1.This Act may be cited as
the Food and Drug Administration
Safety and Innovation Act
.
2.Table of
contents; references in Act
(a)The table of contents of this Act is as follows:
Sec. 1. Short
title.
Sec. 2. Table of contents; 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—Fees relating to devices
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 dates.
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 of the Food and Drug
Administration 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—Pediatric drugs and devices
Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review
Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric
studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Relationship Between Pediatric Labeling and New
Clinical Investigation Exclusivity.
TITLE VI—Medical device regulatory improvements
Sec. 601. Reclassification procedures.
Sec. 602. Condition of approval studies.
Sec. 603. Postmarket surveillance.
Sec. 604. Sentinel.
Sec. 605. Recalls.
Sec. 606. Clinical holds on investigational device
exemptions.
Sec. 607. Unique device identifier.
Sec. 608. Clarification of least burdensome
standard.
Sec. 609. Custom devices.
Sec. 610. Agency documentation and review of certain decisions
regarding devices.
Sec. 611. Good guidance practices relating to
devices.
Sec. 612. Modification of de novo application
process.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Reauthorization of third-party review and
inspections.
Sec. 615. 510(k) device modifications.
TITLE VII—Drug supply chain
Sec. 701. Registration of domestic drug
establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with
product listing.
Sec. 704. Electronic system for registration and
listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Failure to allow foreign inspection.
Sec. 708. Exchange of information.
Sec. 709. Enhancing the safety and quality of the drug
supply.
Sec. 710. Accreditation of third-party auditors for drug
establishments.
Sec. 711. Standards for admission of imported
drugs.
Sec. 712. Notification.
Sec. 713. Protection against intentional
adulteration.
Sec. 714. Enhanced criminal penalty for counterfeiting
drugs.
Sec. 715. Extraterritorial jurisdiction.
Sec. 716. Compliance with international agreements.
TITLE VIII—Generating Antibiotic Incentives Now
Sec. 801. Extension of exclusivity period for
drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. GAO study.
Sec. 805. Clinical trials.
Sec. 806. Regulatory certainty and predictability.
TITLE IX—Drug approval and patient access
Sec. 901. Enhancement of accelerated patient access to new
medical treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases,
targeted therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug
container labels by visually-impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Independent study on medical innovation inducement
model.
TITLE X—Drug shortages
Sec. 1001. Drug shortages.
TITLE XI—Other provisions
Subtitle A—Reauthorizations
Sec. 1101. Reauthorization of provision relating to exclusivity
of certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the Critical Path Public-Private
Partnerships.
Subtitle B—Medical gas product regulation
Sec. 1111. Regulation of medical gas products.
Sec. 1112. Regulations.
Sec. 1113. Applicability.
Subtitle C—Miscellaneous provisions
Sec. 1121. Advisory committee conflicts of
interest.
Sec. 1122. Guidance document regarding product promotion using
the Internet.
Sec. 1123. Electronic submission of applications.
Sec. 1124. Combating prescription drug abuse.
Sec. 1125. Tanning bed labeling.
Sec. 1126. Optimizing global clinical trials.
Sec. 1127. Advancing regulatory science to promote public
health innovation.
Sec. 1128. Information technology.
Sec. 1129. Reporting requirements.
Sec. 1130. Strategic integrated management plan.
Sec. 1131. Drug development and bioequivalence
testing.
(b)Except as otherwise specified, amendments made by this Act to
a section or other provision of law are amendments to such section or other
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
<enum>I</enum><header>Fees
relating to drugs</header>
<section id="H65CA085EBD7749D1997BF06E3BC0F25E"><enum>101.</enum><header>Short title;
finding</header>
<subsection commented="no" display-inline="no-display-inline" id="HF2B6486813E74E888B4F7BBDF49601CC"><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="H4F93331326064657B5A2000DE30E5EF9"><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="HD7E3F76A2C5F411598FAD28476D0394E"><enum>102.</enum><header>Definitions</header><text display-inline="no-display-inline">Paragraph (7) of section 735 (21 U.S.C.
379g) is amended, in the matter preceding subparagraph (A), by striking
<quote>incurred</quote>.</text>
</section><section display-inline="no-display-inline" id="HF15FD79E391142C78953367796D703D6"><enum>103.</enum><header>Authority to
assess and use drug fees</header><text display-inline="no-display-inline">Section 736 (21 U.S.C. 379h) is
amended—</text>
<paragraph id="HBE855BEC13E543DF99CF1612DDC6470C"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a)—</text>
<subparagraph id="HC6CC678F58F747D0A046FC1C940D8FB5"><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="H03BFDE5D8D7D4ADB8069ED44B9F35C87"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1), in clauses (i) and (ii)
of subparagraph (A), by striking <quote>subsection (c)(5)</quote> each place
such term appears and inserting <quote>subsection (c)(4)</quote>;</text>
</subparagraph><subparagraph id="HD05BA16EC3FB4060935ECA8A26CB78E4"><enum>(C)</enum><text>in the matter
following clause (ii) in paragraph (2)(A)—</text>
<clause id="id42BFFC9F2CF24E29B4E491223D126D2D"><enum>(i)</enum><text>by
striking <quote>subsection (c)(5)</quote> and inserting <quote>subsection
(c)(4)</quote>; and</text>
</clause><clause id="idDEA7FB7F28294E67ABC84B2374535007"><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 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>; and</text>
</clause></subparagraph><subparagraph id="H6D9859CB8F934F80BFB288FF90EBE6F9"><enum>(D)</enum><text>in paragraph
(3)—</text>
<clause id="H13434DF3A92540A38E445465CE29442D"><enum>(i)</enum><text>in
subparagraph (A)—</text>
<subclause id="H5D9D764D99214E8FBAE0E15684C63AB8"><enum>(I)</enum><text>by striking
<quote>subsection (c)(5)</quote> and inserting <quote>subsection
(c)(4)</quote>; and</text>
</subclause><subclause id="H46DFD4990E3346E1BCF223149B5F49D0"><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
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>; and</text>
</subclause></clause><clause id="H83D45C2A9F564449810B80BB47925900"><enum>(ii)</enum><text>by
amending subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="H08E12ABE32A64BEABD8FD0BC48095347" style="OLC">
<subparagraph id="H8012083131834EB0B271CB768D22E379"><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="H43095C9A683D4827834167F5575F7B18"><enum>(i)</enum><text>identified on the
list compiled under section 505(j)(7) with a potency described in terms of per
100 mL;</text>
</clause><clause id="H69283E09172245E287E9F4C541D3BFFB"><enum>(ii)</enum><text>the same product
as another product that—</text>
<subclause id="HBB631348CEFD480B83261A285F19B5ED"><enum>(I)</enum><text>was approved under
an application filed under section 505(b) or 505(j); and</text>
</subclause><subclause id="H81D540D7DB0E41F9BB7CD939FF6CD028"><enum>(II)</enum><text>is not in the
list of discontinued products compiled under section 505(j)(7);</text>
</subclause></clause><clause id="H9C25F4FE392E4ED8A69BB236B52E921C"><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="HEC4701ECF3A24CC5970294869D99CCFF"><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="H492D1ED0CB84484B80F91CC1F0A0A06D"><enum>(2)</enum><text>in subsection
(b)—</text>
<subparagraph id="H7F5EF6E5941C409EAA0936BF791D957C"><enum>(A)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause id="HB8B4459031784702B0A88C77B3C3BCC9"><enum>(i)</enum><text>in
the matter preceding subparagraph (A), by striking <quote>fiscal years 2008
through 2012</quote> and inserting <quote>fiscal years 2013 through
2017</quote>;</text>
</clause><clause commented="no" id="HA6B0016ABAEF4A67BFF11B6E5C83490E"><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="H94EB5F7988D84A04900D3320BE99624C"><enum>(iii)</enum><text>by
striking subparagraph (B) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H9A77725788B244049957598E6A1785F3" style="OLC">
<subparagraph id="H7108FB7DCDA44556BF355F78DE3F7760"><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="H7DF87D10222A4A29B9AE014BDC187B0C"><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="H9CF7170585AA44A19F330015B6B20DA3"><enum>(B)</enum><text>by striking
paragraphs (3) and (4) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H24E2F99BCDB94F7D9B3A087EA446099C" style="OLC">
<paragraph id="H751C6FF5D2344C8282B28C32780A79C1"><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="HB9A46BEA5D0F46559E8FBCD43C81EE0F"><enum>(A)</enum><header>Inflation
adjustment</header><text>The inflation adjustment for fiscal year 2013 shall be
the sum of—</text>
<clause id="HF99C1BA914CA4FDBA27F63B9BAD0F722"><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="HD9F87877AC464A16B08855BA35651A42"><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="HE21DD8486C694FF58A96F903168DC41A"><enum>(B)</enum><header>Workload
adjustment</header><text>Subject to subparagraph (C), the workload adjustment
for fiscal 2013 shall be—</text>
<clause id="H2AAC9B1AE13A44DFA720C2AFEB419AC1"><enum>(i)</enum><text>$652,709,000 plus
the amount of the inflation adjustment calculated under subparagraph (A);
multiplied by</text>
</clause><clause id="H1727DA9E954441BFA9EC03D302750250"><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="H7870DCFE07AB4855A5ACF928141D7567"><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="H8E50584762F84DFD916331C6A175F213"><enum>(3)</enum><text>by striking
subsection (c) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="H1DBFD1809D89485EB6D2353AACAE118F" style="OLC">
<subsection id="HFC66220A58BA4E08AAACD332B7140763"><enum>(c)</enum><header>Adjustments</header>
<paragraph id="HDEC402F2913A46A9AF6C19581A7919F0"><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="HD7E8B4781DB840F1A5AE8077B6B0D9B3"><enum>(A)</enum><text>one;</text>
</subparagraph><subparagraph id="H348F60D8187A44619EBC10174DB5C65E"><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="H27DD261A3F3E4770A728EB70CB6597AA"><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 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="H32650FA817B046E0884E72D0F6EBD612"><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="H7201AFE4B6364D4D8BCE4D9314CB4721"><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="H92DDA10471CE416EBC34A27DE162FA85"><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="H6F276D31CD7C4BA98071B7D109242D36"><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="H5D3D806D2C864E86A9D212AF170EB772"><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 paragraph shall not be
made.</text>
</paragraph><paragraph id="H17EFBD1FD2B445A3B9A6D4AE4CCE8172"><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="H9A069ED1FC3F4DA48FD7635F88D01473"><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="HCDD390E347B546E8B11FFFFC9674ED1C"><enum>(4)</enum><text>in subsection
(g)—</text>
<subparagraph id="H1A224273E9364C3095754B21E8BD572A"><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="H769D4A6489534A01AF17E2CF8B7F36CA"><enum>(B)</enum><text>in paragraph
(2)—</text>
<clause id="HC639C6869A414F1DA7CFA36FBEE2B148"><enum>(i)</enum><text>in
subparagraph (A)—</text>
<subclause id="id62EC86FC16404924822A1FA470B61C0C"><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>
</subclause><subclause id="idC84EFFD697EB43969ABD018D17EEAD64"><enum>(II)</enum><text>in clause (ii),
by striking <quote>shall only be collected and available</quote> and inserting
<quote>shall be available</quote>; and</text>
</subclause></clause><clause id="H821F674A045A45C9BA56C9938B62AF6D"><enum>(ii)</enum><text>by
adding at the end the following new subparagraph:</text>
<quoted-block display-inline="no-display-inline" id="HD50EDEEED21F44C28B984A9E0204A5CB" style="OLC">
<subparagraph id="H020AAB3795C24B1F87F837A4F6F674EF"><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="H0E120F2360FE4E789FC1AEE65A5DFF74"><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="HDE99B4451CDE4B5AA6CEFFC6AD92661E"><enum>(D)</enum><text display-inline="yes-display-inline">in paragraph (4)—</text>
<clause id="HF4C5A82D602E41CDB2004D14F24145CD"><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="HCA00076E19E64CA0A1E091751714A173"><enum>(ii)</enum><text>by
striking <quote>fiscal year 2011</quote> and inserting <quote>fiscal year
2016</quote>;</text>
</clause><clause id="H406846CAAE5C4119A4F9B156284C2D30"><enum>(iii)</enum><text>by
striking <quote>fiscal years 2008 though 2011</quote> and inserting
<quote>fiscal years 2013 through 2016</quote>; and</text>
</clause><clause id="HA42513D907DC4131997C290338CA4EAD"><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="HE06A8969CD3A486E8C4E8486A4227DD2"><enum>104.</enum><header>Reauthorization;
reporting requirements</header><text display-inline="no-display-inline">Section
736B (21 U.S.C. 379h–2) is amended—</text>
<paragraph id="HCFA22375C8C540A3BF095825F06A84E7"><enum>(1)</enum><text>by amending
subsection (a) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="HD253F6F7474B4733BB97DF63B79E9929" style="OLC">
<subsection id="HE54E5C23B68843E983B54114CECAE3F1"><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 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. 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>
</subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="H0822FE8C47B9403CA59537C795C5E790"><enum>(2)</enum><text>in subsection (b),
by striking <quote>2008</quote> and inserting <quote>2013</quote>; and</text>
</paragraph><paragraph id="HCCEEE181DB624987BB3EB3445CC5DA5B"><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="HF5BA124C60A64568A1B52CA8800904B8"><enum>105.</enum><header>Sunset
dates</header>
<subsection commented="no" id="id0E85BB2CC9B9423991B3F1132BA4504E"><enum>(a)</enum><header>Authorization</header><text display-inline="yes-display-inline">Sections 735 and 736 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective
October 1, 2017.</text>
</subsection><subsection id="H1B5AC39638C54B658308D3E7C335D385"><enum>(b)</enum><header>Reporting
requirements</header><text>Section 736B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2018.</text>
</subsection><subsection commented="no" id="H7A34DB2AD9D34EC39DD370687404A334"><enum>(c)</enum><header>Previous sunset
provision</header><text>The Prescription Drug User Fee Amendments of 2007 is
amended by striking section 106.</text>
</subsection></section><section id="H55AAF871BB384A20AC065F107080ECB8"><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="HF98F5783DCE74F9F9DBCAB071953C3F5"><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>Fees relating to
devices</header>
<section id="idF5871AC044BB4F3EA2FDAFB6DE7AF77E"><enum>201.</enum><header>Short title;
findings</header>
<subsection id="idAD70564ACAD845A78FCA7B723ABB9F21"><enum>(a)</enum><header>Short
title</header><text>This title may be cited as the <quote><short-title>Medical Device User Fee Amendments of
2012</short-title></quote>.</text>
</subsection><subsection id="id56B30A874E724480826426FC0C0DDB70"><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="idA570CD605DE840E082821EAE8C7578B0"><enum>202.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 737 (21 U.S.C. 379i) is
amended—</text>
<paragraph id="idAF356CFA2374437EBCD6971082CCA9A0"><enum>(1)</enum><text>in paragraph (9),
by striking <quote>incurred</quote> after <quote>expenses</quote>;</text>
</paragraph><paragraph id="id41DF94F433BF4C5991062950CEEB3C20"><enum>(2)</enum><text>in paragraph
(10), by striking <quote>October 2001</quote> and inserting <quote>October
2011</quote>; and</text>
</paragraph><paragraph id="id8CC2762E00124937810C9ADEEE1FFB77"><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="idDD9907D6EAE5422B83ECFAB53848364C"><enum>203.</enum><header>Authority to
assess and use device fees</header>
<subsection id="id0E6E64E591ED49D696765FA72DECBF32"><enum>(a)</enum><header>Types of
fees</header><text>Section 738(a) (21 U.S.C. 379j(a)) is amended—</text>
<paragraph id="idF581737AAFA8467C9AA7AE1C518C5205"><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="idE5A496F57DAE4D68BF69ACC333D04174"><enum>(2)</enum><text>in paragraph
(2)(A)—</text>
<subparagraph id="id6E1AF63D5331493392B4C7095F2AE58F"><enum>(A)</enum><text>in the matter
preceding clause (i)—</text>
<clause id="id1D8C39ACA0B44B8C90952D2572BBDE71"><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="id3343CCDEAF1E4BCBA6665663F7F11F8E"><enum>(ii)</enum><text>by
striking <quote>October 1, 2002</quote> and inserting <quote>October 1,
2012</quote>; and</text>
</clause><clause id="id7452A8815850408D9B1E196CA3301BE4"><enum>(iii)</enum><text>by striking
<quote>subsection (c)(1)</quote> and inserting <quote>subsection (c)</quote>;
and</text>
</clause></subparagraph><subparagraph id="id20DD8471B3AD4B4C8A3B722E13FCDEA3"><enum>(B)</enum><text>in clause (viii),
by striking <quote>1.84</quote> and inserting <quote>2</quote>; and</text>
</subparagraph></paragraph><paragraph id="id9793BD60618F4A929C1B986DFCDD427D"><enum>(3)</enum><text>in paragraph
(3)—</text>
<subparagraph id="id5F5DD99ADB9A47B6816FAC39772C71B3"><enum>(A)</enum><text>in subparagraph
(A)—</text>
<clause id="id778415818B9046D9B2A305B51E9EB469"><enum>(i)</enum><text>by
inserting <quote>and subsection (f)</quote> after <quote>subparagraph
(B)</quote>; and</text>
</clause><clause id="id13B5531381EA4EB8B6694C55B7423C9A"><enum>(ii)</enum><text>by
striking <quote>2008</quote> and inserting <quote>2013</quote>; and</text>
</clause></subparagraph><subparagraph id="idD9EF765E18AB4B6196996D48F4A7FBE2"><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="id3A3DFAFB1A9A432F8D11B4F8DD35C4DD" style="OLC">
<text>later
of—</text><clause id="idF5E23CEB6F024C4F93094CE9802A1E2E"><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="id497B5D1C038949A3A141A126F7DF59AB"><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="idAFF9197A49C94EC2B15C23CB2A035853"><enum>(b)</enum><header>Fee
amounts</header><text>Section 738(b) (21 U.S.C. 379j(b)) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idC2EAF42515A046DA9CCDC0DC39844DBC" style="OLC">
<subsection id="id4881A3807B434581BA9BAA136FA0BEDA"><enum>(b)</enum><header>Fee
amounts</header>
<paragraph id="id1885220DCDBC4806AA9E7C134458267C"><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="idEAA225A7D1164297B43F5B6D528ABBEA"><enum>(2)</enum><header>Base fee
amounts</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="id2A948F20016F42CEBBBF1D733970A17A"><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="id7E69FD621E604506AC22EB4BEB30E95F"><enum>(A)</enum><text>$97,722,301 for
fiscal year 2013.</text>
</subparagraph><subparagraph commented="no" id="idF035DB7BBF0442E6AD5AA953C85F1944"><enum>(B)</enum><text>$112,580,497 for
fiscal year 2014.</text>
</subparagraph><subparagraph commented="no" id="idC3C64EE01E584AB8A9171B4498579E62"><enum>(C)</enum><text>$125,767,107 for
fiscal year 2015.</text>
</subparagraph><subparagraph commented="no" id="id5906184D115944BC9AE8013BE47C05C8"><enum>(D)</enum><text>$129,339,949 for
fiscal year 2016.</text>
</subparagraph><subparagraph commented="no" id="idF931E4BEA12C4209AE2C5C9076065454"><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="id0A53A0C9151A4060A7AC02E0432D705E"><enum>(c)</enum><header>Annual fee
setting; adjustments</header><text display-inline="yes-display-inline">Section
738(c) (21 U.S.C. 379j(c)) is amended—</text>
<paragraph id="id8EF16513D96B4F0A862FDD9F8930D5C1"><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="id4A45E53D16B4474C8958E778C2FDBB13"><enum>(2)</enum><text>by striking
paragraphs (1) and (2);</text>
</paragraph><paragraph id="idCB8688E5CE33446480A2B33A5CEDB92E"><enum>(3)</enum><text>by redesignating
paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and</text>
</paragraph><paragraph id="id49CAF9C64E054E11B2862D821C2D797C"><enum>(4)</enum><text>by inserting
before paragraph (4), as so redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="id1F53288208A04AABBDFF2DB0F18479AD" style="OLC">
<paragraph id="id0E296FCD01C44D64B60D344F8999C477"><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="id8E7015D94E0A43DE94D114878110B29B"><enum>(2)</enum><header>Inflation
adjustments</header>
<subparagraph commented="no" id="idEA5C6CB9B9654354A3A1A201371A4B69"><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 legis-path="(2)(B)">subparagraph (B)</internal-xref> for such year.</text>
</subparagraph><subparagraph commented="no" id="id4AB28D45A90C4C9EA428BB0DB6CE158F"><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="id816618AD548C4432B689DC075429E52C"><enum>(i)</enum><text>for fiscal year
2014, the base inflation adjustment under <internal-xref legis-path="(2)(C)">subparagraph (C)</internal-xref> for such fiscal year;
and</text>
</clause><clause commented="no" id="id43B84B0FA6D74992B269261693DCD771"><enum>(ii)</enum><text>for fiscal year
2015 and each subsequent fiscal year, the product of—</text>
<subclause commented="no" id="id54DA1418B7BF4A20A13A2155C7734E7E"><enum>(I)</enum><text>the base
inflation adjustment under <internal-xref legis-path="(2)(C)">subparagraph
(C)</internal-xref> for such fiscal year; and</text>
</subclause><subclause commented="no" id="id274339F3CA844C27ADA9E1B2AED493D9"><enum>(II)</enum><text>the product of
the base inflation adjustment under <internal-xref 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="idA5C986A2B76F41EC9DD25645E8BA2365"><enum>(C)</enum><header>Base inflation
adjustment to total revenue amounts</header>
<clause commented="no" id="id60CF531D39A84A58B0EDDE66097892EB"><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="id3E81905B28724DE7947840EB0D285507"><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="idC297AB5110C144FB89097F1AC0331E5E"><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="id48A7FF5FD54F487B8D8C53E6773096D0"><enum>(ii)</enum><header>Limitations</header><text>For
purposes of <internal-xref 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="id83E62B4D04ED44BD89F42E3C63921EBA"><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="id29644530935B42548FAB5F6CEBBA7AD0"><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="idD94999C21520454C97EF2F4EB604968E"><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="id72C57F24EBD146B1B0D811ED1101F20E"><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="id423F6D7AD50B476BA7154887402AC4DD"><enum>(d)</enum><header>Fee waiver or
reduction</header><text display-inline="yes-display-inline">Section 738 (21
U.S.C. 379j) is amended by—</text>
<paragraph id="idA3428B7747614B0DA48E0F3FF5090D88"><enum>(1)</enum><text>redesignating
subsections (f) through (k) as subsections (g) through (l), respectively;
and</text>
</paragraph><paragraph id="id7C8A94CD9A0F4E36951D672C9D93037B"><enum>(2)</enum><text>by inserting
after subsection (e) the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="id25C9B244EC9A4845B333129308B2D9D9" style="OLC">
<subsection id="idDE0AA59690DB460A8A1093C6E1A7B1CE"><enum>(f)</enum><header>Fee waiver or
reduction</header>
<paragraph id="id1B5F37FED80F49938C9F5792A5D05788"><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="idAB1391312578415A81159B362C22361F"><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="idD10774846D574E96B8B8E5AC5C1EED35"><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="id4267CD6EE8034B58A79000C8B2101F6D"><enum>(e)</enum><header>Conditions</header><text display-inline="yes-display-inline">Section 738(h)(1)(A) (21 U.S.C.
379j(h)(1)(A)), 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="id9F58EC19B5B4465D8F4EF2CF24A23633"><enum>(f)</enum><header>Crediting and
availability of fees</header><text display-inline="yes-display-inline">Section
738(i) (21 U.S.C. 379j(i)), as redesignated by subsection (d)(1), is
amended—</text>
<paragraph id="idBEE54EED0BA94543AA401CBF10282653"><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="id330B3649F4044618A73827A81CD90803"><enum>(2)</enum><text>in paragraph
(2)—</text>
<subparagraph id="id4166F7253E2B48088020AC6E28D2A0B5"><enum>(A)</enum><text>in subparagraph
(A)—</text>
<clause id="idB0D54298FD9A4FA7BDCC4361C41FD40B"><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="id98114942D81E42109F0A59C18B9A26A8"><enum>(ii)</enum><text>in
clause (ii)—</text>
<subclause id="id1EAA9E6EDD9E41B0BC82F67759982EFE"><enum>(I)</enum><text>by striking
<quote>collected and</quote> after <quote>shall only be</quote>; and</text>
</subclause><subclause id="id3B271D94F6984C7A8BF2507821EF2DF1"><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="id21CBADF5D0554FAC9DCA553025B57A33"><enum>(B)</enum><text>by adding at the
end, the following:</text>
<quoted-block display-inline="no-display-inline" id="idD8FA0DA422F34ADFB43FC3249D2FFAE7" style="OLC">
<subparagraph id="id28C481B070D54EEAB62EBBEC9A7F6EF3"><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>
</subparagraph></paragraph><paragraph id="id4D1E0168F42744CEA18A5B883401F783"><enum>(3)</enum><text>by amending
paragraph (3) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id33A52A6D88A34CE491E2D2C8184021EB" style="OLC">
<paragraph id="idDC99B58E46894ED7954B562BC15AEA38"><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="id54F25FADDB8A4831A88684585A56CFD4"><enum>(4)</enum><text>in paragraph
(4)—</text>
<subparagraph id="id22A30C0D0C7344838CBEB08DD45ED983"><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="idA8506B187BE04CBD81E50305C7C5CB14"><enum>(B)</enum><text>by striking
<quote>fiscal year 2011</quote> and inserting <quote>fiscal year
2016</quote>;</text>
</subparagraph><subparagraph id="id4F4DD520118D40038CDE953C92CF1973"><enum>(C)</enum><text>by striking
<quote>June 30, 2011</quote> and inserting <quote>June 30, 2016</quote>;</text>
</subparagraph><subparagraph id="id497A09E5BE0C49A28223F15F9972C29F"><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="id5410021AA0594901AA8D0F541759F63C"><enum>(E)</enum><text>by striking
<quote>aggregate amount in</quote> before <quote>excess shall be
credited</quote>; and</text>
</subparagraph><subparagraph id="idD329CA085C2845F19A2348226938A716"><enum>(F)</enum><text>by striking
<quote>fiscal year 2012</quote> and inserting <quote>fiscal year
2017</quote>.</text>
</subparagraph></paragraph></subsection><subsection id="id6A02B67E924E47DF9CD3DD22077B2915"><enum>(g)</enum><header>Conforming
amendment</header><text display-inline="yes-display-inline">Section
515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by striking
<quote>738(g)</quote> and inserting <quote>738(h)</quote>.</text>
</subsection></section><section id="idD9C51E5C9E8F47CDBA8D3AB5049B30C6"><enum>204.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="idEC17D1442CAD4E3188FB96196D398584"><enum>(a)</enum><header>Reauthorization</header><text display-inline="yes-display-inline">Section 738A(b) (21 U.S.C. 379j–1(b)) is
amended—</text>
<paragraph id="idB33A53D334024FA5B6FEAD3E9FF2D5E9"><enum>(1)</enum><text>in paragraph (1),
by striking <quote>2012</quote> and inserting <quote>2017</quote>; and</text>
</paragraph><paragraph id="id9AA2D3B214264D6F87B0A36674545AFA"><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="idB2E46DCD4ABA479885D033F99C84428B"><enum>(b)</enum><header>Reports</header><text display-inline="yes-display-inline">Section 738A(a) (21 U.S.C. 379j–1(a)) is
amended—</text>
<paragraph id="id63DBA1A68DDC4030A5A61EE3BFB3FEE5"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>2008 through
2012</quote> each place it appears and inserting <quote>2013 through
2017</quote>; and</text>
</paragraph><paragraph id="id19C1A362158C490C9EBE32FB2B0CF662"><enum>(2)</enum><text>by striking
<quote>section 201(c) of the Food and Drug Administration Amendments Act of
2007</quote> and inserting <quote>section 201(b) of the Medical Device User Fee
Amendments of 2012</quote>.</text>
</paragraph></subsection></section><section id="idF02F5FD6EBF143F19428EF01CC639850"><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 (21 U.S.C. 379i et seq.), as in effect on
the day before the date of the enactment of this title, shall continue to be in
effect with respect to submissions described in section 738(a)(2)(A) of the
Federal Food, Drug, and Cosmetic Act (as in effect 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="id24AB99F9E4CB4C4D9F3ADA9E8376FE67"><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 submissions described in section 738(a)(2)(A) of the Federal Food, Drug,
and Cosmetic Act received on or after October 1, 2012, regardless of the date
of the enactment of this Act.</text>
</section><section commented="no" id="id09808685B5F0447E925FCC304162DE1F"><enum>207.</enum><header>Sunset
dates</header>
<subsection commented="no" id="H66F45C998C5942A6A4C2DFF73C34A806"><enum>(a)</enum><header>Authorizations</header><text display-inline="yes-display-inline">Sections 737 and 738 (21 U.S.C. 739i; 739j)
shall cease to be effective October 1, 2017.</text>
</subsection><subsection commented="no" id="id1927C875564147EB95523AF5A7F84076"><enum>(b)</enum><header>Reporting
requirements</header><text display-inline="yes-display-inline">Section 738A (21
U.S.C. 739j–1) shall cease to be effective January 31, 2018.</text>
</subsection><subsection commented="no" id="idCA1DE77FAF694B148579F041506179A7"><enum>(c)</enum><header>Previous sunset
provision</header><text>The Food and Drug Administration Amendments Act of 2007
is amended by striking section 217.</text>
</subsection></section><section commented="no" id="idC1B484EA06564503A359156A31EA5A8E"><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 (21 U.S.C. 371 et seq.) is amended by inserting after section
713 the following new section:</text>
<quoted-block display-inline="no-display-inline" id="idD653055838B7406C88E17516233C86DC" style="OLC">
<section id="idCC6B05C56DEF4E228B627CAFF1B084F3"><enum>714.</enum><header>Streamlined
hiring authority</header>
<subsection id="id1AB8CEB2B08845E29AC963358D51534A"><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="idDA270033C3384CB5AC92BA6B19170E3A"><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="id21ED26119AE44F9EAF48DEFF2DA4556B"><enum>(c)</enum><header>Objectives
specified</header><text>The objectives specified in this subsection are with
respect to the activities under <internal-xref legis-path="714.(b)(1)">subsection (b)</internal-xref>, the goals referred to
in section 738A(a)(1).</text>
</subsection><subsection id="id6F57DB7FFD234ECB868BB37E90726454"><enum>(d)</enum><header>Internal
controls</header><text>The Secretary shall institute appropriate internal
controls for appointments under this section.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id28FD21BBB45C49C8A981D1A68149F9DB"><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="HD349199194574EFC838B5DE299CA63A5"><enum>301.</enum><header>Short
title</header>
<subsection id="HB14AD61E70C74231BB10055620478FEE"><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="H473A4D10E9C44EA28DC4C4210D1C7B7B"><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="H4E7EB32BEA9E40E19013118DB55CAFAC"><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 (21 U.S.C. 379f
et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HBD5E0901F5A149CB83D7B3BFABE0CAD0" style="OLC">
<part id="id95A3ADE5EA3B4DE0955656928F399696"><enum>7</enum><header>FEES RELATING TO
GENERIC DRUGS </header>
<section id="HF16D3DA3F7D040F3BFCCAD5B12F5B7BF"><enum>744A.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="H10A620E9BFF647D6A91AA7D0A8257E3B"><enum>(1)</enum><text>The term
<term>abbreviated new drug application</term>—</text>
<subparagraph id="HFF4BD41404B2487FBBE3310D049F9B59"><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="H1A654080991E4488A2C45AC6095D38C6"><enum>(B)</enum><text>does not include
an application for a positron emission tomography drug.</text>
</subparagraph></paragraph><paragraph id="H53959F20EE3D410D9E3251345AB39FE7"><enum>(2)</enum><text>The term
<term>active pharmaceutical ingredient</term> means—</text>
<subparagraph id="H85D709AB2B85474F8A51F20827D28328"><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="H0368276283DD4E4CBFE04C24A03C66F3"><enum>(i)</enum><text>to
be used as a component of a drug; and</text>
</clause><clause id="H5C016C19DCE9426CB43F5E9DB352D908"><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="HE4D5DBA3096C4C03B9597FF363211FF7"><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="H4078E21F684B40D1BB7C62CB88069189"><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="H934C256632B541A893C64C3D9C533CF4"><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="H650B8531C07048D2AE0C1EA14123ABEE"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="HF539DAF08A634F8A80514196D169F523"><enum>(B)</enum><text>a third party
controls, or has power to control, both of the business entities.</text>
</subparagraph></paragraph><paragraph id="H1B45A964F8CD4CB78AD8742386708390"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="HB852DF28EA1B4769A1F1E5C5A3B6EF94"><enum>(A)</enum><text>The term
<term>facility</term>—</text>
<clause id="HA08667547CD64C0BA1BF34236B1B668B" indent="up1"><enum>(i)</enum><text>means a business or other
entity—</text>
<subclause id="H1FE7D124DF1248D1B106E932055AC771"><enum>(I)</enum><text>under one management, either direct or
indirect; and</text>
</subclause><subclause id="HDDB7EC5A603D4C6BB80194435D589E44"><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="H90A4370DBA404E7CA20AF127CF98F368" 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="HF04D2B2EAB3D42BCA578083721EF4AD8" 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="HB42511C8410B44A3ABCFC26BB9BF2543"><enum>(i)</enum><text>closely related to the same
business enterprise;</text>
</clause><clause id="H8A4F8C7D7B6549588E9F949801155020"><enum>(ii)</enum><text>under the supervision of the same
local management; and</text>
</clause><clause id="H512EA89D784D41C8B7A7B35C3702BD84"><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="H6F0CCADA16E44ABBBB8E99F5868A3181" 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="H8F23B50DD71D4A0CBCE176057F440550"><enum>(6)</enum><text>The term
<term>finished dosage form</term> means—</text>
<subparagraph id="H17511E703B5545259518610782315401"><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="HE76C91632DDC49FB89EF9BC24667EF8D"><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="H84BBD7A01AD54A6D92946CE3C5111449"><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="H38C3696D7A9D4C5880A434E4D77A6142"><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="HA6E1C54F073740379EDA119FC0BFB79A"><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="H370C08B755C74451BBE8A6D6DB2BEC55"><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="HECA01647FA754AD491B4D4101AED6AC4"><enum>(B)</enum><text>The issuance
of—</text>
<clause id="HC62B7E475CB34B809648270BFBDFB611"><enum>(i)</enum><text>approval letters
which approve abbreviated new drug applications or supplements to such
applications; or</text>
</clause><clause id="H85270A4F351F4D6BB7BC4C0FD0E69BD7"><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="H2F2EF173AA9144CAAF428EE4F204A195"><enum>(C)</enum><text>The issuance of
letters related to Type II active pharmaceutical drug master files
which—</text>
<clause id="H829D175907EF4471B6B12FA7125377DA"><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="HF424C4DFE7C54A928A4F4DF4CFD5B233"><enum>(ii)</enum><text>document that no
deficiencies need to be addressed.</text>
</clause></subparagraph><subparagraph id="HB2D99A20E026404A88E3713A8BD26146"><enum>(D)</enum><text>Inspections
related to generic drugs.</text>
</subparagraph><subparagraph id="H453488A3B5D34702B1EF16126D562BD3"><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="H0481C7A923574FEB9CA7B1FC83E47D86"><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="HD7F99E214A3C42C697BCC3DCD8EACA04"><enum>(i)</enum><text>Collecting,
developing, and reviewing safety information on approved drugs, including
adverse event reports.</text>
</clause><clause id="H4203BB51239C4E27B491E12D1FD8DC16"><enum>(ii)</enum><text>Developing and
using improved adverse-event data-collection systems, including information
technology systems.</text>
</clause><clause id="HF09BAFF9DA744CC99CD29A340C9705FB"><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="H8E59803AA3464BE0A11522BC08299A81"><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="HE734BBDA9D8A4D53A7EF06762A5CAFE2"><enum>(v)</enum><text>Carrying out
section 505(k)(5) (relating to adverse-event reports and postmarket safety
activities).</text>
</clause></subparagraph><subparagraph id="HDCA6EFAC62FF45C1AE712C4F6EF05C96"><enum>(G)</enum><text>Regulatory science
activities related to generic drugs.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="H1AADEE67F93C4CF1A8279C58692D682E"><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="H55BB1478C3E7461D9974C3153D3308E7"><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="H733B73C4804540F5B78E2129DB9CBBB9"><enum>(11)</enum><text>The term
<term>resources allocated for human generic drug activities</term> means the
expenses for—</text>
<subparagraph id="H550BD00C21534D27AEB1D8FC15DFD8E5"><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="H6B18BBF2DBBC4AC3A64FD38CF961A4A6"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="HE5036556A5B94DC3AAA89A12F982744E"><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="H771320F59A924A56ADB9141045F0D745"><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="H2DAEF59BA10140AF99CAEC0DF3598657"><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="HAE0B86F930B74FBDB9D9DEA7BBAE5573"><enum>744B.</enum><header>Authority to
assess and use human generic drug fees</header>
<subsection id="H8E2E70F314A94D42B80C03CE43E72581"><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="H1C016252AE0B4D70872D78C1F0EA00C3"><enum>(1)</enum><header>One-Time Backlog
Fee for Abbreviated New Drug Applications Pending on October 1, 2012</header>
<subparagraph id="H4B6C7647B74340C295D64624E787E446"><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="H5AEB09BC4F6E4EB38F02A2CEEA45B3D3"><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="H63C0F74A9EB445A9B5747DA6C5815C9C"><enum>(C)</enum><header>Notice</header><text>Not
later than October 31, 2012, the Secretary shall publish in the Federal
Register a notice announcing the amount of the fee required by subparagraph
(A).</text>
</subparagraph><subparagraph id="H23E84008BA6D472180E2487F8F6F96A8"><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="HFD250A6F09B647ABB8AF9C7088ED61BD"><enum>(2)</enum><header>Drug Master File
Fee</header>
<subparagraph id="H1F794DCDEC7148848E829548D828486D"><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="H99E88221B0B040ACB106480B49F8FE00"><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="H2D7DD0DB11FD41328CD208F9B43C2F58"><enum>(C)</enum><header>Notice</header>
<clause id="HD0E83E1D2CCD428DAE7B04616611EAE7"><enum>(i)</enum><header>Fiscal year
2013</header><text>Not later than October 31, 2012, the Secretary shall publish
in the Federal Register a notice announcing the amount of the drug master file
fee for fiscal year 2013.</text>
</clause><clause id="HBC23B270F9754531A7205D5D414FD789"><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 publish 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="HE602348AFA474D3496C2404AFE57C68A"><enum>(D)</enum><header>Availability for
reference</header>
<clause commented="no" id="H2317294003E04D96B74E447E7EE424BF"><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="H2115E47E00B04DF1A5CCE151E10BF52B"><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="H8A0C46630BED4ACDA765A1D384EA799B"><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="H1BD83BF2E826498C992728BA05AE05EA"><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="H956FCD9F7A594526BAFA0481ADBB5F2B"><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="HDB066DFB011D4BC59D948EE02D77B079"><enum>(E)</enum><header>Fee Due
Date</header>
<clause id="HABDC1A3A3E9941F78D7F873376371C05"><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="H9F3E86B0C0EE4B069D2F50DD1FBEC677"><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="H6EBE53FF563749CAB67FE1D6B1E078C1"><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="H8115FC6E702F46999903E3B0D1433F8C"><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="H4B895ABD280C465A87D1F4977CEF5BE8"><enum>(3)</enum><header>Abbreviated New
Drug Application and Prior Approval Supplement Filing Fee</header>
<subparagraph id="H86E5EC0FF31C498E97F1175FE97501CC"><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="HEFF43641ADF74F6EA25D44F08B0222F8"><enum>(B)</enum><header>Notice</header>
<clause id="H73A5A6F1EE31444CB59EC1C5CDF4BEDA"><enum>(i)</enum><header>Fiscal year
2013</header><text>Not later than October 31, 2012, the Secretary shall publish
in the Federal Register a notice announcing the amount of the fees under
subparagraph (A) for fiscal year 2013.</text>
</clause><clause id="H492268086559400580E51E288DF4FAB1"><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 publish in the Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.</text>
</clause></subparagraph><subparagraph id="H7C9B066A265140519D464767457049AE"><enum>(C)</enum><header>Fee Due
Date</header>
<clause id="H840DB9EA33C5442494983600E0038D1D"><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="HA85682F4BE7C4FC5937E826555E87D58"><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="HFE9E054D48844270A7FDA4A76FD4F10E"><enum>(I)</enum><text>the date on which
the fee is due under clause (i);</text>
</subclause><subclause id="HEA54E32F894C495AB3ED0D7FD4AAC0FD"><enum>(II)</enum><text>30 calendar days
after publication of the notice referred to in subparagraph (B)(i); or</text>
