1.This Act may be cited as the
Food and Drug Administration Reform
Act of 2012
.
2.The table of contents
of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References in Act.
Title I—Fees relating to drugs
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.
Title II—Medical Device User Fee Amendments of 2012
Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset clause.
Sec. 208. Streamlined hiring authority to support activities
related to the process for the review of device applications.
Title III—Fees relating to generic drugs
Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug
fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority to support activities
related to human generic drugs.
Title IV—Fees relating to biosimilar biological
products
Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological
products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.
Title V—Reauthorization of Best Pharmaceuticals for Children Act
and Pediatric Research Equity Act
Sec. 501. Permanent extension of Best Pharmaceuticals for
Children Act and Pediatric Research Equity Act.
Sec. 502. Food and Drug Administration Report.
Sec. 503. Internal Committee for Review of Pediatric Plans,
Assessments, Deferrals, Deferral Extensions, and Waivers.
Sec. 504. Staff of Office of Pediatric
Therapeutics.
Sec. 505. Continuation of operation of Pediatric Advisory
Committee.
Sec. 506. Pediatric Subcommittee of the Oncologic Drugs
Advisory Committee.
Title VI—Food and Drug Administration administrative
reforms
Sec. 601. Public participation in issuance of FDA guidance
documentsHR3204.
Sec. 602. Conflicts of interest.
Sec. 603. Electronic submission of applications.
Sec. 604. Notification of FDA intent to regulate
laboratory-developed tests.
Title VII—Medical device regulatory improvements
Subtitle A—Premarket predictability
Sec. 701. Investigational device exemptions.
Sec. 702. Clarification of least burdensome
standard.
Sec. 703. Agency documentation and review of significant
decisionsH.R. 3209.
Sec. 704. Transparency in clearance processH.R. 3209.
Sec. 705. Device Modifications Requiring Premarket Notification
Prior to Marketing.
Subtitle B—Patients Come First
Sec. 711. Establishment of schedule and promulgation of
regulationH.R. 3208.
Sec. 712. Program to improve the device recall
systemH.R. 3208.
Subtitle C—Novel device regulatory relief
Sec. 721. Modification of de novo application
processH.R. 3203.
Subtitle D—Keeping America competitive through
harmonization
Sec. 731. Harmonization of device premarket review, inspection,
and labeling symbols; reportH.R.
3230.
Sec. 732. Participation in international fora.
Subtitle E—FDA renewing efficiency from outside reviewer
management
Sec. 741. Reauthorization of Third Party Review.
Sec. 742. Reauthorization of third party
inspection.
Subtitle F—Humanitarian device reform
Sec. 751. Expanded access to humanitarian use
devices.
Subtitle G—Records and Reports on Devices
Sec. 761. Unique device identification system
regulations.
Sec. 762. Effective device sentinel program.
Subtitle H—Miscellaneous
Sec. 771. Custom devices.
Sec. 772. Pediatric device reauthorization.
Sec. 773. Report on regulation of health information
technology.
Title VIII—Drug regulatory improvements
Subtitle A—Drug supply chain
Sec. 801. Registration of producers of drugs.
Sec. 802. Inspection of drugs.
Sec. 803. Drug supply quality and safety.
Sec. 804. Prohibition against delaying, denying, limiting, or
refusing inspection.
Sec. 805. Destruction of adulterated, misbranded, or
counterfeit drugs offered for import.
Sec. 806. Administrative detention.
Sec. 807. Enhanced criminal penalty for counterfeit
drugs.
Sec. 808. Unique facility identification number.
Sec. 809. Documentation for admissibility of
imports.
Sec. 810. Registration of commercial importers.
Sec. 811. Notification.
Sec. 812. Exchange of information.
Sec. 813. Extraterritorial jurisdiction.
Sec. 814. Protection against intentional
adulteration.
Sec. 815. Records for inspection.
Subtitle B—Medical Gas Safety
Sec. 821. Regulation of medical gases.
Sec. 822. Changes to regulations.
Sec. 823. Rules of construction.
Subtitle C—Generating Antibiotic Incentives Now
Sec. 831. Extension of exclusivity period for
drugs.
Sec. 832. Study on incentives for qualified infectious disease
biological products.
Sec. 833. Clinical trials.
Sec. 834. Reassessment of qualified infectious disease product
incentives in 5 years.
Sec. 835. Guidance on pathogen-focused antibacterial drug
development.
Subtitle D—Accelerated approval
Sec. 841. Expedited approval of drugs for serious or
life-threatening diseases or conditions.
Sec. 842. Guidance; amended regulations.
Sec. 843. Independent review.
Subtitle E—Critical path reauthorization
Sec. 851. Reauthorization of the critical path public-private
partnerships.
Subtitle F—Miscellaneous
Sec. 861. Reauthorization of provision relating to exclusivity
of certain drugs containing single enantiomers.
Sec. 862. Extension of period for first applicant To obtain
tentative approval without forfeiting 180-day exclusivity period.
Sec. 863. Final agency action relating to petitions and civil
actions.
Sec. 864. Deadline for determination on certain
petitions.
Sec. 865. Rare pediatric disease priority review voucher
incentive program.
Sec. 866. Combating prescription drug abuse.
Sec. 867. Assessment and modification of REMS.
Sec. 868. Consultation with external experts on rare diseases,
targeted therapies, and genetic targeting of treatments.
Sec. 869. Breakthrough therapies.
Sec. 870. Grants and Contracts for the Development of Orphan
Drugs.
Title IX—Drug shortages
Sec. 901. Discontinuance and interruptions of manufacturing of
certain drugs.
Sec. 902. Drug shortage list.
Sec. 903. Quotas applicable to drugs in shortage.
Sec. 904. Expedited review of major manufacturing changes for
potential and verified shortages of drugs that are life-supporting,
life-sustaining, or intended for use in the prevention of a debilitating
disease or condition.
Sec. 905. Study on drug shortages.
Sec. 906. Annual report on drug shortages.
Sec. 907. Attorney General report on drug
shortages.
Sec. 908. Hospital repackaging of drugs in
shortage.
3.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>Fees
relating to drugs</header>
<section id="HDBFA2A38AE4E4AB2BC7D8B281A9133D0"><enum>101.</enum><header>Short title;
finding</header>
<subsection id="HCD58A9336DBA46F99F8E0B2DE777E873"><enum>(a)</enum><header>Short
title</header><text display-inline="yes-display-inline">This title may be cited
as the <quote><short-title>Prescription Drug User Fee
Amendments of 2012</short-title></quote>.</text>
</subsection><subsection id="H1CF8ECC7A2E44E348547BD512ADDAF12"><enum>(b)</enum><header>Finding</header><text display-inline="yes-display-inline">The Congress finds that the fees authorized
by the amendments made in this title will be dedicated toward expediting the
drug development process and the process for the review of human drug
applications, including postmarket drug safety activities, as set forth in the
goals identified for purposes of part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as set forth in the
Congressional Record.</text>
</subsection></section><section id="H275DD08D9C284AC6AB28AEE1F16D7EBA"><enum>102.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 735(7) (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g</external-xref>) is
amended by striking <quote>expenses incurred in connection with</quote> and
inserting <quote>expenses in connection with</quote>.</text>
</section><section display-inline="no-display-inline" id="H2D4CCABC19BA4C63B978894E4956A286"><enum>103.</enum><header>Authority to
assess and use drug fees</header><text display-inline="no-display-inline">Section 736 (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h</external-xref>) is amended—</text>
<paragraph id="H4EAC7F8DD0E2478CAEE19F38F542171D"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph id="H9FEE6BB9ABB248F6A838A5026E133165"><enum>(A)</enum><text>in the matter
preceding paragraph (1), by striking <quote>fiscal year 2008</quote> and
inserting <quote>fiscal year 2013</quote>;</text>
</subparagraph><subparagraph id="H7E648E021E5F4B8392D5EF7BEC3B8D7A"><enum>(B)</enum><text>in paragraph
(1)(A)—</text>
<clause id="HFFBD2BB2D4AC4541870E177FD47FC5B1"><enum>(i)</enum><text>in
clause (i), by striking <quote>(c)(5)</quote> and inserting
<quote>(c)(4)</quote>; and</text>
</clause><clause id="H789B88EE14F442A9832825A97EDCC96E"><enum>(ii)</enum><text>in
clause (ii), by striking <quote>(c)(5)</quote> and inserting
<quote>(c)(4)</quote>;</text>
</clause></subparagraph><subparagraph id="H7FF127EF8AB84475A359D2929084F13A"><enum>(C)</enum><text>in the matter
following clause (ii) in paragraph (2)(A)—</text>
<clause id="HA8D562F653A541D3B3ED793CB682890A"><enum>(i)</enum><text display-inline="yes-display-inline">by striking <quote>(c)(5)</quote> and
inserting <quote>(c)(4)</quote>; and</text>
</clause><clause id="HA35977FC51B246D2B17F21C103CBC7D9"><enum>(ii)</enum><text>by
striking <quote>payable on or before October 1 of each year</quote> and
inserting <quote>due on the later of the first business day on or after October
1 of such fiscal year or the first business day after the enactment of an
appropriations Act providing for the collection and obligation of fees for such
fiscal year under this section</quote>;</text>
</clause></subparagraph><subparagraph id="H33482327B1BD442584B75315D20363BC"><enum>(D)</enum><text>in paragraph
(3)—</text>
<clause id="H3BFF7DC0B16B4BD29EDF342BE0704A6E"><enum>(i)</enum><text>in
subparagraph (A)—</text>
<subclause id="HFACE6F7F9AF0470E812D966AE49C34DA"><enum>(I)</enum><text>by striking
<quote>subsection (c)(5)</quote> and inserting <quote>subsection
(c)(4)</quote>; and</text>
</subclause><subclause id="HE1BB5056B11E411488338AEAC53C6123"><enum>(II)</enum><text>by striking
<quote>payable on or before October 1 of each year.</quote> and inserting
<quote>due on the later of the first business day on or after October 1 of each
such fiscal year or the first business day after the enactment of an
appropriations Act providing for the collection and obligation of fees for each
such fiscal year under this section.</quote>; and</text>
</subclause></clause><clause id="HDF81BDF64DBE4AB68F93A89D5F756F64"><enum>(ii)</enum><text>by
amending subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HEEB9D8097D2B4EF09A3110E244375244" style="OLC">
<subparagraph id="H1CB071C35B21430E850C3FBC3EB01412"><enum>(B)</enum><header>Exception</header><text>A
prescription drug product shall not be assessed a fee under subparagraph (A) if
such product is—</text>
<clause id="H41BDC6F0878A4BC8B7757CEFC37F6A22"><enum>(i)</enum><text>identified on the
list compiled under section 505(j)(7)(A) with a potency described in terms of
per 100 mL;</text>
</clause><clause id="H15A3C0A5C3744488B357458434F995CD"><enum>(ii)</enum><text>the same product
as another product that—</text>
<subclause id="HD0D892F91FA0410EB49E47BFE8006741"><enum>(I)</enum><text>was approved under
an application filed under section 505(b) or 505(j); and</text>
</subclause><subclause id="H8919982E33984FFAA1D67C940AC3E9B1"><enum>(II)</enum><text>is not in the
list of discontinued products compiled under section 505(j)(7)(A);</text>
</subclause></clause><clause id="H6622DF3F31414847BEB717E91D4A2E30"><enum>(iii)</enum><text>the same product
as another product that was approved under an abbreviated application filed
under section 507 (as in effect on the day before the date of enactment of the
Food and Drug Administration Modernization Act of 1997); or</text>
</clause><clause id="H1CB991B459DB45628FD02680B09C1F69"><enum>(iv)</enum><text>the same product
as another product that was approved under an abbreviated new drug application
pursuant to regulations in effect prior to the implementation of the Drug Price
Competition and Patent Term Restoration Act of
1984.</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph id="HE62AB64760B040D4AE3D565BC5EBAF21"><enum>(2)</enum><text>in subsection
(b)—</text>
<subparagraph id="H5BFD8A6A54C84DC283C526699FD3BB1F"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause id="H68252F0AD61F46AA9B73C2F4EBA82999"><enum>(i)</enum><text>in
the language preceding subparagraph (A), by striking <quote>fiscal years 2008
through 2012</quote> and inserting <quote>fiscal years 2013 through
2017</quote>; and</text>
</clause><clause id="H8A3A95CD26B040DA8ABBB8F7B111A4FF"><enum>(ii)</enum><text>in
subparagraph (A), by striking <quote>$392,783,000; and</quote> and inserting
<quote>$693,099,000;</quote>; and</text>
</clause><clause id="HF6B6C05DB19941B58DAE10F7DA88F409"><enum>(iii)</enum><text>by
striking subparagraph (B) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H3D58B0072E9C44F2A8C2B886BD20D4A6" style="OLC">
<subparagraph id="HB269418CDC80437A82F72ECC21730BFC"><enum>(B)</enum><text>the dollar amount
equal to the inflation adjustment for fiscal year 2013 (as determined under
paragraph (3)(A)); and</text>
</subparagraph><subparagraph id="H973488CEE87F40EAB496CDD5D39D6E43"><enum>(C)</enum><text>the dollar amount
equal to the workload adjustment for fiscal year 2013 (as determined under
paragraph (3)(B)).</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph id="H8DE529CE710C4EB7B67E68A8E737F8A6"><enum>(B)</enum><text>by striking
paragraphs (3) and (4) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="HF2A34FC3F51D4397A4F07A38B22D7F15" style="OLC">
<paragraph id="H8C2420288D1246E593EC832BFA033AA3"><enum>(3)</enum><header>Fiscal year 2013
inflation and workload adjustments</header><text>For purposes of paragraph (1),
the dollar amount of the inflation and workload adjustments for fiscal year
2013 shall be determined as follows:</text>
<subparagraph id="H3532886359954B4D8FCE45A8DEE3A24F"><enum>(A)</enum><header>Inflation
adjustment</header><text>The inflation adjustment for fiscal year 2013 shall be
the sum of—</text>
<clause id="H0C8EB6C5E84E4728B0F554CEE3622924"><enum>(i)</enum><text>$652,709,000
multiplied by the result of an inflation adjustment calculation determined
using the methodology described in subsection (c)(1)(B); and</text>
</clause><clause id="H44B8300A15C9433FA0700C7A8246A48C"><enum>(ii)</enum><text>$652,709,000
multiplied by the result of an inflation adjustment calculation determined
using the methodology described in subsection (c)(1)(C).</text>
</clause></subparagraph><subparagraph id="H573A217517F344CEBBDADA7C7B53D74C"><enum>(B)</enum><header>Workload
adjustment</header><text>Subject to subparagraph (C), the workload adjustment
for fiscal 2013 shall be—</text>
<clause id="H768698E146A24974914DEF38F9215D03"><enum>(i)</enum><text>$652,709,000 plus
the amount of the inflation adjustment calculated under subparagraph (A);
multiplied by</text>
</clause><clause id="HA40406C836BA4B9C9316EC47931A4E98"><enum>(ii)</enum><text>the amount (if
any) by which a percentage workload adjustment for fiscal year 2013, as
determined using the methodology described in subsection (c)(2)(A), would
exceed the percentage workload adjustment (as so determined) for fiscal year
2012, if both such adjustment percentages were calculated using the 5-year base
period consisting of fiscal years 2003 through 2007.</text>
</clause></subparagraph><subparagraph id="H7F7A6E1C4EB94399BCD5DB600F37B092"><enum>(C)</enum><header>Limitation</header><text display-inline="yes-display-inline">Under no circumstances shall the adjustment
under subparagraph (B) result in fee revenues for fiscal year 2013 that are
less than the sum of the amount under paragraph (1)(A) and the amount under
paragraph
(1)(B).</text>
</subparagraph></paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H5E863BD5D2C04A8884DCEDD0F8D45BC2"><enum>(3)</enum><text>by striking
subsection (c) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H8BADC5AEE9C5440F9CD45EE3F78106F7" style="OLC">
<subsection id="H8F65917CC09D463EB561682D809613C7"><enum>(c)</enum><header>Adjustments</header>
<paragraph id="H778FB3E24171408D85E4C9DB2E352A46"><enum>(1)</enum><header>Inflation
adjustment</header><text>For fiscal year 2014 and subsequent fiscal years, the
revenues established in subsection (b) shall be adjusted by the Secretary by
notice, published in the Federal Register, for a fiscal year by the amount
equal to the sum of—</text>
<subparagraph id="H7AB863560397451CB02750AF14D0605F"><enum>(A)</enum><text>one;</text>
</subparagraph><subparagraph id="H819583B0B3FD46AF9A08FF5353047A93"><enum>(B)</enum><text>the average annual
percent change in the cost, per full-time equivalent position of the Food and
Drug Administration, of all personnel compensation and benefits paid with
respect to such positions for the first 3 years of the preceding 4 fiscal
years, multiplied by the proportion of personnel compensation and benefits
costs to total costs of the process for the review of human drug applications
(as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal
years, and</text>
</subparagraph><subparagraph id="H6CDD12BC322B4B448B8D1792E30AC2B1"><enum>(C)</enum><text display-inline="yes-display-inline">the average annual percent change that
occurred in the Consumer Price Index for urban consumers (Washington-Baltimore,
DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3
years of the preceding 4 years of available data multiplied by the proportion
of all costs other than personnel compensation and benefits costs to total
costs of the process for the review of human drug applications (as defined in
section 735(6)) for the first 3 years of the preceding 4 fiscal years.</text>
</subparagraph><continuation-text continuation-text-level="paragraph">The
adjustment made each fiscal year under this paragraph shall be added on a
compounded basis to the sum of all adjustments made each fiscal year after
fiscal year 2013 under this paragraph.</continuation-text></paragraph><paragraph id="H8EBB53B85734446CB39BAA213E0393A1"><enum>(2)</enum><header>Workload
adjustment</header><text>For fiscal year 2014 and subsequent fiscal years,
after the fee revenues established in subsection (b) are adjusted for a fiscal
year for inflation in accordance with paragraph (1), the fee revenues shall be
adjusted further for such fiscal year to reflect changes in the workload of the
Secretary for the process for the review of human drug applications. With
respect to such adjustment:</text>
<subparagraph id="HD496806FF2534080BF1C9529EE01DB61"><enum>(A)</enum><text>The adjustment
shall be determined by the Secretary based on a weighted average of the change
in the total number of human drug applications (adjusted for changes in review
activities, as described in the notice that the Secretary is required to
publish in the Federal Register under this subparagraph), efficacy supplements,
and manufacturing supplements submitted to the Secretary, and the change in the
total number of active commercial investigational new drug applications
(adjusted for changes in review activities, as so described) during the most
recent 12-month period for which data on such submissions is available. The
Secretary shall publish in the Federal Register the fee revenues and fees
resulting from the adjustment and the supporting methodologies.</text>
</subparagraph><subparagraph id="H8C2DB078065148E1BDE58290B664EA89"><enum>(B)</enum><text display-inline="yes-display-inline">Under no circumstances shall the adjustment
result in fee revenues for a fiscal year that are less than the sum of the
amount under subsection (b)(1)(A) and the amount under subsection (b)(1)(B), as
adjusted for inflation under paragraph (1).</text>
</subparagraph><subparagraph id="HFE70CFE2C6F14C56AF10386F9B02B98F"><enum>(C)</enum><text>The Secretary
shall contract with an independent accounting or consulting firm to
periodically review the adequacy of the adjustment and publish the results of
those reviews. The first review shall be conducted and published by the end of
fiscal year 2013 (to examine the performance of the adjustment since fiscal
year 2009), and the second review shall be conducted and published by the end
of fiscal year 2015 (to examine the continued performance of the adjustment).
The reports shall evaluate whether the adjustment reasonably represents actual
changes in workload volume and complexity and present options to discontinue,
retain, or modify any elements of the adjustment. The reports shall be
published for public comment. After review of the reports and receipt of public
comments, the Secretary shall, if warranted, adopt appropriate changes to the
methodology. If the Secretary adopts changes to the methodology based on the
first report, the changes shall be effective for the first fiscal year for
which fees are set after the Secretary adopts such changes and each subsequent
fiscal year.</text>
</subparagraph></paragraph><paragraph id="H20248CBF97AD4A3CA44D2769E0DF67BC"><enum>(3)</enum><header>Final year
adjustment</header><text>For fiscal year 2017, the Secretary may, in addition
to adjustments under this paragraph and paragraphs (1) and (2), further
increase the fee revenues and fees established in subsection (b) if such an
adjustment is necessary to provide for not more than 3 months of operating
reserves of carryover user fees for the process for the review of human drug
applications for the first 3 months of fiscal year 2018. If such an adjustment
is necessary, the rationale for the amount of the increase shall be contained
in the annual notice establishing fee revenues and fees for fiscal year 2017.
If the Secretary has carryover balances for such process in excess of 3 months
of such operating reserves, the adjustment under this subparagraph shall not be
made.</text>
</paragraph><paragraph id="H9EB2555C5BB84AF09123A70B06159437"><enum>(4)</enum><header>Annual fee
setting</header><text>The Secretary shall, not later than 60 days before the
start of each fiscal year that begins after September 30, 2012, establish, for
the next fiscal year, application, product, and establishment fees under
subsection (a), based on the revenue amounts established under subsection (b)
and the adjustments provided under this subsection.</text>
</paragraph><paragraph id="H56C2649E57E346B99B28C08037898522"><enum>(5)</enum><header>Limit</header><text>The
total amount of fees charged, as adjusted under this subsection, for a fiscal
year may not exceed the total costs for such fiscal year for the resources
allocated for the process for the review of human drug
applications.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="HC1C0DAF154D54C85ACE1127B7959291E"><enum>(4)</enum><text>in subsection
(g)—</text>
<subparagraph id="H16CAD362FCA44D7481B8296F8633919A"><enum>(A)</enum><text>in paragraph (1),
by striking <quote>Fees authorized</quote> and inserting <quote>Subject to
paragraph (2)(C), fees authorized</quote>;</text>
</subparagraph><subparagraph id="HDF188CE8689A42CFB6BBC33179EF2D17"><enum>(B)</enum><text>in paragraph
(2)—</text>
<clause id="HB41E1EB66035403CAAD606DDD3BD1807"><enum>(i)</enum><text>in
subparagraph (A)(i), by striking <quote>shall be retained</quote> and inserting
<quote>shall be collected and available</quote>;</text>
</clause><clause id="H2BB2D1B5B5BD48248EF8381FEEC5F7FA"><enum>(ii)</enum><text>in
subparagraph (A)(ii), by striking <quote>shall only be collected and
available</quote> and inserting <quote>shall be available</quote>; and</text>
</clause><clause id="H7BF702713FC14777B6D256198009E093"><enum>(iii)</enum><text>by
adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="H8D7EDD37E06A412393DD43303432F7F5" style="OLC">
<subparagraph id="H49BCC4C8FC544D2DA9589C903C02FE54"><enum>(C)</enum><header>Provision for
early payments</header><text>Payment of fees authorized under this section for
a fiscal year, prior to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in advance in a prior year
appropriations
Act.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph id="H1DBD8551F8BE46F1B9807AB57BCB144D"><enum>(C)</enum><text>in paragraph (3),
by striking <quote>fiscal years 2008 through 2012</quote> and inserting
<quote>fiscal years 2013 through 2017</quote>; and</text>
</subparagraph><subparagraph id="H37FFF25DBF7B4A5BACEA4ADC33BC2EE3"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause id="HAC5B78D25DD149D9AC89FF0E850B84C2"><enum>(i)</enum><text>by
striking <quote>fiscal years 2008 through 2010</quote> and inserting
<quote>fiscal years 2013 through 2015</quote>;</text>
</clause><clause id="H3313018897354EC8B266E7813C90063A"><enum>(ii)</enum><text>by
striking <quote>fiscal year 2011</quote> and inserting <quote>fiscal year
2016</quote>;</text>
</clause><clause id="HDA71C7A6F01447DE8D0F4669CD07A977"><enum>(iii)</enum><text>by
striking <quote>fiscal years 2008 through 2011</quote> and inserting
<quote>fiscal years 2013 through 2016</quote>; and</text>
</clause><clause id="H26876E8F8C714990AB5863384B1F7ADE"><enum>(iv)</enum><text>by
striking <quote>fiscal year 2012</quote> and inserting <quote>fiscal year
2017</quote>.</text>
</clause></subparagraph></paragraph></section><section id="HE37DE122BEE044FBA00F762C1D1FE1A6"><enum>104.</enum><header>Reauthorization;
reporting requirements</header><text display-inline="no-display-inline">Section
736B (<external-xref legal-doc="usc" parsable-cite="usc/21/379h-2">21 U.S.C.
379h–2</external-xref>) is amended—</text>
<paragraph id="H6DDC74D1AB534C9BBDD8E4D16746B9FC"><enum>(1)</enum><text>by amending
subsection (a) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H0498F528C17F4C9CA73C1E35FC442E93" style="OLC">
<subsection id="H279377CFA38444EFBC70099974C03E76"><enum>(a)</enum><header>Performance
report</header>
<paragraph id="H031B8261C79F4F89AC1E8C4C9A79FDA2"><enum>(1)</enum><header>In
general</header><text>Beginning with fiscal year 2013, not later than 120 days
after the end of each fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning—</text>
<subparagraph id="H8B2029534B4B4906A581BF6BF36CD6D9"><enum>(A)</enum><text>the progress of
the Food and Drug Administration in achieving the goals identified in the
letters described in section 101(b) of the <short-title>Prescription Drug User Fee Amendments of
2012</short-title> during such fiscal year and the future plans of the Food and
Drug Administration for meeting the goals, including the status of the
independent assessment described in such letters; and</text>
</subparagraph><subparagraph id="H0E8D48BD82AC4989A05ADCC64F862A20"><enum>(B)</enum><text>the progress of
the Center for Drug Evaluation and Research and the Center for Biologics
Evaluation and Research in achieving the goals, and future plans for meeting
the goals, including, for each review division—</text>
<clause id="H787DF5ABB0C349CF9A2E4CE0AB833FD4"><enum>(i)</enum><text>the number of
original standard new drug applications and biologics license applications
filed per fiscal year for each review division;</text>
</clause><clause id="H7B93F24A558640809CF06190E461DD10"><enum>(ii)</enum><text>the number of
original priority new drug applications and biologics license applications
filed per fiscal year for each review division;</text>
</clause><clause id="HFB4E474F91794BCDB05631DE594E4BFB"><enum>(iii)</enum><text>the number of
standard efficacy supplements filed per fiscal year for each review
division;</text>
</clause><clause id="HD18A659427764B04A828A72C4B468B4A"><enum>(iv)</enum><text>the number of
priority efficacy supplements filed per fiscal year for each review
division;</text>
</clause><clause id="H4F363D0DDCCF44D98BF1EEC14D211325"><enum>(v)</enum><text>the number of
applications filed for review under accelerated approval per fiscal year for
each review division;</text>
</clause><clause id="H4B227507A692489EADC2E0A2D81BADE9"><enum>(vi)</enum><text>the number of
applications filed for review as fast track products per fiscal year for each
review division; and</text>
</clause><clause id="H537A5D8378CD459790A12032E37D64EC"><enum>(vii)</enum><text>the number of
applications filed for orphan-designated products per fiscal year for each
review division.</text>
</clause></subparagraph></paragraph><paragraph id="HEECCAE4EE8964A2CBD9E72D6CA118F81"><enum>(2)</enum><header>Inclusion</header><text>The
report under this subsection for a fiscal year shall include information on all
previous cohorts for which the Secretary has not given a complete response on
all human drug applications and supplements in the
cohort.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="H89D6482748A0448EBDBC3377563CCD57"><enum>(2)</enum><text>in subsection (b),
by striking <quote>2008</quote> and inserting <quote>2013</quote>; and</text>
</paragraph><paragraph id="H13BB65B2F64549669E3CF4762A961A32"><enum>(3)</enum><text>in subsection (d),
by striking <quote>2012</quote> each place it appears and inserting
<quote>2017</quote>.</text>
</paragraph></section><section commented="no" id="H8D708AC312224799850961D4922132CD"><enum>105.</enum><header>Sunset
dates</header>
<subsection commented="no" id="H868DF8CBB2794CA589058608A577671F"><enum>(a)</enum><header>Authorization</header><text display-inline="yes-display-inline">Sections 735 and 736 (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g</external-xref>;
379h) are repealed October 1, 2017.</text>
</subsection><subsection commented="no" id="H516825945FB8414FA623DB95BC2FEB7A"><enum>(b)</enum><header>Reporting
requirements</header><text display-inline="yes-display-inline">Section 736B
(<external-xref legal-doc="usc" parsable-cite="usc/21/379h-2">21 U.S.C.
379h–2</external-xref>) is repealed January 31, 2018.</text>
</subsection><subsection commented="no" id="H9A90985E052E42B9AEC2008F2CEEFA51"><enum>(c)</enum><header>Previous sunset
provision</header>
<paragraph id="H4DF9B41AB07B40429B55BF7B92E067BB"><enum>(1)</enum><header>In
general</header><text>Section 106 of the Prescription Drug User Fee Amendments
of 2007 (Title I of
<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law
110–85</external-xref>) is repealed.</text>
</paragraph><paragraph id="HFFCEF36F08C044B18E841D4405CA3082"><enum>(2)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">The Food and Drug
Administration Amendments Act of 2007 (<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law 110–85</external-xref>) is amended in the
table of contents in section 2, by striking the item relating to section
106.</text>
</paragraph></subsection><subsection commented="no" id="HE660380EE2F2445C82B37DF3EAB7E08F"><enum>(d)</enum><header>Technical
clarifications</header>
<paragraph commented="no" id="H0AC95CAD2CBE47D6893C8C37BCF0260F"><enum>(1)</enum><text display-inline="yes-display-inline">Effective September 30, 2007—</text>
<subparagraph id="H729F2F9396DC41F7A6B7C3D184DE1E15"><enum>(A)</enum><text>section 509 of the
Prescription Drug User Fee Amendments Act of 2002 (Title V of
<external-xref legal-doc="public-law" parsable-cite="pl/107/188">Public Law
107–188</external-xref>) is repealed; and</text>
</subparagraph><subparagraph id="H74CAF1CB85EF436890380082DDCCC2A2"><enum>(B)</enum><text>the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (<external-xref legal-doc="public-law" parsable-cite="pl/107/188">Public Law
107–188</external-xref>) is amended in the table of contents in section 1(b),
by striking the item relating to section 509.</text>
</subparagraph></paragraph><paragraph commented="no" id="HF970522D050E43BC930B17A0B95472F1"><enum>(2)</enum><text>Effective
September 30, 2002—</text>
<subparagraph id="H36F1450FC43F4E2E8002FE8AB4D96715"><enum>(A)</enum><text>section 107 of the
Food and Drug Administration Modernization Act of 1997 (<external-xref legal-doc="public-law" parsable-cite="pl/105/115">Public Law
105–115</external-xref>) is repealed; and</text>
</subparagraph><subparagraph id="H9CBF042FFE794F3E9A0B82C9146CBCA1"><enum>(B)</enum><text>the table of
contents in section 1(c) of such Act is amended by striking the item related to
section 107.</text>
</subparagraph></paragraph><paragraph commented="no" id="H3C892F08FB9E4A178CC354C8D8FACADD"><enum>(3)</enum><text>Effective
September 30, 1997, section 105 of the Prescription Drug User Fee Act of 1992
(<external-xref legal-doc="public-law" parsable-cite="pl/102/571">Public Law
102–571</external-xref>) is repealed.</text>
</paragraph></subsection></section><section id="H04E8684D60C940C8BC262CE6AA8E1EB5"><enum>106.</enum><header>Effective
date</header><text display-inline="no-display-inline">The amendments made by
this title shall take effect on October 1, 2012, or the date of the enactment
of this Act, whichever is later, except that fees under part 2 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed
for all human drug applications received on or after October 1, 2012,
regardless of the date of the enactment of this Act.</text>
</section><section id="H64ECC9071445457B93606BD7A2173A8E"><enum>107.</enum><header>Savings
clause</header><text display-inline="no-display-inline">Notwithstanding the
amendments made by this title, part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date
of the enactment of this title, shall continue to be in effect with respect to
human drug applications and supplements (as defined in such part as of such
day) that on or after October 1, 2007, but before October 1, 2012, were
accepted by the Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a fiscal year prior
to fiscal year 2012.</text>
</section><enum>II</enum><header>Medical Device
User Fee Amendments of 2012</header>
<section id="H1D90BB2CE86A453488CBBD6982DA4B74"><enum>201.</enum><header>Short title;
findings</header>
<subsection id="H8AF1FD7123684CE68AB4413DFC5AFCD8"><enum>(a)</enum><header>Short
title</header><text>This Act may be cited as the <quote><short-title>Medical Device User Fee Amendments of
2012</short-title></quote>.</text>
</subsection><subsection id="H40A0637813D74C30B79AFC9F82D6AE9D"><enum>(b)</enum><header>Findings</header><text>The
Congress finds that the fees authorized under the amendments made by this title
will be dedicated toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of devices, as set
forth in the goals identified for purposes of part 3 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act in the letters from the
Secretary of Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the Chairman of the
Committee on Energy and Commerce of the House of Representatives, as set forth
in the Congressional Record.</text>
</subsection></section><section id="HFB40E8C0A23344B3933AD8E69033A3FB"><enum>202.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 737 (<external-xref legal-doc="usc" parsable-cite="usc/21/379i">21 U.S.C. 379i</external-xref>) is amended—</text>
<paragraph id="HFE4EE09226D24F6BB7454F3E81E6F571"><enum>(1)</enum><text>in paragraph (9),
by striking <quote>incurred</quote> after <quote>expenses</quote>;</text>
</paragraph><paragraph id="H3B606FC5A5CA4243B11A665DD32293EB"><enum>(2)</enum><text>in paragraph (10),
by striking <quote>October 2001</quote> and inserting <quote>October
2011</quote>; and</text>
</paragraph><paragraph id="H40DA47CA37A94824B1E53E2A0E366D71"><enum>(3)</enum><text>in paragraph (13),
by striking <quote>is required to register</quote> and all that follows through
the end of paragraph (13) and inserting the following: <quote>is registered (or
is required to register) with the Secretary under section 510 because such
establishment is engaged in the manufacture, preparation, propagation,
compounding, or processing of a device.</quote>.</text>
</paragraph></section><section id="H7DB247B6F49B4BEA921A5900DBAB9711"><enum>203.</enum><header>Authority to
assess and use device fees</header>
<subsection id="H2CEF5B378A744A44BE8BA178C85F8824"><enum>(a)</enum><header>Types of
fees</header><text>Section 738(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(a)</external-xref>)
is amended—</text>
<paragraph id="H00CF3118FC9644AABA26663A9706146F"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>fiscal year 2008</quote> and inserting <quote>fiscal year
2013</quote>;</text>
</paragraph><paragraph id="HA1EDD2B0970D44949AFAB4178E2CFA89"><enum>(2)</enum><text>in paragraph
(2)(A)—</text>
<subparagraph id="H343B0A9462CF4A47971410995A718D78"><enum>(A)</enum><text>in the matter
preceding clause (i)—</text>
<clause id="HD18631971AB9442EABAA291F65DFA05A"><enum>(i)</enum><text>by
striking <quote>subsections (d) and (e)</quote> and inserting
<quote>subsections (d), (e), and (f)</quote>;</text>
</clause><clause id="HB04218D5DF954B648070AAB6DB69A0EE"><enum>(ii)</enum><text>by
striking <quote>October 1, 2002</quote> and inserting <quote>October 1,
2012</quote>; and</text>
</clause><clause id="H07B01220C9F04F3DBE1518926DDC7037"><enum>(iii)</enum><text>by
striking <quote>subsection (c)(1)</quote> and inserting <quote>subsection
(c)</quote>; and</text>
</clause></subparagraph><subparagraph id="H9C9B99DAB0CD4204811B6CB63D0FC6DA"><enum>(B)</enum><text>in clause (viii),
by striking <quote>1.84</quote> and inserting <quote>2</quote>; and</text>
</subparagraph></paragraph><paragraph id="HACA4A0F22FF64B1983C1496282848D6B"><enum>(3)</enum><text>in paragraph
(3)—</text>
<subparagraph id="H377B7CEF29AC41438F91458C74F6636C"><enum>(A)</enum><text>in subparagraph
(A), by inserting <quote>and subsection (f)</quote> after <quote>subparagraph
(B)</quote>; and</text>
</subparagraph><subparagraph id="H3C2D86CD7D274491B73725A79C8DBB11"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking
<quote>initial registration</quote> and all that follows through <quote>section
510.</quote> and inserting</text>
<quoted-block display-inline="yes-display-inline" id="HA8D5FE30510548408CA11D1C23E8D8F1" style="OLC">
<text>later
of—</text><clause id="H2036350D3C86494AA7F9C7D2A8B9544E"><enum>(i)</enum><text display-inline="yes-display-inline">the initial or annual registration (as
applicable) of the establishment under section 510; or</text>
</clause><clause id="H8C9CD313C1D147F9959DBB1F7BE0AF68"><enum>(ii)</enum><text>the first
business day after the date of enactment of an appropriations Act providing for
the collection and obligation of fees for such year under this
section.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection><subsection id="HCF6CE41D488943D3A8017E5E7B15C23E"><enum>(b)</enum><header>Fee
amounts</header><text>Section 738(b) (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(b)</external-xref>) is amended to
read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H5F685223FC8249ABB5E97DAFCFDB36F5" style="OLC">
<subsection id="H5491792B87844E57973901DFB3D30BF1"><enum>(b)</enum><header>Fee
amounts</header>
<paragraph id="HBCC212BAAE1E4C8A871F2DEDEAC13375"><enum>(1)</enum><header>In
general</header><text>Subject to subsections (c), (d), (e), (f), and (i), for
each of fiscal years 2013 through 2017, fees under subsection (a) shall be
derived from the base fee amounts specified in paragraph (2), to generate the
total revenue amounts specified in paragraph (3).</text>
</paragraph><paragraph id="HDDC9948349434018811E016B63E769E9"><enum>(2)</enum><header>Base fee amounts
specified</header><text>For purposes of paragraph (1), the base fee amounts
specified in this paragraph are as follows:</text>
<table line-rules="hor-ver" rule-weights="4.4.4.4.0.0">
<tgroup cols="6" grid-typeface="1.1" thead-tbody-ldg-size="8.8.8" ttitle-size="10"><colspec coldef="txt" colname="col1" min-data-value="60"></colspec><colspec coldef="fig" colname="col2" min-data-value="8"></colspec><colspec coldef="fig" colname="col3" min-data-value="8"></colspec><colspec coldef="fig" colname="col4" min-data-value="8"></colspec><colspec coldef="fig" colname="col5" min-data-value="8"></colspec><colspec coldef="fig" colname="col6" min-data-value="8"></colspec>
<thead>
<row><entry align="center" colname="col1">Fee Type</entry><entry align="center" colname="col2">Fiscal Year 2013</entry><entry align="center" colname="col3">Fiscal Year 2014</entry><entry align="center" colname="col4">Fiscal Year 2015</entry><entry align="center" colname="col5">Fiscal Year 2016</entry><entry align="center" colname="col6">Fiscal Year 2017</entry>
</row>
</thead>
<tbody>
<row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Premarket Application</entry><entry colname="col2">$248,000</entry><entry colname="col3">$252,960</entry><entry colname="col4">$258,019</entry><entry colname="col5">$263,180</entry><entry colname="col6">$268,443</entry>
</row>
<row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Establishment Registration</entry><entry colname="col2">$2,575</entry><entry colname="col3">$3,200</entry><entry colname="col4">$3,750</entry><entry colname="col5">$3,872</entry><entry colname="col6">$3,872</entry>
</row>
</tbody>
</tgroup>
</table>
</paragraph><paragraph commented="no" id="H014ED16D313A49BB900A78671E0C7008"><enum>(3)</enum><header>Total revenue
amounts</header><text>For purposes of paragraph (1), the total revenue amounts
specified in this paragraph are as follows:</text>
<subparagraph commented="no" id="HE530FE858A4647DEB5A24B139104E7F9"><enum>(A)</enum><text>$97,722,301 for
fiscal year 2013.</text>
</subparagraph><subparagraph commented="no" id="HB9001F3D69FD41118C63BAFFF1AB1DED"><enum>(B)</enum><text>$112,580,497 for
fiscal year 2014.</text>
</subparagraph><subparagraph commented="no" id="H3CEF6D8CB2A0452EB26B0F0B81CAF92E"><enum>(C)</enum><text>$125,767,107 for
fiscal year 2015.</text>
</subparagraph><subparagraph commented="no" id="HA85A2ADF079A44CA8C42DB9B10881CF1"><enum>(D)</enum><text>$129,339,949 for
fiscal year 2016.</text>
</subparagraph><subparagraph commented="no" id="H91A4299266AC4117A2A0073C68EADDC3"><enum>(E)</enum><text>$130,184,348 for
fiscal year
2017.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H4A8731E57AD443EAB0402AB590466E7F"><enum>(c)</enum><header>Annual fee
setting; adjustments</header><text display-inline="yes-display-inline">Section
738(c) (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C.
379j(c)</external-xref>) is amended—</text>
<paragraph id="HFDD1E7C95CB04564BFA982F352B0EEB9"><enum>(1)</enum><text>in the subsection
heading, by inserting <quote><header-in-text level="subsection" style="OLC">;
Adjustments</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Setting</header-in-text></quote>;</text>
</paragraph><paragraph id="H0527D433AD034B5391B1B3C72A0933E0"><enum>(2)</enum><text>by striking
paragraphs (1) and (2);</text>
</paragraph><paragraph id="HAFD361E4953044EBA200BC84805D519D"><enum>(3)</enum><text>by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and</text>
</paragraph><paragraph id="HE2F8E07FDB0F4D639906B4353483BF07"><enum>(4)</enum><text>by inserting
before paragraph (4), as so redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="H2854AE87CF8B4317AFCC40366160869F" style="OLC">
<paragraph id="H801095FBCB5448F99CCC7F29FE39C73C"><enum>(1)</enum><header>In
general</header><text>The Secretary shall, 60 days before the start of each
fiscal year after September 30, 2012, establish fees under subsection (a),
based on amounts specified under subsection (b) and the adjustments provided
under this subsection, and publish such fees, and the rationale for any
adjustments to such fees, in the Federal Register.</text>
</paragraph><paragraph commented="no" id="HA229D6B1B79041109A9C178797A89CDC"><enum>(2)</enum><header>Inflation
adjustments</header>
<subparagraph commented="no" id="H1FC8E5E9C9EF4F08BC6A8E4453DCE836"><enum>(A)</enum><header>Adjustment to
total revenue amounts</header><text>For fiscal year 2014 and each subsequent
fiscal year, the Secretary shall adjust the total revenue amount specified in
subsection (b)(3) for such fiscal year by multiplying such amount by the
applicable inflation adjustment under
<internal-xref idref="H03DB184A2983464BBE8F44CB4B3AC67A" legis-path="(2)(B)">subparagraph (B)</internal-xref> for such year.</text>
</subparagraph><subparagraph commented="no" id="H03DB184A2983464BBE8F44CB4B3AC67A"><enum>(B)</enum><header>Applicable
inflation adjustment to total revenue amounts</header><text>The applicable
inflation adjustment for a fiscal year is—</text>
<clause commented="no" id="HE110BB9D83884738BBCE46F5CEC07103"><enum>(i)</enum><text>for fiscal year
2014, the base inflation adjustment under
<internal-xref idref="HD672C280971F4EEA9B0D89600CB55E08" legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year;
and</text>
</clause><clause commented="no" id="HA887EDD3CAB84A208AEFA4B1C58D1049"><enum>(ii)</enum><text>for fiscal year
2015 and each subsequent fiscal year, the product of—</text>
<subclause commented="no" id="H9EA74B1D246D41EC996AD464952887DD"><enum>(I)</enum><text>the base inflation
adjustment under
<internal-xref idref="HD672C280971F4EEA9B0D89600CB55E08" legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year;
and</text>
</subclause><subclause commented="no" id="HF9C1D4933D8E437081B7DA92AE8221B9"><enum>(II)</enum><text>the product of
the base inflation adjustment under
<internal-xref idref="HD672C280971F4EEA9B0D89600CB55E08" legis-path="(2)(C)">subparagraph (C)</internal-xref> for each of the fiscal
years preceding such fiscal year, beginning with fiscal year 2014.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="HD672C280971F4EEA9B0D89600CB55E08"><enum>(C)</enum><header>Base inflation
adjustment to total revenue amounts</header>
<clause commented="no" id="H2C808093DEC54C478CB31F4B97E3F01F"><enum>(i)</enum><header>In
general</header><text>Subject to further adjustment under clause (ii), the base
inflation adjustment for a fiscal year is the sum of one plus—</text>
<subclause commented="no" id="HBC6412B229CA42D68D5A10D932027CB3"><enum>(I)</enum><text>the average annual
percent change in the cost, per full-time equivalent position of the Food and
Drug Administration, of all personnel compensation and benefits paid with
respect to such positions for the first 3 years of the preceding 4 fiscal
years, multiplied by 0.60; and</text>
</subclause><subclause commented="no" id="HE3FD4001F0D34739A1E539DACDD7274D"><enum>(II)</enum><text>the average
annual percent change that occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All
items; Annual Index) for the first 3 years of the preceding 4 years of
available data multiplied by 0.40.</text>
</subclause></clause><clause commented="no" id="H78453EE4AFB2499181E520C125529846"><enum>(ii)</enum><header>Limitations</header><text>For
purposes of
<internal-xref idref="H03DB184A2983464BBE8F44CB4B3AC67A" legis-path="(2)(B)">subparagraph (B)</internal-xref>, if the base inflation
adjustment for a fiscal year under clause (i)—</text>
<subclause commented="no" id="HE53601245C224841A19AB885E0455859"><enum>(I)</enum><text>is less than 1,
such adjustment shall be considered to be equal to 1; or</text>
</subclause><subclause commented="no" id="H6F6A037138DE4BFA9BFCBEA7B5649A0C"><enum>(II)</enum><text>is greater than
1.04, such adjustment shall be considered to be equal to 1.04.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="H8D96AF532BF34AA289FF71EECE3C5F01"><enum>(D)</enum><header>Adjustment to
base fee amounts</header><text display-inline="yes-display-inline">For each of
fiscal years 2014 through 2017, the base fee amounts specified in subsection
(b)(2) shall be adjusted as needed, on a uniform proportionate basis, to
generate the total revenue amounts under subsection (b)(3), as adjusted for
inflation under subparagraph (A).</text>
</subparagraph></paragraph><paragraph commented="no" id="H3BEBF2BCBAC64BAB897EBFE0C27E1F5A"><enum>(3)</enum><header>Volume-based
adjustments to establishment registration base fees</header><text>For each of
fiscal years 2014 through 2017, after the base fee amounts specified in
subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment
registration fee amounts specified in such subsection shall be further
adjusted, as the Secretary estimates is necessary in order for total fee
collections for such fiscal year to generate the total revenue amounts, as
adjusted under paragraph
(2).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="HB1EBBF2FFC7B4496B1BA41C682E419BA"><enum>(d)</enum><header>Fee waiver or
reduction</header><text display-inline="yes-display-inline">Section 738
(<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C.
379j</external-xref>) is amended by—</text>
<paragraph id="HF1DB8A5929FA476687ADB73FB285127A"><enum>(1)</enum><text>redesignating
subsections (f) through (k) as subsections (g) through (l), respectively;
and</text>
</paragraph><paragraph id="HB8448245049041E8A6A78C1D1C2140CD"><enum>(2)</enum><text>by inserting after
subsection (e) the following new subsection (f):</text>
<quoted-block display-inline="no-display-inline" id="HE569F3B3F1E343468DE35B8B0C79EBA2" style="OLC">
<subsection id="HC5EB36ED2FEB4E408C5910AC58BF95D8"><enum>(f)</enum><header>Fee waiver or
reduction</header>
<paragraph id="H422F663D402145B7AE3040720F8838CA"><enum>(1)</enum><header>In
general</header><text>The Secretary may, at the Secretary’s sole discretion,
grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the
Secretary finds that such waiver or reduction is in the interest of public
health.</text>
</paragraph><paragraph id="HF613E6BBE6104016B9A7F99ABF04E8B8"><enum>(2)</enum><header>Limitation</header><text>The
sum of all fee waivers or reductions granted by the Secretary in any fiscal
year under paragraph (1) shall not exceed 2 percent of the total fee revenue
amounts established for such year under subsection (c).</text>
</paragraph><paragraph id="HDC3BA8617D284B6D9DAEEDFBE7B88887"><enum>(3)</enum><header>Duration</header><text>The
authority provided by this subsection terminates October 1,
2017.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H49ABDF06CCAA46099298FD323BDB473A"><enum>(e)</enum><header>Conditions</header><text display-inline="yes-display-inline">Section 738(h)(1)(A) (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C.
379j(h)(1)(A)</external-xref>), as redesignated by subsection (d)(1), is
amended by striking <quote>$205,720,000</quote> and inserting
<quote>$280,587,000</quote>.</text>
</subsection><subsection id="H043BCC85826147CFB31236AD0F599094"><enum>(f)</enum><header>Crediting and
availability of fees</header><text display-inline="yes-display-inline">Section
738(i) (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C.
379j(i)</external-xref>), as redesignated by subsection (d)(1), is
amended—</text>
<paragraph id="HEE85E55E3236498C902F76D3C9304A53"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>Fees authorized</quote> and inserting <quote>Subject to
paragraph (2)(C), fees authorized</quote>;</text>
</paragraph><paragraph id="H5CBB24FD395443539DD6447B1FB2C52A"><enum>(2)</enum><text>in paragraph
(2)—</text>
<subparagraph id="H061AAD4F4C9E4AB7BD50E86C4DD81145"><enum>(A)</enum><text>in subparagraph
(A)—</text>
<clause id="H8399BE7ABFD74C8393F55B7A94E7DF6C"><enum>(i)</enum><text>in
clause (i), by striking <quote>shall be retained</quote> and inserting
<quote>subject to subparagraph (C), shall be collected and available</quote>;
and</text>
</clause><clause id="H2DD910982F724BE7BE238BB96A5F613D"><enum>(ii)</enum><text>in
clause (ii)—</text>
<subclause id="H2EB57C313204403C8B0F7DFCCA3AB00C"><enum>(I)</enum><text>by striking
<quote>collected and</quote> after <quote>shall only be</quote>; and</text>
</subclause><subclause id="H834F9B5F05444BBCA51FBA17490D5FF1"><enum>(II)</enum><text>by striking
<quote>fiscal year 2002</quote> and inserting <quote>fiscal year 2009</quote>;
and</text>
</subclause></clause></subparagraph><subparagraph id="H310058783CE54D63901518B3E20FD07D"><enum>(B)</enum><text>by adding at the
end, the following:</text>
<quoted-block display-inline="no-display-inline" id="H82FAF5BBC0394FA899672AC11F78F558" style="OLC">
<subparagraph id="H007C82873FC0469D8745C03AC9D4B988"><enum>(C)</enum><header>Provision for
early year payments</header><text>Payment of fees authorized under this section
for a fiscal year, prior to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in advance in a prior year
appropriations
Act.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="H363F44295AC446CBA076F9A2C2CC8A23"><enum>(3)</enum><text>in paragraph (3),
by amending to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H6C710622C03F4B6AA1FA7FDE67BF9DBE" style="OLC">
<paragraph id="H96F1D9C0605D4802B89374966CD330DA"><enum>(3)</enum><header>Authorizations
of appropriations</header><text>For each of the fiscal years 2013 through 2017,
there is authorized to be appropriated for fees under this section an amount
equal to the total revenue amount specified under subsection (b)(3) for the
fiscal year, as adjusted under subsection (c) and, for fiscal year 2017 only,
as further adjusted under paragraph
(4).</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H908A6852A20B462FBA81BF05A8A67707"><enum>(4)</enum><text>in paragraph
(4)—</text>
<subparagraph id="HE6D065FD5ABA466C9765005F20A11A89"><enum>(A)</enum><text>by striking
<quote>fiscal years 2008, 2009, and 2010</quote> and inserting <quote>fiscal
years 2013, 2014, and 2015</quote>;</text>
</subparagraph><subparagraph id="H930FEED30ADC493CAA22EBBA0A8EC2ED"><enum>(B)</enum><text>by striking
<quote>fiscal year 2011</quote> and inserting <quote>fiscal year
2016</quote>;</text>
</subparagraph><subparagraph id="H3414D5D536C94FAC97F220535665F54C"><enum>(C)</enum><text>by striking
<quote>June 30, 2011</quote> and inserting <quote>June 30, 2016</quote>;</text>
</subparagraph><subparagraph id="HC3945B89BF514F399335310C03FB4398"><enum>(D)</enum><text>by striking
<quote>the amount of fees specified in aggregate in</quote> and inserting
<quote>the cumulative amount appropriated pursuant to</quote>;</text>
</subparagraph><subparagraph id="H0D545E0BCC34440FBAC04B7A756B9348"><enum>(E)</enum><text>by striking
<quote>aggregate amount in</quote> before <quote>excess shall be
credited</quote>; and</text>
</subparagraph><subparagraph id="H03FD9D6CCAEB4BE59A147244AE2363D0"><enum>(F)</enum><text>by striking
<quote>fiscal year 2012</quote> and inserting <quote>fiscal year
2017</quote>.</text>
</subparagraph></paragraph></subsection><subsection id="H54284FF6E0604B1C88C633235160CCCD"><enum>(g)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">Section
515(c)(4)(A) (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21
U.S.C. 360e(c)(4)(A)</external-xref>) is amended by striking
<quote>738(g)</quote> and inserting <quote>738(h)</quote>.</text>
</subsection></section><section id="HC9B2659B984E4A8582D9450378FEEF0B"><enum>204.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="HCC5F3A9C0D844DF7A3835B6B7AB92F18"><enum>(a)</enum><header>Reauthorization</header><text display-inline="yes-display-inline">Section 738A(b) (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-1">21 U.S.C.
379j–1(b)</external-xref>) is amended—</text>
<paragraph id="HF0378313425844B497C2C43C26D4B666"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>2012</quote> and inserting <quote>2017</quote>; and</text>
</paragraph><paragraph id="H7AF392C8DA7F483CAE5D4A0549397E52"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (5), by striking
<quote>2012</quote> and inserting <quote>2017</quote>.</text>
</paragraph></subsection><subsection id="HEB5B6738B15648FAAB4F7927A116236E"><enum>(b)</enum><header>Performance
reports</header><text display-inline="yes-display-inline">Section 738A(a)
(<external-xref legal-doc="usc" parsable-cite="usc/21/379j-1">21 U.S.C.
379j–1(a)</external-xref>) is amended—</text>
<paragraph id="HDBEA31C708BA4C81BCDCD4BC119DAF72"><enum>(1)</enum><text>by striking
paragraph (1) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H538FAEBE13294259BF284881C2CDA92C" style="OLC">
<paragraph id="H71A51B2320F64162851E398AEEDC348C"><enum>(1)</enum><header>Performance
report</header>
<subparagraph id="H313A2180A8C848169C5DECAEDBC738D7"><enum>(A)</enum><header>In
general</header><text>Beginning with fiscal year 2013, for each fiscal year for
which fees are collected under this part, the Secretary shall prepare and
submit to the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives annual
reports concerning the progress of the Food and Drug Administration in
achieving the goals identified in the letters described in section 201(b) of
the <short-title>Medical Device User Fee Amendments of
2012</short-title> during such fiscal year and the future plans of the Food and
Drug Administration for meeting the goals.</text>
</subparagraph><subparagraph id="H99CF43B7149341459E9CEB0589E766BC"><enum>(B)</enum><header>Publication</header><text>With
regard to information to be reported by the Food and Drug Administration to
industry on a quarterly and annual basis pursuant to the letters described in
section 201(b) of the Medical Device User Fee Amendments Act of 2012, the
Secretary shall make such information publicly available on the Internet
Website of the Food and Drug Administration not later than 60 days after the
end of each quarter or 120 days after the end of each fiscal year,
respectively, to which such information applies. This information shall include
the status of the independent assessment identified in the letters described in
such section 201(b).</text>
</subparagraph><subparagraph id="H83E2FFC12739466C99D332050A4EC5E5"><enum>(C)</enum><header>Updates</header><text>The
Secretary shall include in each report under subparagraph (A) information on
all previous cohorts for which the Secretary has not given a complete response
on all device premarket applications and reports, supplements, and premarket
notifications in the cohort.</text>
</subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H6AAC984D9C6C4F97B242702B9AF58601"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2), by striking <quote>2008
through 2012</quote> and inserting <quote>2013 through 2017</quote>.</text>
</paragraph></subsection></section><section id="H3A02E8ED4C7F456EAE20C5A1634D9788"><enum>205.</enum><header>Savings
clause</header><text display-inline="no-display-inline">Notwithstanding the
amendments made by this title, part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379i">21 U.S.C. 379i et seq.</external-xref>), as in
effect on the day before the date of the enactment of this title, shall
continue to be in effect with respect to the submissions listed in section
738(a)(2)(A) of such Act (as defined in such part as of such day) that on or
after October 1, 2007, but before October 1, 2012, were accepted by the Food
and Drug Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2013.</text>
</section><section id="HEA94BD8CB88B4DBAB976BF8B30104536"><enum>206.</enum><header>Effective
date</header><text display-inline="no-display-inline">The amendments made by
this title shall take effect on October 1, 2012, or the date of the enactment
of this Act, whichever is later, except that fees under part 3 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed
for all submissions listed in section 738(a)(2)(A) of such Act received on or
after October 1, 2012, regardless of the date of the enactment of this
Act.</text>
</section><section commented="no" id="H0D1E5F270B5A4CB39F65DCBD667BF2BC"><enum>207.</enum><header>Sunset
clause</header>
<subsection commented="no" id="H9C9B441CDCDE48FB994BE8DE9EC1B598"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Sections 737 and 738
of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/739i">21 U.S.C. 739i</external-xref>; 739j) shall cease
to be effective October 1, 2017. Section 738A (<external-xref legal-doc="usc" parsable-cite="usc/21/739j-1">21 U.S.C. 739j–1</external-xref>) of the Federal
Food, Drug, and Cosmetic Act (regarding reauthorization and reporting
requirements) is repealed January 31, 2018.</text>
</subsection><subsection commented="no" id="H61035215697D41D5934EF86B1BC4AFDA"><enum>(b)</enum><header>Previous sunset
provision</header>
<paragraph id="H94AA7A8B84B2415F865E576AB8CF5537"><enum>(1)</enum><header>In
general</header><text>Section 217 of the Medical Device User Fee Amendments of
2007 (Title II of
<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law
110–85</external-xref>) is repealed.</text>
</paragraph><paragraph id="H929E6EAABEF94DD898028F18344A59F4"><enum>(2)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">The Food and Drug
Administration Amendments Act of 2007 (<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law 110–85</external-xref>) is amended in the
table of contents in section 2, by striking the item relating to section
217.</text>
</paragraph></subsection><subsection commented="no" id="H8E974A750CD54BF7BE7CA74509F12988"><enum>(c)</enum><header>Technical
clarification</header><text>Effective September 30, 2007—</text>
<paragraph id="H1D5367BAAE864158B008FE6380AFC538"><enum>(1)</enum><text>section 107 of the
Medical Device User Fee and Modernization Act of 2002 (<external-xref legal-doc="public-law" parsable-cite="pl/107/250">Public Law 107–250</external-xref>) is repealed;
and</text>
</paragraph><paragraph id="HE1594D855D1F4D659BFA78B80C49D419"><enum>(2)</enum><text>the table of
contents in section 1(b) of such Act is amended by striking the item related to
section 107.</text>
</paragraph></subsection></section><section id="H59564E1F85734EAEBCFD3D6781A0518D"><enum>208.</enum><header>Streamlined
hiring authority to support activities related to the process for the review of
device applications</header><text display-inline="no-display-inline">Subchapter
A of chapter VII (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21
U.S.C. 371 et seq.</external-xref>) is amended by inserting after section 713
the following new section:</text>
<quoted-block display-inline="no-display-inline" id="HD059EAD0BF38477C9E850B7035695F94" style="OLC">
<section id="HADE4C790DA5B44CE99C01A073D882934"><enum>714.</enum><header>Streamlined
hiring authority</header>
<subsection id="H4788BF0A416746CCB28CC307F87251AC"><enum>(a)</enum><header>In
general</header><text>In addition to any other personnel authorities under
other provisions of law, the Secretary may, without regard to the provisions of
title 5, United States Code, governing appointments in the competitive service,
appoint employees to positions in the Food and Drug Administration to perform,
administer, or support activities described in subsection (b), if the Secretary
determines that such appointments are needed to achieve the objectives
specified in subsection (c).</text>
</subsection><subsection id="H9B109382821746C7A640517DB6D7136D"><enum>(b)</enum><header>Activities
described</header><text>The activities described in this subsection are
activities under this Act related to the process for the review of device
applications (as defined in section 737(8)).</text>
</subsection><subsection id="HE244C2BC3E254643BF7431835F3BFB6C"><enum>(c)</enum><header>Objectives
specified</header><text>The objectives specified in this subsection are with
respect to the activities under
<internal-xref idref="HE14D6F7452764407B42F76DBF71AC297" legis-path="714.(b)(1)">subsection (b)(1)</internal-xref>, the goals referred
to in section 738A(a)(1).</text>
</subsection><subsection id="HAFA7F50B0F134DBB9F5DDCC92802CF7D"><enum>(d)</enum><header>Internal
controls</header><text>The Secretary shall institute appropriate internal
controls for appointments under this section.</text>
</subsection><subsection id="H23BB1CBF84E94FEFBED94D410B7165F8"><enum>(e)</enum><header>Sunset</header><text>The
authority to appoint employees under this section shall terminate on the date
that is three years after the date of enactment of this
section.</text>
</subsection></section><after-quoted-block>.
