetic Act;</text>
</clause><clause id="id86BD80DF9C7A4F1A8A55394B3F707673"><enum>(vi)</enum><text>an abbreviated
new animal drug application under section 512(b) of such Act;</text>
</clause><clause id="idFADF29DB20F64A5AA4ED04BC19699AE0"><enum>(vii)</enum><text>an application
under section 571 of such Act;</text>
</clause><clause id="id2A1D1BA553A54E3CBE15270E30AE0B1F"><enum>(viii)</enum><text>a request
under section 572 of such Act;</text>
</clause><clause id="id6BEBE471770C4C3A87E4DA1FDEA29195"><enum>(ix)</enum><text>a major
amendment, supplement, or other information submitted to the Secretary with
respect to any application or request described in clauses (i) through
(viii);</text>
</clause><clause id="idB5CB8ED9BC8042038559FE34E0B67BBC"><enum>(x)</enum><text>a
record or report related to the safety or effectiveness of a drug subject to
section 505 of such Act or section 351 of the Public Health Service Act, to an
adverse event under section 505(k) or 760 of the Federal Food, Drug, and
Cosmetic Act, or to a postapproval study or postapproval clinical trial under
section 505(o) of such Act; or</text>
</clause><clause id="ID5ff69e15157e4bc390d23c8eb38e3e83"><enum>(xi)</enum><text>a list under
section 510(i) including the drug; and</text>
</clause></subparagraph><subparagraph id="id6F89145CAA054BDA99DE3121AE8B0B8B"><enum>(B)</enum><text>with respect to a
device—</text>
<clause id="id79BD5E258E354213B43391556123A950"><enum>(i)</enum><text>an application or
report for premarket approval under section 515 of the Federal Food, Drug, and
Cosmetic Act;</text>
</clause><clause id="idD0F483F962F4449FB48DCC1886655B0E"><enum>(ii)</enum><text>an application
for an investigational device exemption under section 520(g) of such
Act;</text>
</clause><clause id="id81AFD6029265481192B7A9498985FF8F"><enum>(iii)</enum><text>a report under
section 510(k) of such Act;</text>
</clause><clause id="id4E05708744904949A9171651E7C614A0"><enum>(iv)</enum><text>an application
for a humanitarian device exemption under section 520(m) of such Act;</text>
</clause><clause id="id777E4725E10F4AFFA85A9AC3302F7514"><enum>(v)</enum><text>a
major amendment, supplement, or other information submitted to the Secretary
with respect to any application or report described in clauses (i) through
(iv);</text>
</clause><clause id="id6221C5B0352643A1BA985E135869B3AC"><enum>(vi)</enum><text>a record or
report related to an adverse event, a report, or postmarket surveillance under
section 519 or 522 of such Act; or</text>
</clause><clause id="ID4a243f0dc2db4e72a8c4c23afc20feb9"><enum>(vii)</enum><text>a list under
section 510(i) including the
device.</text>
</clause></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="idA086B3264D844781BC1AD99CDA9A3427"><enum>(d)</enum><header>Conforming
amendment</header><text>The table of sections for chapter 47 of title 18,
United States Code, is amended by inserting after the item relating to section
1040 the following:</text>
<quoted-block display-inline="no-display-inline" id="idA56450F905554AD0BA16A40B5343E92E" style="OLC">
<toc>
<toc-entry bold="off" level="section">1041. Certification of drug and
device
information.</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="id1ABB3E9DDA5C46E4828005937226CF08"><enum>142.</enum><header>Whistleblower
protections</header><text display-inline="no-display-inline">Chapter IX (21
U.S.C. 391 et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id15BDB10C088740CAB1D65527DC651362" style="OLC">
<section id="id110E5287C7074E71A589F7131DBEECDE"><enum>911.</enum><header>Protections
for employees who refuse to violate, or who disclose violations of, this Act or
section 351 of the public health service act</header>
<subsection id="id5A2CC6C0DCA7481B8A8B2D4BE6E21F2F"><enum>(a)</enum><header>In
general</header>
<paragraph id="id1B0EB1334D594F79A3AE4734A860086A"><enum>(1)</enum><header>Protections for
employees</header><text>No person that submits, or is required to submit to the
Secretary a submission described in paragraph (2), or any officer, employee,
contractor, subcontractor, or agent of such a person, may discharge, demote,