</subclause><subclause id="H0AA016F5B0FE4BC4977672EBC10C3B1C"><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="H006A5C1C8D1140428BEA57F807A833A7"><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="HD7B2F104A5D542E7B5A82C412A2AFF2D"><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="HC0643993137C45978A8654E721DA381E"><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="H9C3041FFADF747EBAFCDADD45023B521"><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="HFD2DAF8C4AF24F15B6ADC9AC186B83BC"><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="HB0D1F7340DAA44CB9AFD813C7E8AC8F1"><enum>(4)</enum><header>Generic Drug
Facility Fee and Active Pharmaceutical Ingredient Facility Fee</header>
<subparagraph id="H96C39B13ECD44768A634DA4A37A90F7B"><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="H0659C3A34E934D8FB637B29775F37EBB"><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="HD5D12EE7B2DE4C9E8C0BDD4C2229DDF8"><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="HFF28DBBBEA2B4916B541B796D757E9C5"><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="H763B34B70CB0489280BF1357E941D215"><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="HDEBB94E285914CC19098B8DBA9545775"><enum>(C)</enum><header>Notice</header>
<clause id="HC2001C2A2D4B4539AB7405D139EF1848"><enum>(i)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013, the Secretary shall publish 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="H8CE2DC2208FF4AF39BA2A9E15B27AB96"><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 publish in the
Federal Register the amount of the fees under subparagraph (A) for such fiscal
year.</text>
</clause></subparagraph><subparagraph id="H2F8147BBEE14470AA10B3079C38AF7AC"><enum>(D)</enum><header>Fee Due
Date</header>
<clause id="H1AC69B4956A443DDB86533EB8EC14AB9"><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="HDA9E5086E3C54FF8BF6A8D48B12221DF"><enum>(I)</enum><text>not later than 45
days after the publication of the notice under subparagraph (B); or</text>
</subclause><subclause id="H283110945CA44C35841A3E0F75D254DB"><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="H00405333D9714A0BA62B5F8D8D9C8B3F"><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="H40849EFB796641F3B505D8CF5DE6B60B"><enum>(I)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</subclause><subclause id="H03383AA190C24528B1E94E2187CE6E25"><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="H02C84EED2D084A15BFE393EDF530E538"><enum>(5)</enum><header>Date of
submission</header><text display-inline="yes-display-inline">For purposes of
this Act, a generic drug submission or Type II pharmaceutical master file is
deemed to be ‘submitted’ to the Food and Drug Administration—</text>
<subparagraph id="id6A02E90151224F08AA87C76571C22E6F"><enum>(A)</enum><text display-inline="yes-display-inline">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; or</text>
</subparagraph><subparagraph id="id7BC70311AC234936AB84DC87514D300F"><enum>(B)</enum><text display-inline="yes-display-inline">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="HF34F96B2A0D64565B95209D47F94F2F5"><enum>(b)</enum><header>Fee revenue
amounts</header>
<paragraph id="HD503A605D6814CB5B0C4754A198D1F9C"><enum>(1)</enum><header>In
general</header>
<subparagraph id="HE9B02AE997F34EF8A31DC113995A7826"><enum>(A)</enum><header>Fiscal year
2013</header><text display-inline="yes-display-inline">For fiscal year 2013,
fees under subsection (a) except as provided in subsection (o) (relating to
waivers) shall be established to generate a total estimated revenue amount
under such subsection of $299,000,000. Of that amount—</text>
<clause id="HDC03E4F7F0DE474FA43EED86A58A2C6E"><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="H6E45217D4680430EBBEAD1B4C0428EC3"><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="H0B105D16954647B1A99E403E787BFA00"><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="H153F45FB8B0945F0AF38DFDFD6407BFD"><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="H690BA6C9CC9246E3B07DA47BDF87A011"><enum>(A)</enum><text>6 percent shall be
derived from fees under subsection (a)(2) (relating to drug master
files).</text>
</subparagraph><subparagraph id="H71BED88830FF49CA91D3D55D5DE4FA83"><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="HA29C63264E484ABDB7C517460D0FBDE1"><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="H28BD54C19369484FB9507AF648965CEA"><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="H36776C7F0C614DABB0EB6164679C34A4"><enum>(c)</enum><header>Adjustments</header>
<paragraph commented="no" id="H2927A3F9FB754D56873537105560E1F6"><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="HD42C74CC62984F17BAA79E86D9CE0091"><enum>(A)</enum><text>one;</text>
</subparagraph><subparagraph commented="no" id="H62EFB9AE2E924E54ACF013077D2E96AB"><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="HA5CA859AC1354802BC55C53652476D7A"><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="H5B5A6B881F034D81AA1ABB4CD39A2990"><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="HA54057A37B2A4CC4A79255530CFF9438"><enum>(d)</enum><header>Annual fee
setting</header>
<paragraph id="H80B09CEEAF344EAF8A3C4D747025EDD5"><enum>(1)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013—</text>
<subparagraph id="H4B11A39BB8404C4E87E35AC1B19AD1A9"><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="HBAD57F25766349E7956AE1899DB78F6B"><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="H76CDCEE3A9F14081BAE69CC01C4EF651"><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="HE13C8AF1349C44B6BFFDA953E89EAC9B"><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="HB6552C2A89A64BA68EFF5E2C39214C87"><enum>(A)</enum><text>the sum of—</text>
<clause id="HCD3A9753FC344588BCDFC26579FE7FA4"><enum>(i)</enum><text>the total number
of such active pharmaceutical ingredients in such submission; and</text>
</clause><clause id="H472E12471D2B426FB223E144BAB33A30"><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="HAFFE9E51079A4A6897D56A930E66D802"><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="HC8E508D7C32D4D1EA27E153321E5B565"><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="HE35D40AE9A6445D6908CF9452667EE81"><enum>(f)</enum><header>Identification
of facilities</header>
<paragraph id="H73EBA345C35C430585BE58576F2F5377"><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 publish 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="H65C0847FB5024327A5C0968685D5014C"><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="H5F23468B46C74E279D75ABFC9D536F67"><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="HCB32EA6429D14B1DAD28A82A1EBC9CF1"><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="H53E93B2E5C2E474ABA448CD27DE4BEFA"><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="H98B97681239641309CA41633E27DCD93"><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="H27A0400F0D7E4140B3142096244EC1DA"><enum>(B)</enum><text>whether the
facility manufactures active pharmaceutical ingredients or finished dosage
forms, or both;</text>
</subparagraph><subparagraph id="H48851B582F7A4AD2881C0BB4B1A0CB90"><enum>(C)</enum><text>whether or not the
facility is located within the United States and its territories and
possessions;</text>
</subparagraph><subparagraph id="H1F71DBC26E8D4894A9469A720EBFAFF7"><enum>(D)</enum><text>whether the
facility manufactures positron emission tomography drugs solely, or in addition
to other drugs; and</text>
</subparagraph><subparagraph id="H20723E39FAA0496FBE723CC404BDE31C"><enum>(E)</enum><text>whether the
facility manufactures drugs that are not generic drugs.</text>
</subparagraph></paragraph><paragraph id="HB9ED05C81EFA469288F7C708D808D237"><enum>(4)</enum><header>Certain sites
and organizations</header>
<subparagraph id="H7778DDE944684B8A80C6C363E55AF5EE"><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="H5012CBF0817D48EF9B6C259F97BEB698"><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="H5FF9D520A4F14C76A99B49E1CB3A87EE"><enum>(i)</enum><text>a
site in which a bioanalytical study is conducted;</text>
</clause><clause id="HE9AEF923029C4385A6203BB828024132"><enum>(ii)</enum><text>a
clinical research organization;</text>
</clause><clause id="HF7F2DE2FF25C4530811C9DD051C49879"><enum>(iii)</enum><text>a contract
analytical testing site; or</text>
</clause><clause id="HF872C1B873B24403A00DCA8019995ABE"><enum>(iv)</enum><text>a
contract repackager site.</text>
</clause></subparagraph><subparagraph id="H29F3DF437DA24D879F892139A6AA6C88"><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="HABD82F96F3664D999D6AE04942F0C0D5"><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="H12A466F5E5F24666A3AEB398FDD79C44"><enum>(g)</enum><header>Effect of
failure To pay fees</header>
<paragraph id="H7EA06B749776486BB53E7CAFBF40545E"><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="H87F09DD3307B4CB4B8DC497F94E689B5"><enum>(2)</enum><header>Drug master file
fee</header>
<subparagraph commented="no" id="H9A72D7FF983746B9AE61BEBE5D98BA8F"><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="H9D479991EB4F445DA8307AD06C31AC18"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H930A7F159306432D85660AD1390F516A"><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="H31B29ED2D25846FE8C93B0BFA55B877D" 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="HDEA3317BA3E04E22B531D0AFDA6DFB76"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="H081E6E99029C4AB8B6D3ED3D1008BBE2"><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="H41B60BF3EB0544A499536491C39BDD63" 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="HBCD1EF2ECCAE4F5F8434739C43EDB4EC"><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="H0083FA08F54843C299B9D676FE57A24A"><enum>(4)</enum><header>Generic drug
facility fee and active pharmaceutical ingredient facility fee</header>
<subparagraph id="H91AD54770C5C4A38A979AC17E63DD407"><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="H5F56475197B84934B3F97BE68F245800"><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="HC295B6D63F5148CE8098689322627EFA"><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="H39B16283678045F09D6337D360EA42FE"><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="H8A959CD864D64F4285FA28C38661B2F8"><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="HBBA6EFADE16D466E97EC652ACCBFF726"><enum>(C)</enum><header>Nonreceival for
nonpayment</header>
<clause id="H150EC51F0F0642E28FAAF79201431262"><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="H4411617D145141CFA3A9F5E5C06EBF81"><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="H43F35BC72DA64CF795B563A7758500F1"><enum>(h)</enum><header>Limitations</header>
<paragraph id="H5C059892D5824E3680AFD83C15AB5875"><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="HD2F9F1BCD4754B96A5A41F573F80DC2F"><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="H7F8A6D8E424E4116B2E2845675B47E3B"><enum>(i)</enum><header>Crediting and
availability of fees</header>
<paragraph id="HA46EAF7523E9427AB7D4A0DB18455D8F"><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="H639565AA03EB4DFB9A78F4FD809AEB62"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="HD8DE9489953B484F921A4622E449B864"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause id="H6C4616A3AC384D1CA4F1411B75C09791"><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="H62B7090847EA490E86F8EC478D6968E4"><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, as defined in section 744A(3), applicable to the fiscal year
involved.</text>
</clause></subparagraph><subparagraph id="H4F19ED57F4DD420C8377086161769024"><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="H60FEF01C96854076B76FEBC3C2681982"><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="H9C8AA0D21E9A4E41AA8F7D3F5EB8EED3"><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="H55D15C9C83F0422CA4DF87B9399FB9AB"><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="H276E53F862E2402AA17119F5E6E76F65"><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 chapter 37 of title 31, United States Code.</text>
</subsection><subsection id="HDED8CA49A1CF403D935A1D321E5C6C3F"><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="H3C895E463AF94B9AAC414F7CE7B64DD1"><enum>(l)</enum><header>Positron
emission tomography drugs</header>
<paragraph id="HF6C475DBB44D4612BCCE8E5EC3F2D9EB"><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="H908AD89B48CE4EB69762AEA2102F9148"><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="H1E2084BA4B4849A3844799EB74FDA985"><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="HEF99BA7A7DF8421D939E636C5661001B"><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="H50BA12F7880B46C3B5F2503CC97F4EBA"><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="HF5D0A4F65A6B466699BBA23D43139219" style="OLC">
<section id="H738651406D72462D80B4908444355F98"><enum>744C.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="H9F3F8EB99D8B49D28883D6528B55AFAB"><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 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>
</subsection><subsection id="H03C97767C5F14CA38830FE176CBCCDEE"><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="H52B725520D6B45B3B558C40DBC4A44F4"><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="HBFC057964843484FAC610D1BD39F1EF7"><enum>(d)</enum><header>Reauthorization</header>
<paragraph id="HD2777F94C16C4CFC888DD1FFEDB1A317"><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="H2A2EB8FEF3E144E4979BA7495690430D"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="HDD61E726B6C6432BB88C1B651DBFC670"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="HC2DB44ECA6974A81BE6C361A312D2F68"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="H9B5A065B3EC7457C80064974B7E34EB6"><enum>(D)</enum><text>health care
professionals;</text>
</subparagraph><subparagraph id="H30183252BBC440A6A7E976552766D351"><enum>(E)</enum><text>representatives of
patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="HFB8673A7D62A44779109C443AE0DDBAA"><enum>(F)</enum><text>the generic drug
industry.</text>
</subparagraph></paragraph><paragraph id="H87E41123B3F6439C917C1932816FDC5D"><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="HFFE0EE17044B48BD8D7DDD5C0ECFF345"><enum>(A)</enum><text>publish a notice
in the Federal Register requesting public input on the reauthorization;</text>
</subparagraph><subparagraph id="H76152CB756F64ED6B75C905CE8D709AE"><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="HED6EF5DBDFB440BC90455219512FE6DA"><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="HFF064201BA4B4566AEBC211C5661D093"><enum>(D)</enum><text>publish the
comments on the Food and Drug Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph id="HDBF23DCD20C24066AC640C795116E053"><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="H5C7BB89722734CBC8C2892AA5E1EA3E4"><enum>(4)</enum><header>Public review of
recommendations</header><text>After negotiations with the generic drug
industry, the Secretary shall—</text>
<subparagraph id="H77F18E02062C41B1B079229C172074F0"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="H9C97C4F114E54481920B74BF905092E5"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="HEF2E847563AA410CAC908AC52632A203"><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="H8763DF4950E24DED8DCC099B058930E0"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="H8F3E00229E5D442CBBC67F36D6DEDE36"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="H52B28B412EE74C479CA539208BFF875E"><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="H6B712C88640A4465982C28D9F8BD4F7D"><enum>(6)</enum><header>Minutes of
negotiation meetings</header>
<subparagraph id="H6F780E3B826548AF9EC2D48D1F9F4DFF"><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="HC78E71E24AE7430D8E11BE16E114B79A"><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 id="H34E33EF8AAAB450682831A50B58F5D4C"><enum>304.</enum><header>Sunset
dates</header>
<subsection id="HC1E10E1A6DB1470E82852556D5102175"><enum>(a)</enum><header>Authorization</header><text>The
amendments made by section 302 cease to be effective October 1, 2017.</text>
</subsection><subsection id="H65D668E69E574F94BA4F6BB6ED8681DA"><enum>(b)</enum><header>Reporting
requirements</header><text>The amendments made by section 303 cease to be
effective January 31, 2018.</text>
</subsection></section><section id="H46D7C2642256452697086C323E55792E"><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="HD3F93C32845744119539B4B70BB136BF"><enum>306.</enum><header>Amendment with
respect to misbranding</header><text display-inline="no-display-inline">Section
502 (21 U.S.C. 352) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H75EC2FD6A4764CDBBE7E4B7A308C95C8" style="OLC">
<subsection id="HBB7177D582804F51B3B272E713FC3E5C"><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 commented="no" id="H3BC953D644B44CBB8B6C599B0483B626"><enum>307.</enum><header>Streamlined
hiring authority of the Food and Drug Administration to support activities
related to human generic drugs</header><text display-inline="no-display-inline">Section 714 of the Federal Food, Drug, and
Cosmetic Act, as added by section 208, is amended—</text>
<paragraph commented="no" id="id07CDB1E05417441EA676FBA18B2C385C"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph commented="no" id="id7C1743AA3D8949E3A39483E238939788"><enum>(A)</enum><text display-inline="yes-display-inline">by striking <quote>are activities</quote>
and inserting “are—</text>
<quoted-block display-inline="no-display-inline" id="idCDAC1AAAB3E64461AD3E907ADF4F61A0" style="OLC">
<paragraph commented="no" id="id4967DCB6E0CF428D993543F2D94A613E"><enum>(1)</enum><text display-inline="yes-display-inline">activities</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</subparagraph><subparagraph commented="no" id="idD938F6C7EB1A4CB9A7D29A8D49A78F6C"><enum>(B)</enum><text display-inline="yes-display-inline">by striking the period at the end and
inserting <quote>; and</quote>; and</text>
</subparagraph><subparagraph commented="no" id="id2BE8935A4D714233ABB331A4068CD44A"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="HCC00482686D74EAC8A262F587048203D" style="OLC">
<paragraph commented="no" id="id518BDC4CD8F64F52B81E583C51BCC956"><enum>(2)</enum><text>activities under
this Act related to human generic drug activities (as defined in section
744A).</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="id1D47D8F4D1194C84AF48AD89A98E5ABE"><enum>(2)</enum><text>by amending
subsection (c) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idCD824226F75F4C67825DB932D985D53B" style="OLC">
<subsection id="HEF15466B0B474D7499B8F30C5B9742BB"><enum>(c)</enum><header>Objectives
specified</header><text>The objectives specified in this subsection are—</text>
<paragraph id="id97DEBA62C5FB4E0EB47856D84517EA3F"><enum>(1)</enum><text>with respect to
the activities under subsection (b)(1), the goals referred to in section
738A(a)(1); and</text>
</paragraph><paragraph id="idD1AB4EB534914568856E3C6952388BF0"><enum>(2)</enum><text>with respect to
the activities under subsection (b)(2), the performance goals with respect to
section 744A (regarding assessment and use of human generic drug fees), as set
forth in the letters described in section 301(b) of the
<short-title>Generic Drug User Fee Amendments of
2012</short-title>.</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="H41FC53C9A3F148FCA92708774E7F58C5"><enum>401.</enum><header>Short title;
finding</header>
<subsection id="H2538D0B6E84943AD8EBDEAE0FD702130"><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="H7379F26A2D7B426FB25CE4E4184B909F"><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="HAF8F2B2589424427A77174C57B5BA317"><enum>402.</enum><header>Fees relating
to biosimilar biological products</header><text display-inline="no-display-inline">Subchapter C of chapter VII (21 U.S.C. 379f
et seq.) is amended by inserting after part 7, as added by title III of this
Act, the following:</text>
<quoted-block id="HFA8F7E7CA8CD4074B1859AB8EAEDF28C" style="OLC">
<part id="HFDD9FCD553C746D5B07A011639F73595"><enum>8</enum><header>FEES
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS</header>
<section id="H0A56D97651FE4D18B3D8073F36BB56B6"><enum>744G.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="HC520158BB6FB46B89F621951FEE922BC"><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="H2E2D783E2A21490EBA6DC959BB7D116B"><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="H796589AF948C436AB885286F91D4962C"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="HC88673D835E148EEB9F66D39A9E92547"><enum>(B)</enum><text>a third party
controls, or has power to control, both of the business entities.</text>
</subparagraph></paragraph><paragraph id="HE56A9B876A184711AB53AD5E54ED1767"><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="H411E846D14B448F697B5D718991F5D23"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H71E00D610C894A44BE4D9E9A5CDAAC28"><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="H88735E75EC764D1FBF4084B2DFD632BD" indent="up1"><enum>(B)</enum><text>Such term does not include—</text>
<clause id="H31C69ADF1E234470A3BB4FC19BCF8662"><enum>(i)</enum><text>a supplement to such an
application;</text>
</clause><clause id="H60B6546623B34E7E8B740B924CE2EEC4"><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="H73E2D2F9B6C8436DADCA7DBB245FFD13"><enum>(iii)</enum><text>an application filed under
section 351(k) of the Public Health Service Act with respect to—</text>
<subclause id="H6C546E14CEE04D2CB2ACC462BA5C960C"><enum>(I)</enum><text>whole blood or a blood component for
transfusion;</text>
</subclause><subclause id="HA2CC3AD0568747E1870413D8552DB2D0"><enum>(II)</enum><text>an allergenic extract product;</text>
</subclause><subclause id="HDA6535CA6DF8492688FEBA72E28B22F1"><enum>(III)</enum><text>an in vitro diagnostic biological
product; or</text>
</subclause><subclause id="H340CE1A9FE21454EB63EDF638CFD3A57"><enum>(IV)</enum><text>a biological product for further
manufacturing use only; or</text>
</subclause></clause><clause id="H0B3DFA8FB51A403CB069BD7CC64016DB"><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="H0EE40B8092F849CC931AD9764AB6219E"><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="HA4C70998410F4190B9576C90CEFAFD46"><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="HCDF1DAF2C02D4EC48245CF7630E573AA"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H279D41AC79A8424495E67E6B83B8EAD5"><enum>(A)</enum><text>The term
<term>biosimilar biological product establishment</term> means a foreign or
domestic place of business—</text>
<clause id="H3D6F0A33F0F04E68930F430E2278102E" 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="HE2D067D738474941AFDEE3A1288DEDA1" 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="H20549EB6F95A40948F97E77ABB450983" 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="H2A6FB7FFCC33450E9F0B1F59DF84D883"><enum>(8)</enum><text>The term
<term>biosimilar initial advisory meeting</term>—</text>
<subparagraph id="HA99F91ED336F475F83C7EB4F86E4C0E5"><enum>(A)</enum><text>means a meeting,
if requested, that is limited to—</text>
<clause id="H7F40DAABFBCA44C5B2D6CAC787F7455F"><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="HB6BDE47C2416411ABD8B6D49879402BA"><enum>(ii)</enum><text>if so, general
advice on the expected content of the development program; and</text>
</clause></subparagraph><subparagraph id="HD3EB5BBD04AF44F88989769616775EF5"><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="H78F459E0977F4C498672B534449866D3"><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="H4ACE0C37321743829FA1AC110423057E"><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="H8903914EE586446180DAA8DD6EB4317D"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="H82ACC9FAE76544A5AEB1EA8E5AEA9994"><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="H0BE4B86773FE4EEA85F98DAE6A4490EF"><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="H2CFA62627448450EB6009B9AD7E2FC6D"><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="H12366526662E4404A561D8DED02989B5"><enum>(11)</enum><text>The term
<term>financial hold</term>—</text>
<subparagraph id="HE345D8A8344F41B1BCD6B83C075C265A"><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="H4E85E215213543C4BB0017A1F89565E8"><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="H69A2A06D1B7043B8BF54D414ADDB772A"><enum>(12)</enum><text>The term
<term>person</term> includes an affiliate of such person.</text>
</paragraph><paragraph id="H9C1E5384DB8D4761A974566BF8048840"><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="HF7763099E6F2407D80FCBC6491807EFA"><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="H6B7BC132FE6F4A05BCABBF52275FF43E"><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="HA6495BA7EC144E99BB16A8CCDDB299CE"><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="HB83AF174F3F84B0498DB469EE491F51D"><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="H5B9A5D0D95F14C998C5A0153215F1A6F"><enum>(E)</enum><text>Monitoring of
research conducted in connection with the review of biosimilar biological
product applications.</text>
</subparagraph><subparagraph id="H377C0208DE8C403081F38A16D8A7F487"><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="H1B7C88DD5F904F73BA7D4BEA15152F3F"><enum>(i)</enum><text>Collecting,
developing, and reviewing safety information on biosimilar biological products,
including adverse-event reports.</text>
</clause><clause id="H1814EFE72F0E46B6AABF17E1B007C4DF"><enum>(ii)</enum><text>Developing and
using improved adverse-event data-collection systems, including information
technology systems.</text>
</clause><clause id="H1745F9031D88467E8DACCEA247E7F5C8"><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="H43C8E41DB1EC4C89B4197A4BA23DB2D3"><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="HA596102813A446F5BDF8E756A19918D8"><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="HFA964895B88F4302AC2F7B7B8016FCD5"><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="H2E4931C4A6AA4B97A92051BD5C8FF448"><enum>744H.</enum><header>Authority to
assess and use biosimilar biological product fees</header>
<subsection id="H888D063DA691488199873B5438C357F1"><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="H50088CD870C54E1D8D8914AC9172B2A0"><enum>(1)</enum><header>Biosimilar
development program fees</header>
<subparagraph id="H1262A831B1914F4183DFA099E66FE5F2"><enum>(A)</enum><header>Initial
biosimilar biological product development fee</header>
<clause id="HC257F9453ED347759358D20EAEF95AB3"><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="HC091AC54161F401FB14F7DFD92D1DCD7"><enum>(ii)</enum><header>Meeting
request</header><text>The meeting request described in this clause is a request
for a biosimilar biological product development meeting for a product.</text>
</clause><clause id="HC6EC90423CE64EF6819B9904CA04478D"><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="H88098462DA7B4591957FD415467DEF77"><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="H5A5B2EFF1BA3416EAF3D116FB729DF03"><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="HF4679468EE344300B3B381109A0C8DFA"><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="H7C958522F1F148A6B04BD0A30DB6F941"><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="H0696E38D607A489986399E7F24C5F244"><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="H4BD844E7CC374D51B87A84C9AD742E37"><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="H877E2390C2344518A3101BC1FA5073DE"><enum>(B)</enum><header>Annual
biosimilar biological product development fee</header>
<clause display-inline="no-display-inline" id="H7A0D8FB143B146B2AFCCB436D55807BC"><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="H03B8CFA95F154418B1E73E76D35FCA92"><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="H386C692517104B78A7B2424864B9393B"><enum>(I)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</subclause><subclause id="HD249130809724717B603D9D01A489F36"><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="HF3702C53470C4ADD98D60BE1EE9DB7DB"><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="HF3AA7E4C56774C51B83153C768E63967"><enum>(I)</enum><text>submitted a
marketing application for the biological product that was accepted for filing;
or</text>
</subclause><subclause id="H55E900ADD3FF4141A4BDA212A2451647"><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="HCA1B53EEBFC94625A071A8A8F1BCCBA3"><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="HCB46DD4E0FB94F0EA324F8F0370EA4EB"><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="HE908B5B2FB2D43F4869186E7283E443B"><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="H17E746F3068B43FC8D0CDB2CF82432FD"><enum>(D)</enum><header>Reactivation
fee</header>
<clause id="HFF63C1C8A8DD44F8A8F31332BC3A5D4A"><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="H4C1223D7CCDF49FBA32A966E8A07BFCD"><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="H1A86876CF2D24BD58E819E7BBC0F0147"><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="H3F7FC63F14264B12A45F067AAEF138C9"><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="H871EF5E80F7B41C5A9F0FE5563C29C9C"><enum>(E)</enum><header>Effect of
failure to pay biosimilar development program fees</header>
<clause id="HC336DFE758064344B2B34837AB1D82A0"><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="H3A495C991BC24A2E9DB9DC52F6092DC9"><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="H2FAD50511F2440A6B3000050993CF550"><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="HE8BE0A2EAD104727944FBA42065C24D5"><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="HCDCE872238704975BB3C0108C7E2B4D8"><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="H96D933FF58BE45B28D41940B541D5FA7"><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="HDEEF064288FE4CFBBEFDBEC9CF6149CF"><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="HB49A9D8D9DCF452A9107CA7D7C28335D"><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="H8CCE4AFC23694A728B3251DFDABC8D30"><enum>(F)</enum><header>Limits regarding
biosimilar development program fees</header>
<clause id="H7900DDBE34034A6FA90514E391EAE0B1"><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="H9201F23C90C741D3B81D8A413DF54BCE"><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="H6DAF7A49A21E45CD86CB1DA159205AAD"><enum>(2)</enum><header>Biosimilar
biological product application and supplement fee</header>
<subparagraph id="H147E49E613BC40E798832CA2A5D3E714"><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="H8ED6E9D59BE749EDA58A952DA085444E"><enum>(i)</enum><text>A
fee for a biosimilar biological product application that is equal to—</text>
<subclause id="H78088F62DF1C4ECA9B0B8CD318A26373"><enum>(I)</enum><text>the amount of the
fee established under subsection (b)(1)(D) for a biosimilar biological product
application; minus</text>
</subclause><subclause id="H2621670B0130400882CDBCE4B866555C"><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="H899CB3FC455A4E3388255A85B0FBC54D"><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="HABC7A4D7D47F4B37B6FEFBE8BCEA4D4C"><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="H096C1B11A97C4E3A9FAA5B67555E91E5"><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="HBA385AE63D5449B0AD3BDB7AC0C46240"><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="H2380BC6E45694E399857A4368F7DD0D5"><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="HE2144AACBA1D4361BA17EEFFD015C5FE"><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="H610193E30EE0461BBD67FA5813F776A7"><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="H75718529BD1A47D9B6236C7DEFE3A4F2"><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="H09DB9A0927424077AE0FF92E435EE9A4"><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="H39A22AE5A303487181017B98C29A5BEE"><enum>(3)</enum><header>Biosimilar
biological product establishment fee</header>
<subparagraph commented="no" id="H746C8E53E3D140259A64A7450990B249"><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="H1C5D0497F80D4BC9AB94F380F62C3982"><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="H4B28F7ADE1B648028AF0BF2B1366BED9"><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="H284FB26B91E44DD8A6560AA712023D89"><enum>(i)</enum><text>the first business
day on or after October 1 of such fiscal year; or</text>
</clause><clause commented="no" id="HAD820D9FA8514165B18B9268884D6E74"><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="HC6B847A56ACF4800A3C22044C16C59CF"><enum>(D)</enum><header>Application to
establishment</header>
<clause id="HB3F7DC5C2F95485782BC4C4B47FC0E7C"><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="H900AE5F79C18486CA3309EAF6689EFDC"><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="H216C2F72A40B44E6AFE8DDCA97508B88"><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="HEA4FFF09559646D996746B1B77678E9E"><enum>(i)</enum><text>that did not
manufacture the biosimilar biological product in the previous fiscal year;
and</text>
</clause><clause commented="no" id="H49D219B219B74F86971134C9B5104DFA"><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="H491CDA0378294E349C84A9A424F94742"><enum>(4)</enum><header>Biosimilar
biological product fee</header>
<subparagraph display-inline="no-display-inline" id="HC362137B5FB94C04A2140B6467AB36BF"><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="H444DE69753104EC9AE0E6254FAD02F54"><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="HC15487EEEC1E47D78E548E107E642C11"><enum>(i)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</clause><clause id="H53B6FD13170B41CE885AC3A200955E6E"><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="HF481D4FB7DD4415E86DDD353A3595FDA"><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="H9CD23D1E5C384CFCA20C045494AFA596"><enum>(b)</enum><header>Fee setting and
amounts</header>
<paragraph id="HF5D22757EE6749E4896C3D52FF7DC0DB"><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="H3B8E335078864FB7927AF8AD4988C108"><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="H3985C4BB1FF74A2B8BB222CC96DA31C1"><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="H70C2BE50765245CDA499E76D25299BB4"><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="HD066F655646C45649F19C63000380974"><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="HE671526C1AF54BB6AA1FA23D3F6BF33C"><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="HD5B1C112A2634032A0AA6C242C2F6B81"><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="H3527672A74AE41D19626AA80240CA5F7"><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="H3977A06A8E404A51AF6E5EFF5E8ED006"><enum>(c)</enum><header>Application fee
waiver for small business</header>
<paragraph id="HAA8D3089B0354369B9688067EA214BBC"><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="H71BF763C73C54C5C9A83235C809CEDC8"><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="HEBBC4B388C784F8B8A20DC052BD9465A"><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="H23F8C5CE96DD45BB87C6316F6C3F1CA0"><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="HE8029BE1E89F42B68F71AEECD9490D48"><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="H1955E28F2E0840CCAF41738F10361FAD"><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="HFA6BC556A1924782A985CCC45D4EC776"><enum>(e)</enum><header>Crediting and
availability of fees</header>
<paragraph id="HBA2D3D385BBB4B93962353BDAD7978B3"><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="H30B1AB70B35241858E15D110D8433BF0"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="HB701B69E9089456BB6300049A2836D0C"><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="H64AD730BD51C4674B10B9D7088BFCBAF"><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="HD419B6E57A4941488FE1BC331EA48D34"><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="H80C0324CC49948999C19665D93F8320C"><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="HD1D863A7A15B4535A1F98FAE994237C4"><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="H202626122BF34697AF37F50579B730B8"><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 chapter 37 of title 31, United States Code.</text>
</subsection><subsection id="H6C26A172DC1B4E439EB676705BDE0729"><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="H8C7E63ABADEE41DF8D96BF894B0061BD"><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="HACD9687A64E04F2DB6B69D611A43A041"><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, is further amended by
inserting after section 744H the following:</text>
<quoted-block id="H090C682BF4C14644AC9C5C44928C130A" style="OLC">
<section id="H8CA8B26FD95D407BAFED2916A9A11288"><enum>744I.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="H71C8D754607E4AEEB0B7D3BA990A9ECE"><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="HE04435F3791944E991BBCD5A7A3ED60B"><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="H22E2654BACC644178C2AA9265A4D4865"><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="HC1F8CD37EAEC451DA9F7EDF6ECF639CE"><enum>(d)</enum><header>Study</header>
<paragraph id="H902CD626A51C4EB8ABEFDCDC550F03A7"><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="HDB2DA79FB0D8482CABE950F5D49A26F3"><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="H4B1D6DCFA5D64861919E532A10F53007"><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="H78189CA9915D4BB3B0E23120C327439A"><enum>(e)</enum><header>Reauthorization</header>
<paragraph id="HDCE746EBBE6449959565FB84EE805764"><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="HB0348519CAE34AD19582AF9B8929DCC7"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="H80D8BF6632DA48AA88D557C572930CE2"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="HF9225A9F116C47C085B7409C9B410302"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="HE58266F0CF77428D8E2D1F75B9437472"><enum>(D)</enum><text>health care
professionals;</text>
</subparagraph><subparagraph id="HE99582866C274530AA2CB46D75479171"><enum>(E)</enum><text>representatives of
patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="H92953FE3D7884EECAF03496F28AB353F"><enum>(F)</enum><text>the regulated
industry.</text>
</subparagraph></paragraph><paragraph id="HE21CEC85981345B2AE07C4F4AF08579F"><enum>(2)</enum><header>Public review of
recommendations</header><text>After negotiations with the regulated industry,
the Secretary shall—</text>
<subparagraph id="HA9B005B609C7422281C6F32AC656DE6C"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="H62245DB8C37E41F4803F947826E5D857"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="HFD2DF0BAB3B34BB8B0EEE942C37917BA"><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="H805A38151CE742F099DA6537D4788FAA"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="H81693ED851554FD18F082B4A0BBF55EF"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="H3ED8166F0B97441B8EDF972AEB97503F"><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 id="HEAEF2C8D6F594D188CD8A71403536C6A"><enum>404.</enum><header>Sunset
dates</header>
<subsection id="H3CCA169AA7DF45018B3BF190707842C7"><enum>(a)</enum><header>Authorization</header><text>The
amendment made by section 402 shall cease to be effective October 1,
2017.</text>
</subsection><subsection id="H05C229ECA442478BBEF645C8DCB5A6F9"><enum>(b)</enum><header>Reporting
requirements</header><text>The amendment made by section 403 shall cease to be
effective January 31, 2018.</text>
</subsection></section><section id="H135E60908606420796BC91950C9B770E"><enum>405.</enum><header>Effective
date</header>
<subsection id="H0C112084C2044709BD17D5381F0C46D8"><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="HC5C3862C0A294196B54881F8B08AC019"><enum>(1)</enum><text>October 1, 2012;
or</text>
</paragraph><paragraph id="HFBC7BCAABA9C49EFBCC14AD89D86932D"><enum>(2)</enum><text>the date of the
enactment of this title.</text>
</paragraph></subsection><subsection id="HFE4C98B2ED9B4F3F81AA1378CC403424"><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="H8D2B0D83A34F44EA93FC9A49451C16A8"><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 commented="no" display-inline="no-display-inline" id="HDD2C7D94D9694901ADB7D6BB5AC041FF" section-type="subsequent-section"><enum>407.</enum><header>Conforming
amendment</header><text display-inline="no-display-inline">Section 735(1)(B)
(21 U.S.C. 379g(1)(B)) is amended by striking <quote>or (k)</quote>.</text>
</section><enum>V</enum><header>Pediatric drugs
and devices</header>
<section id="idF2489FF8C6A34AF49E1D0609858A2585"><enum>501.</enum><header>Permanence</header>
<subsection id="id5641257FBDDE4FB1B3F31944C5B03D3E"><enum>(a)</enum><header>Pediatric
studies of drugs</header><text display-inline="yes-display-inline">Subsection
(q) of section 505A (21 U.S.C. 355a) is amended—</text>
<paragraph id="idA1EF11F6C3554ACAB3DF218B320E0DF8"><enum>(1)</enum><text>in the subsection
heading, by striking <quote><header-in-text level="subsection" style="OLC">Sunset</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">Permanence</header-in-text></quote>;</text>
</paragraph><paragraph id="id955BA9A9C1D44A57A2934E19CA50FFE3"><enum>(2)</enum><text>in paragraph (1),
by striking <quote>on or before October 1, 2012,</quote>; and</text>
</paragraph><paragraph id="idAEA6A40A132F41F991A4829A4129FE51"><enum>(3)</enum><text>in paragraph (2),
by striking <quote>on or before October 1, 2012,</quote>.</text>
</paragraph></subsection><subsection id="id4E53B7FA13C44B1591C9F64677E93D6A"><enum>(b)</enum><header>Research into
pediatric uses for drugs and biological products</header><text>Section 505B (21
U.S.C. 355c) is amended—</text>
<paragraph id="idFE3ADA6D93E54EB481438433E0F4491D"><enum>(1)</enum><text>by striking
subsection (m); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9EF2E50FA7994E5387E1B875CB0D1B75"><enum>(2)</enum><text>by redesignating
subsection (n) as subsection (m).</text>
</paragraph></subsection></section><section id="idE402355083DC4B8D9CDA48075469F3FE"><enum>502.</enum><header>Written
requests</header>
<subsection id="id1D24AC1CAFD043A3AA20963B5F5DBE3C"><enum>(a)</enum><header>Federal Food,
Drug, and Cosmetic Act</header><text display-inline="yes-display-inline">Subsection (h) of section 505A (21 U.S.C.