</after-quoted-block></quoted-block>
</section><enum>III</enum><header>Fees relating to
generic drugs</header>
<section id="HB2F5FAE4359F41C7A235841D27882795"><enum>301.</enum><header>Short
title</header>
<subsection id="H7D26C15B0F044ED089C255B32FCAAE3C"><enum>(a)</enum><header>Short
title</header><text display-inline="yes-display-inline">This title may be cited
as the <quote><short-title>Generic Drug User Fee
Amendments of 2012</short-title></quote>.</text>
</subsection><subsection id="H7C0176C0A96446098E923996CA85FBC8"><enum>(b)</enum><header>Finding</header><text display-inline="yes-display-inline">The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to human generic drug
activities, as set forth in the goals identified for purposes of part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the
letters from the Secretary of Health and Human Services to the Chairman of the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.</text>
</subsection></section><section id="HD5BE79DA8EAE4A3E8F0BA9FE07821BD7"><enum>302.</enum><header>Authority to
assess and use human generic drug fees</header><text display-inline="no-display-inline">Subchapter C of chapter VII (<external-xref legal-doc="usc" parsable-cite="usc/21/379f">21 U.S.C. 379f et
seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF3ED6F659D6C42D3B4879120217C2502" style="OLC">
<part id="HE2477AF707B74F29BB48DAC299AF6D36"><enum>7</enum><header>FEES
RELATING TO GENERIC DRUGS </header>
<section id="HC44A4EE6D32945359734A91A06A6E0F8"><enum>744A.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="H2E16497924A2431FB8174001F2F915CB"><enum>(1)</enum><text>The term
<term>abbreviated new drug application</term>—</text>
<subparagraph id="H558019660F884F689BED65C51F7BBA7F"><enum>(A)</enum><text>means an
application submitted under section 505(j), an abbreviated application
submitted under section 507 (as in effect on the day before the date of
enactment of the Food and Drug Administration Modernization Act of 1997), or an
abbreviated new drug application submitted pursuant to regulations in effect
prior to the implementation of the Drug Price Competition and Patent Term
Restoration Act of 1984; and</text>
</subparagraph><subparagraph id="H04598F3DEF44430BB72162F737ED599F"><enum>(B)</enum><text>does not include
an application for a positron emission tomography drug.</text>
</subparagraph></paragraph><paragraph id="HC33A36625029423A81E841A3047F32A1"><enum>(2)</enum><text>The term
<term>active pharmaceutical ingredient</term> means—</text>
<subparagraph id="HE4B0A31046F14A7EB09B086103895CCE"><enum>(A)</enum><text>a substance, or a
mixture when the substance is unstable or cannot be transported on its own,
intended—</text>
<clause id="H52EC63E8D4FE44AFAF145A1EA77B1438"><enum>(i)</enum><text>to
be used as a component of a drug; and</text>
</clause><clause id="H2ACB305B4CC44FCEBC942E4FACA7FB19"><enum>(ii)</enum><text>to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease, or to affect the structure or
any function of the human body; or</text>
</clause></subparagraph><subparagraph id="H043C067C2EDE4C52BFBC5FA13DD49F99"><enum>(B)</enum><text>a substance
intended for final crystallization, purification, or salt formation, or any
combination of those activities, to become a substance or mixture described in
subparagraph (A).</text>
</subparagraph></paragraph><paragraph id="H646DC84099D842BCBB0A11E0EBB7DDCC"><enum>(3)</enum><text>The term
<term>adjustment factor</term> means a factor applicable to a fiscal year that
is the Consumer Price Index for all urban consumers (all items; United States
city average) for October of the preceding fiscal year divided by such Index
for October 2011.</text>
</paragraph><paragraph id="HBB988D399ABE46D9BA6CE1F77C1F195E"><enum>(4)</enum><text>The term
<term>affiliate</term> means a business entity that has a relationship with a
second business entity if, directly or indirectly—</text>
<subparagraph id="H64A23884A7BD4C7E8FC5453891F8D2AC"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="H34AC84FB4C824202ADA4488D72CFDCE3"><enum>(B)</enum><text>a third party
controls, or has power to control, both of the business entities.</text>
</subparagraph></paragraph><paragraph id="HC9AF743CCFB64690A5898CADE38FC6E1"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HCF341A8FA1374723BFE6F5DB63EC9C49"><enum>(A)</enum><text>The term
<term>facility</term>—</text>
<clause id="H790F2DDB9F5044C9ACC02EC99BFAC748" indent="up1"><enum>(i)</enum><text>means a business or other
entity—</text>
<subclause id="HAACC494750E74A9A832B5C55633666FA"><enum>(I)</enum><text>under one management, either direct or
indirect; and</text>
</subclause><subclause id="H0599CFB3890F40C58F42C6FA61D5539F"><enum>(II)</enum><text>at one geographic location or address
engaged in manufacturing or processing an active pharmaceutical ingredient or a
finished dosage form; and</text>
</subclause></clause><clause id="H1958D40744E144ED93BD9E0B69474B6F" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">does not include a business or other entity
whose only manufacturing or processing activities are one or more of the
following: repackaging, relabeling, or testing.</text>
</clause></subparagraph><subparagraph id="HB875CAFCE3AD48B992589F14F739C99C" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (A), separate
buildings within close proximity are considered to be at one geographic
location or address if the activities in them are—</text>
<clause id="HE1BACB5A65334B969272B48CD6628066"><enum>(i)</enum><text>closely related to the same
business enterprise;</text>
</clause><clause id="H8F43E76AFA944A89A4A88B66DF35EF91"><enum>(ii)</enum><text>under the supervision of the same
local management; and</text>
</clause><clause id="H2F88737C677D4E64900875CFB4D64B23"><enum>(iii)</enum><text>capable of being inspected by the
Food and Drug Administration during a single inspection.</text>
</clause></subparagraph><subparagraph commented="no" id="HDD5331BD29B04C45BC0AE5F39692F96A" indent="up1"><enum>(C)</enum><text>If a business or other entity would
meet the definition of a facility under this paragraph but for being under
multiple management, the business or other entity is deemed to constitute
multiple facilities, one per management entity, for purposes of this
paragraph.</text>
</subparagraph></paragraph><paragraph id="HFFC04C1359494D7C9199BC4461A918C0"><enum>(6)</enum><text>The term
<term>finished dosage form</term> means—</text>
<subparagraph id="HA224B7D42CAC4DE6AA0B0DAB13B11D68"><enum>(A)</enum><text>a drug product in
the form in which it will be administered to a patient, such as a tablet,
capsule, solution, or topical application;</text>
</subparagraph><subparagraph id="H40CCD7C9D0A246A385BD10C4CC985C48"><enum>(B)</enum><text>a drug product in
a form in which reconstitution is necessary prior to administration to a
patient, such as oral suspensions or lyophilized powders; or</text>
</subparagraph><subparagraph id="HB43A2EBE07E2478F8A0FEF83AC15B3EC"><enum>(C)</enum><text>any combination of
an active pharmaceutical ingredient with another component of a drug product
for purposes of production of a drug product described in subparagraph (A) or
(B).</text>
</subparagraph></paragraph><paragraph id="HF2D982D56AFB436B95DE8421B4DE2C33"><enum>(7)</enum><text>The term
<term>generic drug submission</term> means an abbreviated new drug application,
an amendment to an abbreviated new drug application, or a prior approval
supplement to an abbreviated new drug application.</text>
</paragraph><paragraph id="H0062716467B643098FE29AAE3C1F4B1F"><enum>(8)</enum><text>The term
<term>human generic drug activities</term> means the following activities of
the Secretary associated with generic drugs and inspection of facilities
associated with generic drugs:</text>
<subparagraph id="H20B421DF9646425FB3A2ADA4492C7DFE"><enum>(A)</enum><text>The activities
necessary for the review of generic drug submissions, including review of drug
master files referenced in such submissions.</text>
</subparagraph><subparagraph id="H15C07B8875A24DD987AB57EE3B0977F3"><enum>(B)</enum><text>The issuance
of—</text>
<clause id="HD3EDEE482D854D8AAB1E03510997599E"><enum>(i)</enum><text>approval letters
which approve abbreviated new drug applications or supplements to such
applications; or</text>
</clause><clause id="H2E28295C657F4854B7B0B03B038FDEA2"><enum>(ii)</enum><text>complete response
letters which set forth in detail the specific deficiencies in such
applications and, where appropriate, the actions necessary to place such
applications in condition for approval.</text>
</clause></subparagraph><subparagraph id="H8692B83A6C894D918E076EC1C099ECFF"><enum>(C)</enum><text>The issuance of
letters related to Type II active pharmaceutical drug master files
which—</text>
<clause id="H8A62CB67FC7340CA9B9F580E30596F73"><enum>(i)</enum><text>set forth in
detail the specific deficiencies in such submissions, and where appropriate,
the actions necessary to resolve those deficiencies; or</text>
</clause><clause id="HB2FA5A0884F54C9CA76523B3F96BB604"><enum>(ii)</enum><text>document that no
deficiencies need to be addressed.</text>
</clause></subparagraph><subparagraph id="H3AE0914C209449478950E292F81E0038"><enum>(D)</enum><text>Inspections
related to generic drugs.</text>
</subparagraph><subparagraph id="H81C8B4C672DE471E862DE9C45FA0A999"><enum>(E)</enum><text>Monitoring of
research conducted in connection with the review of generic drug submissions
and drug master files.</text>
</subparagraph><subparagraph id="HD87744CC00A94F43954C67BB70F3F83A"><enum>(F)</enum><text>Postmarket safety
activities with respect to drugs approved under abbreviated new drug
applications or supplements, including the following activities:</text>
<clause id="H152F57ABCDF34E1EA900D3A485695222"><enum>(i)</enum><text>Collecting,
developing, and reviewing safety information on approved drugs, including
adverse event reports.</text>
</clause><clause id="HFF97BD2C183D409B9D4107741B4F7C1D"><enum>(ii)</enum><text>Developing and
using improved adverse-event data-collection systems, including information
technology systems.</text>
</clause><clause id="H32AF63E45B05406ABD03A7416DC667B1"><enum>(iii)</enum><text>Developing and
using improved analytical tools to assess potential safety problems, including
access to external data bases.</text>
</clause><clause id="H347D6888EDA14BB39E7BA1BE71B1BD55"><enum>(iv)</enum><text>Implementing and
enforcing section 505(o) (relating to postapproval studies and clinical trials
and labeling changes) and section 505(p) (relating to risk evaluation and
mitigation strategies) insofar as those activities relate to abbreviated new
drug applications.</text>
</clause><clause id="HCC8C35A93D44435EB4EA40F349573230"><enum>(v)</enum><text>Carrying out
section 505(k)(5) (relating to adverse-event reports and postmarket safety
activities).</text>
</clause></subparagraph><subparagraph id="H8B02B2F968E74883A2534E5212408D08"><enum>(G)</enum><text>Regulatory science
activities related to generic drugs.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="HC6D6E741477F4604AB690C4A50EFE68F"><enum>(9)</enum><text>The term
<term>positron emission tomography drug</term> has the meaning given to the
term <term>compounded positron emission tomography drug</term> in section
201(ii), except that paragraph (1)(B) of such section shall not apply.</text>
</paragraph><paragraph id="H7178DAA16488491680C1E52A202C44F9"><enum>(10)</enum><text>The term
<term>prior approval supplement</term> means a request to the Secretary to
approve a change in the drug substance, drug product, production process,
quality controls, equipment, or facilities covered by an approved abbreviated
new drug application when that change has a substantial potential to have an
adverse effect on the identity, strength, quality, purity, or potency of the
drug product as these factors may relate to the safety or effectiveness of the
drug product.</text>
</paragraph><paragraph id="H68C690A9E36B43A483DABCD47DEFD531"><enum>(11)</enum><text>The term
<term>resources allocated for human generic drug activities</term> means the
expenses for—</text>
<subparagraph id="H207B48F5006E4139A24FFDC48FA48476"><enum>(A)</enum><text>officers and
employees of the Food and Drug Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such officers and
employees and to contracts with such contractors;</text>
</subparagraph><subparagraph id="H907F356FBE114EB69A04DD73E4F5D3E2"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="H62F6BC1DFC304D89A6223E91611C456A"><enum>(C)</enum><text>leasing,
maintenance, renovation, and repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and</text>
</subparagraph><subparagraph id="H1F92CF41F1B34F2B8202A983334DA37E"><enum>(D)</enum><text>collecting fees
under subsection (a) and accounting for resources allocated for the review of
abbreviated new drug applications and supplements and inspection related to
generic drugs.</text>
</subparagraph></paragraph><paragraph id="HA51CE439CC994AFFBF3998927251698C"><enum>(12)</enum><text>The term
<term>Type II active pharmaceutical ingredient drug master file</term> means a
submission of information to the Secretary by a person that intends to
authorize the Food and Drug Administration to reference the information to
support approval of a generic drug submission without the submitter having to
disclose the information to the generic drug submission applicant.</text>
</paragraph></section><section id="HD7E9EA01B71F433C860CF18BDCC62DFB"><enum>744B.</enum><header>Authority to
assess and use human generic drug fees</header>
<subsection id="HBA0DEE2BB97347E2BA629968ACF9079F"><enum>(a)</enum><header>Types of
fees</header><text>Beginning in fiscal year 2013, the Secretary shall assess
and collect fees in accordance with this section as follows:</text>
<paragraph id="H8358C1AAFE1C40848BADF58667D83076"><enum>(1)</enum><header>One-Time Backlog
Fee for Abbreviated New Drug Applications Pending on October 1, 2012</header>
<subparagraph id="H8B4B098AFDB6417B9797F062B9609A02"><enum>(A)</enum><header>In
general</header><text>Each person that owns an abbreviated new drug application
that is pending on October 1, 2012, and that has not received a tentative
approval prior to that date, shall be subject to a fee for each such
application, as calculated under subparagraph (B).</text>
</subparagraph><subparagraph id="HBEBEF4F635AD4EDE873CF11C6B144679"><enum>(B)</enum><header>Method of fee
amount calculation</header><text>The amount of each one-time backlog fee shall
be calculated by dividing $50,000,000 by the total number of abbreviated new
drug applications pending on October 1, 2012, that have not received a
tentative approval as of that date.</text>
</subparagraph><subparagraph id="HA420BBBF62C846FDA098CBA6EF05E272"><enum>(C)</enum><header>Notice</header><text>Not
later than October 31, 2012, the Secretary shall cause to be published in the
Federal Register a notice announcing the amount of the fee required by
subparagraph (A).</text>
</subparagraph><subparagraph id="H8EE8B3C6A67E445A9B8B22ACDC97A4E8"><enum>(D)</enum><header>Fee due
date</header><text>The fee required by subparagraph (A) shall be due no later
than 30 calendar days after the date of the publication of the notice specified
in subparagraph (C).</text>
</subparagraph></paragraph><paragraph id="HCD185B6E78A94F919C3E0DC71C1F0262"><enum>(2)</enum><header>Drug Master File
Fee</header>
<subparagraph id="H4D1EE2F0C599461FA8A31956767A40BF"><enum>(A)</enum><header>In
general</header><text>Each person that owns a Type II active pharmaceutical
ingredient drug master file that is referenced on or after October 1, 2012, in
a generic drug submission by any initial letter of authorization shall be
subject to a drug master file fee.</text>
</subparagraph><subparagraph id="H4C750B1EB3E54701A2C00EC51D40A0FB"><enum>(B)</enum><header>One-time
payment</header><text>If a person has paid a drug master file fee for a Type II
active pharmaceutical ingredient drug master file, the person shall not be
required to pay a subsequent drug master file fee when that Type II active
pharmaceutical ingredient drug master file is subsequently referenced in
generic drug submissions.</text>
</subparagraph><subparagraph id="HAB1BDCCABA1345AF922319A98F5E702F"><enum>(C)</enum><header>Notice</header>
<clause id="H45A7A86D9E194346BAAF7862E9F9F8F3"><enum>(i)</enum><header>Fiscal year
2013</header><text>Not later than October 31, 2012, the Secretary shall cause
to be published in the Federal Register a notice announcing the amount of the
drug master file fee for fiscal year 2013.</text>
</clause><clause id="H5DE8045359C6465AB4FF21E876A6D18E"><enum>(ii)</enum><header>Fiscal year
2014 through 2017</header><text>Not later than 60 days before the start of each
of fiscal years 2014 through 2017, the Secretary shall cause to be published in
the Federal Register the amount of the drug master file fee established by this
paragraph for such fiscal year.</text>
</clause></subparagraph><subparagraph id="H16479D83B79545CA91BF3F3C0CABE1A6"><enum>(D)</enum><header>Availability for
reference</header>
<clause commented="no" id="H57F7BFB7DDBD4A1FAACB434F4C378637"><enum>(i)</enum><header>In
general</header><text>Subject to subsection (g)(2)(C), for a generic drug
submission to reference a Type II active pharmaceutical ingredient drug master
file, the drug master file must be deemed available for reference by the
Secretary.</text>
</clause><clause commented="no" id="H943EE54DFE53413EADF28ECC1BAEB5F1"><enum>(ii)</enum><header>Conditions</header><text>A
drug master file shall be deemed available for reference by the Secretary
if—</text>
<subclause commented="no" id="H048278F9BCC94D4695DF3BB2EAC197D5"><enum>(I)</enum><text display-inline="yes-display-inline">the person that owns a Type II active
pharmaceutical ingredient drug master file has paid the fee required under
subparagraph (A) within 20 calendar days after the applicable due date under
subparagraph (E); and</text>
</subclause><subclause commented="no" id="H86E5BF91168D4E3CA0FE0D72613EA2D4"><enum>(II)</enum><text>the drug master
file has not failed an initial completeness assessment by the Secretary, in
accordance with criteria to be published by the Secretary.</text>
</subclause></clause><clause id="H020B33360A144ACF94E7DF407A6BA06B"><enum>(iii)</enum><header>List</header><text display-inline="yes-display-inline">The Secretary shall make publicly available
on the Internet Web site of the Food and Drug Administration a list of the drug
master file numbers that correspond to drug master files that have successfully
undergone an initial completeness assessment, in accordance with criteria to be
published by the Secretary, and are available for reference.</text>
</clause></subparagraph><subparagraph id="H4F5D1836088643C8AED85659A1E4AE1B"><enum>(E)</enum><header>Fee Due
Date</header>
<clause id="H413D8E2AC20E4D43A574F09C9FB4CA06"><enum>(i)</enum><header>In
general</header><text>Subject to clause (ii), a drug master file fee shall be
due no later than the date on which the first generic drug submission is
submitted that references the associated Type II active pharmaceutical
ingredient drug master file.</text>
</clause><clause id="H9FFFA5471C6C48259D9D29A348867642"><enum>(ii)</enum><header>Limitation</header><text display-inline="yes-display-inline">No fee shall be due under subparagraph (A)
for a fiscal year until the later of—</text>
<subclause id="H9522CD5D00184F95AF2500A6F4833E1D"><enum>(I)</enum><text>30 calendar days
after publication of the notice provided for in clause (i) or (ii) of
subparagraph (C), as applicable; or</text>
</subclause><subclause id="HC20854867AE043A69EA9348152BD68AB"><enum>(II)</enum><text>30 calendar days
after the date of enactment of an appropriations Act providing for the
collection and obligation of fees under this section.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="H45C1AE28E3D3404AAB138F10D135369C"><enum>(3)</enum><header>Abbreviated New
Drug Application and Prior Approval Supplement Filing Fee</header>
<subparagraph id="H9D531A61DFD94F62810F83B37D52E1C8"><enum>(A)</enum><header>In
general</header><text>Each applicant that submits, on or after October 1, 2012,
an abbreviated new drug application or a prior approval supplement to an
abbreviated new drug application shall be subject to a fee for each such
submission in the amount established under subsection (d).</text>
</subparagraph><subparagraph id="H02A89F7F5FEB43DDB4BE3F1717E9D19C"><enum>(B)</enum><header>Notice</header>
<clause id="H5297468362CC4D1B9AD9F11350CEE1FE"><enum>(i)</enum><header>Fiscal year
2013</header><text>Not later than October 31, 2012, the Secretary shall cause
to be published in the Federal Register a notice announcing the amount of the
fees under subparagraph (A) for fiscal year 2013.</text>
</clause><clause id="HBB0630F3BACF4977A09BEF228B0802A4"><enum>(ii)</enum><header>Fiscal years
2014 through 2017</header><text display-inline="yes-display-inline">Not later
than 60 days before the start of each of fiscal years 2014 through 2017, the
Secretary shall cause to be published in the Federal Register the amount of the
fees under subparagraph (A) for such fiscal year.</text>
</clause></subparagraph><subparagraph id="H5F2717F2D6904E94B84AEB1A1977E8CB"><enum>(C)</enum><header>Fee Due
Date</header>
<clause id="H53754004B71B44FC8D377AD25D205618"><enum>(i)</enum><header>In
general</header><text>Except as provided in clause (ii), the fees required by
subparagraphs (A) and (F) shall be due no later than the date of submission of
the abbreviated new drug application or prior approval supplement for which
such fee applies.</text>
</clause><clause id="H7A5ACBD2EC02480FA50A80D8C8AFDF31"><enum>(ii)</enum><header>Special rule
for 2013</header><text display-inline="yes-display-inline">For fiscal year
2013, such fees shall be due on the later of—</text>
<subclause id="H87DF39A5C5FC4AA0B5784D95359BA212"><enum>(I)</enum><text>the date on which
the fee is due under clause (i);</text>
</subclause><subclause id="H0ADB6309910A479B98F88D8325003DAE"><enum>(II)</enum><text>30 calendar days
after publication of the notice referred to in subparagraph (B)(i); or</text>
</subclause><subclause id="HEAFDD0979D184907B409F89085506B43"><enum>(III)</enum><text display-inline="yes-display-inline">if an appropriations Act is not enacted
providing for the collection and obligation of fees under this section by the
date of submission of the application or prior approval supplement for which
the fees under subparagraphs (A) and (F) apply, 30 calendar days after the date
that such an appropriations Act is enacted.</text>
</subclause></clause></subparagraph><subparagraph id="H55257CBE387C4259B7CC98C75D715B35"><enum>(D)</enum><header>Refund of fee if
abbreviated new drug application is not considered to have been
received</header><text>The Secretary shall refund 75 percent of the fee paid
under subparagraph (A) for any abbreviated new drug application or prior
approval supplement to an abbreviated new drug application that the Secretary
considers not to have been received within the meaning of section 505(j)(5)(A)
for a cause other than failure to pay fees.</text>
</subparagraph><subparagraph id="H77643640B032411F89091C973DDD9996"><enum>(E)</enum><header>Fee for an
application the secretary considers not to have been received, or that has been
withdrawn</header><text display-inline="yes-display-inline">An abbreviated new
drug application or prior approval supplement that was submitted on or after
October 1, 2012, and that the Secretary considers not to have been received, or
that has been withdrawn, shall, upon resubmission of the application or a
subsequent new submission following the applicant’s withdrawal of the
application, be subject to a full fee under subparagraph (A).</text>
</subparagraph><subparagraph commented="no" id="H60B1E0C066BC4CBD86DE5FC3CE750D20"><enum>(F)</enum><header>Additional fee
for active pharmaceutical ingredient information not included by reference to
Type II active pharmaceutical ingredient drug master file</header><text>An
applicant that submits a generic drug submission on or after October 1, 2012,
shall pay a fee, in the amount determined under subsection (d)(3), in addition
to the fee required under subparagraph (A), if—</text>
<clause commented="no" id="H4B9ED152F7E543209804361ED4A9CF7F"><enum>(i)</enum><text>such submission
contains information concerning the manufacture of an active pharmaceutical
ingredient at a facility by means other than reference by a letter of
authorization to a Type II active pharmaceutical drug master file; and</text>
</clause><clause commented="no" id="H30D01085D96146AD94B8F482E398B708"><enum>(ii)</enum><text>a fee in the
amount equal to the drug master file fee established in paragraph (2) has not
been previously paid with respect to such information.</text>
</clause></subparagraph></paragraph><paragraph id="HB760E95825A1475FB3BA24B229D57519"><enum>(4)</enum><header>Generic Drug
Facility Fee and Active Pharmaceutical Ingredient Facility Fee</header>
<subparagraph id="H9460740523FC44F69A9F10ACB8CEB805"><enum>(A)</enum><header>In
general</header><text>Facilities identified, or intended to be identified, in
at least one generic drug submission that is pending or approved to produce a
finished dosage form of a human generic drug or an active pharmaceutical
ingredient contained in a human generic drug shall be subject to fees as
follows:</text>
<clause id="H794BA402C5054434AAAC0766AF1B436A"><enum>(i)</enum><header>Generic drug
facility</header><text>Each person that owns a facility which is identified or
intended to be identified in at least one generic drug submission that is
pending or approved to produce one or more finished dosage forms of a human
generic drug shall be assessed an annual fee for each such facility.</text>
</clause><clause id="H808148C56FC746EB9669ACA9A3AB98D7"><enum>(ii)</enum><header>Active
pharmaceutical ingredient facility</header><text>Each person that owns a
facility which produces, or which is pending review to produce, one or more
active pharmaceutical ingredients identified, or intended to be identified, in
at least one generic drug submission that is pending or approved or in a Type
II active pharmaceutical ingredient drug master file referenced in such a
generic drug submission, shall be assessed an annual fee for each such
facility.</text>
</clause><clause id="HAAF09D1B58714D649042F38A0CA54232"><enum>(iii)</enum><header>Facilities
producing both active pharmaceutical ingredients and finished dosage
forms</header><text>Each person that owns a facility identified, or intended to
be identified, in at least one generic drug submission that is pending or
approved to produce both one or more finished dosage forms subject to clause
(i) and one or more active pharmaceutical ingredients subject to clause (ii)
shall be subject to fees under both such clauses for that facility.</text>
</clause></subparagraph><subparagraph id="H481817897DA541C1AB37150D6562A713"><enum>(B)</enum><header>Amount</header><text>The
amount of fees established under subparagraph (A) shall be established under
subsection (d).</text>
</subparagraph><subparagraph id="H66D4FBD62BF244709C775AAFAEE63E62"><enum>(C)</enum><header>Notice</header>
<clause id="HDE3791F8F04D40CA8D9C4C64BDEC07D0"><enum>(i)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013, the Secretary shall cause to be
published in the Federal Register a notice announcing the amount of the fees
provided for in subparagraph (A) within the timeframe specified in subsection
(d)(1)(B).</text>
</clause><clause id="HA2342873A1524C1F9934D36A9536D1D1"><enum>(ii)</enum><header>Fiscal years
2014 through 2017</header><text display-inline="yes-display-inline">Within the
timeframe specified in subsection (d)(2), the Secretary shall cause to be
published in the Federal Register the amount of the fees under subparagraph (A)
for such fiscal year.</text>
</clause></subparagraph><subparagraph id="H567D41D0E7AD424D8042B30798492EC5"><enum>(D)</enum><header>Fee Due
Date</header>
<clause id="H6569573865C84882AF0FB2A7041F1324"><enum>(i)</enum><header>Fiscal year
2013</header><text display-inline="yes-display-inline">For fiscal year 2013,
the fees under subparagraph (A) shall be due on the later of—</text>
<subclause id="H5D818048661546F18010B752BF801488"><enum>(I)</enum><text>not later than 45
days after the publication of the notice under subparagraph (B); or</text>
</subclause><subclause id="HE0B97F8E4DE84E2091986085D8D37721"><enum>(II)</enum><text>if an
appropriations Act is not enacted providing for the collection and obligation
of fees under this section by the date of the publication of such notice, 30
days after the date that such an appropriations Act is enacted.</text>
</subclause></clause><clause id="H83C069D94AB64739BB8155A1A3C17E0E"><enum>(ii)</enum><header>Fiscal years
2014 through 2017</header><text>For each of fiscal years 2014 through 2017, the
fees under subparagraph (A) for such fiscal year shall be due on the later
of—</text>
<subclause id="H4DD7B5CA49EB4409A4B832F366A81576"><enum>(I)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</subclause><subclause id="H72BB35AE600F4A6687AFC9562D5AB73E"><enum>(II)</enum><text>the first
business day after the enactment of an appropriations Act providing for the
collection and obligation of fees under this section for such year.</text>
</subclause></clause></subparagraph></paragraph><paragraph id="HA641E667E8614405B65BE50CEA26582C"><enum>(5)</enum><header>Date of
submission</header><text display-inline="yes-display-inline">For purposes of
this part, a generic drug submission or Type II pharmaceutical master file is
deemed to be <quote>submitted</quote> to the Food and Drug
Administration—</text>
<subparagraph id="H4AEAB4C2121240F49298C4F3BEC68D19"><enum>(A)</enum><text>if it is submitted
via a Food and Drug Administration electronic gateway, on the day when
transmission to that electronic gateway is completed, except that a submission
or master file that arrives on a weekend, Federal holiday, or day when the Food
and Drug Administration office that will review that submission is not
otherwise open for business shall be deemed to be submitted on the next day
when that office is open for business; and</text>
</subparagraph><subparagraph id="HA7CBE281E8E045C1AA2E28BEC29097C9"><enum>(B)</enum><text>if it is submitted
in physical media form, on the day it arrives at the appropriate designated
document room of the Food and Drug Administration.</text>
</subparagraph></paragraph></subsection><subsection id="H41B01FCB6DAA44559ABBA4C0745D1965"><enum>(b)</enum><header>Fee revenue
amounts</header>
<paragraph id="H88D08B41C7344C2F89973DB5A26B2CE5"><enum>(1)</enum><header>In
general</header>
<subparagraph id="HE4F0C99932584144B010FE1A75D9CC37"><enum>(A)</enum><header>Fiscal year
2013</header><text display-inline="yes-display-inline">For fiscal year 2013,
fees under subsection (a) shall be established to generate a total estimated
revenue amount under such subsection of $299,000,000. Of that amount—</text>
<clause id="H003D6C9D3319420CAB844F22818DEF79"><enum>(i)</enum><text>$50,000,000 shall
be generated by the one-time backlog fee for generic drug applications pending
on October 1, 2012, established in subsection (a)(1); and</text>
</clause><clause id="H7F4B185D9C4F4F35A0E786815A035CA6"><enum>(ii)</enum><text>$249,000,000
shall be generated by the fees under paragraphs (2) through (4) of subsection
(a).</text>
</clause></subparagraph><subparagraph id="H827A2098AF2840B584F4058A2E5DE7BF"><enum>(B)</enum><header>Fiscal years
2014 through 2017</header><text>For each of the fiscal years 2014 through 2017,
fees under paragraphs (2) through (4) of subsection (a) shall be established to
generate a total estimated revenue amount under such subsection that is equal
to $299,000,000, as adjusted pursuant to subsection (c).</text>
</subparagraph></paragraph><paragraph id="H2E8BA02D9CB44D66AAF88305760B284A"><enum>(2)</enum><header>Types of
fees</header><text display-inline="yes-display-inline">In establishing fees
under paragraph (1) to generate the revenue amounts specified in paragraph
(1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years
2014 through 2017, such fees shall be derived from the fees under paragraphs
(2) through (4) of subsection (a) as follows:</text>
<subparagraph id="H05A0509575E1409685254E5274F6834E"><enum>(A)</enum><text>6 percent shall be
derived from fees under subsection (a)(2) (relating to drug master
files).</text>
</subparagraph><subparagraph id="H3D9B2F3A05594EF4B16E57FA5ADA09F1"><enum>(B)</enum><text>24 percent shall
be derived from fees under subsection (a)(3) (relating to abbreviated new drug
applications and supplements). The amount of a fee for a prior approval
supplement shall be half the amount of the fee for an abbreviated new drug
application.</text>
</subparagraph><subparagraph id="HEF7D73FB52C74EC0BB6CE64B7D0DC541"><enum>(C)</enum><text display-inline="yes-display-inline">56 percent shall be derived from fees under
subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of
the fee for a facility located outside the United States and its territories
and possessions shall be not less than $15,000 and not more than $30,000 higher
than the amount of the fee for a facility located in the United States and its
territories and possessions, as determined by the Secretary on the basis of
data concerning the difference in cost between inspections of facilities
located in the United States, including its territories and possessions, and
those located outside of the United States and its territories and
possessions.</text>
</subparagraph><subparagraph id="H1A10C8C2C01A4B5493462B9BCC1F8611"><enum>(D)</enum><text>14 percent shall
be derived from fees under subsection (a)(4)(A)(ii) (relating to active
pharmaceutical ingredient facilities). The amount of the fee for a facility
located outside the United States and its territories and possessions shall be
not less than $15,000 and not more than $30,000 higher than the amount of the
fee for a facility located in the United States, including its territories and
possessions, as determined by the Secretary on the basis of data concerning the
difference in cost between inspections of facilities located in the United
States and its territories and possessions and those located outside of the
United States and its territories and possessions.</text>
</subparagraph></paragraph></subsection><subsection id="H50C8BF12E2934A91A29C837C5BC9C9DD"><enum>(c)</enum><header>Adjustments</header>
<paragraph commented="no" id="H74EC93F1B4BE4826A1F79F7660E29376"><enum>(1)</enum><header>Inflation
adjustment</header><text>For fiscal year 2014 and subsequent fiscal years, the
revenues established in subsection (b) shall be adjusted by the Secretary by
notice, published in the Federal Register, for a fiscal year, by an amount
equal to the sum of—</text>
<subparagraph commented="no" id="HCFAAE8FE96ED422FAC70728FDC5F5304"><enum>(A)</enum><text>one;</text>
</subparagraph><subparagraph commented="no" id="H36AB2C5603C64BD79D02FC9D63DBD1F7"><enum>(B)</enum><text>the average annual
percent change in the cost, per full-time equivalent position of the Food and
Drug Administration, of all personnel compensation and benefits paid with
respect to such positions for the first 3 years of the preceding 4 fiscal years
multiplied by the proportion of personnel compensation and benefits costs to
total costs of human generic drug activities for the first 3 years of the
preceding 4 fiscal years; and</text>
</subparagraph><subparagraph commented="no" id="H8EC7F07646AD42E584259DFDA238D3CD"><enum>(C)</enum><text>the average annual
percent change that occurred in the Consumer Price Index for urban consumers
(Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual
Index) for the first 3 years of the preceding 4 years of available data
multiplied by the proportion of all costs other than personnel compensation and
benefits costs to total costs of human generic drug activities for the first 3
years of the preceding 4 fiscal years.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">The adjustment made each fiscal year
under this subsection shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2013 under this
subsection.</continuation-text></paragraph><paragraph id="H0432122F4DB34405A58B14C982288D90"><enum>(2)</enum><header>Final year
adjustment</header><text>For fiscal year 2017, the Secretary may, in addition
to adjustments under paragraph (1), further increase the fee revenues and fees
established in subsection (b) if such an adjustment is necessary to provide for
not more than 3 months of operating reserves of carryover user fees for human
generic drug activities for the first 3 months of fiscal year 2018. Such fees
may only be used in fiscal year 2018. If such an adjustment is necessary, the
rationale for the amount of the increase shall be contained in the annual
notice establishing fee revenues and fees for fiscal year 2017. If the
Secretary has carryover balances for such activities in excess of 3 months of
such operating reserves, the adjustment under this subparagraph shall not be
made.</text>
</paragraph></subsection><subsection id="HE9C5110BB6174C24A43A97FC6AD63EA4"><enum>(d)</enum><header>Annual fee
setting</header>
<paragraph id="HF04E343D41DD49C3B3A1D979161BA794"><enum>(1)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013—</text>
<subparagraph id="HBF82AAAE711042AA924AC707518BF91E"><enum>(A)</enum><text>the Secretary
shall establish, by October 31, 2012, the one-time generic drug backlog fee for
generic drug applications pending on October 1, 2012, the drug master file fee,
the abbreviated new drug application fee, and the prior approval supplement fee
under subsection (a), based on the revenue amounts established under subsection
(b); and</text>
</subparagraph><subparagraph id="H4A2172448D464E75A5F7B0DE29D3AAF2"><enum>(B)</enum><text>the Secretary
shall establish, not later than 45 days after the date to comply with the
requirement for identification of facilities in subsection (f)(2), the generic
drug facility fee and active pharmaceutical ingredient facility fee under
subsection (a) based on the revenue amounts established under subsection
(b).</text>
</subparagraph></paragraph><paragraph id="HB81F43745C104D8099657AD2BE6A47B2"><enum>(2)</enum><header>Fiscal years
2014 through 2017</header><text>Not more than 60 days before the first day of
each of fiscal years 2014 through 2017, the Secretary shall establish the drug
master file fee, the abbreviated new drug application fee, the prior approval
supplement fee, the generic drug facility fee, and the active pharmaceutical
ingredient facility fee under subsection (a) for such fiscal year, based on the
revenue amounts established under subsection (b) and the adjustments provided
under subsection (c).</text>
</paragraph><paragraph id="H978AB22D9AFA448680155D653B5DCC30"><enum>(3)</enum><header>Fee for active
pharmaceutical ingredient information not included by reference to Type II
active pharmaceutical ingredient drug master file</header><text display-inline="yes-display-inline">In establishing the fees under paragraphs
(1) and (2), the amount of the fee under subsection (a)(3)(F) shall be
determined by multiplying—</text>
<subparagraph id="H828EBF23CD7845A88ECFD419AD21A28B"><enum>(A)</enum><text>the sum of—</text>
<clause id="H7C440E9AD244491B8FF9F16411DFB648"><enum>(i)</enum><text>the total number
of such active pharmaceutical ingredients in such submission; and</text>
</clause><clause id="HB1C0206207254DBD8F54ABA9742ABF59"><enum>(ii)</enum><text>for each such
ingredient that is manufactured at more than one such facility, the total
number of such additional facilities; and</text>
</clause></subparagraph><subparagraph id="HCBDF88390B3E480590CB100AC1E79888"><enum>(B)</enum><text>the amount equal
to the drug master file fee established in subsection (a)(2) for such
submission.</text>
</subparagraph></paragraph></subsection><subsection id="HD832253C9BA242A7A4404C5F50FDD03F"><enum>(e)</enum><header>Limit</header><text>The
total amount of fees charged, as adjusted under subsection (c), for a fiscal
year may not exceed the total costs for such fiscal year for the resources
allocated for human generic drug activities.</text>
</subsection><subsection id="H250735AF43E947C18A7CEF368B4E6718"><enum>(f)</enum><header>Identification
of facilities</header>
<paragraph id="H17E93A8007DD4D189F0214D4B4B2CC7B"><enum>(1)</enum><header>Publication of
notice; deadline for compliance</header><text display-inline="yes-display-inline">Not later than October 1, 2012, the
Secretary shall cause to be published in the Federal Register a notice
requiring each person that owns a facility described in subsection (a)(4)(A),
or a site or organization required to be identified by paragraph (4), to submit
to the Secretary information on the identity of each such facility, site, or
organization. The notice required by this paragraph shall specify the type of
information to be submitted and the means and format for submission of such
information.</text>
</paragraph><paragraph id="H047EB6236397440F8997FC322AE76A35"><enum>(2)</enum><header>Required
submission of facility identification</header><text>Each person that owns a
facility described in subsection (a)(4)(A) or a site or organization required
to be identified by paragraph (4) shall submit to the Secretary the information
required under this subsection each year. Such information shall—</text>
<subparagraph id="HDE413E5DADC14FB39BFEBD4290897E1E"><enum>(A)</enum><text display-inline="yes-display-inline">for fiscal year 2013, be submitted not
later than 60 days after the publication of the notice under paragraph (1);
and</text>
</subparagraph><subparagraph id="H054F5ADC0CE74D318A69B0A96552223C"><enum>(B)</enum><text>for each
subsequent fiscal year, be submitted, updated, or reconfirmed on or before June
1 of the previous year.</text>
</subparagraph></paragraph><paragraph id="HF4BCCEFA67FB48AD8D977EAC4528CD27"><enum>(3)</enum><header>Contents of
notice</header><text>At a minimum, the submission required by paragraph (2)
shall include for each such facility—</text>
<subparagraph id="H56AAB062AE1A48BA9ECC656F8684EE60"><enum>(A)</enum><text>identification of
a facility identified or intended to be identified in an approved or pending
generic drug submission;</text>
</subparagraph><subparagraph id="H26CCD2E3199B4FD091CAFB9E07C31131"><enum>(B)</enum><text>whether the
facility manufactures active pharmaceutical ingredients or finished dosage
forms, or both;</text>
</subparagraph><subparagraph id="H475ACA7A7645491FB777742FD682DCF7"><enum>(C)</enum><text>whether or not the
facility is located within the United States and its territories and
possessions;</text>
</subparagraph><subparagraph id="HD88EF3CD16AD4B469F39E07D11A900F2"><enum>(D)</enum><text>whether the
facility manufactures positron emission tomography drugs solely, or in addition
to other drugs; and</text>
</subparagraph><subparagraph id="H538ED22BC8224411B755D13F1AB6CC7D"><enum>(E)</enum><text>whether the
facility manufactures drugs that are not generic drugs.</text>
</subparagraph></paragraph><paragraph id="H9C6BE10B2B054FD3AEBB82E7A608E61A"><enum>(4)</enum><header>Certain sites
and organizations</header>
<subparagraph id="H10777A6198BC4997B66953238B4FE17A"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">Any person that owns
or operates a site or organization described in subparagraph (B) shall submit
to the Secretary information concerning the ownership, name, and address of the
site or organization.</text>
</subparagraph><subparagraph id="HF31C48C7A3AE4833BE4D11CF168FFA9E"><enum>(B)</enum><header>Sites and
organizations</header><text>A site or organization is described in this
subparagraph if it is identified in a generic drug submission and is—</text>
<clause id="H2737C821FBEE427788C13FB84F060874"><enum>(i)</enum><text>a
site in which a bioanalytical study is conducted;</text>
</clause><clause id="HC1E5B143D615432FA0966625B4E8C1E6"><enum>(ii)</enum><text>a
clinical research organization;</text>
</clause><clause id="HBB6873F71E824776B11039BF2975A72D"><enum>(iii)</enum><text>a contract
analytical testing site; or</text>
</clause><clause id="H77F87C7DD19941D5B45E5E080DCFB358"><enum>(iv)</enum><text>a
contract repackager site.</text>
</clause></subparagraph><subparagraph id="H8C8709C9F52F452AA8497C8C03DFB668"><enum>(C)</enum><header>Notice</header><text display-inline="yes-display-inline">The Secretary may, by notice published in
the Federal Register, specify the means and format for submission of the
information under subparagraph (A) and may specify, as necessary for purposes
of this section, any additional information to be submitted.</text>
</subparagraph><subparagraph id="H00A9C61BEC854048A58DD7CD88E4B346"><enum>(D)</enum><header>Inspection
authority</header><text>The Secretary’s inspection authority under section
704(a)(1) shall extend to all such sites and organizations.</text>
</subparagraph></paragraph></subsection><subsection id="HF8A47839BA2246BDB2DAA6C64833E892"><enum>(g)</enum><header>Effect of
failure To pay fees</header>
<paragraph id="H597CB92951E04889A4F5CC2456A4797A"><enum>(1)</enum><header>Generic drug
backlog fee</header><text display-inline="yes-display-inline">Failure to pay
the fee under subsection (a)(1) shall result in the Secretary placing the
person that owns the abbreviated new drug application subject to that fee on an
arrears list, such that no new abbreviated new drug applications or supplement
submitted on or after October 1, 2012, from that person, or any affiliate of
that person, will be received within the meaning of section 505(j)(5)(A) until
such outstanding fee is paid.</text>
</paragraph><paragraph id="HD42E6EF0CCAE464483E3679586E33176"><enum>(2)</enum><header>Drug master file
fee</header>
<subparagraph commented="no" id="H14A965F2399843D5B972BBD5795F077C"><enum>(A)</enum><text display-inline="yes-display-inline">Failure to pay the fee under subsection
(a)(2) within 20 calendar days after the applicable due date under subparagraph
(E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall
result in the Type II active pharmaceutical ingredient drug master file not
being deemed available for reference.</text>
</subparagraph><subparagraph id="H1F214C3C23C94C31B64D5001CFCD4725"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HC7C379DBB251419B9749FBF64F17A505"><enum>(i)</enum><text display-inline="yes-display-inline">Any generic drug submission submitted on or
after October 1, 2012, that references, by a letter of authorization, a Type II
active pharmaceutical ingredient drug master file that has not been deemed
available for reference shall not be received within the meaning of section
505(j)(5)(A) unless the condition specified in clause (ii) is met.</text>
</clause><clause id="H2E5C062FD944471C8ADE3DE603AD24BA" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">The condition specified in this clause is
that the fee established under subsection (a)(2) has been paid within 20
calendar days of the Secretary providing the notification to the sponsor of the
abbreviated new drug application or supplement of the failure of the owner of
the Type II active pharmaceutical ingredient drug master file to pay the drug
master file fee as specified in subparagraph (C).</text>
</clause></subparagraph><subparagraph id="H3025D035FB53436E9511343AD3885852"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="H8976BB1B0D9F4927A645FA13DF7405CB"><enum>(i)</enum><text display-inline="yes-display-inline">If an abbreviated new drug application or
supplement to an abbreviated new drug application references a Type II active
pharmaceutical ingredient drug master file for which a fee under subsection
(a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E),
the Secretary shall notify the sponsor of the abbreviated new drug application
or supplement of the failure of the owner of the Type II active pharmaceutical
ingredient drug master file to pay the applicable fee.</text>
</clause><clause id="HC69D4265084C4237B4C4756D646D9052" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">If such fee is not paid within 20 calendar
days of the Secretary providing the notification, the abbreviated new drug
application or supplement to an abbreviated new drug application shall not be
received within the meaning of 505(j)(5)(A).</text>
</clause></subparagraph></paragraph><paragraph id="H2902DB6C23304E7FB33EE22552CEC1DB"><enum>(3)</enum><header>Abbreviated new
drug application fee and prior approval supplement fee</header><text display-inline="yes-display-inline">Failure to pay a fee under subparagraph (A)
or (F) of subsection (a)(3) within 20 calendar days of the applicable due date
under subparagraph (C) of such subsection shall result in the abbreviated new
drug application or the prior approval supplement to an abbreviated new drug
application not being received within the meaning of section 505(j)(5)(A) until
such outstanding fee is paid.</text>
</paragraph><paragraph id="HF6A70CFBF0A74248BC7A7E22446CC32A"><enum>(4)</enum><header>Generic drug
facility fee and active pharmaceutical ingredient facility fee</header>
<subparagraph id="H514857832ED6440EB8FD7A5E9103133A"><enum>(A)</enum><header>In
general</header><text>Failure to pay the fee under subsection (a)(4) within 20
calendar days of the due date as specified in subparagraph (D) of such
subsection shall result in the following:</text>
<clause id="H31783CE5CB9E44FBA721E320F7C4284F"><enum>(i)</enum><text>The Secretary
shall place the facility on a publicly available arrears list, such that no new
abbreviated new drug application or supplement submitted on or after October 1,
2012, from the person that is responsible for paying such fee, or any affiliate
of that person, will be received within the meaning of section
505(j)(5)(A).</text>
</clause><clause id="H1106213CF9C741F7AB92710C596D0779"><enum>(ii)</enum><text>Any new generic
drug submission submitted on or after October 1, 2012, that references such a
facility shall not be received, within the meaning of section 505(j)(5)(A) if
the outstanding facility fee is not paid within 20 calendar days of the
Secretary providing the notification to the sponsor of the failure of the owner
of the facility to pay the facility fee under subsection (a)(4)(C).</text>
</clause><clause id="H74D46516B0DE4326AC42F19A455BF9BC"><enum>(iii)</enum><text>All drugs or
active pharmaceutical ingredients manufactured in such a facility or containing
an ingredient manufactured in such a facility shall be deemed misbranded under
section 502(aa).</text>
</clause></subparagraph><subparagraph id="HBD5E7AB5C2E240FDB5175A07D5F925A9"><enum>(B)</enum><header>Application of
penalties</header><text>The penalties under this paragraph shall apply until
the fee established by subsection (a)(4) is paid or the facility is removed
from all generic drug submissions that refer to the facility.</text>
</subparagraph><subparagraph id="H6A435F820AD54BE5B6E18F31F5D92D15"><enum>(C)</enum><header>Nonreceival for
nonpayment</header>
<clause id="HB3528604A94F4A84A44E2F46102C5B39"><enum>(i)</enum><header>Notice</header><text>If
an abbreviated new drug application or supplement to an abbreviated new drug
application submitted on or after October 1, 2012, references a facility for
which a facility fee has not been paid by the applicable date under subsection
(a)(4)(C), the Secretary shall notify the sponsor of the generic drug
submission of the failure of the owner of the facility to pay the facility
fee.</text>
</clause><clause id="H065A4301F84D4F14B8D41163401E71CF"><enum>(ii)</enum><header>Nonreceival</header><text>If
the facility fee is not paid within 20 calendar days of the Secretary providing
the notification under clause (i), the abbreviated new drug application or
supplement to an abbreviated new drug application shall not be received within
the meaning of section 505(j)(5)(A).</text>
</clause></subparagraph></paragraph></subsection><subsection id="HFCD54BC68A0A4ED6A1F54D669B23B5FA"><enum>(h)</enum><header>Limitations</header>
<paragraph id="HB6D0BC4232D145F1B16BF3E16DB1F371"><enum>(1)</enum><header>In
general</header><text>Fees under subsection (a) shall be refunded for a fiscal
year beginning after fiscal year 2012, unless appropriations for salaries and
expenses of the Food and Drug Administration for such fiscal year (excluding
the amount of fees appropriated for such fiscal year) are equal to or greater
than the amount of appropriations for the salaries and expenses of the Food and
Drug Administration for the fiscal year 2009 (excluding the amount of fees
appropriated for such fiscal year) multiplied by the adjustment factor (as
defined in section 744A) applicable to the fiscal year involved.</text>
</paragraph><paragraph id="HEDDA3DEFE0B547CFB712B8623DB2C6E3"><enum>(2)</enum><header>Authority</header><text>If
the Secretary does not assess fees under subsection (a) 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, for Type II active pharmaceutical ingredient drug
master files, abbreviated new drug applications and prior approval supplements,
and generic drug facilities and active pharmaceutical ingredient facilities at
any time in such fiscal year notwithstanding the provisions of subsection (a)
relating to the date fees are to be paid.</text>
</paragraph></subsection><subsection id="HB7203183AA204B3695D3B3CCA05F0154"><enum>(i)</enum><header>Crediting and
availability of fees</header>
<paragraph id="H302A034A402E4D6B940D9DB7F70D744A"><enum>(1)</enum><header>In
general</header><text>Fees authorized under subsection (a) shall be collected
and available for obligation only to the extent and in the amount provided in
advance in appropriations Acts, subject to paragraph (2). 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 human generic drug activities.</text>
</paragraph><paragraph id="H29A2CE152FAD40159D2EA9B3317D9F67"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="H0661EB6FDCA84240BC005E776C1052DD"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause id="H108BA3860DEB4BD4B678176127DF56A4"><enum>(i)</enum><text>subject to
subparagraphs (C) and (D), shall be collected and available in each fiscal year
in an amount not to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year; and</text>
</clause><clause id="H205290F8AEE844748CD65A86F381FF54"><enum>(ii)</enum><text>shall be
available for a fiscal year beginning after fiscal year 2012 to defray the
costs of human generic drug activities (including such costs for an additional
number of full-time equivalent positions in the Department of Health and Human
Services to be engaged in such activities), only if the Secretary allocates for
such purpose an amount for such fiscal year (excluding amounts from fees
collected under this section) no less than $97,000,000 multiplied by the
adjustment factor defined in section 744A(3) applicable to the fiscal year
involved.</text>
</clause></subparagraph><subparagraph id="HB6EE4C4E61A941A2B81C1C9122240369"><enum>(B)</enum><header>Compliance</header><text>The
Secretary shall be considered to have met the requirements of subparagraph
(A)(ii) in any fiscal year if the costs funded by appropriations and allocated
for human generic activities are not more than 10 percent below the level
specified in such subparagraph.</text>
</subparagraph><subparagraph id="H4706CE0AAB3C44D48333AC8402393161"><enum>(C)</enum><header>Fee collection
during first program year</header><text>Until the date of enactment of an Act
making appropriations through September 30, 2013 for the salaries and expenses
account of the Food and Drug Administration, fees authorized by this section
for fiscal year 2013, may be collected and shall be credited to such account
and remain available until expended.</text>
</subparagraph><subparagraph id="H5EB64F4A881947FD8DFD3EC74C2289FC"><enum>(D)</enum><header>Provision for
early payments in subsequent years</header><text>Payment of fees authorized
under this section for a fiscal year (after fiscal year 2013), prior to the due
date for such fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations Act.</text>
</subparagraph></paragraph><paragraph id="HDF964883779E444D92332667097B2DF1"><enum>(3)</enum><header>Authorization of
appropriations</header><text display-inline="yes-display-inline">For each of
the fiscal years 2013 through 2017, there is authorized to be appropriated for
fees under this section an amount equivalent to the total revenue amount
determined under subsection (b) for the fiscal year, as adjusted under
subsection (c), if applicable, or as otherwise affected under paragraph (2) of
this subsection.</text>
</paragraph></subsection><subsection id="H0E09DC9B9F634CBF852D4205859C3F5C"><enum>(j)</enum><header>Collection of
unpaid fees</header><text>In any case where the Secretary does not receive
payment of a fee assessed under subsection (a) within 30 calendar days after it
is due, such fee shall be treated as a claim of the United States Government
subject to subchapter II of
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31,
United States Code.</text>
</subsection><subsection id="H04A3012184DD4C6E979DC4253369E031"><enum>(k)</enum><header>Construction</header><text>This
section may not be construed to require that the number of full-time equivalent
positions in the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in human generic drug
activities, be reduced to offset the number of officers, employees, and
advisory committees so engaged.</text>
</subsection><subsection id="H741DB6F101DC43D39A9131BA1FF7F5EC"><enum>(l)</enum><header>Positron
emission tomography drugs</header>
<paragraph id="H63627CCB5E66474A88F59EB174F7159B"><enum>(1)</enum><header>Exemption from
fees</header><text>Submission of an application for a positron emission
tomography drug or active pharmaceutical ingredient for a positron emission
tomography drug shall not require the payment of any fee under this section.