suspend, threaten, harass, or in any other manner discriminate against an
employee in the terms and conditions of employment because of any lawful act
done by the employee, including within the ordinary course of the job duties of
such employee—</text>
<subparagraph id="IDf6776fadc53445989c42b6e6ac243b4b"><enum>(A)</enum><text>to provide
information, cause information to be provided, or otherwise assist in any
investigation regarding any conduct which the employee reasonably believes
constitutes a violation of any section of this Act or the Public Health Service
Act described under paragraph (2), any other provision of Federal law relating
to the safety or effectiveness of a drug, biological product, or device, or any
provision of Federal law prohibiting fraud against the Food and Drug
Administration, if the information or assistance is provided to, or an
investigation stemming from the provided information is conducted by—</text>
<clause id="ID1bd551167ae444f8a40a80042b2b3ccc"><enum>(i)</enum><text>a
Federal regulatory or law enforcement agency;</text>
</clause><clause id="IDb3d3267ab1db47a19e66d18ca558b510"><enum>(ii)</enum><text>any Member of
Congress or any committee of Congress; or</text>
</clause><clause id="IDe110f42084104028bcc6d4beb8943ee1"><enum>(iii)</enum><text>a person with
supervisory authority over the employee (or such other person working for the
employer who has the authority to investigate, discover, or terminate the
misconduct);</text>
</clause></subparagraph><subparagraph id="ID18dbd52f25364c3fbba86c223416567b"><enum>(B)</enum><text>to file, cause to
be filed, testify, participate in, or otherwise assist in a proceeding filed or
about to be filed (with any knowledge of the employer) relating to an alleged
violation of any section of this Act or the Public Health Service Act described
under paragraph (2), any other provision of Federal law relating to the safety
or effectiveness of a drug, biological product, or device, or any provision of
Federal law prohibiting fraud against the Food and Drug Administration;
or</text>
</subparagraph><subparagraph id="ID4cc26a4ea2654e04ab5dc0fcf1226511"><enum>(C)</enum><text>to refuse to
violate or assist in the violation of any section of this Act or the Public
Health Service Act listed described paragraph (2), any other provision of
Federal law relating to the safety or effectiveness of a drug, biological
product, or device, or any provision of Federal law prohibiting fraud against
the Food and Drug Administration.</text>
</subparagraph></paragraph><paragraph id="id93E2EB6C20354E69B175238CA0D36788"><enum>(2)</enum><header>Submission</header><text>A
submission described in this paragraph is—</text>
<subparagraph id="id402553D0AF1942E69DDBD91BEB3F6110"><enum>(A)</enum><text>a new drug
application under section 505(b);</text>
</subparagraph><subparagraph id="id859B214050C34D8DB41F7DEB07025E48"><enum>(B)</enum><text>an abbreviated
new drug application under section 505(j);</text>
</subparagraph><subparagraph id="id629707696C7740F49D1772531E71B7FE"><enum>(C)</enum><text>a biologics
license application under section 351 of the Public Health Service Act;</text>
</subparagraph><subparagraph id="idC687CDF7C1E5460A9D8CD1664D375E1E"><enum>(D)</enum><text>an application
for an investigational new drug exemption under section 505(i);</text>
</subparagraph><subparagraph id="idD5B86D00DB4749269FE1264C9713AD12"><enum>(E)</enum><text>a new animal drug
application under section 512(b);</text>
</subparagraph><subparagraph id="idF1AF675FD5CD49B0B7B8F5B37F050F5A"><enum>(F)</enum><text>an abbreviated
new animal drug application under section 512(b);</text>
</subparagraph><subparagraph id="id020D09069CA1433CBDBD6BF033E3D352"><enum>(G)</enum><text>an application
under section 571;</text>
</subparagraph><subparagraph id="idB871B1CB83AF46C1860427CCC6FDF386"><enum>(H)</enum><text>a request under
section 572;</text>
</subparagraph><subparagraph id="id567DF573C5A043BC8C488A99FB38D75D"><enum>(I)</enum><text>an application or
report for premarket approval under section 515;</text>
</subparagraph><subparagraph id="id0177888EBD6148CDAC44F9E2841FD47F"><enum>(J)</enum><text>an application