355a) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idD0AB911A1B6D4279BA644CD3F1ECAEFB" style="OLC">
<subsection commented="no" id="id268FC0F388B54B5A9C3B922DFB2BBFC8"><enum>(h)</enum><header>Relationship to
pediatric research requirements</header><text>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>
</subsection><subsection id="idD2D2069F307A45269467E78E88F156CA"><enum>(b)</enum><header>Public Health
Service Act</header><text>Section 351(m)(1) of the Public Health Service Act
(42 U.S.C. 262(m)(1)) 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></section><section id="id316E2DE0924D498D817DB4658E57BFA7"><enum>503.</enum><header>Communication
with Pediatric Review Committee</header><text display-inline="no-display-inline">Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services (referred to
in this title as the <quote>Secretary</quote>) shall issue internal standard
operating procedures that provide for the review by the internal review
committee established under section 505C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355d) of any significant modifications to initial
pediatric study plans, agreed initial pediatric study plans, and written
requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355c). Such internal standard operating procedures shall be made
publicly available on the Internet website of the Food and Drug
Administration.</text>
</section><section commented="no" id="idB5238D46693743CEA55A04E23BC5C47D"><enum>504.</enum><header>Access to
data</header><text display-inline="no-display-inline">Not later than 3 years
after the date of enactment of this Act, the Secretary shall make available to
the public, including through posting on the Internet website of the Food and
Drug Administration, the medical, statistical, and clinical pharmacology
reviews of, and corresponding written requests issued to an applicant, sponsor,
or holder for, pediatric studies submitted between January 4, 2002 and
September 27, 2007 under subsection (b) or (c) of section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 months of market
exclusivity was granted and that resulted in a labeling change. The Secretary
shall make public the information described in the preceding sentence in a
manner consistent with how the Secretary releases information under section
505A(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).</text>
</section><section id="idD76B2ECBB79A47B0AF7CDB52EC14DF07"><enum>505.</enum><header>Ensuring the
completion of pediatric studies</header>
<subsection id="idEC7B2A9A471346C297B4831ADB38CB46"><enum>(a)</enum><header>Extension of
deadline for deferred studies</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is
amended—</text>
<paragraph id="idC83AFF002BDD4DA993F48A8028C24368"><enum>(1)</enum><text>in subsection
(a)(3)—</text>
<subparagraph commented="no" id="idE9DB7A85B6794CE68380636F347AF5EE"><enum>(A)</enum><text>by redesignating
subparagraph (B) as subparagraph (C);</text>
</subparagraph><subparagraph id="idEDDD85B268B6421DAC012DA005AFDA12"><enum>(B)</enum><text>by inserting
after subparagraph (A) the following:</text>
<quoted-block display-inline="no-display-inline" id="idC347F1DDAD3B4BF7B7452447E4C518E2" style="OLC">
<subparagraph id="idE5385B780EF142508D6601489D5AC9F5"><enum>(B)</enum><header>Deferral
extension</header>
<clause id="id73D4F54B068E4091872606363A1B3066"><enum>(i)</enum><header>In
general</header><text>On the initiative of the Secretary or at the request of
the applicant, the Secretary may grant an extension of a deferral approved
under subparagraph (A) for submission of some or all assessments required under
paragraph (1) if—</text>
<subclause id="idDF58DA708E7E44188762ABF1A184D3BC"><enum>(I)</enum><text>the Secretary
determines that the conditions described in subclause (II) or (III) of
subparagraph (A)(i) continue to be met; and</text>
</subclause><subclause id="id5D1725F1A0334B818AE20B56B4A3CDAC"><enum>(II)</enum><text>the applicant
submits a new timeline under subparagraph (A)(ii)(IV) and any significant
updates to the information required under subparagraph (A)(ii).</text>
</subclause></clause><clause id="id4F2A851EC12143E0A107099D7876133A"><enum>(ii)</enum><header>Timing and
information</header><text>If the deferral extension under this subparagraph is
requested by the applicant, the applicant shall submit the deferral extension
request containing the information described in this subparagraph not less than
90 days prior to the date that the deferral would expire. The Secretary shall
respond to such request not later than 45 days after the receipt of such
letter. If the Secretary grants such an extension, the specified date shall be
the extended date. The sponsor of the required assessment under paragraph (1)
shall not be issued a letter described in subsection (d) unless the specified
or extended date of submission for such required studies has passed or if the
request for an extension is pending. For a deferral that has expired prior to
the date of enactment of the <short-title>Food and Drug
Administration Safety and Innovation Act</short-title> or that will expire
prior to 270 days after the date of enactment of such Act, a deferral extension
shall be requested by an applicant not later than 180 days after the date of
enactment of such Act. The Secretary shall respond to any such request as soon
as practicable, but not later than 1 year after the date of enactment of such
Act. Nothing in this clause shall prevent the Secretary from updating the
status of a study or studies publicly if components of such study or studies
are late or delayed.</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id99EF70C338714EC7BF533AB974103C54"><enum>(C)</enum><text>in subparagraph
(C), as so redesignated—</text>
<clause id="idFAFECE8CA1134D7FA6D9361BA9C16F5F"><enum>(i)</enum><text>in
clause (i), by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id2FF53D8F91D041D385F092AEAC42D65A" style="OLC">
<subclause id="idCD2B3BF9B8CE4878B982A317960A26BA"><enum>(III)</enum><text>Projected
completion date for pediatric studies.</text>
</subclause><subclause id="id3FBFA25168E64C9DA78543ECB37C9D6E"><enum>(IV)</enum><text>The reason or
reasons why a deferral or deferral extension continues to be
necessary.</text>
</subclause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</clause><clause id="id03BAED39FDC24ADCA3D96237BFADEF84"><enum>(ii)</enum><text>in
clause (ii)—</text>
<subclause id="id05AF608E84AC444495F70D5EDD129B27"><enum>(I)</enum><text>by inserting
<quote>, as well as the date of each deferral or deferral extension, as
applicable,</quote> after <quote>clause (i)</quote>; and</text>
</subclause><subclause id="id8E437486893144D3870041542FA78EAA"><enum>(II)</enum><text>by inserting
<quote>not later than 90 days after submission to the Secretary or with the
next routine quarterly update</quote> after <quote>Administration</quote>;
and</text>
</subclause></clause></subparagraph></paragraph><paragraph id="id97CE1E337CC0401EBDE5A64ED87280DC"><enum>(2)</enum><text>in subsection
(f)—</text>
<subparagraph id="id4F4CAB26260049BF901EB31DFB83FAAE"><enum>(A)</enum><text>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 id="idA997AF7754C844EE91271501848FDC2F"><enum>(B)</enum><text>in paragraph (1),
by inserting <quote>, deferral extension, </quote> after
<quote>deferral</quote>; and</text>
</subparagraph><subparagraph id="id2135DD0231FB41428B968FA0FBBD9DC3"><enum>(C)</enum><text>in paragraph
(4)—</text>
<clause id="id20E447B99EC047738ADF5C455893B14F"><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 id="idF9CABFCFDA524FB695087FE10ADAB7AC"><enum>(ii)</enum><text>by
inserting <quote>, deferral extensions, </quote> after
<quote>deferrals</quote>.</text>
</clause></subparagraph></paragraph></subsection><subsection id="id55660CAC16294FFAA41276AD025BD013"><enum>(b)</enum><header>Tracking of
extensions; annual information</header><text display-inline="yes-display-inline">Section 505B(f)(6)(D) (21 U.S.C.
355c(f)(6)(D)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id12A2780D3CAE4C4A91034F337C89EDA9" style="OLC">
<subparagraph id="id84793842BA3A4D16A36FA9AE214975CB"><enum>(D)</enum><text>aggregated on an
annual basis—</text>
<clause id="id5D8AB0AA22764E8AA112A77C0A37AABF"><enum>(i)</enum><text>the total number
of deferrals and deferral extensions requested and granted under this section
and, if granted, the reasons for each such deferral or deferral
extension;</text>
</clause><clause id="id02333096C0D94E90967E3D21462A7D57"><enum>(ii)</enum><text>the timeline for
completion of the assessments; and</text>
</clause><clause id="id0EAB086E4C11481B8D68AF9FCE8B7402"><enum>(iii)</enum><text>the number of
assessments completed and
pending;</text>
</clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="idC4167A3BC0224D8AADCB7221B2EF4BC8"><enum>(c)</enum><header>Action on
failure to complete studies</header>
<paragraph id="id080CB4C471F44465A9FED56A78BDC38A"><enum>(1)</enum><header>Issuance of
letter</header><text>Subsection (d) of section 505B (21 U.S.C. 355c) is amended
to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idD140DFA4ACD1475CA39AB3807CB983CE" style="OLC">
<subsection id="idAE871BEC4B4B4C72B8C93B00D1301E95"><enum>(d)</enum><header>Submission of
assessments</header><text>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), the following shall apply:</text>
<paragraph id="ida1d5fb2046194582818d783a49487b48"><enum>(1)</enum><text>Beginning 270
days after the date of enactment of the <short-title>Food
and Drug Administration Safety and Innovation Act</short-title>, the Secretary
shall issue a non-compliance letter to such person informing them of such
failure to submit or meet the requirements of the applicable subsection. Such
letter shall require the person to respond in writing within 45 calendar days
of issuance of such letter. Such response may include the person’s request for
a deferral extension if applicable. Such letter and the person’s written
response to such letter shall be made publicly available on the Internet Web
site of the Food and Drug Administration 45 calendar days after issuance, with
redactions for any trade secrets and confidential commercial information. If
the Secretary determines that the letter was issued in error, the requirements
of this paragraph shall not apply.</text>
</paragraph><paragraph id="idcd98f89640d745d3a64c7dfd85e3f8d2"><enum>(2)</enum><text>The drug or
biological product that is the subject of an assessment described in subsection
(a)(2), applicable requirements in subsection (a)(3), or 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 such
failure shall not be the basis for a proceeding—</text>
<subparagraph id="id571a08ff79394c6e8ddc3901526bed3a"><enum>(A)</enum><text>to withdraw
approval for a drug under section 505(e); or</text>
</subparagraph><subparagraph id="id66cae100f4bc42cebc94e970aeedf9e1"><enum>(B)</enum><text>to revoke the
license for a biological product under section 351 of the Public Health Service
Act.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="id908944667A824064A77EB23A136E15A9"><enum>(2)</enum><header>Tracking of
letters issued</header><text>Subparagraph (D) of section 505B(f)(6) (21 U.S.C.
355c(f)(6)), as amended by subsection (b), is further amended—</text>
<subparagraph id="id8C7DF0DA622E432C99DF3EAB95CDF2CC"><enum>(A)</enum><text>in clause (ii),
by striking <quote>; and</quote> and inserting a semicolon;</text>
</subparagraph><subparagraph id="id78DFED440100465CBCC5713632EA35A1"><enum>(B)</enum><text>in clause (iii),
by adding <quote>and</quote> at the end; and</text>
</subparagraph><subparagraph id="id8DDC4DE57A3E475FA5139CD3BE55C369"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id78EC752B35AE4777BCC9D377765967A8" style="OLC">
<clause id="id9026287ED84649189197614691136233"><enum>(iv)</enum><text>the number of
postmarket non-compliance letters issued pursuant to subsection (d), and the
recipients of such
letters;</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph></subsection></section><section id="id79C2AB289B3F4103A1584169A34079B2"><enum>506.</enum><header>Pediatric
study plans</header>
<subsection id="idC450AE4BA6374B3F958AD3CCD1FA1112"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Subsection (e) of
section 505B (21 U.S.C. 355c) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idEA23CEF023544EACA84318F9881C7129" style="OLC">
<subsection id="ide1799d7984ca4e6cbbe077e2d374a3d2"><enum>(e)</enum><header>Pediatric study
plans</header>
<paragraph commented="no" id="id8c189a6e33f948f697dac5c00ef3a36d"><enum>(1)</enum><header>In
general</header><text>An applicant subject to subsection (a) shall submit to
the Secretary an initial pediatric study plan prior to the submission of the
assessments described under subsection (a)(2).</text>
</paragraph><paragraph commented="no" id="id9E3B1A66E0B34C058C86230A307AE8BD"><enum>(2)</enum><header>Timing;
content; meeting</header>
<subparagraph commented="no" id="idA5F15D074DBA44CAA7DD3DC0F509EF1F"><enum>(A)</enum><header>Timing</header><text>An
applicant shall submit an initial pediatric study plan to the Secretary not
later than 60 calendar days after the date of the end of phase II meeting or
such other equivalent time agreed upon between the Secretary and the applicant.
Nothing in this paragraph shall preclude the Secretary from accepting the
submission of an initial pediatric study plan earlier than the date described
under the preceding sentence.</text>
</subparagraph><subparagraph commented="no" id="idEBB02F77085941E6A7583D86796D89B4"><enum>(B)</enum><header>Content of
initial plan</header><text>The initial pediatric study plan shall
include—</text>
<clause id="ide92230f9ba2645199481e893111096a1"><enum>(i)</enum><text>an outline of the
pediatric study or studies that the applicant plans to conduct (including, to
the extent practicable study objectives and design, age groups, relevant
endpoints, and statistical approach);</text>
</clause><clause id="idb55901726078480da4ddffc0807a2749"><enum>(ii)</enum><text>any request for
a deferral, partial waiver, or waiver under this section, if applicable, along
with any supporting information; and</text>
</clause><clause id="id16d4c03b0d174f4e88a6de6591441994"><enum>(iii)</enum><text>other
information specified in the regulations promulgated under paragraph
(4).</text>
</clause></subparagraph><subparagraph id="id582AF93383584E22AFB5FEF8E161073F"><enum>(C)</enum><header>Meeting</header><text>The
Secretary—</text>
<clause id="id020834B12A784349AE105EA6D9C9F040"><enum>(i)</enum><text>shall meet with
the applicant to discuss the initial pediatric study plan as soon as
practicable, but not later than 90 calendar days after the receipt of such plan
under subparagraph (A);</text>
</clause><clause id="id85433AF3680B4915A69BBF0BAE8C8428"><enum>(ii)</enum><text>may determine
that a written response to the initial pediatric study plan is sufficient to
communicate comments on the initial pediatric study plan, and that no meeting
is necessary; and</text>
</clause><clause id="id910123E47ED74A2CBE03CD968E9A2E8B"><enum>(iii)</enum><text>if the
Secretary determines that no meeting is necessary, shall so notify the
applicant and provide written comments of the Secretary as soon as practicable,
but not later than 90 calendar days after the receipt of the initial pediatric
study plan.</text>
</clause></subparagraph></paragraph><paragraph id="id089FD577B432460A9361D8D7A3AF0A8F"><enum>(3)</enum><header>Agreed initial
pediatric study plan</header><text>Not later than 90 calendar days following
the meeting under paragraph (2)(C)(i) or the receipt of a written response from
the Secretary under paragraph (2)(C)(iii), the applicant shall document
agreement on the initial pediatric study plan in a submission to the Secretary
marked <quote>Agreed Initial Pediatric Study Plan</quote>, and the Secretary
shall confirm such agreement to the applicant in writing not later than 30
calendar days of receipt of such agreed initial pediatric study plan.</text>
</paragraph><paragraph commented="no" id="id177F09DC1BDC45A182E1750BFF12A4D0"><enum>(4)</enum><header>Deferral and
waiver</header><text>If the agreed initial pediatric study plan contains a
request from the applicant for a deferral, partial waiver, or waiver under this
section, the written confirmation under paragraph (3) shall include a
recommendation from the Secretary as to whether such request meets the
standards under paragraphs (3) or (4) of subsection (a).</text>
</paragraph><paragraph commented="no" id="idCB93CA1780DC41F085816F6DCEEB58C8"><enum>(5)</enum><header>Amendments to
the plan</header><text>At the initiative of the Secretary or the applicant, the
agreed initial pediatric study plan may be amended at any time. The
requirements of paragraph (2)(C) shall apply to any such proposed amendment in
the same manner and to the same extent as such requirements apply to an initial
pediatric study plan under paragraph (1). The requirements of paragraphs (3)
and (4) 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 study plan.</text>
</paragraph><paragraph commented="no" id="id21970D6A77184CC58DA8ECC64C639BB9"><enum>(6)</enum><header>Internal
committee</header><text>The Secretary shall consult the internal committee
under section 505C on the review of the initial pediatric study plan, agreed
initial pediatric plan, and any significant amendments to such plans.</text>
</paragraph><paragraph id="id30256A1617C54F3EAAA638BEAB558DF7"><enum>(7)</enum><header>Required
rulemaking</header><text>Not later than 1 year after the date of enactment of
the <short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall promulgate proposed
regulations and issue proposed guidance to implement the provisions of this
subsection.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="idBA4AE74A8DDA44E8BA5852ED31F52F1C"><enum>(b)</enum><header>Conforming
amendments</header><text>Section 505B (21 U.S.C. 355c)is amended—</text>
<paragraph id="id051F3B4265DF45CEB6C1ED9F9B127E7D"><enum>(1)</enum><text>by amending
subclause (II) of subsection (a)(3)(A)(ii) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id6627CBDC610E42469C42AE2095BFECBD" style="OLC">
<subclause id="id45173FCEF3754308A5199A4A7F7C5E58"><enum>(II)</enum><text>a pediatric
study plan as described in subsection
(e);</text>
</subclause><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id303425FDABD2453EB68E8DA16AC9FE40"><enum>(2)</enum><text>in subsection
(f)—</text>
<subparagraph id="idEB4B1C4AF6B441FAB61669A826180265"><enum>(A)</enum><text>in the subsection
heading, by striking <quote><header-in-text level="subsection" style="OLC">pediatric plans,</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">pediatric study
plans,</header-in-text></quote>;</text>
</subparagraph><subparagraph id="id59FD188F2C5B40958B72BBEF22654335"><enum>(B)</enum><text>in paragraph (1),
by striking <quote>all pediatric plans</quote> and inserting <quote>initial
pediatric study plans, agreed initial pediatric study plans,</quote>;
and</text>
</subparagraph><subparagraph id="id083CE222BDDF42F28D2F871B77F9E4D4"><enum>(C)</enum><text>in paragraph
(4)—</text>
<clause id="idE187F0970E7E4C8CA8A9177D066E68CA"><enum>(i)</enum><text>in
the paragraph heading, by striking <quote><header-in-text level="subsection" style="OLC">pediatric plans,</header-in-text></quote> and inserting
<quote><header-in-text level="subsection" style="OLC">pediatric study
plans,</header-in-text></quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id00F5FDA4D685431BA9B3008355F61E37"><enum>(ii)</enum><text>by striking
<quote>pediatric plans</quote> and inserting <quote>initial pediatric study
plans, agreed initial pediatric study plans,</quote>.</text>
</clause></subparagraph></paragraph></subsection><subsection id="id30D9E6C692674676867CA39004A0CF4D"><enum>(c)</enum><header>Effective
dates</header>
<paragraph id="id75F6CAD77F0246A2850504252826FEFB"><enum>(1)</enum><header>Pediatric study
plans</header><text>Subsection (e) of section 505B of the Federal Food, Drug,
and Cosmetic Act (other than paragraph (4) of such subsection), as amended by
subsection (a), shall take effect 180 days after the date of enactment of this
Act, without regard to whether the Secretary has promulgated final regulations
under paragraph (4) of such subsection by such date.</text>
</paragraph><paragraph id="idAF357D935B5345708BE1D30478773304"><enum>(2)</enum><header>Conforming
amendments</header><text>The amendments made by subsection (b) shall take
effect 180 days after the date of enactment of this Act.</text>
</paragraph></subsection></section><section id="id03333CC21FD44B728BC6E95049F8F9F0"><enum>507.</enum><header>Reauthorizations</header>
<subsection id="id8CD4B7496E5641569190FE563C930E8D"><enum>(a)</enum><header>Pediatric
Advisory Committee</header><text display-inline="yes-display-inline">Section
14(d) of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is
amended by striking <quote>Notwithstanding section 14 of the Federal Advisory
Committee Act, the advisory committee shall continue to operate 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>Section
14 of the Federal Advisory Committee Act shall not apply to the advisory
committee</quote>.</text>
</subsection><subsection id="id37D68AA0BE1748C794CD84AED2AC5532"><enum>(b)</enum><header>Pediatric
Subcommittee of the Oncologic Drugs Advisory Committee</header><text display-inline="yes-display-inline">Section 15(a)(3) of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m 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>for the duration of the operation of the Oncologic Drugs Advisory
Committee</quote>.</text>
</subsection><subsection id="H165EC314854D42369108934DDC0E0BD1"><enum>(c)</enum><header>Humanitarian
device exemption extension</header><text display-inline="yes-display-inline">Section 520(m)(6)(A)(iv) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by
striking <quote>2012</quote> and inserting <quote>2017</quote>.</text>
</subsection><subsection commented="no" id="id95968C8C52D64BB4BCD305F99F810B7B"><enum>(d)</enum><header>Demonstration
grants to improve pediatric device availability</header><text display-inline="yes-display-inline">Section 305(e) of Pediatric Medical Device
Safety and Improvement Act (Public Law 110–85; 42 U.S.C. 282 note)) is amended
by striking <quote>$6,000,000 for each of fiscal years 2008 through
2012</quote> and inserting <quote>$4,500,000 for each of fiscal years 2013
through 2017</quote>.</text>
</subsection><subsection id="HFB7D80B7A26D40CE8E9926131E4F1DC2"><enum>(e)</enum><header>Program for
pediatric study of drugs in PHSA</header><text display-inline="yes-display-inline">Section 409I(e)(1)(B) of the Public Health
Service Act (42 U.S.C. 284m((e)(1)(B)) is amended by striking <quote>of the
four succeeding fiscal years</quote> and inserting <quote>succeeding fiscal
year</quote>.</text>
</subsection></section><section id="id62686C1119184723B041062EC1D71956"><enum>508.</enum><header>Report</header>
<subsection id="id9BDD6FADF5B84AB788B8BB9E13DDBE0E"><enum>(a)</enum><header>In
general</header><text>Not later than October 31, 2016, and at the end of each
subsequent 5-year period, the Secretary shall submit to Congress a report that
evaluates the effectiveness of sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public
Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children
are tested in pediatric populations and properly labeled for use in
children.</text>
</subsection><subsection id="id31394B6D181A48319293109E5C41C7F6"><enum>(b)</enum><header>Contents</header><text>The
report under subsection (a) shall include—</text>
<paragraph id="id77e2b6c92fd540a8af0d42b6739c0690"><enum>(1)</enum><text>the number and
importance of drugs and biological products for children for which studies have
been requested or required (as of the date of such report) under 505A and 505B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section
409I of the Public Health Service Act (42 U.S.C. 284m), including—</text>
<subparagraph id="id4FB671C4C25E4A84A283BC231B561227"><enum>(A)</enum><text>the number of
labeling changes made to drugs and biological products pursuant to such
sections since the date of enactment of this Act; and</text>
</subparagraph><subparagraph id="idE51B4755BDEF494085517670BF5227A7"><enum>(B)</enum><text>the importance of
such drugs and biological products in the improvement of the health of
children;</text>
</subparagraph></paragraph><paragraph id="idd84cb9dabab84365b7a00d59d883bd97"><enum>(2)</enum><text>the number of
required studies under such section 505B that have not met the initial deadline
provided under such section, including—</text>
<subparagraph id="idbc0a2254097643689269f327a433119a"><enum>(A)</enum><text>the number of
deferrals and deferral extensions granted and the reasons such extensions were
granted;</text>
</subparagraph><subparagraph id="ida1a28a5872b14c5fb9334f7faa0c1d67"><enum>(B)</enum><text>the number of
waivers and partial waivers granted; and</text>
</subparagraph><subparagraph id="id7fd3bf7c5f6747e99d7d0cec601f3f8f"><enum>(C)</enum><text>the number of
letters issued under subsection (d) of such section 505B;</text>
</subparagraph></paragraph><paragraph id="idfc402b2b463245178f37811e66836c39"><enum>(3)</enum><text>the number of
written requests issued, declined, and referred to the National Institutes of
Health under such section 505A since the date of enactment of this Act
(including the reasons for such declination), and a description and status of
referrals made under subsection (n) of such section 505A;</text>
</paragraph><paragraph id="id35a379701cd141e19e4e8ba4046f1271"><enum>(4)</enum><text>the number of
proposed pediatric study plans submitted and agreed to as identified in the
marketing application under such section 505B;</text>
</paragraph><paragraph id="id2E1923DA6CDC4DF89975D1BF572E9786"><enum>(5)</enum><text>any labeling
changes recommended by the Pediatric Advisory Committee as a result of the
review by such Committee of adverse events reports;</text>
</paragraph><paragraph id="ideb926f8f84f54e84bf02acb9e98c2867"><enum>(6)</enum><text>the number and
current status of pediatric postmarketing requirements;</text>
</paragraph><paragraph id="id79f9f4e57a3a4bbc83c36a28d3d79dd1"><enum>(7)</enum><text>the number and
importance of drugs and biological products for children that are not being
tested for use in pediatric populations, notwithstanding the existence of the
programs under such sections 505A and 505B and section 409I of the Public
Health Service Act;</text>
</paragraph><paragraph id="idc5d276983e644b159b706651f94b8467"><enum>(8)</enum><text>the possible
reasons for the lack of testing reported under paragraph (7);</text>
</paragraph><paragraph id="idf9c18e4b6efe429cae619a0956fe862c"><enum>(9)</enum><text>the number of
drugs and biological products for which testing is being done (as of the date
of the report) and for which a labeling change is required under the programs
described in paragraph (7), including—</text>
<subparagraph id="id94fa9657da0240218303c97aa98aa8bf"><enum>(A)</enum><text>the date labeling
changes are made;</text>
</subparagraph><subparagraph id="idfdac6f3a28dc4132af41f481029f0d55"><enum>(B)</enum><text>which labeling
changes required the use of the dispute resolution process; and</text>
</subparagraph><subparagraph id="id811f59914798436187ddace8ead0f8af"><enum>(C)</enum><text>for labeling
changes that required such dispute resolution process, a description of—</text>
<clause id="id00d44bd8226344a0b8e6f1a2215d4a11"><enum>(i)</enum><text>the
disputes;</text>
</clause><clause id="idd0344684049d43a69bb9884e76eba9c0"><enum>(ii)</enum><text>the
recommendations of the Pediatric Advisory Committee; and</text>
</clause><clause id="idfb78002d56814dbe96bcc72ad5d5b77a"><enum>(iii)</enum><text>the outcomes of
such process; and</text>
</clause></subparagraph><subparagraph id="id6ad51cf9f2e044538e435874ba0bdfce"><enum>(D)</enum><text>an assessment of
the effectiveness in improving information about pediatric uses of drugs and
biological products;</text>
</subparagraph></paragraph><paragraph id="idDC17A2AFC9C34F4E9024489B146B3A0C"><enum>(10)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idE5AC92A24C504202AEDF14FA57A22301"><enum>(A)</enum><text>the efforts made by the
Secretary to increase the number of studies conducted in the neonatal
population (including efforts made to encourage the conduct of appropriate
studies in neonates by companies with products that have sufficient safety and
other information to make the conduct of the studies ethical and safe);
and</text>
</subparagraph><subparagraph id="id3F67DBC036E541EDB5337967640D085A" indent="up1"><enum>(B)</enum><text>the results of such efforts;</text>
</subparagraph></paragraph><paragraph id="id3FBB59CA6CAB42ACBCC08E25014A4422"><enum>(11)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id007F9E5345F94D619B78FAA1823F89EB"><enum>(A)</enum><text>the number and
importance of drugs and biological products for children with cancer that are
being tested as a result of the programs described in paragraph (7); and</text>
</subparagraph><subparagraph id="id91CBA3440D134250A13315C14E4EE07C" indent="up1"><enum>(B)</enum><text>any recommendations for modifications
to such programs that would lead to new and better therapies for children with
cancer, including a detailed rationale for each recommendation;</text>
</subparagraph></paragraph><paragraph id="id2a533c8ee3da498482f318d8d9bb50b4"><enum>(12)</enum><text>an assessment of
progress made in addressing the recommendations and findings of any prior
report issued by the Comptroller General, the Institute of Medicine, or the
Secretary regarding the topics addressed in the report under this section,
including with respect to—</text>
<subparagraph id="ida8d1120e69ef4faba89d192b8b118ae7"><enum>(A)</enum><text>improving public
access to information from pediatric studies conducted under such sections 505A
and 505B; and</text>
</subparagraph><subparagraph id="id2fb767e2797148de9c6e5f18d7ff25bb"><enum>(B)</enum><text>improving the
timeliness of pediatric studies and pediatric study planning under such
sections 505A and 505B;</text>
</subparagraph></paragraph><paragraph id="ida76e5fdac0ea40d7b7742442b3f568ba"><enum>(13)</enum><text>any
recommendations for modification to the programs that would improve pediatric
drug research and increase pediatric labeling of drugs and biological products;
and</text>
</paragraph><paragraph id="id76B8331C19534CE39275E8769C72DA03"><enum>(14)</enum><text>an assessment of
the successes of and limitations to studying drugs for rare diseases under such
sections 505A and 505B.</text>
</paragraph></subsection><subsection id="id726B923667184F5BA1E0F231FF4942BC"><enum>(c)</enum><header>Consultation on
recommendations</header><text>At least 180 days before the report is due under
subsection (a), and no sooner than 4 years after the date of enactment of this
Act, the Secretary shall consult with representatives of patient groups,
including pediatric patient groups, consumer groups, regulated industry,
scientific and medical communities, academia, and other interested parties to
obtain any recommendations or information relevant to the effectiveness of the
programs described in subsection (b)(7), including suggestions for
modifications to such programs.</text>
</subsection></section><section id="idCDDFFFAF982A471582FB91E2204157DE"><enum>509.</enum><header>Technical
amendments</header>
<subsection id="H1BAC448E077547EFAFA3E2C9323A01F5"><enum>(a)</enum><header>Pediatric
studies of drugs in FFDCA</header><text display-inline="yes-display-inline">Section 505A (21 U.S.C. 355a) is
amended—</text>
<paragraph id="H17967E2BE279461FA32A97F36B8C6C50"><enum>(1)</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 id="H91C8263BA7DD422A9E11182A0C70F74C"><enum>(2)</enum><text>in subsection
(n)—</text>
<subparagraph commented="no" id="H8D0D932C19C44D6CB9E198C2A2BE3F0A"><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="H3207DD39BBEF4EB59DFF58D66525C10C"><enum>(B)</enum><text>in paragraph
(1)—</text>
<clause commented="no" id="H86FF35A2EC52473CAC9A0880FC7B84D3"><enum>(i)</enum><text>in the matter
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 or if the applicant or holder does not agree to the
request</quote>;</text>
</clause><clause id="H3A92A0DC15CC4A53A4A46001C63214B4"><enum>(ii)</enum><text>in
subparagraph (A)—</text>
<subclause id="id8517CE5FB435402D9A927118316AC341"><enum>(I)</enum><text>in the first
sentence, by inserting <quote>, or for which a period of exclusivity eligible
for extension under subsection (b)(1) or (c)(1) of this section or under
subsection (m)(2) or (m)(3) of section 351 of the Public Health Service Act has
not ended</quote> after <quote>expired</quote>; and</text>
</subclause><subclause id="idD15DA78DD59C4206A1001BE623B6521C"><enum>(II)</enum><text>by striking
<quote>Prior to</quote> and all that follows through the period at the end;
and</text>
</subclause></clause><clause id="H1D6CBD7FF36E4F579CA4A591ECEF88B2"><enum>(iii)</enum><text>in
subparagraph (B), by striking <quote>no listed patents or has 1 or more listed
patents that have expired,</quote> and inserting <quote>no unexpired listed
patents and for which no unexpired periods of exclusivity eligible for
extension under subsection (b)(1) or (c)(1) of this section or under subsection
(m)(2) or (m)(3) of section 351 of the Public Health Service Act
apply,</quote>; and</text>
</clause></subparagraph></paragraph><paragraph id="idF86E477413BB4D6EB2A2EB8E6A5B2834"><enum>(3)</enum><text>in subsection
(o)(2), by amendment subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id240960FF016644BE822537D3317D062F" style="OLC">
<subparagraph id="idDF857E7FB0A445E584D036E8E5D339E9"><enum>(B)</enum><text>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>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H34A31FD9600D4C0FA7A6939B1EF3EDC4"><enum>(b)</enum><header>Research into
pediatric uses for drugs and biological projects in FFDCA</header><text display-inline="yes-display-inline">Section 505B (21 U.S.C. 355c) is
amended—</text>
<paragraph id="H59801FBE2CA242A19D1B135E66B79DFB"><enum>(1)</enum><text>in subsection
(a)—</text>
<subparagraph id="H6165418E7FF64E6EB4022D08BF171AEE"><enum>(A)</enum><text>in paragraph
(1)—</text>
<clause id="H673B209D092340ED9FB89F3E86F6F0A0"><enum>(i)</enum><text>in
the matter preceding subparagraph (A), by inserting <quote>for a drug</quote>
after <quote>(or supplement to an application)</quote>;</text>
</clause><clause commented="no" id="H83D7FF2F76EC429B869A16622861CCEE"><enum>(ii)</enum><text>in subparagraph
(A), by striking <quote>for a</quote> and inserting <quote>, including, with
respect to a drug, an application (or supplement to an application) for
a</quote>;</text>
</clause><clause commented="no" id="HE36A7D9C576E4DABBD1C538C5054AAE6"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>for
a</quote> and inserting <quote>, including, with respect to a drug, an
application (or supplement to an application) for a</quote>; and</text>
</clause><clause commented="no" id="id36F9EB7ECCE54D03A8D20A9B76C1A927"><enum>(iv)</enum><text>in the matter
following subparagraph (B), by inserting <quote>(or supplement)</quote> after
<quote>application</quote>; and</text>
</clause></subparagraph><subparagraph id="HFD56E69D53A84111BDD9A942BF286418"><enum>(B)</enum><text>in paragraph
(4)(C)—</text>
<clause id="H3DEF49944001481E9429C095CCD6D59C"><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="H8E256C3BD8464930B3BCB37994E82120"><enum>(ii)</enum><text>in the second
sentence, by striking <quote>either a full or</quote> and inserting <quote>such
a</quote>;</text>
</clause></subparagraph></paragraph><paragraph commented="no" id="id7F6218D188AC474381DCF56EFEF7167D"><enum>(2)</enum><text>in subsection
(b)(1), in the matter preceding subparagraph (A), by striking <quote>After
providing notice</quote> and all that follows through <quote>studies),
the</quote> and inserting <quote>The</quote>;</text>
</paragraph><paragraph id="H09C6B78092314BB28AB0E00B51E5967D"><enum>(3)</enum><text>in subsection
(g)—</text>
<subparagraph id="H289A4D3A7F3142E39FB3A8F1DC81635F"><enum>(A)</enum><text>in paragraph
(1)(A), by inserting <quote>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> after <quote>after the date of the submission of the
application or supplement</quote>; and</text>
</subparagraph><subparagraph id="H1650B10F6CB14C2EA5A7081353CFDDCE"><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>; and</text>
</subparagraph></paragraph><paragraph id="HF77C0C7DC6944FCAB1ACCCAD3765C82B"><enum>(4)</enum><text>in subsection
(h)(1)—</text>
<subparagraph id="HA60FFF224F6C4E359B57D81449D075C9"><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 id="H694D8375821E423BBD4C3D3893F78778"><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></subsection><subsection id="id1F4601CCCD79444D901EE4E044DC60CD"><enum>(c)</enum><header>Internal review
committee</header><text>The heading of section 505C (21 U.S.C. 355d) is amended
by inserting <quote><header-in-text level="section" style="OLC">and deferral
extensions</header-in-text></quote> after <quote><header-in-text level="section" style="OLC">deferrals</header-in-text></quote>.</text>
</subsection><subsection id="idF235DF72D4BA41F7BFA5AD87BB4A4C36"><enum>(d)</enum><header>Program for
pediatric studies of drugs</header><text>Section 409I(c) of the Public Health
Service Act (42 U.S.C. 284m(c)) is amended—</text>
<paragraph id="id460C64975E3A45FAA132592FE82EFFFF"><enum>(1)</enum><text>in paragraph
(1)—</text>