Facilities that solely produce positron emission tomography drugs shall not be
required to pay a facility fee as established in subsection (a)(4).</text>
</paragraph><paragraph id="HBD2F5F28E68147319DFC45FA901A752E"><enum>(2)</enum><header>Identification
requirement</header><text display-inline="yes-display-inline">Facilities that
produce positron emission tomography drugs or active pharmaceutical ingredients
of such drugs are required to be identified pursuant to subsection (f).</text>
</paragraph></subsection><subsection id="H0E90B26514EB4586BFFDCF03758B5CBC"><enum>(m)</enum><header>Disputes
concerning fees</header><text>To qualify for the return of a fee claimed to
have been paid in error under this section, a person shall submit to the
Secretary a written request justifying such return within 180 calendar days
after such fee was paid.</text>
</subsection><subsection id="H74A725014F0C40F5B60604BABEA6C0E4"><enum>(n)</enum><header>Substantially
complete applications</header><text>An abbreviated new drug application that is
not considered to be received within the meaning of section 505(j)(5)(A)
because of failure to pay an applicable fee under this provision within the
time period specified in subsection (g) shall be deemed not to have been
<quote>substantially complete</quote> on the date of its submission within the
meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug
application that is not substantially complete on the date of its submission
solely because of failure to pay an applicable fee under the preceding sentence
shall be deemed substantially complete and received within the meaning of
section 505(j)(5)(A) as of the date such applicable fee is
received.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H024658910C954387A6840DFCFEA40798"><enum>303.</enum><header>Reauthorization;
reporting requirements</header><text display-inline="no-display-inline">Part 7
of subchapter C of chapter VII, as added by section 302 of this Act, is amended
by inserting after section 744B the following:</text>
<quoted-block id="H9A72391F9CD24CBAB7986354A8A17922" style="OLC">
<section id="H7F2EC55098AA48B8B6083847ACF11010"><enum>744C.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="H8CBC8B3EC8DB4ECA8428674BD6306E1A"><enum>(a)</enum><header>Performance
report</header>
<paragraph id="HC3FC3BB1E4A946839E13B6B507B9639B"><enum>(1)</enum><header>In
general</header><text>Beginning with fiscal year 2013, not later than 120 days
after the end of each fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of the Food and
Drug Administration in achieving the goals identified in the letters described
in section 301(b) of the <short-title>Generic Drug User
Fee Amendments of 2012</short-title> during such fiscal year and the future
plans of the Food and Drug Administration for meeting the goals.</text>
</paragraph><paragraph id="HEB056FC438F748A29B0AB9814F2DC1FA"><enum>(2)</enum><header>Regulatory
science accountability metrics</header><text display-inline="yes-display-inline">The report required by paragraph (1) shall
describe the amounts spent, data generated, and activities undertaken,
including any FDA Advisory Committee consideration, by the Secretary for each
of the local acting bioequivalence topics (Topics 1–3) in the Regulatory
Science Plan described in the letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2012.</text>
</paragraph></subsection><subsection id="H7DF112EA991F4D07ACD477D42BC00631"><enum>(b)</enum><header>Fiscal
report</header><text>Beginning with fiscal year 2013, not later than 120 days
after the end of each fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report on the implementation of the authority for
such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.</text>
</subsection><subsection id="HE9DFD8CD2F0E4474893DC3B6E14528E1"><enum>(c)</enum><header>Public
availability</header><text>The Secretary shall make the reports required under
subsections (a) and (b) available to the public on the Internet Web site of the
Food and Drug Administration.</text>
</subsection><subsection id="H67E2853040BE4CE3A958142814044017"><enum>(d)</enum><header>Reauthorization</header>
<paragraph id="HEDE516BE951E4253A5950B1463065F64"><enum>(1)</enum><header>Consultation</header><text>In
developing recommendations to present to the Congress with respect to the
goals, and plans for meeting the goals, for human generic drug activities for
the first 5 fiscal years after fiscal year 2017, and for the reauthorization of
this part for such fiscal years, the Secretary shall consult with—</text>
<subparagraph id="HE159D052638445E2B0055D705A2064D1"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="H1EF54F727B604A8897EB0C029750F80C"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="H2EA7B8A6C36B4AD6A5822BA8E7F34E5B"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="H247578E0CEB64122A65A9DF137F7CAE0"><enum>(D)</enum><text>health care
professionals;</text>
</subparagraph><subparagraph id="H22BC73CCC45A4E1AA4893CA0A7933480"><enum>(E)</enum><text>representatives of
patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="H3F0D72693A0C4F0BAFAE2CD4773B6813"><enum>(F)</enum><text>the generic drug
industry.</text>
</subparagraph></paragraph><paragraph id="H3BD0A256BDF34D84B0D4F46DA203F883"><enum>(2)</enum><header>Prior public
input</header><text>Prior to beginning negotiations with the generic drug
industry on the reauthorization of this part, the Secretary shall—</text>
<subparagraph id="H9A8A5C97F4A34762AD1EB46AFFC8FDA5"><enum>(A)</enum><text>publish a notice
in the Federal Register requesting public input on the reauthorization;</text>
</subparagraph><subparagraph id="HB9A8FC72EEAB494292D405BDCA8FDE33"><enum>(B)</enum><text>hold a public
meeting at which the public may present its views on the reauthorization,
including specific suggestions for changes to the goals referred to in
subsection (a);</text>
</subparagraph><subparagraph id="H7D1FA1E27C35407C92655625FD0A4A4B"><enum>(C)</enum><text>provide a period
of 30 days after the public meeting to obtain written comments from the public
suggesting changes to this part; and</text>
</subparagraph><subparagraph id="H2B46EC4FD3DF4971A47FE2FB1AB111B9"><enum>(D)</enum><text>publish the
comments on the Food and Drug Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph id="H3C5F02CF46734A9BA8BD67FFF97EED24"><enum>(3)</enum><header>Periodic
consultation</header><text>Not less frequently than once every month during
negotiations with the generic drug industry, the Secretary shall hold
discussions with representatives of patient and consumer advocacy groups to
continue discussions of their views on the reauthorization and their
suggestions for changes to this part as expressed under paragraph (2).</text>
</paragraph><paragraph id="H091CB46A694847C78A6005E953030C60"><enum>(4)</enum><header>Public review of
recommendations</header><text>After negotiations with the generic drug
industry, the Secretary shall—</text>
<subparagraph id="HF40ACC7A15824A34A157859B641116DC"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="HC82E6B068E5B4D27B96BA5BBEF004BE8"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="HED3865601CB04C899F455A7CA783CFA6"><enum>(C)</enum><text>provide for a
period of 30 days for the public to provide written comments on such
recommendations;</text>
</subparagraph><subparagraph id="H97AF7E79DC6D4102B4D9768C0F750DDB"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="H60C468311CF546289693A4B2DC9CBEBA"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="H5685BF011DFC42BE80551AC6AEF6E634"><enum>(5)</enum><header>Transmittal of
recommendations</header><text>Not later than January 15, 2017, the Secretary
shall transmit to the Congress the revised recommendations under paragraph (4),
a summary of the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views and
comments.</text>
</paragraph><paragraph id="HBE096DFBF41B4B958165EC72D32C6036"><enum>(6)</enum><header>Minutes of
negotiation meetings</header>
<subparagraph id="H8DCB890EB2F94042A362FF74869060D3"><enum>(A)</enum><header>Public
availability</header><text>Before presenting the recommendations developed
under paragraphs (1) through (5) to the Congress, the Secretary shall make
publicly available, on the Internet Web site of the Food and Drug
Administration, minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the generic drug
industry.</text>
</subparagraph><subparagraph id="H0ED31F3070824C49A9F9950EB3A7439F"><enum>(B)</enum><header>Content</header><text>The
minutes described under subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well as significant
controversies or differences of opinion during the negotiations and their
resolution.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H73809879DF2F4741ACDD9C09BD2BE764"><enum>304.</enum><header>Sunset
dates</header>
<subsection commented="no" id="H47B350DAE4384461AD4D76500480EB15"><enum>(a)</enum><header>Authorization</header><text display-inline="yes-display-inline">Sections 744A and 744B, as added by section
302 of this Act, are repealed October 1, 2017.</text>
</subsection><subsection commented="no" id="H98B32CB4009F469F8CC84AEC489710BF"><enum>(b)</enum><header>Reporting
requirements</header><text display-inline="yes-display-inline">Section 744C, as
added by section 303 of this Act, is repealed January 31, 2018.</text>
</subsection></section><section id="HB034019D437A48A8BF50095D0E59C9F6"><enum>305.</enum><header>Effective
date</header><text display-inline="no-display-inline">The amendments made by
this title shall take effect on October 1, 2012, or the date of the enactment
of this title, whichever is later, except that fees under section 302 shall be
assessed for all human generic drug submissions and Type II active
pharmaceutical drug master files received on or after October 1, 2012,
regardless of the date of enactment of this title.</text>
</section><section id="H78DA4CF2A8574261AEF899E127167082"><enum>306.</enum><header>Amendment with
respect to misbranding</header><text display-inline="no-display-inline">Section
502 (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C.
352</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF5CD3B25CB9E43CD8675BF2CF0BE8501" style="OLC">
<subsection id="HDD817A0D80FC4F39834E7EBD1609CD70"><enum>(aa)</enum><text display-inline="yes-display-inline">If it is a drug, or an active
pharmaceutical ingredient, and it was manufactured, prepared, propagated,
compounded, or processed in a facility for which fees have not been paid as
required by section 744A(a)(4) or for which identifying information required by
section 744B(f) has not been submitted, or it contains an active pharmaceutical
ingredient that was manufactured, prepared, propagated, compounded, or
processed in such a
facility.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H1EF70364483E4540A71D26272BBB7F39"><enum>307.</enum><header>Streamlined
hiring authority to support activities related to human generic
drugs</header><text display-inline="no-display-inline">Section 714, as added by
section 208 of this Act, is amended—</text>
<paragraph id="HC0E1AE11374D4D5797485D69D28A8804"><enum>(1)</enum><text>by amending
subsection (b) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H17BADA6D90894972A4F5DC924FD6E4BD" style="OLC">
<subsection id="H5BA184EF5090411BB43EEFD85C9E9E36"><enum>(b)</enum><header>Activities
described</header><text>The activities described in this subsection are—</text>
<paragraph id="HA88B7D3C66D1435B84297B65388FE725"><enum>(1)</enum><text>activities under
this Act related to the process for the review of device applications (as
defined in section 737(8)); and</text>
</paragraph><paragraph id="HE9A57805778B4C06A27C74F5ACD9A5D9"><enum>(2)</enum><text display-inline="yes-display-inline">activities under this Act related to human
generic drug activities (as defined in section
744A).</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H006BBC7D461D4786B1DE5526B0D35367"><enum>(2)</enum><text>by amending
subsection (c) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HA6D40D901EF143DFA9A4230155DA9497" style="OLC">
<subsection id="H549A602239654E19816BC251749ACF9A"><enum>(c)</enum><header>Objectives
specified</header><text>The objectives specified in this subsection are—</text>
<paragraph id="HF571285C9FBE4A219EE99B6B122C99EE"><enum>(1)</enum><text>with respect to
the activities under
<internal-xref idref="HE14D6F7452764407B42F76DBF71AC297" legis-path="714.(b)(1)">subsection (b)(1)</internal-xref>, the goals referred
to in section 738A(a)(1); and</text>
</paragraph><paragraph id="HF1A3604F82F0454CAECDB60F7B69ABC3"><enum>(2)</enum><text display-inline="yes-display-inline">with respect to the activities under
<internal-xref idref="HE14D6F7452764407B42F76DBF71AC297" legis-path="714.(b)(2)">subsection (b)(2)</internal-xref>, the goals referred
to in section
744C(a).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><enum>IV</enum><header>Fees
relating to biosimilar biological products</header>
<section id="H56ABDF519B894842BE35F8114965EB98"><enum>401.</enum><header>Short title;
finding</header>
<subsection id="H0DDCE60C9799404B95737BEF79B79020"><enum>(a)</enum><header>Short
title</header><text display-inline="yes-display-inline">This title may be cited
as the <quote><short-title>Biosimilar User Fee Act of
2012</short-title></quote>.</text>
</subsection><subsection id="H44581418A20841559B19C45EC2DD1117"><enum>(b)</enum><header>Finding</header><text display-inline="yes-display-inline">The Congress finds that the fees authorized
by the amendments made in this title will be dedicated to expediting the
process for the review of biosimilar biological product applications, including
postmarket safety activities, as set forth in the goals identified for purposes
of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, in the letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.</text>
</subsection></section><section id="H6DAA9767180C4878A642C86E7D78D0DF"><enum>402.</enum><header>Fees relating
to biosimilar biological products</header><text display-inline="no-display-inline">Subchapter C of chapter VII (<external-xref legal-doc="usc" parsable-cite="usc/21/379f">21 U.S.C. 379f et
seq.</external-xref>) is amended by inserting after part 7, as added by title
III of this Act, the following:</text>
<quoted-block id="H95B013DDD1BF48C0BF26DA081FB11164" style="OLC">
<part id="HD6F6AE68C4A64ABEB1EFBFF24F977963"><enum>8</enum><header>FEES
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS</header>
<section id="H20BE212C3A8C48EA93EF88C26EB14502"><enum>744G.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="HD3370F8B86954A1FB2613AE9E0AE6F01"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>adjustment factor</term>
applicable to a fiscal year that is the Consumer Price Index for all urban
consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All
items) of the preceding fiscal year divided by such Index for September
2011.</text>
</paragraph><paragraph id="H82DE90E9DD714CECA1D4BA2304E5B2F1"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>affiliate</term> means a
business entity that has a relationship with a second business entity if,
directly or indirectly—</text>
<subparagraph id="H074721ECF478450C8019FA51A7B9CDF8"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="H82B3211123BB4F5E9017BE02BC6A2A0A"><enum>(B)</enum><text>a third party
controls, or has power to control, both of the business entities.</text>
</subparagraph></paragraph><paragraph id="H9E6E67C7AAA645068A4C9FE9DA0B7A0A"><enum>(3)</enum><text>The term
<term>biosimilar biological product</term> means a product for which a
biosimilar biological product application has been approved.</text>
</paragraph><paragraph id="HD46FE12E801D4007B620773AFFF2C743"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HC7F3F69B2B284C469A0DD433361D3C68"><enum>(A)</enum><text>Subject to subparagraph
(B), the term <term>biosimilar biological product application</term> means an
application for licensure of a biological product under section 351(k) of the
Public Health Service Act.</text>
</subparagraph><subparagraph id="H02AA588114514CB280604D613F2D8B0D" indent="up1"><enum>(B)</enum><text>Such term does not include—</text>
<clause id="HB4301E66C63E4DA8AACE8496DCFE505C"><enum>(i)</enum><text>a supplement to such an
application;</text>
</clause><clause id="H27B76293A0164F0585BBBD3ABA22D200"><enum>(ii)</enum><text>an application filed under section
351(k) of the Public Health Service Act that cites as the reference product a
bovine blood product for topical application licensed before September 1, 1992,
or a large volume parenteral drug product approved before such date;</text>
</clause><clause id="H27452694E09F4F0CAC5303BB74CEA6BE"><enum>(iii)</enum><text>an application filed under
section 351(k) of the Public Health Service Act with respect to—</text>
<subclause id="H6981BE7475A7474F90BDA066EFB393BE"><enum>(I)</enum><text>whole blood or a blood component for
transfusion;</text>
</subclause><subclause id="H2190C9E1BB364352A5858B0705760F9F"><enum>(II)</enum><text>an allergenic extract product;</text>
</subclause><subclause id="H69341BA59F964A57AF3D2D2AA2CD6B7C"><enum>(III)</enum><text>an in vitro diagnostic biological
product; or</text>
</subclause><subclause id="H9D601B352480475A8556B3C574D86156"><enum>(IV)</enum><text>a biological product for further
manufacturing use only; or</text>
</subclause></clause><clause id="HA06B0B4A6FC048F4B32538E6A8FC1B25"><enum>(iv)</enum><text>an application for licensure under
section 351(k) of the Public Health Service Act that is submitted by a State or
Federal Government entity for a product that is not distributed
commercially.</text>
</clause></subparagraph></paragraph><paragraph id="HCFF148A84A5B4E3DA4D8A947DCB2B248"><enum>(5)</enum><text>The term
<term>biosimilar biological product development meeting</term> means any
meeting, other than a biosimilar initial advisory meeting, regarding the
content of a development program, including a proposed design for, or data
from, a study intended to support a biosimilar biological product
application.</text>
</paragraph><paragraph id="H20CAD390000F4DFCA7736CD974D2FC36"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>biosimilar biological
product development program</term> means the program under this part for
expediting the process for the review of submissions in connection with
biosimilar biological product development.</text>
</paragraph><paragraph id="H9DA5477E4A2E4BFB868B05DDC31DC3E2"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H7DCA4180ABAB4020AE032CD8510E4CBA"><enum>(A)</enum><text>The term
<term>biosimilar biological product establishment</term> means a foreign or
domestic place of business—</text>
<clause id="HA7B9E241BEEE4CB2BD0F298740824551" indent="up1"><enum>(i)</enum><text>that is at one general physical
location consisting of one or more buildings, all of which are within five
miles of each other; and</text>
</clause><clause id="HD4BFB65C37184980A772BFE4E9C8EA5F" indent="up1"><enum>(ii)</enum><text>at which one or more biosimilar
biological products are manufactured in final dosage form.</text>
</clause></subparagraph><subparagraph id="H019260E0ABCB45D1BC413925534BE6F7" indent="up1"><enum>(B)</enum><text>For purposes of subparagraph (A)(ii),
the term <term>manufactured</term> does not include packaging.</text>
</subparagraph></paragraph><paragraph id="H747B17E4EF4847D89B026F86D270782B"><enum>(8)</enum><text>The term
<term>biosimilar initial advisory meeting</term>—</text>
<subparagraph id="HE4CB9AA142794BC88B73F69F7710E35C"><enum>(A)</enum><text>means a meeting,
if requested, that is limited to—</text>
<clause id="HF990DCFB90CA4753A579087724E3432D"><enum>(i)</enum><text>a
general discussion regarding whether licensure under section 351(k) of the
Public Health Service Act may be feasible for a particular product; and</text>
</clause><clause id="H07B6C0DD64C74640BB1A542E9CE8AC05"><enum>(ii)</enum><text>if so, general
advice on the expected content of the development program; and</text>
</clause></subparagraph><subparagraph id="H9AEFD96A26654DBCB65F8FE482B5D038"><enum>(B)</enum><text>does not include
any meeting that involves substantive review of summary data or full study
reports.</text>
</subparagraph></paragraph><paragraph id="H2000923864A74054A10A67CA58C3A963"><enum>(9)</enum><text>The term
<term>costs of resources allocated for the process for the review of biosimilar
biological product applications</term> means the expenses in connection with
the process for the review of biosimilar biological product applications
for—</text>
<subparagraph id="H66A76A1D02C34A389746B2984905ECA9"><enum>(A)</enum><text>officers and
employees of the Food and Drug Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to such officers
employees and committees and to contracts with such contractors;</text>
</subparagraph><subparagraph id="H49995BD354DF4697B18D21D8D2EAA11B"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="H1DBE010EA2394CD5AF641BCF83CC664F"><enum>(C)</enum><text>leasing,
maintenance, renovation, and repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and</text>
</subparagraph><subparagraph id="HAFE180895B6C4F7BA85DF2F02D5495E5"><enum>(D)</enum><text>collecting fees
under section 744H and accounting for resources allocated for the review of
submissions in connection with biosimilar biological product development,
biosimilar biological product applications, and supplements.</text>
</subparagraph></paragraph><paragraph id="H577987D760F44E17A4276BCE61C97E54"><enum>(10)</enum><text>The term
<term>final dosage form</term> means, with respect to a biosimilar biological
product, a finished dosage form which is approved for administration to a
patient without substantial further manufacturing (such as lyophilized products
before reconstitution).</text>
</paragraph><paragraph id="HC9009FDEE8884E3FB1B17DBB4BF72F2E"><enum>(11)</enum><text>The term
<term>financial hold</term>—</text>
<subparagraph id="H1C9C16FD03034D98891FE6DB64570434"><enum>(A)</enum><text>means an order
issued by the Secretary to prohibit the sponsor of a clinical investigation
from continuing the investigation if the Secretary determines that the
investigation is intended to support a biosimilar biological product
application and the sponsor has failed to pay any fee for the product required
under subparagraph (A), (B), or (D) of section 744H(a)(1); and</text>
</subparagraph><subparagraph id="HBE6386A36D924D069898A5BEC89B5DC1"><enum>(B)</enum><text>does not mean that
any of the bases for a <quote>clinical hold</quote> under section 505(i)(3)
have been determined by the Secretary to exist concerning the
investigation.</text>
</subparagraph></paragraph><paragraph id="HC305E84793274DDDB6B07A4B66BC3C15"><enum>(12)</enum><text>The term
<term>person</term> includes an affiliate of such person.</text>
</paragraph><paragraph id="H9DB80D97D071437E83D9D6824A92E663"><enum>(13)</enum><text>The term
<term>process for the review of biosimilar biological product
applications</term> means the following activities of the Secretary with
respect to the review of submissions in connection with biosimilar biological
product development, biosimilar biological product applications, and
supplements:</text>
<subparagraph id="H3B2CDBE7C31142C492F589F4736CC794"><enum>(A)</enum><text>The activities
necessary for the review of submissions in connection with biosimilar
biological product development, biosimilar biological product applications, and
supplements.</text>
</subparagraph><subparagraph id="H29902A4B2BD34DD4845C3B74BD7D533F"><enum>(B)</enum><text>Actions related to
submissions in connection with biosimilar biological product development, the
issuance of action letters which approve biosimilar biological product
applications or which set forth in detail the specific deficiencies in such
applications, and where appropriate, the actions necessary to place such
applications in condition for approval.</text>
</subparagraph><subparagraph id="H5AE33C8E7112459BAB80175558E4B442"><enum>(C)</enum><text>The inspection of
biosimilar biological product establishments and other facilities undertaken as
part of the Secretary’s review of pending biosimilar biological product
applications and supplements.</text>
</subparagraph><subparagraph id="HE4602AC03E1649D0B82BABE2563B605D"><enum>(D)</enum><text>Activities
necessary for the release of lots of biosimilar biological products under
section 351(k) of the Public Health Service Act.</text>
</subparagraph><subparagraph id="H6AAB6A8A380F45EDB6B4FF1E16FC2F65"><enum>(E)</enum><text>Monitoring of
research conducted in connection with the review of biosimilar biological
product applications.</text>
</subparagraph><subparagraph id="HFC701C7B9C814EF3902E3CE1AFEA8B36"><enum>(F)</enum><text>Postmarket safety
activities with respect to biologics approved under biosimilar biological
product applications or supplements, including the following activities:</text>
<clause id="HA5231BCA987A472BA1E07DE1CC0A3D40"><enum>(i)</enum><text>Collecting,
developing, and reviewing safety information on biosimilar biological products,
including adverse-event reports.</text>
</clause><clause id="H96923ED9927641B6B420D1B5A5F613F5"><enum>(ii)</enum><text>Developing and
using improved adverse-event data-collection systems, including information
technology systems.</text>
</clause><clause id="H729E8A01E7064AB5BE5D6DD85B7FB644"><enum>(iii)</enum><text>Developing and
using improved analytical tools to assess potential safety problems, including
access to external data bases.</text>
</clause><clause id="H1C8608A4A06443EE8C44ACA2ECC2FAC1"><enum>(iv)</enum><text>Implementing and
enforcing section 505(o) (relating to postapproval studies and clinical trials
and labeling changes) and section 505(p) (relating to risk evaluation and
mitigation strategies).</text>
</clause><clause id="HB2CA7E2A49A84674815CF9893BBE8A27"><enum>(v)</enum><text>Carrying out
section 505(k)(5) (relating to adverse-event reports and postmarket safety
activities).</text>
</clause></subparagraph></paragraph><paragraph id="H8C763BCF4EF247CB9136FCAB5C4434CD"><enum>(14)</enum><text>The term
<term>supplement</term> means a request to the Secretary to approve a change in
a biosimilar biological product application which has been approved, including
a supplement requesting that the Secretary determine that the biosimilar
biological product meets the standards for interchangeability described in
section 351(k)(4) of the Public Health Service Act.</text>
</paragraph></section><section id="HE80C0C2D600F44E3996C65DC073E7C21"><enum>744H.</enum><header>Authority to
assess and use biosimilar biological product fees</header>
<subsection id="H7FCE0A8494704F65BEB0B4CDC7FBBD49"><enum>(a)</enum><header>Types of
fees</header><text>Beginning in fiscal year 2013, the Secretary shall assess
and collect fees in accordance with this section as follows:</text>
<paragraph id="H86B5E552C37A49D1A157CA9489C3E2F9"><enum>(1)</enum><header>Biosimilar
development program fees</header>
<subparagraph id="H86F4AF1E35514D61AD7FD39BE84640A4"><enum>(A)</enum><header>Initial
biosimilar biological product development fee</header>
<clause id="H255F15BDFC504046846D40CF71B2AA23"><enum>(i)</enum><header>In
general</header><text>Each person that submits to the Secretary a meeting
request described under clause (ii) or a clinical protocol for an
investigational new drug protocol described under clause (iii) shall pay for
the product named in the meeting request or the investigational new drug
application the initial biosimilar biological product development fee
established under subsection (b)(1)(A).</text>
</clause><clause id="HBA3D0AEC293F4B5D8D0B3BEF9DBF76BF"><enum>(ii)</enum><header>Meeting
request</header><text>The meeting request defined in this clause is a request
for a biosimilar biological product development meeting for a product.</text>
</clause><clause id="H5E01F65D3DBD49AE8CF77A57CA84C514"><enum>(iii)</enum><header>Clinical
protocol for IND</header><text display-inline="yes-display-inline">A clinical
protocol for an investigational new drug protocol described in this clause is a
clinical protocol consistent with the provisions of section 505(i), including
any regulations promulgated under section 505(i), (referred to in this section
as <quote>investigational new drug application</quote>) describing an
investigation that the Secretary determines is intended to support a biosimilar
biological product application for a product.</text>
</clause><clause id="HB69753155C6646BBA6C1BD5EE940B126"><enum>(iv)</enum><header>Due
Date</header><text>The initial biosimilar biological product development fee
shall be due by the earlier of the following:</text>
<subclause id="HA3E482DE570340B68DA79BD076522647"><enum>(I)</enum><text>Not later than 5
days after the Secretary grants a request for a biosimilar biological product
development meeting.</text>
</subclause><subclause id="H2BC3762B986A4C229F019B419633EF4C"><enum>(II)</enum><text>The date of
submission of an investigational new drug application describing an
investigation that the Secretary determines is intended to support a biosimilar
biological product application.</text>
</subclause></clause><clause id="H3A08474C7F8D42759727DA63E8289179"><enum>(v)</enum><header>Transition
rule</header><text>Each person that has submitted an investigational new drug
application prior to the date of enactment of the Biosimilars User Fee Act of
2012 shall pay the initial biosimilar biological product development fee by the
earlier of the following:</text>
<subclause id="HA7E36895FEF54A6EBE34E19E563FC185"><enum>(I)</enum><text>Not later than 60
days after the date of the enactment of the Biosimilars User Fee Act of 2012,
if the Secretary determines that the investigational new drug application
describes an investigation that is intended to support a biosimilar biological
product application.</text>
</subclause><subclause id="H58D3256718DD4E6C9BE7F57D271EEDC7"><enum>(II)</enum><text>Not later than 5
days after the Secretary grants a request for a biosimilar biological product
development meeting.</text>
</subclause></clause></subparagraph><subparagraph id="H2DEACF6BB7CF4E6CA559C480D1A9887A"><enum>(B)</enum><header>Annual
biosimilar biological product development fee</header>
<clause display-inline="no-display-inline" id="H67EBFBCF2F1D4F5FA847C9DCD748B3A8"><enum>(i)</enum><header>In
general</header><text>A person that pays an initial biosimilar biological
product development fee for a product shall pay for such product, beginning in
the fiscal year following the fiscal year in which the initial biosimilar
biological product development fee was paid, an annual fee established under
subsection (b)(1)(B) for biosimilar biological product development (referred to
in this section as <quote>annual biosimilar biological product development
fee</quote>).</text>
</clause><clause id="H9E45B36B0C0749F6BCB1F3C0E3EBC826"><enum>(ii)</enum><header>Due
date</header><text>The annual biosimilar biological product development program
fee for each fiscal year will be due on the later of—</text>
<subclause id="H80F9C99AE0D64FA994111D0001339C00"><enum>(I)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</subclause><subclause id="H4646056B08A646FE84E0A59DC388DFE9"><enum>(II)</enum><text display-inline="yes-display-inline">the first business day after the enactment
of an appropriations Act providing for the collection and obligation of fees
for such year under this section.</text>
</subclause></clause><clause id="H7B37CEB155284C1EB1D4DF62856D0917"><enum>(iii)</enum><header>Exception</header><text>The
annual biosimilar development program fee for each fiscal year will be due on
the date specified in clause (ii), unless the person has—</text>
<subclause id="HAC67FC1DF30344E0A1A8BF0F98ABF736"><enum>(I)</enum><text>submitted a
marketing application for the biological product that was accepted for filing;
or</text>
</subclause><subclause id="H66D5F09EC4684F3F8AEF8E6C0ED5954F"><enum>(II)</enum><text>discontinued
participation in the biosimilar biological product development program for the
product under subparagraph (C).</text>
</subclause></clause></subparagraph><subparagraph id="H65CDD0F20E2043149A1E1BE41E327228"><enum>(C)</enum><header>Discontinuation
of fee obligation</header><text display-inline="yes-display-inline">A person
may discontinue participation in the biosimilar biological product development
program for a product effective October 1 of a fiscal year by, not later than
August 1 of the preceding fiscal year—</text>
<clause id="HD1B82C31F6B94DF2B543C9185666CFFE"><enum>(i)</enum><text>if
no investigational new drug application concerning the product has been
submitted, submitting to the Secretary a written declaration that the person
has no present intention of further developing the product as a biosimilar
biological product; or</text>
</clause><clause id="HA457F05DF2CB43C39355542E5499BB3C"><enum>(ii)</enum><text>if an
investigational new drug application concerning the product has been submitted,
by withdrawing the investigational new drug application in accordance with part
312 of title 21, Code of Federal Regulations (or any successor
regulations).</text>
</clause></subparagraph><subparagraph id="H89734FE84EA14CB0A420FD85FD8E1FB0"><enum>(D)</enum><header>Reactivation
fee</header>
<clause id="H1C91872877A449C9A3B75312CDE2039B"><enum>(i)</enum><header>In
general</header><text>A person that has discontinued participation in the
biosimilar biological product development program for a product under
subparagraph (C) shall pay a fee (referred to in this section as
<quote>reactivation fee</quote>) by the earlier of the following:</text>
<subclause id="H1D5504CECDF040BC86A604069245C01F"><enum>(I)</enum><text display-inline="yes-display-inline">Not later than 5 days after the Secretary
grants a request for a biosimilar biological product development meeting for
the product (after the date on which such participation was
discontinued).</text>
</subclause><subclause id="H93C90F88EAF14E0494EC3CF2E65DD98E"><enum>(II)</enum><text display-inline="yes-display-inline">Upon the date of submission (after the date
on which such participation was discontinued) of an investigational new drug
application describing an investigation that the Secretary determines is
intended to support a biosimilar biological product application for that
product.</text>
</subclause></clause><clause id="HA5378FF5C0C848FA8433AFEE197DD848"><enum>(ii)</enum><header>Application of
annual fee</header><text>A person that pays a reactivation fee for a product
shall pay for such product, beginning in the next fiscal year, the annual
biosimilar biological product development fee under subparagraph (B).</text>
</clause></subparagraph><subparagraph id="H151DB79A609E426596E3464364285BD9"><enum>(E)</enum><header>Effect of
failure to pay biosimilar development program fees</header>
<clause id="H97F50561931B48E284FBCBC94F6C6039"><enum>(i)</enum><header>No biosimilar
biological product development meetings</header><text>If a person has failed to
pay an initial or annual biosimilar biological product development fee as
required under subparagraph (A) or (B), or a reactivation fee as required under
subparagraph (D), the Secretary shall not provide a biosimilar biological
product development meeting relating to the product for which fees are
owed.</text>
</clause><clause id="H5C5DC2536BD14BD7A6220989ACA1BC23"><enum>(ii)</enum><header>No receipt of
investigational new drug applications</header><text>Except in extraordinary
circumstances, the Secretary shall not consider an investigational new drug
application to have been received under section 505(i)(2) if—</text>
<subclause id="H1850010D13C94626A678A456FA7F3750"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the
investigation is intended to support a biosimilar biological product
application; and</text>
</subclause><subclause id="HA466461B5E1541739F003840E7CF9F2B"><enum>(II)</enum><text>the sponsor has
failed to pay an initial or annual biosimilar biological product development
fee for the product as required under subparagraph (A) or (B), or a
reactivation fee as required under subparagraph (D).</text>
</subclause></clause><clause id="H1AE0247897344B5FA87DBD41E0F36BF0"><enum>(iii)</enum><header>Financial
hold</header><text>Notwithstanding section 505(i)(2), except in extraordinary
circumstances, the Secretary shall prohibit the sponsor of a clinical
investigation from continuing the investigation if—</text>
<subclause id="H7017F02E30494F93B49ADC304BF07683"><enum>(I)</enum><text display-inline="yes-display-inline">the Secretary determines that the
investigation is intended to support a biosimilar biological product
application; and</text>
</subclause><subclause id="H7BC06FB209904019B2DB1099D60E5BDB"><enum>(II)</enum><text>the sponsor has
failed to pay an initial or annual biosimilar biological product development
fee for the product as required under subparagraph (A) or (B), or a
reactivation fee for the product as required under subparagraph (D).</text>
</subclause></clause><clause id="HD1F57A24302A4E9BA4E5738266BB3570"><enum>(iv)</enum><header>No acceptance
of biosimilar biological product applications or supplements</header><text display-inline="yes-display-inline">If a person has failed to pay an initial or
annual biosimilar biological product development fee as required under
subparagraph (A) or (B), or a reactivation fee as required under subparagraph
(D), any biosimilar biological product application or supplement submitted by
that person shall be considered incomplete and shall not be accepted for filing
by the Secretary until all such fees owed by such person have been paid.</text>
</clause></subparagraph><subparagraph id="H580EB107048A417ABC9EA987EB1F1264"><enum>(F)</enum><header>Limits regarding
biosimilar development program fees</header>
<clause id="H99F5BAB77F3543959F1A33E5B211F411"><enum>(i)</enum><header>No
refunds</header><text>The Secretary shall not refund any initial or annual
biosimilar biological product development fee paid under subparagraph (A) or
(B), or any reactivation fee paid under subparagraph (D).</text>
</clause><clause id="H3E6AE1F74CD243D1A43B40A0E5ADBCF6"><enum>(ii)</enum><header>No waivers,
exemptions, or reductions</header><text>The Secretary shall not grant a waiver,
exemption, or reduction of any initial or annual biosimilar biological product
development fee due or payable under subparagraph (A) or (B), or any
reactivation fee due or payable under subparagraph (D).</text>
</clause></subparagraph></paragraph><paragraph id="HD63214C84A014E3B98BC20649004C080"><enum>(2)</enum><header>Biosimilar
biological product application and supplement fee</header>
<subparagraph id="H11B6B78C3733405FA514584C426572E4"><enum>(A)</enum><header>In
general</header><text>Each person that submits, on or after October 1, 2012, a
biosimilar biological product application or a supplement shall be subject to
the following fees:</text>
<clause id="H41556CA09C8F4D27AA6323407C814D4A"><enum>(i)</enum><text>A
fee for a biosimilar biological product application that is equal to—</text>
<subclause id="HC628B734F8514532AEC5642DD170B6AF"><enum>(I)</enum><text display-inline="yes-display-inline">the amount of the fee established under
subsection (b)(1)(D) for a biosimilar biological product application for which
clinical data (other than comparative bioavailability studies) with respect to
safety or effectiveness are required for approval; minus</text>
</subclause><subclause id="HC38E60CA96754051ACE4616F1F940014"><enum>(II)</enum><text>the cumulative
amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph
(1) for the product that is the subject of the application.</text>
</subclause></clause><clause id="H46C2DAF4F399475DAC74781F0DC8C0B1"><enum>(ii)</enum><text>A
fee for a biosimilar biological product application for which clinical data
(other than comparative bioavailability studies) with respect to safety or
effectiveness are not required, that is equal to—</text>
<subclause id="H8ADFC990310140ACA343025D14B35C56"><enum>(I)</enum><text>half of the amount
of the fee established under subsection (b)(1)(D) for a biosimilar biological
product application; minus</text>
</subclause><subclause id="HB06CDD0705FD485E831D13E273D5A4A4"><enum>(II)</enum><text>the cumulative
amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph
(1) for that product.</text>
</subclause></clause><clause id="H8646E84D2375484E9F8CC01744C53863"><enum>(iii)</enum><text>A fee for a
supplement for which clinical data (other than comparative bioavailability
studies) with respect to safety or effectiveness are required, that is equal to
half of the amount of the fee established under subsection (b)(1)(D) for a
biosimilar biological product application.</text>
</clause></subparagraph><subparagraph id="H30538D38C93448208F3A7FC2E4C7A203"><enum>(B)</enum><header>Reduction in
fees</header><text>Notwithstanding section 404 of the Biosimilars User Fee Act
of 2012, any person who pays a fee under subparagraph (A), (B), or (D) of
paragraph (1) for a product before October 1, 2017, but submits a biosimilar
biological product application for that product after such date, shall be
entitled to the reduction of any biosimilar biological product application fees
that may be assessed at the time when such biosimilar biological product
application is submitted, by the cumulative amount of fees paid under
subparagraphs (A), (B), and (D) of paragraph (1) for that product.</text>
</subparagraph><subparagraph id="H0E99D1D321F24BA5B0FBD720CFDFC163"><enum>(C)</enum><header>Payment due
date</header><text>Any fee required by subparagraph (A) shall be due upon
submission of the application or supplement for which such fee applies.</text>
</subparagraph><subparagraph id="H570A45917FAD4E88B4673792BD1470F1"><enum>(D)</enum><header>Exception for
previously filed application or supplement</header><text>If a biosimilar
biological product application or supplement was submitted by a person that
paid the fee for such application or supplement, was accepted for filing, and
was not approved or was withdrawn (without a waiver), the submission of a
biosimilar biological product application or a supplement for the same product
by the same person (or the person’s licensee, assignee, or successor) shall not
be subject to a fee under subparagraph (A).</text>
</subparagraph><subparagraph id="HA71A9B0BBBC7490B892B7166956693E5"><enum>(E)</enum><header>Refund of
application fee if application refused for filing or withdrawn before
filing</header><text>The Secretary shall refund 75 percent of the fee paid
under this paragraph for any application or supplement which is refused for
filing or withdrawn without a waiver before filing.</text>
</subparagraph><subparagraph id="H39B773320114471698D01B8E1C5F8C07"><enum>(F)</enum><header>Fees for
applications previously refused for filing or withdrawn before
filing</header><text>A biosimilar biological product application or supplement
that was submitted but was refused for filing, or was withdrawn before being
accepted or refused for filing, shall be subject to the full fee under
subparagraph (A) upon being resubmitted or filed over protest, unless the fee
is waived under subsection (c).</text>
</subparagraph></paragraph><paragraph commented="no" id="H9D0187A057F7488EBA65219D71D10635"><enum>(3)</enum><header>Biosimilar
biological product establishment fee</header>
<subparagraph commented="no" id="HFD743DEFC3CF418A88BBD4D2DE3000E1"><enum>(A)</enum><header>In
general</header><text>Except as provided in subparagraph (E), each person that
is named as the applicant in a biosimilar biological product application shall
be assessed an annual fee established under subsection (b)(1)(E) for each
biosimilar biological product establishment that is listed in the approved
biosimilar biological product application as an establishment that manufactures
the biosimilar biological product named in such application.</text>
</subparagraph><subparagraph commented="no" id="HEA6AB2AADB304AAB9A74BD20047F1131"><enum>(B)</enum><header>Assessment in
fiscal years</header><text>The establishment fee shall be assessed in each
fiscal year for which the biosimilar biological product named in the
application is assessed a fee under paragraph (4) unless the biosimilar
biological product establishment listed in the application does not engage in
the manufacture of the biosimilar biological product during such fiscal
year.</text>
</subparagraph><subparagraph commented="no" id="H3D3A1F1FCD684A1190F5310DF629877C"><enum>(C)</enum><header>Due
date</header><text>The establishment fee for a fiscal year shall be due on the
later of—</text>
<clause commented="no" id="H07CF8EB72A6E4BCFAD0B119F6C11F97F"><enum>(i)</enum><text>the first business
day on or after October 1 of such fiscal year; or</text>
</clause><clause commented="no" id="HF762740C30B24E11839636601CD0924A"><enum>(ii)</enum><text>the first
business day after the enactment of an appropriations Act providing for the
collection and obligation of fees for such fiscal year under this
section.</text>
</clause></subparagraph><subparagraph commented="no" id="H5090AAA5EF434E3DA81B91468D297504"><enum>(D)</enum><header>Application to
establishment</header>
<clause id="H7C263CD76C3E4BC8AD9BDFC2C8C73A89"><enum>(i)</enum><text>Each biosimilar
biological product establishment shall be assessed only one fee per biosimilar
biological product establishment, notwithstanding the number of biosimilar
biological products manufactured at the establishment, subject to clause
(ii).</text>
</clause><clause id="H62BB6EF1CDF34BBB89C3D349345D0034"><enum>(ii)</enum><text>In the event an
establishment is listed in a biosimilar biological product application by more
than one applicant, the establishment fee for the fiscal year shall be divided
equally and assessed among the applicants whose biosimilar biological products
are manufactured by the establishment during the fiscal year and assessed
biosimilar biological product fees under paragraph (4).</text>
</clause></subparagraph><subparagraph commented="no" id="H14C53BD3767B4C6082FDBDD948B3E472"><enum>(E)</enum><header>Exception for
new products</header><text>If, during the fiscal year, an applicant initiates
or causes to be initiated the manufacture of a biosimilar biological product at
an establishment listed in its biosimilar biological product
application—</text>
<clause commented="no" id="HA73E2A8BEE4B4F3CB31DB90FB8FF75D1"><enum>(i)</enum><text>that did not
manufacture the biosimilar biological product in the previous fiscal year;
and</text>
</clause><clause commented="no" id="H11A93A80962B42B5982E8F8B12FDB46C"><enum>(ii)</enum><text>for which the
full biosimilar biological product establishment fee has been assessed in the
fiscal year at a time before manufacture of the biosimilar biological product
was begun,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">the applicant shall not be
assessed a share of the biosimilar biological product establishment fee for the
fiscal year in which the manufacture of the product began.</continuation-text></subparagraph></paragraph><paragraph id="H26DD3FAD2E714DC9B7235542F2EAA9AC"><enum>(4)</enum><header>Biosimilar
biological product fee</header>
<subparagraph display-inline="no-display-inline" id="HBDC9DE2AB5864FE79F216710E99FD5F7"><enum>(A)</enum><header>In
general</header><text>Each person who is named as the applicant in a biosimilar
biological product application shall pay for each such biosimilar biological
product the annual fee established under subsection (b)(1)(F).</text>
</subparagraph><subparagraph id="HF736F07CAD7E4F52B02F369BFF8788CD"><enum>(B)</enum><header>Due
date</header><text>The biosimilar biological product fee for a fiscal year
shall be due on the later of—</text>
<clause id="H9BA56A5B0494418C82A5AA6B8085A795"><enum>(i)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</clause><clause id="H859EA1706ACB4D768E992AEFECF8584B"><enum>(ii)</enum><text display-inline="yes-display-inline">the first business day after the enactment
of an appropriations Act providing for the collection and obligation of fees
for such year under this section.</text>
</clause></subparagraph><subparagraph id="H1E72FA4A4C704366BF17D1E01AFB7A0D"><enum>(C)</enum><header>One fee per
product per year</header><text>The biosimilar biological product fee shall be
paid only once for each product for each fiscal year.</text>
</subparagraph></paragraph></subsection><subsection id="HC4A012E84D894B108DFD6486685A256A"><enum>(b)</enum><header>Fee setting and
amounts</header>
<paragraph id="HD56751572EC94F19B2197738A76E62A8"><enum>(1)</enum><header>In
general</header><text>Subject to paragraph (2), the Secretary shall, 60 days
before the start of each fiscal year that begins after September 30, 2012,
establish, for the next fiscal year, the fees under subsection (a). Except as
provided in subsection (c), such fees shall be in the following amounts:</text>
<subparagraph id="HEBE4D17473E9441F96851657D25C37EB"><enum>(A)</enum><header>Initial
biosimilar biological product development fee</header><text>The initial
biosimilar biological product development fee under subsection (a)(1)(A) for a
fiscal year shall be equal to 10 percent of the amount established under
section 736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="HAD0EC863D5B24690B2C9355408C8C365"><enum>(B)</enum><header>Annual
biosimilar biological product development fee</header><text>The annual
biosimilar biological product development fee under subsection (a)(1)(B) for a
fiscal year shall be equal to 10 percent of the amount established under
section 736(c)(4) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="HB0153745A9704BB5812ABB57DE645E9A"><enum>(C)</enum><header>Reactivation
fee</header><text display-inline="yes-display-inline">The reactivation fee
under subsection (a)(1)(D) for a fiscal year shall be equal to 20 percent of
the amount of the fee established under section 736(c)(4) for a human drug
application described in section 736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="H590811BB082446CCB2297EFB6B12796A"><enum>(D)</enum><header>Biosimilar
biological product application fee</header><text display-inline="yes-display-inline">The biosimilar biological product
application fee under subsection (a)(2) for a fiscal year shall be equal to the
amount established under section 736(c)(4) for a human drug application
described in section 736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="H9DA2845BC621488890CB4E87C372B4DB"><enum>(E)</enum><header>Biosimilar
biological product establishment fee</header><text>The biosimilar biological
product establishment fee under subsection (a)(3) for a fiscal year shall be
equal to the amount established under section 736(c)(4) for a prescription drug
establishment for that fiscal year.</text>
</subparagraph><subparagraph id="H62469D02D86C47EDA284D85AE41D7C8E"><enum>(F)</enum><header>Biosimilar
biological product fee</header><text>The biosimilar biological product fee
under subsection (a)(4) for a fiscal year shall be equal to the amount
established under section 736(c)(4) for a prescription drug product for that
fiscal year.</text>
</subparagraph></paragraph><paragraph id="HA92D73BBCA6E4B4A9D89FE8A62115FCF"><enum>(2)</enum><header>Limit</header><text>The
total amount of fees charged for a fiscal year under this section may not
exceed the total amount for such fiscal year of the costs of resources
allocated for the process for the review of biosimilar biological product
applications.</text>
</paragraph></subsection><subsection id="H3589EA824F7940F385465486E59C08B2"><enum>(c)</enum><header>Application fee
waiver for small business</header>
<paragraph id="H2DF97052FA8E46E6B8839FC6201E5074"><enum>(1)</enum><header>Waiver of
application fee</header><text>The Secretary shall grant to a person who is
named in a biosimilar biological product application a waiver from the
application fee assessed to that person under subsection (a)(2)(A) for the
first biosimilar biological product application that a small business or its
affiliate submits to the Secretary for review. After a small business or its
affiliate is granted such a waiver, the small business or its affiliate shall
pay—</text>
<subparagraph id="H7B8F637C592846DB8CA1EF265A93B991"><enum>(A)</enum><text>application fees
for all subsequent biosimilar biological product applications submitted to the
Secretary for review in the same manner as an entity that is not a small
business; and</text>
</subparagraph><subparagraph id="HDB45442F0CCA43B39588F15699D0C651"><enum>(B)</enum><text>all supplement
fees for all supplements to biosimilar biological product applications
submitted to the Secretary for review in the same manner as an entity that is
not a small business.</text>
</subparagraph></paragraph><paragraph id="H97716F24534540E9B29947E579453A17"><enum>(2)</enum><header>Considerations</header><text>In
determining whether to grant a waiver of a fee under paragraph (1), the
Secretary shall consider only the circumstances and assets of the applicant
involved and any affiliate of the applicant.</text>
</paragraph><paragraph id="H91CF821C2A5043D7A7D38213D5EB0BF6"><enum>(3)</enum><header>Small business
defined</header><text>In this subsection, the term <term>small business</term>
means an entity that has fewer than 500 employees, including employees of
affiliates, and does not have a drug product that has been approved under a
human drug application (as defined in section 735) or a biosimilar biological
product application (as defined in section 744G(4)) and introduced or delivered
for introduction into interstate commerce.</text>
</paragraph></subsection><subsection id="H035214A7AF234A3F8ABE11BE28629941"><enum>(d)</enum><header>Effect of
failure To pay fees</header><text>A biosimilar biological product application
or supplement submitted by a person subject to fees under subsection (a) shall
be considered incomplete and shall not be accepted for filing by the Secretary
until all fees owed by such person have been paid.</text>
</subsection><subsection id="HB13D5F48B30F4EA293FDEF99A4EF2B41"><enum>(e)</enum><header>Crediting and
availability of fees</header>
<paragraph id="H948A845A17F543E5A187FA77D48BD8B3"><enum>(1)</enum><header>In
general</header><text>Subject to paragraph (2), fees authorized under
subsection (a) shall be collected and available for obligation only to the
extent and in the amount provided in advance in appropriations Acts. Such fees
are authorized to remain available until expended. Such sums as may be
necessary may be transferred from the Food and Drug Administration salaries and
expenses appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such fiscal year
limitation. The sums transferred shall be available solely for the process for
the review of biosimilar biological product applications.</text>
</paragraph><paragraph id="HA874341F528C4FDDB14D3842EECB2797"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="H4F773D5A83C54128A8A4A55AD4870971"><enum>(A)</enum><header>In
general</header><text>Subject to subparagraphs (C) and (D), the fees authorized
by this section shall be collected and available in each fiscal year in an
amount not to exceed the amount specified in appropriation Acts, or otherwise
made available for obligation for such fiscal year.</text>
</subparagraph><subparagraph id="HB847352DBEE44147912A79839C0E5692"><enum>(B)</enum><header>Use of fees and
limitation</header><text display-inline="yes-display-inline">The fees
authorized by this section shall be available for a fiscal year beginning after
fiscal year 2012 to defray the costs of the process for the review of
biosimilar biological product applications (including such costs for an
additional number of full-time equivalent positions in the Department of Health
and Human Services to be engaged in such process), only if the Secretary
allocates for such purpose an amount for such fiscal year (excluding amounts
from fees collected under this section) no less than $20,000,000, multiplied by
the adjustment factor applicable to the fiscal year involved.</text>
</subparagraph><subparagraph id="H0EE7277E793143019F3CB5F1AEE1643A"><enum>(C)</enum><header>Fee collection
during first program year</header><text>Until the date of enactment of an Act
making appropriations through September 30, 2013, for the salaries and expenses
account of the Food and Drug Administration, fees authorized by this section
for fiscal year 2013 may be collected and shall be credited to such account and
remain available until expended.</text>
</subparagraph><subparagraph id="H32F8A28F6FFC452485AA1AE3EC1E13B6"><enum>(D)</enum><header>Provision for
early payments in subsequent years</header><text>Payment of fees authorized
under this section for a fiscal year (after fiscal year 2013), prior to the due
date for such fees, may be accepted by the Secretary in accordance with
authority provided in advance in a prior year appropriations Act.</text>
</subparagraph></paragraph><paragraph id="HE179B0CAF9E64E81930F76D3F57C38D8"><enum>(3)</enum><header>Authorization of
appropriations</header><text>For each of fiscal years 2013 through 2017, there
is authorized to be appropriated for fees under this section an amount
equivalent to the total amount of fees assessed for such fiscal year under this
section.</text>
</paragraph></subsection><subsection id="H72287D582F8B4C04A53AE59333B2C5DF"><enum>(f)</enum><header>Collection of
unpaid fees</header><text>In any case where the Secretary does not receive
payment of a fee assessed under subsection (a) within 30 days after it is due,
such fee shall be treated as a claim of the United States Government subject to
subchapter II of
<external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31,
United States Code.</text>
</subsection><subsection id="H5C2D07B12C244EDB98F1224AF77797CE"><enum>(g)</enum><header>Written requests
for waivers and refunds</header><text>To qualify for consideration for a waiver
under subsection (c), or for a refund of any fee collected in accordance with
subsection (a)(2)(A), a person shall submit to the Secretary a written request
for such waiver or refund not later than 180 days after such fee is due.</text>
</subsection><subsection id="H281DFD11999D499A9E311E24A3B75423"><enum>(h)</enum><header>Construction</header><text>This
section may not be construed to require that the number of full-time equivalent
positions in the Department of Health and Human Services, for officers,
employers, and advisory committees not engaged in the process of the review of
biosimilar biological product applications, be reduced to offset the number of
officers, employees, and advisory committees so
engaged.</text>
</subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H92F1B530AFDA48708CC369B4ADF87A5E"><enum>403.</enum><header>Reauthorization;
reporting requirements</header><text display-inline="no-display-inline">Part 8
of subchapter C of chapter VII, as added by section 402 of this Act, is further
amended by inserting after section 744H the following:</text>
<quoted-block id="HCF161DD5751446C3A2B463B0A2428103" style="OLC">
<section id="H7A87CEAA03394B0989066F14D7C98A05"><enum>744I.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="HB4A34F238E1E43F5B9F37C42FE144554"><enum>(a)</enum><header>Performance
report</header><text>Beginning with fiscal year 2013, not later than 120 days
after the end of each fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report concerning the progress of the Food and
Drug Administration in achieving the goals identified in the letters described
in section 401(b) of the <short-title>Biosimilar User Fee
Act of 2012</short-title> during such fiscal year and the future plans of the
Food and Drug Administration for meeting such goals. The report for a fiscal
year shall include information on all previous cohorts for which the Secretary
has not given a complete response on all biosimilar biological product
applications and supplements in the cohort.</text>
</subsection><subsection id="H4ABACC0435334B81B9695AB564CBA835"><enum>(b)</enum><header>Fiscal
report</header><text>Not later than 120 days after the end of fiscal year 2013
and each subsequent fiscal year for which fees are collected under this part,
the Secretary shall prepare and submit to the Committee on Energy and Commerce
of the House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the Senate a report on the implementation of the authority for
such fees during such fiscal year and the use, by the Food and Drug
Administration, of the fees collected for such fiscal year.</text>
</subsection><subsection id="H54965C4054144B4DA0355D714EA0CD22"><enum>(c)</enum><header>Public
availability</header><text>The Secretary shall make the reports required under
subsections (a) and (b) available to the public on the Internet Web site of the
Food and Drug Administration.</text>
</subsection><subsection id="H5529318E01374A9B87D242629BD0DD4B"><enum>(d)</enum><header>Study</header>
<paragraph id="H5D35E9CED6214F8BBEA66CAD1C9C38FB"><enum>(1)</enum><header>In
general</header><text>The Secretary shall contract with an independent
accounting or consulting firm to study the workload volume and full costs
associated with the process for the review of biosimilar biological product
applications.</text>
</paragraph><paragraph id="H9E2233C7D577481ABFC88F11977AF8A0"><enum>(2)</enum><header>Interim
results</header><text>Not later than June 1, 2015, the Secretary shall publish,
for public comment, interim results of the study described under paragraph
(1).</text>
</paragraph><paragraph id="H8741A018BC7E41C295477E6AB51FB77B"><enum>(3)</enum><header>Final
results</header><text>Not later than September 30, 2016, the Secretary shall
publish, for public comment, the final results of the study described under
paragraph (1).</text>
</paragraph></subsection><subsection id="H5ACE37850D304ACC958E872A73FE3AC2"><enum>(e)</enum><header>Reauthorization</header>
<paragraph id="HA97F581CE19A4252BB67E9984CF0AF87"><enum>(1)</enum><header>Consultation</header><text display-inline="yes-display-inline">In developing recommendations to present to
the Congress with respect to the goals described in subsection (a), and plans
for meeting the goals, for the process for the review of biosimilar biological
product applications for the first 5 fiscal years after fiscal year 2017, and
for the reauthorization of this part for such fiscal years, the Secretary shall
consult with—</text>
<subparagraph id="H9EEB1750C9404C98832F0D87E68928C6"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="HBD6795EEB5294CA291F3BB3569CCC071"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="H448722C2CF2A49C4ADEB6F60F7190E6A"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="H0F0AD48C4F1F49C999119DB7B1E6A1A9"><enum>(D)</enum><text>health care
professionals;</text>
</subparagraph><subparagraph id="HD02C097DA9514724A6165D2BA3BF74AB"><enum>(E)</enum><text>representatives of
patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="HD16118E73F534480B36B9A0FC4BE1322"><enum>(F)</enum><text>the regulated
industry.</text>
</subparagraph></paragraph><paragraph id="H2AAFC5E15CC94F148873DC12EB31BFCC"><enum>(2)</enum><header>Public review of
recommendations</header><text>After negotiations with the regulated industry,
the Secretary shall—</text>
<subparagraph id="H20E1B0C0E69F4120BAB1E451B2EF5A30"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="H87476237D1BE4A50BEEE7539D4FFCD62"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="HAE899A40F3C74912BA430BDE579CF16A"><enum>(C)</enum><text>provide for a
period of 30 days for the public to provide written comments on such
recommendations;</text>
</subparagraph><subparagraph id="H356B425BC7304B73B32FC0F199A2113C"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="H95717EA4A8C14B6E819D551509A0BDFF"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="H64C6F508C5BB450B920E693E3D475CAB"><enum>(3)</enum><header>Transmittal of
recommendations</header><text>Not later than January 15, 2017, the Secretary
shall transmit to the Congress the revised recommendations under paragraph (2),
a summary of the views and comments received under such paragraph, and any
changes made to the recommendations in response to such views and
comments.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="HB15190DCC62E418A99C85FE76803C155"><enum>404.</enum><header>Sunset
dates</header>
<subsection commented="no" id="H36616AA2AB26405FBF4DF278D83D2698"><enum>(a)</enum><header>Authorization</header><text display-inline="yes-display-inline">Sections 744G and 744H, as added by section
402 of this Act, are repealed October 1, 2017.</text>
</subsection><subsection commented="no" id="H994A2B998D75437F9A7FAB154E1E66EA"><enum>(b)</enum><header>Reporting
requirements</header><text display-inline="yes-display-inline">Section 744I, as
added by section 403 of this Act, is repealed January 31, 2018.</text>
</subsection></section><section id="HC960D791A00F4A9FA65A782CE463E08D"><enum>405.</enum><header>Effective
date</header>
<subsection id="H8EF0CA6969214414A21AF33F8378D882"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Except as provided
under subsection (b), the amendments made by this title shall take effect on
the later of—</text>
<paragraph id="HDF7B8D7A65BD40039F8187AF2E01D94C"><enum>(1)</enum><text>October 1, 2012;
or</text>
</paragraph><paragraph id="H73626B0DA010422D90586808E030B37B"><enum>(2)</enum><text>the date of the
enactment of this title.</text>
</paragraph></subsection><subsection id="HF16CE962049D410B85B1693BEFA398CF"><enum>(b)</enum><header>Exception</header><text>Fees
under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as added by this title, shall be assessed for all biosimilar
biological product applications received on or after October 1, 2012,
regardless of the date of the enactment of this title.</text>
</subsection></section><section id="H5E041A8054FA428F9E346D19F759E289"><enum>406.</enum><header>Savings
clause</header><text display-inline="no-display-inline">Notwithstanding the
amendments made by this title, part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date
of the enactment of this title, shall continue to be in effect with respect to
human drug applications and supplements (as defined in such part as of such
day) that were accepted by the Food and Drug Administration for filing on or
after October 1, 2007, but before October 1, 2012, with respect to assessing
and collecting any fee required by such part for a fiscal year prior to fiscal
year 2013.</text>
</section><section id="HBABFF7CB6E6F488EB5B82AF2F677F8CE"><enum>407.</enum><header>Conforming
amendment</header><text display-inline="no-display-inline">Section 735(1)(B)
(<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C.