for an investigational device exemption under section 520(g);</text>
</subparagraph><subparagraph id="id8E122D030E754C53BF6506AA9BFFCCFE"><enum>(K)</enum><text>a report under
section 510(k);</text>
</subparagraph><subparagraph id="idC4DE8AC493494555878C45C804012495"><enum>(L)</enum><text>an application
for a humanitarian device exemption under section 520(m);</text>
</subparagraph><subparagraph id="id06846412AA824DED994D34C62B8B6199"><enum>(M)</enum><text>an amendment,
supplement, or other submission with respect to any such application or report
described in subparagraphs (A) through (L); or</text>
</subparagraph><subparagraph id="id9C5AD87DEBD140ECB37AC4BED6961915"><enum>(N)</enum><text>a record or
report related to an adverse event, a postapproval study, a postapproval
clinical trial, a report, or postmarket surveillance under section 505(k),
505(o), 519, 522, or 760.</text>
</subparagraph></paragraph></subsection><subsection id="id3BAC2DBBF79247E3B3F6DBA44864233A"><enum>(b)</enum><header>Enforcement
action</header>
<paragraph id="idAFCC78E92B09439BAD67948EF63B8016"><enum>(1)</enum><header>In
general</header><text>An employee who alleges discharge, or other
discrimination in violation of subsection (a), may seek relief in accordance
with the provisions of subsection (c), by—</text>
<subparagraph id="ID27b66d7e8c12442198f257b730bc49a6"><enum>(A)</enum><text>filing a
complaint with the Secretary of Labor; or</text>
</subparagraph><subparagraph id="ID1a14c09cd8d94f1281c4055759004688"><enum>(B)</enum><text>if the Secretary
of Labor has not issued a final decision within 210 days of the filing of the
complaint and there is no showing that such delay is due to the bad faith of
the claimant, bringing an action at law or equity for de novo review in the
appropriate district court of the United States, which shall have jurisdiction
over such an action without regard to the amount in controversy.</text>
</subparagraph></paragraph><paragraph id="id161D28185E6F4644A9E27F90A3267C12"><enum>(2)</enum><header>Procedure</header>
<subparagraph id="IDf35fb9b85715495d8964dd414ae78a05"><enum>(A)</enum><header>In
general</header><text>Any action under paragraph (1) shall be governed under
the rules and procedures set forth in section 42121(b) of title 49, United
States Code.</text>
</subparagraph><subparagraph commented="no" id="IDf68d63af79b84e2ebcef6322d248cd29"><enum>(B)</enum><header>Exception</header><text>Notification
in an action under paragraph (1) shall be made in accordance with section
42121(b)(1) of title 49, United States Code, except that such notification
shall be made to the person named in the complaint and to the employer.</text>
</subparagraph><subparagraph id="ID84ac18db56c347c1b7e012f6a25a014b"><enum>(C)</enum><header>Burdens of
proof</header><text>An action brought under paragraph (1)(B) shall be governed
by the legal burdens of proof set forth in section 42121(b) of title 49, United
States Code.</text>
</subparagraph><subparagraph id="ID4c985ae193eb4979be150f8b4ad28112"><enum>(D)</enum><header>Statute of
limitations</header><text>An action under paragraph (1) shall be commenced not
later than 180 days after the date on which the violation occurs.</text>
</subparagraph></paragraph></subsection><subsection id="id540BCD7C7D554FDD91D70BC2D8DB7DDD"><enum>(c)</enum><header>Remedies</header>
<paragraph id="ID015149dce9d24e2298a2e71f3a794873"><enum>(1)</enum><header>In
general</header><text>An employee prevailing in any action under subsection
(b)(1) shall be entitled to all relief necessary to make the employee
whole.</text>
</paragraph><paragraph id="ID1bfab9b6b5bc40a8b391c8f0654fec0d"><enum>(2)</enum><header>Compensatory
damages</header><text>Relief in an action under subsection (b) shall
include—</text>
<subparagraph id="ID86cfe5e99440448f81e31b5cf1a4cc31"><enum>(A)</enum><text>reinstatement
with the same seniority status that the employee would have had, but for the
discrimination;</text>
</subparagraph><subparagraph id="IDa5653118e2c64a37808a94a21c25801d"><enum>(B)</enum><text>the amount of
backpay owed to the employee, with interest; and</text>