<subparagraph id="id2E92B99D13DC43D9ACC68EDAA5BC020A"><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 id="id85A204CF0D8E42FB827A46FE2F762A87"><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 id="id0D37364964A046E89384F63B7680F79C"><enum>(C)</enum><text>by amending
subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id06B36A93FD4246BD9C1618EB7DAB3C8A" style="OLC">
<subparagraph id="id6A4ACA1D46A64AC9A1DD1B228DBD2CE9"><enum>(B)</enum><text>there remains no
patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and
Cosmetic Act, and 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>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="idDBAAA9DA0B2D4B5D841C4595BE3B19D2"><enum>(2)</enum><text>in paragraph
(2)—</text>
<subparagraph id="id7485FF3D2BCA4EBDA360220207D74BB7"><enum>(A)</enum><text>in the paragraph
heading, by striking <quote><header-in-text level="paragraph" style="OLC">for
drugs lacking exclusivity</header-in-text></quote>; and</text>
</subparagraph><subparagraph id="id249D2C05F6F74731B10BC926F1838A30"><enum>(B)</enum><text>by striking
<quote>under section 505 of the Federal Food, Drug, and Cosmetic Act</quote>;
and</text>
</subparagraph><subparagraph id="id67C0650880F2478AAC6DCF79FBE28EFB"><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>.</text>
</subparagraph></paragraph></subsection><subsection id="id80496A27E8DC4986B1F2809BEC85D714"><enum>(e)</enum><header>Pediatric
subcommittee of the Oncologic Advisory Committee</header><text>Section 15(a) of
the Best Pharmaceuticals for Children Act (Public Law 107–109), as amended by
section 502(e) of the Food and Drug Administration Amendments Act of 2007
(Public Law 110–85), is amended in paragraph (1)(D), by striking ‘‘section
505B(f)’’ and inserting <quote>‘section 505C’</quote>.</text>
</subsection><subsection id="idEAD0890751BD4FD8B369DEF7494555BA"><enum>(f)</enum><header>Foundation of
national institutes of health</header><text>Section 499(c)(1)(C) of the Public
Health Service Act (42 U.S.C. 290b(c)(1)(C)) 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" display-inline="no-display-inline" id="id896808B765C349488B1F44209FF92C8E"><enum>(g)</enum><header>Application</header><text>Notwithstanding
any provision of section 505A and 505B of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355a, 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 title to such a provision applies beginning on the date
of the enactment of this Act.</text>
</subsection></section><section id="id36C9322F0A5946839EA1C2529C4D7AF6"><enum>510.</enum><header>Relationship
Between Pediatric Labeling and New Clinical Investigation Exclusivity</header>
<subsection id="id9D9041C0916944E6BEFF89FC1496DF5C"><enum>(a)</enum><header>In
general</header><text>Section 505 (21 U.S.C. 351) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idB4D80827280F4C7B8948C7018A53FFC3" style="OLC">
<subsection id="id411C5B9BB876439986717C8E7B98174E"><enum>(w)</enum><header>Relationship
Between Pediatric Labeling and New Clinical Investigation
Exclusivity</header><text>The period of market exclusivity described in clauses
(iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection
(j)(5)(F) shall not apply to a pediatric study conducted under section 505A or
505B that results, pursuant to section 505B(g)(2), in the inclusion in the
labeling of the product a determination that the product is not indicated for
use in pediatric populations or subpopulations or information indicating that
the results of a study were inconclusive or did not demonstrate that the
product is safe or effective in pediatric populations or
subpopulations.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id7926971D829C481AAEFEC337ACED7506"><enum>(b)</enum><header>Pediatric
studies of drugs</header><text>Section 505A(m) (21 U.S.C. 355a(m)) is
amended—</text>
<paragraph id="id5B03F25A0C024B05952ACBE397333700"><enum>(1)</enum><text>by striking
<quote>(m) <header-in-text level="subsection" style="OLC">Clarification of
Interaction of Market Exclusivity Under This Section and Market Exclusivity
Awarded to An Applicant for Approval of A Drug Under Section
505<enum-in-header>(j)</enum-in-header>.—</header-in-text>If a</quote> and all
that follows through the end of the matter that precedes paragraph (1) and
inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="id9B00F23F30EA45BDA443430157520B55" style="OLC">
<subsection id="id109D616526C44E9DB8BB8E08D96379EB"><enum>(m)</enum><header>Clarification
of Interaction of Market Exclusivity Under This Section and Market Exclusivity
Awarded to An application or supplement under subsection (c) or (j) of Section
505</header>
<paragraph id="id9007CEABB7994A84BAF08AA4CAAA506C"><enum>(1)</enum><header>180-day
exclusivity period</header><text>If a 180-day period under section
505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this section,
so that the applicant for approval of a drug under section 505(j) entitled to
the 180-day period under that section loses a portion of the 180-day period to
which the applicant is entitled for the drug, the 180-day period shall be
extended
from—</text>
</paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id7F4DF7F8AC3E4AF3A8FA30AA03CD2C69"><enum>(2)</enum><text>by redesignating
paragraphs (1) and (2) as subparagraphs (A) and (B) and moving such
subparagraphs, as so redesignated, 2 ems to the right; and</text>
</paragraph><paragraph id="id15853579B4D24A8CB2F177C47A24C221"><enum>(3)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idF15B7509167B45FABEF5FABADBA3F8D1" style="OLC">
<paragraph id="id351C8A5458D1424D8413E60897992A5F"><enum>(2)</enum><header>3-year
exclusivity period</header><text>The 3-year period of exclusivity under clauses
(iii) and (iv) of subsection 505(c)(3)(E) and clauses (iii) and (iv) of
subsection 505(j)(5)(F) are not available for approval of applications or
supplements to applications based on reports of pediatric studies conducted
under sections 505A or 505B that resulted, pursuant to section 505A(j) or
505B(g)(2), in the inclusion in the labeling of the product a determination
that the product is not indicated for use in pediatric populations or
subpopulations or information indicating that the results of an assessment were
inconclusive or did not demonstrate that the product is safe or effective in
pediatric populations or
subpopulation.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="id0138B06581DF47EDB2D7D6D404132814"><enum>(c)</enum><header>Prompt Approval
of Drugs</header><text>Section 505A(o) (21 U.S.C. 355a(o)) is amended—</text>
<paragraph id="idF8FBE90EB6244470B1312E7830331858"><enum>(1)</enum><text>in the heading,
by striking <quote><header-in-text level="subsection" style="OLC">section
505(j)</header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC">subsections (c) and (j) of section
505</header-in-text></quote>;</text>
</paragraph><paragraph id="id9EFE5F5D84D141ECB66CB44C95C1E76A"><enum>(2)</enum><text>in paragraph (1),
by striking <quote>under section 505(j)</quote> and inserting <quote>under
subsection (b)(2), (c), or (j) of section 505</quote>;</text>
</paragraph><paragraph id="idF7862F529FE042A3AE0A2E8F8769158F"><enum>(3)</enum><text>in paragraph (2),
in the matter preceding subparagraph (A), by inserting <quote>clauses (iii) and
(iv) of section 505(c)(3)(E) or</quote> after <quote>Notwithstanding</quote>;
and</text>
</paragraph><paragraph id="id23D42CBB7F88433D90C8C6A0D62399D3"><enum>(4)</enum><text>in paragraph
(3)—</text>
<subparagraph id="id525D70D2E3D94A59859486C8CB64F84C"><enum>(A)</enum><text>in subparagraph
(B), by inserting <quote>that differ from adult formulations</quote> before the
semicolon at the end; and</text>
</subparagraph><subparagraph id="id4BC19B19D3554E0BB096897BF6AD5190"><enum>(B)</enum><text>in subparagraph
(C)—</text>
<clause id="idD1A98CF31C004FAFA821548A3E517BCE"><enum>(i)</enum><text>by
striking <quote>under section 505(j)</quote> and inserting <quote>under
subsection (c) or (j) of section 505</quote>; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id288A70092464469D85C10A7571B9C5E9"><enum>(ii)</enum><text>by inserting
<quote>clauses (iii) or (iv) of section 505(c)(3)(E) or</quote> after
<quote>exclusivity under</quote>.</text>
</clause></subparagraph></paragraph></subsection></section><enum>VI</enum><header>Medical device
regulatory improvements</header>
<section id="idFEED59A4A3C5488988A92A438D21DC48"><enum>601.</enum><header>Reclassification
procedures</header>
<subsection commented="no" id="id258D7E27D4C940938CF6D25766649F95"><enum>(a)</enum><header>Classification
changes</header>
<paragraph commented="no" id="idCACAF737D0884F46BA5FBD24FC8FEAA3"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 513(e)(1) (21
U.S.C. 360c(e)(1)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id9EDA4E3302EB4E35AC195DA26437AA90" style="OLC">
<subsection commented="no" id="id2F2E81065B1B4031934590CE37D09EFB"><enum>(e)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id6B5A4F3CD92F4A8F9CA9E814697D09AB"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idFDCA754A988F41CAA3CEC9527E6097C7"><enum>(A)</enum><text>Based on new
information respecting a device, the Secretary may, upon the initiative of the
Secretary or upon petition of an interested person, change the classification
of such device, and revoke, on account of the change in classification, any
regulation or requirement in effect under section 514 or 515 with respect to
such device, by administrative order published in the Federal Register
following publication of a proposed reclassification order in the Federal
Register, a meeting of a device classification panel described in subsection
(b), and consideration of comments to a public docket, notwithstanding
subchapter II of Chapter 5 of title 5 of the United States Code. An order under
this subsection changing the classification of a device from class III to class
II may provide that such classification shall not take effect until the
effective date of a performance standard established under section 514 for such
device.</text>
</subparagraph><subparagraph commented="no" id="id0D68A64601044F55A98874376A59DA4A" indent="up2"><enum>(B)</enum><text>Authority to issue such
administrative order shall not be delegated below the Commissioner. The
Commissioner shall issue such an order as proposed by the Director of the
Center for Devices and Radiological Health unless the Commissioner, in
consultation with the Office of the Secretary of Health and Human Services,
concludes that the order exceeds the legal authority of the Food and Drug
Administration or that the order would be lawful, but unlikely to advance the
public
health.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph commented="no" id="id563F0DB957C643A59F65D7D84903E14C"><enum>(2)</enum><header>Technical and
conforming amendments</header>
<subparagraph commented="no" id="idA1883313A72B4F4EB154CF21ECD15380"><enum>(A)</enum><text>Section 513(e)(2)
(21 U.S.C. 360c(e)(2)) is amended by striking <quote>regulation
promulgated</quote> and inserting <quote>an order issued</quote>.</text>
</subparagraph><subparagraph commented="no" id="idA13F8D0E55DC46879409E0374F974D19"><enum>(B)</enum><text>Section 514(a)(1)
(21 U.S.C. 360d(a)(1)) is amended by striking <quote>under a regulation under
section 513(e) but such regulation</quote> and inserting <quote>under an
administrative order under section 513(e) (or a regulation promulgated under
such section prior to the date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>) but such order (or regulation)</quote>;</text>
</subparagraph><subparagraph commented="no" id="id80A5C1B4010E400CBFBB39FFB26C487F"><enum>(C)</enum><text>Section 517(a)(1)
(21 U.S.C. 360g(a)(1)) is amended by striking <quote>or changing the
classification of a device to class I</quote> and inserting <quote>, an
administrative order changing the classification of a device to class
I,</quote>.</text>
</subparagraph></paragraph><paragraph id="id0D4C7FC923DE4761A108B96E5F4C78D9"><enum>(3)</enum><header>Devices
reclassified prior to the date of enactment of this Act</header>
<subparagraph id="idE3F9D9E365D04910A29C5807888D8820"><enum>(A)</enum><header>In
general</header><text>The amendments made by this subsection shall have no
effect on a regulation promulgated with respect to the classification of a
device under section 513(e) of the Federal Food, Drug, and Cosmetic Act prior
to the date of enactment of this Act.</text>
</subparagraph><subparagraph id="idF15AE49291954D76A4DCC247383BBF09"><enum>(B)</enum><header>Applicability
of other provisions</header><text>In the case of a device reclassified under
section 513(e) of the Federal Food, Drug, and Cosmetic Act by regulation prior
to the date of enactment of this Act, section 517(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to such regulation
promulgated under section 513(e) of such Act with respect to such device in the
same manner such section 517(a)(1) applies to an administrative order issued
with respect to a device reclassified after the date of enactment of this
Act.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="idA2D63728F1AB4731BD6A167D231B3DED"><enum>(b)</enum><header>Devices
marketed before May 28, 1976</header>
<paragraph commented="no" id="idF03AC1BBD89F405190B8D68EF3D813A9"><enum>(1)</enum><header>Premarket
approval</header><text>Section 515 (21 U.S.C. 360e) is amended—</text>
<subparagraph commented="no" id="idD93EE5B03E0F4CAEB49F6F38F6A84B70"><enum>(A)</enum><text>in subsection
(a), by striking <quote>regulation promulgated under subsection (b)</quote> and
inserting <quote>an order issued under subsection (b) (or a regulation
promulgated under such subsection prior to the date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>)</quote>;</text>
</subparagraph><subparagraph commented="no" id="idB9AD224374FC4026BECDA0C279F897F8"><enum>(B)</enum><text>in subsection
(b)—</text>
<clause commented="no" id="id36608F9336DC458299A26967B18E1C75"><enum>(i)</enum><text>in paragraph
(1)—</text>
<subclause commented="no" id="id72835E038D7A4546BA0FC8C5E793D453"><enum>(I)</enum><text>in the heading,
by striking <quote>Regulation</quote> and inserting <quote>Order</quote>;
and</text>
</subclause><subclause commented="no" id="id086103721080430A8D512267C56C470D"><enum>(II)</enum><text>in the matter
following subparagraph (B)—</text>
<item commented="no" id="id3BF38A1E4834427AAA033CAE95C7AF40"><enum>(aa)</enum><text>by striking
<quote>by regulation, promulgated in accordance with this subsection</quote>
and inserting <quote>by administrative order following publication of a
proposed order in the Federal Register, a meeting of a device classification
panel described in section 513(b), and consideration of comments from all
affected stakeholders, including patients, payors, and providers,
notwithstanding subchapter II of chapter 5 of title 5, United States
Code</quote>; and</text>
</item><item commented="no" id="idB41E8EBFF467434D8AA11DC51A114128"><enum>(bb)</enum><text>by adding at the
end the following:</text>
</item></subclause></clause></subparagraph><continuation-text continuation-text-level="paragraph" indent="subsection"><quote>Authority to issue such administrative order
shall not be delegated below the Commissioner. Before publishing such
administrative order, the Commissioner shall consult with the Office of the
Secretary. The Commissioner shall issue such an order as proposed by the
Director of the Center for Devices and Radiological Health unless the
Commissioner, in consultation with the Office of the Secretary, concludes that
the order exceeds the legal authority of the Food and Drug Administration or
that the order would be lawful, but unlikely to advance the public
health.</quote>;</continuation-text><subparagraph id="LEXA-Repairid72170C3B048C481F9613D2C42C8B305F"><enum></enum><clause commented="no" id="idBE1DD4D3A51C42D7B473F5554276B134"><enum>(ii)</enum><text>in paragraph
(2)—</text>
<subclause commented="no" id="idED79473DB83C461487827CB1BA064BDA"><enum>(I)</enum><text>by striking
subparagraph (B); and</text>
</subclause><subclause commented="no" id="id1567453C19774EA1839AFE3D2D10DAB7"><enum>(II)</enum><text>in subparagraph
(A)—</text>
<item commented="no" id="idD83D709644424DBB8945CBEDD836CB67"><enum>(aa)</enum><text>by striking
<quote>(2)(A) A proceeding for the promulgation of a regulation under paragraph
(1) respecting a device shall be initiated by the publication in the Federal
Register of a notice of proposed rulemaking. Such notice shall contain—</quote>
and inserting <quote>(2) A proposed order required under paragraph (1) shall
contain—</quote>;</text>
</item><item commented="no" id="idB09F214E96D74B0295A2A935C4CED908"><enum>(bb)</enum><text>by redesignating
clauses (i) through (iv) as subparagraphs (A) through (D), respectively;</text>
</item><item commented="no" id="id41E6D1F453334ADFA9FDCCF0AE4ED286"><enum>(cc)</enum><text>in subparagraph
(A), as so redesignated, by striking <quote>regulation</quote> and inserting
<quote>order</quote>; and</text>
</item><item commented="no" id="id48BD3AC44D0E4D9CBF82D3C735F51382"><enum>(dd)</enum><text>in subparagraph
(C), as so redesignated, by striking <quote>regulation</quote> and inserting
<quote>order</quote>;</text>
</item></subclause></clause><clause commented="no" id="id796166F4A09B4F118599AD02552B8B14"><enum>(iii)</enum><text>in paragraph
(3)—</text>
<subclause commented="no" id="id4B14226CD15E41DB9DFC761042B221CD"><enum>(I)</enum><text>by striking
<quote>proposed regulation</quote> each place such term appears and inserting
<quote>proposed order</quote>;</text>
</subclause><subclause commented="no" id="idDDF3930A21E04E0B899FBF3C8FF23549"><enum>(II)</enum><text>by striking
<quote>paragraph (2) and after</quote> and inserting <quote>paragraph
(2),</quote>;</text>
</subclause><subclause commented="no" id="id42C56CE619FF4912888FFAA5F6B4C64F"><enum>(III)</enum><text>by inserting
<quote>and a meeting of a device classification panel described in section
513(b),</quote> after <quote>such proposed regulation and
findings,</quote>;</text>
</subclause><subclause commented="no" id="id569CD1EE82604A8F914FCCD3C27039E9"><enum>(IV)</enum><text>by striking
<quote>(A) promulgate such regulation</quote> and inserting <quote>(A) issue an
administrative order under paragraph (1)</quote>;</text>
</subclause><subclause commented="no" id="id8374AC189E244DD99026FA0BF8E45A26"><enum>(V)</enum><text>by striking
<quote>paragraph (2)(A)(ii)</quote> and inserting <quote>paragraph
(2)(B)</quote>; and</text>
</subclause><subclause commented="no" id="id60CFDB9CF94E48A1AA6D8EA56D6A1B6B"><enum>(VI)</enum><text>by striking
<quote>promulgation of the regulation</quote> and inserting <quote>issuance of
the administrative order</quote>; and</text>
</subclause></clause><clause commented="no" id="id98055A6F87924F30BF767270397CF4D8"><enum>(iv)</enum><text>by striking
paragraph (4); and</text>
</clause></subparagraph><subparagraph commented="no" id="idDBAC5BDA73CD4459A95DC9787737CC61"><enum>(C)</enum><text>in subsection
(i)—</text>
<clause commented="no" id="id6322942401B14F4DA68F8A550FFD2AE6"><enum>(i)</enum><text>in paragraph
(2)—</text>
<subclause commented="no" id="id27CC962541E34900A4B6C514C46FF1BD"><enum>(I)</enum><text>in the matter
preceding subparagraph (A)—</text>
<item commented="no" id="id5EC3F3D910264CAFA25942ABCD4D1A4C"><enum>(aa)</enum><text>by striking
<quote>December 1, 1995</quote> and inserting <quote>the date that is 2 years
after the date of enactment of the <short-title>Food and
Drug Administration Safety and Innovation Act</short-title></quote>; and</text>
</item><item commented="no" id="idBDE3703398034DBCB682CE71435018EE"><enum>(bb)</enum><text>by striking
<quote>publish a regulation in the Federal Register</quote> and inserting
<quote>issue an administrative order following publication of a proposed order
in the Federal Register, a meeting of a device classification panel described
in section 513(b), and consideration of comments from all affected
stakeholders, including patients, payors, and providers, notwithstanding
subchapter II of chapter 5 of title 5, United States Code,</quote>;</text>
</item></subclause><subclause commented="no" id="idFA5FD76FEBCB477AA9F5BF54DD911483"><enum>(II)</enum><text>in subparagraph
(B), by striking <quote>final regulation has been promulgated under section
515(b)</quote> and inserting <quote>administrative order has been issued under
subsection (b) (or no regulation has been promulgated under such subsection
prior to the date of enactment of the <short-title>Food
and Drug Administration Safety and Innovation
Act</short-title>)</quote>;</text>
</subclause><subclause commented="no" id="id341BA7B5401141F48F3A1C425F463BED"><enum>(III)</enum><text>in the matter
following subparagraph (B), by striking <quote>regulation requires</quote> and
inserting <quote>administrative order issued under this paragraph
requires</quote>; and</text>
</subclause><subclause commented="no" id="idFC7C5AEFF1F54C53BAB702ABDA42928E"><enum>(IV)</enum><text>by striking the
third and fourth sentences; and</text>
</subclause></clause><clause commented="no" id="id801F59A24CC5465886911DCADDF5C0BB"><enum>(ii)</enum><text>in paragraph
(3)—</text>
<subclause commented="no" id="id2929FABEA40E4F4FA6B2EBDAA08C9362"><enum>(I)</enum><text>by striking
<quote>regulation requiring</quote> each place such term appears and inserting
<quote>order requiring</quote>; and</text>
</subclause><subclause commented="no" id="id7F132220194243759973E6DA1471BAF8"><enum>(II)</enum><text>by striking
<quote>promulgation of a section 515(b) regulation</quote> and inserting
<quote>issuance of an administrative order under subsection (b)</quote>.</text>
</subclause></clause></subparagraph></paragraph><paragraph commented="no" id="id40374A15017143B691554EFF8D2CC19F"><enum>(2)</enum><header>Technical and
conforming amendments</header><text>Section 501(f) (21 U.S.C. 351(f)) is
amended—</text>
<subparagraph commented="no" id="id581EFD323554439ABA95E326BFAAA54D"><enum>(A)</enum><text>in subparagraph
(1)(A)—</text>
<clause commented="no" id="id0FA23730A2D34AB9B5BFF9DD182A5904"><enum>(i)</enum><text>in subclause (i),
by striking <quote>a regulation promulgated</quote> and inserting <quote>an
order issued</quote>; and</text>
</clause><clause commented="no" id="id860EB980F36F4611ACB2FC73575C62B0"><enum>(ii)</enum><text>in subclause
(ii), by striking <quote>promulgation of such regulation</quote> and inserting
<quote>issuance of such order</quote>;</text>
</clause></subparagraph><subparagraph commented="no" id="id39CE0784652B468FAFBE284A7FC53281"><enum>(B)</enum><text>in subparagraph
(2)(B)—</text>
<clause commented="no" id="idC9BBBD1EE600408F889B50D6AA6560F7"><enum>(i)</enum><text>by striking
<quote>a regulation promulgated</quote> and inserting <quote>an order
issued</quote>; and</text>
</clause><clause commented="no" id="id30E2D680EDF54D6087129CC89E01B8AA"><enum>(ii)</enum><text>by striking
<quote>promulgation of such regulation</quote> and inserting <quote>issuance of
such order</quote>; and</text>
</clause></subparagraph><subparagraph commented="no" id="id87C742F2AD4A411CA5A99CE8622F7672"><enum>(C)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id4B85E97B936B4A20857DF04710B5ADD0" style="OLC">
<paragraph commented="no" id="idE0F5786668B6460D826AEBE1506DB7F0" indent="up1"><enum>(3)</enum><text>In the case of a device with respect
to which a regulation was promulgated under section 515(b) prior to the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>, a reference in this subsection to an
order issued under section 515(b) shall be deemed to include such
regulation.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph commented="no" id="id5892375A4CD149D5A9EF9337EB672EE9"><enum>(3)</enum><header>Approval by
regulation prior to the date of enactment of this Act</header><text>The
amendments made by this subsection shall have no effect on a regulation that
was promulgated prior to the date of enactment of this Act requiring that a
device have an approval under section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval.</text>
</paragraph></subsection><subsection commented="no" id="id231E74D1578644C3BD795283B1919BAC"><enum>(c)</enum><header>Reporting</header><text>The
Secretary of Health and Human Services shall annually post on the Internet web
site of the Food and Drug Administration—</text>
<paragraph id="id9142b9d6699f4cc08c35a423b05f7799"><enum>(1)</enum><text>the number and
type of class I and class II devices reclassified as class II or class III in
the previous calendar year under section 513(e)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360c(e)(1));</text>
</paragraph><paragraph id="idd1e22e620d0f48a9a8194a8d5c4ca73f"><enum>(2)</enum><text>the number and
type of class II and class III devices reclassified as class I or class II in
the previous calendar year under such section 513(e)(1); and</text>
</paragraph><paragraph id="id1275f5982be04466867e176a6e12e8fe"><enum>(3)</enum><text>the number and
type of devices reclassified in the previous calendar year under section 515 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e).</text>
</paragraph></subsection></section><section id="H5B4BD8FFF9B249DFB48557842AFC6A4B" section-type="subsequent-section"><enum>602.</enum><header>Condition of
approval studies</header><text display-inline="no-display-inline">Section
515(d)(1)(B)(ii) (21 U.S.C. 360e(d)(1)(B)(ii)) is amended—</text>
<paragraph id="idE0439B83D804436493282D9EAD33B23D"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>(ii)</quote> and
inserting <quote>(ii)(I)</quote>; and</text>
</paragraph><paragraph id="id97F24A7FA62A4475A163CDB562014F18"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id814B9A15EEA24CE780157C46EEDC3A86" style="OLC">
<subclause id="id8AE61B8802B1458FB28CB2B00A95B2F4" indent="up4"><enum>(II)</enum><text>An order approving an application
for a device may require as a condition to such approval that the applicant
conduct a postmarket study regarding the
device.</text>
</subclause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id4F8825F8E585402085B465C90A9C982A"><enum>603.</enum><header>Postmarket
surveillance</header><text display-inline="no-display-inline">Section 522 (21
U.S.C. 360l) is amended—</text>
<paragraph id="idb584753e03784e29aada90c87624be55"><enum>(1)</enum><text>in subsection
(a)(1)(A), in the matter preceding clause (i), by inserting <quote>, at the
time of approval or clearance of a device or at any time thereafter,</quote>
after <quote>by order</quote>; and</text>
</paragraph><paragraph id="id23eb00a7b6b043a9a7dbb9568e0aeda3"><enum>(2)</enum><text>in subsection
(b)(1), by inserting <quote>The manufacturer shall commence surveillance under
this section not later than 15 months after the day on which the Secretary
issues an order under this section.</quote> after the second sentence.</text>
</paragraph></section><section id="id7A5CCEB120014F51B8E5278B38049471" section-type="subsequent-section"><enum>604.</enum><header>Sentinel</header><text display-inline="no-display-inline">Section 519 (21 U.S.C. 360i) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7769A9DAC63C4B46B5E0D7BDA2D89AFD" style="OLC">
<subsection id="id4ABFA21E3C2840C5965E79B79931CD13"><enum>(h)</enum><header>Inclusion of
devices in the postmarket risk identification and analysis system</header>
<paragraph id="id47F97B1AC7B64F1DBE4A58661342396C"><enum>(1)</enum><header>In
general</header>
<subparagraph id="id219F78F38A5A42A09CF7B75C9D0DBC62"><enum>(A)</enum><header>Application to
devices</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>
</subparagraph><subparagraph id="id06E82C72E4134311A9AD01E0CE59E814"><enum>(B)</enum><header>Exception</header><text>Subclause
(II) of clause (i) of section 505(k)(3)(C) shall not apply to devices.</text>
</subparagraph><subparagraph id="id2DEF2910EFC84CA5BEDE4739C86A47F7"><enum>(C)</enum><header>Clarification</header><text>With
respect to devices, the private sector health-related electronic data provided
under section 505(k)(3)(C)(i)(III)(bb) may include medical device utilization
data, health insurance claims data, and procedure and device registries.</text>
</subparagraph></paragraph><paragraph id="id4C3E0395978745F98DDE380D26A7D0AF"><enum>(2)</enum><header>Data</header><text display-inline="yes-display-inline">In expanding the system as described in
paragraph (1)(A), the Secretary shall use relevant data with respect to devices
cleared under section 510(k) or approved under section 515, including claims
data, patient survey data, and any other data deemed appropriate by the
Secretary.</text>
</paragraph><paragraph id="idD8EA3C4A170E4F128ED8F24FA60AAE2C"><enum>(3)</enum><header>Stakeholder
input</header><text>To help ensure effective implementation of the system
described in paragraph (1)(A), the Secretary shall engage outside stakeholders
in development of the system through a public hearing, advisory committee
meeting, public docket, or other like public measures, as appropriate.</text>
</paragraph><paragraph id="id75A82C1E25BE45E8A7D686855CAAD71B"><enum>(4)</enum><header>Voluntary
surveys</header><text display-inline="yes-display-inline">Chapter 35 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 for
devices.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id94935B96AA68442A8ECFD9E2E36A3B55"><enum>605.</enum><header>Recalls</header>
<subsection commented="no" id="id7574B4BF3FB24DC5A0696DE518E714DA"><enum>(a)</enum><header>Assessment of
device recall information</header>
<paragraph commented="no" id="id2BDA70693A0B4311B99FA63AD11944C9"><enum>(1)</enum><header>In
general</header>
<subparagraph commented="no" id="idDA597ACD8A134C15B25FDD8B18767520"><enum>(A)</enum><header>Assessment
program</header><text>The Secretary of Health and Human Services (referred to
in this section as the <quote>Secretary</quote>) shall enhance the Food and
Drug Administration's recall program to routinely and systematically
assess—</text>
<clause commented="no" id="id7B995417CC044D5387D478319DFBEED4"><enum>(i)</enum><text>information
submitted to the Secretary pursuant to a device recall order under section
518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e));
and</text>
</clause><clause commented="no" id="idB42BA307E66542F2ACB2D1E3581335BF"><enum>(ii)</enum><text>information
required to be reported to the Secretary regarding a correction or removal of a
device under section 519(g) of such Act (21 U.S.C. 360i(g)).</text>
</clause></subparagraph><subparagraph commented="no" id="idAB4758761C114CDE9017980E2747CCA0"><enum>(B)</enum><header>Use</header><text>The
Secretary shall use the assessment of information described under subparagraph
(A) to proactively identify strategies for mitigating health risks presented by
defective or unsafe devices.</text>
</subparagraph></paragraph><paragraph commented="no" id="idCBD18E92D9DF4E72BD00730C91924BC4"><enum>(2)</enum><header>Design</header><text>The
program under paragraph (1) shall, at a minimum, identify—</text>
<subparagraph commented="no" id="id6D4F9513FAB7433281BB28EA79EE6763"><enum>(A)</enum><text>trends in the
numbers and types of device recalls;</text>
</subparagraph><subparagraph commented="no" id="id97BADB1607904D82A7885D997512BAD2"><enum>(B)</enum><text>the types of
devices in each device class that are most frequently recalled;</text>
</subparagraph><subparagraph commented="no" id="id34385E8DC26D4488AE9A5804BD314E63"><enum>(C)</enum><text>the causes of
device recalls; and</text>
</subparagraph><subparagraph commented="no" id="idD649F47FCC294424A5443F7015C623E3"><enum>(D)</enum><text>any other
information as the Secretary determines appropriate.</text>
</subparagraph></paragraph></subsection><subsection commented="no" id="idF9FAA18E33C541C38C289A424FDABF66"><enum>(b)</enum><header>Audit check
procedures</header><text>The Secretary shall clarify procedures for conducting
device recall audit checks to improve the ability of investigators to perform
these checks in a consistent manner.</text>
</subsection><subsection commented="no" id="idA94346BC53C547A7830D7CDCBCA98D3F"><enum>(c)</enum><header>Assessment
criteria</header><text>The Secretary shall develop explicit criteria for
assessing whether a person subject to a recall order under section 518(e) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or to a
requirement under section 519(g) of such Act (21 U.S.C. 360i(g)) has performed
an effective recall under such section 518(e) or an effective correction or
removal action under such section 519(g), respectively.</text>
</subsection><subsection commented="no" id="id55CC427188A844719F189D11D3C2E832"><enum>(d)</enum><header>Termination of
recalls</header><text>The Secretary shall document the basis for the
termination by the Food and Drug Administration of—</text>
<paragraph commented="no" id="id8E480836F10C472AB58BC7177E1AEC83"><enum>(1)</enum><text>an individual
device recall ordered under section 518(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360h(e)); and</text>
</paragraph><paragraph commented="no" id="id7C0783CE289F4E19BCFFE2EDD59C8E0B"><enum>(2)</enum><text>any correction or
removal action for which a report is required to be submitted to the Secretary
under section 519(g) of such Act (21 U.S.C. 360i(g)).</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id85FA69F1D6DB427597EF237BF597FF56" section-type="subsequent-section"><enum>606.</enum><header display-inline="yes-display-inline">Clinical holds on investigational device
exemptions</header><text display-inline="no-display-inline">Section 520(g) (21
U.S.C. 360j(g)) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idB444F98447654E0698683D69127AF51E" style="OLC">
<paragraph commented="no" display-inline="no-display-inline" id="idD84163FF5DA145F38ABD0C15753B71D0" indent="up1"><enum>(8)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idF122652A2D374D79942351596F2AB7AD"><enum>(A)</enum><text>At any time, the
Secretary may prohibit the sponsor of an investigation from conducting the
investigation (referred to in this paragraph as a <quote>clinical hold</quote>)
if the Secretary makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold, including the specific
information available to the Secretary which served as the basis for such
clinical hold, and confirm such determination in writing.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id950876A9D24640168A0B504F61292DF1" indent="up1"><enum>(B)</enum><text>For purposes of subparagraph (A), a
determination described in this subparagraph with respect to a clinical hold is
a determination that—</text>
<clause commented="no" display-inline="no-display-inline" id="id08E46C78D083484FA2EA7FB2A3532938"><enum>(i)</enum><text>the device involved represents an
unreasonable risk to the safety of the persons who are the subjects of the
clinical investigation, taking into account the qualifications of the clinical
investigators, information about the device, the design of the clinical
investigation, the condition for which the device is to be investigated, and
the health status of the subjects involved; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idD353EE62560B49A595A0B0ACF3877E7D"><enum>(ii)</enum><text>the clinical hold should be issued
for such other reasons as the Secretary may by regulation establish.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idDFE9E38025F6463EB5575E459ECB42CE" indent="up1"><enum>(C)</enum><text>Any written request to the Secretary
from the sponsor of an investigation that a clinical hold be removed shall
receive a decision, in writing and specifying the reasons therefor, within 30
days after receipt of such request. Any such request shall include sufficient
information to support the removal of such clinical
hold.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idAC27D4D2A7404BE6A0182B125EA21359"><enum>607.</enum><header>Unique device
identifier</header><text display-inline="no-display-inline">Section 519(f) (21
U.S.C. 360i(f)) is amended—</text>
<paragraph id="id96F36CAE6F524A7497408E00DD389FB3"><enum>(1)</enum><text display-inline="yes-display-inline">by striking <quote>The Secretary shall
promulgate</quote> and inserting <quote>Not later than December 31, 2012, the
Secretary shall issue proposed</quote>; and</text>
</paragraph><paragraph id="id44CFC9E5759949608E9E8B8F1163DCC9"><enum>(2)</enum><text display-inline="yes-display-inline">by adding at the end the following:
<quote>The Secretary shall finalize the proposed regulations not later than 6
months after the close of the comment period and shall implement the final
regulations with respect to devices that are implantable, life-saving, and life
sustaining not later than 2 years after the regulations are
finalized.</quote>.</text>
</paragraph></section><section id="idB2283E024CB8410D85307BBD430AAE09"><enum>608.</enum><header>Clarification
of least burdensome standard</header>
<subsection commented="no" id="ID004d11d8635440fd9ca8164d3ea2abc8"><enum>(a)</enum><header>Premarket
approval</header><text>Section 513(a)(3)(D) (21 U.S.C. 360c(a)(3)(D)) is
amended—</text>
<paragraph commented="no" id="id11299212E2C940B5B574732B93DC2776"><enum>(1)</enum><text>by redesignating
clause (iii) as clause (v); and</text>
</paragraph><paragraph commented="no" id="id0A725A4D9CEB45A3BD10DE48AC59691E"><enum>(2)</enum><text>by inserting
after clause (ii) the following:</text>
<quoted-block display-inline="no-display-inline" id="id08EA84B4BCFF48D7866426F54283188F" style="OLC">
<clause commented="no" id="id107B4637E9D84EE795D3F9A66D371D2F" indent="up3"><enum>(iii)</enum><text>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="id60B408C71E2B4DF2B9A40F914C5553C0" 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 id="IDeb8176f45d4946a59d1b046d6627d0b9"><enum>(b)</enum><header>Premarket
notification under section 510(k)</header><text>Section 513(i)(1)(D) (21 U.S.C.