379g(1)(B)</external-xref>) is amended by striking <quote>or
(k)</quote>.</text>
</section><enum>V</enum><header>Reauthorization of
Best Pharmaceuticals for Children Act and Pediatric Research Equity
Act</header>
<section commented="no" id="HBD919094A06346FD922AF2AA36C6FE8D"><enum>501.</enum><header>Permanent
extension of Best Pharmaceuticals for Children Act and Pediatric Research
Equity Act</header>
<subsection commented="no" id="H4715C29432C64441BB6CF9896818D049"><enum>(a)</enum><header>Program for
pediatric studies of drugs</header><text display-inline="yes-display-inline">Section 409I(c) of the Public Health
Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42
U.S.C. 284m(c)</external-xref>) is amended—</text>
<paragraph commented="no" id="H08569468D6E0454D9ED19672443C1757"><enum>(1)</enum><text>in subsection
(c)(1)—</text>
<subparagraph commented="no" id="H877C6138936D4657B175DD7F44A083D6"><enum>(A)</enum><text>in the matter
preceding subparagraph (A), by inserting <quote>or section 351(m) of this
Act,</quote> after <quote>Cosmetic Act,</quote>;</text>
</subparagraph><subparagraph commented="no" id="HDAE65018CA75430AB3D8ADB24B306692"><enum>(B)</enum><text>in subparagraph
(A)(i), by inserting <quote>or section 351(k) of this Act</quote> after
<quote>Cosmetic Act</quote>; and</text>
</subparagraph><subparagraph commented="no" id="H895AA32E35904FFEAD7F12855A5840D4"><enum>(C)</enum><text>by amending
subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H8E208F5EE3DD4DF283E49656C6CB6B48" style="OLC">
<subparagraph commented="no" id="H6F8832FFDD484E3AA9D9CA21EA3CE30C"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HE772E72D0FE04FA6B67813E9F3D19EA5"><enum>(i)</enum><text>there remains no patent
listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic
Act; and</text>
</clause><clause commented="no" id="H3F84D7DC72CD42EFAA8A9606343DD28D" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">every three-year and five-year period
referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E(iv),
(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal
Food, Drug and Cosmetic Act, or applicable twelve-year period referred to in
section 351(k)(7) of this Act, and any seven-year period referred to in section
527 of the Federal Food, Drug, and Cosmetic Act, has ended for at least one
form of the drug;
and</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="HD03547430873406D9252F3E15817C02A"><enum>(2)</enum><text>in subsection
(c)(2)—</text>
<subparagraph commented="no" id="HE302163C4B304B9F904B15F328FE087E"><enum>(A)</enum><text>in the heading of
paragraph (2), by striking <quote><header-in-text level="paragraph" style="OLC">for drugs lacking exclusivity</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" id="HE3F90E9E407C41D6BE103A8D9D7C6D3D"><enum>(B)</enum><text>by striking
<quote>under section 505 of the Federal Food, Drug, and Cosmetic Act</quote>;
and</text>
</subparagraph><subparagraph commented="no" id="HEE0E493A64724223893909200FA980F2"><enum>(C)</enum><text>by striking
<quote>505A of such Act</quote> and inserting <quote>505A of the Federal Food,
Drug, and Cosmetic Act or section 351(m) of this Act</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" id="H054C8C0DE6AC4EA79F712E3D36892406"><enum>(3)</enum><text display-inline="yes-display-inline">in subsection (e)(1), by striking <quote>to
carry out this section</quote> and all that follows through the end of
paragraph (1) and inserting <quote>$25,000,000 for each of fiscal years 2013
through 2017.</quote>.</text>
</paragraph></subsection><subsection commented="no" id="H8285063F68D944898C2F6AC2E896D391"><enum>(b)</enum><header>Pediatric
studies of drugs in FFDCA</header><text display-inline="yes-display-inline">Section 505A (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>) is
amended—</text>
<paragraph commented="no" id="H7D09195E2C2D47A9BA2DD096268AA437"><enum>(1)</enum><text>in subsection
(d)(1)(A), by adding at the end the following: <quote>If a request under this
subparagraph does not request studies in neonates, such request shall include a
statement describing the rationale for not requesting studies in
neonates.</quote>;</text>
</paragraph><paragraph commented="no" id="H8F32A76D57FA460BA86E9EBAC73BBF73"><enum>(2)</enum><text>by amending
subsection (h) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H313D8ABC93DD4A7FB0B92191D431A16A" style="OLC">
<subsection commented="no" id="H44A9757E622F48BBB8947F4835D9D9D1"><enum>(h)</enum><header>Relationship to
pediatric research requirements</header><text display-inline="yes-display-inline">Exclusivity under this section shall only
be granted for the completion of a study or studies that are the subject of a
written request and for which reports are submitted and accepted in accordance
with subsection (d)(3). Written requests under this section may consist of a
study or studies required under section
505B.</text>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H458CBB5463F146B4B6E4FDEA9B7B5218"><enum>(3)</enum><text>in subsection
(k)(2), by striking <quote>subsection (f)(3)(F)</quote> and inserting
<quote>subsection (f)(6)(F)</quote>;</text>
</paragraph><paragraph commented="no" id="HED325498B55D459CBD9F93990A0889DF"><enum>(4)</enum><text>in subsection
(l)—</text>
<subparagraph commented="no" id="H6765CC202F4C40D7A679BF31A617C5F9"><enum>(A)</enum><text>in paragraph
(1)—</text>
<clause commented="no" id="H7E019DB762E84D86A983F97D14AFD69B"><enum>(i)</enum><text>in the paragraph
heading, by striking <quote><header-in-text level="paragraph" style="OLC">year
one</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">first 18-month period</header-in-text></quote>;
and</text>
</clause><clause commented="no" id="H824BB1A0917241D88725CBEF3EBF8B60"><enum>(ii)</enum><text>by striking
<quote>one-year</quote> and inserting <quote>18-month</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="H7B5E9E4B15454450B427255D346310B7"><enum>(B)</enum><text>in paragraph
(2)—</text>
<clause commented="no" id="HD28DE02885AC47529EE3D203D869EFBB"><enum>(i)</enum><text>in the paragraph
heading, by striking <quote><header-in-text level="paragraph" style="OLC">years</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">periods</header-in-text></quote>; and</text>
</clause><clause commented="no" id="H933358D8382349C4B154AE2AD00F6F38"><enum>(ii)</enum><text>by striking
<quote>one-year period</quote> and inserting <quote>18-month
period</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="HB8CFF5E5BB774B2A8632B807C50D6F5D"><enum>(C)</enum><text>by redesignating
paragraph (3) as paragraph (4); and</text>
</subparagraph><subparagraph commented="no" id="H931AFBF319E7425EA1438AFD3A404C6E"><enum>(D)</enum><text>by inserting after
paragraph (2) the following:</text>
<quoted-block display-inline="no-display-inline" id="HF4E657B3F1264F21874BD32751CE7C81" style="OLC">
<paragraph commented="no" id="H7C970EF0188D4D1E9548B97E2A1F3CA5"><enum>(3)</enum><header>Preservation of
authority</header><text display-inline="yes-display-inline">Nothing in this
subsection shall prohibit the Office of Pediatric Therapeutics from providing
for the review of adverse event reports by the Pediatric Advisory Committee
prior to the 18-month period referred to in paragraph (1), if such review is
necessary to ensure safe use of a drug in a pediatric
population.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="HD95B2FC420C646498983DF4D0FDED10E"><enum>(5)</enum><text>in subsection
(n)—</text>
<subparagraph commented="no" id="HE98D8B991B324E6F970E9A0B4FA08683"><enum>(A)</enum><text>in the subsection
heading, by striking <quote><header-in-text level="subsection" style="OLC">Completed</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">Submitted</header-in-text></quote>; and</text>
</subparagraph><subparagraph commented="no" id="HB64FC8A8DDA942FDA5326C87329B4E16"><enum>(B)</enum><text>in paragraph
(1)—</text>
<clause commented="no" id="HC66E1FC8905346C38F741FF43930E4D4"><enum>(i)</enum><text>in the text
preceding subparagraph (A), by striking <quote>have not been completed</quote>
and inserting <quote>have not been submitted by the date specified in the
written request issued and agreed upon</quote>; and</text>
</clause><clause commented="no" id="H69131E7F7ECC4015A24B82A9E891B9AF"><enum>(ii)</enum><text>by revising
subparagraphs (A) and (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HA09BAA98EFF144E5B623CA1663611C45" style="OLC">
<subparagraph commented="no" id="H444CF8B29B6E4A5894146C6BCEB67157"><enum>(A)</enum><text display-inline="yes-display-inline">For a drug for which there remains any
listed patent or exclusivity protection eligible for extension under subsection
(b)(1) or (c)(1) of this section, or any exclusivity protection eligible for
extension under subsection (m)(2) or (m)(3) of section 351 of the Public Health
Service Act, the Secretary shall make a determination regarding whether an
assessment shall be required to be submitted under section 505B(b).</text>
</subparagraph><subparagraph commented="no" id="H7F28EE9354DB483998839C52B31A47D8"><enum>(B)</enum><text display-inline="yes-display-inline">For a drug that has no remaining listed
patents or exclusivity protection eligible for extension under subsection
(b)(1) or (c)(1) of this section, or any exclusivity protection eligible for
extension under subsection (m)(2) or (m)(3) of section 351 of the Public Health
Service Act, the Secretary shall refer the drug for inclusion on the list
established under section 409I of the Public Health Service Act for the conduct
of
studies.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph commented="no" id="HD9FD2865D9FA4266965B1827D98C5FFF"><enum>(6)</enum><text>in subsection
(o)(2), by amending subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H35E0457105894C7D91819282A771CC77" style="OLC">
<subparagraph commented="no" id="HE942DFB5AF8E42CFBC07F176BA9C8AC6"><enum>(B)</enum><text display-inline="yes-display-inline">a statement of any appropriate pediatric
contraindications, warnings, precautions, or other information that the
Secretary considers necessary to assure safe
use.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="HDCA21A48FDA74D65A5C01277E004E02F"><enum>(7)</enum><text>by striking
subsection (q) (relating to a sunset).</text>
</paragraph></subsection><subsection commented="no" id="HA37E1C7696F544AA9E375A8DB99A59C1"><enum>(c)</enum><header>Research into
pediatric uses for drugs and biological projects in FFDCA</header><text display-inline="yes-display-inline">Section 505B (<external-xref legal-doc="usc" parsable-cite="usc/21/355c">21 U.S.C. 355c</external-xref>) is
amended—</text>
<paragraph commented="no" id="H7487545DE9CE4088B40B9E41B1F7D2F2"><enum>(1)</enum><text>in subsection
(a)—</text>
<subparagraph commented="no" id="HB28E0EB9DB3C4CBFA2CB567E30BD49A1"><enum>(A)</enum><text>in paragraph (1),
in the matter before subparagraph (A), by inserting <quote>for a drug</quote>
after <quote>(or supplement to an application)</quote>;</text>
</subparagraph><subparagraph commented="no" id="HFE9DFDE5D914468C99245406DD793A92"><enum>(B)</enum><text>in paragraph
(3)—</text>
<clause commented="no" id="H84B4D990883D494B87079DEF7CF98AFF"><enum>(i)</enum><text>by redesignating
subparagraph (B) as subparagraph (D); and</text>
</clause><clause commented="no" id="HCD6823929F4F48C99687F32C819C8AD8"><enum>(ii)</enum><text>by inserting
after subparagraph (A) the following:</text>
<quoted-block display-inline="no-display-inline" id="HAA8A094AFA214CEAB0BDF5FE2FF21A7A" style="OLC">
<subparagraph commented="no" id="H651FF84CCAAE491BA59C00F7282078D3"><enum>(B)</enum><header>Deferral
extension</header><text display-inline="yes-display-inline">On the initiative
of the Secretary or at the request of the applicant, the Secretary may grant an
extension of a deferral under subparagraph (A) if—</text>
<clause commented="no" id="HDAFC8E3D5E9748C3BE286F96E55D56DA"><enum>(i)</enum><text>the Secretary
finds that the criteria specified in subclause (II) or (III) of subparagraph
(A)(i) continue to be met; and</text>
</clause><clause commented="no" id="H7B0C93F7E1A34ECBADF8F1E68A34D3E3"><enum>(ii)</enum><text>the applicant
submits the materials required under subparagraph (A)(ii).</text>
</clause></subparagraph><subparagraph commented="no" id="HD429AE7252524D56A84E234547B0071A"><enum>(C)</enum><header>Consideration
during deferral period</header><text display-inline="yes-display-inline">If the
Secretary has under this paragraph deferred the date by which an assessment
must be submitted, then until the date specified in the deferral under
subparagraph (A) (including any extension of such date under subparagraph
(B))—</text>
<clause commented="no" id="H169D82A6F4754B08A4C1DA13DAFD8F29"><enum>(i)</enum><text>the assessment
shall not be considered late or delayed; and</text>
</clause><clause commented="no" id="H489BA6EF00B342D693699D43B11A45B2"><enum>(ii)</enum><text>the Secretary
shall not classify the assessment as late or delayed in any report, database,
or public posting.</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause commented="no" id="H63CA850320864E1BB75F3D98AEFD62AF"><enum>(iii)</enum><text>in subparagraph
(D), as redesignated, by amending clause (ii) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HD9A807435593488390B457CF4600BA3F" style="OLC">
<clause commented="no" id="HECA45478F94F496AB56CB1FDDD2A18E4"><enum>(ii)</enum><header>Public
availability</header><text display-inline="yes-display-inline">Not later than
60 days after the submission to the Secretary of the information submitted
through the annual review under clause (i), the Secretary shall make available
to the public in an easily accessible manner, including through the Web site of
the Food and Drug Administration—</text>
<subclause commented="no" id="HBAB3C7EF897349CDBF9C103C8F15AB04"><enum>(I)</enum><text>such
information;</text>
</subclause><subclause commented="no" id="HB760EB69BF374730A533B21FDF7F9FCC"><enum>(II)</enum><text>the name of the
applicant for the product subject to the assessment;</text>
</subclause><subclause commented="no" id="HDDBDE85101C44F1AA733FA12BB35BC39"><enum>(III)</enum><text>the date on
which the product was approved; and</text>
</subclause><subclause commented="no" id="H0D13AB6E06E94D1DAEF7CD18F9D10C29"><enum>(IV)</enum><text>the date of each
deferral or deferral extension under this paragraph for the
product.</text>
</subclause></clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph commented="no" id="HC54C0F7705A2461FAD07AFFFDA1C8E42"><enum>(C)</enum><text>in paragraph
(4)(C)—</text>
<clause commented="no" id="H444D11E43F8B4E489C7ADEAE1D6BAEDB"><enum>(i)</enum><text>in the first
sentence, by inserting <quote>partial</quote> before <quote>waiver is
granted</quote>; and</text>
</clause><clause commented="no" id="H5B7596966E2748EF80A0282A4AD78F7F"><enum>(ii)</enum><text>in the second
sentence, by striking <quote>either a full or partial waiver</quote> and
inserting <quote>a partial waiver</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H318EE3C3659541A19D2CC2FAFE7DAF4C"><enum>(2)</enum><text display-inline="yes-display-inline">in subsection (b)(1), by striking
<quote>After providing notice in the form of a letter (that, for a drug
approved under section 505, references a declined written request under section
505A for a labeled indication which written request is not referred under
section 505A(n)(1)(A) to the Foundation of the National Institutes of Health
for the pediatric studies), the Secretary</quote> and inserting <quote>The
Secretary</quote>;</text>
</paragraph><paragraph commented="no" id="H293148CBF80E409AAC6E4DA6348D224C"><enum>(3)</enum><text>by amending
subsection (d) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H2DB7AAA05C924BB8BB42199440413CF8" style="OLC">
<subsection commented="no" id="H898C502AE6A947A4AE5FF0E57FD541A7"><enum>(d)</enum><header>Failure To meet
requirements</header><text display-inline="yes-display-inline">If a person
fails to submit a required assessment described in subsection (a)(2), fails to
meet the applicable requirements in subsection (a)(3), or fails to submit a
request for approval of a pediatric formulation described in subsection (a) or
(b), in accordance with applicable provisions of subsections (a) and
(b)—</text>
<paragraph commented="no" id="H2374A7F68C24480586FFBE92ECA511CD"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H16C217F9669D402494A77D6A95FA1C86"><enum>(A)</enum><text>the Secretary shall
issue a letter to such person informing such person of such failure;</text>
</subparagraph><subparagraph commented="no" id="H4110B3B9345644F08853D9FE6220AD65" indent="up1"><enum>(B)</enum><text>not later than 30 calendar days after
the issuance of a letter under
<internal-xref idref="H16C217F9669D402494A77D6A95FA1C86" legis-path="(d)(1)(A)">subparagraph (A)</internal-xref>, the person who
receives such letter shall submit to the Secretary a written response to such
letter; and</text>
</subparagraph><subparagraph commented="no" id="H41C94935B290493C874CC37355C28108" indent="up1"><enum>(C)</enum><text>not later than 45 calendar days after
the issuance of a letter under
<internal-xref idref="H16C217F9669D402494A77D6A95FA1C86" legis-path="(d)(1)(A)">subparagraph (A)</internal-xref>, the Secretary shall
make such letter, and any response to such letter under
<internal-xref idref="H4110B3B9345644F08853D9FE6220AD65" legis-path="(d)(1)(B)">subparagraph (B)</internal-xref>, available to the
public on the Web site of the Food and Drug Administration, with appropriate
redactions made to protect trade secrets and confidential commercial
information, except that, if the Secretary determines that the letter under
subparagraph (A) was issued in error, the requirements of this subparagraph
shall not apply with respect to such letter; and</text>
</subparagraph></paragraph><paragraph commented="no" id="H79EC4A89139347DC930EFC1FB0083869"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HE2D1491271764197B409C620E925A3E2"><enum>(A)</enum><text>the drug or biological
product that is the subject of the required assessment, applicable requirements
in subsection (a)(3), or required request for approval of a pediatric
formulation may be considered misbranded solely because of that failure and
subject to relevant enforcement action (except that the drug or biological
product shall not be subject to action under section 303); but</text>
</subparagraph><subparagraph commented="no" id="H16A575B925F346B88A82290B9081E455" indent="up1"><enum>(B)</enum><text display-inline="yes-display-inline">the failure to submit the required
assessment, meet the applicable requirements in subsection (a)(3), or submit
the required request for approval of a pediatric formulation shall not be the
basis for a proceeding—</text>
<clause commented="no" id="H221B3129F6634DC3B292E9F7DCE94F74"><enum>(i)</enum><text>to withdraw approval for a drug
under section 505(e); or</text>
</clause><clause commented="no" id="HA95EF43973644276A04942222C3B10FD"><enum>(ii)</enum><text>to revoke the license for a
biological product under section 351 of the Public Health Service
Act.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="HE08114ABB3C74D5480A6458EDAA55B1B"><enum>(4)</enum><text>by amending
subsection (e) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HC77F80135BFD42D1B12E46FA1086E6C2" style="OLC">
<subsection commented="no" id="HC3788B41F3754D948847F0565C7A13F7"><enum>(e)</enum><header>Initial
pediatric plan</header>
<paragraph commented="no" id="H897D1CCB9306419CBAC77C96AB082110"><enum>(1)</enum><header>In
general</header>
<subparagraph commented="no" id="HA471D2B05044426A9B9BD32A40CE3107"><enum>(A)</enum><header>Submission</header><text display-inline="yes-display-inline">An applicant who is required to submit an
assessment under subsection (a)(1) shall submit an initial pediatric
plan.</text>
</subparagraph><subparagraph commented="no" id="H01722380F53948789D1A9F3FCDA2EA7D"><enum>(B)</enum><header>Timing</header><text>An
applicant shall submit the initial pediatric plan under
<internal-xref idref="H897D1CCB9306419CBAC77C96AB082110" legis-path="(e)(1)">paragraph (1)</internal-xref>—</text>
<clause commented="no" id="H1F995D05004A45F593526836C735C33D"><enum>(i)</enum><text>before the date on
which the applicant submits the assessments under subsection (a)(2); and</text>
</clause><clause commented="no" id="H819A51F0E79E401D9C5964C134763781"><enum>(ii)</enum><text>not later
than—</text>
<subclause commented="no" id="HAB9EA6E1B3AC4CF9BADE09B2369356B7"><enum>(I)</enum><text display-inline="yes-display-inline">60 calendar days after the date of
end-of-Phase 2 meeting (as such term is used in
<external-xref legal-doc="regulation" parsable-cite="cfr/21/312.47">section
312.47</external-xref> of title 21, Code of Federal Regulations, or successor
regulations); or</text>
</subclause><subclause commented="no" id="H1306D69B1921446D96E17E4089841467"><enum>(II)</enum><text>such other time
as may be agreed upon between the Secretary and the applicant.</text>
</subclause></clause><continuation-text commented="no" continuation-text-level="subparagraph">Nothing in this section shall
preclude the Secretary from accepting the submission of an initial pediatric
plan earlier than the date otherwise applicable under this subparagraph.</continuation-text></subparagraph><subparagraph commented="no" id="HA8C8ECD2C43A4FC5908243BB548FF219"><enum>(C)</enum><header>Contents</header><text>The
initial pediatric plan shall include—</text>
<clause commented="no" id="H94E27193541647398B939326247AAC9D"><enum>(i)</enum><text>an outline of the
pediatric studies that the applicant plans to conduct;</text>
</clause><clause commented="no" id="H67865E0DE96C4A478DE169784926E67F"><enum>(ii)</enum><text>any request for a
deferral, partial waiver, or waiver under this section, along with supporting
information; and</text>
</clause><clause commented="no" id="H770108DB6B68489691E7E180EDAE1F16"><enum>(iii)</enum><text>other
information the Secretary determines necessary, including any information
specified in regulations under paragraph (5).</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H572A03AA08A546DC91F800EC577A625B"><enum>(2)</enum><header>Meeting</header>
<subparagraph commented="no" id="HF2349E53157B4EADA384BE3457545CFB"><enum>(A)</enum><header>In
general</header><text>Subject to
<internal-xref idref="H109A8D9B58D24760B1164FADFAEF2E55" legis-path="(e)(3)(B)">subparagraph (B)</internal-xref>, not later than 90
calendar days after receiving an initial pediatric plan under
<internal-xref idref="H897D1CCB9306419CBAC77C96AB082110" legis-path="(e)(1)">paragraph (1)</internal-xref>, the Secretary shall meet
with the applicant to discuss the plan.</text>
</subparagraph><subparagraph commented="no" id="H109A8D9B58D24760B1164FADFAEF2E55"><enum>(B)</enum><header>Written
response</header><text>If the Secretary determines that a written response to
the initial pediatric plan is sufficient to communicate comments on the initial
pediatric plan, and that no meeting is necessary the Secretary shall, not later
than 90 days after receiving an initial pediatric plan under
<internal-xref idref="H897D1CCB9306419CBAC77C96AB082110" legis-path="(e)(1)">paragraph (1)</internal-xref>—</text>
<clause commented="no" id="HE33C55D813974676A535AD7441D2E815"><enum>(i)</enum><text>notify the
applicant of such determination; and</text>
</clause><clause commented="no" id="HC1ED615EB413407F996D72BA39097D8B"><enum>(ii)</enum><text>provide to the
applicant the Secretary’s written comments on the plan.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="HCC576DAD6F2A413FB69BF948D27BDB7C"><enum>(3)</enum><header>Agreed initial
pediatric plan</header>
<subparagraph commented="no" id="H5DDFBBDF5BB7413DB61F5A9EBD406460"><enum>(A)</enum><header>Submission</header><text>The
applicant shall submit to the Secretary a document reflecting the agreement
between the Secretary and the applicant on the initial pediatric plan (referred
to in this subsection as an <quote>agreed initial pediatric
plan</quote>).</text>
</subparagraph><subparagraph commented="no" id="H047D832C5F09484FAFF154AC82A40DF0"><enum>(B)</enum><header>Confirmation</header><text>Not
later than 30 days after receiving the agreed initial pediatric plan under
<internal-xref idref="H5DDFBBDF5BB7413DB61F5A9EBD406460" legis-path="(e)(3)(A)">subparagraph (A)</internal-xref>, the Secretary shall
provide written confirmation to the applicant that such plan reflects the
agreement of the Secretary.</text>
</subparagraph><subparagraph commented="no" id="HD788EB6CC2244D7BAE74AE19C453BDF5"><enum>(C)</enum><header>Deferral and
waiver</header><text display-inline="yes-display-inline">If the agreed initial
pediatric plan contains a request from the applicant for a deferral, partial
waiver, or waiver under this section, the written confirmation under
<internal-xref idref="H047D832C5F09484FAFF154AC82A40DF0" legis-path="(e)(3)(B)">subparagraph (B)</internal-xref> shall include a
recommendation from the Secretary as to whether such request meets the
standards under paragraphs (3) or (4) of subsection (a).</text>
</subparagraph><subparagraph commented="no" id="HEDDEF28451634E1187127D4B574AB081"><enum>(D)</enum><header>Amendments to
the plan</header><text display-inline="yes-display-inline">At the initiative of
the Secretary or the applicant, the agreed initial pediatric plan may be
amended at any time. The requirements of paragraph (2) shall apply to any such
proposed amendment in the same manner and to the same extent as such
requirements apply to an initial pediatric plan under paragraph (1). The
requirements of subparagraphs (A) through (C) of this paragraph shall apply to
any agreement resulting from such proposed amendment in the same manner and to
the same extent as such requirements apply to an agreed initial pediatric
plan.</text>
</subparagraph></paragraph><paragraph commented="no" id="HF7584826FECB4A46840174C0A506CD69"><enum>(4)</enum><header>Internal
committee</header><text display-inline="yes-display-inline">The Secretary shall
consult the internal committee under section 505C on the review of the initial
pediatric plan, greed initial pediatric plan, and any amendments to such
plans.</text>
</paragraph><paragraph commented="no" id="HF0B793D10C984748AA4FDE438A7D31C9"><enum>(5)</enum><header>Mandatory
rulemaking</header><text display-inline="yes-display-inline">Not later than one
year after the date of enactment of the <short-title>Food
and Drug Administration Reform Act of 2012</short-title>, the Secretary shall
promulgate proposed regulations and guidance to implement the provisions of
this subsection.</text>
</paragraph><paragraph commented="no" id="H1A090EE547184D7D8837BF5820BE1C4C"><enum>(6)</enum><header>Effective
date</header><text display-inline="yes-display-inline">The provisions of this
subsection shall take effect 180 calendar days after the date of enactment of
the <short-title>Food and Drug Administration Reform Act
of 2012</short-title>, irrespective of whether the Secretary has promulgated
final regulations to carry out this subsection by such
date.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H282D92535FC74C46B1350762A904E4C9"><enum>(5)</enum><text>in subsection
(f)—</text>
<subparagraph commented="no" id="H2D8F5006635A4B66BD07C5B0F2C89104"><enum>(A)</enum><text display-inline="yes-display-inline">in the subsection heading, by inserting
<quote><header-in-text level="subsection" style="OLC">Deferral
Extensions,</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Deferrals,</header-in-text></quote>;</text>
</subparagraph><subparagraph commented="no" id="H6FDD7D48BDF34C2EB3A26E9ABD0F921B"><enum>(B)</enum><text>in paragraph
(4)—</text>
<clause commented="no" id="H3D20F6852E42460587B452DBA8EA03B9"><enum>(i)</enum><text>in the paragraph
heading, by inserting <quote><header-in-text level="paragraph" style="OLC">deferral extensions,</header-in-text></quote> after
<quote><header-in-text level="paragraph" style="OLC">deferrals,</header-in-text></quote>; and</text>
</clause><clause commented="no" id="H11E2C2D5697949CF8036722A7019E24D"><enum>(ii)</enum><text>in the second
sentence, by inserting <quote>, deferral extensions,</quote> after
<quote>deferrals</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" id="H9AD1B729D3F941B5A2E268D00C898C3B"><enum>(C)</enum><text>in paragraph
(6)(D)—</text>
<clause commented="no" id="H4B240FE391CA4BC09B8BC5E13FCA7567"><enum>(i)</enum><text>by inserting
<quote>and deferral extensions</quote> before <quote>requested and
granted</quote>; and</text>
</clause><clause commented="no" id="H64022F8090274950B9B6B6604C263638"><enum>(ii)</enum><text>by inserting
<quote>and deferral extensions</quote> after <quote>the reasons for such
deferrals</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H6BF09ED1D466435F808563001C7D7A3B"><enum>(6)</enum><text>in subsection
(g)—</text>
<subparagraph commented="no" id="HF6D66AB9F7C248679A3D73DD263788C4"><enum>(A)</enum><text>in paragraph
(1)(A), by striking <quote>after the date of the submission of the application
or supplement</quote> and inserting <quote>after the date of the submission of
an application or supplement that receives a priority review or 330 days after
the date of the submission of an application or supplement that receives a
standard review</quote>; and</text>
</subparagraph><subparagraph commented="no" id="H26804B927C2640F6925685369DE484FA"><enum>(B)</enum><text>in paragraph (2),
by striking <quote>the label of such product</quote> and inserting <quote>the
labeling of such product</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" id="H63E098D3497744F3B73C94554DAE058E"><enum>(7)</enum><text>in subsection
(h)(1)—</text>
<subparagraph commented="no" id="H4CA9A1C6DAD543D5942C6705BAE18806"><enum>(A)</enum><text>by inserting
<quote>an application (or supplement to an application) that contains</quote>
after <quote>date of submission of</quote>; and</text>
</subparagraph><subparagraph commented="no" id="H7F10DE2D5F5146B683459EEA49C4B01F"><enum>(B)</enum><text>by inserting
<quote>if the application (or supplement) receives a priority review, or not
later than 330 days after the date of submission of an application (or
supplement to an application) that contains a pediatric assessment under this
section, if the application (or supplement) receives a standard review,</quote>
after <quote>under this section,</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" id="HA82A36E6314541A6A00AC91B6A409EDC"><enum>(8)</enum><text>in subsection
(i)—</text>
<subparagraph commented="no" id="HCEA1761256944FF186185BB161C7B3A3"><enum>(A)</enum><text>in paragraph
(1)—</text>
<clause commented="no" id="H3BE0CB54ABC14172ADE8718380E93B61"><enum>(i)</enum><text>in the paragraph
heading, by striking <quote><header-in-text level="paragraph" style="OLC">year
one</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">first 18-month period</header-in-text></quote>;
and</text>
</clause><clause commented="no" id="HFCCFC6E1DA9F4691A9BC76DC78D6CF21"><enum>(ii)</enum><text>by striking
<quote>one-year</quote> and inserting <quote>18-month</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="H71C1A5419CB4409AADC69C6B1D324AC0"><enum>(B)</enum><text>in paragraph
(2)—</text>
<clause commented="no" id="HE98608F47D784904942351F031749D33"><enum>(i)</enum><text>in the paragraph
heading, by striking <quote><header-in-text level="paragraph" style="OLC">years</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">periods</header-in-text></quote>; and</text>
</clause><clause commented="no" id="HBAAB1DEB2F634AE7935C97A6EE3B4239"><enum>(ii)</enum><text>by striking
<quote>one-year period</quote> and inserting <quote>18-month
period</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="H83664E8395EE40F1977FB3799E0F78CB"><enum>(C)</enum><text>by redesignating
paragraph (3) as paragraph (4); and</text>
</subparagraph><subparagraph commented="no" id="H3EA738BFF9584AD28B5DDCA83C92247B"><enum>(D)</enum><text>by inserting after
paragraph (2) the following:</text>
<quoted-block display-inline="no-display-inline" id="H739C77184935489880FDE393FFB1B9D2" style="OLC">
<paragraph commented="no" id="HD5E306D409464C158D13BBB336A859B2"><enum>(3)</enum><header>Preservation of
authority</header><text display-inline="yes-display-inline">Nothing in this
subsection shall prohibit the Office of Pediatric Therapeutics from providing
for the review of adverse event reports by the Pediatric Advisory Committee
prior to the 18-month period referred to in paragraph (1), if such review is
necessary to ensure safe use of a drug in a pediatric
population.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="HB71CEF0C23714D5F98B0B99CDAE01AC2"><enum>(9)</enum><text>by striking
subsection (m) (relating to integration with other pediatric studies);
and</text>
</paragraph><paragraph commented="no" id="H130AA500F4E54E00B8A280192712F7CF"><enum>(10)</enum><text>by redesignating
subsection (n) as subsection (m).</text>
</paragraph></subsection><subsection commented="no" id="H508D2AC2D2854620865401D6E534BAD7"><enum>(d)</enum><header>Pediatric
studies of biological products in PHSA</header><text>Section 351(m)(1) of the
Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262(m)(1)</external-xref>) is amended by
striking <quote>(f), (i), (j), (k), (l), (p), and (q)</quote> and inserting
<quote>(f), (h), (i), (j), (k), (l), (n), and (p)</quote>.</text>
</subsection><subsection commented="no" id="HF66DEFCEAA8140E4A5300AC3D1727CBA"><enum>(e)</enum><header>Application;
transition rule</header>
<paragraph commented="no" id="HCE8DF19E64914B06A315B035A80910CE"><enum>(1)</enum><header>Application</header><text display-inline="yes-display-inline">Notwithstanding any provision of section
505A and 505B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>,
355c) stating that a provision applies beginning on the date of the enactment
of the Best Pharmaceuticals for Children Act of 2007 or the date of the
enactment of the Pediatric Research Equity Act of 2007, any amendment made by
this Act to such a provision applies beginning on the date of the enactment of
this Act.</text>
</paragraph><paragraph commented="no" id="H9DA0C00714C647C9BEEF14EABE2C20C5"><enum>(2)</enum><header>Transitional
rule for adverse event reporting</header><text>With respect to a drug for which
a labeling change described under section 505A(l)(1) or 505B(i)(1) of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a(l)(1)</external-xref>; 355c(i)(1))
is approved or made, respectively, during the one-year period that ends on the
day before the date of enactment of this Act, the Secretary shall apply section
505A(l) and section 505B(i), as applicable, to such drug, as such sections were
in effect on such day.</text>
</paragraph></subsection><subsection commented="no" id="HB7638DBD04394579AD6F0F2386E3DA62"><enum>(f)</enum><header>Conforming
amendment</header><text>Section 499(c)(1)(C) of the Public Health Service Act
(<external-xref legal-doc="usc" parsable-cite="usc/42/290b">42 U.S.C.
290b(c)(1)(C)</external-xref>) is amended by striking <quote>for which the
Secretary issues a certification in the affirmative under section 505A(n)(1)(A)
of the Federal Food, Drug, and Cosmetic Act</quote>.</text>
</subsection><subsection commented="no" id="HC9D530314514489EA9B5961608E94AFC"><enum>(g)</enum><header>Public meeting
on pediatric cancers</header><text display-inline="yes-display-inline">Not
later than December 31, 2013, the Secretary of Health and Human Services shall
hold a public meeting on the impact of sections 505A and 505B of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>, 355c) on the
development of new therapies for children with cancer.</text>
</subsection></section><section commented="no" id="H569F604F8EB34D2EB6CBE9C4E3322493" section-type="subsequent-section"><enum>502.</enum><header>Food and Drug
Administration Report</header>
<subsection commented="no" id="H7592CEC819AB4AB5B04B73E4CD44232A"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Not later than four
years after the date of enactment of this Act and every five years thereafter,
the Secretary of Health and Human Services shall prepare and submit to the
Committee on Health, Education, Labor and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives, and make
publicly available, including through posting on the Web site of the Food and
Drug Administration, a report on the implementation of section 505A and
505B.</text>
</subsection><subsection commented="no" id="H5E7AFC8EEB714E9B8727BAC39E285D8A"><enum>(b)</enum><header>Contents</header><text display-inline="yes-display-inline">The report described in paragraph (1) shall
include—</text>
<paragraph commented="no" id="HD053AE508CB44C57B7FC4B292CD8132B"><enum>(1)</enum><text>an assessment of
the effectiveness of sections 505A and 505B in improving information about
pediatric uses for approved drugs and biologics, including the number and type
of labeling changes made since the date of enactment of this Act;</text>
</paragraph><paragraph commented="no" id="H2129AA4D6C3A4B5FA61B7B58E641FE2F"><enum>(2)</enum><text>the number of
waivers and partial waivers granted under section 505B since the date of
enactment of this Act, and the reasons such waivers and partial waivers were
granted;</text>
</paragraph><paragraph commented="no" id="HE98AC5E2DB2349E9BADB527EC8C1FBFD"><enum>(3)</enum><text>the number of
deferrals and deferral extensions granted under section 505B since the date of
enactment of this Act, and the reasons such deferrals and deferral extensions
were granted;</text>
</paragraph><paragraph commented="no" id="H39DFEC75FFBE44E5835F25A494FA5FEC"><enum>(4)</enum><text>the number of
letters issued under section 505B(d);</text>
</paragraph><paragraph commented="no" id="H14B28C3D44E247569409FD5BF7BBFDBD"><enum>(5)</enum><text>an assessment of
the timeliness and effectiveness of pediatric study planning since the date of
enactment of this Act, including the number of pediatric plans not submitted in
accordance with the requirements of section 505B(e) and any resulting
rulemaking;</text>
</paragraph><paragraph commented="no" id="H6279FA8DFCFB44AABCC09910DF5EFEE3"><enum>(6)</enum><text>the number of
written requests issued, accepted, and declined under section 505A since the
date of enactment of this Act, and a listing of any important gaps in pediatric
information as a result of such declined requests;</text>
</paragraph><paragraph commented="no" id="H11586D9C464D4F1BAC37AEE735877457"><enum>(7)</enum><text>a description and
current status of referrals made under section 505A(n);</text>
</paragraph><paragraph commented="no" id="HDA6B479E6B3B45EB939DB7A43915B050"><enum>(8)</enum><text>an assessment of
the effectiveness of studying drugs for rare diseases under 505A;</text>
</paragraph><paragraph commented="no" id="H45BC1A4A48274988B71D2CDF8106A3D9"><enum>(9)</enum><text>an assessment of
the effectiveness of studying drugs for children with cancer under 505A and
505B, and any recommendations for modifications to the programs under such
sections that would lead to new and better therapies for children with
cancer;</text>
</paragraph><paragraph commented="no" id="HE41AB0717BEE425DA5A19E53734AE7DA"><enum>(10)</enum><text>an assessment of
the effectiveness of studying drugs in the neonate population under 505A and
505B;</text>
</paragraph><paragraph commented="no" id="HD273915804F84C1FB2545A3412F8F0B9"><enum>(11)</enum><text>an assessment of
the effectiveness of studying biological products in pediatric populations
under 505A and 505B;</text>
</paragraph><paragraph commented="no" id="HD7EC3F4D07C349098AC83CCC26D1DF87"><enum>(12)</enum><text>an assessment of
the Secretary’s efforts to address the suggestions and options described in the
report required under 505A(p); and</text>
</paragraph><paragraph commented="no" id="H964AC1DEBE7E4B89839830B2B380F645"><enum>(13)</enum><text>any suggestions
for modification to the programs that would improve pediatric drug research and
increase pediatric labeling of drugs and biologics that the Secretary
determines to be appropriate.</text>
</paragraph></subsection><subsection commented="no" id="HA62BB7317BC941B4B4036C188ACA4262"><enum>(c)</enum><header>Stakeholder
comment</header><text display-inline="yes-display-inline">At least 180 days
prior to the submission of the report required in paragraph (1), the Secretary
shall consult with representatives of patient groups, including pediatric
patient groups, consumer groups, regulated industry, academia, and other
interested parties to obtain any recommendations or information relevant to the
study and report including suggestions for modifications that would improve
pediatric drug research and pediatric labeling of drugs and biologics.</text>
</subsection></section><section commented="no" id="H2B405A4F25E043A89F9E1A2FC1CD24D0"><enum>503.</enum><header>Internal
Committee for Review of Pediatric Plans, Assessments, Deferrals, Deferral
Extensions, and Waivers</header><text display-inline="no-display-inline">Section 505C (<external-xref legal-doc="usc" parsable-cite="usc/21/355d">21 U.S.C. 355d</external-xref>) is amended—</text>
<paragraph commented="no" id="HE523770DF3934BBF9F7E0FB05FF29FBB"><enum>(1)</enum><text>in the section
heading, by inserting <quote><header-in-text level="section" style="OLC">deferral extensions,</header-in-text></quote> after
<quote><header-in-text level="section" style="OLC">deferrals,</header-in-text></quote>; and</text>
</paragraph><paragraph commented="no" id="HECC689BE559948F19BE482FCEE8615EA"><enum>(2)</enum><text>by inserting
<quote>neonatology</quote> after <quote>pediatric ethics</quote>.</text>
</paragraph></section><section commented="no" id="HDFD83F0446C84C398D7BFF0CA117D467"><enum>504.</enum><header>Staff of Office
of Pediatric Therapeutics</header><text display-inline="no-display-inline">Section 6(c) of the Best Pharmaceuticals for
Children Act (<external-xref legal-doc="usc" parsable-cite="usc/21/393a">21
U.S.C. 393a(c)</external-xref>) is amended—</text>
<paragraph commented="no" id="H521FBC4500B647BABCD75B52D2A91A2D"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>and</quote> at the end;</text>
</paragraph><paragraph commented="no" id="H0FE8B89C134A465CBA2CFD7AF596D1F1"><enum>(2)</enum><text>by redesignating
paragraph (2) as paragraph (4);</text>
</paragraph><paragraph commented="no" id="H5BD9CD4988BB401599EF26BA33F4C7E4"><enum>(3)</enum><text>by inserting after
paragraph (1) the following:</text>
<quoted-block display-inline="no-display-inline" id="H49AA47268B7A42759350BC9CACF52439" style="OLC">
<paragraph commented="no" id="H589D6327C60249EF9B805104858AFD5F"><enum>(2)</enum><text display-inline="yes-display-inline">one or more additional individuals with
expertise in neonatology;</text>
</paragraph><paragraph commented="no" id="H78137F9CE5F44245B8D08607CFAA960C"><enum>(3)</enum><text>one or more
additional individuals with expertise in pediatric epidemiology;
and</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" id="HF34D8ED63FD04AB0916313EDB7FC7E58"><enum>505.</enum><header>Continuation of
operation of Pediatric Advisory Committee</header><text display-inline="no-display-inline">Section 14(d) of the Best Pharmaceuticals
for Children Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42
U.S.C. 284m</external-xref> note) is amended by striking <quote>during the
five-year period beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007</quote> and inserting <quote>to carry
out the advisory committee’s responsibilities under sections 505A, 505B, and
520(m) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355a">21 U.S.C. 355a</external-xref>,
355c, and 360j(m))</quote>.</text>
</section><section commented="no" id="HC21DE4FCACA546B89348D0946AE15953"><enum>506.</enum><header>Pediatric
Subcommittee of the Oncologic Drugs Advisory Committee</header><text display-inline="no-display-inline">Section 15(a) of the Best Pharmaceuticals
for Children Act (<external-xref legal-doc="public-law" parsable-cite="pl/107/109">Public Law 107–109</external-xref>), as amended by
section 502(e) of the Food and Drug Administration Amendments Act of 2007
(<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law
110–85</external-xref>), is amended—</text>
<paragraph commented="no" id="H4E6F987D59724358A4D33D7FEED11558"><enum>(1)</enum><text>in paragraph
(1)(D), by striking <quote>section 505B(f)</quote> and inserting <quote>section
505C</quote>; and</text>
</paragraph><paragraph commented="no" id="HA242E2C471684D51BC99C1F292B90BF7"><enum>(2)</enum><text>in paragraph (3),
by striking <quote>during the five-year period beginning on the date of the
enactment of the Best Pharmaceuticals for Children Act of 2007</quote> and
inserting <quote>to carry out the Subcommittee’s responsibilities under this
section</quote>.</text>
</paragraph></section><enum>VI</enum><header>Food
and Drug Administration administrative reforms</header>
<section commented="no" id="HE848B9E9594243C282A483808FB84BE1"><enum>601.</enum><header>Public
participation in issuance of FDA guidance documents<inline-comment display="no">HR3204</inline-comment></header><text display-inline="no-display-inline">Section 701(h)(1) (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371(h)(1)</external-xref>)
is amended by striking subparagraph (C) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H46F1051F45B64928A8625A3031FF48A1" style="OLC">
<subparagraph commented="no" id="H99D7A352BCE04F3CA7AE413AAFF42070" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">For any guidance document that sets forth
initial interpretations of a statute or regulation, sets forth changes in
interpretation or policy that are of more than a minor nature, includes complex
scientific issues, or covers highly controversial issues—</text>
<clause commented="no" id="H429321DCBC6144D6AB4CE5342B3D4BD2"><enum>(i)</enum><text display-inline="yes-display-inline">the Secretary—</text>
<subclause commented="no" id="H738362278DC14652A4B991990E8056C9"><enum>(I)</enum><text>at least 30 days before issuance of
a draft of such guidance document, shall publish notice in the Federal Register
of the Secretary’s intent to prepare such guidance document; and</text>
</subclause><subclause commented="no" id="H2E611D118E3C425EB879D69E523F7815"><enum>(II)</enum><text>during preparation and before
issuance of such guidance document, may meet with interested stakeholders,
including industry, medical, and scientific experts and others, and solicit
public comment;</text>
</subclause></clause><clause commented="no" id="H6C14A53916F74D9999A2AC7ADD42D60C"><enum>(ii)</enum><text display-inline="yes-display-inline">if the Secretary for good cause finds that,
with respect to such guidance document, compliance with clause (i) is
impracticable, unnecessary, or contrary to the public interest—</text>
<subclause commented="no" id="HAB4766CDBD8E43C4913EA72252F406D4"><enum>(I)</enum><text>the Secretary shall publish such
finding and a brief statement of the reasons for such finding in the Federal
Register;</text>
</subclause><subclause commented="no" id="H333BF601ABFD4573987CFA056521D13A"><enum>(II)</enum><text>clause (i) shall not apply with
respect to such guidance document; and</text>
</subclause><subclause commented="no" id="H3DA4B96488294EB5BC6DB65DDD0CB139"><enum>(III)</enum><text display-inline="yes-display-inline">during a 90-day period beginning not later
than the date of issuance of such guidance document, the Secretary may meet
with interested stakeholders, including industry, medical, and scientific
experts and others, and shall solicit public comment;</text>
</subclause></clause><clause commented="no" id="H2B7E6D0FB714400BBD33A317AB5318F0"><enum>(iii)</enum><text>beginning on the date of enactment
of the <short-title>Food and Drug Administration Reform
Act of 2012</short-title>, upon issuance of a draft guidance document under
clause (i) or (ii), the Secretary shall—</text>
<subclause commented="no" id="H14A12C00021047E5BF3F55480D4B97F5"><enum>(I)</enum><text display-inline="yes-display-inline">designate the document as draft or final;
and</text>
</subclause><subclause commented="no" id="H6BCC8A5685464CF39F72ACA740F7CC38"><enum>(II)</enum><text display-inline="yes-display-inline">not later than 18 months after the close of
the comment period for such guidance, issue a final version of such guidance
document in accordance with clauses (i) and (ii);</text>
</subclause></clause><clause commented="no" id="HF875C773FA944FC4A31B61FF51B901A8"><enum>(iv)</enum><text display-inline="yes-display-inline">the Secretary may extend the deadline for
issuing final guidance under clause (iii)(II) by not more than 180 days upon
submission by the Secretary of a notification of such extension in the Federal
Register;</text>
</clause><clause commented="no" id="H18A9D8E5C06C491A9F7D5BB1C4913DAE"><enum>(v)</enum><text display-inline="yes-display-inline">if
the Secretary issues a draft guidance document and fails to finalize the draft
by the deadline determined under clause (iii)(II), as extended under clause
(iv), the Secretary shall, beginning on the date of such deadline, treat the
draft as null and void; and</text>
</clause><clause commented="no" id="HE27762DA87F044D688B22C97500B32A0"><enum>(vi)</enum><text>not less than every 5 years after the
issuance of a final guidance document in accordance with clause (iii), the
Secretary shall—</text>
<subclause commented="no" id="H23A681F7D6ED40999C8FA8A9230CE556"><enum>(I)</enum><text display-inline="yes-display-inline">conduct a retrospective analysis of such
guidance document to ensure it is not outmoded, ineffective, insufficient, or
excessively burdensome; and</text>
</subclause><subclause commented="no" id="H8952A91D0B3340D89C4EFE2EA640B21B"><enum>(II)</enum><text>based on such analysis, modify,
streamline, expand, or repeal the guidance document in accordance with what has
been learned.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="HDB454E6BC0594E63B39C4C21FF91D2DD" indent="up2"><enum>(D)</enum><text display-inline="yes-display-inline">With respect to devices, a notice to
industry guidance letter, a notice to industry advisory letter, and any similar
notice that sets forth initial interpretations of a statute or regulation or
sets forth changes in interpretation or policy shall be treated as a guidance
document for purposes of subparagraph (C).</text>
</subparagraph><subparagraph commented="no" id="H46D1ACF411E54FDEA1BA5E1ADB0A3631" indent="up2"><enum>(E)</enum><text display-inline="yes-display-inline">The following shall not be treated as a
guidance document for purposes of subparagraph (C):</text>
<clause commented="no" id="H141EEBFDA6984604A73F62716F3DC8C9"><enum>(i)</enum><text>Any document that does not set forth
an initial interpretation or a reinterpretation of a statute or
regulation.</text>
</clause><clause commented="no" id="H48EACA264BC04DDB9379E3823F5044A9"><enum>(ii)</enum><text>Any document that sets forth or
changes a policy relating to internal procedures of the Food and Drug
Administration.</text>
</clause><clause commented="no" id="H90C0345013FF41B49654D180A2E0BB86"><enum>(iii)</enum><text>Agency reports, general information
documents provided to consumers or health professionals, speeches, journal
articles and editorials, media interviews, press materials, warning letters,
memoranda of understanding, or communications directed to individual persons or
firms.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H25B02D1ABF4A4784A7C42CADF990180E"><enum>602.</enum><header>Conflicts of
interest</header>
<subsection id="HCC9A374FEB544B029D6CC1598103F6F9"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 712
(<external-xref legal-doc="usc" parsable-cite="usc/21/379d-1">21 U.S.C.
379d–1</external-xref>) is amended—</text>
<paragraph id="H296D5EBF22474E898BD6AC26430A87D3"><enum>(1)</enum><text>by striking
subsections (b) and (c) and inserting the following subsections:</text>
<quoted-block display-inline="no-display-inline" id="HFCBE4A2B8DD04177A7338905DCB73330" style="OLC">
<subsection id="H62B6FFF95AA64EF581E3927A811CC704"><enum>(b)</enum><header>Recruitment for
advisory committees</header>
<paragraph id="HB5636DF05EDD4F69A245AB445D0C6560"><enum>(1)</enum><header>In
general</header><text>The Secretary shall—</text>
<subparagraph id="HC10D74133C8A4392B218743D7BD5021B"><enum>(A)</enum><text>develop and
implement strategies on effective outreach to potential members of advisory
committees at universities, colleges, other academic research centers,
professional and medical societies, and patient and consumer groups;</text>
</subparagraph><subparagraph id="HD70E1339E8E241BDBEABB0C456E9988B"><enum>(B)</enum><text>seek input from
professional medical and scientific societies to determine the most effective
informational and recruitment activities;</text>
</subparagraph><subparagraph id="H576077BAD8834AEBBFE4C1706C72CD4C"><enum>(C)</enum><text>at least every 180
days, request referrals for potential members of advisory committees from a
variety of stakeholders, including—</text>
<clause id="H78D5B500990E4445A78020DC0E2F02E3"><enum>(i)</enum><text>product
developers, patient groups, and disease advocacy organizations; and</text>
</clause><clause id="HF91151C8F5E34CEF82979D665C9AC61F"><enum>(ii)</enum><text>relevant—</text>
<subclause id="HBFB0A655BDE94BAC8700123432BEF5FD"><enum>(I)</enum><text>professional
societies;</text>
</subclause><subclause id="HE9BA9CACC1A842E2A961204964B632E5"><enum>(II)</enum><text>medical
societies;</text>
</subclause><subclause id="HD05FF0EEB65143E3847849FFAC3DDA9F"><enum>(III)</enum><text>academic
organizations; and</text>
</subclause><subclause id="HBF180C1963EC43CDBD90587D682931CB"><enum>(IV)</enum><text>governmental
organizations; and</text>
</subclause></clause></subparagraph><subparagraph id="H8BB5B746D61D417AB71E4C5E2D78C601"><enum>(D)</enum><text display-inline="yes-display-inline">in carrying out subparagraphs (A) and (B),
take into account the levels of activity (including the numbers of annual
meetings) and the numbers of vacancies of the advisory committees.</text>
</subparagraph></paragraph><paragraph id="HBDBDA40BF2394238AF736238F1FA689B"><enum>(2)</enum><header>Recruitment
activities</header><text>The recruitment activities under paragraph (1) may
include—</text>
<subparagraph id="HFEF528ED017C40F58604F5F14EFB5DAE"><enum>(A)</enum><text>advertising the
process for becoming an advisory committee member at medical and scientific
society conferences;</text>
</subparagraph><subparagraph id="H62611102C8EF44D9811E45D8E62109BB"><enum>(B)</enum><text>making widely
available, including by using existing electronic communications channels, the
contact information for the Food and Drug Administration point of contact
regarding advisory committee nominations; and</text>
</subparagraph><subparagraph id="H254999A75957493AA4261664C8EE9544"><enum>(C)</enum><text>developing a
method through which an entity receiving funding from the National Institutes
of Health, the Agency for Healthcare Research and Quality, the Centers for
Disease Control and Prevention, or the Veterans Health Administration can
identify a person whom the Food and Drug Administration can contact regarding
the nomination of individuals to serve on advisory committees.</text>
</subparagraph></paragraph><paragraph commented="no" id="H8109D3E28CEF413AAEDBD6B912106F2D"><enum>(3)</enum><header>Expertise</header><text display-inline="yes-display-inline">In carrying out this subsection, the
Secretary shall seek to ensure that the Secretary has access to the most
current expert advice.</text>
</paragraph></subsection><subsection id="HDB24616395034837B4FBB748105F27A3"><enum>(c)</enum><header>Disclosure of
determinations and certifications</header><text>Notwithstanding section
107(a)(2) of the Ethics in Government Act of 1978, the following shall
apply:</text>
<paragraph id="HEBEA5A380B234417A6C49042648A8A1C"><enum>(1)</enum><header>15 or more days
in advance</header><text>As soon as practicable, but (except as provided in
paragraph (2)) not later than 15 days prior to a meeting of an advisory
committee to which a written determination as referred to in
<external-xref legal-doc="usc" parsable-cite="usc/18/208">section
208(b)(1)</external-xref> of title 18, United States Code, or a written
certification as referred to in section 208(b)(3) of such title, applies, the
Secretary shall disclose (other than information exempted from disclosure under
section <external-xref legal-doc="usc" parsable-cite="usc/5/552">552</external-xref> or section
<external-xref legal-doc="usc" parsable-cite="usc/5/552a">552a</external-xref>
of title 5, United States Code (popularly known as the Freedom of Information
Act and the Privacy Act of 1974, respectively)) on the Internet Website of the
Food and Drug Administration—</text>
<subparagraph id="H7B35411454ED4229B60D9CE6CC542B9B"><enum>(A)</enum><text>the type, nature,
and magnitude of the financial interests of the advisory committee member to
which such determination or certification applies; and</text>
</subparagraph><subparagraph id="H2CEE8F52F2654C7E93C663B7E9716CA9"><enum>(B)</enum><text display-inline="yes-display-inline">the reasons of the Secretary for such
determination or certification, including, as appropriate, the public health
interest in having the expertise of the member with respect to the particular
matter before the advisory committee.</text>
</subparagraph></paragraph><paragraph id="H14D91E4E0EBA4E389E8AD128F06D95A7"><enum>(2)</enum><header>Less than 30
days in advance</header><text>In the case of a financial interest that becomes
known to the Secretary less than 30 days prior to a meeting of an advisory
committee to which a written determination as referred to in
<external-xref legal-doc="usc" parsable-cite="usc/18/208">section
208(b)(1)</external-xref> of title 18, United States Code, or a written
certification as referred to in section 208(b)(3) of such title applies, the
Secretary shall disclose (other than information exempted from disclosure under
section <external-xref legal-doc="usc" parsable-cite="usc/5/552">552</external-xref> or
<external-xref legal-doc="usc" parsable-cite="usc/5/552a">552a</external-xref>
of title 5, United States Code) on the Internet Website of the Food and Drug
Administration, the information described in subparagraphs (A) and (B) of
paragraph (1) as soon as practicable after the Secretary makes such
determination or certification, but in no case later than the date of such
meeting.</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="H7E767660B6604EAC9EDE301E735B86A5"><enum>(2)</enum><text>in subsection (d),
by striking <quote>subsection (c)(3)</quote> and inserting <quote>subsection
(c)</quote>;</text>
</paragraph><paragraph id="H7C4007B3CA134FA7B71EDE72CADBB1F6"><enum>(3)</enum><text>by amending
subsection (e) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H1AC23CA348E944FD90D2FF4C1F719FA8" style="OLC">
<subsection id="H1715FCB8CAA2425BAB8DED4DFE897090"><enum>(e)</enum><header>Annual
report</header>
<paragraph id="H2EFF3677B8EA43F380455F13DFC80A83"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Not later than
February 1 of each year, the Secretary shall submit to the Committee on
Appropriations and the Committee on Health, Education, Labor, and Pensions of
the Senate, and the Committee on Appropriations and the Committee on Energy and
Commerce of the House of Representatives, a report that describes—</text>
<subparagraph id="H4E83BDE4535F4C4CA0FA0405EEE99F56"><enum>(A)</enum><text display-inline="yes-display-inline">with respect to the fiscal year that ended
on September 30 of the previous year, the number of persons nominated for
participation at meetings for each advisory committee, the number of persons so
nominated, and willing to serve, the number of vacancies on each advisory
committee, and the number of persons contacted for service as members on each
advisory committee meeting for each advisory committee who did not participate
because of the potential for such participation to constitute a disqualifying
financial interest under
<external-xref legal-doc="usc" parsable-cite="usc/18/208">section
208</external-xref> of title 18, United States Code;</text>
</subparagraph><subparagraph id="H5F1C461AEC2A4567B83FF7EE1976F2A3"><enum>(B)</enum><text>with respect to
such year, the number of persons contacted for services as members for each
advisory committee meeting for each advisory committee who did not participate
because of reasons other than the potential for such participation to
constitute a disqualifying financial interest under
<external-xref legal-doc="usc" parsable-cite="usc/18/208">section
208</external-xref> of title 18, United States Code;</text>
</subparagraph><subparagraph id="H68C97E4380D34B8FA8955611C3DC8DDE"><enum>(C)</enum><text>with respect to
such year, the number of members attending meetings for each advisory
committee; and</text>
</subparagraph><subparagraph id="H77BA87A06E7B4105A7555F072F3E7F35"><enum>(D)</enum><text>with respect to
such year, the aggregate number of disclosures required under subsection (d)
and the percentage of individuals to whom such disclosures did not apply who
served on such committee.</text>
</subparagraph></paragraph><paragraph id="HE6C1BEF2F2934E0FBAE82B6FF723D237"><enum>(2)</enum><header>Public
availability</header><text>Not later than 30 days after submitting any report
under paragraph (1) to the committees specified in such paragraph, the
Secretary shall make each such report available to the
public.</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="H070E6E5672DC491DA74A4C55714CA7B5"><enum>(4)</enum><text>in subsection (f),
by striking <quote>shall review guidance</quote> and all that follows through
the end of the subsection and inserting the
following:</text>
<quoted-block display-inline="yes-display-inline" id="HA100E1D84F5B4E6A96839F41B29C8FCD" style="OLC">
<text>shall—</text><paragraph id="HC94CAE1A69D94FC89040811B9B2E0B96"><enum>(1)</enum><text display-inline="yes-display-inline">review guidance of the Food and Drug
Administration with respect to advisory committees regarding disclosure of
conflicts of interest and the application of
<external-xref legal-doc="usc" parsable-cite="usc/18/208">section
208</external-xref> of title 18, United States Code; and</text>
</paragraph><paragraph id="H610AFC9210FD4D6D94A6741943E3DC00"><enum>(2)</enum><text>update such
guidance as necessary to ensure that the Food and Drug Administration receives
appropriate access to needed scientific expertise, with due consideration of
the requirements of such section
208.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H909E6EADFD69453EB87E0026F7122B54"><enum>(b)</enum><header>Applicability</header><text>The
amendments made by subsection (a) apply beginning on October 1, 2012.</text>
</subsection></section><section commented="no" id="H687E5EDD5E2E4C8B8010E4B0546CC58A"><enum>603.</enum><header>Electronic
submission of applications</header><text display-inline="no-display-inline">Subchapter D of chapter VII (<external-xref legal-doc="usc" parsable-cite="usc/21/379k">21 U.S.C. 379k et
seq.</external-xref>) is amended by inserting after section 745 the
following:</text>
<quoted-block display-inline="no-display-inline" id="HE91C05E9A2CB4ACFB0CDEF19B1EA7A1D" style="OLC">
<section commented="no" id="H3462E0809FDF4827B88AEB8BAEE15E04"><enum>745A.</enum><header>Electronic
format for submissions</header>
<subsection commented="no" id="H41B9256CF6334A348AB69CECBEEB9424"><enum>(a)</enum><header>Drugs and
biologics</header>
<paragraph commented="no" id="HCFD83F72619E46859197F0656AAA733C"><enum>(1)</enum><header>In
general</header><text>Beginning no earlier than 24 months after the issuance of
a final guidance issued after public notice and opportunity for comment,
submissions under subsection (b), (i), or (j) of section 505 of this Act or
subsection (a) or (k) of section 351 of the Public Health Service Act shall be
submitted in such electronic format as specified by the Secretary in such
guidance.</text>
</paragraph><paragraph commented="no" id="H51B458EDB39D48E8AE7AF6097302652C"><enum>(2)</enum><header>Guidance
contents</header><text display-inline="yes-display-inline">In the guidance
under
<internal-xref idref="HCFD83F72619E46859197F0656AAA733C" legis-path="745A.(a)(1)">paragraph (1)</internal-xref>, the Secretary
may—</text>
<subparagraph id="H377203C43F9842B7ABA6707CD7611D78"><enum>(A)</enum><text>provide a
timetable for establishment by the Secretary of further standards for
electronic submission as required by such paragraph; and</text>
</subparagraph><subparagraph id="H20377AC524994B60AA91560B8313B55E"><enum>(B)</enum><text>set forth criteria
for waivers of and exemptions from the requirements of this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" id="H50AB9B61074D432CBD6489013CA29406"><enum>(3)</enum><header>Exception</header><text>This
subsection shall not apply to submissions described in section 561.</text>
</paragraph></subsection><subsection commented="no" id="HB311CD10DDF44619AA6F6436A8A69539"><enum>(b)</enum><header>Devices</header>
<paragraph commented="no" id="HF30E2994CE6243A081B76833EB222754"><enum>(1)</enum><header>In
general</header><text>Beginning after the issuance of final guidance
implementing this paragraph, pre-submissions and submissions for devices under
section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of
this Act or section 351 of the Public Health Service Act, and any supplements
to such pre-submissions or submissions, shall include an electronic copy of
such pre-submissions or submissions.</text>
</paragraph><paragraph commented="no" id="H34629C95FBA14C96813AE91334825300"><enum>(2)</enum><header>Guidance
contents</header><text display-inline="yes-display-inline">In the guidance
under
<internal-xref idref="HF30E2994CE6243A081B76833EB222754" legis-path="745A.(b)(1)">paragraph (1)</internal-xref>, the Secretary
may—</text>
<subparagraph id="H2F438D979CA34698BB346B65F3494F62"><enum>(A)</enum><text>provide standards
for the electronic copy required under such paragraph; and</text>
</subparagraph><subparagraph id="HBD3F953F40204586B02DC902A4C7A336"><enum>(B)</enum><text>set forth criteria
for waivers of and exemptions from the requirements of this
subsection.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H3748E4A3C0AD40519FF09519A9296D16" section-type="subsequent-section"><enum>604.</enum><header>Notification of FDA
intent to regulate laboratory-developed tests</header><text display-inline="no-display-inline">The Food and Drug Administration may not
issue any draft or final guidance on the regulation of laboratory-developed
tests under the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et
seq.</external-xref>) without, at least 60 days prior to such issuance—</text>
<paragraph id="HFB4E22E5D381424BB8174C27E620FFB4"><enum>(1)</enum><text>notifying the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate of the
Administration’s intent to take such action; and</text>
</paragraph><paragraph id="H0F8A26E35D6C4730AABF31C2F704C432"><enum>(2)</enum><text>including in such
notification the anticipated details of such action.</text>
</paragraph></section><enum>VII</enum><header>Medical device
regulatory improvements</header>
<subtitle commented="no" id="H8F9FD8B0E16049DDBF561A97F14F20CE"><enum>A</enum><header>Premarket
predictability</header>
<section commented="no" id="HB8008657619B4612BDB867644B62100E"><enum>701.</enum><header>Investigational
device exemptions</header><text display-inline="no-display-inline">Section
520(g) (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C.