</subparagraph><subparagraph id="ID1361ec9f96aa4d0686cbc5be1ffea558"><enum>(C)</enum><text>compensation for
any special damages sustained as a result of the discrimination, including
litigation costs, expert witness fees, and reasonable attorney fees.</text>
</subparagraph></paragraph></subsection><subsection id="idE1AF2812E1F44E0395DF3B818776D8EC"><enum>(d)</enum><header>Rights retained
by employee</header><text>Nothing in this section shall be deemed to diminish
the rights, privileges, or remedies of any employee under any Federal or State
law or under any collective bargaining agreement. The rights and remedies in
this section may not be waived by any agreement, policy, form, or condition of
employment.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id1C73FDB384694B37BA4A02BC670645BC"><enum>143.</enum><header>Study by the
Institute of Medicine regarding the review of medical devices</header>
<subsection id="idF4BB998B5FDC498F85F3E6C47FED04DB"><enum>(a)</enum><header>In
general</header><text>The Secretary of Health and Human Services shall enter
into a contract with the Institute of Medicine to conduct a study to—</text>
<paragraph id="ID7a9e303dd1754ecbb2200c0ccdb55228"><enum>(1)</enum><text>evaluate the
organizational structure and operations of the Food and Drug Administration
with respect to the review of medical devices for clearance under section
510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) and for
premarket approval under section 515 of such Act (21 U.S.C. 360e);</text>
</paragraph><paragraph id="ID94fb69f59f17466c847c03234fb80a6a"><enum>(2)</enum><text>evaluate the
analytical and methodological tools used by such Administration to conduct such
reviews; and</text>
</paragraph><paragraph id="ID5104e103273b42948e30e1c65c912e06"><enum>(3)</enum><text>identify
strengths, weaknesses, and limitations of the system used by such
Administration to conduct such reviews.</text>
</paragraph></subsection><subsection id="id3508DD9F627D49F1AE0694D3C99235C8"><enum>(b)</enum><header>Report</header><text>Not
later than September 31, 2010, the Institute of Medicine shall complete the
study described under subsection (a) and submit to the Secretary of Health and
Human Services, the Committee on Health, Education, Labor, and Pensions and the
Committee on Finance of the Senate, and the Committee on Energy and Commerce of
the House of Representatives a report that—</text>
<paragraph id="id705936F6752844C3BBDB7828B8D3598A"><enum>(1)</enum><text>describes the
findings of such study; and</text>
</paragraph><paragraph id="ID1a4160bb1fb0497ca1de9880319acc16"><enum>(2)</enum><text>makes
recommendations regarding the organization structure and operations of the Food
and Drug Administration, legislation, and regulation to improve or enhance the
review of medical devices by such Administration.</text>
</paragraph></subsection></section></subtitle><enum>II</enum><header>General
authorities to enhance food and drug administration oversight of products from
a global market</header>
<section id="id2B9320052B084C41BD63648F00BB9940"><enum>201.</enum><header>Dedicated
foreign inspectorate</header><text display-inline="no-display-inline">Section
704 (21 U.S.C. 374) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id1391E5B61DF94B6F9A2EDBC1630573A9" style="OLC">
<subsection commented="no" id="IDee97b57f67e146e5b22f5262170ca982"><enum>(h)</enum><header>Foreign
inspectorate</header>
<paragraph commented="no" id="idFBE9A4FC44AC481EA960FCBA9E2A8893"><enum>(1)</enum><header>In
general</header><text>The Secretary shall establish and maintain a corps of
inspectors dedicated to inspections of foreign establishments registered under
section 510 and foreign facilities registered under section 415. Such corps
shall include personnel, in numbers sufficient to act as inspectors or
translators for inspectors on each inspection by such corps, who are able to
understand and speak the language used in the establishment or facility under
inspection.</text>
</paragraph><paragraph id="ID1d523e03e79c4457a81f233935e02d74"><enum>(2)</enum><header>Organization</header><text>The