360c(i)(1)(D)) is amended—</text>
<paragraph id="ID9ee54a7001364d60b26186c9359cca51"><enum>(1)</enum><text>by striking
<quote>(D) Whenever</quote> and inserting <quote>(D)(i) Whenever</quote>;
and</text>
</paragraph><paragraph id="ID6b72835dad684048bf9fadbb04ca5ce8"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id8DD0085D28384DE6B1E612FE352FA3CC" style="OLC">
<clause id="id5A240C1C38824D6DACC77DE45998E84D" indent="up3"><enum>(ii)</enum><text>For purposes of clause (i), the term
<quote>necessary</quote> means the minimum required information that would
support a determination of substantial equivalence between a new device and a
predicate device.</text>
</clause><clause id="idF1E646A72DA040E993A47EC972F5F337" 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 id="H74E76642A162469F8A9D5E657A590DA9"><enum>609.</enum><header>Custom
devices</header><text display-inline="no-display-inline">Section 520(b) (21
U.S.C. 360j(b)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idB3FA81BC661641349965C25D8BDE9511" style="OLC">
<subsection id="idD397A78723B44733A284FFCFA147CF55"><enum>(b)</enum><header>Custom
devices</header>
<paragraph id="id85448162DC2D45588CFC0FFA18DC73E0"><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="id9E0D7873870B46008C23703577715BF6"><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="id134252A30FFE48A282881444AE3CA05F"><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="id2216a50ea7e24dcfb68fd37b330169a4"><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="id92B1769B6EC34F7A930B16F2C7164D3D"><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="idc142431cca8346b0a4b6306a736d218a"><enum>(E)</enum><clause commented="no" display-inline="yes-display-inline" id="idF8FD4BDD85D94218941C69344817FF75"><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="idD00151D241C7437BB45E5FC0C9B734D0" 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="id2D3894666C5E402EB89325E8809CA761"><enum>(F)</enum><text>is assembled from
components or manufactured and finished on a case-by-case basis to accommodate
the unique needs described in clause (i) or (ii) of subparagraph (E);
and</text>
</subparagraph><subparagraph id="id53C48165E6CE4A63AAEA3D923D47E4E8"><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="id8F65C2D4A5594CEF8B9BE2B19619EE6E"><enum>(2)</enum><header>Limitations</header><text>Paragraph
(1) shall apply to a device only if—</text>
<subparagraph id="id8b75fb970d9a4d848fd19cef73a7999d"><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; and</text>
</subparagraph><subparagraph id="id2ca04780336540a393775f25fda7c7f2"><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.</text>
</subparagraph></paragraph><paragraph id="idD9B48DF763414AEAB4287E52944F29A6"><enum>(3)</enum><header>Exception</header><text>Paragraph
(1) shall not apply to oral facial devices.</text>
</paragraph><paragraph id="id664640835bb945beb35d0ef428ea9967"><enum>(4)</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><paragraph id="id59c23493cd304a068cea951c7e2a5fd5"><enum>(5)</enum><header>Notification to
the Secretary</header><text>The manufacturer of a device created or modified as
described in paragraph (1) shall notify the Secretary, in a manner prescribed
by the Secretary, of the manufacture of such
device.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id3ACE621146F04D3AAB45AF6231FE5FCD"><enum>610.</enum><header>Agency
documentation and review of certain decisions regarding devices</header><text display-inline="no-display-inline">Chapter V (21 U.S.C. 351 et seq.) is amended
by inserting after section 517 the following:</text>
<quoted-block display-inline="no-display-inline" id="idA6E1A43A5B4D4F8DBB1BE8DA269A5A94" style="OLC">
<section id="H4140E73E7A8940918D24D33CF825C035"><enum>517A.</enum><header>Agency
documentation and review of certain decisions regarding devices</header>
<subsection id="H31C675365E874EE69D914FD96CD69F0E"><enum>(a)</enum><header>Documentation of
rationale for denial</header><text>If the Secretary renders a final decision to
deny clearance of a premarket notification under section 510(k) or approval of
a premarket application under section 515, or when the Secretary disapproves an
application for an investigational exemption under 520(g), the written
correspondence to the applicant communicating that decision shall provide a
substantive summary of the scientific and regulatory rationale for the
decision.</text>
</subsection><subsection id="id89A9B0F933D843AFA45B090F3FA6F9EA"><enum>(b)</enum><header>Review of
denial</header>
<paragraph id="idF4A60C5603644476A0B1539D5FF94594"><enum>(1)</enum><header>In
general</header><text>A person who has submitted a report under section 510(k),
an application under section 515, or an application for an exemption under
section 520(g) and for whom clearance of the report or approval of the
application is denied may request a supervisory review of the decision to deny
such clearance or approval. Such review shall be conducted by an individual at
the organizational level above the organization level at which the decision to
deny the clearance of the report or approval of the application is made.</text>
</paragraph><paragraph id="id10258B9DAEEC4C0AB7C85118E0011BAC"><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 denial and shall indicate in the request whether such person seeks an
in-person meeting or a teleconference review.</text>
</paragraph><paragraph id="id36853995D0F34725966EFC08A0F4755B"><enum>(3)</enum><header>Timeframe</header>
<subparagraph id="id8803F6D7F79E4EC6AA686F415E0F5726"><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 id="id9996C880ED7742BDA46D5BF301AFB995"><enum>(B)</enum><header>Exception</header><text>Subparagraph
(A) shall not apply in cases that involve consultation with experts outside of
the Food and Drug Administration, or in cases in which the sponsor seeks to
introduce evidence not already in the administrative record at the time the
denial decision was
made.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id4C7596BD649D4BBBACEB688F3F038F7E"><enum>611.</enum><header>Good guidance
practices relating to devices</header><text display-inline="no-display-inline">Subparagraph (C) of section 701(h)(1) (21
U.S.C. 371(h)(1)) is amended—</text>
<paragraph id="idC8E0BF51440C4AD8BE33BAC9D17DF58F"><enum>(1)</enum><text>by striking
<quote>(C) For guidance documents</quote> and inserting <quote>(C)(i) For
guidance documents</quote>; and</text>
</paragraph><paragraph id="id6dc0e0ac7dd24a17b373eba91c7dc9f7"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id12130BA6DA6C4015B62FF9D6075BF051" style="OLC">
<clause id="id13554E7B855C44DD8198B980CBFB55B4" indent="up2"><enum>(ii)</enum><text display-inline="yes-display-inline">With respect to devices, if a notice to
industry guidance letter, a notice to industry advisory letter, or any similar
notice sets forth initial interpretations of a regulation or policy or sets
forth changes in interpretation or policy, such notice shall be treated as a
guidance document for purposes of this
subparagraph.</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="idAA9A98F6D95040FEAB1AC9797CCB610D" section-type="subsequent-section"><enum>612.</enum><header>Modification of de
novo application process</header>
<subsection id="H82D2A65503FE48D5A18DD1F0580ECF5A"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 513(f)(2) (21
U.S.C. 360c(f)(2)) is amended—</text>
<paragraph id="id760690EB130B410D907A3D1FDB9A5106"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating subparagraphs (B) and (C)
as subparagraphs (C) and (D), respectively;</text>
</paragraph><paragraph id="id393192464D00416E882FF7680C98B7D9"><enum>(2)</enum><text display-inline="yes-display-inline">by amending subparagraph (A) to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="id174A528B178141EBB6807014FD269C78" style="OLC">
<subparagraph id="idF53C1C15A77E46BE850263D94E3B286C" indent="up2"><enum>(A)</enum><text>In the case of a type of device that
has not previously been classified under this Act, a person may do one of the
following:</text>
<clause id="id6E8D8B1AE4F0429ABEBC28EFC49DF8B5"><enum>(i)</enum><text>Submit a report under section 510(k),
and, if the device is classified into class III under paragraph (1), such
person may request, not later than 30 days after receiving written notice of
such a classification, the Secretary to classify the device under the criteria
set forth in subparagraphs (A) through (C) of subsection (a)(1). The person
may, in the request, recommend to the Secretary a classification for the
device. Any such request shall describe the device and provide detailed
information and reasons for the recommended classification.</text>
</clause><clause id="id5BF91B40AFDB49A68186A19F76D8639B"><enum>(ii)</enum><text>Submit a request for initial
classification of the device under this subparagraph, if the person declares
that there is no legally marketed device upon which to base a substantial
equivalence determination as that term is defined in subsection (i). Subject to
subparagraph (B), the Secretary shall classify the device under the criteria
set forth in subparagraphs (A) through (C) of subsection (a)(1). 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. Requests under this clause shall be subject to
the electronic copy requirements of section
745A(b).</text>
</clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id03471BC7F4804CA28BA2830602DAB754"><enum>(3)</enum><text>by inserting
after subparagraph (A) the following:</text>
<quoted-block display-inline="no-display-inline" id="idAFFAD84F9FEC4B9EBA99FAB25EA6914A" style="OLC">
<subparagraph id="idAB3478F6BA654DB49D94790A3CE3757E" indent="up2"><enum>(B)</enum><text>The Secretary may decline to
undertake a classification request submitted under clause (2)(A)(ii) if the
Secretary identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence under paragraph (1), or when the
Secretary determines that the device submitted is not of low-moderate risk or
that general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be
developed.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id030F17A1AF38457B8359B56A4F9C89F1"><enum>(4)</enum><text>in subparagraph
(C), as so redesignated—</text>
<subparagraph id="id55C537068E4E4AEF8669B9DB1E55A5ED"><enum>(A)</enum><text>in clause (i), by
striking <quote>Not later than 60 days after the date of the submission of the
request under subparagraph (A),</quote> and inserting <quote>Not later than 120
days after the date of the submission of the request under subparagraph (A)(i)
or 150 days after the date of the submission of the request under subparagraph
(A)(ii),</quote>; and</text>
</subparagraph><subparagraph id="id369CD0D62BEA434EB1F1A05F8FCD8FA4"><enum>(B)</enum><text>in clause (ii),
by inserting <quote>or is classified in</quote> after <quote>remains
in</quote>.</text>
</subparagraph></paragraph></subsection><subsection id="HCE68B301675547C89A40113E4662007A"><enum>(b)</enum><header>GAO
report</header><text>Not later than 2 years after the date of enactment of this
Act, the Comptroller General of the United States shall complete a study and
submit to Congress a report on the effectiveness of the review pathway under
section 513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by
this Act.</text>
</subsection><subsection id="id7AFFAB6BC3DD444299707E6B46E14C6A"><enum>(c)</enum><header>Conforming
amendment</header><text>Section 513(f)(1)(B) (21 U.S.C. 360c(f)(1)(B)) is
amended by inserting <quote>a request under paragraph (2) or</quote> after
<quote>response to</quote>.</text>
</subsection></section><section id="id641C9DE5D92B405289AA45534CAA7E41"><enum>613.</enum><header>Humanitarian
device exemptions</header>
<subsection id="id760274F5B2BB4816BFE8438DCD26660D"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 520(m) (21
U.S.C. 360j(m)) is amended—</text>
<paragraph id="id3ECCA0DB7D024D869756A3495BA3D5CA"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (6)—</text>
<subparagraph id="idDD8BE0F829F046A2A93C9E7552C26373"><enum>(A)</enum><text display-inline="yes-display-inline">in subparagraph (A)—</text>
<clause id="id2222D5B2A2AC40ED83F42FBA7535264C"><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 id="id2F0938A61D5D4A7B9C9E7AA7C3AED0EB"><enum>(ii)</enum><text display-inline="yes-display-inline">by striking clause (i) and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id4C82F2158BF24AA9876591F3CD36A51E" style="OLC">
<clause id="idAC59E8928BA2496ABDCD4B2D597B6D56" indent="up2"><enum>(i)</enum><text display-inline="yes-display-inline">The device with respect to which the
exemption is granted—</text>
<subclause id="id16B8559ABE124C79AC45B62C6753F44B"><enum>(I)</enum><text display-inline="yes-display-inline">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 id="idD23E59AD59054FA693E276142D9503BB"><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>;
and</after-quoted-block></quoted-block>
</clause><clause id="idCEB94377D5A74EDF9918A2E00AF32A22"><enum>(iii)</enum><text>by striking
clause (ii) and inserting the following:</text>
<quoted-block display-inline="no-display-inline" id="idF461CC0747604577882AAA58D470158B" style="OLC">
<clause id="idDDAE5D9AA0B94DE4900D00B9D9A9004F" indent="up2"><enum>(ii)</enum><text>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 <term>annual distribution
number</term>).</text>
</clause><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph><subparagraph id="id2A45819D5EA245A886AA894A41AED3C8"><enum>(B)</enum><text>by striking
subparagraph (C);</text>
</subparagraph><subparagraph id="idB40A219DA4814294926F584051328079"><enum>(C)</enum><text>by redesignating
subparagraphs (D) and (E) as subparagraphs (C) and (D), respectively;
and</text>
</subparagraph><subparagraph id="idC970CCECFB8C4BF9B3298EE9444AF820"><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 id="idC0D533A7CA424FEEB4BD6E7787B7B0DF"><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 id="id3A313BFF1AE649BDA86DFCFD4AECD2C8"><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 id="id09C9315FB1294045AE53DB75C5E1BA6E"><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 (21 U.S.C. 360j(m)) before the date of enactment of this Act
may seek a determination under subclause (I) or (II) of section 520(m)(6)(A)(i)
(as amended by subsection (a)). If the Secretary determines that such subclause
(I) or (II) applies with respect to a device, 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" display-inline="no-display-inline" id="idA9A85B7DB4D3418D84FEE01DA0F259AC"><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 id="id2d7b9d27c80d4f72969bfee41d8c6e68"><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 id="idfda0a0e169934c93896326b5f8011a75"><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 (21 U.S.C. 360j(m)) prior to the date of enactment of this
Act;</text>
</paragraph><paragraph id="id3a086b1aa3db4de3a48ddbf31f17422d"><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) (as amended by subsection (a)) and costs
to patients of such devices;</text>
</paragraph><paragraph id="id51c53f7a6fde4b13b667ea2f2e019d3a"><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 id="id1951a223680449bcb0fa3edd792f92ed"><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><section id="id7C89DC8780B04462A21F0B94624B251B"><enum>614.</enum><header>Reauthorization
of third-party review and inspections</header>
<subsection id="id3F574DEBB8A64F6A85BC0560A0FEB017"><enum>(a)</enum><header>Third party
review</header><text display-inline="yes-display-inline">Section 523(c) (21
U.S.C. 360m(c)) is amended by striking <quote>2012</quote> and inserting
<quote>2017</quote>.</text>
</subsection><subsection id="id13AD21A50AEE462B97377343E127F74D"><enum>(b)</enum><header>Third party
inspections</header><text>Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended
by striking <quote>2012</quote> and inserting <quote>2017</quote>.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id300F1D72A29644ED8115F10B48B959E6" section-type="subsequent-section"><enum>615.</enum><header>510(k) device
modifications</header><text display-inline="no-display-inline">Having
acknowledged to Congress potential unintended consequences that may result from
the implementation of the Food and Drug Administration 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>,
the Secretary of Health and Human Services shall withdraw such guidance
promptly and ensure that, before any future guidance document on this issue is
made final, affected stakeholders are provided with an opportunity to
comment.</text>
</section><enum>VII</enum><header>Drug supply
chain</header>
<section id="id5424BA20DC8A4EB7B61C5025D9008112"><enum>701.</enum><header>Registration
of domestic drug establishments</header><text display-inline="no-display-inline">Section 510 (21 U.S.C. 360) is
amended—</text>
<paragraph id="id66C0835F84244A3F8E6C728A3BF35E82"><enum>(1)</enum><text>in subsection
(b)—</text>
<subparagraph id="id121DA592118C42F5A0174C4FDF37CE14"><enum>(A)</enum><text>in paragraph (1),
by striking <quote>On or before</quote> and all that follows through the period
at the end and inserting the following: “During the period beginning on October
1 and ending on December 31 of each year, every person who owns or operates any
establishment in any State engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs shall register with
the Secretary—</text>
<quoted-block display-inline="no-display-inline" id="id8C12EAB9619D49819254D4E025259133" style="OLC">
<subparagraph id="id926D46A3CD044D9AAAE26BBD6866C790" indent="up1"><enum>(A)</enum><text>the name of such person, places of
business of such person, all such establishments, the unique facility
identifier of each such establishment, and a point of contact e-mail address;
and</text>
</subparagraph><subparagraph id="idBC46BD766AE74A7B8F11D119F0B649EF" indent="up1"><enum>(B)</enum><text>the name and place of business of each
drug importer that takes physical possession of a drug (other than an
excipient), with which the person conducts business, including all
establishments of each such drug importer, the unique facility identifier of
each such establishment, and a point of contact e-mail address for each such
drug importer.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="idFCFF9EEBA7244F66820D19C6C8B716B4"><enum>(B)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7D8CA6FCCD5149168E849D9F0B3F5E25" style="OLC">
<paragraph id="id4C875743EB9D4DF984C77F6F41CFF69A" indent="up1"><enum>(3)</enum><text>The Secretary may specify the unique
facility identifier system that shall be used by registrants under paragraph
(1).</text>
</paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="idAAD711C45EAF43F886B33024151BFE6C"><enum>(2)</enum><text>in subsection
(c), by striking <quote>with the Secretary his name, place of business, and
such establishment</quote> and inserting “with the Secretary—</text>
<quoted-block display-inline="no-display-inline" id="id8ED1034D9DEF4E59A0732EE68AE055D5" style="OLC">
<paragraph id="idE061B71598B24F1690362E5E8AB6B91C"><enum>(1)</enum><text>with respect to
drugs, the information described under subsection (b)(1); and</text>
</paragraph><paragraph id="idDE9786F15C9D4F8DAA3B2A5B52F4B8AB"><enum>(2)</enum><text>with respect to
devices, the information described under subsection
(b)(2).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="id81939C3005F24A1EA39675A1551AFAE6"><enum>702.</enum><header>Registration
of foreign establishments</header>
<subsection id="id1D5D99888FD74E439341E240A482C178"><enum>(a)</enum><header>Enforcement of
registration of foreign establishments</header><text>Section 502(o) (21 U.S.C.
352(o)) is amended by striking <quote>in any State</quote>.</text>
</subsection><subsection id="idCC8BA99FCAD54CA3AD709C5CE64773E7"><enum>(b)</enum><header>Registration of
foreign drug establishments</header><text>Section 510(i) (U.S.C. 360(i)) is
amended—</text>
<paragraph id="id29DE0FE73DE0448E8249610AA1851AFE"><enum>(1)</enum><text>in paragraph
(1)—</text>
<subparagraph id="idA5992C35E2E8488390F4513AD3341AC0"><enum>(A)</enum><text>by amending the
matter preceding subparagraph (A) to read as follows: <quote>Every person who
owns or operates any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a drug or
device that is imported or offered for import into the United States shall,
through electronic means in accordance with the criteria of the
Secretary—</quote>;</text>
</subparagraph><subparagraph id="idA146ADA2635845888B17BE026F3672B7"><enum>(B)</enum><text>by amending
subparagraph (A) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idA2B73D5639014876B8B063CA29928916" style="OLC">
<subparagraph id="id4329A054522440E0B49F403092F09037" indent="up1"><enum>(A)</enum><text>upon first engaging in any such
activity, immediately submit a registration to the Secretary that
includes—</text>
<clause id="idF6E87914D72A4F6090266D47C32F5082"><enum>(i)</enum><text>with respect to drugs, the name and
place of business of such person, all such establishments, the unique facility
identifier of each such establishment, a point of contact e-mail address, the
name of the United States agent of each such establishment, the name and place
of business of each drug importer with which such person conducts business,
including all establishments of each such drug importer, the unique facility
identifier of each such establishment, and a point of contact e-mail address
for each such drug importer; and</text>
</clause><clause id="id6B07894D9C2D41ACB7060629CB4ED560"><enum>(ii)</enum><text>with respect to devices, the name
and place of business of the establishment, the name of the United States agent
for the establishment, the name of each importer of such device in the United
States that is known to the establishment, and the name of each person who
imports or offers for import such device to the United States for purposes of
importation; and</text>
</clause></subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph><subparagraph id="id0194F9373FDB415BA0ED8F1A65C60A05"><enum>(C)</enum><text>by amending
subparagraph (B) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id325B12E31AA34B2C882A0D79DC2AF61C" style="OLC">
<subparagraph id="id140299CBE20043909A5A5288E45DDB4B" indent="up1"><enum>(B)</enum><text>each establishment subject to the
requirements of subparagraph (A) shall thereafter register with the Secretary
during the period beginning on October 1 and ending on December 31 of each
year.</text>
</subparagraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</subparagraph></paragraph><paragraph id="id8532BD0C36A24585A46C554C47E3F559"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE5796CFB5D0B498DBDED7F53A5B8732A" style="OLC">
<paragraph id="id68113216881247C3A4908D0200572238" indent="up1"><enum>(4)</enum><text>The Secretary may specify the unique
facility identifier system that shall be used by registrants under paragraph
(1) with respect to
drugs.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection></section><section id="idAFC21F44CE1D498CBA97EC7F25BAE67F"><enum>703.</enum><header>Identification
of drug excipient information with product listing</header><text display-inline="no-display-inline">Section
510(j)(1) (21 U.S.C. 360(j)(1)) is amended—</text>
<paragraph id="id3FC7EE59E3A0465489D2D60D4C80CDF4"><enum>(1)</enum><text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>;
and</quote> and inserting a semicolon;</text>
</paragraph><paragraph id="idA544DC1295F94329A2AA144BE89F97F3"><enum>(2)</enum><text>in subparagraph
(D), by striking the period at the end and inserting <quote>; and</quote>;
and</text>
</paragraph><paragraph id="id330638D23E8F4907A5B6898093D90FAE"><enum>(3)</enum><text display-inline="yes-display-inline">by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id5532B5ADCFF244B396FF8FF142ABFED5" style="OLC">
<subparagraph id="idEBD89A74FF45416CA539D1FDD325D831" indent="up1"><enum>(E)</enum><text>in the case of a drug contained in the
applicable list and subject to section 505 or 512, the name and place of
business of each manufacturer of an excipient of the listed drug with which the
person listing the drug conducts business, including all establishments used in
the production of such excipient, the unique facility identifier of each such
establishment, and a point of contact e-mail address for each such excipient
manufacturer.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="ID0004de7635dc455babdb1f4557a1f1a8"><enum>704.</enum><header>Electronic
system for registration and listing</header><text display-inline="no-display-inline">Section 510(p) (21 U.S.C. 360(p)) is
amended—</text>
<paragraph id="id3A2A885ECF934D37B4431C1C8FAB5BC1"><enum>(1)</enum><text>by striking
<quote>(p) Registrations and listings</quote> and inserting the
following:</text>
<quoted-block display-inline="no-display-inline" id="id5300ECAB773C476CB3EF12B06CD1D276" style="OLC">
<subsection id="idBBAA462FB5984D1490055E1983BC0B95"><enum>(p)</enum><header>Electronic
registration and listing</header>
<paragraph id="idA09798DE96144B1187C5194230D59978"><enum>(1)</enum><header>In
general</header><text>Registration and
listing</text>
</paragraph></subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="idF51B205BC280459DAD979716EEF35E41"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id9F76231E32A94723B2D2DA2BF9BB66A0" style="OLC">
<paragraph id="id532A92016CDD418BA5B99A6FB00E41C3"><enum>(2)</enum><header>Electronic
database</header><text>Not later than 2 years after the Secretary specifies a
unique facility identifier system under subsections (b) and (i), the Secretary
shall maintain an electronic database, which shall not be subject to inspection
under subsection (f), populated with the information submitted as described
under paragraph (1) that—</text>
<subparagraph id="idF518F310BAE44D38813DB09AAFC852BC"><enum>(A)</enum><text>enables personnel
of the Food and Drug Administration to search the database by any field of
information submitted in a registration described under paragraph (1), or
combination of such fields; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID3f36428a0047478daa7f4eb8d5b8ebe4"><enum>(B)</enum><text>uses the unique
facility identifier system to link with other relevant databases within the
Food and Drug Administration, including the database for submission of
information under section 801(r).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3F9E402080FA4088858D320DD2AB0B8E"><enum>(3)</enum><header>Risk-based
information and coordination</header><text>The Secretary shall ensure the
accuracy and coordination of relevant Food and Drug Administration databases in
order to identify and inform risk-based inspections under section
510(h).</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="id1AEEB52823154353BC171139C9AEF143"><enum>705.</enum><header>Risk-based
inspection frequency</header><text display-inline="no-display-inline">Section
510(h) (21 U.S.C. 360(h)) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id167B346B876F49E6A49A93AD637BA5A4" style="OLC">
<subsection id="idBD3A5047ADF9476C953E70DC3427C481"><enum>(h)</enum><header>Inspections</header>
<paragraph id="id69E3FD5FBE824993A45447898486E09A"><enum>(1)</enum><header>In
general</header><text>Every establishment that is required to be registered
with the Secretary under this section shall be subject to inspection pursuant
to section 704.</text>
</paragraph><paragraph id="id9AE8AD1D15F14F749FBB85EE75780534"><enum>(2)</enum><header>Biennial
inspections for devices</header><text>Every establishment described in
paragraph (1) that is engaged in the manufacture, propagation, compounding, or
processing of a device or devices classified in class II or III shall be so
inspected by one or more officers or employees duly designated by the
Secretary, or by persons accredited to conduct inspections under section
704(g), at least once in the 2-year period beginning with the date of
registration of such establishment pursuant to this section and at least once
in every successive 2-year period thereafter.</text>
</paragraph><paragraph commented="no" id="idE826E7A431114BBFAB16253A116E3BB8"><enum>(3)</enum><header>Risk-based
schedule for drugs</header><text>The Secretary, acting through one or more
officers or employees duly designated by the Secretary, shall inspect
establishments described in paragraph (1) that are engaged in the manufacture,
preparation, propagation, compounding, or processing of a drug or drugs
(referred to in this subsection as <quote>drug establishments</quote>) in
accordance with a risk-based schedule established by the Secretary.</text>
</paragraph><paragraph commented="no" id="idE2E543D54FD74ABD837A7874DFC1F69A"><enum>(4)</enum><header>Risk
factors</header><text>In establishing the risk-based scheduled under paragraph
(3), the Secretary shall inspect establishments according to the known safety
risks of such establishments, which shall be based on the following
factors:</text>
<subparagraph id="ID592610d836b244f795562b0f323d35cb"><enum>(A)</enum><text>The compliance
history of the establishment.</text>
</subparagraph><subparagraph id="ID6c6f470600f346c39cc4e01be3ad8942"><enum>(B)</enum><text>The record,
history, and nature of recalls linked to the establishment.</text>
</subparagraph><subparagraph id="ID41ee6daeed654fc4a1e8d2ac0234f0fc"><enum>(C)</enum><text>The inherent risk
of the drug manufactured, prepared, propagated, compounded, or processed at the
establishment.</text>
</subparagraph><subparagraph id="id0204BDC800EE4990A0A3B4D421A87F2C"><enum>(D)</enum><text>The
certifications described under sections 801(r) and 809 for the
establishment.</text>
</subparagraph><subparagraph id="id8D7BDE6B1A514D49A84737BD6682E239"><enum>(E)</enum><text>Whether the
establishment has been inspected in the preceding 4-year period.</text>
</subparagraph><subparagraph id="ID014b8b8f095d434395ace6cdb1490a76"><enum>(F)</enum><text>Any other
criteria deemed necessary and appropriate by the Secretary for purposes of
allocating inspection resources.</text>
</subparagraph></paragraph><paragraph id="idC66C27FE1FA54FE3A26C9A2975A63291"><enum>(5)</enum><header>Effect of
status</header><text>In determining the risk associated with an establishment
for purposes of establishing a risk-based schedule under paragraph (3), the
Secretary shall not consider whether the drugs manufactured, prepared,
propagated, compounded, or processed by such establishment are drugs described
in section 503(b).</text>
</paragraph><paragraph id="ID76a5c94bdf1c495caf33d500ebdfe26a"><enum>(6)</enum><header>Annual report
on inspections of establishments</header><text>Not later than February 1 of
each year, the Secretary shall submit a report to Congress regarding—</text>
<subparagraph id="IDc9c3d221d7bf4624b7952f3bd0ad223f"><enum>(A)</enum><clause commented="no" display-inline="yes-display-inline" id="id9C00BE7A538A4F7E82DC006E6A152CEA"><enum>(i)</enum><text>the number of domestic
and foreign establishments registered pursuant to this section in the previous
fiscal year; and</text>
</clause><clause id="id4B4E84E331B24D9A98727CAF8943DB7C" indent="up1"><enum>(ii)</enum><text>the number of such domestic
establishments and the number of such foreign establishments that the Secretary
inspected in the previous fiscal year;</text>
</clause></subparagraph><subparagraph commented="no" id="idF4942D369C844D34B5C037A4852D9E90"><enum>(B)</enum><text>with respect to
establishments that manufacture, prepare, propagate, compound, or process an
active ingredient of a drug, a finished drug product, or an excipient of a
drug, the number of each such type of establishment; and</text>
</subparagraph><subparagraph commented="no" id="id119E20DF2EDC465BACDAA54054AF8F94"><enum>(C)</enum><text>the percentage of
the budget of the Food and Drug Administration used to fund the inspections
described under subparagraph (A).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD99A9CB2EFD94B1BA38EEE58C1D6B879"><enum>(7)</enum><header>Public
availability of annual reports</header><text>The Secretary shall make the
report required under paragraph (6) available to the public on the Internet Web
site of the Food and Drug
Administration.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id6845CF0C38414BCFB65B562B083992FF"><enum>706.</enum><header>Records for
inspection</header><text display-inline="no-display-inline">Section 704(a) (21
U.S.C. 374(a)) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idA25698D1F7A04BE9ACBA6C3078E46EB2" style="OLC">
<paragraph commented="no" id="id51726BE5984A40A48AC4183FA8114A70" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="id95976670E028440786BF210733657F21"><enum>(A)</enum><text>Any records or other
information that the Secretary is entitled to request 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 within a reasonable time frame, within reasonable limits and in a
reasonable manner, and in electronic form, at the expense of such person. The
Secretary’s request shall include a clear description of the records
requested.</text>
</subparagraph><subparagraph commented="no" id="id201C3377BA5A447CB9491B5438B85182" indent="up1"><enum>(B)</enum><text>Upon receipt of the records requested
under subparagraph (A), the Secretary shall provide to the person confirmation
of the receipt of such records.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id69553DDAADF2429895BD3B677500FE00" 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 by an establishment with this
Act.</text>
</subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id1969B59346AD41CEB55C4C8454AB1160"><enum>707.</enum><header>Failure to
allow foreign inspection</header><text display-inline="no-display-inline">Section 801(a) (21 U.S.C. 381(a)) is amended
by adding at the end the following: <quote>Notwithstanding any other provision
of this subsection, the Secretary of Homeland Security shall, upon request from
the Secretary of Health and Human Services refuse to admit into the United
States any article if the article was manufactured, prepared, propagated,
compounded, processed, or held at an establishment that has refused to permit
the Secretary of Health and Human Services to enter or inspect the
establishment in the same manner and to the same extent as the Secretary may
inspect establishments under section 704.</quote>.</text>
</section><section commented="no" id="id4BDA3E224B87402185B5D761C34DD467"><enum>708.</enum><header>Exchange of
information</header><text display-inline="no-display-inline">Section 708 (21
U.S.C. 379) is amended—</text>
<paragraph id="IDbbdf075c81c74f269798cfa532609cd2"><enum>(1)</enum><text>by striking
<quote><header-in-text level="section" style="traditional">Confidential
information</header-in-text></quote> and all that follows through <quote>The
Secretary</quote> and inserting <header-in-text level="section" style="OLC">“Confidential information.</header-in-text></text>
<quoted-block display-inline="no-display-inline" id="id27F1C236241A4033A6DBC5628441695A" style="OLC">
<subsection id="id21091D257EA04F21B893701EC8530E33"><enum>(a)</enum><header>Contractors</header><text display-inline="yes-display-inline">The
Secretary</text>
</subsection><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="idB9193C2464D0466FADA0C7B039DC01EF"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id7A3A94AE5C5841C6A77F707A4063AD1E" style="OLC">
<subsection id="ID79a6d59141da4485ab6bafdbd91e6353"><enum>(b)</enum><header>Ability to
receive and protect confidential information</header><text>The Secretary shall
not be required to disclose under section 552 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,
except pursuant to an order of a court of the United States. For purposes of
section 552 of title 5, United States Code, this subsection shall be considered
a statute described in section 552(b)(3)(B).</text>
</subsection><subsection id="IDd5b530ceb4b84152aa0ce7982ad47f4f"><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 id="ID67c60c36a82848589ef54d6e5bb4d575"><enum>(1)</enum><header>Certification</header><text>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.</text>
</paragraph><paragraph id="ID10890179e8e747ee8176025ca4251ce3"><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 id="IDb7aee44cb87742a8a8c700f8c0aaccf4"><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 id="IDeedb27cbb3a542a4a64abf18cdc575b1"><enum>(A)</enum><text>Information
concerning the inspection of a facility may be provided if—</text>
<clause id="IDbb551facf30a4a3ea1080466b0913ba7"><enum>(i)</enum><text>the Secretary
reasonably believes, or that the written agreement described in paragraph (2)
establishes, that the government has authority to otherwise obtain such
information; and</text>
</clause><clause id="ID6076a08201b94228b5a4f284e29c6526"><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" display-inline="no-display-inline" id="ID1efe1ae0eae240699867a7e74150e4a3"><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 to humans
or animals.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id7AB95BD63E9341058F23BA77D2C8C649"><enum>(4)</enum><header>Effect of
subsection</header><text>Nothing in this subsection affects the ability of the
Secretary to enter into any written agreement authorized by other provisions of
law to share confidential
information.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="idFDB0F873DBA446B982F129C85551419E"><enum>709.</enum><header>Enhancing the
safety and quality of the drug supply</header><text display-inline="no-display-inline">Section 501 (21 U.S.C. 351) is amended by