360j(g)</external-xref>) is amended—</text>
<paragraph commented="no" id="H6B28A70CC57B4811BF9372C99D47E05A"><enum>(1)</enum><text>in paragraph
(2)(B)(ii), by inserting <quote>safety or effectiveness</quote> before
<quote>data obtained</quote>; and</text>
</paragraph><paragraph commented="no" id="HEA4BA1D3650C42A8847F5DA98AAA0E09"><enum>(2)</enum><text>in paragraph (4),
by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HB9A9E12D93BB4E3AAEC7F0E0141C8A9B" style="OLC">
<subparagraph commented="no" id="H3113D739142E443E843501BF7E13AC89" indent="up2"><enum>(C)</enum><text display-inline="yes-display-inline">Consistent with paragraph (1), the
Secretary shall not disapprove an application under this subsection because the
Secretary determines that—</text>
<clause commented="no" id="HF321B8B7AA40497FBBFBD431674D2507"><enum>(i)</enum><text>the investigation may not support a
substantial equivalence or de novo classification determination or approval of
the device;</text>
</clause><clause commented="no" id="HD3A74E2E936E4228B112D1B33A64F6AD"><enum>(ii)</enum><text>the investigation may not meet a
requirement, including a data requirement, relating to the approval or
clearance of a device; or</text>
</clause><clause commented="no" id="HA35D2E14A588483F9699D366A52B1B0E"><enum>(iii)</enum><text>an additional or different
investigation may be necessary to support clearance or approval of the
device.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" id="H6FBFFA3CCA034C85A245DBA858395043"><enum>702.</enum><header>Clarification
of least burdensome standard</header>
<subsection commented="no" id="H01AC91E8A4C0426F963AECAE60EC9427"><enum>(a)</enum><header>Premarket
approval</header><text display-inline="yes-display-inline">Section 513(a)(3)(D)
(<external-xref legal-doc="usc" parsable-cite="usc/21/360c">21 U.S.C.
360c(a)(3)(D)</external-xref>) is amended—</text>
<paragraph commented="no" id="HA6C169115C804FE8A1E2A4BBA1152DA6"><enum>(1)</enum><text>by redesignating
clause (iii) as clause (v); and</text>
</paragraph><paragraph commented="no" id="HA8997410F76C48D192FF9F6193974259"><enum>(2)</enum><text>by inserting after
clause (ii) the following:</text>
<quoted-block display-inline="no-display-inline" id="H876E3A6289904930AD3D51430C1395A9" style="OLC">
<clause commented="no" id="H93268EE23CF547749992CF22B4752AED" indent="up3"><enum>(iii)</enum><text display-inline="yes-display-inline">For purposes of clause (ii), the term
<term>necessary</term> means the minimum required information that would
support a determination by the Secretary that an application provides
reasonable assurance of the effectiveness of the device.</text>
</clause><clause commented="no" id="H1094EB209B7E4C24AAB067C884DBF4BD" indent="up3"><enum>(iv)</enum><text>Nothing in this subparagraph shall
alter the criteria for evaluating an application for premarket approval of a
device.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="H417B62B0C8F840059635DAA7F4C926E9"><enum>(b)</enum><header>Premarket
notification under section
510<enum-in-header>(k)</enum-in-header></header><text>Section 513(i)(1)(D)
(<external-xref legal-doc="usc" parsable-cite="usc/21/360c">21 U.S.C.
360c(i)(1)(D)</external-xref>) is amended—</text>
<paragraph commented="no" id="HC5EB3417E5D74642BB864C8DAFBC79BE"><enum>(1)</enum><text>by striking ‘‘(D)
Whenever’’ and inserting ‘‘(D)(i) Whenever’’; and</text>
</paragraph><paragraph commented="no" id="H0C1B99892BC64CC6B7FB8E4AD38915C9"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="H95CC025243134B02A6FFD2F232D09C00" style="OLC">
<clause commented="no" id="H984374563D394E1C91A28D1C21E2FCC6" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">For purposes of clause (i), the term
<term>necessary</term> means the minimum required information that would
support a determination of substantial equivalence between a new device and a
predicate device.</text>
</clause><clause commented="no" id="H8C130BA6EF044E2FAF78DC7545055E3F" indent="up3"><enum>(iii)</enum><text>Nothing in this subparagraph shall
alter the standard for determining substantial equivalence between a new device
and a predicate
device.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section commented="no" id="H2DCD880BA7ED424F95DA68C56A8F387E"><enum>703.</enum><header>Agency
documentation and review of significant decisions<inline-comment display="no">H.R. 3209</inline-comment></header><text display-inline="no-display-inline">Chapter V is amended by inserting after
section 517 (<external-xref legal-doc="usc" parsable-cite="usc/21/360g">21
U.S.C. 360g</external-xref>) the following:</text>
<quoted-block display-inline="no-display-inline" id="HB288A2F5616A46A7AD1000EF05BCC44C" style="OLC">
<section commented="no" id="HE224654CFF2F4941B93B7B1017E36532"><enum>517A.</enum><header>Agency
documentation and review of significant decisions regarding devices</header>
<subsection commented="no" id="HF8CF720023F14AF3A1DBE2C70DDE48AE"><enum>(a)</enum><header>Documentation of
rationale for significant decisions</header>
<paragraph commented="no" id="H3710FA12964E42DBB8BD77D3EC08E5C3"><enum>(1)</enum><header>In
general</header><text>The Secretary shall completely document the scientific
and regulatory rationale for any significant decision of the Center for Devices
and Radiological Health regarding submission or review of a report under
section 510(k), an application under section 515, or an application for an
exemption under section 520(g), including documentation of significant
controversies or differences of opinion and the resolution of such
controversies or differences of opinion.</text>
</paragraph><paragraph commented="no" id="HE52AF2AC31FC4D10BB93B6CED62025D4"><enum>(2)</enum><header>Provision of
documentation</header><text>Upon request, the Secretary shall furnish such
complete documentation to the person who is seeking to submit, or who has
submitted, such report or application.</text>
</paragraph></subsection><subsection commented="no" id="H248D5451E21D45739C432B83996CD0CB"><enum>(b)</enum><header>Review of
significant decisions</header>
<paragraph commented="no" id="HBE8F5CE7914E4571957C15E48873BF54"><enum>(1)</enum><header>Request for
supervisory review of significant decision</header><text>Any person may request
a supervisory review of the significant decision described in subsection
(a)(1). Such review may be conducted at the next supervisory level or higher
above the individual who made the significant decision.</text>
</paragraph><paragraph commented="no" id="HB301287C933E4B6F8B8D68443256B699"><enum>(2)</enum><header>Submission of
request</header><text>A person requesting a supervisory review under paragraph
(1) shall submit such request to the Secretary not later than 30 days after
such decision and shall indicate in the request whether such person seeks an
in-person meeting or a teleconference review.</text>
</paragraph><paragraph commented="no" id="HC74016B6B4F1459B80F623AEFE8FFE9B"><enum>(3)</enum><header>Timeframe</header>
<subparagraph commented="no" id="H2BBDB51CBC794271B9F559A1FB9D8920"><enum>(A)</enum><header>In
general</header><text>Except as provided in subparagraph (B), the Secretary
shall schedule an in-person or teleconference review, if so requested, not
later than 30 days after such request is made. The Secretary shall issue a
decision to the person requesting a review under this subsection not later than
45 days after the request is made under paragraph (1), or, in the case of a
person who requests an in-person meeting or teleconference, 30 days after such
meeting or teleconference.</text>
</subparagraph><subparagraph commented="no" id="H1ED9BE6276A64A3ABBF73E37E94493B7"><enum>(B)</enum><header>Exception</header><text>Subparagraph
(A) shall not apply in cases that are referred to experts outside of the Food
and Drug
Administration.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H1E4599DF7B294A7B8B701679A680D333"><enum>704.</enum><header>Transparency in
clearance process<inline-comment display="no">H.R.
3209</inline-comment></header>
<subsection commented="no" id="H49AD7C665767404BA1EA8239CB6E58DE"><enum>(a)</enum><header>Publication of
detailed decision summaries</header><text display-inline="yes-display-inline">Section 520(h) (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C. 360j(h)</external-xref>)
is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF674A7385A0B4EC79A2524A7E9172AB6" style="OLC">
<subsection commented="no" id="H5A9A52D6F4DF43898B4A1667AB2395E2"><enum>(5)</enum><text display-inline="yes-display-inline">Subject to subsection (c) and section
301(j), the Secretary shall regularly publish detailed decision summaries for
each clearance of a device under section 510(k) requiring clinical
data.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H2EABC6E6293642BEA6FA49975652DFF1"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">The requirement of section 520(h)(5) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only
with respect to clearance of a device occurring after the date of the enactment
of this Act.</text>
</subsection></section><section commented="no" id="HD4D201B587A44993842899024382E374"><enum>705.</enum><header>Device
Modifications Requiring Premarket Notification Prior to Marketing</header><text display-inline="no-display-inline">Section 510(n) (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(n)</external-xref>) is
amended by—</text>
<paragraph commented="no" id="H7D4CF5C6AAA549DFACE322DCCB1918AF"><enum>(1)</enum><text>striking
<quote>(n) The Secretary</quote> and inserting <quote>(n)(1) The
Secretary</quote>; and</text>
</paragraph><paragraph commented="no" id="H63A37140020D4E9599616993B189FFCC"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDC1E3A92AB474E5C94F3E5B42DE40498" style="OLC">
<paragraph commented="no" id="H6812484CEE1F41EA8308321880C3AB2F"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HBBA00D6718094B7181BAA0F6542B92B9"><enum>(A)</enum><text display-inline="yes-display-inline">Not later than 18 months after the
enactment of this paragraph, the Secretary shall submit to the Committee on
Energy and Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report regarding when a
premarket notification under subsection (k) should be submitted for a
modification or change to a legally marketed device. The report shall include
the Secretary’s interpretation of the following terms: <quote>could
significantly affect the safety or effectiveness of the device</quote>,
<quote>a significant change or modification in design, material, chemical
composition, energy source, or manufacturing process,</quote>, and <quote>major
change or modification in the intended use of the device</quote>. The report
also shall discuss possible processes for industry to use to determine whether
a new submission under subsection (k) is required and shall analyze how to
leverage existing quality system requirements to reduce premarket burden,
facilitate continual device improvement. and provide reasonable assurance of
safety and effectiveness of modified devices. In developing such report, the
Secretary shall consider the input of interested stakeholders.</text>
</subparagraph><subparagraph commented="no" id="HA31398A5E088492AB20459636B749CE8" indent="up1"><enum>(B)</enum><text>The Secretary shall withdraw the Food
and Drug Administration draft guidance entitled <quote>Guidance for Industry
and FDA Staff—510(k) Device Modifications: Deciding When to Submit a 510(k) for
a Change to an Existing Device</quote>, dated July 27, 2011, and shall not use
this draft guidance as part of, or for the basis of, any premarket review or
any compliance or enforcement decisions or actions. The Secretary shall not
issue—</text>
<clause commented="no" id="HC9FFDA6D11D24C02BD9CBDCE59BAFC38"><enum>(i)</enum><text display-inline="yes-display-inline">any draft guidance or proposed regulation
that addresses when to submit a premarket notification submission for changes
and modifications made to a manufacturer’s previously cleared device before the
receipt by the Committee on Energy and Commerce of the House of Representatives
and the Committee on Health, Education, Labor, and Pensions of the Senate of
the report required in subparagraph (A); and</text>
</clause><clause commented="no" id="H77C94787A83B46AA8DF95CC1E1781585"><enum>(ii)</enum><text>any final guidance or regulation
on that topic for one year after date of receipt of such report by the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate.</text>
</clause></subparagraph><subparagraph commented="no" id="H37F6BD8571914FF9960F2D3A0F3573DD" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">The Food and Drug Administration guidance
entitled <quote>Deciding When to Submit a 510(k) for a Change to an Existing
Device</quote>, dated January 10, 1997, shall be in effect until the subsequent
issuance of guidance or promulgation, if appropriate, of a regulation described
in subparagraph (B), and the Secretary shall interpret such guidance in a
manner that is consistent with the manner in which the Secretary has
interpreted such guidance since
1997.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section></subtitle><subtitle commented="no" id="HA2EE9FB7ED8F40929DD3E6406CC86664"><enum>B</enum><header>Patients Come
First</header>
<section commented="no" id="HCBF389B5BBC145D49767E62D46164108"><enum>711.</enum><header>Establishment
of schedule and promulgation of regulation<inline-comment display="no">H.R.
3208</inline-comment></header>
<subsection commented="no" id="H3DEE7891F25D4C0AB6E9BA02E5E8144E"><enum>(a)</enum><header>Establishment of
schedule</header><text display-inline="yes-display-inline">Not later than 90
days after the date of enactment of this Act, the Secretary of Health and Human
Services shall establish the schedule referred to in section 515(i)(3) of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21 U.S.C. 360e(i)(3)</external-xref>).</text>
</subsection><subsection commented="no" id="H8AD6CE54A195497BAA2DEF601732E163"><enum>(b)</enum><header>Regulation</header><text display-inline="yes-display-inline">Not later than one year after the date that
the schedule is established under such section 515(i)(3) (as required by
<internal-xref idref="H3DEE7891F25D4C0AB6E9BA02E5E8144E" legis-path="3.(a)">subsection (a)</internal-xref>) the Secretary shall issue a
final regulation under section 515(b) of such Act for each device that the
Secretary requires to remain in class III through a determination under section
515(i)(2) of such Act.</text>
</subsection></section><section commented="no" id="H5702FF555DED4EA89D8082F3D448E7DD"><enum>712.</enum><header>Program to
improve the device recall system<inline-comment display="no">H.R.
3208</inline-comment></header><text display-inline="no-display-inline">Chapter
V is amended by inserting after section 518 (<external-xref legal-doc="usc" parsable-cite="usc/21/360h">21 U.S.C. 360h</external-xref>) the
following:</text>
<quoted-block display-inline="no-display-inline" id="H53CB7A06F4664CB2AED3A23A5AC5CE65" style="OLC">
<section commented="no" id="H53F62EC798B34A7CB04DFCD3CE404976"><enum>518A.</enum><header>Program to
improve the device recall system</header>
<subsection commented="no" id="H1AAD48ECCB5A4C4898695FC50B3D29A1"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary
shall—</text>
<paragraph commented="no" id="H0AE898D3E853438290D6C40E7422A6D3"><enum>(1)</enum><text>establish a
program to routinely and systematically assess information relating to device
recalls and use such information to proactively identify strategies for
mitigating health risks presented by defective or unsafe devices;</text>
</paragraph><paragraph commented="no" id="HD81F1EC7E8864AA5BEBA211692AAAEBD"><enum>(2)</enum><text>clarify procedures
for conducting device recall audit checks to improve the ability of
investigators to perform those checks in a consistent manner;</text>
</paragraph><paragraph commented="no" id="HCBCBE4EC17F847848CED610AAFECF18D"><enum>(3)</enum><text>develop detailed
criteria for assessing whether a person performing a device recall has
performed an effective correction or action plan for the recall; and</text>
</paragraph><paragraph commented="no" id="HE2E51D3DA26A4737A9938FB80544DD53"><enum>(4)</enum><text>document the basis
for each termination by the Food and Drug Administration of a device
recall.</text>
</paragraph></subsection><subsection commented="no" id="H0233D5DA351E48739E45A28F991BD537"><enum>(b)</enum><header>Assessment
content</header><text>The program established under subsection (a)(1) shall, at
a minimum, identify—</text>
<paragraph commented="no" id="HA3B783B66A03415CBFA96ED492EB6CF1"><enum>(1)</enum><text>trends in the
number and types of device recalls;</text>
</paragraph><paragraph commented="no" id="H6316AC5EE004406CAC4C575DF37D8145"><enum>(2)</enum><text>devices that are
most frequently the subject of a recall; and</text>
</paragraph><paragraph commented="no" id="H31A34EB806FA4879852820ED9DCDB995"><enum>(3)</enum><text>underlying causes
of device recalls.</text>
</paragraph></subsection><subsection commented="no" id="H3C916FC4DF924BB8914FC35F7808A4FD"><enum>(c)</enum><header>Definition</header><text display-inline="yes-display-inline">In this section, the term
<term>recall</term> means—</text>
<paragraph commented="no" id="H6573D66AC36D4249A1684DC3FBACAC83"><enum>(1)</enum><text>the removal from
the market of a device pursuant to an order of the Secretary under subsection
(b) or (e) of section 518; or</text>
</paragraph><paragraph commented="no" id="H004E2A6616E14FD0BF697869FF3AA241"><enum>(2)</enum><text>the correction or
removal from the market of a device at the initiative of the manufacturer or
importer of the device that is required to be reported to the Secretary under
section
519(g).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle commented="no" id="H95446BB01ABB475F9591D54A04E484D8"><enum>C</enum><header>Novel device
regulatory relief</header>
<section commented="no" id="H7F3C2C76049443B1A74A602A9770F6F5" section-type="subsequent-section"><enum>721.</enum><header>Modification of de
novo application process<inline-comment display="no">H.R.
3203</inline-comment></header>
<subsection commented="no" id="H18167CEEBEF94672858123235BACC1B8"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 513(f)(2)
(<external-xref legal-doc="usc" parsable-cite="usc/21/360c">21 U.S.C.
360c(f)(2)</external-xref>) is amended—</text>
<paragraph commented="no" id="H0A52AF2122434B529C9076332D37D84E"><enum>(1)</enum><text>by inserting
<quote>(i)</quote> after <quote>(2)(A)</quote>;</text>
</paragraph><paragraph commented="no" id="H7D18D62ECB714C46908D31C9929C6122"><enum>(2)</enum><text>in subparagraph
(A)(i), as so designated by paragraph (1), by striking <quote>under the
criteria set forth</quote> and all that follows through the end of subparagraph
(A) and inserting a period;</text>
</paragraph><paragraph commented="no" id="HD4CBB0BD4A4345E0AAC875181561DFD7"><enum>(3)</enum><text>by adding at the
end of subparagraph (A) the following:</text>
<quoted-block display-inline="no-display-inline" id="HEF37C86F0700453BA081109B00B97A41" style="OLC">
<clause commented="no" id="HBBBB0F15793C417FAA799ABAAF5EAF16" indent="up3"><enum>(ii)</enum><text display-inline="yes-display-inline">In lieu of submitting a report under
section 510(k) and submitting a request for classification under clause (i) for
a device, if a person determines there is no legally marketed device upon which
to base a determination of substantial equivalence (as defined in subsection
(i)), a person may submit a request under this clause for the Secretary to
classify the device.</text>
</clause><clause commented="no" id="HCE9381A19F8E41C2AE4A9B4180E2B6F2" indent="up3"><enum>(iii)</enum><text>Upon receipt of a request under
clause (i) or (ii), the Secretary shall classify the device subject to the
request under the criteria set forth in subparagraphs (A) through (C) of
subsection (a)(1) within 120 days.</text>
</clause><clause id="H1DBB58F73A7C4AB49232E0ADAC48D017" indent="up3"><enum>(iv)</enum><text display-inline="yes-display-inline">Notwithstanding clause (iii), the Secretary
may decline to undertake a classification of a device pursuant to a request
under clause (ii) if the Secretary—</text>
<subclause id="H7B6C98959D624782B651ACC547E99EB3"><enum>(I)</enum><text>identifies a legally marketed device
that would permit a substantial equivalence determination under paragraph (1)
for the device; or</text>
</subclause><subclause id="H82037F25F86640449E595575833862F8"><enum>(II)</enum><text display-inline="yes-display-inline">determines that the device submitted is not
of low-moderate risk or special controls to mitigate the risks cannot be
developed for the device.</text>
</subclause></clause><clause commented="no" id="H9AE5C813022D477299CBEF97131A8BE5" indent="up3"><enum>(v)</enum><text display-inline="yes-display-inline">The person submitting the request for
classification under this subparagraph may recommend to the Secretary a
classification for the device and shall, if recommending classification in
class II, include in the request an initial draft proposal for applicable
special controls, as described in subsection (a)(1)(B), that are necessary, in
conjunction with general controls, to provide reasonable assurance of safety
and effectiveness and a description of how the special controls provide such
assurance. Any such request shall describe the device and provide detailed
information and reasons for the recommended
classification.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H90BA5175B5034A7C8E3D6B70036B0AAC"><enum>(4)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>Not
later than 60 days after the date of the submission of the request under
subparagraph (A), the Secretary</quote> and inserting <quote>The
Secretary</quote>.</text>
</paragraph></subsection><subsection commented="no" id="HDAB1BBF050A34DE6B4D08FC3256A12B8"><enum>(b)</enum><header>Conforming
amendments</header><text>Section 513(f) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360c">21 U.S.C. 360c(f)</external-xref>)
is amended in paragraph (1)—</text>
<paragraph commented="no" display-inline="no-display-inline" id="H789DC2A3EC004A0A81DF336344E73604"><enum>(1)</enum><text>in subparagraph
(A), by striking <quote>, or</quote> at the end and inserting a
semicolon;</text>
</paragraph><paragraph commented="no" id="H3C2A8D58D1D24E36B994D608118749C1"><enum>(2)</enum><text>in subparagraph
(B), by striking the period and inserting <quote>; or</quote>; and</text>
</paragraph><paragraph commented="no" id="HD091CCF3D1EC48E9AFCBA4009C68DA53"><enum>(3)</enum><text>by inserting after
subparagraph (B) the following:</text>
<quoted-block display-inline="no-display-inline" id="H8955B2A253BA4F32A0DC2A9917275D6A" style="OLC">
<subparagraph commented="no" id="HE20695C14773457993DA78B1A9FDF22A" indent="up1"><enum>(C)</enum><text>the device is classified pursuant to a
request submitted under paragraph
(2).</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section></subtitle><subtitle commented="no" id="H4EEFF47590994D37980B176B34888E80"><enum>D</enum><header>Keeping America
competitive through harmonization</header>
<section commented="no" id="HCAAD794E0E544179AE6B73C9CAD846B5"><enum>731.</enum><header>Harmonization
of device premarket review, inspection, and labeling symbols;
report<inline-comment display="no">H.R. 3230</inline-comment></header>
<subsection commented="no" id="H39F9F194AF1F4F5C920E80126A202801"><enum>(a)</enum><header>In
general</header><text>Paragraph (4) of section 803(c) (<external-xref legal-doc="usc" parsable-cite="usc/21/383">21 U.S.C. 383(c)</external-xref>) is amended to read
as follows:</text>
<quoted-block display-inline="no-display-inline" id="H41CB18030580471EBEC0DB41041FE2EF" style="OLC">
<paragraph commented="no" id="HB04F4731F4224C0D984F12187C16FD7D" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">With respect to devices, the Secretary may,
when appropriate, enter into arrangements with nations regarding methods and
approaches to harmonizing regulatory requirements for activities, including
inspections and common international labeling
symbols.</text>
</paragraph><after-quoted-block>.
</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HBAB753122B224CD4AED05A7D35A5AB5D"><enum>(b)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human Services shall submit
to the Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of Representatives a report
on the Food and Drug Administration’s harmonization activities, itemizing
methods and approaches that have been harmonized pursuant to section 803(c)(4)
of the Federal Food, Drug, and Cosmetic Act, as amended by subsection
(a).</text>
</subsection></section><section commented="no" id="H36648B23F437486BA55E3EEF9A2CE398"><enum>732.</enum><header>Participation
in international fora</header><text display-inline="no-display-inline">Paragraph (3) of section 803(c)
(<external-xref legal-doc="usc" parsable-cite="usc/21/383">21 U.S.C.
383(c)</external-xref>) is amended—</text>
<paragraph commented="no" id="H6758A4D31FA34CF9A5941F5707FF3AD2"><enum>(1)</enum><text>by striking
<quote>(3)</quote> and inserting <quote>(3)(A)</quote>; and</text>
</paragraph><paragraph commented="no" id="H24B07BE0CA3442C3BB3BA17F1D295806"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HC97BB5B79A53439F9EE7259B6C35CDCE" style="OLC">
<subparagraph commented="no" id="HC229671EC49A4360B784D7AF1B959C5D" indent="up2"><enum>(B)</enum><text display-inline="yes-display-inline">In carrying out subparagraph (A), the
Secretary may participate in appropriate fora, including the International
Medical Device Regulators Forum, and may—</text>
<clause commented="no" id="HA800DEF931964523AA01908DF730E021"><enum>(i)</enum><text>provide guidance to such fora on
strategies, policies, directions, membership, and other activities of a forum
as appropriate;</text>
</clause><clause commented="no" id="H95FF4431C52849AF8C3DA5C14FA49F23"><enum>(ii)</enum><text>to the extent appropriate, solicit,
review, and consider comments from industry, academia, health care
professionals, and patient groups regarding the activities of such fora;
and</text>
</clause><clause commented="no" id="H46656E7B0F0548778870A8BE10CD9D6C"><enum>(iii)</enum><text>to the extent appropriate, inform
the public of the Secretary’s activities within such fora, and share with the
public any documentation relating to a forum’s strategies, policies, and other
activities of such
fora.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section></subtitle><subtitle commented="no" id="HBE0F401666F444EFA14A55B580272369"><enum>E</enum><header>FDA renewing
efficiency from outside reviewer management</header>
<section commented="no" id="H2364FD5AC7AD4E538CDB6B350E3BF251"><enum>741.</enum><header>Reauthorization
of Third Party Review</header>
<subsection commented="no" id="H822EA7769F0B4017915BDEE3BB3ED94C"><enum>(a)</enum><header>Periodic
reaccreditation</header><text display-inline="yes-display-inline">Section
523(b)(2) (<external-xref legal-doc="usc" parsable-cite="usc/21/360m">21 U.S.C.
360m(b)(2)</external-xref>) is amended by adding at the end of the
following:</text>
<quoted-block display-inline="no-display-inline" id="HF9E0A204A39A45A089BB4177F0E49B08" style="OLC">
<subparagraph commented="no" id="H9112E9F692244BF3B166AB072032D2FC"><enum>(E)</enum><header>Periodic
reaccreditation</header>
<clause commented="no" id="HE8D241A96D324C4299840433E0578313"><enum>(i)</enum><header>Period</header><text display-inline="yes-display-inline">Subject to suspension or withdrawal under
subparagraph (B), any accreditation under this section shall be valid for a
period of 3 years after its issuance.</text>
</clause><clause commented="no" id="H18D5CDC29DA843BCA75092200A1D44EF"><enum>(ii)</enum><header>Response to
reaccreditation request</header><text>Upon the submission of a request by an
accredited person for reaccreditation under this section, the Secretary shall
approve or deny such request not later than 60 days after receipt of the
request.</text>
</clause><clause commented="no" id="HCFB80EE539564EFBA4F5DEA232FF9AB8"><enum>(iii)</enum><header>Criteria</header><text>Not
later than 120 days after the date of the enactment of this subparagraph, the
Secretary shall establish and publish in the Federal Register criteria to
reaccredit or deny reaccreditation to persons under this section. The
reaccreditation of persons under this section shall specify the particular
activities under subsection (a), and the devices, for which such persons are
reaccredited.</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H6C3D52E784554331BF9278A29D94663D"><enum>(b)</enum><header>Duration of
authority</header><text>Section 523(c) (<external-xref legal-doc="usc" parsable-cite="usc/21/360m">21 U.S.C. 360m(c)</external-xref>) is amended by
striking <quote>October 1, 2012</quote> and inserting <quote>October 1,
2017</quote>.</text>
</subsection></section><section commented="no" id="H04DD58397FBB44C68B41C1A5D2271964" section-type="subsequent-section"><enum>742.</enum><header>Reauthorization of
third party inspection</header><text display-inline="no-display-inline">Section
704(g)(11) (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C.
374(g)(11)</external-xref>) is amended by striking <quote>October 1,
2012</quote> and inserting <quote>October 1, 2017</quote>.</text>
</section></subtitle><subtitle commented="no" id="H8735E77837054E969C1DE07BD1B3494B"><enum>F</enum><header>Humanitarian
device reform</header>
<section commented="no" id="HDBA744C897ED4A04B1866E8B716A67D2"><enum>751.</enum><header>Expanded access
to humanitarian use devices</header>
<subsection commented="no" id="H68F8CC9B4D3A469EAB3D8BFB71E24B8C"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 520(m)
(<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C.
360j(m)</external-xref>) is amended—</text>
<paragraph commented="no" id="H6255394760E14BAE86BC0DA6D70022BD"><enum>(1)</enum><text>in paragraph
(6)—</text>
<subparagraph commented="no" id="H46526DDCD3094249B74AE68CFEB611C3"><enum>(A)</enum><text>in subparagraph
(A)—</text>
<clause commented="no" id="H27BA1A8A9C9848F08DDDF421DAD8DFDE"><enum>(i)</enum><text>in the matter
preceding clause (i), by striking <quote>subparagraph (D)</quote> and inserting
<quote>subparagraph (C)</quote>;</text>
</clause><clause commented="no" id="H713CB1CD408E4229825C46749CB4BD67"><enum>(ii)</enum><text>by striking
clause (i) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H6994E7EAA1094C5C8231AC6BE5C31AD6" style="OLC">
<clause commented="no" id="H788E94B4063B465AADBD403709601C4D" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">The device with respect to which the
exemption is granted—</text>
<subclause commented="no" id="HBF80816D7FC4467F8E4FAC07D987AACB"><enum>(I)</enum><text>is intended for the treatment or
diagnosis of a disease or condition that occurs in pediatric patients or in a
pediatric subpopulation, and such device is labeled for use in pediatric
patients or in a pediatric subpopulation in which the disease or condition
occurs; or</text>
</subclause><subclause commented="no" id="H1177FDCFB4FD4713B55E159BE39FEF5E"><enum>(II)</enum><text>is intended for the treatment or
diagnosis of a disease or condition that does not occur in pediatric patients
or that occurs in pediatric patients in such numbers that the development of
the device for such patients is impossible, highly impracticable, or
unsafe.</text>
</subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block>
</clause><clause commented="no" id="HDBBBCD783B1C4F31B28A63FFA2A82A8F"><enum>(iii)</enum><text>by striking
clause (ii) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="HDFF31485C9F64B148D1F9C6C431A5220" style="OLC">
<clause commented="no" id="H1F497882FA024526B72523AA6E39B97E" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">During any calendar year, the number of
such devices distributed during that year under each exemption granted under
this subsection does not exceed the number of such devices needed to treat,
diagnose, or cure a population of 4,000 individuals in the United States
(referred to in this paragraph as the <quote>annual distribution
number</quote>).</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause commented="no" id="H4313E40BDC7A4FAFA9DE8F5703D3353F"><enum>(iv)</enum><text>in clause (iv),
by striking <quote>2012</quote> and inserting <quote>2017</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="H07430C7E73874A70BCF4D06C9B15C40E"><enum>(B)</enum><text>by striking
subparagraph (C);</text>
</subparagraph><subparagraph commented="no" id="HBF8AFDF7DDB643F4A71127F990704B1B"><enum>(C)</enum><text>by redesignating
subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively;
and</text>
</subparagraph><subparagraph commented="no" id="HE6B567BA625549328787B604C018FB73"><enum>(D)</enum><text>in subparagraph
(C), as so redesignated, by striking <quote>and modified under subparagraph
(C), if applicable,</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" id="H49022AD57EC641FA8C04BAA499FE6E3B"><enum>(2)</enum><text>in paragraph (7),
by striking <quote>regarding a device</quote> and inserting <quote>regarding a
device described in paragraph (6)(A)(i)(I)</quote>; and</text>
</paragraph><paragraph commented="no" id="H0EE13451C41E4D0AB6F7CE0EA154E6AF"><enum>(3)</enum><text>in paragraph (8),
by striking <quote>of all devices described in paragraph (6)</quote> and
inserting <quote>of all devices described in paragraph
(6)(A)(i)(I)</quote>.</text>
</paragraph></subsection><subsection commented="no" id="HB4299B4777844505BB0A2DB7776464B9"><enum>(b)</enum><header>Applicability to
Existing Devices</header><text>A sponsor of a device for which an exemption was
approved under paragraph (2) of section 520(m) of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21
U.S.C. 360j(m)</external-xref>) before the date of enactment of this Act may
seek a determination under subclause (I) or (II) of paragraph (6)(A)(i) of such
section 520(m) (as amended by subsection (a)). If the Secretary determines that
such subclause (I) or (II) applies with respect to a device, then clauses (ii),
(iii), and (iv) of subparagraph (A) and subparagraphs (B), (C), and (D) of
paragraph (6) of such section 520(m) shall apply to such device.</text>
</subsection><subsection commented="no" id="H73EEE843CE7E4E5D88B62F81952A5EEB"><enum>(c)</enum><header>Report</header><text>Not
later than January 1, 2017, the Comptroller General of the United States shall
submit to Congress a report that evaluates and describes—</text>
<paragraph commented="no" id="H1BC07512D7924DEB8B161519DB378E33"><enum>(1)</enum><text>the effectiveness
of the amendments made by subsection (a) in stimulating innovation with respect
to medical devices, including any favorable or adverse impact on pediatric
device development;</text>
</paragraph><paragraph commented="no" id="H5421DF7501714DE589D6D3EB14E3F88F"><enum>(2)</enum><text>the impact of such
amendments on pediatric device approvals for devices that received a
humanitarian use designation under section 520(m) of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21
U.S.C. 360j(m)</external-xref>) prior to the date of enactment of this
Act;</text>
</paragraph><paragraph commented="no" id="H8F86BA4B69D6483DADC321DC16562F45"><enum>(3)</enum><text>the status of
public and private insurance coverage of devices granted an exemption under
paragraph (2) of such section 520(m) and costs to patients of such
devices;</text>
</paragraph><paragraph commented="no" id="H54F01683DA214D1EAE9EE5B145C0B69F"><enum>(4)</enum><text>the impact that
paragraph (4) of such section 520(m) has had on access to and insurance
coverage of devices granted an exemption under paragraph (2) of such section
520(m); and</text>
</paragraph><paragraph commented="no" id="H7603B67FAA224525B2C581064CADF3D9"><enum>(5)</enum><text>the effect of the
amendments made by subsection (a) on patients described in such section
520(m).</text>
</paragraph></subsection></section></subtitle><subtitle id="H888E245BB2A5400B9ABA396E0DF6762E"><enum>G</enum><header>Records and
Reports on Devices</header>
<section id="HC60B478B9A3B4D2CB5F7A9BF575C860B" section-type="subsequent-section"><enum>761.</enum><header>Unique device
identification system regulations</header><text display-inline="no-display-inline">Not later than 120 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
promulgate the regulations required by section 519(f) of the Federal Food,
Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360i">21 U.S.C. 360i(f)</external-xref>).</text>
</section><section id="HE8F54E44837945FCA3292952AC1D3BEE"><enum>762.</enum><header>Effective
device sentinel program</header>
<subsection id="H8D9E961217074B7ABC55921DE1571AB8"><enum>(a)</enum><header>Inclusion of
devices in postmarket risk identification and analysis system</header><text display-inline="yes-display-inline">Section 519 (<external-xref legal-doc="usc" parsable-cite="usc/21/360i">21 U.S.C. 360i</external-xref>) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HE733F44CA14F4F0CA958E5A1AF57DD02" style="OLC">
<subsection id="HABB0A90F97B74C3B90779B503FA62D04"><enum>(h)</enum><header>Inclusion of
devices in postmarket risk identification and analysis system</header>
<paragraph id="HB9F1E48FE94D4F13AE748DCFA4391F48"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
amend the procedures established and maintained under clauses (i), (ii), (iii),
and (v) of section 505(k)(3)(C) in order to expand the postmarket risk
identification and analysis system established under such section to include
and apply to devices.</text>
</paragraph><paragraph id="H590ED09F10794EF7B90F7955645D2371"><enum>(2)</enum><header>Data</header><text>In
expanding the system as described in paragraph (1), the Secretary shall use
relevant data with respect to devices cleared under section 510(k) or approved
under section 515, which may include claims data, patient survey data, and
standardized analytic files that allow for the pooling and analysis of data
from disparate data environments.</text>
</paragraph><paragraph commented="no" id="HED3DB3F6F2624A72A3FB47EEC26C2F52"><enum>(3)</enum><header>Stakeholder
input</header><text display-inline="yes-display-inline">To help ensure
effective implementation of the system as described in paragraph (1) with
respect to devices, the Secretary shall engage outside stakeholders in
development of the system, and gather information from outside stakeholders
regarding the content of an effective sentinel program, through a public
hearing, advisory committee meeting, maintenance of a public docket, or other
similar public measures.</text>
</paragraph><paragraph id="H5BC840661D0142739AAEE41D6C1C38F7"><enum>(4)</enum><header>Voluntary
surveys</header><text display-inline="yes-display-inline"><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter
35</external-xref> of title 44, United States Code, shall not apply to the
collection of voluntary information from health care providers, such as
voluntary surveys or questionnaires, initiated by the Secretary for purposes of
postmarket risk identification, mitigation, and analysis for
devices.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H957F7D70D16449CEB2BCF5AA92CD95DD"><enum>(b)</enum><header>Amendments to
postmarket risk identification and analysis system</header><text>Section
505(k)(3)(C)(i) (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21
U.S.C. 355(k)(3)(C)(i)</external-xref>) is amended—</text>
<paragraph id="HA0440ED9550549C094401A65078D3E55"><enum>(1)</enum><text>by striking
subclause (II);</text>
</paragraph><paragraph id="H0DD1AF6ED9674AC09BB33C110971D91E"><enum>(2)</enum><text>by redesignating
subclauses (III) through (VI) as subclauses (II) through (V), respectively;
and</text>
</paragraph><paragraph id="H7F9374059B1F40349726BA4F87364D02"><enum>(3)</enum><text>in item (bb) of
subclause (II), as so redesignated, by striking <quote>pharmaceutical purchase
data and health insurance claims data</quote> and inserting <quote>medical
device utilization data, health insurance claims data, and procedure and device
registries</quote>.</text>
</paragraph></subsection></section></subtitle><subtitle id="H24BCD6D4A9884925A943FCDD8DC61740"><enum>H</enum><header>Miscellaneous</header>
<section id="H2037CE8C51584D0D9A58A1EECB73206E"><enum>771.</enum><header>Custom
devices</header><text display-inline="no-display-inline">Section 520(b)
(<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C.
360j</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HF3F397CC347E4DE39EA8897BD6E5D3DB" style="OLC">
<subsection id="H4446C14DE89E42B48CA91ECF32F54C71"><enum>(b)</enum><header>Custom
devices</header>
<paragraph id="HA11C599040894358A79015CBB97872FE"><enum>(1)</enum><header>In
general</header><text>The requirements of sections 514 and 515 shall not apply
to a device that—</text>
<subparagraph id="H06E9C5F0717F4856844BBDC741CE81AE"><enum>(A)</enum><text>is created or
modified in order to comply with the order of an individual physician or
dentist (or any other specially qualified person designated under regulations
promulgated by the Secretary after an opportunity for an oral hearing);</text>
</subparagraph><subparagraph id="HC9390DCD3B474DA5AE978F6E5C755D1F"><enum>(B)</enum><text>in order to comply
with an order described in subparagraph (A), necessarily deviates from an
otherwise applicable performance standard under section 514 or requirement
under section 515;</text>
</subparagraph><subparagraph id="H6D6AE0636C444F7B8B025930638E2AE0"><enum>(C)</enum><text>is not generally
available in the United States in finished form through labeling or advertising
by the manufacturer, importer, or distributor for commercial
distribution;</text>
</subparagraph><subparagraph id="H147917E50BBE48B29642276BE1B66FCF"><enum>(D)</enum><text>is designed to
treat a unique pathology or physiological condition that no other device is
domestically available to treat;</text>
</subparagraph><subparagraph id="HCAA40EEC817A4B358D2F863BA1F4C6F5"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="HB0E9AB5D687D4B91A9A807E820723E87"><enum>(i)</enum><text>is intended to meet the
special needs of such physician or dentist (or other specially qualified person
so designated) in the course of the professional practice of such physician or
dentist (or other specially qualified person so designated); or</text>
</clause><clause id="HF6E16A73FE8A438DB053D7DA290770AF" indent="up1"><enum>(ii)</enum><text>is intended for use by an
individual patient named in such order of such physician or dentist (or other
specially qualified person so designated);</text>
</clause></subparagraph><subparagraph id="H14F012D5AEBF4F2B8EDAE05FD4FB92CB"><enum>(F)</enum><text display-inline="yes-display-inline">is assembled from components or
manufactured and finished on a case-by-case basis to accommodate the unique
needs of individuals described in clause (i) or (ii) of subparagraph (E);
and</text>
</subparagraph><subparagraph id="H080D954256F14E3DB2FFCDCD2EE82E49"><enum>(G)</enum><text>may have common,
standardized design characteristics, chemical and material compositions, and
manufacturing processes as commercially distributed devices.</text>
</subparagraph></paragraph><paragraph id="H3FD1C348B8B74094B986DD9585013B67"><enum>(2)</enum><header>Limitations</header><text>Paragraph
(1) shall apply to a device only if—</text>
<subparagraph id="H3483FC858FDF439D8E8E7DB5E6C66AB6"><enum>(A)</enum><text>such device is for
the purpose of treating a sufficiently rare condition, such that conducting
clinical investigations on such device would be impractical;</text>
</subparagraph><subparagraph id="HF3DE3F374B8D471DBEC23A98150A05FB"><enum>(B)</enum><text>production of such
device under paragraph (1) is limited to no more than 5 units per year of a
particular device type, provided that such replication otherwise complies with
this section; and</text>
</subparagraph><subparagraph id="H6896BFC773764EB7BB8262CF1AFDFBE8"><enum>(C)</enum><text display-inline="yes-display-inline">the manufacturer of such device notifies
the Secretary on an annual basis, in a manner prescribed by the Secretary, of
the manufacture of such device.</text>
</subparagraph></paragraph><paragraph id="H2225BF997A4940119C02E94C397BA0A2"><enum>(3)</enum><header>Guidance</header><text>Not
later than 2 years after the date of enactment of this section, the Secretary
shall issue final guidance on replication of multiple devices described in
paragraph
(2)(B).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H56D4FC58F4CA42FB89866D2F718DE204"><enum>772.</enum><header>Pediatric
device reauthorization</header>
<subsection id="H8586735C4F2541CC9B1E5C3100D03166"><enum>(a)</enum><header>Final rule
relating To tracking of pediatric uses of devices</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services
shall issue—</text>
<paragraph id="HF16B3CC6C18F46208CDD40243B0AEBF8"><enum>(1)</enum><text>a
proposed rule implementing section 515A(a)(2) of the Federal Food, Drug and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e-1">21
U.S.C. 360e–1(a)(2)</external-xref>) not later than December 31, 2012;
and</text>
</paragraph><paragraph id="H52605CC840E14B96B2E29764D2D88DDC"><enum>(2)</enum><text>a
final rule implementing such section not later than December 31, 2013.</text>
</paragraph></subsection><subsection id="H9C46512DCA28429F9779A327057E6BA9"><enum>(b)</enum><header>Demonstration
grants To improve pediatric device availability</header><text display-inline="yes-display-inline">Section 305(e) of the Pediatric Medical
Device Safety and Improvement Act of 2007 (Title III of
<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law
110–85</external-xref>) is amended by striking <quote>2008 through 2012</quote>
and inserting <quote>2013 through 2017</quote>.</text>
</subsection></section><section id="H4218710230744B5CA5426F0576B133FF" section-type="subsequent-section"><enum>773.</enum><header>Report on regulation
of health information technology</header>
<subsection id="H9BBE2B855C1848F7A855C63AA1047ECA"><enum>(a)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human Services, in
consultation with the Commissioner of Food and Drugs, the National Coordinator
for Health Information Technology, and the Chairman of the Federal
Communications Commission, shall submit to the Committee on Energy and Commerce
of the House of Representatives and the appropriate committees of the Senate a
report that contains—</text>
<paragraph id="H3424123C14004BA2BF2D4EF5BCE255BA"><enum>(1)</enum><text>a
strategy for coordinating the regulation of health information technology in
order to avoid regulatory duplication; and</text>
</paragraph><paragraph id="H64D7A2B2B03C4BE3A04613FD1695E815"><enum>(2)</enum><text>recommendations on
an appropriate regulatory framework for health information technology,
including a risk-based framework.</text>
</paragraph></subsection><subsection id="H02BF713C30C940CEBF7AE5545A1D6423"><enum>(b)</enum><header>Definition</header><text>In
this section, the terms <term>health information technology</term> has the
meaning given such term in section 3000(5) of the Public Health Service Act and
includes technologies such as electronic health records, personal health
records, mobile medical applications, computerized health care provider order
entry systems, and clinical decision support.</text>
</subsection></section></subtitle><enum>VIII</enum><header>Drug regulatory
improvements</header>
<subtitle commented="no" id="HF4AE5B0A2731453D981CE4DA4D305460"><enum>A</enum><header>Drug supply
chain</header>
<section commented="no" id="H4B42693A2F094A469EE50A815AFF5142"><enum>801.</enum><header>Registration of
producers of drugs</header>
<subsection commented="no" id="H57ED7D7D1FFD442489F4D4C5AE46BFA4"><enum>(a)</enum><header>Timing</header><text display-inline="yes-display-inline">Section 510 (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360</external-xref>) is amended—</text>
<paragraph commented="no" id="HED9CF2BD657A488FAF5C544343E5B662"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)(1), by striking <quote>On
or before</quote> and inserting <quote>During the period beginning on October 1
and ending on</quote>; and</text>
</paragraph><paragraph commented="no" id="HC01C38639019455C9A45FBDB2F45BB9C"><enum>(2)</enum><text>in subsection
(i)(1)(B)(i), by striking <quote>on or before</quote> and inserting
<quote>during the period beginning on October 1 and ending on</quote>.</text>
</paragraph></subsection><subsection commented="no" id="H04CCCF20DC744CBFB5FFAA4FD2DCCC4B"><enum>(b)</enum><header>Establishments
not duly registered; misbranding</header><text display-inline="yes-display-inline">Section 502(o) (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C. 352(o)</external-xref>) is
amended by striking <quote>in any State</quote>.</text>
</subsection></section><section commented="no" id="HE5253317CA9641A48C34939E6386404D"><enum>802.</enum><header>Inspection of
drugs</header><text display-inline="no-display-inline">Subsection (h) of
section 510 (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21
U.S.C. 360</external-xref>) is amended—</text>
<paragraph commented="no" id="HBC6C78A68412494CA16B4F07F6886EAB"><enum>(1)</enum><text>by striking
<quote>(h)</quote> and inserting <quote>(h)(1)</quote>;</text>
</paragraph><paragraph commented="no" id="HF9C61E4E9C1A4208871F6788055FA6E8"><enum>(2)</enum><text>by inserting
<quote>with respect to the manufacture, preparation, propagation, compounding,
or processing of a device</quote> after <quote>registered with the Secretary
pursuant to this section</quote>;</text>
</paragraph><paragraph commented="no" id="H4360462B60D848308A3505E7C960B77C"><enum>(3)</enum><text>by striking
<quote>of a drug or drugs or</quote>; and</text>
</paragraph><paragraph commented="no" id="HDAE7818559DE472590912C7063A8AC51"><enum>(4)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HC8AC1CEE7B6F4DB2805B50B00C5CA149" style="OLC">
<paragraph commented="no" id="H9E001D04CDE84990B8C2597226E0BC2B" indent="up1"><enum>(2)</enum><header>Inspections with respect to drug
establishments</header><text display-inline="yes-display-inline">With respect
to the manufacture, preparation, propagation, compounding, or processing of a
drug:</text>
<subparagraph commented="no" id="HEDA94CA1ECC34FF4989D71E0F99521AA"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Every establishment that is required to be
registered with the Secretary under this section shall be subject to inspection
pursuant to section 704.</text>
</subparagraph><subparagraph commented="no" id="HA68A2621499A4322BD0980261DA52C15"><enum>(B)</enum><header>Risk-based schedule</header><text>In
the case of an establishment that is engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs (referred to in this
subsection as a <quote>drug establishment</quote>), the inspections required
under subparagraph (A) shall be conducted by officers or employees duly
designated by the Secretary, on a risk-based schedule established by the
Secretary.</text>
</subparagraph><subparagraph commented="no" id="HD8C0264604CD4549A0DD9D95E0FA6117"><enum>(C)</enum><header>Risk factors</header><text display-inline="yes-display-inline">In establishing the risk-based schedule
under subparagraph (B), the Secretary shall allocate resources to inspect
establishments according to the known safety risks of such establishments,
based on the following factors:</text>
<clause commented="no" id="HC95E03A9F79E413FA19CA58C066D80EF"><enum>(i)</enum><text>The compliance history of the
establishment.</text>
</clause><clause commented="no" id="H1C4EAC9ADED64CF8830A0280834A0596"><enum>(ii)</enum><text>The inspection frequency and
history of the establishment, including whether it has been inspected pursuant
to section 704 within the last four years.</text>
</clause><clause commented="no" id="H30F089C4F78B46FAAA1A1D917620934C"><enum>(iii)</enum><text>The record, history, and nature
of recalls linked to the establishment.</text>
</clause><clause commented="no" id="H39630020177748409F59E2DAC3C14B61"><enum>(iv)</enum><text>The inherent risk of the drug
manufactured, prepared, propagated, compounded, or processed at the
establishment.</text>
</clause><clause commented="no" id="HF595EEE06CCB472CA9BD4CF83B41B6A3"><enum>(v)</enum><text>Any other criteria deemed necessary
and appropriate by the Secretary for purposes of allocating inspection
resources.</text>
</clause></subparagraph><subparagraph commented="no" id="H56D23C9AC1B0407AAEBA716F7F180E2B"><enum>(D)</enum><header>Effect of status</header><text display-inline="yes-display-inline">In determining the risk associated with an
establishment for purposes of establishing a risk-based schedule under
subparagraph (B), the Secretary shall not consider whether the drugs
manufactured, prepared, propagated, compounded, or processed by such
establishment are drugs described in section 503(b)(1).</text>
</subparagraph><subparagraph commented="no" id="HBE2561B653FE45CBB217EAA5B070B39D"><enum>(E)</enum><header>Annual report on inspections of
establishments</header><text display-inline="yes-display-inline">Not later than
February 1 of each year, the Secretary shall submit to Congress a report that
contains the following:</text>
<clause commented="no" id="H7073E9ED236F4079A96531A3C2A7167D"><enum>(i)</enum><text>The number of domestic and foreign
establishments registered pursuant to this section in the previous calendar
year.</text>
</clause><clause commented="no" id="HEAE8D004B4FD4BD68098943F894CFCD5"><enum>(ii)</enum><text>The number of such registered
domestic and foreign establishments that the Secretary inspected in the
previous calendar year.</text>
</clause><clause commented="no" id="H618C80522F3F4E289F8799248F06616E"><enum>(iii)</enum><text>The number of such registered
establishments that list one or more drugs approved pursuant to an application
filed under section 505(j).</text>
</clause><clause commented="no" id="HC4F291E45C0341AF8A56DC924B06F533"><enum>(iv)</enum><text>The number of such registered
establishments that list one or more drugs approved pursuant to an application
filed under section 505(b).</text>
</clause><clause commented="no" id="H56325D9778544371B7D235B85847EDC4"><enum>(v)</enum><text>The number of registered
establishments that list both drug products approved pursuant to an application
filed under section 505(j) and drug products approved pursuant to an
application filed under section 505(b).</text>
</clause><clause commented="no" id="HDCE2C8C1C7FE4FEB90B09E0FE409DEA8"><enum>(vi)</enum><text>A description of how the Secretary
implemented the risk-based schedule under subparagraph (B) utilizing the
factors under subparagraph (C).</text>
</clause></subparagraph><subparagraph commented="no" id="H3A4AFB9792D24DAB95E6B9234F7D50D3"><enum>(F)</enum><header>Public availability of annual
reports</header><text display-inline="yes-display-inline">The Secretary shall
make the report required under subparagraph (E) available to the public on the
Internet Web site of the Food and Drug
Administration.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" id="H21BBCB5B090C4A97946C000E2AB4FAC7"><enum>803.</enum><header>Drug supply
quality and safety</header><text display-inline="no-display-inline">Paragraph
(a) of section 501 (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351</external-xref>) is amended by adding
at the end the following: <quote>For purposes of subparagraph (2)(B), the term
<term>current good manufacturing practice</term> includes the implementation of
oversight and controls over the manufacture of drugs to ensure quality,
including managing the risk of and establishing the safety of raw materials,
materials used in the manufacturing of drugs, and finished drug
products.</quote>.</text>
</section><section commented="no" id="HA13B0A682AA34D39A7B804D2DD001E57"><enum>804.</enum><header>Prohibition
against delaying, denying, limiting, or refusing inspection</header>
<subsection commented="no" id="H55D2FC1061F449259DD2B1036771448F"><enum>(a)</enum><header>In
general</header><text>Section 501 (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351</external-xref>) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H2854EA7E267D46DFA956074C89167E3A" style="OLC">
<subsection commented="no" id="H9C21A3CD85C04ED7AB4BBA9622D8193B"><enum>(j)</enum><text display-inline="yes-display-inline">If it is a drug and it has been
manufactured, processed, packed, or held in any factory, warehouse, or
establishment and the owner, operator, or agent of such factory, warehouse, or
establishment delays, denies, or limits an inspection, or refuses to permit
entry or
inspection.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HA808C205E9AA4FCC96BA673CE27923BA"><enum>(b)</enum><header>Guidance</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this section, the Secretary of Health and Human Services shall
issue guidance that defines the circumstances that would constitute delaying,
denying, or limiting inspection, or refusing to permit entry or inspection, for
purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act (as
added by
<internal-xref idref="H55D2FC1061F449259DD2B1036771448F" legis-path="805.(a)">subsection (a)</internal-xref>).</text>
</subsection></section><section commented="no" id="H37509E7CDAC84BD89E70DE7BD10FDD34"><enum>805.</enum><header>Destruction of
adulterated, misbranded, or counterfeit drugs offered for import</header>
<subsection commented="no" id="H196CB4314BCF4F47A8E770F0961D8BA5"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The sixth sentence of
section 801(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21
U.S.C. 381(a)</external-xref>) is amended by inserting before the period at the
end the following: <quote>, except that the Secretary of Health and Human
Services, in consultation with the Secretary of Homeland Security, may cause
the destruction, without the opportunity for export, of any drug refused
admission that has reasonable probability of causing serious adverse health
consequences or death, as determined by the Secretary of Health and Human
Services, or that is valued at an amount that is $2,000 or less (or such higher
amount as the Secretary of Homeland Security may set by regulation pursuant to
section 498 of the Tariff Act of 1930 (<external-xref legal-doc="usc" parsable-cite="usc/19/1498">19 U.S.C. 1498</external-xref>))</quote>.</text>
</subsection><subsection commented="no" id="HFAE78118BDC840DAA99243FAF01735FB"><enum>(b)</enum><header>Notice</header><text>Section
801(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C.