corps established under paragraph (1) shall be organized into the following 4
units:</text>
<subparagraph id="IDaf7e40f8b88b41aeafb600675e3ed81b"><enum>(A)</enum><text>A unit with
expertise in inspections of food facilities.</text>
</subparagraph><subparagraph id="ID1bfeb93533a44391ad3a48c18f5b7815"><enum>(B)</enum><text>A unit with
expertise in inspections of human drug establishments.</text>
</subparagraph><subparagraph id="ID93926606f7e0479fbb8f04db731c7aed"><enum>(C)</enum><text>A unit with
expertise in inspections of animal drug establishments.</text>
</subparagraph><subparagraph id="ID1ab3a2a5fcda408886ec0fb8a490f6e6"><enum>(D)</enum><text>A unit with
expertise in inspections of medical device establishments.</text>
</subparagraph></paragraph><paragraph id="ID2430d373ed6f4185aef3cff615f617fe"><enum>(3)</enum><header>Staffing and
funding</header><text>Each unit shall be staffed and funded by the Secretary at
a level sufficient to allow the unit to conduct inspections, as
applicable—</text>
<subparagraph id="IDa420b43cf97e40f7b55f95acfd82be17"><enum>(A)</enum><text>of foreign
establishments registered under section 510 at a frequency, considering risk,
that is comparable to the inspection rate of domestic establishments registered
under section 510; or</text>
</subparagraph><subparagraph id="ID43aa799ccd6649c4a7bcb8420ad2b3a9"><enum>(B)</enum><text>of foreign
facilities registered under section 415 at a frequency, considering risk, that
is comparable to the inspection rate of domestic facilities registered under
section 415.</text>
</subparagraph></paragraph><paragraph id="ID6f1964c3c3f648fbb0bc1c453caabb70"><enum>(4)</enum><header>Distribution</header><text>The
Secretary shall distribute the staff of each unit described in paragraph (2) in
countries, and may modify such distribution over time, considering—</text>
<subparagraph id="ID006e25b8064648ea866d14915b4bafaf"><enum>(A)</enum><text>the volume of
product exported from such country to the United States;</text>
</subparagraph><subparagraph id="IDbb8fc08805e6412182da8ef5ecf77fad"><enum>(B)</enum><text>an assessment of
the effectiveness of the regulatory oversight provided by such country for such
products;</text>
</subparagraph><subparagraph id="IDe96056d115c94c0193a354899bbf9c7e"><enum>(C)</enum><text>an assessment of
the risk posed by such products; and</text>
</subparagraph><subparagraph id="IDcc76d9cedcc445fa89a32577cfd382dc"><enum>(D)</enum><text>such other
factors as the Secretary determines are relevant to such
distribution.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="ID3e3138f3dce545c09e3bd497639778b0"><enum>202.</enum><header>Authority to
exchange confidential information with foreign government officials</header>
<subsection id="ID5f6befb9ef284fba8dc6ea9ed33548e3"><enum>(a)</enum><header>Authority To
exchange confidential information with foreign government
officials</header><text>Section 803 (21 U.S.C. 383) is amended by adding the
following:</text>
<quoted-block display-inline="no-display-inline" id="id8DA05FD1A53D42F1828004EA077B51C1" style="OLC">
<subsection id="IDd822f538740546508b793da92d24ccd2"><enum>(d)</enum><header>Exchange of
confidential information</header>
<paragraph id="IDe4611212e7ef477eae3b55652af63f47"><enum>(1)</enum><header>Disclosure by
Secretary</header><text>The Secretary may disclose information about food,
drugs, devices, and cosmetics to officials of a foreign government if—</text>
<subparagraph id="IDac86c32219c94e1b8a4239d8256030b3"><enum>(A)</enum><text>such government
is able, and agrees, to guard the confidentiality and guarantee nondisclosure
of such information; and</text>
</subparagraph><subparagraph id="ID5c8ed639a1004e04a671cec78e2ed41d"><enum>(B)</enum><text>the Secretary
determines that such disclosure is necessary to promote a regulatory,
enforcement, or other public health function.</text>
</subparagraph></paragraph><paragraph id="IDe93d8796854d46119f8ec23088aeb79a"><enum>(2)</enum><header>Disclosure to
Secretary</header><text>The Secretary may receive information from officials of
foreign governments under conditions of confidentiality. Such information shall