adding at the end the following flush text:</text>
<quoted-block display-inline="no-display-inline" id="idB692EBA6B993449C92D9407E2BD026F6" style="OLC">
<quoted-block-continuation-text quoted-block-continuation-text-level="section">For purposes
of subsection (a)(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.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="IDe16dc6c0251d4dbfb305d352e9a36854"><enum>710.</enum><header>Accreditation
of third-party auditors for drug establishments</header>
<subsection id="IDfcdfaa700d9542269646726d8ac8f523"><enum>(a)</enum><header>In
General</header><text>Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idEFA132996BB2479B8656E3E2692241A4" style="OLC">
<section id="ID67346e7d223844bbbac1be430107e296"><enum>809.</enum><header>Accreditation
of third-party auditors for drug establishments</header>
<subsection id="IDbb470d8b90f1473081885ef67e0503b6"><enum>(a)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="ID8d067997bf7d464c879b1462f0c03d7a"><enum>(1)</enum><header>Accreditation
body</header><text>The term <term>accreditation body</term> means an authority
that performs accreditation of third-party auditors.</text>
</paragraph><paragraph id="IDe826003eabce45cd9f69d2eb5c15a523"><enum>(2)</enum><header>Accredited
third-party auditor</header><text>The term <term>accredited third-party
auditor</term> means a third-party auditor (which may be an individual)
accredited by an accreditation body to conduct drug safety and quality
audits.</text>
</paragraph><paragraph id="IDdb018b6e096845da872d9a972fbe9714"><enum>(3)</enum><header>Audit
agent</header><text>The term <term>audit agent</term> means an individual who
is an employee or agent of an accredited third-party auditor and, although not
individually accredited, is qualified to conduct drug safety and quality audits
on behalf of an accredited third-party auditor.</text>
</paragraph><paragraph id="idCA9B7E92070C4229A0476BC5F306D683"><enum>(4)</enum><header>Consultative
audit</header><text>The term <term>consultative audit</term> means an audit of
an eligible entity intended for internal purposes only to determine whether an
establishment is in compliance with the provisions of this Act and applicable
industry practices, or any other such service.</text>
</paragraph><paragraph id="IDcc2508c78c2a46d492635204ebdb7d56"><enum>(5)</enum><header>Drug safety and
quality audit</header><text>The term <term>drug safety and quality
audit</term>—</text>
<subparagraph id="id4EF44155297A49F5ABC03B06A8F21FD5"><enum>(A)</enum><text>means an audit of
an eligible entity to certify that the eligible entity meets the requirements
of this Act applicable to drugs, including the requirements of section 501 with
respect to drugs; and</text>
</subparagraph><subparagraph id="idCE65D4098121405DAC2EBADDC947DCD0"><enum>(B)</enum><text>is not a
consultative audit.</text>
</subparagraph></paragraph><paragraph id="IDee2a932a8ea1485c87ad0627f61e32b2"><enum>(6)</enum><header>Eligible
entity</header><text>The term <term>eligible entity</term> means an entity,
including a foreign drug establishment registered under section 510(c), in the
drug supply chain that chooses to be audited by an accredited third-party
auditor or the audit agent of such accredited third-party auditor.</text>
</paragraph><paragraph id="ID149d5d263f29469a92836f10c04af2d7"><enum>(7)</enum><header>Third-party
auditor</header><text>The term <term>third-party auditor</term> means a foreign
government, agency of a foreign government or any other third party (which may
be an individual), as the Secretary determines appropriate in accordance with
the criteria described in subsection (c)(1), that is eligible to be considered
for accreditation to conduct drug safety and quality audits.</text>
</paragraph></subsection><subsection id="ID000f34a9360f4bda8dc309f40091fef0"><enum>(b)</enum><header>Accreditation
system</header>
<paragraph id="ID83c7e30ca97d41d0871747c8912ac917"><enum>(1)</enum><header>Recognition of
accreditation bodies</header>
<subparagraph id="IDbceeb950667a41d08bed3c7b3a2534df"><enum>(A)</enum><header>In
general</header><text>Not later than 2 years after date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall establish a system for the
recognition of accreditation bodies that accredit third-party auditors to
conduct drug safety and quality audits.</text>
</subparagraph><subparagraph id="ID13b3ade667074c6f9099f1c83eb2a5b9"><enum>(B)</enum><header>Direct
accreditation</header>
<clause id="id94C8282AFC0B4F7AB8F99B7A54EB5316"><enum>(i)</enum><header>In
general</header><text>If, by the date that is 2 years after the date of
establishment of the system described in subparagraph (A), the Secretary has
not identified and recognized an accreditation body to meet the requirements of
this section, the Secretary may directly accredit third-party auditors.</text>
</clause><clause id="IDfbde40d26a274f4aa208e594b8089975"><enum>(ii)</enum><header>Certain direct
accreditations</header><text>Notwithstanding subparagraph (A) or clause (i),
the Secretary may directly accredit any foreign government or any agency of a
foreign government as a third-party auditor at any time after the date of
enactment of the <short-title>Food and Drug Administration
Safety and Innovation Act</short-title>.</text>
</clause></subparagraph></paragraph><paragraph id="IDe84d5d05edf4481cb44c02ce60fbc0a6"><enum>(2)</enum><header>Notification</header><text>Each
accreditation body recognized by the Secretary shall submit to the
Secretary—</text>
<subparagraph id="ID3178839bfe5f4e02acd90c6d0bc47392"><enum>(A)</enum><text>a list of all
accredited third-party auditors accredited by such body (including the name,
contact information, and scope and duration of accreditation for each such
auditor), and the audit agents of such auditors; and</text>
</subparagraph><subparagraph id="ID37400af82a4848de9649eab69602b373"><enum>(B)</enum><text>updated lists as
needed to ensure the list held by the Secretary is accurate.</text>
</subparagraph></paragraph><paragraph id="ID247667a7fe694cc89e2c93de93bc10c0"><enum>(3)</enum><header>Revocation of
recognition as an accreditation body</header><text>The Secretary shall promptly
revoke, after the opportunity for an informal hearing, the recognition of any
accreditation body found not to be in compliance with the requirements of this
section.</text>
</paragraph><paragraph id="ID120a9082a97f4fc8a71b512ece063dab"><enum>(4)</enum><header>Reinstatement</header><text>The
Secretary shall establish procedures to reinstate recognition of an
accreditation body if the Secretary determines, based on evidence presented by
such accreditation body, that revocation was inappropriate or that the body
meets the requirements for recognition under this section.</text>
</paragraph><paragraph id="ID6113ebef71ae4e44a3a23211aa28c372"><enum>(5)</enum><header>Model
accreditation standards</header>
<subparagraph id="ID11fed5b7dd2046f793768ef9f440c2ee"><enum>(A)</enum><header>In
general</header><text>Not later than 18 months after the date of enactment of
the <short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall develop model standards,
including standards for drug safety and quality audit results, reports, and
certifications, and each recognized accreditation body shall ensure that
third-party auditors and audit agents of such auditors meet such standards in
order to qualify such third-party auditors as accredited third-party auditors
under this section.</text>
</subparagraph><subparagraph id="id08428D4344514F3B8E6C1911952F2AFC"><enum>(B)</enum><header>Content</header><text>The
standards developed under subparagraph (A) may—</text>
<clause id="ID2cdc1ec0cb484db1a9a378e8ee0507db"><enum>(i)</enum><text>include a
description of required standards relating to the training procedures,
competency, management responsibilities, quality control, and conflict of
interest requirements of accredited third-party auditors; and</text>
</clause><clause id="IDd4891ec3380c400dae97a7416591d7ff"><enum>(ii)</enum><text>set forth
procedures for the periodic renewal of the accreditation of accredited
third-party auditors.</text>
</clause></subparagraph><subparagraph id="IDed7b8fe4ced44560aa8fef1148bc763d"><enum>(C)</enum><header>Requirement to
provide results and reports to the Secretary</header><text>An accreditation
body (or, in the case of direct accreditation under subsection (b)(1)(B), the
Secretary) may not accredit a third-party auditor unless such third-party
auditor agrees to provide to the Secretary, upon request, the results and
reports of any drug safety and quality audit conducted pursuant to the
accreditation provided under this section.</text>
</subparagraph></paragraph><paragraph id="ID70cbe274c0654aba94159f0c4689362c"><enum>(6)</enum><header>Disclosure</header><text>The
Secretary shall maintain on the Internet Web site of the Food and Drug
Administration a list of recognized accreditation bodies and accredited
third-party auditors under this section.</text>
</paragraph></subsection><subsection id="ID0f3f97b1095a4854b2c04aa5ce032f20"><enum>(c)</enum><header>Accredited
third-party auditors</header>
<paragraph id="ID057936debabf4496beadf133b220ec9d"><enum>(1)</enum><header>Requirements
for accreditation as a third-party auditor</header>
<subparagraph id="ID2930d6f0d51846d58b49afc8e7471552"><enum>(A)</enum><header>Foreign
governments</header><text>Prior to accrediting a foreign government or an
agency of a foreign government as an accredited third-party auditor, the
accreditation body (or, in the case of direct accreditation under subsection
(b)(1)(B), the Secretary) shall perform such reviews and audits of drug safety
programs, systems, and standards of the government or agency of the government
as the Secretary deems necessary, including requirements under the standards
developed under subsection (b)(5), to determine that the foreign government or
agency of the foreign government is capable of adequately ensuring that
eligible entities or drugs certified by such government or agency meet the
requirements of this Act.</text>
</subparagraph><subparagraph id="ID8a96ae3b22504767a3e1fbf0fa9711b1"><enum>(B)</enum><header>Other third
parties</header><text>Prior to accrediting any other third party to be an
accredited third-party auditor, the accreditation body (or, in the case of
direct accreditation under subsection (b)(1)(B), the Secretary) shall perform
such reviews and audits of the training and qualifications of audit agents used
by that party and conduct such reviews of internal systems and such other
investigation of the party as the Secretary deems necessary, including
requirements under the standards developed under subsection (b)(5), to
determine that the third-party auditor is capable of adequately ensuring that
an eligible entity or drug certified by such third-party auditor meets the
requirements of this Act.</text>
</subparagraph></paragraph><paragraph id="ID4c2e491db1354e02ade1ea7bfbbe0bd5"><enum>(2)</enum><header>Use of audit
agents</header><text>An accredited third-party auditor may conduct drug safety
and quality audits and may employ or use audit agents to conduct drug safety
and quality audits, but must ensure that such audit agents comply with all
requirements the Secretary deems necessary, including requirements under
paragraph (1) and subsection (b)(5).</text>
</paragraph><paragraph id="ID9dab0779dd5d45f296a1f16475af0479"><enum>(3)</enum><header>Revocation of
accreditation</header>
<subparagraph id="ID82b36c9dd11a4638a62b61bb524f8954"><enum>(A)</enum><header>In
general</header><text>The Secretary shall promptly revoke, after the
opportunity for an informal hearing, the accreditation of an accredited
third-party auditor—</text>
<clause id="ID1fa26199fd4f41babbf168a2afdd6a40"><enum>(i)</enum><text>if, following an
evaluation, the Secretary finds that the accredited third-party auditor is not
in compliance with the requirements of this section; or</text>
</clause><clause id="IDe7c246a0a2dc473eac288e84bafafacf"><enum>(ii)</enum><text>following a
refusal to allow United States officials to conduct such audits and
investigations as may be necessary to determine compliance with the
requirements set forth in this section.</text>
</clause></subparagraph><subparagraph id="ID727c553e0ae9445f8b36bb120a81bfc6"><enum>(B)</enum><header>Additional
basis for revocation of accreditation</header><text>The Secretary may revoke
accreditation from an accredited third-party auditor in the case that such
third-party auditor is accredited by an accreditation body for which
recognition as an accreditation body under subsection (b)(3) is revoked, if the
Secretary determines that there is good cause for the revocation of
accreditation.</text>
</subparagraph></paragraph><paragraph id="ID3ecb7c07abf84a45acac5e1741e7520a"><enum>(4)</enum><header>Reaccreditation</header><text>The
Secretary shall establish procedures to reinstate the accreditation of a
third-party auditor for which accreditation has been revoked under paragraph
(3)—</text>
<subparagraph id="IDe15b99dfdaf0484f858d0fb465678418"><enum>(A)</enum><text>if the Secretary
determines, based on evidence presented, that—</text>
<clause id="ID192e60a93e2f4bda920654a86712fe2b"><enum>(i)</enum><text>the third-party
auditor satisfies the requirements of this section; and</text>
</clause><clause id="ID185c206149844085901399f487b82444"><enum>(ii)</enum><text>adequate grounds
for revocation no longer exist; and</text>
</clause></subparagraph><subparagraph id="IDc3e23be6e2e540c0ab459ae220f53028"><enum>(B)</enum><text>in the case of a
third-party auditor accredited by an accreditation body for which recognition
as an accreditation body is revoked under subsection (b)(3)—</text>
<clause id="ID8114d34cef7f425c9f00f01ce1a82b17"><enum>(i)</enum><text>if the
third-party auditor becomes accredited not later than 1 year after revocation
of accreditation under paragraph (3), through direct accreditation under
subsection (b)(1)(B), or by an accreditation body in good standing; or</text>
</clause><clause id="IDe8e2cc378d8d49c29733735a3b53903d"><enum>(ii)</enum><text>under such other
conditions as the Secretary may require.</text>
</clause></subparagraph></paragraph><paragraph id="ID88e37b5e327642db9c1889eaccb77489"><enum>(5)</enum><header>Requirement to
issue certification of eligible entities for compliance with current good
manufacturing practice</header>
<subparagraph id="ID8059865cf67f419ca7bbaaf0805561f4"><enum>(A)</enum><header>In
general</header><text>An accreditation body (or, in the case of direct
accreditation under subsection (b)(1)(B), the Secretary) may not accredit a
third-party auditor unless such third-party auditor agrees to issue a written
and, as appropriate, electronic, document or certification, as the Secretary
may require under this Act, regarding compliance with section 501. The
Secretary may consider any such document or certification to satisfy
requirements under section 801(r) and to target inspection resources under
section 510(h).</text>
</subparagraph><subparagraph id="ID68aafcd00cc44d9b9e57c77f14838776"><enum>(B)</enum><header>Requirements
for issuing certification</header>
<clause id="ID16a87cc0d28e4ff4a398a70147bf8e05"><enum>(i)</enum><header>In
general</header><text>An accredited third-party auditor shall issue a drug
certification described in subparagraph (A) only after conducting a drug safety
and quality audit and such other activities that may be necessary to establish
compliance with the provisions of section 501.</text>
</clause><clause id="ID2a3ca59ebea74fc084b24c8fc5a4b007"><enum>(ii)</enum><header>Provision of
certification</header><text>Only an accredited third-party auditor or the
Secretary may provide a drug certification described in subparagraph
(A).</text>
</clause></subparagraph><subparagraph id="IDc4f9ae18832a4965b34f3bbaf97bf971"><enum>(C)</enum><header>Records</header><text>Following
any accreditation of a third-party auditor, the Secretary may, at any time,
require the accredited third-party auditor or any audit agent of such auditor
to submit to the Secretary a drug safety and quality audit report and such
other reports or documents required as part of the drug safety and quality
audit process, for any eligible entity for which the accredited third-party
auditor or audit agent of such auditor performed a drug safety and quality
audit. The Secretary may require documentation that the eligible entity is in
compliance with any applicable registration requirements.</text>
</subparagraph><subparagraph id="IDa076bdac08224ac697e36be3896d8536"><enum>(D)</enum><header>Limitation</header><text>The
requirement under subparagraph (C) shall not include any report or other
documents resulting from a consultative audit, except that the Secretary may
access the results of a consultative audit in accordance with section
704.</text>
</subparagraph><subparagraph id="ID6955cc1642ae4fef915d77c62908701c"><enum>(E)</enum><header>Declaration of
audit type</header><text>Before an accredited third-party auditor begins any
audit or provides any consultative service to an eligible entity, both the
accredited third-party auditor and eligible entity shall establish in writing
whether the audit is intended to be a drug safety and quality audit. Any audit,
inspection, or consultative service of any type provided by an accredited
third-party auditor on behalf of an eligible entity shall be presumed to be a
drug safety and quality audit in the absence of such a written agreement. Once
a drug safety and quality audit is initiated, it shall be subject to the
requirements of this section, and no person may withhold from the Secretary any
document subject to subparagraph (C) on the grounds that the audit was a
consultative audit or otherwise not a drug safety and quality audit.</text>
</subparagraph><subparagraph id="ID63d3266dfe60442090daf5a2d692baf9"><enum>(F)</enum><header>Rule of
Construction</header><text>Nothing in this section shall be construed to limit
the authority of the Secretary under section 704.</text>
</subparagraph></paragraph><paragraph id="ID275e42a9de704ab8885e6bce870dcfa2"><enum>(6)</enum><header>Requirements
regarding serious risks to the public health</header><text>If, at any time
during a drug safety and quality audit, an accredited third-party auditor or an
audit agent of such auditor discovers a condition that could cause or
contribute to a serious risk to the public health, such auditor shall
immediately notify the Secretary of—</text>
<subparagraph id="ID52f9758f175a40498876e60a9351a040"><enum>(A)</enum><text>the identity and
location of the eligible entity subject to the drug safety and quality audit;
and</text>
</subparagraph><subparagraph id="ID17206c90cef2441a8737fc7c41e95265"><enum>(B)</enum><text>such
condition.</text>
</subparagraph></paragraph><paragraph id="ID061c69bd10f64c0a87d8ad1c948fbe24"><enum>(7)</enum><header>Limitations</header>
<subparagraph id="IDfad161dc5ced4892a0e72a314160de55"><enum>(A)</enum><header>In
general</header><text>An audit agent of an accredited third-party auditor may
not perform a drug safety and quality audit of an eligible entity if such audit
agent has performed a drug safety and quality audit or consultative audit of
such eligible entity during the previous 13-month period.</text>
</subparagraph><subparagraph id="ID2f9345b690c84ad3a3c3f072f96179bd"><enum>(B)</enum><header>Waiver</header><text>The
Secretary may waive the application of subparagraph (A) if the Secretary
determines that there is insufficient access to accredited third-party auditors
in a country or region or that the use of the same audit agent or accredited
third-party auditor is otherwise necessary.</text>
</subparagraph></paragraph><paragraph id="IDd6f0d426ca8f469aa849152ca7e79c0a"><enum>(8)</enum><header>Conflicts of
interest</header>
<subparagraph id="id49F89B3949644537A769DCB57DC4536A"><enum>(A)</enum><header>Accreditation
bodies</header><text>A recognized accreditation body shall—</text>
<clause id="id7094A5736D174AEB9F852E42D78E9E8F"><enum>(i)</enum><text>not be owned,
managed, or controlled by any person that owns or operates a third-party
auditor to be accredited by such body;</text>
</clause><clause id="idE855A25E1712428A94E214C6843742D8"><enum>(ii)</enum><text>in carrying out
accreditation of third-party auditors under this section, have procedures to
ensure against the use of any officer or employee of such body that has a
financial conflict of interest regarding a third-party auditor to be accredited
by such body; and</text>
</clause><clause id="id57DB93A3C1624634B7D660D2C51E6031"><enum>(iii)</enum><text>annually make
available to the Secretary disclosures of the extent to which such body and the
officers and employees of such body have maintained compliance with clauses (i)
and (ii) relating to financial conflicts of interest.</text>
</clause></subparagraph><subparagraph id="ID64d1a06fedfa47c9a0719f81e6e150f7"><enum>(B)</enum><header>Accredited
third-party auditors</header><text>An accredited third-party auditor
shall—</text>
<clause id="IDeec59cee230f4829a52ce2dc3c0545af"><enum>(i)</enum><text>not be owned,
managed, or controlled by any person that owns or operates an eligible entity
to be certified by such auditor;</text>
</clause><clause id="ID9dd226de76984e14b2c6fdefdc1432b3"><enum>(ii)</enum><text>in carrying out
drug safety and quality audits of eligible entities under this section, have
procedures to ensure against the use of any officer or employee of such auditor
that has a financial conflict of interest regarding an eligible entity to be
certified by such auditor; and</text>
</clause><clause id="IDcc4bda33428041d59b1c28fec8ef1f5e"><enum>(iii)</enum><text>annually make
available to the Secretary disclosures of the extent to which such auditor and
the officers and employees of such auditor have maintained compliance with
clauses (i) and (ii) relating to financial conflicts of interest.</text>
</clause></subparagraph><subparagraph id="IDe6c487f371aa4e70a1d667bd052a1975"><enum>(C)</enum><header>Audit
agents</header><text>An audit agent shall—</text>
<clause id="ID906f36d904b04a2188345e71d0a2ba81"><enum>(i)</enum><text>not own or
operate an eligible entity to be audited by such agent;</text>
</clause><clause id="ID1ea2af2230624410ae83d9e65fb9d91c"><enum>(ii)</enum><text>in carrying out
audits of eligible entities under this section, have procedures to ensure that
such agent does not have a financial conflict of interest regarding an eligible
entity to be audited by such agent; and</text>
</clause><clause id="IDc2bff19e5ccb4822899dc8d7ebdad38a"><enum>(iii)</enum><text>annually make
available to the Secretary disclosures of the extent to which such agent has
maintained compliance with clauses (i) and (ii) relating to financial conflicts
of interest.</text>
</clause></subparagraph></paragraph></subsection><subsection id="ID6902e60d669a490286629a3e0dbf585b"><enum>(d)</enum><header>False
statements</header><text>Any statement or representation made—</text>
<paragraph id="ID23b08a52e506439d950bb765194c0cea"><enum>(1)</enum><text>by an employee or
agent of an eligible entity to an accredited third-party auditor or audit
agent; or</text>
</paragraph><paragraph id="IDb28596ba80d54d2f8b2c875cdd81ec81"><enum>(2)</enum><text>by an
accreditation body, accredited third-party auditor, or audit agent of such
auditor to the Secretary, shall be subject to section 1001 of title 18, United
States Code.</text>
</paragraph></subsection><subsection id="ID81ad2713395947ec9928e9a9decee910"><enum>(e)</enum><header>Monitoring</header><text>To
ensure compliance with the requirements of this section, the Secretary—</text>
<paragraph id="ID0b0a1c31456e4504bc9872e255b0dfc6"><enum>(1)</enum><text>shall
periodically, or at least once every 4 years, reevaluate the accreditation
bodies described in subsection (b)(1);</text>
</paragraph><paragraph id="IDaf6f49ed81494bc4a29a0e048b84e608"><enum>(2)</enum><text>shall
periodically, or at least once every 4 years, evaluate the performance of each
accredited third-party auditor, through the review of regulatory audit reports
by such auditors, the compliance history as available of eligible entities
certified by such auditors, and any other measures deemed necessary by the
Secretary;</text>
</paragraph><paragraph id="IDfbebed70aecc4a8b963cde3ac217834a"><enum>(3)</enum><text>may at any time,
conduct an onsite audit of any eligible entity certified by an accredited
third-party auditor, with or without the auditor present; and</text>
</paragraph><paragraph id="ID29578104bdf842759d439e2207769e27"><enum>(4)</enum><text>shall take any
other measures deemed necessary by the Secretary.</text>
</paragraph></subsection><subsection id="ID08f577b7d0ee41c4a1289a3d27624018"><enum>(f)</enum><header>Effect of
Audit</header><text>The results of a drug safety and quality audit by an
accredited third-party auditor under this section—</text>
<paragraph id="IDaaeb83302f67419d9a5c15e6448df835"><enum>(1)</enum><text>may be used by
the eligible entity—</text>
<subparagraph id="ID3adcf940e3bd4276944fe0ab4a8e265f"><enum>(A)</enum><text>as documentation
of compliance with section 501(a)(2)(B) or section 801(r); and</text>
</subparagraph><subparagraph id="IDd27cf76fadf84f8ba443ee62aa62e1dd"><enum>(B)</enum><text>for other
purposes as determined appropriate by the Secretary; and</text>
</subparagraph></paragraph><paragraph id="ID56a51b6f31ec4f95b8760175edf60abb"><enum>(2)</enum><text>shall be used by
the Secretary in establishing the risk-based inspection schedules under section
510(h).</text>
</paragraph></subsection><subsection id="ID433500e2382e4d708300afd8152d8be0"><enum>(g)</enum><header>Costs</header>
<paragraph id="idE97B8612C74746E881D7AE0BC207F86C"><enum>(1)</enum><header>Authorized fees
of Secretary</header><text>The Secretary may assess fees on accreditation
bodies and accredited third-party auditors in such an amount necessary to
establish and administer the recognition and accreditation program under this
section. The Secretary may require accredited third-party auditors and audit
agents to reimburse the Food and Drug Administration for the work performed to
carry out this section. The Secretary shall not generate surplus revenue from
such a reimbursement mechanism. Fees authorized under this paragraph shall be
collected and available for obligation only to the extent and in the amount
provided in advance in appropriation Acts. Such fees are authorized to remain
available until expended.</text>
</paragraph><paragraph id="id3763F8B9598643518210BB6C28FF7F65"><enum>(2)</enum><header>Authorized fees
for recognized accreditation bodies</header><text>An accreditation body
recognized by the Secretary under subsection (b) may assess a reasonable fee to
accredit third-party auditors.</text>
</paragraph></subsection><subsection id="IDe04e7a87efb748eba77d14957e951b91"><enum>(h)</enum><header>Limitations</header>
<paragraph id="ID6b8dec22800e481681b971b4e1edd747"><enum>(1)</enum><header>No effect on
Section 704 inspections</header><text>The drug safety and quality audits
performed under this section shall not be considered inspections under section
704.</text>
</paragraph><paragraph id="ID07031aee73ec481f8a85f5ce9c626b68"><enum>(2)</enum><header>No effect on
inspection authority</header><text>Nothing in this section affects the
authority of the Secretary to inspect any eligible entity pursuant to this
Act.</text>
</paragraph></subsection><subsection id="id9378023F09FD4462B95B63EE8136F5EF"><enum>(i)</enum><header>Regulations</header>
<paragraph id="idBFEB694C95214132B38635C34F214B14"><enum>(1)</enum><header>In
general</header><text>Not later than 18 months after the date of enactment of
the <short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall adopt final regulations
implementing this section.</text>
</paragraph><paragraph id="id3866460178304E13ADEE1B8CC7A306DC"><enum>(2)</enum><header>Procedure</header><text>In
promulgating the regulations implementing this section, the Secretary
shall—</text>
<subparagraph id="id93e511827f9e4aecb1319057c092a931"><enum>(A)</enum><text>issue a notice of
proposed rulemaking that includes the proposed regulation;</text>
</subparagraph><subparagraph id="id5a4ad5e2254c4b53a60c98f01cd995c0"><enum>(B)</enum><text>provide a period
of not less than 60 days for comments on the proposed regulation; and</text>
</subparagraph><subparagraph id="id454a5a33afff4bb5b0e36abd73c3afe3"><enum>(C)</enum><text>publish the final
regulation not less than 30 days before the effective date of the
regulation.</text>
</subparagraph></paragraph><paragraph id="idD7F44AD739FC40B3BE2BFE4C75025E1D"><enum>(3)</enum><header>Content</header><text>Such
regulations shall include—</text>
<subparagraph id="id2fe1ccab7b2e45bcb1a69979143516b8"><enum>(A)</enum><text>requirements
that, to the extent practicable, drug safety and quality audits performed under
this section be unannounced;</text>
</subparagraph><subparagraph id="id0872a9544cc94fe39b05d0d54ab460ee"><enum>(B)</enum><text>a structure to
decrease the potential for conflicts of interest, including timing and public
disclosure, for fees paid by eligible entities to accredited third-party
auditors; and</text>
</subparagraph><subparagraph id="idcae4e53c5f62480499da76dbd8a39363"><enum>(C)</enum><text>appropriate
limits on financial affiliations between an accredited third-party auditor or
audit agents of such auditor and any person that owns or operates an eligible
entity to be audited by such auditor, as described in subparagraphs (A) and
(B).</text>
</subparagraph></paragraph><paragraph id="id73541F7E068B4C049BA0BAF78A13B4A0"><enum>(4)</enum><header>Restrictions</header><text>Notwithstanding
any other provision of law, the Secretary shall promulgate regulations
implementing this section only as described in paragraph
(2).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="IDf6f59bb9d0f14ab38d8ac8aa8e9b2d7b"><enum>(b)</enum><header>Report on
accredited third-party auditors</header><text>Not later than January 20, 2017,
the Comptroller General of the United States shall submit to Congress a report
that addresses the following, with respect to the period beginning on the date
of implementation of section 809 of the Federal Food, Drug, and Cosmetic Act
(as added by subsection (a)) and ending on the date of such report:</text>
<paragraph id="IDad99d4a09cd44673a91d17d4cd607147"><enum>(1)</enum><text>The extent to
which drug safety and quality audits completed by accredited third-party
auditors under such section 809 are being used by the Secretary of Health and
Human Services (referred to in this subsection as the <quote>Secretary</quote>)
in establishing or applying the risk-based inspection schedules under section
510(h) of such Act (as amended by section 705).</text>
</paragraph><paragraph id="IDa483cd70629d41e2ab59c6efec913d17"><enum>(2)</enum><text>The extent to
which drug safety and quality audits completed by accredited third-party
auditors or agents are assisting the Food and Drug Administration in evaluating
compliance with sections 501(a)(2)(B) of such Act (21 U.S.C. 351(a)(2)(B)) and
801(r) of such Act (as added by section 711).</text>
</paragraph><paragraph id="ID2ec7a6b81560468ab58bb56244977823"><enum>(3)</enum><text>Whether the
Secretary has been able to access drug safety and quality audit reports
completed by accredited third-party auditors under such section 809.</text>
</paragraph><paragraph id="ID1eba10d5d47c470d9b69f51119a3045c"><enum>(4)</enum><text>Whether
accredited third-party auditors accredited under such section 809 have adhered
to the conflict of interest provisions set forth in such section.</text>
</paragraph><paragraph id="IDa9422dd2c9da4798a2127525c3f3df27"><enum>(5)</enum><text>The extent to
which the Secretary has audited recognized accreditation bodies or accredited
third-party auditors to ensure compliance with the requirements of such section
809.</text>
</paragraph><paragraph id="IDb369fc16b31243e5906371d559633af5"><enum>(6)</enum><text>The number of
waivers under subsection (c)(7)(B) of such section 809 issued during the most
recent 12-month period and the official justification by the Secretary for each
determination that there was insufficient access to an accredited third-party
auditor.</text>
</paragraph><paragraph id="ID5eecba5b5439464c9edd626c683c45e7"><enum>(7)</enum><text>The number of
times a manufacturer has used the same accredited third-party auditor for 2 or
more consecutive drug safety and quality audits under such section 809.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="IDcb3c0a19cac648ce9b30bbc09ec03746"><enum>(8)</enum><text>Recommendations
to Congress regarding the accreditation program under such section 809,
including whether Congress should continue, modify, or terminate the
program.</text>
</paragraph></subsection></section><section id="idA1D22A7EC1B64FC8898B6B75C14E264A"><enum>711.</enum><header>Standards for
admission of imported drugs</header><text display-inline="no-display-inline">Section 801 (21 U.S.C. 381) is
amended—</text>
<paragraph id="IDb825945ea2dd43cda0f6fae5218efa17"><enum>(1)</enum><text>in subsection
(o), by striking <quote>drug or</quote>; and</text>
</paragraph><paragraph id="ID11701596f70a4624bb3566322d8f16bd"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE8FC6D02F5D84AE0AA3B97D5B59364AE" style="OLC">
<subsection id="ID7cbf27fae2574bc18497b9996d083a76"><enum>(r)</enum><paragraph commented="no" display-inline="yes-display-inline" id="id9EE749E1C53D4C678EB9A90BCE4EA0AD"><enum>(1)</enum><text>The Secretary may
require, as a condition of granting admission to a drug imported or offered for
import into the United States, that the importer electronically submit
information demonstrating that the drug complies with applicable requirements
of this Act.</text>
</paragraph><paragraph id="idC69F816584D047B4BEDD686C821BBB68" indent="up1"><enum>(2)</enum><text>The information described under
paragraph (1) may include—</text>
<subparagraph id="id8F22B4290CDB47468FE808C529998155"><enum>(A)</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>
</subparagraph><subparagraph id="idB7CE4E94666342F39F129E2178B96CB0"><enum>(B)</enum><text>facility information, such as proof of
registration and the unique facility identifier;</text>
</subparagraph><subparagraph id="id70837CE379F5451489CC149EDCEC78A6"><enum>(C)</enum><text>indication of compliance with current
good manufacturing practice, testing results, certifications relating to
satisfactory inspections, and compliance with the country of export
regulations; and</text>
</subparagraph><subparagraph id="id357B89D8CC7A45CDB34C71F90301B05F"><enum>(D)</enum><text>any other information deemed necessary
and appropriate by the Secretary to assess compliance of the article being
offered for import.</text>
</subparagraph></paragraph><paragraph id="idE25E46B1739B492281D7B2947D4EEC26" indent="up1"><enum>(3)</enum><text>Information requirements referred to
in paragraph (2)(C) may, at the discretion of the Secretary, be
satisfied—</text>
<subparagraph id="id278498F1039E4085809DDCA0FABFF66C"><enum>(A)</enum><text>by certifications from accredited
third parties, as described under section 809;</text>
</subparagraph><subparagraph id="id83167F75D94241829CDADE5E0011BD16"><enum>(B)</enum><text>through representation by a foreign
government, if such inspection is conducted using standards and practices as
agreed to by the Secretary; or</text>
</subparagraph><subparagraph id="id45ACF498F3A04D3B95F3E33A1058D342"><enum>(C)</enum><text>other appropriate documentation or
evidence as described by the Secretary.</text>
</subparagraph></paragraph><paragraph id="id372F15B2E715464E8CFC9AC861F78203" indent="up1"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idE1A2DFE6675B44E5A7BDA62404B56648"><enum>(A)</enum><text>Not later than 18
months after the date of enactment of the <short-title>Food and Drug Administration Safety and Innovation
Act</short-title>, the Secretary shall adopt final regulations implementing
this subsection. Such requirements shall be appropriate for the type of import,
such as whether the drug is for import into the United States for use in
preclinical research or in a clinical investigation under an investigational
new drug exemption under 505(i).</text>
</subparagraph><subparagraph id="id443037FB3B6343F1A6C1CFBDEECF178A" indent="up1"><enum>(B)</enum><text>In promulgating the regulations
implementing this subsection, the Secretary shall—</text>
<clause id="id6B9EE8B8144B43179B1054CA5C137F70"><enum>(i)</enum><text>issue a notice of proposed rulemaking
that includes the proposed regulation;</text>
</clause><clause id="id308CCFA4BEF047D48E525F8116A988A5"><enum>(ii)</enum><text>provide a period of not less than 60
days for comments on the proposed regulation; and</text>
</clause><clause id="id3069A3CCB4D54F248EA98F13452CC656"><enum>(iii)</enum><text>publish the final regulation not
less than 30 days before the effective date of the regulation.</text>
</clause></subparagraph><subparagraph id="idD86B762C49DD4F64AB48390AE59F48BF" indent="up1"><enum>(C)</enum><text>Notwithstanding any other provision
of law, the Secretary shall promulgate regulations implementing this subsection
only as described in subparagraph
(B).</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="id2D7DA711089C46E4BBF4A4BD072E0FA3"><enum>712.</enum><header>Notification</header>
<subsection id="H7D098237617F42D6AF988FDB401AD70B"><enum>(a)</enum><header>Prohibited
acts</header><text display-inline="yes-display-inline">Section 301 (21 U.S.C.
331) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HA39872E5EAB047418893B3F32BF58B0F" style="OLC">
<subsection id="H444AFF2BBD0047458056EB6BC8CD5D93"><enum>(aaa)</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 id="HD75AEC2B9CDB4C32B5561E4F4D14CF57"><enum>(b)</enum><header>Notification</header>
<paragraph id="id443E0DF494C145F5A8DC55D5239459B2"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">Subchapter E of
chapter V (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="H33ED3FD3815744ECBB2470548FDD2AFB" style="OLC">
<section id="H722B56F4840544B0BCBDAC1D0E23047B"><enum>568.</enum><header>Notification</header>
<subsection id="H2B5E8C0DA52C47938E957EA6DE632BCC"><enum>(a)</enum><header>Notification to
Secretary</header><text>With respect to a drug, the Secretary may require
notification to the Secretary by a covered person if the covered person
knows—</text>
<paragraph id="HC7BB6C5F7B3D4356B7B3836DE6D09FF0"><enum>(1)</enum><text>of a substantial
loss or theft of such drug; or</text>
</paragraph><paragraph id="HF3D540AC187E4B92B44EFD220EA7B709"><enum>(2)</enum><text>that such
drug—</text>
<subparagraph id="id632102726F884791B2D31588316A6641"><enum>(A)</enum><text>has been or is
being counterfeited; and</text>
</subparagraph><subparagraph id="id163BB1E673984E3DA784AAB360C101CA"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="id14858433CDAC4C77B1FC9BDA4FC1F867"><enum>(i)</enum><text>is the counterfeit
product in commerce in the United States; or</text>
</clause><clause id="id0CCECCB2BA4C4AEF8E100A593BC93A10" indent="up1"><enum>(ii)</enum><text>is offered for import into the
United States.</text>
</clause></subparagraph></paragraph></subsection><subsection id="HAF173351C71E4A4AA4384E3F43DA5AAC"><enum>(b)</enum><header>Manner of
notification</header><text>Notification under this section shall be made in a
reasonable time, in such reasonable manner, and by such reasonable means as the
Secretary may require by regulation or specify in guidance.</text>
</subsection><subsection id="HBCEE3B93F44649E58961F9212441737F"><enum>(c)</enum><header>Definition</header><text>In
this section, the term <term>covered person</term> means—</text>
<paragraph id="id25625F74B9944042A53D2BDF89DB4BB0"><enum>(1)</enum><text>a person who is
required to register under section 510 with respect to an establishment engaged
in the manufacture, preparation, propagation, compounding, or processing of a
drug; or</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idB32BBCAD10B547769EA046A48C7689EB"><enum>(2)</enum><text>a person engaged
in the wholesale distribution (as defined in section 503(e)(3)(B)) of a
drug.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph><paragraph id="id3C75B365F96B4B7D8709C8EE95A40642"><enum>(2)</enum><header>Applicability</header><text>Notifications
under section 568 of the Federal Food, Drug, and Cosmetic Act (as added by
paragraph (1)) apply to losses, thefts, or counterfeiting, as described in
subsection (a) of such section 568, that occur on or after the date of
enactment of this Act.</text>
</paragraph></subsection></section><section id="idB29873BB00D148C98B2DED704C6928D7"><enum>713.</enum><header>Protection
against intentional adulteration</header><text display-inline="no-display-inline">Section 303(b) (21 U.S.C. 333(b)) is amended
by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE561C5425CD6464D93ED053490B7E773" style="OLC">
<paragraph id="id29A494F28B004AD69E12FA8070F04508" indent="up1"><enum>(7)</enum><text>Notwithstanding subsection (a)(2),
any person that knowingly and intentionally adulterates a drug such that the
drug is adulterated under subsection (a)(1), (b), (c), or (d) of section 501
and has a reasonable probability of causing serious adverse health consequences
or death to humans or animals 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 id="id1F340342123043B7B584EF1728E23CDF"><enum>714.</enum><header>Enhanced
criminal penalty for counterfeiting drugs</header><text display-inline="no-display-inline">Section 303(b) (21 U.S.C. 333(b)), as
amended by section 713, is further amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id8214019E0FFB452CAD242967557217FD" style="OLC">
<paragraph id="id62AC972AC2824EDE8567B7F8AEAC7E05" indent="up1"><enum>(8)</enum><text>Notwithstanding subsection (a)(2),
any person who knowingly and intentionally violates section 301(i) shall be
imprisoned for not more than 20 years or fined not more than $4,000,000 or
both.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H9BB01346CF6B479788E476946D65B29B"><enum>715.</enum><header>Extraterritorial
jurisdiction</header><text display-inline="no-display-inline">Chapter III (21
U.S.C. 331 et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H0A9F924258E943DEA93A098799090A44" style="OLC">
<section commented="no" id="H754929EDBB8E4C8F942BB85110FB6691"><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" display-inline="no-display-inline" id="id83EB9A7397164AEE8474588B80FFE927" section-type="subsequent-section"><enum>716.</enum><header>Compliance with
international agreements</header><text display-inline="no-display-inline">The
provisions of this title (and the amendments made by this title) shall be
applied in a manner that the Secretary of Health and Human Services, in
consultation with the United States Trade Representative, considers necessary
to comply with the obligations of the United States under international
agreements.</text>
</section><enum>VIII</enum><header>Generating
Antibiotic Incentives Now </header>
<section id="HC986BF0659A14F07A290324F4BACCDB5"><enum>801.</enum><header>Extension of
exclusivity period for drugs</header>
<subsection id="HA102724C96334802A8A78053102BB108"><enum>(a)</enum><header>In
general</header><text>Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 505D the following:</text>
<quoted-block id="H284DF96D9A8848C591E5E07F8377E82D" style="OLC">
<section id="HABFAE1B4194C4518B6627042AF78AA7D"><enum>505E.</enum><header>Extension of
exclusivity period for new qualified infectious disease products</header>
<subsection id="HED04EE26C8D644DB99A825C196E6CDD0"><enum>(a)</enum><header>Extension</header><text>If
the Secretary approves an application pursuant to section 505 for a drug that
has been designated as a qualified infectious disease product under subsection
(d), the 4- and 5-year periods described in subsections (c)(3)(E)(ii) and
(j)(5)(F)(ii) of section 505, the 3-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 7-year period described in section 527, as applicable,
shall be extended by 5 years.</text>
</subsection><subsection id="H37057B05A8144ED7B32C5B4E6BFDBE50"><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="H8CE65356987F4656B7AE357425B68FA0"><enum>(c)</enum><header>Limitations</header><text>Subsection
(a) does not apply to the approval of—</text>
<paragraph commented="no" id="HAC4AF468A900415B8B8CD4F378F049A3"><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="H5D79D3C3273B4E998BAE22A26BA4A58D"><enum>(2)</enum><text>a subsequent
application filed with respect to a product approved under section 505 for a
change that results in a new indication, route of administration, dosing
schedule, dosage form, delivery system, delivery device, or strength; or</text>
</paragraph><paragraph commented="no" id="id540904D3F4E74EF5860CC781203EED0D"><enum>(3)</enum><text>an application
for a product that is not approved for the use for which it received a
designation under subsection (d).</text>
</paragraph></subsection><subsection commented="no" id="HBE3CBF2896164C38AF49C8476D5CB400"><enum>(d)</enum><header>Designation</header>
<paragraph commented="no" id="id57407AB4650042A385664080D07567B4"><enum>(1)</enum><header>In
general</header><text>The manufacturer or sponsor of a drug may request the
Secretary to designate a drug as a qualified infectious disease product at any
time before the submission of an application under section 505(b) for such
drug. The Secretary shall, not later than 60 days after the submission of such
a request, determine whether the drug is a qualified infectious disease
product.</text>
</paragraph><paragraph commented="no" id="idFC10E49BAC964CCB980904B4AA9F6AC7"><enum>(2)</enum><header>Limitation</header><text>Except
as provided in paragraph (3), a designation under this subsection shall not be
withdrawn for any reason, including modifications to the list of qualifying
pathogens under subsection (f)(2)(C).</text>
</paragraph><paragraph commented="no" id="idBDB75ABE44964A5485F14AA61CB5D0B7"><enum>(3)</enum><header>Revocation of
designation</header><text>The Secretary may revoke a designation of a drug as a
qualified infectious disease product if the Secretary finds that the request
for such designation contained an untrue statement of material fact.</text>
</paragraph></subsection><subsection id="HD1A24DDF73604F0998365FB5D4D59852"><enum>(e)</enum><header>Regulations</header>
<paragraph id="id09A9450C9FC1460081673D41E094D6DC"><enum>(1)</enum><header>In
general</header><text>Not later than 2 years after the date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall adopt final regulations
implementing this section.</text>
</paragraph><paragraph id="id06EDA4BBF75F460E945B3A53A9405348"><enum>(2)</enum><header>Procedure</header><text>In
promulgating a regulation implementing this section, the Secretary
shall—</text>
<subparagraph id="iddacc561555a2461cbd0d109ad8a2587c"><enum>(A)</enum><text>issue a notice of
proposed rulemaking that includes the proposed regulation;</text>
</subparagraph><subparagraph id="id09a9988be2d74bbdac21221fff1c4565"><enum>(B)</enum><text>provide a period
of not less than 60 days for comments on the proposed regulation; and</text>
</subparagraph><subparagraph id="id1f8f9739e75d4da19c4314223c6657e4"><enum>(C)</enum><text>publish the final
regulation not less than 30 days before the effective date of the
regulation.</text>
</subparagraph></paragraph><paragraph id="id3B8692D95296471C92772EE892E638FB"><enum>(3)</enum><header>Restrictions</header><text>Notwithstanding
any other provision of law, the Secretary shall promulgate regulations
implementing this section only as described in paragraph (2), except that the
Secretary may issue interim guidance for sponsors seeking designation under
subsection (d) prior to the promulgation of such regulations.</text>
</paragraph><paragraph id="idE70223B9EE9F4150A749F8214AC3AC93"><enum>(4)</enum><header>Designation
prior to regulations</header><text>The Secretary may designate drugs as
qualified infectious disease products under subsection (d) prior to the
promulgation of regulations under this subsection.</text>
</paragraph></subsection><subsection id="H84A1621F08E54C07AF9CAFF0D0B76763"><enum>(f)</enum><header>Qualifying
pathogen</header>
<paragraph id="id3847cd585d8c42a6ba23e61448d53031"><enum>(1)</enum><header>Definition</header><text>In
this section, the term <term>qualifying pathogen</term> means a pathogen
identified and listed by the Secretary under paragraph (2) that has the
potential to pose a serious threat to public health, such as—</text>
<subparagraph id="idccc047896dca4ba495c434bcdbe1397e"><enum>(A)</enum><text>resistant gram
positive pathogens, including methicillin-resistant Staphylococcus aureus,
vancomycin-resistant Staphylococcus aureus, and vancomycin-resistant
enterococcus;</text>
</subparagraph><subparagraph id="id164D910AF6574E6DBD01E6B3FC1133CF"><enum>(B)</enum><text>multi-drug
resistant gram negative bacteria, including Acinetobacter, Klebsiella,
Pseudomonas, and E. coli species;</text>
</subparagraph><subparagraph id="id3568E4C10E4C49159DF90162915E49C5"><enum>(C)</enum><text>multi-drug
resistant tuberculosis; and</text>
</subparagraph><subparagraph id="idac4c62a8b3054073b48bd7b5586ae126"><enum>(D)</enum><text>Clostridium
difficile.</text>
</subparagraph></paragraph><paragraph id="id0766311a84fc4f67817a8020b298d3b7"><enum>(2)</enum><header>List of
qualifying pathogens</header>
<subparagraph id="id2CA4D853332B4EFC9D7A3515DF26E270"><enum>(A)</enum><header>In
general</header><text>The Secretary shall establish and maintain a list of
qualifying pathogens, and shall make public the methodology for developing such
list.</text>
</subparagraph><subparagraph id="id789970BED3604EC6B69466A47DD1CCDB"><enum>(B)</enum><header>Considerations</header><text>In
establishing and maintaining the list of pathogens described under this section
the Secretary shall—</text>
<clause id="id070794be2e424df2883c5517b5397f13"><enum>(i)</enum><text>consider—</text>
<subclause id="id909bd2b0d9174ba0a0e2d902d4f85c3e"><enum>(I)</enum><text>the impact on the
public health due to drug-resistant organisms in humans;</text>
</subclause><subclause id="idb01d6ff7f48943159d2b8cd7ed5f75fe"><enum>(II)</enum><text>the rate of
growth of drug-resistant organisms in humans;</text>
</subclause><subclause id="id105a0bd9765f433595776eb8c9e34fc0"><enum>(III)</enum><text>the increase in
resistance rates in humans; and</text>
</subclause><subclause id="idc18cb0f7c8b744fa877405f6a57011f6"><enum>(IV)</enum><text>the morbidity
and mortality in humans; and</text>
</subclause></clause><clause id="id5a9da34c349b418abe76abe613bff599"><enum>(ii)</enum><text>consult with
experts in infectious diseases and antibiotic resistance, including the Centers
for Disease Control and Prevention, the Food and Drug Administration, medical
professionals, and the clinical research community.</text>
</clause></subparagraph><subparagraph id="id9ef5b67a22924b7f9d5a39593da6ac25"><enum>(C)</enum><header>Review</header><text>Every
5 years, or more often as needed, the Secretary shall review, provide
modifications to, and publish the list of qualifying pathogens under
subparagraph (A) and shall by regulation revise the list as necessary, in
accordance with subsection (e).</text>
</subparagraph></paragraph></subsection><subsection id="id9F4048AACE5A4A2CA41917CEF5B091DA"><enum>(g)</enum><header>Qualified
infectious disease product</header><text>The term <term>qualified infectious
disease product</term> means an antibacterial or antifungal drug for human use
intended to treat serious or life-threatening infections, including those
caused by—</text>
<paragraph id="id7917C3A0C9CD4707A540A91B4BC01CDC"><enum>(1)</enum><text>an antibacterial
or antifungal resistant pathogen, including novel or emerging infectious
pathogens; or</text>
</paragraph><paragraph id="idFDC26827C5A2417580496CFDF0EAFD76"><enum>(2)</enum><text>qualifying
pathogens listed by the Secretary under subsection
(f).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="H6786C7D1DFEF4A9EB1A3C585DD80FC73"><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 (21 U.S.C. 355(c)) on or after the date of the enactment of this
Act.</text>
</subsection></section><section id="HA97B0566708B44E4BA403E2562E038A0"><enum>802.</enum><header>Priority
review</header>
<subsection id="H1B13A240DC3A461FBD7C4636397EDDF1"><enum>(a)</enum><header>Amendment</header><text>Chapter
V (21 U.S.C. 351 et seq.) is amended by inserting after section 524 the
following:</text>
<quoted-block id="H415A857D92D1484AA98322EB2052CCBA" style="OLC">
<section id="HC1C9F3B79C44460AB6A04143DDEA57F9"><enum>524A.</enum><header>Priority
review for qualified infectious disease products</header>
<subsection id="HC7718EE06353449B8E81B55337049781"><enum></enum><text>If the
Secretary designates a drug under section 505E(d) as a qualified infectious
disease product, then the Secretary shall give priority review to any
application submitted for approval for such drug under section
505(b).</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="HFA0CF6A2DB8D441D933EACECEED54E4C"><enum>(b)</enum><header>Application</header><text>Section
524A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a),
applies only with respect to an application that is submitted under section
505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of
this Act.</text>
</subsection></section><section id="HFA79EA0D5532414A852F0A7D7B277E1B"><enum>803.</enum><header>Fast track
product</header><text display-inline="no-display-inline">Section 506(a)(1) (21
U.S.C. 356(a)(1)), as amended by section 901(b), is amended by inserting
<quote>, or if the Secretary designates the drug as a qualified infectious
disease product under section 505E(d)</quote> before the period at the end of
the first sentence.</text>
</section><section id="H8EBCA8724AF64CA0B676BA002F70E74B"><enum>804.</enum><header>GAO
study</header>
<subsection id="H161D17275D004ACBB3ABD95A17DF0EB3"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Comptroller
General of the United States shall—</text>
<paragraph id="HE96F3F6EDFE8496795141735D2EB0FA3"><enum>(1)</enum><text>conduct a
study—</text>
<subparagraph id="id6FE1168261F04DCA9022E6E0711FC3DA"><enum>(A)</enum><text>on the need for,
and public health impact of, incentives to encourage the research, development,
and marketing of qualified infectious disease biological products and
antifungal products; and</text>
</subparagraph><subparagraph id="id7E716510332C44ED93D6071D71D13C76"><enum>(B)</enum><text>consistent with
trade and confidentiality data protections, assessing, for all antibacterial
and antifungal drugs, including biological products, the average or
aggregate—</text>
<clause id="idA5975858040C4442BBD0F81EC2B5427D"><enum>(i)</enum><text>costs of all
clinical trials for each phase;</text>
</clause><clause id="id8418223FD3AB4CD683E9F7217525DB49"><enum>(ii)</enum><text>percentage of
success or failure at each phase of clinical trials; and</text>
</clause><clause id="id9BCCBCE70D3E4FB2B847D534E986D0CA"><enum>(iii)</enum><text>public versus
private funding levels of the trials for each phase; and</text>
</clause></subparagraph></paragraph><paragraph id="H2778D9C1BC294F518B92645E05E8BB22"><enum>(2)</enum><text>not later than 1
year after the date of enactment of this Act, submit a report to 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 id="idFD131C8567124E6BAFD22BA679BEE4C4"><enum>(b)</enum><header>Contents</header><text>The
part of the study described in subsection (a)(1)(A) shall include—</text>
<paragraph id="id63C962F4AC2F462DABBC6D9E186C8901"><enum>(1)</enum><text>an assessment of
any underlying regulatory issues related to qualified infectious disease
products, including qualified infectious disease biological products;</text>
</paragraph><paragraph id="id60B46C9FF3924A768CD1365269BD144D"><enum>(2)</enum><text>an assessment of
the management by the Food and Drug Administration of the review of qualified
infectious disease products, including qualified infectious disease biological
products and the regulatory certainty of related regulatory pathways for such
products;</text>
</paragraph><paragraph id="id81B65DEBA56A43D48AF31237C0010537"><enum>(3)</enum><text>a description of
any regulatory impediments to the clinical development of new qualified
infectious disease products, including qualified infectious disease biological
products, and the efforts of the Food and Drug Administration to address such
impediments; and</text>
</paragraph><paragraph id="id1AAC63529AE24984B60A912F6FD02ED0"><enum>(4)</enum><text>recommendations
with respect to—</text>
<subparagraph id="id49FA6E7AFD1D4505A8F26BC6EAFBE146"><enum>(A)</enum><text>improving the
review and predictability of regulatory pathways for such products; and</text>
</subparagraph><subparagraph id="idD2140B51B5A64808B8807701C647FC94"><enum>(B)</enum><text>overcoming any
regulatory impediments identified in paragraph (3).</text>
</subparagraph></paragraph></subsection><subsection id="H0E584B3AC17146C096EDD1F97A954BCF"><enum>(c)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="H735B1BCEC5A14F54AAED608FA62DCD60"><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 (42 U.S.C. 262).</text>
</paragraph><paragraph commented="no" id="idE01D81B326BA4D4A8DA1164D4CEF026E"><enum>(2)</enum><text>The term
<term>qualified infectious disease biological product</term> means a biological
product intended to treat a serious or life-threatening infection described in
section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added by
section 801.</text>
</paragraph><paragraph id="H596F1E4EEB504D8DB988A133E5747F12"><enum>(3)</enum><text>The term
<term>qualified infectious disease product</term> has the meaning given such
term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added
by section 801.</text>
</paragraph></subsection></section><section id="H152795DE48754C8D8AC778BCEFFF17E6"><enum>805.</enum><header>Clinical
trials</header>
<subsection id="H5EC8E1789F48498187A2364FAF51F88E"><enum>(a)</enum><header>Review and
revision of guidance documents</header>
<paragraph id="H01CF879027BC451BBAD0F079842F3A92"><enum>(1)</enum><header>In
general</header><text>The Secretary of Health and Human Services (referred to
in this section as the <quote>Secretary</quote>) shall review and, as
appropriate, revise not fewer than 3 guidance documents per year, which shall
include—</text>
<subparagraph id="H611C9E252564497E8C24D71666334764"><enum>(A)</enum><text>reviewing the
guidance documents of the Food and Drug Administration for the conduct of
clinical trials with respect to antibacterial and antifungal drugs; and</text>
</subparagraph><subparagraph id="H6FEAE7AF78E649B7A6AAE8E8BDFD3E59"><enum>(B)</enum><text>as appropriate,
revising such guidance documents to reflect developments in scientific and
medical information and technology and to ensure clarity regarding the
procedures and requirements for approval of antibacterial and antifungal drugs
under chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et
seq.).</text>
</subparagraph></paragraph><paragraph id="H558347E1B6D44E16BCD7419BC9867CDA"><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
micro-biological surrogate markers, the use of non-inferiority versus
superiority trials, trial enrollment, data requirements, and appropriate delta
values for non-inferiority trials.</text>
</paragraph><paragraph id="HECE3B52526E5486E96FA8760683AF4D7"><enum>(3)</enum><header>Rule of
construction</header><text>Except to the extent to which the Secretary makes
revisions under paragraph (1)(B), nothing in this section shall be construed to
repeal or otherwise effect the guidance documents of the Food and Drug
Administration.</text>
</paragraph></subsection><subsection id="H1CF6958BB23342B982CC6ECB34AC66F7"><enum>(b)</enum><header>Recommendations
for investigations</header>
<paragraph id="H7FFACA4710B342B6A6105D7F3DED825A"><enum>(1)</enum><header>Request</header><text>The
sponsor of a drug intended to be designated as a qualified infectious disease
product may request that the Secretary provide written recommendations for
nonclinical and clinical investigations which the Secretary believes may be
necessary to be conducted with the drug before such drug may be approved under
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use
in treating, detecting, preventing, or identifying a qualifying pathogen, as
defined in section 505E of such Act.</text>
</paragraph><paragraph id="HB9EA5750403942C4A335C632C2A9DCCA"><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 (21 U.S.C. 355) of such drug for the use described in
paragraph (1).</text>
</paragraph></subsection><subsection id="H917C78DAF1424072B1FACE9EE65825B4"><enum>(c)</enum><header>GAO
study</header><text>Not later than January 1, 2016, the Comptroller General of
the United States shall submit to Congress a report—</text>
<paragraph id="id36e33c1b7e764c8eaa262a3db090383c"><enum>(1)</enum><text>regarding the
review and revision of the clinical trial guidance documents required under
subsection (a) and the impact such review and revision has had on the review
and approval of qualified infectious disease products;</text>
</paragraph><paragraph id="ida3f255ffb86a48d69d9c10b141ac86d7"><enum>(2)</enum><text>assessing—</text>
<subparagraph id="idF7D335300A894545B6AFA4B170EAC4F7"><enum>(A)</enum><text>the effectiveness
of the results-oriented metrics managers employ to ensure that reviewers of
such products are familiar with, and consistently applying, clinical trial
guidance documents; and</text>
</subparagraph><subparagraph id="id713F3167631C455082F01451206830DC"><enum>(B)</enum><text>the
predictability of related regulatory pathways and review;</text>
</subparagraph></paragraph><paragraph id="id96ae5d9beddd4dd7bd0ec97d41f38de8"><enum>(3)</enum><text>identifying any
outstanding regulatory impediments to the clinical development of qualified
infectious disease products;</text>
</paragraph><paragraph id="id50369e7bcf7f4ed199c46c9e5cb077c9"><enum>(4)</enum><text>reporting on the
progress the Food and Drug Administration has made in addressing the
impediments identified under paragraph (3); and</text>
</paragraph><paragraph id="id4b073858a254496eaf8fded40d55ecd5"><enum>(5)</enum><text>containing
recommendations regarding how to improve the review of, and regulatory pathway
for, such products.</text>
</paragraph></subsection><subsection id="id44B02AD9EF4745A48ABBE9FBF404FCD8"><enum>(d)</enum><header>Qualified
infectious disease product</header><text>For purposes of this section, the term
<term>qualified infectious disease product</term> has the meaning given such
term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added
by section 801.</text>
</subsection></section><section id="idD340067CCDDF4AF59A9C022A8F5A5A98"><enum>806.</enum><header>Regulatory
certainty and predictability</header>
<subsection id="id4AC3FD1D844D4F16B30D52CFA4D0FBAF"><enum>(a)</enum><header>Initial
strategy and implementation plan</header><text>Not later than 1 year after the
date of enactment of this Act, the Secretary of Health and Human Services
(referred to in this section as the <quote>Secretary</quote>) shall submit to
Congress a strategy and implementation plan with respect to the requirements of
this Act. The strategy and implementation plan shall include—</text>
<paragraph id="idf4bd0999d2e94563b4288c924ecb9d78"><enum>(1)</enum><text>a description of
the regulatory challenges to clinical development, approval, and licensure of
qualified infectious disease products;</text>
</paragraph><paragraph id="id7796247116384b63ab4d4c55dcd3bb67"><enum>(2)</enum><text>the regulatory
and scientific priorities of the Secretary with respect to such challenges;
and</text>
</paragraph><paragraph id="id5ec22d0877164dd08e644b883cb955fe"><enum>(3)</enum><text>the steps the
Secretary will take to ensure regulatory certainty and predictability with
respect to qualified infectious disease products, including steps the Secretary
will take to ensure managers and reviewers are familiar with related regulatory
pathways, requirements of the Food and Drug Administration, guidance documents
related to such products, and applying such requirements consistently.</text>
</paragraph></subsection><subsection id="id1d4ff48d2c474dcab41deb4c2a20515b"><enum>(b)</enum><header>Subsequent
report</header><text>Not later than 3 years after the date of enactment of this
Act, the Secretary shall submit to Congress a report on—</text>
<paragraph id="idfbb9f36c8ec549ca8c3cde5edcbdd166"><enum>(1)</enum><text>the progress made
toward the priorities identified under subsection (a)(2);</text>
</paragraph><paragraph id="id46b9e9825beb4ba98be1f2a0f91820e9"><enum>(2)</enum><text>the number of
qualified infectious disease products that have been submitted for approval or
licensure on or after the date of enactment of this Act;</text>
</paragraph><paragraph commented="no" id="id4dcc1a7c2a0d4bacb939c343b7e303fc"><enum>(3)</enum><text>a list of
qualified infectious disease products with information on the types of
exclusivity granted for each product, consistent with the information published
under section 505(j)(7)(A)(iii) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(7)(A)(iii));</text>
</paragraph><paragraph id="idf66a1b6d16414f7f8919eac8ced794cc"><enum>(4)</enum><text>the number of
such qualified infectious disease products and that have been approved or
licensed on or after the date of enactment of this Act; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida8724dcc287c48468ef5f0100db8e1b3"><enum>(5)</enum><text>the number of
calendar days it took for the approval or licensure of the qualified infectious
disease products approved or licensed on or after the date of enactment of this
Act.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idC790550915A842B5AE99CEB818CDCFA9"><enum>(c)</enum><header>Qualified
infectious disease product</header><text>For purposes of this section, the term
<term>qualified infectious disease product</term> has the meaning given such
term in section 505E(g) of the Federal Food, Drug, and Cosmetic Act, as added
by section 801.</text>
</subsection></section><enum>IX</enum><header>Drug approval
and patient access</header>
<section id="id546198B563BF47D1803CC3D2A9B0FED3"><enum>901.</enum><header>Enhancement of
accelerated patient access to new medical treatments</header>
<subsection id="id25E9603603DE4CACAEB2E594A613BCA9"><enum>(a)</enum><header>Findings; Sense
of Congress</header>
<paragraph id="id4B9E699945E34E9CAAB0042B80E471D9"><enum>(1)</enum><header>Findings</header><text>Congress
finds as follows:</text>
<subparagraph id="ID8b06ecf8a5774ac59cfcd19f56f1a8ae"><enum>(A)</enum><text>The Food and Drug
Administration (referred to in this section as the <quote>FDA</quote>) serves a
critical role in helping to assure that new medicines are safe and effective.