381(a)</external-xref>), as amended by
<internal-xref idref="H196CB4314BCF4F47A8E770F0961D8BA5" legis-path="806.(a)">subsection (a)</internal-xref>, is further amended by
inserting after the sixth sentence the following: <quote>The Secretary of
Health and Human Services shall issue regulations providing for notice and an
opportunity for a hearing on the destruction of a drug under the previous
sentence. For a drug with a value less than and or equal to $2,000 (or, as
described in the sixth sentence of this subsection, such higher amount as the
Secretary of Homeland Security may set by regulation pursuant to section 498 of
the Tariff Act of 1930 (<external-xref legal-doc="usc" parsable-cite="usc/19/1498">19 U.S.C. 1498</external-xref>)) the regulations
under the previous sentence shall provide for prompt notice and an opportunity
for a hearing for the owner or consignee before or after the destruction has
occurred. For a drug with a value greater than $2,000 (or, as described in the
sixth sentence of this subsection, such higher amount as the Secretary of
Homeland Security may set by regulation pursuant to section 498 of the Tariff
Act of 1930 (<external-xref legal-doc="usc" parsable-cite="usc/19/1498">19
U.S.C. 1498</external-xref>)) that has reasonable probability of causing
serious adverse health consequences or death as determined by the Secretary of
Health and Human Services, the regulations under the seventh sentence of this
subsection shall provide for notice and an opportunity for a hearing to the
owner or consignee before the destruction occurs.</quote>.</text>
</subsection><subsection commented="no" id="HD7E3EAD6237548CF854CBD045E5F89EA"><enum>(c)</enum><header>Restitution</header><text display-inline="yes-display-inline">In the regulations described in the seventh
sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (as
added by
<internal-xref idref="HFAE78118BDC840DAA99243FAF01735FB" legis-path="806.(b)">subsection (b)</internal-xref>), the Secretary of Health
and Human Services shall establish an administrative process whereby an owner
or consignee of a drug destroyed without an opportunity for a hearing on
destruction may obtain restitution for the value of the drug destroyed under
the sixth sentence of such section upon demonstration that such drug was
wrongfully destroyed.</text>
</subsection><subsection commented="no" id="H589FBF70993E47CF968C2C76A2D4B49D"><enum>(d)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">The first sentence
of section 801(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21
U.S.C. 381(a)</external-xref>) is amended by inserting <quote>, except as
otherwise described in the sixth and seventh sentences of this
subsection,</quote> after <quote>giving notice thereof</quote>.</text>
</subsection></section><section commented="no" id="H5C07686127A045F8A95ED3FB030F38BC"><enum>806.</enum><header>Administrative
detention</header>
<subsection commented="no" id="HC6F36C3607BE43E4918925FD51344B57"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 304(g)
(<external-xref legal-doc="usc" parsable-cite="usc/21/335a">21 U.S.C.
335a(g)</external-xref>) is amended—</text>
<paragraph commented="no" id="HFE1B41AA5BC640B0B50702C6F437A3D9"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1), by inserting <quote>,
drug,</quote> after <quote>device</quote>, each place it appears;</text>
</paragraph><paragraph commented="no" id="HEA8D70798D10400984999658357CF858"><enum>(2)</enum><text>in paragraph
(2)(A), by inserting <quote>, drug,</quote> after <quote>(B), a device</quote>;
and</text>
</paragraph><paragraph commented="no" id="H073746320677498FB314BA3E28E66ADB"><enum>(3)</enum><text>in paragraph
(2)(B), by inserting <quote>or drug</quote> after <quote>device</quote> each
place it appears.</text>
</paragraph></subsection><subsection commented="no" id="HF9B829E6BA21463590ADF8F0A49F1D4E"><enum>(b)</enum><header>Regulation</header><text>Not
later than 2 years after the date of the enactment of this Act, the Secretary
of Health and Human Services shall promulgate regulations to implement
administrative detention authority with respect to drugs, as authorized by the
amendments made by
<internal-xref idref="HC6F36C3607BE43E4918925FD51344B57" legis-path="807.(a)">subsection (a)</internal-xref>. Before promulgating such
regulations, the Secretary shall consult with stakeholders, including
manufacturers of drugs.</text>
</subsection><subsection commented="no" id="H20C8DF67A8EF487C8FCB791CF444EF01"><enum>(c)</enum><header>Effective
date</header><text>The amendments made by
<internal-xref idref="HC6F36C3607BE43E4918925FD51344B57" legis-path="807.(a)">subsection (a)</internal-xref> shall not take effect until
the Secretary has issued a final regulation under
<internal-xref idref="HF9B829E6BA21463590ADF8F0A49F1D4E" legis-path="807.(b)">subsection (b)</internal-xref>.</text>
</subsection></section><section commented="no" id="HD33EFBF281FB4A6DA0BD80887E1827F1"><enum>807.</enum><header>Enhanced
criminal penalty for counterfeit drugs</header>
<subsection commented="no" id="H6C7CECB3C0094BA3BA5FC202ECE5A5F1"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 303(a)
(<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C.
333(a)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H739B2BF63F264944B9947C920FC81F5B" style="OLC">
<paragraph commented="no" id="H3897373A22814ABEA77ADFCA9EF1FB3C" indent="up1"><enum>(3)</enum><text display-inline="yes-display-inline">Notwithstanding paragraph (2), any person
who engages in any conduct described in section 301(i)(2) knowing or having
reason to know that the conduct concerns the rendering of a drug as a
counterfeit drug, or who engages in conduct described in section 301(i)(3)
knowing or having reason to know that the conduct will cause a drug to be a
counterfeit drug or knowing or having reason to know that a drug held, sold, or
dispensed is a counterfeit drug, shall be fined in accordance with title 18,
United States Code, or imprisoned not more than 20 years, or both, except that
if the use of the counterfeit drug by a consumer is the proximate cause of the
death of the consumer, the term of imprisonment shall be any term of years or
for
life.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H1A0DF7FDC6A04429A1A8E382BCBE9EA1"><enum>(b)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">Section 201(g)(2)
(<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C.
321(g)(2)</external-xref>) is amended by adding at the end the following
sentence: <quote>The term <term>counterfeit drug</term> shall not include a
drug or placebo intended for use in a clinical trial that is intentionally
labeled or marked to maintain proper blinding of the study.</quote>.</text>
</subsection></section><section commented="no" id="HAA7BACE070C54A0C917BD092B6074BEE"><enum>808.</enum><header>Unique facility
identification number</header>
<subsection commented="no" id="HBA94CB76B4DA4B5C88E9C9AF5489BEB9"><enum>(a)</enum><header>Domestic
establishments</header><text display-inline="yes-display-inline">Section 510
(<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C.
360</external-xref>) is amended—</text>
<paragraph commented="no" id="HC0161610E30543D095695A3C9BAEC210"><enum>(1)</enum><text>in subsection
(b)(1), by striking <quote>and all such establishments</quote> and inserting
<quote>all such establishments, and the unique facility identifier of each such
establishment</quote>; and</text>
</paragraph><paragraph commented="no" id="HFC79A8C9526144708EB6F872E204CED5"><enum>(2)</enum><text>in subsection (c),
by striking <quote>and such establishment</quote> and inserting <quote>such
establishment, and the unique facility identifier of such
establishment</quote>.</text>
</paragraph></subsection><subsection commented="no" id="HAA8B4034FAFD4AC3BD3E31F74934DBF7"><enum>(b)</enum><header>Foreign
establishments</header><text display-inline="yes-display-inline">Subparagraph
(A) of section 510(i)(1) (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C. 360(i)(1)</external-xref>) is amended by
inserting <quote>the unique facility identifier of the establishment,</quote>
after <quote>the name and place of business of the
establishment,</quote>.</text>
</subsection><subsection commented="no" id="HECA09586185844C0B263C635DB37F14A"><enum>(c)</enum><header>Guidance</header><text>Section
510 (<external-xref legal-doc="usc" parsable-cite="usc/21/360">21 U.S.C.
360</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H08F8D5E0E8534A50B422ACC4698A84EF" style="OLC">
<subsection commented="no" id="H9EFC4955B08142D39D8306A22928AC28"><enum>(q)</enum><header>Guidance on
submission of unique facility identifiers</header>
<paragraph commented="no" id="H6D85562254B34A2F86575A893487CEC4"><enum>(1)</enum><header>In
general</header><text>Not later than 2 years after the date of the enactment of
this subsection, the Secretary shall, by guidance, specify—</text>
<subparagraph commented="no" id="H4CB6FA4A555048E7B5327029B53948BE"><enum>(A)</enum><text>the unique
facility identifier system to be used to meet the requirements of—</text>
<clause commented="no" id="H0B2723B73694420B938580992B6E060C"><enum>(i)</enum><text>subsections
(b)(1), (c), and (i)(1)(A) of this section; and</text>
</clause><clause commented="no" id="H780FA9D6D4A744958E22FC3EC1BC1534"><enum>(ii)</enum><text>section 801(s)
(relating to registration of commercial importers); and</text>
</clause></subparagraph><subparagraph commented="no" id="H62E7ED908F194602A7A688561C84856C"><enum>(B)</enum><text>the form, manner,
and timing of submissions of unique facility identifiers under the provisions
specified in subparagraph (A).</text>
</subparagraph></paragraph><paragraph commented="no" id="H9D80F9B3515F41359880B5070A29188E"><enum>(2)</enum><header>Consideration</header><text>In
developing the guidance under
<internal-xref idref="H6D85562254B34A2F86575A893487CEC4" legis-path="1013.(c)(1)">paragraph (1)</internal-xref>, the Secretary shall
take into account the utilization of existing unique identification schemes and
compatibility with customs automated
systems.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H471C8099C5AF4DE8A427763F2B006DDF"><enum>(d)</enum><header>Importation</header><text>Section
801(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C.
381(a)</external-xref>) is amended by inserting <quote>or (5) for an article
that is a drug, the appropriate unique facility identifiers under subsection
(s) (relating to commercial importers) and section 510(i) (relating to foreign
establishments), as specified by the Secretary, are not provided,</quote>
before <quote>then such article shall be refused admission</quote>.</text>
</subsection></section><section commented="no" id="HB0311CA5356547DF86A0A0D3BF18E95C"><enum>809.</enum><header>Documentation
for admissibility of imports</header><text display-inline="no-display-inline">Section 801 (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381</external-xref>) is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HE6BD023A73D64B5DA019BF4714DFCA6E" style="OLC">
<subsection commented="no" id="H7B1007F3B1274871BEC49E112AC4CA1E"><enum>(r)</enum><header>Documentation</header>
<paragraph commented="no" id="H74F9416F3CE54A3A99F23894BD2B1328"><enum>(1)</enum><header>Submission</header><text display-inline="yes-display-inline">The Secretary may require, in consultation
with the Secretary of Homeland Security acting through U.S. Customs and Border
Protection as determined appropriate by the Secretary, the submission of
documentation or other information for a drug that is imported or offered for
import into the United States.</text>
</paragraph><paragraph commented="no" id="HE0A8598C519245D5A97A77D4C1B8FF24"><enum>(2)</enum><header>Refusal of
admission</header><text>A drug imported or offered for import into the United
States shall be refused admission unless all documentation and information the
Secretary requires under this Act, the Public Health Service Act, or both, as
appropriate, for such article is submitted.</text>
</paragraph><paragraph commented="no" id="HE0EF7DA4CBB44596A9329AEF55D13DB1"><enum>(3)</enum><header>Regulations</header>
<subparagraph commented="no" id="H56454ABC328A47B99FED782353C15105"><enum>(A)</enum><header>Documents and
information</header><text>The Secretary shall issue a regulation to specify the
documentation or other information that is described in
<internal-xref idref="H74F9416F3CE54A3A99F23894BD2B1328" legis-path="(s)(1)">paragraph (1)</internal-xref>. Such information may
include—</text>
<clause commented="no" id="HA9EF745F5D9E41ABA77FF0178A5FF477"><enum>(i)</enum><text>information
demonstrating the regulatory status of the drug, such as the new drug
application, abbreviated new drug application, or investigational new drug or
Drug Master File number;</text>
</clause><clause commented="no" id="HE31C9DFCCC034C43A3B5A33223F64B97"><enum>(ii)</enum><text>facility
information, such as proof of registration and the unique facility identifier;
and</text>
</clause><clause commented="no" id="HA9691059213546DA99617DBBE03E4E66"><enum>(iii)</enum><text>indication of
compliance with current good manufacturing practice, such as satisfactory
testing results, certifications relating to satisfactory inspections, and
compliance with the country of export regulations.</text>
</clause></subparagraph><subparagraph commented="no" id="H1564474D7A3C41B0BCF3B731B94C095C"><enum>(B)</enum><header>Exemption</header><text>The
Secretary may, by regulation, exempt drugs imported for research purposes only
and other types of drug imports from some or all of the requirements of this
subsection.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="HD087A577C69A4770AB2C6AE346519A35"><enum>(4)</enum><header>Effective
date</header><text>The final rule under paragraph (3)(A) shall take effect not
less than 180 days after the Secretary promulgates such final
rule.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="HA5A4B04A675540A8AC7A30CFA7D5B339"><enum>810.</enum><header>Registration of
commercial importers</header>
<subsection commented="no" id="HFBB00A756B264A24852B1EC484D0A122"><enum>(a)</enum><header>Prohibitions</header><text display-inline="yes-display-inline">Section 301 (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HC8965D8B90184F55A7656FAE2BD53FC8" style="OLC">
<subsection commented="no" id="H9843D8A051DD465DAA83530DD51E028E"><enum>(aaa)</enum><text display-inline="yes-display-inline">The failure to register in accordance with
section
801(s).</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HA3831B76D0A04E76BB2EE31D13A40C52"><enum>(b)</enum><header>Registration</header><text>Section
801 (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C.
381</external-xref>), as amended by
<internal-xref idref="HB0311CA5356547DF86A0A0D3BF18E95C" legis-path="810.">section 809</internal-xref>, is further amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H944E96CB548C4550A7BB00DBB110A142" style="OLC">
<subsection commented="no" id="H1A5AAE9789574E068006CAA5D694B0DE"><enum>(s)</enum><header>Registration of
commercial importers</header>
<paragraph commented="no" id="HDE00098B0A4C4A8B85D7C974C9B789BC"><enum>(1)</enum><header>Registration</header><text display-inline="yes-display-inline">The Secretary shall require a commercial
importer of drugs—</text>
<subparagraph commented="no" id="HA398DD09CF084B1299ED9B5AAFB704A7"><enum>(A)</enum><text>to be registered
with the Secretary in a form and manner specified by the Secretary; and</text>
</subparagraph><subparagraph commented="no" id="H590C3E621D934B5295519537E0628A78"><enum>(B)</enum><text display-inline="yes-display-inline">consistent with the guidance under section
510(q), to submit, at the time of registration, a unique identifier for the
principal place of business for which the importer is required to register
under this subsection.</text>
</subparagraph></paragraph><paragraph commented="no" id="H3AC17662036B4F3DB624F2A55D7C59C4"><enum>(2)</enum><header>Regulations</header>
<subparagraph commented="no" id="HE9BF747A0CDA451B9A30F2DF91027F4D"><enum>(A)</enum><header>In
general</header><text>The Secretary, in consultation with the Secretary of
Homeland Security acting through U.S. Customs and Border Protection, shall
promulgate regulations to establish good importer practices that specify the
measures an importer shall take to ensure imported drugs are in compliance with
the requirements of this Act and the Public Health Service Act.</text>
</subparagraph><subparagraph commented="no" id="H3201A3FB736F4A4583A4EF42E0E6D167"><enum>(B)</enum><header>Expedited
clearance for certain importers</header><text>In promulgating good importer
practice regulations under
<internal-xref idref="HE9BF747A0CDA451B9A30F2DF91027F4D" legis-path="(t)(2)(A)">subparagraph (A)</internal-xref>, the Secretary may, as
appropriate, take into account differences among importers and types of
imports, and, based on the level of risk posed by the imported drug, provide
for expedited clearance for those importers that volunteer to participate in
partnership programs for highly compliant companies.</text>
</subparagraph></paragraph><paragraph commented="no" id="H78D8C34CB3D5430C913A7D077B82B7E5"><enum>(3)</enum><header>Discontinuance
of registration</header><text display-inline="yes-display-inline">The Secretary
shall discontinue the registration of any commercial importer of drugs that
fails to comply with the regulations promulgated under this subsection.</text>
</paragraph><paragraph commented="no" id="H33E0B3C6719E4D7AA44E91B81097AC4C"><enum>(4)</enum><header>Exemptions</header><text>The
Secretary, by notice in the Federal Register, may establish exemptions from the
requirements of this
subsection.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HC5966716491A4E67A347B696B8AF123D"><enum>(c)</enum><header>Misbranding</header><text>Section
502(o) (<external-xref legal-doc="usc" parsable-cite="usc/21/352">21 U.S.C.
352</external-xref>) is amended by inserting <quote>if it is a drug and was
imported or offered for import by a commercial importer of drugs not duly
registered under section 801(s),</quote> after <quote>not duly registered under
section 510,</quote>.</text>
</subsection><subsection commented="no" id="H2C97D5076C314F96BF507C4CD115AC92"><enum>(d)</enum><header>Regulations</header>
<paragraph commented="no" id="HDB91B64D706442D1A69EE623D4463BDF"><enum>(1)</enum><header>In
general</header><text>Not later than 36 months after the date of the enactment
of this Act, the Secretary of Health and Human Services, in consultation with
the Secretary of Homeland Security acting through U.S. Customs and Border
Protection, shall promulgate the regulations required to carry out section
801(s) of the Federal Food, Drug, and Cosmetic Act, as added by
<internal-xref idref="HA3831B76D0A04E76BB2EE31D13A40C52" legis-path="811.(b)">subsection (b)</internal-xref>.</text>
</paragraph><paragraph commented="no" id="H66DECF503E6A4636858B79117D4BE9FE"><enum>(2)</enum><header>Effective
date</header><text>In establishing the effective date of the regulations under
<internal-xref idref="HDB91B64D706442D1A69EE623D4463BDF" legis-path="811.(c)(1)">paragraph (1)</internal-xref>, the Secretary of Health
and Human Services shall, in consultation with the Secretary of Homeland
Security acting through U.S. Customs and Border Protection, as determined
appropriate by the Secretary of Health and Human Services, provide a reasonable
period of time for an importer of a drug to comply with good importer
practices, taking into account differences among importers and types of
imports, including based on the level of risk posed by the imported
product.</text>
</paragraph></subsection></section><section commented="no" id="HCDB55E48EB8045958DAEDA01B795A734"><enum>811.</enum><header>Notification</header>
<subsection commented="no" id="HC1199935CB284DDC9F998E29D7F50656"><enum>(a)</enum><header>Prohibited
acts</header><text display-inline="yes-display-inline">Section 301
(<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C.
331</external-xref>), as amended by
<internal-xref idref="HA5A4B04A675540A8AC7A30CFA7D5B339" legis-path="811.">section 810</internal-xref>, is further amended by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H09C45C225D844076947BC2B2B000BE45" style="OLC">
<subsection commented="no" id="H2BE350FB3F3045698399B60C5D5A39CE"><enum>(bbb)</enum><text display-inline="yes-display-inline">The failure to notify the Secretary in
violation of section
568.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HA9FA634A9441486BA5BADF70D2A34176"><enum>(b)</enum><header>Notification</header><text>Subchapter
E of chapter V (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb">21
U.S.C. 360bbb et seq.</external-xref>) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H1117347CF26948029D439C9B08DEE0CC" style="OLC">
<section commented="no" id="H76CB615BE453411EB5627AE65A3D8DDB"><enum>568.</enum><header>Notification</header>
<subsection commented="no" id="H2AF63DC7D3CA4F9990A72F6309BB2610"><enum>(a)</enum><header>Notification to
Secretary</header><text display-inline="yes-display-inline">With respect to a
drug, the Secretary may require notification to the Secretary by a regulated
person if the regulated person knows—</text>
<paragraph commented="no" id="H3BB47E688DF846CD80C282DE67DAFA20"><enum>(1)</enum><text>that the use of
such drug in the United States may result in serious injury or death;</text>
</paragraph><paragraph commented="no" id="H245D9D45039A40B1B099406F0731BA43"><enum>(2)</enum><text>of a significant
loss or known theft of such drug intended for use in the United States;
or</text>
</paragraph><paragraph commented="no" id="H590A55E7D3F04FAB90A7FBF368650DDA"><enum>(3)</enum><text>that—</text>
<subparagraph commented="no" id="H0638B75E360F4A57BDDF8D011F129342"><enum>(A)</enum><text>such drug has been
or is being counterfeited; and</text>
</subparagraph><subparagraph commented="no" id="HCDB515BF0D2C476CAD463E1B776A37A2"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HA4FBFC7C90414C458FA42CD70572D144"><enum>(i)</enum><text display-inline="yes-display-inline">the counterfeit product is in commerce in
the United States or could be reasonably expected to be introduced into
commerce; or</text>
</clause><clause commented="no" id="H88FA3DD2DFFC41198858B70E79F783B9" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">such drug has been or is being imported
into the United States or may reasonably be expected to be offered for import
into the United States.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" id="HE8EA3C72DE3E4D77A39FE4E1A5692D48"><enum>(b)</enum><header>Manner of
notification</header><text>Notification under this section shall be made in
such manner and by such means as the Secretary may specify by regulation or
guidance.</text>
</subsection><subsection id="H0F13366BD25A42F38B057550C11B433D"><enum>(c)</enum><header>Savings
clause</header><text display-inline="yes-display-inline">Nothing in this
section shall be construed as limiting any other authority of the Secretary to
require notifications related to a drug under any other provision of this Act
or the Public Health Service Act.</text>
</subsection><subsection commented="no" id="HAD2AAB454D5A4C75AC0E558755CA98FD"><enum>(d)</enum><header>Definition</header><text>In
this section, the term <term>regulated person</term> means—</text>
<paragraph commented="no" id="H5D74C0E359FF407FA7BB660E1E377A23"><enum>(1)</enum><text>a person who is
required to register under section 510 or 801(s);</text>
</paragraph><paragraph commented="no" id="H30F4CA88B7EC437AB6C176734A2FAE19"><enum>(2)</enum><text>a wholesale
distributor of a drug product; or</text>
</paragraph><paragraph commented="no" id="HE76CA4D65CED4F4CA011688859DC8B91"><enum>(3)</enum><text>any other person
that distributes drugs except a person that distributes drugs exclusively for
retail
sale.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" id="HA4F5E7C5E23A446F878BDCC86C6BBCCF"><enum>812.</enum><header>Exchange of
information</header><text display-inline="no-display-inline">Section 708
(<external-xref legal-doc="usc" parsable-cite="usc/21/379">21 U.S.C.
379</external-xref>) is amended—</text>
<paragraph commented="no" id="H75A3E5FB108843ACA2682823106A6C5F"><enum>(1)</enum><text>by striking
<quote>The Secretary may provide</quote> and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H9F9B5B1554C4484BB1D9C31F302065DD" style="OLC">
<subsection commented="no" id="HF38FA6AEA7004626B52C875F33023A6C"><enum>(a)</enum><header>Contractors</header><text display-inline="yes-display-inline">The Secretary may
provide</text>
</subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="H7AA91CE33A764302B70F67AA94A2CBC5"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HF26163BE618F4C29852547096EF35222" style="OLC">
<subsection commented="no" id="H59FE7A10501549A4AEF717DC7BADB384"><enum>(b)</enum><header>Ability To
receive and protect confidential information</header><text display-inline="yes-display-inline">Except pursuant to an order of a court of
the United States, the Secretary shall not be required to disclose under
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552</external-xref> of title 5, United States Code, or any other provision of
law, any information relating to drugs obtained from a Federal, State, or local
government agency, or from a foreign government agency, if the agency has
requested that the information be kept confidential. For purposes of
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552</external-xref> of title 5, United States Code, this subsection shall be
considered a statute described in section 552(b)(3)(B).</text>
</subsection><subsection commented="no" id="H25246665254C47119AE7BC33B289FE53"><enum>(c)</enum><header>Authority To
enter into memoranda of understanding for purposes of information
exchange</header><text>The Secretary may enter into written agreements
regarding the exchange of information referenced in section 301(j) subject to
the following criteria:</text>
<paragraph commented="no" id="H3ACFFFB7E7694C6CAD0205F913C4E675"><enum>(1)</enum><header>Certification</header><text display-inline="yes-display-inline">The Secretary may only enter into written
agreements under this subsection with foreign governments that the Secretary
has certified as having the authority and demonstrated ability to protect trade
secret information from disclosure. Responsibility for this certification shall
not be delegated to any officer or employee other than the Commissioner of Food
and Drugs.</text>
</paragraph><paragraph commented="no" id="HB6E99BA0633741B6A04444FAB52BAC06"><enum>(2)</enum><header>Written
agreement</header><text>The written agreement under this subsection shall
include a commitment by the foreign government to protect information exchanged
under this subsection from disclosure unless and until the sponsor gives
written permission for disclosure or the Secretary makes a declaration of a
public health emergency pursuant to section 319 of the Public Health Service
Act that is relevant to the information.</text>
</paragraph><paragraph commented="no" id="HCF187822625948F1AF516979D9F5B0D0"><enum>(3)</enum><header>Information
exchange</header><text>The Secretary may provide to a foreign government that
has been certified under paragraph (1), and that has executed a written
agreement under paragraph (2), information referenced in section 301(j) in the
following circumstances:</text>
<subparagraph commented="no" id="H4F8397C5CF70471B9CE5FB696C3915E4"><enum>(A)</enum><text>Information
concerning the inspection of a facility may be provided if—</text>
<clause commented="no" id="HF745C23307D0493EB5524A73DF842B94"><enum>(i)</enum><text>the Secretary
reasonably believes, or the written agreement described in paragraph (2)
establishes, that the government has authority to otherwise obtain such
information; and</text>
</clause><clause commented="no" id="H711F6AE38E644712A7F71559442D9368"><enum>(ii)</enum><text>the written
agreement executed under paragraph (2) limits the recipient’s use of the
information to the recipient’s civil regulatory purposes.</text>
</clause></subparagraph><subparagraph commented="no" id="HB201CF0BB3DF453BADFD0171C2ABCD17"><enum>(B)</enum><text>Information not
described in subparagraph (A) may be provided as part of an investigation, or
to alert the foreign government to the potential need for an investigation, if
the Secretary has reasonable grounds to believe that a drug has a reasonable
probability of causing serious adverse health consequences or death.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H608CFB1E58134EA8811B77EC2ECEAA65"><enum>(d)</enum><header>No limitation on
authority</header><text>This section shall not affect the authority of the
Secretary to provide or disclose information under any other provision of
law.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" id="HB6AF88DB96C14ABB9D7406B3DD4920CB"><enum>813.</enum><header>Extraterritorial
jurisdiction</header><text display-inline="no-display-inline">Chapter III
(<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331 et
seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HDE844C3CFF94470EA6DFCECB22EBD774" style="OLC">
<section commented="no" id="H0776F64F952B4598AC70A79ED61A6F88"><enum>311.</enum><header>Extraterritorial
jurisdiction</header><text display-inline="no-display-inline">There is
extraterritorial jurisdiction over any violation of this Act relating to any
article regulated under this Act if such article was intended for import into
the United States or if any act in furtherance of the violation was committed
in the United
States.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="HA4BD536F12E046C29DBEF9279EDEBE13"><enum>814.</enum><header>Protection
against intentional adulteration</header><text display-inline="no-display-inline">Section 303(b) (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(b)</external-xref>) is
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H9962550BF3D64C62A758F29C9D9D1F87" style="OLC">
<paragraph commented="no" id="H1572AEB58E4F41DE90BFBABC86BE1E3E" indent="up1"><enum>(7)</enum><text display-inline="yes-display-inline">Notwithstanding subsection (a)(2), any
person that knowingly and intentionally engages in an activity that results in
a drug becoming adulterated under subsection (a)(1), (b), (c), or (d) of
section 501 and having a reasonable probability of causing serious adverse
health consequences or death shall be imprisoned for not more than 20 years or
fined not more than $1,000,000, or
both.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H6C306E172B1447D9B529184FF12E34FB"><enum>815.</enum><header>Records for
inspection</header><text display-inline="no-display-inline">Section 704(a)
(<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C.
374(a)</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HE06713B834774F87BD2895C26ADA1091" style="OLC">
<paragraph commented="no" id="H33DF9CA5C0854E8B8BBBC6F828CAA179" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H2E5C794A646E426E8A1750B219813FE5"><enum>(A)</enum><text>Any records or other
information that the Secretary may inspect under this section from a person
that owns or operates an establishment that is engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug shall, upon the
request of the Secretary, be provided to the Secretary by such person, in
advance of or in lieu of an inspection, within a reasonable timeframe, within
reasonable limits, and in a reasonable manner, and in either electronic or
physical form, at the expense of such person. The Secretary’s request shall
include a sufficient description of the records requested.</text>
</subparagraph><subparagraph commented="no" id="H048D862F703646BDAEB830409A0DE8D5" indent="up1"><enum>(B)</enum><text>Upon receipt of the records requested
under
<internal-xref idref="H2E5C794A646E426E8A1750B219813FE5" legis-path="(4)(A)">subparagraph (A)</internal-xref>, the Secretary shall
provide to the person confirmation of receipt.</text>
</subparagraph><subparagraph commented="no" id="H0B230AD5429F4C28919FD0468911EF9B" indent="up1"><enum>(C)</enum><text>Nothing in this paragraph supplants
the authority of the Secretary to conduct inspections otherwise permitted under
this Act in order to ensure compliance with this
Act.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle commented="no" id="HF2E0869C6020411E9A3A56412A1188A5"><enum>B</enum><header>Medical Gas
Safety</header>
<section commented="no" id="H1968847B81E44755A5882D6C4DD417F7"><enum>821.</enum><header>Regulation of
medical gases</header><text display-inline="no-display-inline">Chapter V
(<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et
seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H426C7E2D707848CB89C33FE4155F1CDB" style="OLC">
<subchapter commented="no" id="H921E1A24366043848314EA31A0654D46"><enum>G</enum><header>Medical
gases</header>
<section commented="no" id="H27820D1FF0E048BE8D98FC58BBD0F7BE"><enum>575.</enum><header>Definitions</header><text display-inline="no-display-inline">In this subchapter:</text>
<paragraph commented="no" id="HCC208C3851804CB0834C6E2CF9DF50DA"><enum>(1)</enum><text>The term
<term>designated medical gas</term> means any of the following:</text>
<subparagraph commented="no" id="H6E30CF273FED4E52AE14C1874F969365"><enum>(A)</enum><text>Oxygen that meets
the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="HE708B97D5B0745629C347C1ED90E3165"><enum>(B)</enum><text>Nitrogen that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="H9FBD28CA375C4D54910A08B5AFBE245B"><enum>(C)</enum><text>Nitrous oxide that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="H5F452BBBECFA4686B2352998A559EA8D"><enum>(D)</enum><text>Carbon dioxide
that meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="H32B463476A7D4B0FA726CCFCC5069903"><enum>(E)</enum><text>Helium that meets
the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="H8FEC16B6351B475693EACB8FD044080E"><enum>(F)</enum><text>Carbon monoxide
that meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="HC63B561733E14DFDBB577A5536B5AD19"><enum>(G)</enum><text>Medical air that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph commented="no" id="HE756B30065854530914090E246DE6077"><enum>(H)</enum><text display-inline="yes-display-inline">Any other medical gas deemed appropriate by
the Secretary, after taking into account any investigational new drug
application or investigational new animal drug application for the same medical
gas submitted in accordance with regulations applicable to such applications in
title 21 of the Code of Federal Regulations, unless any period of exclusivity
under section 505(c)(3)(E)(ii) or section 505(j)(5)(F)(ii), or the extension of
any such period under section 505A, applicable to such medical gas has not
expired.</text>
</subparagraph></paragraph><paragraph commented="no" id="H2AF268DF487948C0B5C1DB6CE47F89E5"><enum>(2)</enum><text>The term
<term>medical gas</term> means a drug that—</text>
<subparagraph commented="no" id="H3DF5A53C8C12401195403F8D3B133E4A"><enum>(A)</enum><text>is manufactured or
stored in a liquefied, nonliquefied, or cryogenic state; and</text>
</subparagraph><subparagraph commented="no" id="H85377D5DE1DB491DAD667ECF1AA58C19"><enum>(B)</enum><text>is administered as
a gas.</text>
</subparagraph></paragraph></section><section commented="no" id="HFABDDADED4FF4E2B82EB27D7AE7F0D8C"><enum>576.</enum><header>Regulation of
medical gases</header>
<subsection commented="no" id="H351361DC2F324BEC86F0C0D188802F22"><enum>(a)</enum><header>Certification of
designated medical gases</header>
<paragraph commented="no" id="H173676988A4D44DF93F1DD47D059B9F4"><enum>(1)</enum><header>Submission</header><text>Beginning
180 days after the date of enactment of this section, any person may file with
the Secretary a request for certification of a medical gas as a designated
medical gas. Any such request shall contain the following information:</text>
<subparagraph commented="no" id="H3A8089CF8E9D45AEA070D25CFB66DCAF"><enum>(A)</enum><text>A description of
the medical gas.</text>
</subparagraph><subparagraph commented="no" id="H3BD3619C032B4176B3C99CAD5D3A9422"><enum>(B)</enum><text>The name and
address of the sponsor.</text>
</subparagraph><subparagraph commented="no" id="HD6F34847794C4D80A1B3AE1463811A28"><enum>(C)</enum><text>The name and
address of the facility or facilities where the medical gas is or will be
manufactured.</text>
</subparagraph><subparagraph commented="no" id="HB2859FDF76734D59B656AEA1E2F1DD70"><enum>(D)</enum><text>Any other
information deemed appropriate by the Secretary to determine whether the
medical gas is a designated medical gas.</text>
</subparagraph></paragraph><paragraph commented="no" id="H6156E57EE28742DDAE66B6C39CE0C119"><enum>(2)</enum><header>Grant of
certification</header><text display-inline="yes-display-inline">The
certification requested under paragraph (1) is deemed to be granted unless,
within 60 days of the filing of such request, the Secretary finds that—</text>
<subparagraph commented="no" id="HD06A559EA9784D779070B64083B8F27D"><enum>(A)</enum><text>the medical gas
subject to the certification is not a designated medical gas;</text>
</subparagraph><subparagraph commented="no" id="H35ACE3F10CB84E93B678E7D5DD8F6E96"><enum>(B)</enum><text>the request does
not contain the information required under paragraph (1) or otherwise lacks
sufficient information to permit the Secretary to determine that the medical
gas is a designated medical gas; or</text>
</subparagraph><subparagraph commented="no" id="H48C416E6599140A5BD7D4531F09F1E33"><enum>(C)</enum><text>denying the
request is necessary to protect the public health.</text>
</subparagraph></paragraph><paragraph commented="no" id="H34A0D4BAED4D4E73AE89498413B7B28C"><enum>(3)</enum><header>Effect of
certification</header>
<subparagraph commented="no" id="H3C9918A8643A40709B3167A70AF65D11"><enum>(A)</enum><header>In
general</header>
<clause commented="no" id="H853C9A1EF1BB4A03972DB2A55E80E527"><enum>(i)</enum><header>Approved
uses</header><text display-inline="yes-display-inline">A designated medical gas
for which a certification is granted under paragraph (2) is deemed, alone or in
combination, as medically appropriate, with another designated medical gas or
gases for which a certification or certifications have been granted, to have in
effect an approved application under section 505 or 512, subject to all
applicable post-approval requirements, for the following indications for
use:</text>
<subclause commented="no" id="H253AFDB470184784AA8859920471A91D"><enum>(I)</enum><text display-inline="yes-display-inline">In the case of oxygen, the treatment or
prevention of hypoxemia or hypoxia.</text>
</subclause><subclause commented="no" id="HCB145337FC11455BB6403B26E5599A57"><enum>(II)</enum><text display-inline="yes-display-inline">In the case of nitrogen, use in hypoxic
challenge testing.</text>
</subclause><subclause commented="no" id="H722AAC7EA2B2425D8ED4A31926661672"><enum>(III)</enum><text display-inline="yes-display-inline">In the case of nitrous oxide,
analgesia.</text>
</subclause><subclause commented="no" id="HA9FAD227BBF549A78CA7D2C58CF1B281"><enum>(IV)</enum><text display-inline="yes-display-inline">In the case of carbon dioxide, use in
extracorporeal membrane oxygenation therapy or respiratory stimulation.</text>
</subclause><subclause commented="no" id="HAED34722F36F42F7ADF000E2DA042DF9"><enum>(V)</enum><text display-inline="yes-display-inline">In the case of helium, the treatment of
upper airway obstruction or increased airway resistance.</text>
</subclause><subclause commented="no" id="H01F79486F2234F3D9F0733735A9B71CB"><enum>(VI)</enum><text display-inline="yes-display-inline">In the case of medical air, to reduce the
risk of hyperoxia.</text>
</subclause><subclause commented="no" id="HBD7B7E56F940444E9FFB2C49EB3EB646"><enum>(VII)</enum><text display-inline="yes-display-inline">In the case of carbon monoxide, use in lung
diffusion testing.</text>
</subclause><subclause commented="no" id="H3E030E46CE8541FF96FAF16B7D233DD0"><enum>(VIII)</enum><text display-inline="yes-display-inline">Any other indication for use for a
designated medical gas or combination of designated medical gases deemed
appropriate by the Secretary, unless any period of exclusivity under clause
(iii) or (iv) of section 505(c)(3)(E), clause (iii) or (iv) of section
505(j)(5)(F), or section 527, or the extension of any such period under section
505A, applicable to such indication for use for such gas or combination of
gases has not expired.</text>
</subclause></clause><clause commented="no" id="H244C0C2D928F4CEF92928D7B4AA16DA5"><enum>(ii)</enum><header>Labeling</header><text>The
requirements of sections 503(b)(4) and 502(f) are deemed to have been met for a
designated medical gas if the labeling on final use container for such medical
gas bears—</text>
<subclause commented="no" id="HC1DF0DB2C4534B7286B7BC6BA47EE18B"><enum>(I)</enum><text>the information
required by section 503(b)(4);</text>
</subclause><subclause commented="no" id="H8DAA5FC31F2E4BFB9955E9E0C67D6012"><enum>(II)</enum><text>a warning
statement concerning the use of the medical gas as determined by the Secretary
by regulation; and</text>
</subclause><subclause commented="no" id="H0F2FB44183664207A147D88BAFF445F0"><enum>(III)</enum><text>appropriate
directions and warnings concerning storage and handling.</text>
</subclause></clause></subparagraph><subparagraph commented="no" id="HEAC8C5B725F647509E88D549B3A4F9B7"><enum>(B)</enum><header>Inapplicability
of exclusivity provisions</header>
<clause commented="no" id="H06389BBEF50B4C518D5F68D17D7B9751"><enum>(i)</enum><header>No exclusivity
for a certified medical gas</header><text>No designated medical gas deemed
under subparagraph (A)(i) to have in effect an approved application is eligible
for any period of exclusivity under section 505(c), 505(j), or 527, or the
extension of any such period under section 505A, on the basis of such deemed
approval.</text>
</clause><clause commented="no" id="H5F8E1F68F98C487094E7CA7011F4B45D"><enum>(ii)</enum><header>Effect on
certification</header><text>No period of exclusivity under section 505(c),
505(j), or section 527, or the extension of any such period under section 505A,
with respect to an application for a drug product shall prohibit, limit, or
otherwise affect the submission, grant, or effect of a certification under this
section, except as provided in subsection (a)(3)(A)(i)(VIII) and section
575(1)(H).</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H657F936E00FD413B888B9D4FF6AEB842"><enum>(4)</enum><header>Withdrawal,
suspension, or revocation of approval</header>
<subparagraph commented="no" id="H6F51B7ABE63D4855BA0DBD7898057985"><enum>(A)</enum><header>Withdrawal,
suspension of approval</header><text>Nothing in this subchapter limits the
Secretary's authority to withdraw or suspend approval of a drug product,
including a designated medical gas deemed under this section to have in effect
an approved application under section 505 or section 512 of this Act.</text>
</subparagraph><subparagraph commented="no" id="H3D365978A3CB45A5992BB376621E7494"><enum>(B)</enum><header>Revocation of
certification</header><text>The Secretary may revoke the grant of a
certification under paragraph (2) if the Secretary determines that the request
for certification contains any material omission or falsification.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H64DBA28586984709A5B7B9E323DCCB4A"><enum>(b)</enum><header>Prescription
requirement</header>
<paragraph commented="no" id="H173FE541AE0A41F0A5041513E3AC449E"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">A designated medical
gas shall be subject to the requirements of section 503(b)(1) unless the
Secretary exercises the authority provided in section 503(b)(3) to remove such
medical gas from the requirements of section 503(b)(1), the gas is approved for
use without a prescription pursuant to an application under section 505 or 512,
or the use in question is authorized pursuant to another provision of this Act
relating to use of medical products in emergencies.</text>
</paragraph><paragraph commented="no" id="HBECFF6045D404F61BE112641394006E6"><enum>(2)</enum><header>Oxygen</header>
<subparagraph commented="no" id="H12BAC6592A8B43B8B9E06573B974C864"><enum>(A)</enum><header>No prescription
required for certain uses</header><text>Notwithstanding paragraph (1), oxygen
may be provided without a prescription for the following uses:</text>
<clause commented="no" id="H8158891E31854150A227CC56A3B6B1C6"><enum>(i)</enum><text>For use in the
event of depressurization or other environmental oxygen deficiency.</text>
</clause><clause commented="no" id="H7FBBA23CD776480786D6CD68A714D6B6"><enum>(ii)</enum><text>For oxygen
deficiency or for use in emergency resuscitation, when administered by properly
trained personnel.</text>
</clause></subparagraph><subparagraph commented="no" id="H8C136A22662D4FD08749ECF88314D741"><enum>(B)</enum><header>Labeling</header><text>For
oxygen provided pursuant to subparagraph (A), the requirements of section
503(b)(4) shall be deemed to have been met if its labeling bears a warning that
the oxygen can be used for emergency use only and for all other medical
applications a prescription is required.</text>
</subparagraph></paragraph></subsection></section><section commented="no" id="H35F2ECCEA5E64DA4A077FBB29E9E6961"><enum>577.</enum><header>Inapplicability
of drug fees to designated medical gases</header><text display-inline="no-display-inline">A designated medical gas, alone or in
combination with another designated gas or gases (as medically appropriate)
deemed under section 576 to have in effect an approved application shall not be
assessed fees under section 736(a) on the basis of such deemed
approval.</text>
</section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H341B9D84BCDD4D208669B5A932F1481A"><enum>822.</enum><header>Changes to
regulations</header>
<subsection commented="no" id="H8C698A6B95594ACEACF8FC897FCF7966"><enum>(a)</enum><header>Report</header><text display-inline="yes-display-inline">Not later than 18 months after the date of
the enactment of this Act, the Secretary, after obtaining input from medical
gas manufacturers and any other interested members of the public, shall—</text>
<paragraph commented="no" id="H855D892DD01D405EB7043209505ABF56"><enum>(1)</enum><text>determine whether
any changes to the Federal drug regulations are necessary for medical gases;
and</text>
</paragraph><paragraph commented="no" id="H9721B8811AA94B25AB96327B6DC0F7A2"><enum>(2)</enum><text>submit to the
Committee on Health, Education, Labor and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives a report
regarding any such changes.</text>
</paragraph></subsection><subsection commented="no" id="H74C311E095CF40B49D791EE9A552ECC1"><enum>(b)</enum><header>Regulations</header><text display-inline="yes-display-inline">If the Secretary determines under
subsection (a) that changes to the Federal drug regulations are necessary for
medical gases, the Secretary shall issue final regulations revising the Federal
drug regulations with respect to medical gases not later than 48 months after
the date of the enactment of this Act.</text>
</subsection><subsection commented="no" id="H1BE56C8B5D3B4CAB900E847041B4C7FE"><enum>(c)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="H6400463145104778AD226B1C335DB763"><enum>(1)</enum><text>The term
<term>Federal drug regulations</term> means regulations in title 21 of the Code
of Federal Regulations pertaining to drugs.</text>
</paragraph><paragraph commented="no" id="H24EFC308BED94836A92D94F670F52F1C"><enum>(2)</enum><text>The term
<term>medical gas</term> has the meaning given to such term in section 575 of
the Federal Food, Drug, and Cosmetic Act, as added by section 821 of this
Act.</text>
</paragraph><paragraph commented="no" id="H2BEF2A899137435E9B6D464F17E30C4B"><enum>(3)</enum><text>The term
<term>Secretary</term> means the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs.</text>
</paragraph></subsection></section><section commented="no" id="H858CA88D0A59482A888178F74001364B"><enum>823.</enum><header>Rules of
construction</header><text display-inline="no-display-inline">Nothing in this
subtitle and the amendments made by this subtitle applies with respect
to—</text>
<paragraph commented="no" id="H87D5BF31769B4CA2B1E4E39890B89B60"><enum>(1)</enum><text>a drug that is
approved prior to May 1, 2012, pursuant to an application submitted under
section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>,
360b);</text>
</paragraph><paragraph commented="no" id="H36DCD3B455FF4DBC9A187A5B2709F286"><enum>(2)</enum><text>any gas listed in
subparagraphs (A) through (G) of section 575(1) of the Federal Food, Drug, and
Cosmetic Act, as added by section 821 of this Act, or any combination of any
such gases, for an indication that—</text>
<subparagraph commented="no" id="HB7C4C279B9E24E4192EFDE12B992A50E"><enum>(A)</enum><text>is not included
in, or is different from, those specified in subclauses (I) through (VII) of
section 576(a)(3)(A)(i) of such Act; and</text>
</subparagraph><subparagraph commented="no" id="HD25AD7A77D71498E8BA95A7E462C5AE7"><enum>(B)</enum><text>is approved on or
after May 1, 2012, pursuant to an application submitted under Section 505 or
512; or</text>
</subparagraph></paragraph><paragraph commented="no" id="H44A173230B084CE0AB962C47FBBFE3DE"><enum>(3)</enum><text display-inline="yes-display-inline">any designated medical gas added pursuant
to subparagraph (H) of section 575(1) of such Act for an indication
that—</text>
<subparagraph commented="no" id="H58652936CA9045A7A07FE30387F63942"><enum>(A)</enum><text>is not included
in, or is different from, those originally added pursuant to subparagraph (H)
of section 575(1) and section 576(a)(3)(A)(i)(VIII); and</text>
</subparagraph><subparagraph commented="no" id="HABBE177E198A4E31A69AF105961A872F"><enum>(B)</enum><text>is approved on or
after May 1, 2012, pursuant to an application submitted under section 505 or
512 of such Act.</text>
</subparagraph></paragraph></section></subtitle><subtitle commented="no" id="HE19B0E9DA2AA4311A2A9604066DAC0B1"><enum>C</enum><header>Generating
Antibiotic Incentives Now</header>
<section commented="no" id="HD49E3B68263D4C78B3F051DA0F17D780"><enum>831.</enum><header>Extension of
exclusivity period for drugs</header>
<subsection commented="no" id="H89D9AD26E2954801BB50BC99F46D1ED3"><enum>(a)</enum><header>In
general</header><text>The Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 505D (<external-xref legal-doc="usc" parsable-cite="usc/21/355e">21 U.S.C. 355e</external-xref>) the
following:</text>
<quoted-block id="H8DD98E8B118D4B399F24580415FBFACD" style="OLC">
<section commented="no" id="HAEB5ACEED7F9427BB14C359D11BEFA4B"><enum>505E.</enum><header>Extension of
exclusivity period for new qualified infectious disease products</header>
<subsection commented="no" id="HB3E674FC60254642B1E7828B6AD45417"><enum>(a)</enum><header>Extension</header><text>If
the Secretary approves an application pursuant to section 505 for a drug that
has been determined to be a qualified infectious disease product under
subsection (d), then the four- and five-year periods described in subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the three-year periods
described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii)
and (iv) of subsection (j)(5)(F) of section 505, or the seven year period
described in section 527, as applicable, shall be extended by five
years.</text>
</subsection><subsection commented="no" id="HC7A08784BD4848A49B2D06729DE1E33E"><enum>(b)</enum><header>Relation to
pediatric exclusivity</header><text>Any extension under subsection (a) of a
period shall be in addition to any extension of the period under section 505A
with respect to the drug.</text>
</subsection><subsection commented="no" id="H473AB5AD4BDF4DE0B0322875F125E4EB"><enum>(c)</enum><header>Limitations</header><text>Subsection
(a) does not apply to the approval of—</text>
<paragraph commented="no" id="HCF6752D0A88A4802AE0C329D4E0015A2"><enum>(1)</enum><text>a supplement to an
application under section 505(b) for any qualified infectious disease product
for which an extension described in subsection (a) is in effect or has
expired;</text>
</paragraph><paragraph commented="no" id="H86247B6D67BA4588BCC496876EE3215F"><enum>(2)</enum><text>a subsequent
application filed by the same sponsor or manufacturer of a qualified infectious
disease product described in paragraph (1) (or a licensor, predecessor in
interest, or other related entity) for—</text>
<subparagraph commented="no" id="H7E2BE584E7BF43C096EBB4A563D19025"><enum>(A)</enum><text>a change (not
including a modification to the active moiety of the qualified infectious
disease product) that results in a new indication, route of administration,
dosing schedule, dosage form, delivery system, delivery device, or strength;
or</text>
</subparagraph><subparagraph commented="no" id="HA4682793928C4EB5AFB5A08B8E1B8218"><enum>(B)</enum><text>a modification to
the active moiety of the qualified infectious disease product that does not
result in a change in safety or effectiveness; or</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H22BD420E17D14ED3AA6F97B1291860E9"><enum>(3)</enum><text display-inline="yes-display-inline">a product that does not meet the definition
of a qualified infectious disease product under subsection (f) based upon its
approved uses.</text>
</paragraph></subsection><subsection commented="no" id="H45655E3B19BE4B50A4EA0FC9E135F048"><enum>(d)</enum><header>Determination</header><text display-inline="yes-display-inline">The manufacturer or sponsor of a drug may
request that the Secretary designate a drug as a qualified infectious disease
product at any time in the drug development process prior to the submission of
an application under section 505(b) for the drug, but not later than 45 days
before the submission of such application. The Secretary shall, not later than
30 days after the submission of such request, determine whether the drug is a
qualified infectious disease product.</text>
</subsection><subsection commented="no" id="H826E8F562BCE48DA9E97ED6119FC5551"><enum>(e)</enum><header>Regulations</header><text>The
Secretary shall promulgate regulations for carrying out this section. The
Secretary shall promulgate the initial regulations for carrying out this
section not later than 12 months after the date of the enactment of this
section.</text>
</subsection><subsection commented="no" id="HB6A4BFA041024C15B1FDD6A1107A4035"><enum>(f)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="H77A4E01F46DD4151AD1C848368A68513"><enum>(1)</enum><header>Qualified
infectious disease product</header><text display-inline="yes-display-inline">The term <term>qualified infectious disease
product</term> means an antibacterial or antifungal drug for human use that
treats or prevents an infection caused by a qualifying pathogen.</text>
</paragraph><paragraph commented="no" id="HD21F8CA0F7974273810CFEA531555D3D"><enum>(2)</enum><header>Qualifying
pathogen</header><text>The term <term>qualifying pathogen</term> means—</text>
<subparagraph commented="no" id="H3B63139A6E3142A2A1E620E817F2D9E4"><enum>(A)</enum><text>resistant
gram-positive pathogens, including methicillin-resistant Staphylococcus aureus
(MRSA), vancomycin-resistant Staphylococcus aureus (VRSA), and
vancomycin-resistant enterococcus (VRE);</text>
</subparagraph><subparagraph commented="no" id="H019428E3B624460CAD3BB8CD43CEA959"><enum>(B)</enum><text>multidrug
resistant gram-negative bacteria, including Acinetobacter, Klebsiella,
Pseudomonas, and E. coli species;</text>
</subparagraph><subparagraph commented="no" id="H6465F0192B0F47DEA44098F7B2D36200"><enum>(C)</enum><text>multi-drug
resistant tuberculosis; or</text>
</subparagraph><subparagraph commented="no" id="H1A6C772F95FB4B0BB134957AD3269191"><enum>(D)</enum><text>any other
infectious pathogen identified for purposes of this section by the
Secretary.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H5CDB1FB34DC145A2B4CB93C6264F9713"><enum>(b)</enum><header>Application</header><text>Section
505E of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a),
applies only with respect to a drug that is first approved under section 505(c)
of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21
U.S.C. 355(c)</external-xref>) on or after the date of the enactment of this
Act.</text>
</subsection></section><section commented="no" id="HA313AB1524014E8B80B81714099EE012"><enum>832.</enum><header>Study on
incentives for qualified infectious disease biological products</header>
<subsection commented="no" id="HC64F06CD4F824E35A08A3214AC45D61B"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Comptroller
General of the United States shall—</text>
<paragraph commented="no" id="H133CC82BF9EB42CE963DD01E484E3261"><enum>(1)</enum><text>conduct a study on
the need for incentives to encourage research on and development and marketing
of qualified infectious disease biological products; and</text>
</paragraph><paragraph commented="no" id="HE218D36AE56949E2918EE64BA006E5F6"><enum>(2)</enum><text>not later than 1
year after the date of the enactment of this Act, submit a report to the
Congress on the results of such study, including any recommendations of the
Comptroller General on appropriate incentives for addressing such need.</text>
</paragraph></subsection><subsection commented="no" id="HAE03A322D59B42748D08C4789D361FD2"><enum>(b)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="HAF493433EC2845EFB4834F622C1FF96F"><enum>(1)</enum><text>The term
<term>biological product</term> has the meaning given to such term in section
351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>).</text>
</paragraph><paragraph commented="no" id="HDB4A83A519264A889D688FE06BA51AAF"><enum>(2)</enum><text>The term
<term>qualified infectious disease biological product</term> means a biological
product for human use that treats or prevents an infection caused by a
qualifying pathogen.</text>
</paragraph><paragraph commented="no" id="HBA4F0B3505244F0A833ACB6BE2919EE4"><enum>(3)</enum><text>The term
<term>qualifying pathogen</term> has the meaning given to such term in section
505E of the Federal Food, Drug, and Cosmetic Act, as added by section 831 of
this Act.</text>
</paragraph></subsection></section><section commented="no" id="H60497F25815344DCAD3D51C5202A117B"><enum>833.</enum><header>Clinical
trials</header>
<subsection commented="no" id="H05D7F3BF0D434214B992552507E4F5BC"><enum>(a)</enum><header>Review and
revision of guidelines</header>
<paragraph commented="no" id="HDB08F8760C0E4CE095F60586E43E43FF"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the date of the enactment of
this Act, and not later than 4 years thereafter, the Secretary shall—</text>
<subparagraph commented="no" id="H94CAEFC7D6604F229E3BE225D4B1569A"><enum>(A)</enum><text display-inline="yes-display-inline">review the guidance of the Food and Drug
Administration for the conduct of clinical trials with respect to antibacterial
and antifungal drugs; and</text>
</subparagraph><subparagraph commented="no" id="H1195E31209D24F9BADFD53E87EB79DDA"><enum>(B)</enum><text>as appropriate,
revise such guidance to reflect developments in scientific and medical
information and technology and to ensure clarity regarding the procedures and
requirements for approval of an antibiotic and antifungal drug under chapter V
of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et seq.</external-xref>).</text>
</subparagraph></paragraph><paragraph commented="no" id="HF29550F795CA4285B282A8ADA638AB66"><enum>(2)</enum><header>Issues for
review</header><text>At a minimum, the review under paragraph (1) shall address
the appropriate animal models of infection, in vitro techniques, valid
microbiological surrogate markers, the use of noninferiority versus superiority
trials, and appropriate delta values for noninferiority trials.</text>
</paragraph><paragraph commented="no" id="H61943817343E43D6A4FA91FF806453D1"><enum>(3)</enum><header>Rule of
construction</header><text>Except to the extent to which the Secretary of
Health and Human Services makes revisions under paragraph (1)(B), nothing in
this section shall be construed to repeal or otherwise affect the guidance of
the Food and Drug Administration.</text>
</paragraph></subsection><subsection commented="no" id="H07277C2F3BA341FABE654CFA33971E16"><enum>(b)</enum><header>Recommendations
for investigations</header>
<paragraph commented="no" id="H45B69F1084A84155982AF20A59601E8A"><enum>(1)</enum><header>Request</header><text>The
sponsor of a drug intended to be used to treat or prevent a qualifying pathogen
may request that the Secretary provide written recommendations for nonclinical
and clinical investigations which may be conducted with the drug before it may
be approved for such use under section 505 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21
U.S.C. 355</external-xref>).</text>
</paragraph><paragraph commented="no" id="HB7BCC8B8300D47D28F4F8E74182E2AFF"><enum>(2)</enum><header>Recommendations</header><text>If
the Secretary has reason to believe that a drug for which a request is made
under this subsection is a qualified infectious disease product, the Secretary
shall provide the person making the request written recommendations for the
nonclinical and clinical investigations which the Secretary believes, on the
basis of information available to the Secretary at the time of the request,
would be necessary for approval under section 505 of the Federal Food, Drug,
and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21
U.S.C. 355</external-xref>) of such drug for the use described in paragraph
(1).</text>
</paragraph></subsection><subsection commented="no" id="H5EE74984F504482F94239AA87AA2CB70"><enum>(c)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="H9853D397735A4BDE9E25A66C13B4853E"><enum>(1)</enum><text>The term
<term>drug</term> has the meaning given to such term in section 201 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>).</text>
</paragraph><paragraph commented="no" id="H8421866237C74C7F9B3AEC4E2BF66FEF"><enum>(2)</enum><text>The term
<term>qualified infectious disease product</term> has the meaning given to such
term in section 505E of the Federal Food, Drug, and Cosmetic Act, as added by
section 831 of this Act.</text>
</paragraph><paragraph commented="no" id="H6AFC49217D9C4972863DD94D00E3268C"><enum>(3)</enum><text>The term
<term>qualifying pathogen</term> has the meaning given to such term in section
505E of the Federal Food, Drug, and Cosmetic Act, as added by section 831 of
this Act.</text>
</paragraph><paragraph commented="no" id="H2A72986E710F4091B0FE3A394EA69166"><enum>(4)</enum><text>The term
<term>Secretary</term> means the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs.</text>
</paragraph></subsection></section><section commented="no" id="H6B110E9C8B374436B5454D270A8F8C75"><enum>834.</enum><header>Reassessment of
qualified infectious disease product incentives in 5 years</header><text display-inline="no-display-inline">Not later than five years after the date of
enactment of this Act, the Secretary of Health and Human Services shall, in
consultation with the Food and Drug Administration, Centers for Disease Control
and Prevention and other appropriate agencies, submit to the Committee on
Energy and Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report that contains the
following:</text>
<paragraph commented="no" id="H303FF3DCE8074CDBAC4561078CBD8DDF"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H8BB373107E7E462889231E802391D02F"><enum>(A)</enum><text>The number of initial
designations of drugs as qualified infectious disease products under section
505E of the Federal Food, Drug, and Cosmetic Act;</text>
</subparagraph><subparagraph commented="no" id="HF35973AEE29240F5A9548F9AEF2504E3" indent="up1"><enum>(B)</enum><text>the number of qualified infectious
disease products approved under this program; and</text>
</subparagraph><subparagraph commented="no" id="HF0BF2C99C35D4B9486AAA009CB47131D" indent="up1"><enum>(C)</enum><text display-inline="yes-display-inline">whether such products address the need for
antibacterial and antifungal drugs to treat serious and life-threatening
infections.</text>
</subparagraph></paragraph><paragraph commented="no" id="HF582E82054D74C7F8B961A0E05ABFFF8"><enum>(2)</enum><text display-inline="yes-display-inline">Recommendations—</text>
<subparagraph commented="no" id="H856D186C41F7412CB63AEE740ACE6609"><enum>(A)</enum><text>based on the
information in paragraph (1) and any other relevant data, on any changes that
should be made to the list of pathogens that are defined as qualifying
pathogens under section 505E(f)(2) of the Federal Food, Drug, and Cosmetic Act,
as added by section 831; and</text>
</subparagraph><subparagraph commented="no" id="H26DE8734A996456882FFB289BC4CEB6B"><enum>(B)</enum><text display-inline="yes-display-inline">on whether any additional program (such as
the development of public-private collaborations to advance antibacterial drug
innovation) or changes to the incentives under this subtitle may be needed to
promote the development of antibacterial drugs.</text>
</subparagraph></paragraph><paragraph commented="no" id="HE744BB72CAAD484399F2120D7EBB0C66"><enum>(3)</enum><text display-inline="yes-display-inline">An examination of—</text>
<subparagraph commented="no" id="HDFF94F5AA9864D278D821A5B0BC3D95A"><enum>(A)</enum><text display-inline="yes-display-inline">the adoption of programs to measure the use
of antibacterial drugs in health care settings; and</text>
</subparagraph><subparagraph commented="no" id="H91226C5F5A7B40CE9832C514F3486BA9"><enum>(B)</enum><text>the implementation
and effectiveness of antimicrobial stewardship protocols across all health care
settings.</text>
</subparagraph></paragraph><paragraph commented="no" id="H7F062DA06BD54C249729E7A520398AE1"><enum>(4)</enum><text>Any
recommendations for ways to encourage further development and establishment of
stewardship programs.</text>
</paragraph></section><section id="H9B228C1AF1F94C93BD0FAB96AA0018BE"><enum>835.</enum><header>Guidance on
pathogen-focused antibacterial drug development</header>
<subsection id="H90127D6A65C14F17AAB8DCBA4E16B095"><enum>(a)</enum><header>Draft
guidance</header><text display-inline="yes-display-inline">Not later than June
30, 2013, in order to facilitate the development of antibacterial drugs for
serious or life-threatening bacterial infections, particularly in areas of
unmet need, the Secretary of Health and Human Services shall publish draft
guidance that—</text>
<paragraph id="H020A5708BA584A0B832BF62092F11480"><enum>(1)</enum><text>specifies how
preclinical and clinical data can be utilized to inform an efficient and
streamlined pathogen-focused antibacterial drug development program that meets
the approval standards of the Food and Drug Administration; and</text>
</paragraph><paragraph id="H4B08D22C42AD43AA9AF7EFFA2DA1D3DC"><enum>(2)</enum><text>provides advice on
approaches for the development of antibacterial drugs that target a more
limited spectrum of pathogens.</text>
</paragraph></subsection><subsection id="H2896A6F9ECEE4391881241D7AF808F48"><enum>(b)</enum><header>Final
guidance</header><text display-inline="yes-display-inline">Not later than
December 31, 2014, after notice and opportunity for public comment on the draft
guidance under
<internal-xref idref="H90127D6A65C14F17AAB8DCBA4E16B095" legis-path="__.(a)">subsection (a)</internal-xref>, the Secretary of Health and
Human Services shall publish final guidance consistent with this
section.</text>
</subsection></section></subtitle><subtitle commented="no" id="H9C34B5AE56784D9892A2BDA750200DD4"><enum>D</enum><header>Accelerated
approval</header>
<section commented="no" id="H53B858A9CB7F45EA9FA20615C82377F3"><enum>841.</enum><header>Expedited
approval of drugs for serious or life-threatening diseases or
conditions</header>
<subsection commented="no" id="HE702FB94ECAB431D9BD3C5EEEC688BE1"><enum>(a)</enum><header>Findings; sense
of Congress</header>
<paragraph commented="no" id="H56DDFB818CF845AE8ADF19FB8EDCE324"><enum>(1)</enum><header>Findings</header><text>The
Congress finds as follows:</text>
<subparagraph commented="no" id="H65C0958E7CC4450AA7B39C91D9F37F89"><enum>(A)</enum><text>The Food and Drug
Administration (referred to in this subsection as the <quote>FDA</quote>)
serves a critical role in helping to assure that new medicines are safe and
effective. Regulatory innovation is 1 element of the Nation’s strategy to
address serious and life-threatening diseases or conditions by promoting
investment in and development of innovative treatments for unmet medical
needs.</text>
</subparagraph><subparagraph commented="no" id="H31ECE524E78C4B19AA0ED97AA4A6FA2F"><enum>(B)</enum><text>During the 2
decades following the establishment of the accelerated approval mechanism,
advances in medical sciences, including genomics, molecular biology, and
bioinformatics, have provided an unprecedented understanding of the underlying
biological mechanism and pathogenesis of disease. A new generation of modern,
targeted medicines is under development to treat serious and life-threatening
diseases, some applying drug development strategies based on biomarkers or
pharmacogenomics, predictive toxicology, clinical trial enrichment techniques,
and novel clinical trial designs, such as adaptive clinical trials.</text>
</subparagraph><subparagraph commented="no" id="HADE7FC5855804996B5B5EB86BC83999D"><enum>(C)</enum><text>As a result of
these remarkable scientific and medical advances, the FDA should be encouraged
to implement more broadly effective processes for the expedited development and
review of innovative new medicines intended to address unmet medical needs for
serious or life-threatening diseases or conditions, including those for rare
diseases or conditions, using a broad range of surrogate or clinical endpoints
and modern scientific tools earlier in the drug development cycle when
appropriate. This may result in fewer, smaller, or shorter clinical trials for
the intended patient population or targeted subpopulation without compromising
or altering the high standards of the FDA for the approval of drugs.</text>
</subparagraph><subparagraph commented="no" id="H5FFAC4439FAD4BF990C6F1526EFB81FF"><enum>(D)</enum><text>Patients benefit
from expedited access to safe and effective innovative therapies to treat unmet
medical needs for serious or life-threatening diseases or conditions.</text>
</subparagraph><subparagraph commented="no" id="HF9202F4F7B7140F2A066C8E1BB91ED77"><enum>(E)</enum><text>For these reasons,
the statutory authority in effect on the day before the date of enactment of
this Act governing expedited approval of drugs for serious or life-threatening
diseases or conditions should be amended in order to enhance the authority of
the FDA to consider appropriate scientific data, methods, and tools, and to
expedite development and access to novel treatments for patients with a broad
range of serious or life-threatening diseases or conditions.</text>
</subparagraph></paragraph><paragraph commented="no" id="HC2F9B6C428284BBA8B8BF7703C9590E5"><enum>(2)</enum><header>Sense of
Congress</header><text>It is the sense of the Congress that the FDA should
apply the accelerated approval and fast track provisions set forth in section
506 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C. 356</external-xref>), as amended by this
section, to help expedite the development and availability to patients of
treatments for serious or life-threatening diseases or conditions while
maintaining safety and effectiveness standards for such treatments.</text>
</paragraph></subsection><subsection commented="no" id="H48649788AA6949368ACE65CC013EE0A4"><enum>(b)</enum><header>Expedited
approval</header><text display-inline="yes-display-inline">Section 506
(<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C.