be exempt from disclosure under section 552 of title 5, United States
Code.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ID5bd9750ffe744453adefd406198c46b7"><enum>(b)</enum><header>Conforming
amendment</header><text>Section 301(j) (21 U.S.C. 331(j)) is amended by
inserting <quote>or pursuant to section 803(d),</quote> after <quote>judicial
proceeding under this Act,</quote>.</text>
</subsection></section><section id="idBA054046D42746D3AB722B9E619F00D4"><enum>203.</enum><header>Subpoena
authority</header><text display-inline="no-display-inline">Section 702 (21
U.S.C. 372) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idDC228EA07F6143B19C86AF4B14A2C53F" style="OLC">
<subsection id="idAEB036F910CA4211A52E2553E41FA7EB"><enum>(f)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id3950924F6B39425CAD70438450DECD9E"><enum>(1)</enum><text>The Secretary may
conduct investigations as the Secretary deems necessary—</text>
<subparagraph id="id18B2AF0B216044BEAE34E5411102F6FA" indent="up1"><enum>(A)</enum><text>to carry out the authority of the
Secretary under this Act or section 351 of the Public Health Service Act;
or</text>
</subparagraph><subparagraph id="idABC1A2E3D47A48448936ED68DD4F94EE" indent="up1"><enum>(B)</enum><text>to determine whether any person has
engaged or is about to engage in any act that constitutes or will constitute a
violation of this Act or such section 351.</text>
</subparagraph></paragraph><paragraph id="idE47EA4834F7C4400A8C15198EF2A7120" indent="up1"><enum>(2)</enum><text>For the purpose of any investigation
conducted under paragraph (1), the Secretary may administer oaths and
affirmations, subpoena witnesses, compel the attendance of such witnesses, take
evidence, and require the production of any books, papers, documents, or other
materials that are relevant to the investigation.</text>
</paragraph><paragraph id="id79789976201D4DCF9D2D2F4F9C794A23" indent="up1"><enum>(3)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id68A3DB2D8FE048C99E21C2F113F33949"><enum>(A)</enum><text>In case of contumacy or
refusal to obey a subpoena issued under paragraph (2), the district court of
the United States for the judicial district in which such investigation or
proceeding is conducted, or in which the subpoenaed person resides or conducts
business, may issue an order requiring such person to appear before the
Secretary, testify, or produce books, papers, documents, or other materials
that are relevant to the investigation. All process in any such case may be
served in the judicial district in which such person resides or may be
found.</text>
</subparagraph><subparagraph id="id4C62A4DC6CA14F78819B1B383920CC09" indent="up1"><enum>(B)</enum><text>Any failure to obey an order issued
under subparagraph (A) may be punished by the court as contempt of
court.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id06608464342441ABA9B5EFDE044E77C1"><enum>204.</enum><header>Information
reporting</header><text display-inline="no-display-inline">Subchapter G of
chapter VII (21 U.S.C. 379v et seq.) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idB341C70E1E2A4F188C089FB39832D6FA" style="OLC">
<section id="idDF88E496EA024A2A9F3ACE02C3BD2C28"><enum>757.</enum><header>Information
reporting</header>
<subsection id="IDac89b8d8a4ed4005be3bf97c351fbb33"><enum>(a)</enum><header>Notification of
settlements or judgments</header><text>If a particular product regulated by the
Secretary under this Act or section 351 of the Public Health Service Act is the
subject of at least 3 civil actions that have been filed in Federal or State
court alleging death, serious injury, or serious illness caused in whole or in
part by such product which, in any 24-month period, result in either a final
settlement involving the manufacturer or a court judgment in favor of the
plaintiff, the manufacturer of such product shall, in accordance with
subsection (b), report to the Secretary each such civil action not later than
30 days after the final settlement or court judgment in the third of such civil
actions, and report to the Secretary any other such action not later than 30