356</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HF7F87BD3CDA0427E990E62725C9050B8" style="OLC">
<section commented="no" id="HB18F425F1E324652B4F8843DD3EC76E8"><enum>506.</enum><header>Expedited
approval of drugs for serious or life-threatening diseases or
conditions</header>
<subsection commented="no" id="H4C85A93058E2485CBBCC88452E4C8B51"><enum>(a)</enum><header>Designation of
drug as a fast track product</header>
<paragraph commented="no" id="H8722C6FEDAC948FFB12778E61B84166F"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall,
at the request of the sponsor of a new drug, facilitate the development and
expedite the review of such drug if it is intended, whether alone or in
combination with one or more other drugs, for the treatment of a serious or
life-threatening disease or condition, and it demonstrates the potential to
address unmet medical needs for such a disease or condition. In this section,
such a drug is referred to as a <quote>fast track product</quote>.</text>
</paragraph><paragraph commented="no" id="HAD94762E3BB34FE0B75426AC2890F408"><enum>(2)</enum><header>Request for
designation</header><text>The sponsor of a new drug may request the Secretary
to designate the drug as a fast track product. A request for the designation
may be made concurrently with, or at any time after, submission of an
application for the investigation of the drug under section 505(i) of this Act
or section 351(a)(3) of the Public Health Service Act.</text>
</paragraph><paragraph commented="no" id="H9B9B0F10914F4E2D9B127CB30E185CCB"><enum>(3)</enum><header>Designation</header><text>Within
60 calendar days after the receipt of a request under paragraph (2), the
Secretary shall determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the Secretary finds that the
drug meets the criteria, the Secretary shall designate the drug as a fast track
product and shall take such actions as are appropriate to expedite the
development and review of the application for approval of such product.</text>
</paragraph></subsection><subsection commented="no" id="HA92E2C4216D040F1BEB93821CB7EE566"><enum>(b)</enum><header>Accelerated
approval of a drug for a serious or life-Threatening disease or condition,
including a fast track product</header>
<paragraph commented="no" id="HB0E78F6A73544599905B2C76F10DF245"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary may
approve an application for approval of a product for a serious or
life-threatening disease or condition, including a fast track product, under
section 505(c) of this Act or section 351(a) of the Public Health Service Act
upon making a determination that the product has an effect on—</text>
<subparagraph commented="no" id="H08D1030015434FD78F800D1C34B58519"><enum>(A)</enum><text>a surrogate
endpoint that is reasonably likely to predict clinical benefit; or</text>
</subparagraph><subparagraph commented="no" id="HB4621EF7872240C189B197A8458792A6"><enum>(B)</enum><text>a clinical
endpoint that can be measured earlier than irreversible morbidity or mortality,
that is reasonably likely to predict an effect on irreversible morbidity or
mortality or other clinical benefit,</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">taking into account the severity or
rarity of the disease or condition and the availability of alternative
treatments. The evidence to support that an endpoint is reasonably likely to
predict clinical benefit may include epidemiological, pathophysiologic,
pharmacologic, therapeutic or other evidence developed using, for example,
biomarkers, or other scientific methods or tools.</continuation-text></paragraph><paragraph commented="no" id="H763DA8062C0049BE8B90D0556205687B"><enum>(2)</enum><header>Limitation</header><text>Approval
of a product under this subsection may, as determined by the Secretary, be
subject to the following requirements—</text>
<subparagraph commented="no" id="HFAFD1EFDA0C94B5991C62B864B07563E"><enum>(A)</enum><text>that the sponsor
conduct appropriate post-approval studies to verify and describe the predicted
effect of the product on irreversible morbidity or mortality or other clinical
benefit; and</text>
</subparagraph><subparagraph commented="no" id="HFDF94BCB752F4803877759032F1EDCEB"><enum>(B)</enum><text>that the sponsor
submit copies of all promotional materials related to the product, at least 30
days prior to dissemination of the materials—</text>
<clause commented="no" id="H8614ABF9A24441B6B82CA699379CF7E5"><enum>(i)</enum><text display-inline="yes-display-inline">during the preapproval review period;
and</text>
</clause><clause commented="no" id="HBB5CB58A53FF49248442EA2ACA0E1F3C"><enum>(ii)</enum><text display-inline="yes-display-inline">following approval, for a period that the
Secretary determines to be appropriate.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="HBA21404E13CF40018F2D8B61288B6258"><enum>(3)</enum><header>Expedited
withdrawal of approval</header><text>The Secretary may withdraw approval of a
product approved pursuant to this subsection using expedited procedures (as
prescribed by the Secretary in regulations, which shall include an opportunity
for an informal hearing) if—</text>
<subparagraph commented="no" id="H6C5EDF510BF541D7BC31604A4619CEB5"><enum>(A)</enum><text>the sponsor fails
to conduct any required post-approval study of the product with due
diligence;</text>
</subparagraph><subparagraph commented="no" id="HC9A77257B7C54AD3A51810B538B6EAD9"><enum>(B)</enum><text>a study required
to verify and describe the predicted effect on irreversible morbidity or
mortality or other clinical benefit of the product fails to verify and describe
such effect or benefit;</text>
</subparagraph><subparagraph commented="no" id="H6AA229F801FA446A94F44F308D74F7CC"><enum>(C)</enum><text>other evidence
demonstrates that the product is not safe or effective under the conditions of
use; or</text>
</subparagraph><subparagraph commented="no" id="HB22E6B0C652E44EB8580B389A5FD47BB"><enum>(D)</enum><text>the sponsor
disseminates false or misleading promotional materials with respect to the
product.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HFE5D9E6B7E674CF29DB99936FF6CAE92"><enum>(c)</enum><header>Review of
incomplete applications for approval of a fast track product</header>
<paragraph commented="no" id="HC810F4546CFB4D86A718049DA8FE9208"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">If the Secretary
determines, after preliminary evaluation of clinical data submitted by the
sponsor, that a fast track product may be effective, the Secretary shall
evaluate for filing, and may commence review of portions of, an application for
the approval of the product before the sponsor submits a complete application.
The Secretary shall commence such review only if the applicant—</text>
<subparagraph commented="no" id="H3BD2E44AD589441CB404852C7079972A"><enum>(A)</enum><text>provides a
schedule for submission of information necessary to make the application
complete; and</text>
</subparagraph><subparagraph commented="no" id="H2BAB9914B7844C4C9FD0E42CC021E558"><enum>(B)</enum><text>pays any fee that
may be required under section 736.</text>
</subparagraph></paragraph><paragraph commented="no" id="H4DB6CD9774ED40038C536388B2FE5CCF"><enum>(2)</enum><header>Exception</header><text>Any
time period for review of human drug applications that has been agreed to by
the Secretary and that has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under section 736 to expedite
the drug development process and the review of human drug applications) shall
not apply to an application submitted under paragraph (1) until the date on
which the application is complete.</text>
</paragraph></subsection><subsection commented="no" id="H13E5FBC1B0694A87B3809D2401180C08"><enum>(d)</enum><header>Awareness
efforts</header><text>The Secretary shall—</text>
<paragraph commented="no" id="H43C0F48E665B48C2A93445124F53D100"><enum>(1)</enum><text>develop and
disseminate to physicians, patient organizations, pharmaceutical and
biotechnology companies, and other appropriate persons a description of the
provisions of this section applicable to accelerated approval and fast track
products; and</text>
</paragraph><paragraph commented="no" id="HCBA174A36A864AE38557D9938521633C"><enum>(2)</enum><text>establish a
program to encourage the development of surrogate and clinical endpoints,
including biomarkers, and other scientific methods and tools that can assist
the Secretary in determining whether the evidence submitted in an application
is reasonably likely to predict clinical benefit for serious or
life-threatening conditions for which there exist significant unmet medical
needs.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section commented="no" id="H303955724DC94698BA6B71AD655B62E3"><enum>842.</enum><header>Guidance;
amended regulations</header>
<subsection commented="no" id="HD518C15678B64AB687DCB3D1A3827A6A"><enum>(a)</enum><header>Initial
guidance</header><text display-inline="yes-display-inline">Not later than one
year after the date of enactment of this Act, the Secretary of Health and Human
Services (in this subtitle referred to as the <quote>Secretary</quote>) shall
issue draft guidance to implement the amendment made by section 841.</text>
</subsection><subsection commented="no" id="H46245A94743C43E78350AB95D76938C4"><enum>(b)</enum><header>Final
guidance</header><text display-inline="yes-display-inline">Not later than one
year after the issuance of draft guidance under
<internal-xref idref="HD518C15678B64AB687DCB3D1A3827A6A" legis-path="3.(a)">subsection (a)</internal-xref>, after an opportunity for
public comment, the Secretary shall—</text>
<paragraph commented="no" id="H6589D6ED376F493DA14ECF8A64D9D107"><enum>(1)</enum><text display-inline="yes-display-inline">issue final guidance to implement the
amendment made by section 841; and</text>
</paragraph><paragraph commented="no" id="H5C48BF0CE00A4FD382A0A8DCA1805C2A"><enum>(2)</enum><text display-inline="yes-display-inline">amend the regulations governing accelerated
approval in parts 314 and 601 of title 21, Code of Federal Regulations, as
necessary to conform such regulations with the amendments made by section
841.</text>
</paragraph></subsection><subsection commented="no" id="H0CD49AD02D77421681F699E7A70703DF"><enum>(c)</enum><header>Considerations</header><text>In
developing the guidance under subsections (a) and (b)(1) and the amendments
under subsection (b)(2), the Secretary shall consider—</text>
<paragraph commented="no" id="H0BD0FCF721654E378CDECE2ABD401F2A"><enum>(1)</enum><text display-inline="yes-display-inline">issues arising under the accelerated
approval and fast track processes under section 506 of the Federal Food, Drug,
and Cosmetic Act (as amended by section 841) for drugs designated for a rare
disease or condition under section 526 of the Federal, Food, Drug, and Cosmetic
Act; and</text>
</paragraph><paragraph commented="no" id="H22C8EAEA91C84FCBA2CB97BC1A996601"><enum>(2)</enum><text>how to incorporate
novel approaches to the review of surrogate endpoints based on pathophysiologic
and pharmacologic evidence in such guidance, especially in instances where the
low prevalence of a disease renders the existence or collection of other types
of data unlikely or impractical.</text>
</paragraph></subsection><subsection commented="no" id="H7E1B1404B5C74139957BE17147EB56A2"><enum>(d)</enum><header>No delay in
review or approval</header><text display-inline="yes-display-inline">The
issuance (or non-issuance) of guidance or conforming regulations implementing
the amendments made by section 841 shall not preclude the review of, or action
on, a request for designation or an application for approval submitted pursuant
to section 506 of the Federal Food, Drug, and Cosmetic Act, as amended by
section 841.</text>
</subsection></section><section commented="no" id="HF5AABD391FD24DB6AB832FEFF7EAFB5B"><enum>843.</enum><header>Independent
review</header>
<subsection commented="no" id="H47345D4CD5864FB0A29B71DD9F130549"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary may, in
conjunction with other planned reviews of the new drug review process, contract
with an independent entity with expertise in assessing the quality and
efficiency of biopharmaceutical development and regulatory review programs, to
evaluate the Food and Drug Administration’s application of the processes
described in section 506 of the Federal Food, Drug, and Cosmetic Act, as
amended by section 841, and the impact of such processes on the development and
timely availability of innovative treatments for patients suffering from
serious or life-threatening conditions.</text>
</subsection><subsection commented="no" id="H9EC2226A293541EFB00433F3FDE2EC0B"><enum>(b)</enum><header>Consultation</header><text>Any
evaluation under
<internal-xref idref="H47345D4CD5864FB0A29B71DD9F130549" legis-path="4.(a)">subsection (a)</internal-xref> shall include consultation
with regulated industries, patient advocacy and disease research foundations,
and relevant academic medical centers.</text>
</subsection></section></subtitle><subtitle commented="no" id="H62EF36DC21C34A0A820B8152C2F0031A"><enum>E</enum><header>Critical path
reauthorization</header>
<section commented="no" id="HBDE412BB3B844601AF514A78604B0858"><enum>851.</enum><header>Reauthorization
of the critical path public-private partnerships</header><text display-inline="no-display-inline">Subsection (f) of section 566
(<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-5">21 U.S.C.
360bbb–5</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H4ED907A997D144BDBBB69821A8C3988C" style="OLC">
<subsection commented="no" id="H32F0099C1A9F4799A462805272495B4B"><enum>(f)</enum><header>Authorization of
appropriations</header><text display-inline="yes-display-inline">To carry out
this section, there is authorized to be appropriated $6,000,000 for each of
fiscal years 2013 through
2017.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section></subtitle><subtitle commented="no" id="HA66DF5B95304436CA445FC09BAE41D63"><enum>F</enum><header>Miscellaneous</header>
<section commented="no" id="HFEC5B7D303854832B27F80D17E9A9608"><enum>861.</enum><header>Reauthorization
of provision relating to exclusivity of certain drugs containing single
enantiomers</header><text display-inline="no-display-inline">Section 505(u)(4)
(<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C.
355(u)(4)</external-xref>) is amended by striking <quote>2012</quote> and
inserting <quote>2017</quote>.</text>
</section><section id="H586DB0022C9E4BCF92BB16DCE405259D" section-type="subsequent-section"><enum>862.</enum><header>Extension of period
for first applicant To obtain tentative approval without forfeiting 180-day
exclusivity period</header>
<subsection id="H6E1076D130CF4F32B5757257A6C429B6"><enum>(a)</enum><header>Extension</header>
<paragraph id="H2B7AB4BF99B04DFF90A55C5359CF74DB"><enum>(1)</enum><header>In
general</header><text>If a first applicant files an application during the
30-month period ending on the date of enactment of this Act and such
application initially contains a certification described in paragraph
(2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, and Cosmetic Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C.
355(j)</external-xref>), or if a first applicant files an application and the
application is amended during such period to first contain such a
certification, the phrase <quote>30 months</quote> in paragraph (5)(D)(i)(IV)
of such section shall, with respect to such application, be read as
meaning—</text>
<subparagraph id="H1AA36912B3314B30861C38D603F16272"><enum>(A)</enum><text>during the period
beginning on the date of enactment of this Act, and ending on September 30,
2013, <quote>45 months</quote>;</text>
</subparagraph><subparagraph id="H2C2F9013EF2C40DE80CB6BC2761415F9"><enum>(B)</enum><text>during the period
beginning on October 1, 2013, and ending on September 30, 2014, <quote>42
months</quote>;</text>
</subparagraph><subparagraph id="HE0E99E70BBCF44A49676F78B794F7D3C"><enum>(C)</enum><text display-inline="yes-display-inline">during the period beginning on October 1,
2014, and ending on September 30, 2015, <quote>39 months</quote>; and</text>
</subparagraph><subparagraph id="H2859132B47764363B802A989F34438A3"><enum>(D)</enum><text display-inline="yes-display-inline">during the period beginning on October 1,
2015, and ending on September 30, 2016, <quote>36 months</quote>.</text>
</subparagraph></paragraph><paragraph id="H4D7BAA65B40440818BA190D2B9F0D14D"><enum>(2)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">In the case of an
application to which an extended period under paragraph (1) applies, the
reference to the 30-month period under section 505(q)(1)(G) of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(q)(1)(G)</external-xref>) shall be
read to be the applicable period under paragraph (1).</text>
</paragraph></subsection><subsection id="H07041359B2BB4747BEFF3A96939867B0"><enum>(b)</enum><header>Period for
obtaining tentative approval of certain applications</header><text display-inline="yes-display-inline">If an application is filed on or before the
date of enactment of this Act and such application is amended during the period
beginning on the day after the date of enactment of this Act and ending on
September 30, 2017, to first contain a certification described in paragraph
(2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, and Cosmetic Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C.
355(j)</external-xref>), the date of the filing of such amendment (rather than
the date of the filing of such application) shall be treated as the beginning
of the 30-month period described in paragraph (5)(D)(i)(IV) of such section
505(j).</text>
</subsection><subsection id="HC65F97A77C85469B86A28FDCFED85260"><enum>(c)</enum><header>Definitions</header><text display-inline="yes-display-inline">For the purposes of this section, the terms
<quote>application</quote> and <quote>first applicant</quote> mean application
and first applicant, as such terms are used in section 505(j)(5)(D)(i)(IV) of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C.
355(j)(5)(D)(i)(IV)</external-xref>).</text>
</subsection></section><section commented="no" id="H3FB9B4B214CF4E54B5E69BD0347307E1" section-type="subsequent-section"><enum>863.</enum><header>Final agency action
relating to petitions and civil actions</header><text display-inline="no-display-inline">Section 505(q) (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(q)</external-xref>) is
amended—</text>
<paragraph commented="no" id="H75FD8A48AC0E4AD0BA0BE2B05238F808"><enum>(1)</enum><text>in paragraph
(1)—</text>
<subparagraph id="HE1E8C6B42F614FB7BB7A6C7A9160F193"><enum>(A)</enum><text>in subparagraph
(A), by striking <quote>subsection (b)(2) or (j)</quote> inserting
<quote>subsection (b)(2) or (j) of the Act or 351(k) of the Public Health
Service Act</quote>; and</text>
</subparagraph><subparagraph id="HDBAA9B8224384728B91947797E4D9DF6"><enum>(B)</enum><text>in subparagraph
(F), by striking <quote>180 days</quote> and inserting <quote>150 days</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" id="HBD07DFADE56F4A04904D90351831AFCB"><enum>(2)</enum><text>in paragraph
(2)(A)—</text>
<subparagraph commented="no" id="H5F0E88C42B1344CD8A68DDCB73D7991D"><enum>(A)</enum><text display-inline="yes-display-inline">in the subparagraph heading, by striking
<quote><header-in-text level="subparagraph" style="OLC">180</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">150</header-in-text></quote>; and</text>
</subparagraph><subparagraph commented="no" id="H92F1F9798DC74440A83D854301345092"><enum>(B)</enum><text>in clause (i), by
striking <quote>180-day</quote> and inserting <quote>150-day</quote>;
and</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="HFBB6304BCA4D433093C47E551EA5FB26"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (5), by striking
<quote>subsection (b)(2) or (j)</quote> inserting <quote>subsection (b)(2) or
(j) of the Act or 351(k) of the Public Health Service Act</quote>.</text>
</paragraph></section><section commented="no" id="H2EE8B184D221470A9C19AB9B130B7131"><enum>864.</enum><header>Deadline for
determination on certain petitions</header>
<subsection commented="no" id="H66DA13AC8B134385B79D4BA169ED021B"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 505
(<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C.
355</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H386B6277AEAC47D9BE12C81BF67DD5B7" style="OLC">
<subsection commented="no" id="H7BC4568A4DDC470A80465E62A0CA562D"><enum>(w)</enum><header>Deadline for
determination on certain petitions</header><text display-inline="yes-display-inline">The Secretary shall issue a final,
substantive determination on a petition submitted pursuant to subsection (b) of
<external-xref legal-doc="regulation" parsable-cite="cfr/21/314.161">section
314.161</external-xref> of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date the petition is
submitted.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="H2A382D614BE54CC2AF883EE390A4AD88"><enum>(b)</enum><header>Application</header><text display-inline="yes-display-inline">The amendment made by
<internal-xref idref="H66DA13AC8B134385B79D4BA169ED021B" legis-path="__.(a)">subsection (a)</internal-xref> shall apply to any petition
that is submitted pursuant to subsection (b) of
<external-xref legal-doc="regulation" parsable-cite="cfr/21/314.161">section
314.161</external-xref> of title 21, Code of Federal Regulations (or any
successor regulations), on or after the date of enactment of this Act.</text>
</subsection></section><section commented="no" id="HBA82DA9DDEF8489EBF927F539A13B034"><enum>865.</enum><header>Rare pediatric
disease priority review voucher incentive program</header><text display-inline="no-display-inline">Subchapter B of Chapter V (<external-xref legal-doc="usc" parsable-cite="usc/21/360aa">21 U.S.C. 360aa et
seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H26C8126D6DD34888A3308A2ECF830849" style="OLC">
<section commented="no" id="H1AA0AB28FD024788BB50BB2E1B500B0B"><enum>529.</enum><header>Priority review
to encourage treatments for rare pediatric diseases</header>
<subsection commented="no" id="H5CDD78F3FC88476E93EB1A4C9515EA65"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="HE23964FBB6CB42F6B61E77E35DC9AE3B"><enum>(1)</enum><header>Priority
review</header><text>The term <term>priority review</term>, with respect to a
human drug application as defined in section 735(1), means review and action by
the Secretary on such application not later than 6 months after receipt by the
Secretary of such application, as described in the Manual of Policies and
Procedures of the Food and Drug Administration and goals identified in the
letters described in section 101(b) of the Prescription Drug User Fee
Amendments of 2012.</text>
</paragraph><paragraph commented="no" id="H0D51F89CE9184E5FBB8D803F5F241C6C"><enum>(2)</enum><header>Priority review
voucher</header><text>The term <term>priority review voucher</term> means a
voucher issued by the Secretary to the sponsor of a rare pediatric disease
product application that entitles the holder of such voucher to priority review
of a single human drug application submitted under section 505(b)(1) or section
351(a) of the Public Health Service Act after the date of approval of the rare
pediatric disease product application.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="HF50CB830D89D408296553B67C167B61A"><enum>(3)</enum><header>Rare pediatric
disease</header><text>The term <term>rare pediatric disease</term> means a
disease that meets each of the following criteria:</text>
<subparagraph commented="no" id="HB6E6F26D50B14401BACE414EA2EB9E9B"><enum>(A)</enum><text>The disease
primarily affects individuals aged from birth to 18 years, including age groups
often called neonates, infants, children, and adolescents.</text>
</subparagraph><subparagraph commented="no" id="H4E73E4DBD9B04A3B94F95F8807C3C225"><enum>(B)</enum><text>The disease is a
rare disease or condition, within the meaning of section 526.</text>
</subparagraph></paragraph><paragraph commented="no" id="HD0194AF2B971410DAD17C1513F5BF47F"><enum>(4)</enum><header>Rare pediatric
disease product application</header><text>The term <term>rare pediatric disease
product application</term> means a human drug application, as defined in
section 735(1), that—</text>
<subparagraph commented="no" id="HD3F4A3E72E5142618BD74D328C89C0BB"><enum>(A)</enum><text>is for a drug or
biological product—</text>
<clause commented="no" id="H7D788EB1A2E94CBBAB894AB6AC20CC79"><enum>(i)</enum><text>that is for the
prevention or treatment of a rare pediatric disease; and</text>
</clause><clause commented="no" id="H35B7B661DC694BD8AAE6D11F3DD5A8E2"><enum>(ii)</enum><text>that contains no
active ingredient (including any ester or salt of the active ingredient) that
has been previously approved in any other application under section 505(b)(1),
505(b)(2), or 505(j) of this Act or section 351(a) or 351(k) of the Public
Health Service Act;</text>
</clause></subparagraph><subparagraph commented="no" id="HE53BD34A1EED492785BEBD74758A8470"><enum>(B)</enum><text>is submitted under
section 505(b)(1) of this Act or section 351(a) of the Public Health Service
Act;</text>
</subparagraph><subparagraph commented="no" id="HE43EB20077644B69A7AD26C114A1F668"><enum>(C)</enum><text>the Secretary
deems eligible for priority review;</text>
</subparagraph><subparagraph commented="no" id="HE63C5C85901942F1A5266ED74D43FC5A"><enum>(D)</enum><text>that relies on
clinical data derived from studies examining a pediatric population and dosages
of the drug intended for that population;</text>
</subparagraph><subparagraph commented="no" id="H7242865547194CC1B9005E0A34602A04"><enum>(E)</enum><text>that does not seek
approval for an adult indication in the original rare pediatric disease product
application; and</text>
</subparagraph><subparagraph commented="no" id="H7462C1C82E504A02A4E2F3D15C9B02D4"><enum>(F)</enum><text>is approved after
the date of the enactment of the Prescription Drug User Fee Amendments of
2012.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H625FF981BC9F4E1EB5F8961A3BD48185"><enum>(b)</enum><header>Priority Review
Voucher</header>
<paragraph commented="no" id="H36C7564786E3467C8710642C3B3E43F3"><enum>(1)</enum><header>In
general</header><text>The Secretary shall award a priority review voucher to
the sponsor of a rare pediatric disease product application upon approval by
the Secretary of such rare pediatric disease product application.</text>
</paragraph><paragraph commented="no" id="HCE09B482AC61444894BABCA788C137A5"><enum>(2)</enum><header>Transferability</header>
<subparagraph commented="no" id="H35219A70BCCE4576A5994AB1D990D8E8"><enum>(A)</enum><header>In
general</header><text>The sponsor of a rare pediatric disease product
application that receives a priority review voucher under this section may
transfer (including by sale) the entitlement to such voucher. There is no limit
on the number of times a priority review voucher may be transferred before such
voucher is used.</text>
</subparagraph><subparagraph commented="no" id="H583D90F94A62409CA5574961CA0F6F72"><enum>(B)</enum><header>Notification of
transfer</header><text>Each person to whom a voucher is transferred shall
notify the Secretary of such change in ownership of the voucher not later than
30 days after such transfer.</text>
</subparagraph></paragraph><paragraph commented="no" id="H0A258A8DF44342278C06F077B0B88D3B"><enum>(3)</enum><header>Limitation</header><text display-inline="yes-display-inline">A sponsor of a rare pediatric disease
product application may not receive a priority review voucher under this
section if the rare pediatric disease product application was submitted to the
Secretary prior to the date that is 90 days after the date of enactment of the
Prescription Drug User Fee Amendments of 2012.</text>
</paragraph><paragraph commented="no" id="H9390943EFD6141E4916354741E9024AD"><enum>(4)</enum><header>Notification</header>
<subparagraph commented="no" id="H427F0D3B709C4BD5A644CA210A065A58"><enum>(A)</enum><header>In
general</header><text>The sponsor of a human drug application shall notify the
Secretary not later than 90 days prior to submission of the human drug
application that is the subject of a priority review voucher of an intent to
submit the human drug application, including the date on which the sponsor
intends to submit the application. Such notification shall be a legally binding
commitment to pay for the user fee to be assessed in accordance with this
section.</text>
</subparagraph><subparagraph commented="no" id="HF2C4874F98FD4E6DA7723CB647FE4B1E"><enum>(B)</enum><header>Transfer after
notice</header><text>The sponsor of a human drug application that provides
notification of the intent of such sponsor to use the voucher for the human
drug application under
<internal-xref idref="H427F0D3B709C4BD5A644CA210A065A58" legis-path="529.(b)(4)(A)">subparagraph (A)</internal-xref> may transfer the
voucher after such notification is provided, if such sponsor has not yet
submitted the human drug application described in the notification.</text>
</subparagraph></paragraph><paragraph commented="no" id="H89914ED806104D5CAF33958A3C2EFBE0"><enum>(5)</enum><header>Termination of
authority</header><text display-inline="yes-display-inline">The Secretary may
not award any priority review vouchers under
<internal-xref idref="H36C7564786E3467C8710642C3B3E43F3" legis-path="529.(b)(1)">paragraph (1)</internal-xref> after the last day of the
1-year period that begins on the date that the Secretary awards the third rare
pediatric disease priority voucher under this section.</text>
</paragraph></subsection><subsection commented="no" id="HFA0175AA106B446480BB2E885632F8CE"><enum>(c)</enum><header>Priority Review
User Fee</header>
<paragraph commented="no" id="HBC25F7B1C4E64F33969E95E2A28A8B9E"><enum>(1)</enum><header>In
general</header><text>The Secretary shall establish a user fee program under
which a sponsor of a human drug application that is the subject of a priority
review voucher shall pay to the Secretary a fee determined under paragraph (2).
Such fee shall be in addition to any fee required to be submitted by the
sponsor under chapter VII.</text>
</paragraph><paragraph commented="no" id="HBDDE60B294A34F8EB0D9CABDC901CE6D"><enum>(2)</enum><header>Fee
amount</header><text>The amount of the priority review user fee shall be
determined each fiscal year by the Secretary, based on the difference
between—</text>
<subparagraph commented="no" id="H5B910C5909974743BF8E21575819475B"><enum>(A)</enum><text>the average cost
incurred by the Food and Drug Administration in the review of a human drug
application subject to priority review in the previous fiscal year; and</text>
</subparagraph><subparagraph commented="no" id="H095A6A0C614C4DA39F77BA1CA70D6C07"><enum>(B)</enum><text>the average cost
incurred by the Food and Drug Administration in the review of a human drug
application that is not subject to priority review in the previous fiscal
year.</text>
</subparagraph></paragraph><paragraph commented="no" id="HF02594E088374E39B4931E9E9B4FD4B4"><enum>(3)</enum><header>Annual fee
setting</header><text>The Secretary shall establish, before the beginning of
each fiscal year beginning after September 30, 2012, the amount of the priority
review user fee for that fiscal year.</text>
</paragraph><paragraph commented="no" id="H1A6D49707D80460D91D0D8D46BB5D733"><enum>(4)</enum><header>Payment</header>
<subparagraph commented="no" id="HCC90A7D3BD614B02930F6CC02D243027"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">The priority review
user fee required by this subsection shall be due upon the notification by a
sponsor of the intent of such sponsor to use the voucher, as specified in
subsection (b)(4)(A). All other user fees associated with the human drug
application shall be due as required by the Secretary or under applicable
law.</text>
</subparagraph><subparagraph commented="no" id="H8C260E59A0BA42ADAC5C995FAE869C80"><enum>(B)</enum><header>Complete
application</header><text>An application described under subparagraph (A) for
which the sponsor requests the use of a priority review voucher shall be
considered incomplete if the fee required by this subsection and all other
applicable user fees are not paid in accordance with the Secretary's procedures
for paying such fees.</text>
</subparagraph><subparagraph commented="no" id="H86DED5B1D7A84CF4A903865A00B60D1D"><enum>(C)</enum><header>No waivers,
exemptions, reductions, or refunds</header><text display-inline="yes-display-inline">The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due and payable under this
section.</text>
</subparagraph></paragraph><paragraph commented="no" id="H111C4990773C41078F0341399507F4BB"><enum>(5)</enum><header>Offsetting
collections</header><text>Fees collected pursuant to this subsection for any
fiscal year—</text>
<subparagraph commented="no" id="H8E827F1789A44AE3AD179FE8F1ED2302"><enum>(A)</enum><text>shall be deposited
and credited as offsetting collections to the account providing appropriations
to the Food and Drug Administration; and</text>
</subparagraph><subparagraph commented="no" id="H1A109E94F07C4D939A629EA8070EBE92"><enum>(B)</enum><text>shall not be
collected for any fiscal year except to the extent provided in advance in
appropriation Acts.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="HB5E79D03B17546D28DBD4AE961A0D833"><enum>(d)</enum><header>Designation
process</header>
<paragraph commented="no" id="HF81473A6CAF04B8C946DEC5F950B262E"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Upon the request of
the manufacturer or the sponsor of a new drug, the Secretary may
designate—</text>
<subparagraph commented="no" id="H80CA7B948E4F4FDBB63424097DD02F4D"><enum>(A)</enum><text>the new drug as a
drug for a rare pediatric disease; and</text>
</subparagraph><subparagraph commented="no" id="H52109FF6000648C2867F01DDB223804B"><enum>(B)</enum><text>the application
for the new drug as a rare pediatric disease product application.</text>
</subparagraph></paragraph><paragraph commented="no" id="H308EE162A9F947C2BE8964E43A828E73"><enum>(2)</enum><header>Request for
designation</header><text>The request for a designation under
<internal-xref idref="HF81473A6CAF04B8C946DEC5F950B262E" legis-path="529.(d)(1)">paragraph (1)</internal-xref>, shall be made at the
same time a request for designation of orphan disease status under section 526
or fast-track designation under section 506 is made. Requesting designation
under this subsection is not a prerequisite to receiving a priority review
voucher under this section.</text>
</paragraph><paragraph commented="no" id="HEAADB57D10A743DC88D83E28AAA737A2"><enum>(3)</enum><header>Determination by
Secretary</header><text>Not later than 60 days after a request is submitted
under
<internal-xref idref="HF81473A6CAF04B8C946DEC5F950B262E" legis-path="529.(d)(1)">paragraph (1)</internal-xref>, the Secretary shall
determine whether—</text>
<subparagraph commented="no" id="H6FFE02B358344AB2AD541B34E9DCACB4"><enum>(A)</enum><text>the disease or
condition that is the subject of such request is a rare pediatric disease;
and</text>
</subparagraph><subparagraph commented="no" id="HDFE4130884EE40F59B5B51E88CEFD365"><enum>(B)</enum><text>the application
for the new drug is a rare pediatric disease product application.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="HF096EA3A806549ABB28B7827B6FBE793"><enum>(e)</enum><header>Marketing of
rare pediatric disease products</header>
<paragraph commented="no" id="H1FCC6AD68CB340CFB624FFE3E00508C3"><enum>(1)</enum><header>In
general</header><text>The Secretary shall deem a rare pediatric disease product
application incomplete if such application does not contain a description of
the plan of the sponsor of such application to market the product in the United
States.</text>
</paragraph><paragraph commented="no" id="H2D279C9C040141C48D2A4BB69430311F"><enum>(2)</enum><header>Revocation</header><text display-inline="yes-display-inline">The Secretary may revoke any priority
review voucher awarded under
<internal-xref idref="H625FF981BC9F4E1EB5F8961A3BD48185" legis-path="529.(b)">subsection (b)</internal-xref> if the rare pediatric
disease product for which such voucher was awarded is not marketed in the
United States within the 365 day period beginning on the date of the approval
of such drug under section 505 of this Act or section 351 of the Public Health
Service Act.</text>
</paragraph><paragraph commented="no" id="H8F28AC6DE85C4F97A1CA55D4C302F2EE"><enum>(3)</enum><header>Postapproval
production report</header><text>The sponsor of an approved rare pediatric
disease product shall submit a report to the Secretary not later than 5 years
after the approval of the applicable rare pediatric disease product
application. Such report shall provide the following information, with respect
to each of the first 4 years after approval of such product:</text>
<subparagraph commented="no" id="H3CC90C3766D147FAA4A086695C545E8F"><enum>(A)</enum><text>The estimated
population in the United States suffering from the rare pediatric
disease.</text>
</subparagraph><subparagraph commented="no" id="H30F9B85899784EE2B513FA91F87D2E64"><enum>(B)</enum><text>The estimated
demand in the United States for such rare pediatric disease product.</text>
</subparagraph><subparagraph commented="no" id="HED147DAFFCE443B8A8716883E82FD59B"><enum>(C)</enum><text>The actual amount
of such rare pediatric disease product distributed in the United States.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H34F12C1CFCA0453488185B54CB3CC3D4"><enum>(f)</enum><header>Notice and
report</header>
<paragraph commented="no" id="HACE49BDBDEE94D8F9CCAAF6B6B952C58"><enum>(1)</enum><header>Notice of
issuance of voucher and approval of products under voucher</header><text display-inline="yes-display-inline">The Secretary shall publish a notice in the
Federal Register and on the Web site of the Food and Drug Administration not
later than 30 days after the occurrence of each of the following:</text>
<subparagraph commented="no" id="H06021F04ADCF456A9D0F22BA2072B8FF"><enum>(A)</enum><text>The Secretary
issues a priority review voucher under this section.</text>
</subparagraph><subparagraph commented="no" id="H13EC10AAC1CB4F52BC93495CCA9F937A"><enum>(B)</enum><text display-inline="yes-display-inline">The Secretary approves a drug pursuant to
an application submitted under section 505(b) of this Act or section 351(a) of
the Public Health Service Act for which the sponsor of the application used a
priority review voucher under this section.</text>
</subparagraph></paragraph><paragraph commented="no" id="H4276FE3BFEC348D4BF08D44A99A28464"><enum>(2)</enum><header>Report</header><text display-inline="yes-display-inline">If, after the last day of the 1-year period
that begins on the date that the Secretary awards the third rare pediatric
disease priority voucher under this section, a sponsor of an application
submitted under section 505(b) of this Act or section 351(a) of the Public
Health Service Act for a drug uses a priority review voucher under this section
for such application, the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a document—</text>
<subparagraph commented="no" id="H58E9B57F20E047CF96ADC98209EE1833"><enum>(A)</enum><text>notifying such
Committees of the use of such voucher; and</text>
</subparagraph><subparagraph commented="no" id="H293C1D83F6B047F48F6B63AEB45DA7DD"><enum>(B)</enum><text>identifying the
drug for which such priority review voucher is used.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="H1A69729FFF8B4F33A5DC126EF6EA69F1"><enum>(g)</enum><header>Eligibility for
other programs</header><text>Nothing in this section precludes a sponsor who
seeks a priority review voucher under this section from participating in any
other incentive program, including under this Act.</text>
</subsection><subsection commented="no" id="H057358838F3548BD9D5CA06BE9E69B79"><enum>(h)</enum><header>Relation to
other provisions</header><text>The provisions of this section shall supplement,
not supplant, any other provisions of this Act or the Public Health Service Act
that encourage the development of drugs for tropical diseases and rare
pediatric diseases.</text>
</subsection><subsection commented="no" id="H47706891D8A64D8FA410DC34A1A976FF"><enum>(i)</enum><header>GAO study and
report</header>
<paragraph commented="no" id="HD762312F18674D698BA95F832F079F94"><enum>(1)</enum><header>Study</header>
<subparagraph commented="no" id="HDF18F3E5C1614C138F58D3C1A4D9C918"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">Beginning on the date
that the Secretary awards the third rare pediatric disease priority voucher
under this section, the Comptroller General of the United States shall conduct
a study of the effectiveness of awarding rare pediatric disease priority
vouchers under this section in the development of on human drug products that
treat or prevent such diseases.</text>
</subparagraph><subparagraph commented="no" id="H29BD3D5F6278466985E0211ED9D5749B"><enum>(B)</enum><header>Contents of
study</header><text>In conducting the study under
<internal-xref idref="HDF18F3E5C1614C138F58D3C1A4D9C918" legis-path="529.(i)(1)(A)">subparagraph (A)</internal-xref>, the Comptroller
General shall examine the following:</text>
<clause commented="no" id="HFC699BE97F30420696206F5C41D4E121"><enum>(i)</enum><text>The indications
for which each rare disease product for which a priority review voucher was
awarded was approved under section 505 or section 351 of the Public Health
Service Act.</text>
</clause><clause commented="no" id="H14D7B909A77848059302193380826B30"><enum>(ii)</enum><text>Whether, and to
what extent, an unmet need related to the treatment or prevention of a rare
pediatric disease was met through the approval of such a rare disease
product.</text>
</clause><clause commented="no" id="HAE09B8C3E7144E8FA2ECF772DD201EFE"><enum>(iii)</enum><text display-inline="yes-display-inline">The value of the priority review voucher if
transferred.</text>
</clause><clause commented="no" id="H840D4DB31FB9432FA3F4DBDE7F82392A"><enum>(iv)</enum><text>Identification of
each drug for which a priority review voucher was used.</text>
</clause><clause commented="no" id="H48BD4F3F61664420977C6EC850EA9990"><enum>(v)</enum><text>The length of the
period of time between the date on which a priority review voucher was awarded
and the date on which it was used.</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H652F68287C5A40AA8B9DCA1BC5DF3101"><enum>(2)</enum><header>Report</header><text>Not
later than 1 year after the date under
<internal-xref idref="HDF18F3E5C1614C138F58D3C1A4D9C918" legis-path="529.(i)(1)(A)">paragraph (1)(A)</internal-xref>, the Comptroller
General shall submit to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and Pensions of
the Senate, a report containing the results of the study under
<internal-xref idref="HD762312F18674D698BA95F832F079F94" legis-path="529.(i)(1)">paragraph
(1)</internal-xref>.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="H8E274DCD00224DAEA43949233DB8BE51" section-type="subsequent-section"><enum>866.</enum><header>Combating
prescription drug abuse</header>
<subsection commented="no" display-inline="no-display-inline" id="H8CEE496F1E084C84B68BD31687A8241B"><enum>(a)</enum><header>In
general</header><text>To combat the significant rise in prescription drug abuse
and the consequences of such abuse, the Secretary of Health and Human Services
(referred to in this section as the <quote>Secretary</quote>), acting through
the Commissioner of Food and Drugs (referred to in this section as the
<quote>Commissioner</quote>) and in coordination with other Federal agencies,
as appropriate, shall review current Federal initiatives and identify gaps and
opportunities with respect to ensuring the safe use of prescription drugs with
the potential for abuse.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="HDE22807006974885944C9474C1A31EAF"><enum>(b)</enum><header>Report</header><text>Not
later than 1 year after the date of enactment of this Act, the Secretary shall
issue a report to Congress on the findings of the review under subsection (a).
Such report shall include recommendations on—</text>
<paragraph commented="no" id="H9F76AE26BB3C4C26BB1B0B0E5F4AA6F8"><enum>(1)</enum><text>how best to
leverage and build upon existing Federal and federally funded data sources,
such as prescription drug monitoring program data and the sentinel initiative
of the Food and Drug Administration under section 505(k)(3) of the Federal
Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351(k)(3)</external-xref>), as it relates
to collection of information relevant to adverse events, patient safety, and
patient outcomes, to create a centralized data clearinghouse and early warning
tool;</text>
</paragraph><paragraph commented="no" id="H59C08EB212D74B98880CBCB152A85D5D"><enum>(2)</enum><text>how best to
develop and disseminate widely best practices models and suggested standard
requirements to States for achieving greater interoperability and effectiveness
of prescription drug monitoring programs, especially with respect to producing
standardized data on adverse events, patient safety, and patient outcomes;
and</text>
</paragraph><paragraph commented="no" id="HCA98D660200241F38151CE2BA45C45E3"><enum>(3)</enum><text>how best to
develop provider and patient education tools and a strategy to widely
disseminate such tools and assess the efficacy of such tools.</text>
</paragraph></subsection><subsection commented="no" id="H4DE955CDDE334EC1A29309D9694F9DFA"><enum>(c)</enum><header>Guidance on
tamper-Deterrent products</header><text>Not later than 6 months after the date
of enactment of this Act, the Secretary, acting through the Commissioner, shall
promulgate guidance on the development of tamper-deterrent drug
products.</text>
</subsection></section><section commented="no" id="H266670E6B9BB4AE2AB9ADE238B323661" section-type="subsequent-section"><enum>867.</enum><header>Assessment and
modification of REMS</header>
<subsection commented="no" id="HED85B420645C45B7B37B1FD4C958EA65"><enum>(a)</enum><header>Assessment and
modification of approved strategy</header><text display-inline="yes-display-inline">Section 505–1(g) (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C.
355–1(g)</external-xref>) is amended—</text>
<paragraph commented="no" id="H0A91C592DB074EA6BCA0116965E9BA40"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>, and propose a modification to,</quote>;</text>
</paragraph><paragraph commented="no" id="HD9281FB930BF4020B7B07939B1EF448D"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text>
<subparagraph commented="no" id="H156EE8B3CE5E4035A55A70E0B4F825FD"><enum>(A)</enum><text>in the matter
before subparagraph (A)—</text>
<clause commented="no" id="H478C605C0CF24DAC93D45D71DB6C023D"><enum>(i)</enum><text>by striking
<quote>, subject to paragraph (5),</quote>; and</text>
</clause><clause commented="no" id="H7FE7B39B46AF486ABCD47021B5A3AFBC"><enum>(ii)</enum><text>by striking
<quote>, and may propose a modification to,</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="H9F2AAF45D6CA4831B32188D54385FCB6"><enum>(B)</enum><text>in subparagraph
(C), by striking <quote>new safety or effectiveness information indicates
that</quote> and all that follows and inserting the
following:</text>
<quoted-block display-inline="yes-display-inline" id="HCD089795294A49D289C3F11D648C07F3" style="OLC">
<text>an assessment is needed to evaluate
whether the approved strategy should be modified to—</text><clause commented="no" id="HDEA9831A0BC9481BA747F3014D4E5F99"><enum>(i)</enum><text display-inline="yes-display-inline">ensure the benefits of the drug outweigh
the risks of the drug; or</text>
</clause><clause commented="no" id="H667513F6CE2C402C8EE0CF28F9CAE7F3"><enum>(ii)</enum><text>minimize the
burden on the health care delivery system of complying with the
strategy.</text>
</clause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="H7AE514CD1FAA4AB1AEF5766F27C47C60"><enum>(C)</enum><text>by striking
subparagraph (D);</text>
</subparagraph></paragraph><paragraph commented="no" id="H62AB700355D34EC6920E71AF37363E53"><enum>(3)</enum><text display-inline="yes-display-inline">in paragraph (3), by striking <quote>for a
drug shall include—</quote> and all that follows and inserting the following
<quote>for a drug shall include, with respect to each goal included in the
strategy, an assessment of the extent to which the approved strategy, including
each element of the strategy, is meeting the goal or whether 1 or more such
goals or such elements should be modified.</quote>; and</text>
</paragraph><paragraph commented="no" id="H9717184DFEED4ADDA7E2CDBAF3514D0D"><enum>(4)</enum><text>by amending
paragraph (4) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HF7758AD7C4BF434A82F9AB2975020251" style="OLC">
<paragraph commented="no" id="H54E457EF07AA408ABDA71D963D3B1969"><enum>(4)</enum><header>Modification</header>
<subparagraph commented="no" id="HBCB1B15AE7DE401F8AA6ACF755F3B022"><enum>(A)</enum><header>On initiative of
responsible person</header><text display-inline="yes-display-inline">After the
approval of a risk evaluation and mitigation strategy by the Secretary, the
responsible person may, at any time, submit to the Secretary a proposal to
modify the approved strategy. Such proposal may propose the addition,
modification, or removal of any goal or element of the approved strategy and
shall include an adequate rationale to support such proposed addition,
modification, or removal of any goal or element of the strategy.</text>
</subparagraph><subparagraph commented="no" id="H8D7766429C6743D6A18ED6C46C75D4BE"><enum>(B)</enum><header>On initiative of
Secretary</header><text display-inline="yes-display-inline">After the approval
of a risk evaluation and mitigation strategy by the Secretary, the Secretary
may, at any time, require a responsible person to submit a proposed
modification to the strategy within 120 days or within such reasonable time as
the Secretary specifies, if the Secretary, in consultation with the offices
described in subsection (c)(2), determines that 1 or more goals or elements
should be added, modified, or removed from the approved strategy to—</text>
<clause commented="no" id="H6E5821043FA94373BB8A0B0360958C22"><enum>(i)</enum><text>ensure the
benefits of the drug outweigh the risks of the drug; or</text>
</clause><clause commented="no" id="H274A217CB43544F39AE75BBAAD86646A"><enum>(ii)</enum><text>minimize the
burden on the health care delivery system of complying with the
strategy.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="HFEFAD215D30E4DAB83A661CE8DB11B87"><enum>(b)</enum><header>Review of
proposed strategies; review of assessments and modifications of approved
strategies</header><text display-inline="yes-display-inline">Section 505–1(h)
(<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C.