days after any subsequent such settlement or judgment that—</text>
<paragraph id="idDAF40935AB8448C28ABD8C3EEE2DCEB2"><enum>(1)</enum><text>occurs within 24
months of any other 2 such settlements or judgments; and</text>
</paragraph><paragraph id="id71F412BAEA4D427EB8B67E3F3BFCF65B"><enum>(2)</enum><text>has not been
previously reported to the Secretary under this section.</text>
</paragraph></subsection><subsection id="id61F960C541C345AABB590C9CAD97266A"><enum>(b)</enum><header>Information To
be reported</header>
<paragraph id="ID78a2e3f5bc2d415a9e0acc7e31e4e77a"><enum>(1)</enum><header>Required
information</header><text>The information required by subsection (a) to be
reported to the Secretary, with respect to each civil action described in such
subsection, shall include and, in addition to any voluntary information
provided under paragraph (2), shall be limited to the following:</text>
<subparagraph id="ID1cc76bb7950c42509c8bd042bf86c2d0"><enum>(A)</enum><text>The name and
address of the manufacturer.</text>
</subparagraph><subparagraph id="ID1a326cd6032f41dea234e57fbb88dbd0"><enum>(B)</enum><text>The name or model
of the product subject to the civil action.</text>
</subparagraph><subparagraph id="ID62559d46bbd344729a9e0e585808fd19"><enum>(C)</enum><text>A statement as to
whether the civil action alleged death, injury, or illness and in the case of
an allegation of injury, a statement of the category of such injury.</text>
</subparagraph><subparagraph id="ID2cf225d47a714ee7abd0cf4825cfe9b1"><enum>(D)</enum><text>A statement as to
whether the civil action resulted in a final settlement or a judgment in favor
of the plaintiff.</text>
</subparagraph><subparagraph id="ID952f7d7caaa341e9936034c7010f1a2b"><enum>(E)</enum><text>In the case of a
judgment in favor of the plaintiff, the name of the civil action, the number
assigned the civil action, and the court in which the civil action was
filed.</text>
</subparagraph></paragraph><paragraph id="ID7d9f07c0f3874ee885f7d9e062b208f0"><enum>(2)</enum><header>Voluntary
information</header><text>A manufacturer furnishing the report required by
paragraph (1) may include—</text>
<subparagraph id="ID22703ff4d68c4b28bd13b38d1c856b8a"><enum>(A)</enum><text>a statement as to
whether any judgment in favor of the plaintiff is under appeal or is expected
to be appealed; or</text>
</subparagraph><subparagraph id="ID27175d4f36de473c97315c686de61764"><enum>(B)</enum><text>any other
information which the manufacturer chooses to provide.</text>
</subparagraph></paragraph></subsection><subsection id="ID82ed3287bad443c581b02b687b01a3cf"><enum>(c)</enum><header>Safety
report</header><text>A report of a civil action described in subsection (a)
shall be considered a safety report under section 756 and may be accompanied by
a statement, which shall be part of any report released for public disclosure,
that denies that the report constitutes an admission that the product involved
caused or contributed to a death, serious injury, or serious illness.</text>
</subsection><subsection id="id7EB1822B2AD548ED9700C012671FD6AA"><enum>(d)</enum><header>Admission</header><text>A
report of a civil action described in subsection (a) shall not be considered an
admission that the product involved is adulterated or caused or contributed to
a death, serious injury, or serious illness.</text>
</subsection><subsection id="id4F1E417EF9CD40F8A17BCE407855A2C9"><enum>(e)</enum><header>Definitions</header><text>The
terms <term>serious illness</term> and <quote>serious injury</quote> mean
illness or injury, respectively, that—</text>
<paragraph id="IDD94E090636FD432295C193E236B55365"><enum>(1)</enum><text>is life
threatening,</text>
</paragraph><paragraph id="ID838760A874CB4E18BA7504E8573D5947"><enum>(2)</enum><text>results in
permanent impairment of a body function or permanent damage to a body
structure, or</text>
</paragraph><paragraph id="ID854C29015FF44DB4BCC3FC5C74A6EAE1"><enum>(3)</enum><text>necessitates
medical or surgical intervention to preclude permanent impairment of a body
function or permanent damage to a body
structure.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section>