355–1(h)</external-xref>) is amended—</text>
<paragraph commented="no" id="HA8C8B29293744D1F81936A78B62E8F19"><enum>(1)</enum><text display-inline="yes-display-inline">in the subsection heading by inserting
<quote><header-in-text level="subsection" style="OLC">and
Modifications</header-in-text></quote> after <quote><header-in-text level="subsection" style="OLC">Review of
Assessments</header-in-text></quote>;</text>
</paragraph><paragraph commented="no" id="H702F51AEF66F42AA8E890FD5DDA837AA"><enum>(2)</enum><text>in paragraph
(1)—</text>
<subparagraph commented="no" id="HF7C06238348D4DB9A22C9CE1AE5DCA83"><enum>(A)</enum><text>by inserting
<quote>and proposed modification to</quote> after <quote>under subsection (a)
and each assessment of</quote>; and</text>
</subparagraph><subparagraph commented="no" id="H8769F6C3146C4A72B334066C3080895C"><enum>(B)</enum><text>by inserting
<quote>, and, if necessary, promptly initiate discussions with the responsible
person about such proposed strategy, assessment, or modification</quote> after
<quote>subsection (g)</quote>;</text>
</subparagraph></paragraph><paragraph commented="no" id="HCDC71AEA728B4B5294B0CC49ED1D9753"><enum>(3)</enum><text>by striking
paragraph (2);</text>
</paragraph><paragraph commented="no" id="HB83A45C1E4094CBE9A1BFC4AC0F25E8F"><enum>(4)</enum><text>by redesignating
paragraphs (3) through (9) as paragraphs (2) through (8), respectively;</text>
</paragraph><paragraph commented="no" id="H08A100C3AD5D4575B9BFDB097763711A"><enum>(5)</enum><text>in paragraph (2),
as redesignated by paragraph (4)—</text>
<subparagraph commented="no" id="H1ED9EB39395A469696EC4DAEDC566B2C"><enum>(A)</enum><text>by amending
subparagraph (A) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H28129C0AF2AD4E5ABBE10C0D4850C69F" style="OLC">
<subparagraph commented="no" id="H24EE247822084E3F8C88AFDDF33A082C"><enum>(A)</enum><header>In
general</header>
<clause commented="no" id="H2C5BE7F862E8411CA27D3BA2F732721D"><enum>(i)</enum><header>Timeframe</header><text display-inline="yes-display-inline">Unless the dispute resolution process
described under paragraph (3) or (4) applies, and, except as provided in clause
(ii) or clause (iii) below, the Secretary, in consultation with the offices
described in subsection (c)(2), shall review and act on the proposed risk
evaluation and mitigation strategy for a drug or any proposed modification to
any required strategy within 180 days of receipt of the proposed strategy or
modification.</text>
</clause><clause commented="no" id="HDE82399860F14E5BA3E019738DFD7CCC"><enum>(ii)</enum><header>Minor
modifications</header><text>The Secretary shall review and act on a proposed
minor modification, as defined by the Secretary in guidance, within 60 days of
receipt of such modification.</text>
</clause><clause commented="no" id="HBB1AA39B5D81416E95588EAE0E1034A2"><enum>(iii)</enum><header>REMS
modification due to safety label changes</header><text display-inline="yes-display-inline">Not later than 60 days after the Secretary
receives a proposed modification to an approved risk evaluation and mitigation
strategy to conform the strategy to approved safety label changes, including
safety labeling changes initiated by the sponsor in accordance with FDA
regulatory requirements, or to a safety label change that the Secretary has
directed the holder of the application to make pursuant to section 505(o)(4),
the Secretary shall review and act on such proposed modification to the
approved strategy.</text>
</clause><clause commented="no" id="H16C031DBE43E40B1967A3186D4C244D8"><enum>(iv)</enum><header>Guidance</header><text>The
Secretary shall establish, through guidance, that responsible persons may
implement certain modifications to an approved risk evaluation and mitigation
strategy following notification to the
Secretary.</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="HBB4097BC1332425A8D559D10FC1ABEBF"><enum>(B)</enum><text>by amending
subparagraph (C) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H5FDD95AA83874194B8F25A31FE48EF5E" style="OLC">
<subparagraph commented="no" id="H79B703EBCA6F4C9CA420FBE03DF1EBBC"><enum>(C)</enum><header>Public
availability</header><text display-inline="yes-display-inline">Upon acting on a
proposed risk evaluation and mitigation strategy or proposed modification to a
risk evaluation and mitigation strategy under subparagraph (A), the Secretary
shall make publicly available an action letter describing the actions taken by
the Secretary under such subparagraph
(A).</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="H17C83C2C721F4B87A60D6D8B8FAEECD8"><enum>(6)</enum><text>in paragraph (4),
as redesignated by paragraph (4)—</text>
<subparagraph commented="no" id="H37ADEF53B45848E8A3D281AE33C92F0A"><enum>(A)</enum><text>in subparagraph
(A)(i)—</text>
<clause commented="no" id="H3DC8EA9C18AB4D8F984B487DDFF89172"><enum>(i)</enum><text>by striking
<quote>Not earlier than 15 days, and not later than 35 days, after discussions
under paragraph (2) have begun, the</quote> and inserting <quote>The</quote>;
and</text>
</clause><clause commented="no" id="H5AD009BBD7A1414A82AB923966A9A75C"><enum>(ii)</enum><text>by inserting
<quote>, after the sponsor is required to make a submission under subsection
(a)(2) or (g),</quote> before <quote>request in writing</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" id="H698F99DCFC9446FFA6906F2E9B7DD49C"><enum>(B)</enum><text>in subparagraph
(I)—</text>
<clause commented="no" id="HF7455797E5654A2FB34D09D02969114A"><enum>(i)</enum><text>by striking
clauses (i) and (ii); and</text>
</clause><clause commented="no" id="HCDB67153B551445CA2E7FA9A7B729526"><enum>(ii)</enum><text>by striking
<quote>if the Secretary—</quote> and inserting <quote>if the Secretary has
complied with the timing requirements of scheduling review by the Drug Safety
Oversight Board, providing a written recommendation, and issuing an action
letter under subparagraphs (B), (F), and (G), respectively.</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H62251E8A7BA54183AC37FF98F2C9A6EC"><enum>(7)</enum><text>in paragraph (5),
as redesignated by paragraph (4)—</text>
<subparagraph commented="no" id="HACBFABD1A9CE442E9BE8CE00CF094BA4"><enum>(A)</enum><text>in subparagraph
(A), by striking <quote>any of subparagraphs (B) through (D)</quote> and
inserting <quote>subparagraph (B) or (C)</quote>; and</text>
</subparagraph><subparagraph commented="no" id="H5811591BA9D542AE8C34DFD7A14A8E49"><enum>(B)</enum><text>in subparagraph
(C), by striking <quote>paragraph (4) or (5)</quote> and inserting
<quote>paragraph (3) or (4)</quote>; and</text>
</subparagraph></paragraph><paragraph commented="no" id="HDE49E8BEEDA24626AE035255C8F62C4E"><enum>(8)</enum><text>in paragraph (8),
as redesignated by paragraph (4), by striking <quote>paragraphs (7) and
(8)</quote> and inserting <quote>paragraphs (6) and (7).</quote>.</text>
</paragraph></subsection><subsection commented="no" id="H11DD7A6275DA4860B3F73903FD118730"><enum>(c)</enum><header>Guidance</header><text display-inline="yes-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services shall issue
guidance that, for purposes of section 505–1(h)(2)(A) of the Federal Food,
Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355-1">21 U.S.C. 355–1(h)(2)(A)</external-xref>),
describes the types of modifications to approved risk evaluation and mitigation
strategies that shall be considered to be minor modifications of such
strategies.</text>
</subsection></section><section commented="no" id="H88DD8D5087C34627B7571BC70B05B72A" section-type="subsequent-section"><enum>868.</enum><header>Consultation with
external experts on rare diseases, targeted therapies, and genetic targeting of
treatments</header><text display-inline="no-display-inline">Subchapter E of
chapter V (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb">21
U.S.C. 360bbb et seq.</external-xref>), as amended by section 811(b), is
further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA232B5B623BC41029E041854FD3C6B8E" style="OLC">
<section commented="no" id="HED54413108A545A7B5AC8A134AC23D69"><enum>569.</enum><header>Consultation
with external experts on rare diseases, targeted therapies, and genetic
targeting of treatments</header>
<subsection commented="no" id="HB9A1CB9F9C254D249D70FEE967E8B470"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">For the purpose of
promoting the efficiency of and informing the review by the Food and Drug
Administration of new drugs and biological products for rare diseases and drugs
and biological products that are genetically targeted, the following shall
apply:</text>
<paragraph commented="no" id="H8D58495231A1409C957BE1CF247D7D8A"><enum>(1)</enum><header>Consultation
with stakeholders</header><text display-inline="yes-display-inline">Consistent
with sections X.C and IX.E.4 of the PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through 2017, as referenced in the letters
described in section 101(b) of the Prescription Drug User Fee Amendments of
2012, the Secretary shall ensure that opportunities exist, at a time the
Secretary determines appropriate, for consultations with stakeholders on the
topics described in subsection (b).</text>
</paragraph><paragraph commented="no" id="H1DC844D11E9C45258DD4FBE13918370A"><enum>(2)</enum><header>Consultation
with external experts</header>
<subparagraph commented="no" id="H64391DEAF74345D08AF4EA61B96511DD"><enum>(A)</enum><header>In
general</header><text>The Secretary shall develop and maintain a list of
external experts who, because of their special expertise, are qualified to
provide advice on rare disease issues, including topics described in subsection
(c). The Secretary may, when appropriate to address a specific regulatory
question, consult such external experts on issues related to the review of new
drugs and biological products for rare diseases and drugs and biological
products that are genetically targeted, including the topics described in
subsection (b), when such consultation is necessary because the Secretary lacks
the specific scientific, medical, or technical expertise necessary for the
performance of the Secretary’s regulatory responsibilities and the necessary
expertise can be provided by the external experts.</text>
</subparagraph><subparagraph commented="no" id="H0F4EC9EDE79A472FB5DD3EDAD6A8A3C0"><enum>(B)</enum><header>External
experts</header><text>For purposes of subparagraph (A), external experts are
individuals who possess scientific or medical training that the Secretary lacks
with respect to one or more rare diseases.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H5CE90CB6EF7B4BF792D6B830B85123D6"><enum>(b)</enum><header>Topics for
consultation</header><text>Topics for consultation pursuant to this section may
include—</text>
<paragraph commented="no" id="H87DD7636EFC544CAA82691012F287C91"><enum>(1)</enum><text>rare
diseases;</text>
</paragraph><paragraph commented="no" id="H6F5A6AE3BC1F478A9B267027346DC6A6"><enum>(2)</enum><text>the severity of
rare diseases;</text>
</paragraph><paragraph commented="no" id="HDC9D7F00A5E34FCBB49FEC56AFF65F24"><enum>(3)</enum><text>the unmet medical
need associated with rare diseases;</text>
</paragraph><paragraph commented="no" id="H57C7A8FC72D24C9E92C5BBA583E1CB91"><enum>(4)</enum><text>the willingness
and ability of individuals with a rare disease to participate in clinical
trials;</text>
</paragraph><paragraph commented="no" id="H62CFC4C5BA324A2DB89D8F15B769F5B9"><enum>(5)</enum><text>an assessment of
the benefits and risks of therapies to treat rare diseases;</text>
</paragraph><paragraph commented="no" id="HEA28DBAE2CB14044A263B2C668DE4247"><enum>(6)</enum><text>the general design
of clinical trials for rare disease populations and subpopulations; and</text>
</paragraph><paragraph commented="no" id="HF601A9FCEE354F6099FBC7D56724242F"><enum>(7)</enum><text>the demographics
and the clinical description of patient populations.</text>
</paragraph></subsection><subsection commented="no" id="HB9A5D741B9354DFDA51F1628EAD8230C"><enum>(c)</enum><header>Classification
as special government employees</header><text>The external experts who are
consulted under this section may be considered special government employees, as
defined under <external-xref legal-doc="usc" parsable-cite="usc/18/202">section
202</external-xref> of title 18, United States Code.</text>
</subsection><subsection commented="no" id="HCAC084FE252741C3BAA9FDFBF2C0D916"><enum>(d)</enum><header>Protection of
confidential information and trade secrets</header>
<paragraph commented="no" id="H407C20C661594C4FBB7F840F1937E496"><enum>(1)</enum><header>Rule of
construction</header><text display-inline="yes-display-inline">Nothing in this
section shall be construed to alter the protections offered by laws,
regulations, and policies governing disclosure of confidential commercial or
trade secret information, and any other information exempt from disclosure
pursuant to <external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552(b)</external-xref> of title 5, United States Code, as such provisions would
be applied to consultation with individuals and organizations prior to the date
of enactment of this section.</text>
</paragraph><paragraph commented="no" id="H66A2967907D9434F895D66AE8E49FF98"><enum>(2)</enum><header>Consent required
for disclosure</header><text display-inline="yes-display-inline">The Secretary
shall not disclose confidential commercial or trade secret information to an
expert consulted under this section without the written consent of the sponsor
unless the expert is a special government employee (as defined under
<external-xref legal-doc="usc" parsable-cite="usc/18/202">section
202</external-xref> of title 18, United States Code) or the disclosure is
otherwise authorized by law.</text>
</paragraph></subsection><subsection commented="no" id="H4F8F2BDFC1C141B38E4BDFD54573D099"><enum>(e)</enum><header>Other
consultation</header><text>Nothing in this section shall be construed to limit
the ability of the Secretary to consult with individuals and organizations as
authorized prior to the date of enactment of this section.</text>
</subsection><subsection commented="no" id="HC28ED1C787E24117AAA084B33D882F71"><enum>(f)</enum><header>No right or
obligation</header>
<paragraph commented="no" id="H8714AC8DDEB049AE8B8A17219BAB1EF8"><enum>(1)</enum><header>No right to
consultation</header><text>Nothing in this section shall be construed to create
a legal right for a consultation on any matter or require the Secretary to meet
with any particular expert or stakeholder.</text>
</paragraph><paragraph commented="no" id="HADF0A767251744A98A10D4E90E7AADB6"><enum>(2)</enum><header>No altering of
goals</header><text>Nothing in this section shall be construed to alter agreed
upon goals and procedures identified in the letters described in section 101(b)
of the Prescription Drug User Fee Amendments of 2012.</text>
</paragraph><paragraph commented="no" id="H27940C83EA204F9FB01B95FA48B687CA"><enum>(3)</enum><header>No change to
number of review cycles</header><text>Nothing in this section is intended to
increase the number of review cycles as in effect before the date of enactment
of this section.</text>
</paragraph></subsection><subsection commented="no" id="H41D9C0B4529F4A6EA513AF43E810F594"><enum>(g)</enum><header>No delay in
product review</header><text>Prior to a consultation with an external expert,
as described in this section, relating to an investigational new drug
application under section 505(i), a new drug application under section 505(b),
or a biologics license application under section 351 of the Public Health
Service Act, the Director of the Center for Drug Evaluation and Research or the
Director of the Center for Biologics Evaluation and Research (or appropriate
Division Director), as appropriate, shall determine that—</text>
<paragraph commented="no" id="H0BAA7690F6714249BCF4870DEB919BFE"><enum>(1)</enum><text>such consultation
will—</text>
<subparagraph commented="no" id="H0E0E7EB89D4242B4B24D4E46F7C1864E"><enum>(A)</enum><text>facilitate the
Secretary’s ability to complete the Secretary’s review;</text>
</subparagraph><subparagraph commented="no" id="HC0F646AE4E9848E39814FE31EE522E84"><enum>(B)</enum><text>address
outstanding deficiencies in the application; and</text>
</subparagraph><subparagraph commented="no" id="H33A1230EDDB743579691815FC233C260"><enum>(C)</enum><text>increase the
likelihood of an approval decision in the current review cycle; or</text>
</subparagraph></paragraph><paragraph commented="no" id="H2DD88EC096114476AD4ADEB80B3A802D"><enum>(2)</enum><text>the sponsor
authorized such
consultation.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H1D77F16211E34633AA1A3F708E973C20"><enum>869.</enum><header>Breakthrough
therapies</header>
<subsection commented="no" id="H06E354B8E8854ED1BB45482BD6550EDE"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 506
(<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C.
356</external-xref>), as amended by section 841, is further amended—</text>
<paragraph commented="no" id="H14B4DEDC53F34DBEBC5BD6D3F00B8D97"><enum>(1)</enum><text>by redesignating
subsection (d) as subsection (e);</text>
</paragraph><paragraph commented="no" id="H0F44CBDF5C1347CBB89899A4173E49D2"><enum>(2)</enum><text>by redesignating
subsections (a) through (c) as subsections (b) through (d),
respectively;</text>
</paragraph><paragraph commented="no" id="H88527EC4E4F548498654E265C8FBC9DF"><enum>(3)</enum><text>by inserting
before subsection (b), as so redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="H59CC0170016E47B6A8A2D525D52A2B28" style="OLC">
<subsection commented="no" id="H327F5A3CBBD74555B120B46FE8587B9B"><enum>(a)</enum><header>Designation of a
drug as a breakthrough therapy</header>
<paragraph commented="no" id="HF99713CB8BB5418DB7C9E7A663DA7223"><enum>(1)</enum><header>In
general</header><text>The Secretary shall, at the request of the sponsor of a
drug, expedite the development and review of such drug if the drug is intended,
alone or in combination with 1 or more other drugs, to treat a serious or
life-threatening disease or condition and preliminary clinical evidence
indicates that the drug may demonstrate substantial improvement over existing
therapies on 1 or more clinically significant endpoints, such as substantial
treatment effects observed early in clinical development. In this section, such
a drug is referred to as a <term>breakthrough therapy</term>.</text>
</paragraph><paragraph commented="no" id="HD496735606A845139588A1557EB01198"><enum>(2)</enum><header>Request for
designation</header><text>The sponsor of a drug may request the Secretary to
designate the drug as a breakthrough therapy. A request for the designation may
be made concurrently with, or at any time after, the submission of an
application for the investigation of the drug under section 505(i) or section
351(a)(3) of the Public Health Service Act.</text>
</paragraph><paragraph commented="no" id="H13A7C1A4E5A64F0485B2C13F069922F1"><enum>(3)</enum><header>Designation</header>
<subparagraph commented="no" id="HF3EEF0196848400F8DA65D1CE96A871F"><enum>(A)</enum><header>In
general</header><text>Not later than 60 calendar days after the receipt of a
request under paragraph (2), the Secretary shall determine whether the drug
that is the subject of the request meets the criteria described in paragraph
(1). If the Secretary finds that the drug meets the criteria, the Secretary
shall designate the drug as a breakthrough therapy and shall take such actions
as are appropriate to expedite the development and review of the application
for approval of such drug.</text>
</subparagraph><subparagraph commented="no" id="HC4677451CF924AF493D32C59A5CC6707"><enum>(B)</enum><header>Actions</header><text>The
actions to expedite the development and review of an application under
subparagraph (A) may include, as appropriate—</text>
<clause commented="no" id="H09445F66A5954003ADF825FD31FE2423"><enum>(i)</enum><text>holding meetings
with the sponsor and the review team throughout the development of the
drug;</text>
</clause><clause commented="no" id="H0431BCB9DF1241B7A32FCF6B6B160BA8"><enum>(ii)</enum><text>providing timely
advice to, and interactive communication with, the sponsor regarding the
development of the drug to ensure that the development program to gather the
non-clinical and clinical data necessary for approval is as efficient as
practicable;</text>
</clause><clause commented="no" id="H07E1D188F3034CC7AD3205284CB02B94"><enum>(iii)</enum><text>involving senior
managers and experienced review staff, as appropriate, in a collaborative,
cross-disciplinary review;</text>
</clause><clause commented="no" id="HE5A724A3DC4149538F704B36B28B344C"><enum>(iv)</enum><text>assigning a
cross-disciplinary project lead for the Food and Drug Administration review
team to facilitate an efficient review of the development program and to serve
as a scientific liaison between the review team and the sponsor; and</text>
</clause><clause commented="no" id="HFBC1B7DE31A94A3FAC867786C1F5BB27"><enum>(v)</enum><text>taking steps to
ensure that the design of the clinical trials is as efficient as practicable,
when scientifically appropriate, such as by minimizing the number of patients
exposed to a potentially less efficacious
treatment.</text>
</clause></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="HFF57689692534F7789545833552C5E21"><enum>(4)</enum><text>in subsection
(e)(1), as so redesignated, by striking <quote>applicable to accelerated
approval</quote> and inserting <quote>applicable to breakthrough therapies,
accelerated approval,</quote>; and</text>
</paragraph><paragraph commented="no" id="H1606D5A006B8416585A42577C51CF790"><enum>(5)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HAD57FBBA9B704956899929983F9FF5F0" style="OLC">
<subsection commented="no" id="H9A0D07C3631E4E6AB84782E83BBCEB18"><enum>(f)</enum><header>Report</header><text>Beginning
in fiscal year 2013, the Secretary shall annually prepare and submit to the
Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives, and make
publicly available, with respect to this section for the previous fiscal
year—</text>
<paragraph commented="no" id="H43FF8460BF3F408C9EBB28BBC4AB3B99"><enum>(1)</enum><text>the number of
drugs for which a sponsor requested designation as a breakthrough
therapy;</text>
</paragraph><paragraph commented="no" id="H96B4131E100C4D3BA54B5DCA3F4B07F3"><enum>(2)</enum><text>the number of
products designated as a breakthrough therapy; and</text>
</paragraph><paragraph commented="no" id="HD8CB8F8A788C4A968CAFB5F69C3B7213"><enum>(3)</enum><text>for each product
designated as a breakthrough therapy, a summary of the actions taken under
subsection
(a)(3).</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="H50335D506ECD4DEC9AD263E054C21367"><enum>(b)</enum><header>Guidance;
amended regulations</header>
<paragraph commented="no" id="HC69766C0654841ECAC6472B0322AD930"><enum>(1)</enum><header>In
general</header>
<subparagraph commented="no" id="H507A34FB3DBB4EDE93A0A2A58AFA2F2F"><enum>(A)</enum><header>Guidance</header><text>Not
later than 18 months after the date of enactment of this Act, the Secretary of
Health and Human Services (referred to in this section as the
<quote>Secretary</quote>) shall issue draft guidance on implementing the
requirements with respect to breakthrough therapies, as set forth in section
506(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356">21 U.S.C. 356(a)</external-xref>),
as amended by this section. The Secretary shall issue final guidance not later
than 1 year after the close of the comment period for the draft
guidance.</text>
</subparagraph><subparagraph commented="no" id="H349BBC54F29A44778092E4FEA52299AE"><enum>(B)</enum><header>Amended
regulations</header>
<clause commented="no" id="H84E19762A502449899F723696485DB65"><enum>(i)</enum><header>In
general</header><text>If the Secretary determines that it is necessary to amend
the regulations under title 21, Code of Federal Regulations in order to
implement the amendments made by this section to section 506(a) of the Federal
Food, Drug, and Cosmetic Act, the Secretary shall amend such regulations not
later than 2 years after the date of enactment of this Act.</text>
</clause><clause commented="no" id="H2BD69D5CE25B4452923B936D0BB492B2"><enum>(ii)</enum><header>Procedure</header><text>In
amending regulations under clause (i), the Secretary shall—</text>
<subclause commented="no" id="H5C6631B8F7BE4981B3DDD50ED929941E"><enum>(I)</enum><text>issue a notice of
proposed rulemaking that includes the proposed regulation;</text>
</subclause><subclause commented="no" id="H63501FFC8D3B4C5A994C22AB0D18A438"><enum>(II)</enum><text>provide a period
of not less than 60 days for comments on the proposed regulation; and</text>
</subclause><subclause commented="no" id="H6197069D7CF14A17A91E47063CC5B5D3"><enum>(III)</enum><text>publish the
final regulation not less than 30 days before the effective date of the
regulation.</text>
</subclause></clause><clause commented="no" id="H4BFCD13ED5FD4671BCDA8A7B1844EB3F"><enum>(iii)</enum><header>Restrictions</header><text>Notwithstanding
any other provision of law, the Secretary shall promulgate regulations
implementing the amendments made by section only as described in clause
(ii).</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="H2A59EC1ED61344C3ACFBE5C1CDB2F133"><enum>(2)</enum><header>Requirements</header><text>Guidance
issued under this section shall—</text>
<subparagraph commented="no" id="H8D9BB684EE27495A8388CC8BD8B2FF23"><enum>(A)</enum><text>specify the
process and criteria by which the Secretary makes a designation under section
506(a)(3) of the Federal Food, Drug, and Cosmetic Act; and</text>
</subparagraph><subparagraph commented="no" id="H3284967CC2364610AC4960098ADA9976"><enum>(B)</enum><text>specify the
actions the Secretary shall take to expedite the development and review of a
breakthrough therapy pursuant to such designation under such section 506(a)(3),
including updating good review management practices to reflect breakthrough
therapies.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H2A5A0A0E335E49FEB639DDD4A6260A31"><enum>(c)</enum><header>Independent
review</header><text>Not later than 3 years after the date of enactment of this
Act, the Comptroller General of the United States, in consultation with
appropriate experts, shall assess the manner by which the Food and Drug
Administration has applied the processes described in section 506(a) of the
Federal Food, Drug, and Cosmetic Act, as amended by this section, and the
impact of such processes on the development and timely availability of
innovative treatments for patients affected by serious or life-threatening
conditions. Such assessment shall be made publicly available upon
completion.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="H01808037C78947709B676B14F0F44325"><enum>(d)</enum><header>Conforming
amendments</header><text>Section 506B(e) (<external-xref legal-doc="usc" parsable-cite="usc/21/356b">21 U.S.C. 356b</external-xref>) is amended by
striking <quote>section 506(b)(2)(A)</quote> each place such term appears and
inserting <quote>section 506(c)(2)(A)</quote>.</text>
</subsection></section><section id="HE200B210806A47E4B55DBF52AE3B441A"><enum>870.</enum><header>Grants and
Contracts for the Development of Orphan Drugs</header>
<subsection id="H99FB462C85E74D04B714D3AB45E458CD"><enum>(a)</enum><header>Qualified
testing definition</header><text display-inline="yes-display-inline">Section
5(b)(1)(A)(ii) of the Orphan Drug Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ee">21 U.S.C. 360ee(b)(1)(A)(ii)</external-xref>) is
amended by striking <quote>after the date such drug is designated under section
526 of such Act and</quote>.</text>
</subsection><subsection id="H664A096716CF404C9D8401EBEC2F62D9"><enum>(b)</enum><header>Authorization of
Appropriations</header><text display-inline="yes-display-inline">Section 5(c)
of the Orphan Drug Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ee">21 U.S.C. 360ee(c)</external-xref>) is amended to
read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H22C675682F624FCDB4E6E6D02272FDC3" style="OLC">
<subsection id="H28977FCCEABB4667BE3F85CA207439A3"><enum>(c)</enum><header>Authorization of
appropriations</header><text display-inline="yes-display-inline">For grants and
contracts under subsection (a), there is authorized to be appropriated
$30,000,000 for each of fiscal years 2013 through
2017.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section></subtitle><enum>IX</enum><header>Drug
shortages</header>
<section commented="no" id="H376FE0B7E7934DCDABBB3A31A4A9DD2A"><enum>901.</enum><header>Discontinuance
and interruptions of manufacturing of certain drugs</header>
<subsection commented="no" id="HB878FF02F9D741B58D2D4F6116586892"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 506C
(<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21 U.S.C.
356c</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H1F77794C49AA4E4691C556362199E100" style="OLC">
<section commented="no" id="H8AD97CC1C4F94C348C55D5C37878C471"><enum>506C.</enum><header>Discontinuance
and interruptions of manufacturing of certain drugs</header>
<subsection commented="no" id="HFD3AB17786674F41BB47B53C5E114521"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">A manufacturer of a
drug subject to section 503(b)(1)—</text>
<paragraph commented="no" id="H3AC7B88EFD05477BBDA6E4E413395F0E"><enum>(1)</enum><text>that is—</text>
<subparagraph commented="no" id="H998B036804714C129CCC64F07A29B170"><enum>(A)</enum><text>life-supporting;</text>
</subparagraph><subparagraph commented="no" id="HD291A84F2B5A47448B622CD8619CD7B8"><enum>(B)</enum><text>life-sustaining;
or</text>
</subparagraph><subparagraph commented="no" id="HC6FD09D72E14427FB665D5C2E2106B9A"><enum>(C)</enum><text>intended for use
in the prevention or treatment of a debilitating disease or condition;
and</text>
</subparagraph></paragraph><paragraph commented="no" id="H78F52D5D79504CB290068E015DA1302F"><enum>(2)</enum><text display-inline="yes-display-inline">that is not a radio pharmaceutical drug
product, a product derived from human plasma protein and their recombinant
analogs, or any other product as designated by the Secretary,</text>
</paragraph></subsection><continuation-text commented="no" continuation-text-level="section">shall notify the Secretary of a
discontinuance of the manufacture of the drug, or an interruption of the
manufacture of the drug that is likely to lead to a meaningful disruption in
the manufacturer’s supply of the drug, and the reason for such discontinuance
or interruption, in accordance with subsection (b).</continuation-text></section><subsection commented="no" id="HD61DB27F4DE54387ACAC83651B53E686"><enum>(b)</enum><header>Timing</header><text display-inline="yes-display-inline">A notice required by subsection (a) shall
be submitted to the Secretary—</text>
<paragraph commented="no" id="HDA85C57CA8C94B18995B8C085EAAE853"><enum>(1)</enum><text>at least 6 months
prior to the date of the discontinuance or interruption; or</text>
</paragraph><paragraph commented="no" id="HA4CA9EDFEDC148098B8D8C3A95DDF136"><enum>(2)</enum><text>if compliance with
paragraph (1) is not possible, as soon as practicable.</text>
</paragraph></subsection><subsection commented="no" id="H1FA8F7144EDA41C1812F208A1DA029D1"><enum>(c)</enum><header>Distribution</header><text display-inline="yes-display-inline">To the maximum extent practicable, the
Secretary shall distribute information on the discontinuation or interruption
of the manufacture of the drugs described in subsection (a) to appropriate
organizations, including physician, health provider, and patient organizations,
as described in section 506D.</text>
</subsection><subsection commented="no" id="H694C0B76692B4EEA888EA20A56CDC08F"><enum>(d)</enum><header>Confidentiality</header><text>Nothing
in this section shall be construed as authorizing the Secretary to disclose any
information that is a trade secret or confidential information subject to
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552(b)(4)</external-xref> of title 5, United States Code, or
<external-xref legal-doc="usc" parsable-cite="usc/18/1905">section
1905</external-xref> of title 18, United States Code.</text>
</subsection><subsection commented="no" id="H08BFB59184F0493AB6CF9936555E5B41"><enum>(e)</enum><header>Coordination
with Attorney General</header><text display-inline="yes-display-inline">Not
later than 30 days after the receipt of a notification described in subsection
(a), the Secretary shall—</text>
<paragraph commented="no" id="H034D7B21BBB247FBAD93719A1ADDA46D"><enum>(1)</enum><text>determine whether
the notification pertains to a controlled substance subject to a production
quota under section 306 of the Controlled Substances Act; and</text>
</paragraph><paragraph commented="no" id="H66C9D1648E9C45958AA5812517F355CE"><enum>(2)</enum><text>if necessary, as
determined by the Secretary—</text>
<subparagraph commented="no" id="H122D6EB4C5DD4C2D8120126F2A55E464"><enum>(A)</enum><text>notify the
Attorney General that the Secretary has received such a notification;</text>
</subparagraph><subparagraph commented="no" id="H96CB5A03243E4CC6BA2ED3F867761427"><enum>(B)</enum><text>request that the
Attorney General increase the aggregate and individual production quotas under
section 306 of the Controlled Substances Act applicable to such controlled
substance and any ingredient therein to a level the Secretary deems necessary
to address a shortage of a controlled substance based on the best available
market data; and</text>
</subparagraph><subparagraph commented="no" id="H456F1D74E0F84BE982B75D8F74B89716"><enum>(C)</enum><text>if the Attorney
General determines that the level requested is not necessary to address a
shortage of a controlled substance, the Attorney General shall provide to the
Secretary a written response detailing the basis for the Attorney General’s
determination.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">The Secretary shall make the written
response provided under subparagraph (C) available to the public on the Web
site of the Food and Drug Administration.</continuation-text></paragraph></subsection><subsection commented="no" id="HFCC1E45E494C4BBD96A85D7DF161B40B"><enum>(f)</enum><header>Failure To meet
requirements</header><text display-inline="yes-display-inline">If a person
fails to submit information required under subsection (a) in accordance with
subsection (b)—</text>
<paragraph commented="no" id="HBD2E6E9DE3824D90830E724CEE38B710"><enum>(1)</enum><text>the Secretary
shall issue a letter to such person informing such person of such
failure;</text>
</paragraph><paragraph commented="no" id="H72B8C9A73B774B078C15A7B4C7ABF4DF"><enum>(2)</enum><text>not later than 30
calendar days after the issuance of a letter under paragraph (1), the person
who receives such letter shall submit to the Secretary a written response to
such letter setting forth the basis for noncompliance and providing information
required under subsection (a); and</text>
</paragraph><paragraph commented="no" id="HFDE7E7894FAF40CBB7840E25BB872542"><enum>(3)</enum><text>not later than 45
calendar days after the issuance of a letter under paragraph (1), the Secretary
shall make such letter and any response to such letter under paragraph (2)
available to the public on the Web site of the Food and Drug Administration,
with appropriate redactions made to protect information described in subsection
(d), except that, if the Secretary determines that the letter under paragraph
(1) was issued in error or, after review of such response, the person had a
reasonable basis for not notifying as required under subsection (a), the
requirements of this paragraph shall not
apply.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" id="HDFD46DC495A8473D8CB30922EA0AECF7"><enum>(b)</enum><header>Regulations</header>
<paragraph commented="no" id="H1ABE0BF548C4445B8249EC4ACE3DBEC7"><enum>(1)</enum><header>In
general</header><text>Not later than 18 months after the date of the enactment
of this Act, the Secretary of Health and Human Services, after issuing a notice
of proposed rule and holding a public hearing, shall promulgate final
regulations that implement the amendment made by subsection (a).</text>
</paragraph><paragraph commented="no" id="HE1F20B7FC66D49A999D143C7EADC10FB"><enum>(2)</enum><header>Contents</header><text>Such
regulations shall, for purposes of section 506C of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356c">21
U.S.C. 356c</external-xref>)—</text>
<subparagraph commented="no" id="HBA088EB3C8FB4F4083B397A5ECB4964A"><enum>(A)</enum><text>define the terms
<term>life-supporting</term>, <term>life-sustaining</term>, and <term>intended
for use in the prevention or treatment of a debilitating disease or
condition</term>; and</text>
</subparagraph><subparagraph commented="no" id="H9650B8979F5C4119A0C323EE65EB54B6"><enum>(B)</enum><text>define the term
<term>interruption of the manufacture of the drug that is likely to lead to a
meaningful disruption in the manufacturer’s supply of the drug</term> to mean a
change in production that is highly likely to lead to more than a negligible
reduction in the supply of the drug and affects the ability of the manufacturer
to meet demand for such drug, but not to include a change in production due to
matters such as routine maintenance or insignificant changes in manufacturing
so long as the manufacturer expects to resume operations in a short period of
time.</text>
</subparagraph></paragraph></subsection></section><section commented="no" id="H25C7F4EBFC7B48A0902328EC6F465B01"><enum>902.</enum><header>Drug shortage
list</header><text display-inline="no-display-inline">Title V (<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et
seq.</external-xref>) is amended by inserting after section 506C the following
new section:</text>
<quoted-block display-inline="no-display-inline" id="H20BC92ADA15A414EA6A80C8F1C931C66" style="OLC">
<section commented="no" id="H36B8CC9A9D4F4A558BF5D852B9832215"><enum>506D.</enum><header>Drug shortage
list</header>
<subsection commented="no" id="H0519E8325D8641958A38D3F1FB4E4ED2"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">The Secretary shall maintain an up-to-date
list of drugs that are determined by the Secretary to be in shortage in the
United States.</text>
</subsection><subsection commented="no" id="HC016CCD6B8EA43BFBE723D43832E5E9B"><enum>(b)</enum><header>Contents</header><text>For
each drug on such list, the Secretary shall include the following
information:</text>
<paragraph commented="no" id="H8A7C0645DA284A368FB82FD38F88CC65"><enum>(1)</enum><text>The name of the
drug in shortage.</text>
</paragraph><paragraph commented="no" id="H11A4E5289E834205BFB2DCB46BD48B77"><enum>(2)</enum><text>The name of each
manufacturer of such drug.</text>
</paragraph><paragraph commented="no" id="H19470B0B92B94C0087CC681E0FA0DAFD"><enum>(3)</enum><text display-inline="yes-display-inline">The reason for the shortage, as determined
by the Secretary, selecting from the following categories:</text>
<subparagraph commented="no" id="HD65C9CC9FD864827A4C6BE3B6AFFA81E"><enum>(A)</enum><text>Requirements
related to complying with good manufacturing practices.</text>
</subparagraph><subparagraph commented="no" id="HA4377920C53B40BFAE6C30708719ABC2"><enum>(B)</enum><text>Regulatory
delay.</text>
</subparagraph><subparagraph commented="no" id="H0CBE29441FA44F669F3389AEF3AAF461"><enum>(C)</enum><text>Shortage of an
active ingredient.</text>
</subparagraph><subparagraph commented="no" id="HEDF1BD2C8DF1405F968F189BBE5BC707"><enum>(D)</enum><text>Shortage of an
inactive ingredient component.</text>
</subparagraph><subparagraph commented="no" id="HAB6FB34064C14BFF80A2D071914F0FC6"><enum>(E)</enum><text>Discontinuation of
the manufacture of the drug.</text>
</subparagraph><subparagraph commented="no" id="HE6BF6C08DD064C00BF97ACAFA4951B9B"><enum>(F)</enum><text>Delay in shipping
of the drug.</text>
</subparagraph><subparagraph commented="no" id="H650321F6F7664A3081E3E3A930AC6350"><enum>(G)</enum><text>Demand increase
for the drug.</text>
</subparagraph></paragraph><paragraph commented="no" id="HEC3274B60BF547D886A8EEF0C9955842"><enum>(4)</enum><text>The estimated
duration of the shortage as determined by the Secretary.</text>
</paragraph></subsection><subsection commented="no" id="H3DF7B606D7CD4E1BBF4D831286A835E8"><enum>(c)</enum><header>Public
availability</header>
<paragraph commented="no" id="H3E84864F14874B2E87052AA8DC62FE8A"><enum>(1)</enum><header>In
general</header><text>Subject to paragraphs (2) and (3), the Secretary shall
make the information in such list publicly available.</text>
</paragraph><paragraph commented="no" id="H1007B1D01DD9433A9B653258D85E202C"><enum>(2)</enum><header>Trade secrets
and confidential information</header><text display-inline="yes-display-inline">Nothing in this section alters or amends
<external-xref legal-doc="usc" parsable-cite="usc/18/1905">section
1905</external-xref> of title 18, United States Code, or
<external-xref legal-doc="usc" parsable-cite="usc/5/552">section
552(b)(4)</external-xref> of title 5 of such Code.</text>
</paragraph><paragraph commented="no" id="HEF048EAE099447A8B96DC7301AC6D732"><enum>(3)</enum><header>Public health
exception</header><text display-inline="yes-display-inline">The Secretary may
choose not to make information collected under this section publicly available
under
<internal-xref idref="H3E84864F14874B2E87052AA8DC62FE8A" legis-path="506D.(c)(1)">paragraph (1)</internal-xref> if the Secretary
determines that disclosure of such information would adversely affect the
public health (such as by increasing the possibility of hoarding or other
disruption of the availability of drug products to
patients).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="HE01F558163674D61931676B9C2004281"><enum>903.</enum><header>Quotas
applicable to drugs in shortage</header><text display-inline="no-display-inline">Section 306 of the Controlled Substances Act
(<external-xref legal-doc="usc" parsable-cite="usc/21/826">21 U.S.C.
826</external-xref>) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HD93FB420089C4FAF9C42D0537EC3C28F" style="OLC">
<subsection commented="no" id="HBC9BEF655C7F431DB4E429258ED08184"><enum>(h)</enum><paragraph commented="no" display-inline="yes-display-inline" id="H542774EC24F642B5B7DE1D34DA417378"><enum>(1)</enum><text>Not later than 30 days
after the receipt of a request described in paragraph (2), the Attorney General
shall—</text>
<subparagraph commented="no" id="H7E6DDA27753C4DD4AF207AD70D81CB3A" indent="up1"><enum>(A)</enum><text>complete review of such request;
and</text>
</subparagraph><subparagraph commented="no" id="H3CD079B9BA2F41C9A8BBC1091367FBC2" indent="up1"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="HC3EB1DD1F32D4A7B98E7885103219254"><enum>(i)</enum><text display-inline="yes-display-inline">as necessary to address a shortage of a
controlled substance, increase the aggregate and individual production quotas
under this section applicable to such controlled substance and any ingredient
therein to the level requested; or</text>
</clause><clause commented="no" id="H2CA68F95C4334429A2A1F933940AF095" indent="up1"><enum>(ii)</enum><text display-inline="yes-display-inline">if the Attorney General determines that the
level requested is not necessary to address a shortage of a controlled
substance, the Attorney General shall provide a written response detailing the
basis for the Attorney General’s determination.</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">The Secretary shall make the
written response provided under subparagraph (B)(ii) available to the public on
the Web site of the Food and Drug Administration.</continuation-text></subparagraph></paragraph><paragraph commented="no" id="H424221E3B847423B9210808C7263BF43" indent="up1"><enum>(2)</enum><text>A request is described in this
paragraph if—</text>
<subparagraph commented="no" id="H49E24615EE01428BA177DE1DAAAC184B"><enum>(A)</enum><text display-inline="yes-display-inline">the request pertains to a controlled
substance on the list of drugs in shortage maintained under section 506D of the
Federal Food, Drug, and Cosmetic Act;</text>
</subparagraph><subparagraph commented="no" id="H43EDD8316F174136A66961F359BEF689"><enum>(B)</enum><text>the request is submitted by the
manufacturer of the controlled substance; and</text>
</subparagraph><subparagraph commented="no" id="HED531D84BCC34252813A4BCD532F68AC"><enum>(C)</enum><text>the controlled substance is in
schedule
II.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H4AA5A7C0216846C1A4C3DF8DA7FE9190"><enum>904.</enum><header>Expedited
review of major manufacturing changes for potential and verified shortages of
drugs that are life-supporting, life-sustaining, or intended for use in the
prevention of a debilitating disease or condition</header><text display-inline="no-display-inline">Subsection (c) of section 506A
(<external-xref legal-doc="usc" parsable-cite="usc/21/356a">21 U.S.C.
356a</external-xref>) is amended by adding at the end the following new
paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H7E32F46376124AB39D23E49CADC979DB" style="OLC">
<paragraph commented="no" id="HD084BB6D4A9D4AE086D0455D3595D183"><enum>(3)</enum><header>Changes
addressing a drug shortage</header>
<subparagraph commented="no" id="H15D932256DBB4E589E8DEC73AC532801"><enum>(A)</enum><header>Certification</header>
<clause commented="no" display-inline="no-display-inline" id="H7031E89BBEF34C08806F68095831D5F0"><enum>(i)</enum><header>Description</header><text display-inline="yes-display-inline">A certification is described in this
subparagraph if the manufacturer, having notified the Secretary of an
interruption or discontinuance of a drug in accordance with Section 506C,
certifies (in such certification) that the major manufacturing change for which
approval is being sought may prevent or alleviate a discontinuance or
interruption of such drug.</text>
</clause><clause commented="no" id="H8C56C20EB7F94441B81188DC5CFA9058"><enum>(ii)</enum><header>Bad faith
exception</header><text>Subparagraphs (B) and (C) do not apply in the case of a
certification which the Secretary determines to be made in bad faith.</text>
</clause></subparagraph><subparagraph commented="no" id="HD535B35D0D834E88BE0595B071B4D75E"><enum>(B)</enum><header>Expedited
review</header><text display-inline="yes-display-inline">If a certification
described in subparagraph (A) is submitted in connection with a supplemental
application for a major manufacturing change, the Secretary shall—</text>
<clause commented="no" id="H98CA79813FD44DD6923F57D9A674B3E2"><enum>(i)</enum><text display-inline="yes-display-inline">expedite any technical review or inspection
necessary for consideration of the supplemental application;</text>
</clause><clause commented="no" id="H0D1D01C5F7A347ECBBDED19220215B5C"><enum>(ii)</enum><text>provide any
technical assistance necessary to facilitate approval of the supplemental
application; and</text>
</clause><clause commented="no" id="HC7135674A7B147D5A966F8D9CE2F410C"><enum>(iii)</enum><text display-inline="yes-display-inline">not later than 60 days after receipt of the
certification, complete review of the supplemental
application.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="HBA6748827E6043558768240DDB6A78A1"><enum>905.</enum><header>Study on drug
shortages</header>
<subsection commented="no" id="H86E6ECE4E73D4872A400205710828FC5"><enum>(a)</enum><header>Study</header><text display-inline="yes-display-inline">The Comptroller General of the United
States shall conduct a study to examine the cause of drug shortages and
formulate recommendations on how to prevent or alleviate such shortages.</text>
</subsection><subsection commented="no" id="HDF6F07B08E8A455F91C9C194000B0BB9"><enum>(b)</enum><header>Consideration</header><text>In
conducting the study under this section, the Comptroller General shall consider
the following questions:</text>
<paragraph commented="no" id="H19A497E281554EA88892A94CD0E4CD59"><enum>(1)</enum><text>What are the
dominant characteristics of drugs that have gone into actual shortage over the
preceding three years?</text>
</paragraph><paragraph commented="no" id="H0203BEA60ADB437784D6B33AAB4C44A5"><enum>(2)</enum><text display-inline="yes-display-inline">Are there systemic high-risk factors (such
as drug pricing structure, including Federal reimbursements, or the number of
manufacturers producing a drug product) that have led to the concentration of
drug shortages in certain drug products that have made such products vulnerable
to drug shortages?</text>
</paragraph><paragraph commented="no" id="HDC0A87E8C4C44D69B458DC6D9991D00C"><enum>(3)</enum><text>Is there a reason
why drug shortages have occurred primarily in the sterile injectable market and
in certain therapeutic areas?</text>
</paragraph><paragraph commented="no" id="HA1BEC3685ED649A785259DEBD6B33E34"><enum>(4)</enum><text display-inline="yes-display-inline">How have regulations, guidance documents,
regulatory practices, and other actions of Federal departments and agencies
(including the effectiveness of interagency and intraagency coordination,
communication, strategic planning, and decision-making) affected drug
shortages?</text>
</paragraph><paragraph commented="no" id="H4D61574C601448F483309B307AEBF66C"><enum>(5)</enum><text>How does hoarding
affect drug shortages?</text>
</paragraph><paragraph commented="no" id="H7D76C3A64FF8451DB7D96D39074DECC2"><enum>(6)</enum><text>How would
incentives alleviate or prevent drug shortages?</text>
</paragraph><paragraph commented="no" id="HE38338222732459EBB417230576E36A5"><enum>(7)</enum><text>How are healthcare
providers, including hospitals and physicians responding to drug shortages, to
what extent are such providers able to adjust care effectively to compensate
for such shortages, and what impediments exist that hinder provider ability to
adjust to such shortages?</text>
</paragraph></subsection><subsection commented="no" id="HBA20E204F7FB4AC386175A62BDE167D3"><enum>(c)</enum><header>Consultation
with stakeholders</header><text display-inline="yes-display-inline">In
conducting the study under this section, the Comptroller General shall consult
with relevant stakeholders, including physicians, pharmacists, hospitals,
patients, drug manufacturers, and other health providers.</text>
</subsection><subsection commented="no" id="HFB594F9D238B45DC905BAD0312D1E9B4"><enum>(d)</enum><header>Report</header><text>Note
later than 18 months after the date of the enactment of this Act, the
Comptroller General shall submit a report to the Committee on Energy and
Commerce of the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate on the results of the study under
this section.</text>
</subsection></section><section commented="no" id="H800342B9858041BC817FCC6C705270F9"><enum>906.</enum><header>Annual report
on drug shortages</header><text display-inline="no-display-inline">Not later
than 18 months after the date of the enactment of this Act, and annually
thereafter, the Secretary of Health and Human Services shall submit to the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the Senate a report on
drug shortages that—</text>
<paragraph commented="no" id="HA71197844C8D4CFEAD491CDEB0297734"><enum>(1)</enum><text display-inline="yes-display-inline">describes the communication between the
field investigators of the Food and Drug Administration and the staff of the
Center for Drug Evaluation and Research’s Office of Compliance and Drug
Shortage Program, including the Food and Drug Administration’s procedures for
enabling and ensuring such communication;</text>
</paragraph><paragraph commented="no" id="HCF4EB886F0654188A637D8E856BE8390"><enum>(2)</enum><text>describes the Food
and Drug Administration’s efforts to expedite the review of new manufacturing
sites, new suppliers, and specification changes to prevent or alleviate a drug
shortage;</text>
</paragraph><paragraph commented="no" id="H9512EB045ED9415E9C9CCD9C90E1DB78"><enum>(3)</enum><text display-inline="yes-display-inline">describes the coordination between the Food
and Drug Administration and the Drug Enforcement Administration on efforts to
prevent or alleviate drug shortages;</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="H04B537CAEC6E461BACB041CF74392F31"><enum>(4)</enum><text>identifies the
number of, and describes the instances in which the Food and Drug
Administration exercised regulatory flexibility and discretion to prevent or
alleviate a drug shortage;</text>
</paragraph><paragraph commented="no" id="H773FC79D262B44F9BF0CAE268861679F"><enum>(5)</enum><text>identifies the
number of instances in which the Food and Drug Administration asked firms to
increase production to prevent or alleviate a shortage;</text>
</paragraph><paragraph commented="no" id="H23F7F97F3BA348BFA38295ABFB06BA5C"><enum>(6)</enum><text>identifies the
number of notifications submitted to the Secretary under section 506C of the
Federal Food, Drug, and Cosmetic Act, as amended by section 901 of this Act,
including the percentage of such notifications for a drug that is a sterile
injectable;</text>
</paragraph><paragraph commented="no" id="H402D7C774AD844A993EEDCB05C96F01B"><enum>(7)</enum><text>describes the Food
and Drug Administration’s implementation of section 506D of the Federal Food,
Drug, and Cosmetic Act (relating to a drug shortage list), as added by section
902 of this Act, and identifies—</text>
<subparagraph commented="no" id="H862815E420EB4451A7E939E2F4F8F0A3"><enum>(A)</enum><text>the name of each
drug on the list under such section 506D at any point during the period covered
by the report;</text>
</subparagraph><subparagraph commented="no" id="HB37C6F1EE0B44777A61D0F7CC78A8E14"><enum>(B)</enum><text>the name of each
manufacturer of each such drug;</text>
</subparagraph><subparagraph commented="no" id="H4410049FEAD3441181035F9B3D427FEC"><enum>(C)</enum><text>the reason for the
shortage of each such drug; and</text>
</subparagraph><subparagraph commented="no" id="HFE22BA8E42A94DC7BE73F26973992E64"><enum>(D)</enum><text>the anticipated
or, if known, actual duration of the shortage of each such drug;</text>
</subparagraph></paragraph><paragraph commented="no" id="H44D64E24F7B8494295D4D984E15500C7"><enum>(8)</enum><text>identifies
whether, and how, the Food and Drug Administration expedited the review of
regulatory submissions to prevent or alleviate shortages, including how the
Administration utilized the authority in section 506A(c)(3) of the Federal
Food, Drug, and Cosmetic Act, as added by section 904 of this Act;</text>
</paragraph><paragraph commented="no" id="HCA6DBF07734940EEBCA4AA28C580F41A"><enum>(9)</enum><text display-inline="yes-display-inline">identifies the number of certifications
submitted under such section 506A(c)(3) and, for each such certification,
whether the Food and Drug Administration completed expedited review within 60
days as required by subparagraph (B) of such section 506A(c)(3);</text>
</paragraph><paragraph commented="no" id="H40718CA2A2814F3581001DACC5CEE568"><enum>(10)</enum><text display-inline="yes-display-inline">describes the Secretary’s public engagement
on drug shortages with stakeholders, including physicians, pharmacists,
patients, hospitals, drug manufacturers, and other health providers; and</text>
</paragraph><paragraph commented="no" id="H236BDB78CCF240058472B320D3C02AC4"><enum>(11)</enum><text display-inline="yes-display-inline">contains the Secretary’s plan for
addressing drug shortages in the upcoming year, including with respect to the
issues described in paragraphs (1) through (10).</text>
</paragraph></section><section commented="no" id="HAC656951812C4174972E1840DEF174E1"><enum>907.</enum><header>Attorney
General report on drug shortages</header><text display-inline="no-display-inline">Not later than 6 months after the date of
the enactment of this Act, and annually thereafter, the Attorney General shall
submit to the Committee on Energy and Commerce of the House of Representatives
and the Committee on the Judiciary of the Senate a report on drug shortages
that—</text>
<paragraph commented="no" id="H56CD50309A11477599F5CB6B168E790E"><enum>(1)</enum><text display-inline="yes-display-inline">identifies the number of requests received
under section 306(h) of the Controlled Substances Act (as added by section 903
of this Act), the average review time for such requests, the number of requests
granted and denied under such section, and, for each of the requests denied
under such section, the basis for such denial;</text>
</paragraph><paragraph commented="no" id="HD24A8FE6282B4BD0BDE9A82E270601B5"><enum>(2)</enum><text>describes the
coordination between the Drug Enforcement Administration and Food and Drug
Administration on efforts to prevent or alleviate drug shortages; and</text>
</paragraph><paragraph commented="no" id="H203E97F0B4254E6B956B46A8AD6799D8"><enum>(3)</enum><text>identifies drugs
containing a controlled substance subject to section 306 of the Controlled
Substances Act when such a drug is determined by the Secretary of Health and
Human Services to be in shortage.</text>
</paragraph></section><section commented="no" id="H6ACCF676DD704B268329F9A1BF954F84" section-type="subsequent-section"><enum>908.</enum><header>Hospital repackaging
of drugs in shortage</header><text display-inline="no-display-inline">Chapter V
(<external-xref legal-doc="usc" parsable-cite="usc/21/351">21 U.S.C. 351 et
seq.</external-xref>), as amended by section 902 of this Act, is further
amended by inserting after section 506D the following:</text>
<quoted-block display-inline="no-display-inline" id="HB3887784D52444AC90CD32DEF8DE0795" style="OLC">
<section commented="no" id="HB62A8DA34F7D453DA4FDB6C69F1947B8"><enum>506E.</enum><header>Hospital
repackaging of drugs in shortage</header>
<subsection commented="no" id="H03E3BCF7BE0244F5AADAC055CBDC4476"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="HBC4D2CB303394477A9A598F75A883688"><enum>(1)</enum><header>Drug</header><text>The
term <term>drug</term> excludes any controlled substance (as such term is
defined in section 102 of the Controlled Substances Act).</text>
</paragraph><paragraph commented="no" id="HC080D25BE568414AB1125859B2FA2460"><enum>(2)</enum><header>Health
system</header><text>The term <term>health system</term> means a collection of
hospitals that are owned and operated by the same entity and that share access
to databases with drug order information for their patients.</text>
</paragraph><paragraph commented="no" id="HCF29DE6457F94BE28770238825D689C6"><enum>(3)</enum><header>Repackage</header><text>For
the purposes of this section only, the term <term>repackage</term>, with
respect to a drug, means to divide the volume of a drug into smaller amounts in
order to—</text>
<subparagraph commented="no" id="H68282CED6F584AC1A05201A6278494F3"><enum>(A)</enum><text>extend the supply
of a drug in response to the placement of the drug on a drug shortage list
described in subsection (b); and</text>
</subparagraph><subparagraph commented="no" id="H8A26C75ADBA746C78D7AB73FA6EC200B"><enum>(B)</enum><text>facilitate access
to the drug by hospitals within the same health system.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="H86B437B0E0E345589E4B1CE9F23CBEF8"><enum>(b)</enum><header>Exclusion from
registration</header><text display-inline="yes-display-inline">Notwithstanding
any other provision of this Act, a hospital shall not be considered an
establishment for which registration is required under section 510 solely
because it repackages a drug and transfers it to another hospital within the
same health system in accordance with the conditions in subsection (c)—</text>
<paragraph commented="no" id="HCFD1CAABDF604F2F8D89B20899AF4242"><enum>(1)</enum><text>during any period
in which the drug is listed on the Drug Shortage List of the Food and Drug
Administration; or</text>
</paragraph><paragraph commented="no" id="H53FD1F82D66F4E238875F55757A4FACC"><enum>(2)</enum><text>during the 60-day
period following any period described in paragraph (1).</text>
</paragraph></subsection><subsection commented="no" id="H384135D3F3AE4CCA832F5E2A5742B156"><enum>(c)</enum><header>Conditions</header><text>Subsection
(b) shall only apply to a hospital, with respect to the repackaging of a drug
for transfers to another hospital within the same health system, if the
following conditions are met:</text>
<paragraph commented="no" id="H1315080D3C164AD2AE77A3A7743C9F5A"><enum>(1)</enum><header>Drug for
intrasystem use only</header><text>In no case may a drug that has been
repackaged in accordance with this section be sold or otherwise distributed by
the health system or a hospital within the system to an entity or individual
that is not a hospital within such health system.</text>
</paragraph><paragraph commented="no" id="HA849838B179E41448745DE7BF0B18860"><enum>(2)</enum><header>Compliance with
State rules</header><text>Repackaging of a drug under this section shall be
done in compliance with applicable State requirements in which the health
system is located.</text>
</paragraph></subsection><subsection commented="no" id="H870D6C0564264394B03986ED9559082C"><enum>(d)</enum><header>Termination</header><text>This
section shall not apply on or after the date on which the Secretary issues
final guidance that clarifies the policy of the Food and Drug Administration
regarding hospital pharmacies repackaging and safely transferring repackaged
drugs to other hospitals within the same health system during a drug
shortage.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section>
Passed the House of
Representatives May 30, 2012.
Karen L. Haas,
Clerk
June 4, 2012
Received; read twice and placed on the
calendar