Regulatory innovation is 1 element of the Nation’s strategy to address serious
and life-threatening diseases or conditions by promoting investment in and
development of innovative treatments for unmet medical needs.</text>
</subparagraph><subparagraph id="IDd843aa53e7ba4edda26a80c67ae94c45"><enum>(B)</enum><text>During the 2
decades following the establishment of the accelerated approval mechanism,
advances in medical sciences, including genomics, molecular biology, and
bioinformatics, have provided an unprecedented understanding of the underlying
biological mechanism and pathogenesis of disease. A new generation of modern,
targeted medicines is under development to treat serious and life-threatening
diseases, some applying drug development strategies based on biomarkers or
pharmacogenomics, predictive toxicology, clinical trial enrichment techniques,
and novel clinical trial designs, such as adaptive clinical trials.</text>
</subparagraph><subparagraph id="ID199d3f8ab85a43f5a45518d954b4a3f1"><enum>(C)</enum><text>As a result of
these remarkable scientific and medical advances, the FDA should be encouraged
to implement more broadly effective processes for the expedited development and
review of innovative new medicines intended to address unmet medical needs for
serious or life-threatening diseases or conditions, including those for rare
diseases or conditions, using a broad range of surrogate or clinical endpoints
and modern scientific tools earlier in the drug development cycle when
appropriate. This may result in fewer, smaller, or shorter clinical trials for
the intended patient population or targeted subpopulation without compromising
or altering the high standards of the FDA for the approval of drugs.</text>
</subparagraph><subparagraph id="ID4850b263b89f4f2f8a360b984a0b1d3e"><enum>(D)</enum><text>Patients benefit
from expedited access to safe and effective innovative therapies to treat unmet
medical needs for serious or life-threatening diseases or conditions.</text>
</subparagraph><subparagraph id="ID2947b9b1ebfa4c33afb4990a2c947a9a"><enum>(E)</enum><text>For these
reasons, the statutory authority in effect on the day before the date of
enactment of this Act governing expedited approval of drugs for serious or
life-threatening diseases or conditions should be amended in order to enhance
the authority of the FDA to consider appropriate scientific data, methods, and
tools, and to expedite development and access to novel treatments for patients
with a broad range of serious or life-threatening diseases or
conditions.</text>
</subparagraph></paragraph><paragraph id="idC9302FD150D8445E8301FDF81D9B959C"><enum>(2)</enum><header>Sense of
Congress</header><text>It is the sense of Congress that the Food and Drug
Administration should apply the accelerated approval and fast track provisions
set forth in section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356), as amended by this section, to 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 id="idC6652EFA71744A3EA9D88092F22D1C63"><enum>(b)</enum><header>Expedited
approval of drugs for serious or life-Threatening diseases or
conditions</header><text>Section 506 (21 U.S.C. 356) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idE67B2E2906EC427E95DAA35C0BDD02C2" style="OLC">
<section id="idCD9480451A254EDFB8CBE652D84620F6"><enum>506.</enum><header>Expedited
approval of drugs for serious or life-threatening diseases or
conditions</header>
<subsection id="idC237C07D608E44D78E0E43773923825E"><enum>(a)</enum><header>Designation of
drug as fast track product</header>
<paragraph id="id749DD557C2DB4B7B890103BCF8ED7B21"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall,
at the request of the sponsor of a new drug, facilitate the development and
expedite the review of such drug if it is intended, whether alone or in
combination with one or more other drugs, for the treatment of a serious or
life-threatening disease or condition, and it demonstrates the potential to
address unmet medical needs for such a disease or condition. (In this section,
such a drug is referred to as a <quote>fast track product</quote>.)</text>
</paragraph><paragraph id="IDf252eb570dd74afb9810887ccbf242e3"><enum>(2)</enum><header>Request for
designation</header><text>The sponsor of a new drug may request the Secretary
to designate the drug as a fast track product. A request for the designation
may be made concurrently with, or at any time after, submission of an
application for the investigation of the drug under section 505(i) or section
351(a)(3) of the Public Health Service Act.</text>
</paragraph><paragraph id="ID984b3cfcc9a041e0bb19415ad1bf2091"><enum>(3)</enum><header>Designation</header><text>Within
60 calendar days after the receipt of a request under paragraph (2), the
Secretary shall determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the Secretary finds that the
drug meets the criteria, the Secretary shall designate the drug as a fast track
product and shall take such actions as are appropriate to expedite the
development and review of the application for approval of such product.</text>
</paragraph></subsection><subsection id="idBC75AD2A1F9E406DA9078D543BEDF21B"><enum>(b)</enum><header>Accelerated
approval of a drug for a serious or life-Threatening disease or condition,
including a fast track product</header>
<paragraph id="idA46FCF2291414A6D85D37080D1E9A3A6"><enum>(1)</enum><header>In
general</header>
<subparagraph id="id23F084F0ABEF4403814AB093A37E4ED3"><enum>(A)</enum><header>Accelerated
approval</header><text>The Secretary may approve an application for approval of
a product for a serious or life-threatening disease or condition, including a
fast track product, under section 505(c) or section 351(a) of the Public Health
Service Act upon a determination that the product has an effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit, or on a
clinical endpoint that can be measured earlier than irreversible morbidity or
mortality, that is reasonably likely to predict an effect on irreversible
morbidity or mortality or other clinical benefit, taking into account the
severity, rarity, or prevalence of the condition and the availability or lack
of alternative treatments. The approval described in the preceding sentence is
referred to in this section as <quote>accelerated approval</quote>.</text>
</subparagraph><subparagraph id="idA8B820E670D841389899F9A56E6672A9"><enum>(B)</enum><header>Evidence</header><text>The
evidence to support that an endpoint is reasonably likely to predict clinical
benefit under subparagraph (A) may include epidemiological, pathophysiological,
therapeutic, pharmacologic, or other evidence developed using biomarkers, for
example, or other scientific methods or tools.</text>
</subparagraph></paragraph><paragraph id="idDE597B668F7446A2B14A24F826F39438"><enum>(2)</enum><header>Limitation</header><text>Approval
of a product under this subsection may be subject to 1 or both of the following
requirements:</text>
<subparagraph id="IDd8850ce52e634ad0af4a57d4d19d3fa5"><enum>(A)</enum><text>That the sponsor
conduct appropriate post-approval studies to verify and describe the predicted
effect on irreversible morbidity or mortality or other clinical benefit.</text>
</subparagraph><subparagraph id="IDe45f3d51fd784e50af6d98f3c6bdd99e"><enum>(B)</enum><text>That the sponsor
submit copies of all promotional materials related to the product during the
preapproval review period and, following approval and for such period
thereafter as the Secretary determines to be appropriate, at least 30 days
prior to dissemination of the materials.</text>
</subparagraph></paragraph><paragraph id="id3CFC9F47B55B407A9CA5ED497B17B0DD"><enum>(3)</enum><header>Expedited
withdrawal of approval</header><text>The Secretary may withdraw approval of a
product approved under accelerated approval using expedited procedures (as
prescribed by the Secretary in regulations which shall include an opportunity
for an informal hearing) if—</text>
<subparagraph id="IDad1fc860e0e54f699ceccfa9e5ab8f8a"><enum>(A)</enum><text>the sponsor fails
to conduct any required post-approval study of the drug with due
diligence;</text>
</subparagraph><subparagraph id="ID48f0fed8277c455c9eafab4f348324df"><enum>(B)</enum><text>a study required
to verify and describe the predicted effect on irreversible morbidity or
mortality or other clinical benefit of the product fails to verify and describe
such effect or benefit;</text>
</subparagraph><subparagraph id="ID4ec84decfa244aee8acf742d852e3103"><enum>(C)</enum><text>other evidence
demonstrates that the product is not safe or effective under the conditions of
use; or</text>
</subparagraph><subparagraph id="ID9aeb9e5e7609431892feabf2d474a9b0"><enum>(D)</enum><text>the sponsor
disseminates false or misleading promotional materials with respect to the
product.</text>
</subparagraph></paragraph></subsection><subsection id="id12E4475CBBC84C95912559D39BB01D10"><enum>(c)</enum><header>Review of
incomplete applications for approval of a fast track product</header>
<paragraph id="idC6B33E0CD60B48B29D620F7D3787C578"><enum>(1)</enum><header>In
general</header><text>If the Secretary determines, after preliminary evaluation
of clinical data submitted by the sponsor, that a fast track product may be
effective, the Secretary shall evaluate for filing, and may commence review of
portions of, an application for the approval of the product before the sponsor
submits a complete application. The Secretary shall commence such review only
if the applicant—</text>
<subparagraph id="ID4b120e782844458da9476bcbf6031e7b"><enum>(A)</enum><text>provides a
schedule for submission of information necessary to make the application
complete; and</text>
</subparagraph><subparagraph id="ID55a23a2dc83648bfb56642fa64b751fa"><enum>(B)</enum><text>pays any fee that
may be required under section 736.</text>
</subparagraph></paragraph><paragraph id="id713103005A534B68885BF7F2BC66BE41"><enum>(2)</enum><header>Exception</header><text>Any
time period for review of human drug applications that has been agreed to by
the Secretary and that has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under section 736 to expedite
the drug development process and the review of human drug applications) shall
not apply to an application submitted under paragraph (1) until the date on
which the application is complete.</text>
</paragraph></subsection><subsection id="idBD5779746B61422A9C4BEE6B8F74F142"><enum>(d)</enum><header>Awareness
efforts</header><text>The Secretary shall—</text>
<paragraph id="IDa5dccd99fdd84f84a21480e7576509b5"><enum>(1)</enum><text>develop and
disseminate to physicians, patient organizations, pharmaceutical and
biotechnology companies, and other appropriate persons a description of the
provisions of this section applicable to accelerated approval and fast track
products; and</text>
</paragraph><paragraph id="IDe04a5d3e0cad4c12a48641824866f5f6"><enum>(2)</enum><text>establish a
program to encourage the development of surrogate and clinical endpoints,
including biomarkers, and other scientific methods and tools that can assist
the Secretary in determining whether the evidence submitted in an application
is reasonably likely to predict clinical benefit for serious or
life-threatening conditions for which significant unmet medical needs
exist.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idD71ECE9ABBD14F0180220B05C29400B7"><enum>(e)</enum><header>Construction</header>
<paragraph commented="no" display-inline="no-display-inline" id="id37D1BEEB1CA24DC395B7A2F58AF78CC1"><enum>(1)</enum><header>Purpose</header><text>The
amendments made by the <short-title>Food and Drug
Administration Safety and Innovation Act</short-title> to this section are
intended to encourage the Secretary to utilize innovative and flexible
approaches to the assessment of products under accelerated approval for
treatments for patients with serious or life-threatening diseases or conditions
and unmet medical needs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idA69135F40E2E45A68742132E40D9F0CD"><enum>(2)</enum><header>Construction</header><text>Nothing
in this section shall be construed to alter the standards of evidence under
subsection (c) or (d) of section 505 (including the substantial evidence
standard in section 505(d)) of this Act or under section 351(a) of the Public
Health Service Act. Such sections and standards of evidence apply to the review
and approval of products under this section, including whether a product is
safe and effective. Nothing in this section alters the ability of the Secretary
to rely on evidence that does not come from adequate and well-controlled
investigations for the purpose of determining whether an endpoint is reasonably
likely to predict clinical benefit as described in subsection
(b)(1)(B).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id25A4D91E395D4209A68BFD6190913254"><enum>(c)</enum><header>Guidance;
amended regulations</header>
<paragraph id="id2250DB4AE0AF47AEBCF8731553671A96"><enum>(1)</enum><header>Draft
guidance</header><text>Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services (referred to in this
section as the <quote>Secretary</quote>) shall issue draft guidance to
implement the amendments made by this section. In developing such guidance, the
Secretary shall specifically consider issues arising under the accelerated
approval and fast track processes under section 506 of the Federal Food, Drug,
and Cosmetic Act, as amended by subsection (b), for drugs designated for a rare
disease or condition under section 526 of such Act (21 U.S.C. 360bb) and shall
also consider any unique issues associated with very rare diseases.</text>
</paragraph><paragraph id="id9CCEAAAE524C48D196D3C169F4F54A61"><enum>(2)</enum><header>Final
guidance</header><text>Not later than 1 year after the issuance of draft
guidance under paragraph (1), and after an opportunity for public comment, the
Secretary shall issue final guidance.</text>
</paragraph><paragraph id="idFA31A8BEAD714D879F0C220F8A49D73D"><enum>(3)</enum><header>Conforming
changes</header><text>The Secretary shall issue, as necessary, conforming
amendments to the applicable regulations under title 21, Code of Federal
Regulations, governing accelerated approval.</text>
</paragraph><paragraph id="idB9E73ABCAD644931BB611AA463E1ABE6"><enum>(4)</enum><header>No effect of
inaction on requests</header><text>If the Secretary fails to issue final
guidance or amended regulations as required by this subsection, such failure
shall not preclude the review of, or action on, a request for designation or an
application for approval submitted pursuant to section 506 of the Federal Food,
Drug, and Cosmetic Act, as amended by subsection (b).</text>
</paragraph></subsection><subsection id="id39AC1403DD044667AF7C5F60166165A8"><enum>(d)</enum><header>Independent
review</header><text>The Secretary may, in conjunction with other planned
reviews, contract with an independent entity with expertise in assessing the
quality and efficiency of biopharmaceutical development and regulatory review
programs to evaluate the Food and Drug Administration’s application of the
processes described in section 506 of the Federal Food, Drug, and Cosmetic Act,
as amended by subsection (b), and the impact of such processes on the
development and timely availability of innovative treatments for patients
suffering from serious or life-threatening conditions. Any such evaluation
shall include consultation with regulated industries, patient advocacy and
disease research foundations, and relevant academic medical centers.</text>
</subsection></section><section id="idE187C1928F134846B1ABD8555A341E6A"><enum>902.</enum><header>Breakthrough
therapies</header>
<subsection id="idA4D892C3347C44219BF32B091A8B2D5D"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 506 (21
U.S.C. 356), as amended by section 901, is further amended—</text>
<paragraph id="id3393ED8FE8634D19816A634166DAC350"><enum>(1)</enum><text>by redesignating
subsections (a) through (c) as subsections (b) through (d),
respectively;</text>
</paragraph><paragraph id="id190517AA791F469DA954FD55F5C674FE"><enum>(2)</enum><text>by redesignating
subsection (d) as subsection (f);</text>
</paragraph><paragraph id="idB6B28E719AC54BF6804362BA2AC44CFA"><enum>(3)</enum><text>by inserting
before subsection (b), as so redesignated, the following:</text>
<quoted-block display-inline="no-display-inline" id="id61E905894AC5441D8C94A2A160343AEE" style="OLC">
<subsection id="idA5F5BACD6B8F4B85B19CC4FF42C05CF5"><enum>(a)</enum><header>Designation of
a drug as a breakthrough therapy</header>
<paragraph id="idD3F30C5C5E72488FB3212A88A358310C"><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 id="idD046823B9B534C82A17315CE5D645A1A"><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 id="idA06862D5BE714EA2BC74CA38C94B79D2"><enum>(3)</enum><header>Designation</header>
<subparagraph id="id74AB210DAA594D9D9A4B43DB43EDAE5B"><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 id="idEDB4A3E3FE284CDD99B59557531FD2B6"><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 id="id9624A0946B8C49BCA383E085D749F489"><enum>(i)</enum><text>holding meetings
with the sponsor and the review team throughout the development of the
drug;</text>
</clause><clause id="id55b9a49b44664b29ba694cfac0e9d270"><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 id="id559f1ae57b4b447db254fc80d56855f0"><enum>(iii)</enum><text>involving
senior managers and experienced review staff, as appropriate, in a
collaborative, cross-disciplinary review;</text>
</clause><clause id="ide27b7187dbe84fe9ac841fa2945487ce"><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="id2d874e6ea7cb4475861fb34742b8dfda"><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 id="idC9A7E05772474E91AD149BAFF7C08DD5"><enum>(4)</enum><text>in subsection
(f)(1), as so redesignated, by striking <quote>applicable to accelerated
approval</quote> and inserting <quote>applicable to breakthrough therapies,
accelerated approval, and</quote>; and</text>
</paragraph><paragraph id="id393F009AB77B4A2F9B2C099AFF9B8E09"><enum>(5)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id19E0D8139C2D4750B448346857A9BF9A" style="OLC">
<subsection id="id3FA826473ABE4247B226480C70D6C43E"><enum>(g)</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 id="id7d24ad153ed34b55bdb22259ecbfdfc4"><enum>(1)</enum><text>the number of
drugs for which a sponsor requested designation as a breakthrough
therapy;</text>
</paragraph><paragraph id="idac9b378193a743aebae5d9a47396b63c"><enum>(2)</enum><text>the number of
products designated as a breakthrough therapy; and</text>
</paragraph><paragraph id="id37799d414e694ae3ad61eb78e43aea04"><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="id9227968B6DD94F698498D246606B6574"><enum>(b)</enum><header>Guidance;
amended regulations</header>
<paragraph commented="no" id="id7ad186de8da345b1b94b4a215e2cf725"><enum>(1)</enum><header>In
general</header>
<subparagraph commented="no" id="idE525EEC00FA5487BBA662D7A32A34453"><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 (21 U.S.C. 356(a)), 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="idc8323bf1b22847298042d9c4d4c1e47f"><enum>(B)</enum><header>Amended
regulations</header>
<clause commented="no" id="id5ED27D66EB85405B9880FDF873B391B7"><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="idBEF71D6B44824E599419EAF83BE1949A"><enum>(ii)</enum><header>Procedure</header><text>In
amending regulations under clause (i), the Secretary shall—</text>
<subclause id="id52c84432c0bd42919cc3cff46d609292"><enum>(I)</enum><text>issue a notice of
proposed rulemaking that includes the proposed regulation;</text>
</subclause><subclause id="idb22dab367f0a43a3b6ba1beeca0cf62c"><enum>(II)</enum><text>provide a period
of not less than 60 days for comments on the proposed regulation; and</text>
</subclause><subclause id="id08c1b1e9b3a745ea8fa8e83ada76991e"><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="idb23060d1c8714369bba60315a6cd4f6a"><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="idcd37cf70be7e42c089f36cf150b87579"><enum>(2)</enum><header>Requirements</header><text>Guidance
issued under this section shall—</text>
<subparagraph commented="no" id="idC7E2494BD9644F14BDA38345BB973A84"><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="id06e85daf61024f1581ccff3bcf47a741"><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="idD29450F940C046AEA95F1B5DC18F5B27"><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="idA048349C3D09461A8512ABCFC2641CDD"><enum>(d)</enum><header>Conforming
amendments</header><text>Section 506B(e) (21 U.S.C. 356b) 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="HFFC74674B79C4211868620D596C306FA"><enum>903.</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 (21 U.S.C. 360bbb
et seq.), as amended by section 712, is further amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="HF56F66B17F7D43B7AA7526A5167C5F6C" style="OLC">
<section id="HF225883E2A034D8C904922928E1BF91A"><enum>569.</enum><header>Consultation
with external experts on rare diseases, targeted therapies, and genetic
targeting of treatments</header>
<subsection id="idA258BC5907BE4D439D599820E4C06B19"><enum>(a)</enum><header>In
general</header><text>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 id="idd544435ceb234dae9ab229f452ff792c"><enum>(1)</enum><header>Consultation
with stakeholders</header><text>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
(c).</text>
</paragraph><paragraph id="id975d2cbf5c7a4e399abf0df6dc0aa609"><enum>(2)</enum><header>Consultation
with external experts</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 (c), when such consultation is necessary because the
Secretary lacks specific scientific, medical, or technical expertise necessary
for the performance of its regulatory responsibilities and the necessary
expertise can be provided by the external experts.</text>
</paragraph></subsection><subsection id="id61575929DF60476E9ABD218E761BB90F"><enum>(b)</enum><header>External
experts</header><text>For purposes of subsection (a)(2), external experts are
those who possess scientific or medical training that the Secretary lacks with
respect to one or more rare diseases.</text>
</subsection><subsection id="id29DC87B354844F42B8DA2B334EC5DA9C"><enum>(c)</enum><header>Topics for
consultation</header><text>Topics for consultation pursuant to this section may
include—</text>
<paragraph id="ide21a93d26f6f4ff586ee7d125dba5e1d"><enum>(1)</enum><text>rare
diseases;</text>
</paragraph><paragraph id="idddf5d49e3b8b47b7a4bdaafe23dbfd2e"><enum>(2)</enum><text>the severity of
rare diseases;</text>
</paragraph><paragraph id="id4da1a99840034a13aca1072aa89d25a3"><enum>(3)</enum><text>the unmet medical
need associated with rare diseases;</text>
</paragraph><paragraph id="id41d71488536942a89efe624bf9f2cda6"><enum>(4)</enum><text>the willingness
and ability of individuals with a rare disease to participate in clinical
trials;</text>
</paragraph><paragraph id="idf1dbad786b1944f995ba745ead2ef004"><enum>(5)</enum><text>an assessment of
the benefits and risks of therapies to treat rare diseases;</text>
</paragraph><paragraph id="ideed60a835f95447c8ede97a5cb14de36"><enum>(6)</enum><text>the general
design of clinical trials for rare disease populations and subpopulations;
and</text>
</paragraph><paragraph id="idb92edcba6bc14fa2b2513cec541a43de"><enum>(7)</enum><text>demographics and
the clinical description of patient populations.</text>
</paragraph></subsection><subsection id="id1249E09A1CD44942A789A14AD1E2CDD5"><enum>(d)</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 section 202 of title 18, United States Code.</text>
</subsection><subsection id="id3BD3FE5B6F78429AB8CEED96A6D32B3D"><enum>(e)</enum><header>Protection of
proprietary information</header><text>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 section 552(b) 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>
</subsection><subsection id="idCA7FD6612C4C489B962D152916BC21C3"><enum>(f)</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 id="id5AA4400A918C4313A9CD1A7BFFC7308E"><enum>(g)</enum><header>No right or
obligation</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. 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. 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>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="id930D8B15A5314157B84695F141DF30D2"><enum>904.</enum><header>Accessibility
of information on prescription drug container labels by visually-impaired and
blind consumers</header>
<subsection id="id6706437709b64cf7923697604a70821f"><enum>(a)</enum><header>Establishment
of Working Group</header>
<paragraph id="id6cf18fe961e9483c839c231171f8500e"><enum>(1)</enum><header>In
general</header><text>The Architectural and Transportation Barriers Compliance
Board (referred to in this section as the <quote>Access Board</quote>) shall
convene a stakeholder working group (referred to in this section as the
<quote>working group</quote>) to develop best practices on access to
information on prescription drug container labels for individuals who are blind
or visually impaired.</text>
</paragraph><paragraph id="id4f4309dffcf143338a91bf639c607c30"><enum>(2)</enum><header>Members</header><text>The
working group shall be comprised of representatives of national organizations
representing blind and visually-impaired individuals, national organizations
representing the elderly, and industry groups representing stakeholders,
including retail, mail order, and independent community pharmacies, who would
be impacted by such best practices. Representation within the working group
shall be divided equally between consumer and industry advocates.</text>
</paragraph><paragraph id="idccfebd61e4fe43469ec5f7698bc35629"><enum>(3)</enum><header>Best
practices</header>
<subparagraph id="id9B2D1CC480BF4646B7B9461C53A9EE71"><enum>(A)</enum><header>In
general</header><text>The working group shall develop, not later than 1 year
after the date of the enactment of this Act, best practices for pharmacies to
ensure that blind and visually-impaired individuals have safe, consistent,
reliable, and independent access to the information on prescription drug
container labels.</text>
</subparagraph><subparagraph id="id44B19632FAF6495DADB68DB28930F117"><enum>(B)</enum><header>Public
availability</header><text>The best practices developed under subparagraph (A)
may be made publicly available, including through the Internet Web sites of the
working group participant organizations, and through other means, in a manner
that provides access to interested individuals, including individuals with
disabilities.</text>
</subparagraph><subparagraph id="id864C3A54F6CD4328BB028A20DE2BC4E2"><enum>(C)</enum><header>Limitations</header><text>The
best practices developed under subparagraph (A) shall not be construed as
accessibility guidelines or standards of the Access Board, and shall not confer
any rights or impose any obligations on working group participants or other
persons. Nothing in this section shall be construed to limit or condition any
right, obligation, or remedy available under the Americans with Disabilities
Act of 1990 (42 U.S.C. 12101 et seq.) or any other Federal or State law
requiring effective communication, barrier removal, or nondiscrimination on the
basis of disability.</text>
</subparagraph></paragraph><paragraph id="id6dfb0ab84bd74edba6978944fe52afb6"><enum>(4)</enum><header>Considerations</header><text>In
developing and issuing the best practices under paragraph (3)(A), the working
group shall consider—</text>
<subparagraph id="id1dd9f8a3888a421ab528aac58fdf8195"><enum>(A)</enum><text>the use
of—</text>
<clause id="id9b53215a40924e989fee6665edbbf820"><enum>(i)</enum><text>Braille;</text>
</clause><clause id="id4e7855c855f94c608d5e6d61dbfb94ce"><enum>(ii)</enum><text>auditory means,
such as—</text>
<subclause id="id488a20696645492aad26c8f8b6183aa4"><enum>(I)</enum><text><quote>talking
bottles</quote> that provide audible container label information;</text>
</subclause><subclause id="id424152039e814d87b9bdd082e89891c9"><enum>(II)</enum><text>digital voice
recorders attached to the prescription drug container; and</text>
</subclause><subclause id="id1454ca6094874e19a4ef4b2083493ebd"><enum>(III)</enum><text>radio frequency
identification tags;</text>
</subclause></clause><clause id="idbb731ddfda064aff9ab4b866897011c6"><enum>(iii)</enum><text>enhanced visual
means, such as—</text>
<subclause id="id43744ee5d4534f249b161a65b82812b9"><enum>(I)</enum><text>large font labels
or large font <quote>duplicate</quote> labels that are affixed or matched to a
prescription drug container;</text>
</subclause><subclause id="ide0577d4850c54aba99092882ac8313a8"><enum>(II)</enum><text>high-contrast
printing; and</text>
</subclause><subclause id="id454db0b00d2347a29940d19dde3426d3"><enum>(III)</enum><text>sans-serf font;
and</text>
</subclause></clause><clause id="idb39265bb11f44ea4898663643d1e7b6f"><enum>(iv)</enum><text>other relevant
alternatives as determined by the working group;</text>
</clause></subparagraph><subparagraph id="id57fbc2258797483ba350ff81a0e653ae"><enum>(B)</enum><text>whether there are
technical, financial, manpower, or other factors unique to pharmacies with 20
or fewer retail locations which may pose significant challenges to the adoption
of the best practices; and</text>
</subparagraph><subparagraph id="idf6e75660305b4b6199c866684da867af"><enum>(C)</enum><text>such other
factors as the working group determines to be appropriate.</text>
</subparagraph></paragraph><paragraph id="idadcebf97d6cf41c7a896a2b570129958"><enum>(5)</enum><header>Information
campaign</header><text>Upon completion of development of the best practices
under subsection (a)(3), the National Council on Disability, in consultation
with the working group, shall conduct an informational and educational campaign
designed to inform individuals with disabilities, pharmacists, and the public
about such best practices.</text>
</paragraph><paragraph id="id8FC2C11F5FDC40D29DE4613355B4C48C"><enum>(6)</enum><header>FACA
waiver</header><text>The Federal Advisory Committee Act (5 U.S.C. App.) shall
not apply to the working group.</text>
</paragraph></subsection><subsection id="idb8752fc5cae642dc90af3d7fc5ff6642"><enum>(b)</enum><header>GAO
Study</header>
<paragraph id="idacc80e6e7be74a538077c06ff7d5e253"><enum>(1)</enum><header>In
general</header><text>Beginning 18 months after the completion of the
development of best practices under subsection (a)(3)(A), the Comptroller
General of the United States shall conduct a review of the extent to which
pharmacies are utilizing such best practices, and the extent to which barriers
to accessible information on prescription drug container labels for blind and
visually-impaired individuals continue.</text>
</paragraph><paragraph id="id77b44d4b68fd4eda81fa58cf4f55a6ee"><enum>(2)</enum><header>Report</header><text>Not
later than September 30, 2016, the Comptroller General of the United States
shall submit to Congress a report on the review conducted under paragraph (1).
Such report shall include recommendations about how best to reduce the barriers
experienced by blind and visually-impaired individuals to independently
accessing information on prescription drug container labels.</text>
</paragraph></subsection><subsection id="id132214b24fd44ab39ebfef1c91394e50"><enum>(c)</enum><header>Definitions</header><text>In
this section—</text>
<paragraph id="ida21121be91e846e680a9e17933b0f780"><enum>(1)</enum><text>the term
<term>pharmacy</term> includes a pharmacy that receives prescriptions and
dispenses prescription drugs through an Internet Web site or by mail;</text>
</paragraph><paragraph id="id3cccb3fc24274d098b71b1fda112fd30"><enum>(2)</enum><text>the term
<term>prescription drug</term> means a drug subject to section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)); and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id973392F295354F8EB4524F1F09AC46B5"><enum>(3)</enum><text>the term
<term>prescription drug container label</term> means the label with the
directions for use that is affixed to the prescription drug container by the
pharmacist and dispensed to the consumer.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id22CD509C09804E3DAC6BCAC4500752D1"><enum>905.</enum><header>Risk-benefit
framework</header><text display-inline="no-display-inline">Section 505(d) (21
U.S.C. 355(d)) is amended by adding at the end the following: <quote>The
Secretary shall implement a structured risk-benefit assessment framework in the
new drug approval process to facilitate the balanced consideration of benefits
and risks, a consistent and systematic approach to the discussion and
regulatory decisionmaking, and the communication of the benefits and risks of
new drugs. Nothing in the preceding sentence shall alter the criteria for
evaluating an application for premarket approval of a drug.</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="id6E282F929C2A4B65AA5227787D5E978E"><enum>906.</enum><header>Independent
study on medical innovation inducement model</header>
<subsection commented="no" display-inline="no-display-inline" id="id2880AA89F757496EAF00895FB45A64FC"><enum>(a)</enum><header>In
general</header><text>The Secretary of Health and Human Services shall enter
into an agreement with the National Academies to provide expert consultation
and conduct a study that evaluates the feasibility and possible consequences of
the use of innovation inducement prizes to reward successful medical
innovations. Under the agreement, the National Academies shall submit to the
Secretary a report on such study not later than 15 months after the date of
enactment of this Act.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idB857ED182E4945D28AEC6723C72453BB"><enum>(b)</enum><header>Requirements</header>
<paragraph commented="no" display-inline="no-display-inline" id="id51450944A35B4DA5AF5AD24E25E61EC3"><enum>(1)</enum><header>In
general</header><text>The study conducted under subsection (a) shall model at
least 3 separate segments on the medical technologies market as candidate
targets for the new incentive system and consider different medical innovation
inducement prize design issues, including the challenges presented in the
implementation of prizes for end products, open source dividend prizes, and
prizes for upstream research.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idC2E03C58E02E442A9FF5AE75A8DBBAAE"><enum>(2)</enum><header>Market
segments</header><text>The segments on the medical technologies market that
shall be considered under paragraph (1) include—</text>
<subparagraph id="id449287a6e30444c5ae09b291d2ab77f3"><enum>(A)</enum><text>all
pharmaceutical and biologic drugs and vaccines;</text>
</subparagraph><subparagraph id="idb81a72db7c344d0bbef6f7c1c4e47ab9"><enum>(B)</enum><text>drugs and
vaccines used solely for the treatment of HIV/AIDS; and</text>
</subparagraph><subparagraph id="ida391b63a3cc049ef9e841bd1327e4412"><enum>(C)</enum><text>antibiotics.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idFE854B6C8B204DAF83B9FA469A4625FD"><enum>(c)</enum><header>Elements</header><text>The
study conducted under subsection (a) shall include consideration of each of the
following:</text>
<paragraph id="id8cff4bdc2a594031bec24d5c557ec9cd"><enum>(1)</enum><text>Whether a system
of large innovation inducement prizes could work as a replacement for the
existing product monopoly/patent-based system, as in effect on the date of
enactment of this Act.</text>
</paragraph><paragraph id="id5cf2f586f72d479798435871479f27d2"><enum>(2)</enum><text>How large the
innovation prize funds would have to be in order to induce at least as much
research and development investment in innovation as is induced under the
current system of time-limited market exclusivity, as in effect on the date of
enactment of this Act.</text>
</paragraph><paragraph id="id18f7edba8dd74e738335e72e72fdeaea"><enum>(3)</enum><text>Whether a system
of large innovation inducement prizes would be more or less expensive than the
current system of time-limited market exclusivity, as in effect on the date of
enactment of this Act, calculated over different time periods.</text>
</paragraph><paragraph id="id2d83d2895b234d7593e4c7acc316058c"><enum>(4)</enum><text>Whether a system
of large innovation inducement prizes would expand access to new products and
improve health outcomes.</text>
</paragraph><paragraph id="ide4a54002e0714abb8d191397ccb48723"><enum>(5)</enum><text>The type of
information and decisionmaking skills that would be necessary to manage end
product prizes.</text>
</paragraph><paragraph id="id05bd4f6b23124d9c9877507d027de939"><enum>(6)</enum><text>Whether there
would there be major advantages in rewarding the incremental impact of
innovations, as benchmarked against existing products.</text>
</paragraph><paragraph id="id789f1c4279f64420a9dfe0c4eb11acc7"><enum>(7)</enum><text>How open-source
dividend prizes could be managed, and whether such prizes would increase access
to knowledge, materials, data and technologies.</text>
</paragraph><paragraph id="id6e6f8c8a3b554204b90078bfc80f91a7"><enum>(8)</enum><text>Whether a system
of competitive intermediaries for interim research prizes would provide an
acceptable solution to the valuation challenges for interim prizes.</text>
</paragraph></subsection></section><enum>X</enum><header>Drug
shortages</header>
<section id="id6530F8CD0BF4473D940B20FAA3BC159A"><enum>1001.</enum><header>Drug
shortages</header>
<subsection id="id08FDBE9B4F034EE5B18F88D33ADC6E65"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 506C (21
U.S.C. 356c) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id612A494ED87C4456BF6F202ABB71C65B" style="OLC">
<section id="idF3FCB5016B3F489298E2FB222F01C1B2"><enum>506C.</enum><header>Discontinuance
or interruption in the production of life-saving drugs</header>
<subsection id="idbdf59971d70547369b4fdef70f20cabf"><enum>(a)</enum><header>In
general</header><text>A manufacturer of a drug—</text>
<paragraph id="idf37b6ed1d20c420e955549debe2974a6"><enum>(1)</enum><text>that is—</text>
<subparagraph id="id98c014cfacf147bf8080588e30257d6c"><enum>(A)</enum><text>life-supporting;</text>
</subparagraph><subparagraph id="id4bdbce1c654c46409e3a2539f1f3c599"><enum>(B)</enum><text>life-sustaining;</text>
</subparagraph><subparagraph id="ida1a9367155084b1c9e9943fddbce8469"><enum>(C)</enum><text>intended for use
in the prevention of a debilitating disease or condition;</text>
</subparagraph><subparagraph id="id277A66CA39ED446AB7CA2A99B12D24B2"><enum>(D)</enum><text>a sterile
injectable product; or</text>
</subparagraph><subparagraph id="idD05E9267BCCD4A559A4D293233C0D6D2"><enum>(E)</enum><text>used in emergency
medical care or during surgery; and</text>
</subparagraph></paragraph><paragraph id="id789ad14ca32143e8ac0ed91bcef21ad1"><enum>(2)</enum><text>that is not a
radio pharmaceutical drug product, a human tissue replaced by a recombinant
product, a product derived from human plasma protein, or any other product as
designated by the Secretary,</text>
</paragraph><continuation-text continuation-text-level="subsection">shall
notify the Secretary, in accordance with subsection (b), of a permanent
discontinuance in the manufacture of the drug or an interruption of the
manufacture of the drug that could lead to a meaningful disruption in the
supply of that drug in the United States.</continuation-text></subsection><subsection id="id3B2885CA969C474E8970F7616E999B0A"><enum>(b)</enum><header>Timing</header><text>A
notice required under subsection (a) shall be submitted to the
Secretary—</text>
<paragraph id="id9A60E741FED74F798B4B48BC847329D4"><enum>(1)</enum><text>at least 6 months
prior to the date of the discontinuance or interruption; or</text>
</paragraph><paragraph id="id3745ED4E0896480AB2A3B8182338725E"><enum>(2)</enum><text>if compliance
with paragraph (1) is not possible, as soon as practicable.</text>
</paragraph></subsection><subsection id="id63d17fcbcca741618bbbf8c91a8df22c"><enum>(c)</enum><header>Expedited
inspections and reviews</header><text>If, based on notifications described in
subsection (a) or any other relevant information, the Secretary concludes that
there is, or is likely to be, a drug shortage of a drug described in subsection
(a), the Secretary may—</text>
<paragraph id="id311993f6f0c840deafeca578cc0034ba"><enum>(1)</enum><text>expedite the
review of a supplement to a new drug application submitted under section
505(b), an abbreviated new drug application submitted under section 505(j), or
a supplement to such an application submitted under section 505(j) that could
help mitigate or prevent such shortage; or</text>
</paragraph><paragraph id="idd4f0b484423b4ef09e83cbc72b93ad90"><enum>(2)</enum><text>expedite an
inspection or reinspection of an establishment that could help mitigate or
prevent such drug shortage.</text>
</paragraph></subsection><subsection id="idfa8b1a9a2e384afa9886d2aa8e7a6fa8"><enum>(d)</enum><header>Coordination</header>
<paragraph id="id6e0732e876674b34a5213445cc8d8369"><enum>(1)</enum><header>Task force and
strategic plan</header>
<subparagraph id="idAAE3C651A4FA4890BC062B88CF0844BF"><enum>(A)</enum><header>In
general</header>
<clause id="id958A14BA1EA94681B6468A9D2E04BDAB"><enum>(i)</enum><header>Task
Force</header><text>As soon as practicable after the date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall establish a Task Force to
develop and implement a strategic plan for enhancing the Secretary’s response
to preventing and mitigating drug shortages.</text>
</clause><clause id="id4A7197A262DE4B2CA637E1E4BFC50E1B"><enum>(ii)</enum><header>Strategic
plan</header><text>The strategic plan described in clause (i) shall
include—</text>
<subclause id="idd7a985b534714e3d9551a524cd26cc9f"><enum>(I)</enum><text>plans for
enhanced interagency and intraagency coordination, communication, and
decisionmaking;</text>
</subclause><subclause id="idd6e8f615a56d4a2f92d5bc54ff5bc923"><enum>(II)</enum><text>plans for
ensuring that drug shortages are considered when the Secretary initiates a
regulatory action that could precipitate a drug shortage or exacerbate an
existing drug shortage;</text>
</subclause><subclause id="id9a03e77138fe48338cb62bed6d4197f5"><enum>(III)</enum><text>plans for
effective communication with outside stakeholders, including who the Secretary
should alert about potential or actual drug shortages, how the communication
should occur, and what types of information should be shared; and</text>
</subclause><subclause id="id9C34ACA8840740089A9E43CC0AF1635E"><enum>(IV)</enum><text>plans for
considering the impact of drug shortages on research and clinical
trials.</text>
</subclause></clause><clause id="idD0686225917B4C8DA8027FE049721A1D"><enum>(iii)</enum><header>Consultation</header><text>In
carrying out this subparagraph, the Task Force shall ensure consultation with
the appropriate offices within the Food and Drug Administration, including the
Office of the Commissioner, the Center for Drug Evaluation and Research, the
Office of Regulatory Affairs, and employees within the Department of Health and
Human Services with expertise regarding drug shortages. The Secretary shall
engage external stakeholders and experts as appropriate.</text>
</clause></subparagraph><subparagraph id="id7A740275EB5340589FB372C385346897"><enum>(B)</enum><header>Timing</header><text>Not
later than 1 year after the date of enactment <short-title>Food and Drug Administration Safety and Innovation
Act</short-title>, the Task Force shall—</text>
<clause id="id5771DB7A69CE4E2DB20339F1AADAC8A7"><enum>(i)</enum><text>publish the
strategic plan described in subparagraph (A); and</text>
</clause><clause id="id3F207C921F3F42ECBB3450EFDDF38B41"><enum>(ii)</enum><text>submit such plan
to Congress.</text>
</clause></subparagraph></paragraph><paragraph id="idc0a024e3a2b84c6080d0fdbb79ffc401"><enum>(2)</enum><header>Communication</header><text>The
Secretary shall ensure that, prior to any enforcement action or issuance of a
warning letter that the Secretary determines could reasonably be anticipated to
lead to a meaningful disruption in the supply in the United States of a drug
described under subsection (a), there is communication with the appropriate
office of the Food and Drug Administration with expertise regarding drug
shortages regarding whether the action or letter could cause, or exacerbate, a
shortage of the drug.</text>
</paragraph><paragraph id="id81ed5840a8d64d01b3dc11535abbfc0c"><enum>(3)</enum><header>Action</header><text>If
the Secretary determines, after the communication described in paragraph (2),
that an enforcement action or a warning letter could reasonably cause or
exacerbate a shortage of a drug described under subsection (a), then the
Secretary shall evaluate the risks associated with the impact of such shortage
upon patients and those risks associated with the violation involved before
taking such action or issuing such letter, unless there is imminent risk of
serious adverse health consequences or death to humans.</text>
</paragraph><paragraph id="id8B76A22DA1284EF4A314662DA562A331"><enum>(4)</enum><header>Reporting by
other entities</header><text>The Secretary shall identify or establish a
mechanism by which healthcare providers and other third-party organizations may
report to the Secretary evidence of a drug shortage.</text>
</paragraph><paragraph id="id8904eb7140ab4bec963ec046c63d41e9"><enum>(5)</enum><header>Review and
construction</header><text>No determination, finding, action, or omission of
the Secretary under this subsection shall—</text>
<subparagraph id="id66c2ae3a776041fdb139de443c805043"><enum>(A)</enum><text>be subject to
judicial review; or</text>
</subparagraph><subparagraph id="id64d0e1fad0d54013a22dc433947ff654"><enum>(B)</enum><text>be construed to
establish a defense to an enforcement action by the Secretary.</text>
</subparagraph></paragraph></subsection><subsection id="id34449166d5414e3a8b9194a7446c842e"><enum>(e)</enum><header>Recordkeeping
and reporting</header>
<paragraph id="id62EF006B76984183BA4FE4BDA7CF66A5"><enum>(1)</enum><header>Recordkeeping</header><text>The
Secretary shall maintain records related to drug shortages, including with
respect to each of the following:</text>
<subparagraph id="id7b07f87326d6429c9f8f3de858c6cf46"><enum>(A)</enum><text>The number of
manufacturers that submitted a notification to the Secretary under subsection
(a) in each calendar year.</text>
</subparagraph><subparagraph id="id805933a023334236a7aafd9c409cf5c0"><enum>(B)</enum><text>The number of
drug shortages that occurred in each calendar year and a list of drug names,
drug types, and classes that were the subject of such shortages.</text>
</subparagraph><subparagraph id="idea25a6e31fce43f7bc64fdf6c02c3539"><enum>(C)</enum><text>A list of the
known factors contributing to the drug shortages described in subparagraph
(B).</text>
</subparagraph><subparagraph id="idff0cac9017144712a1dd52d5e576d26e"><enum>(D)</enum><clause commented="no" display-inline="yes-display-inline" id="id7112A8BCA29A4169B62C9916CB72908D"><enum>(i)</enum><text>A list of major actions
taken by the Secretary to prevent or mitigate the drug shortages described in
subparagraph (B).</text>
</clause><clause id="idD009DE7D96D842118909CB3931069509" indent="up1"><enum>(ii)</enum><text>The Secretary shall include in the
list under clause (i) the following:</text>
<subclause id="id8F4EE6685AC44A30B4316F43D9D3DAA0"><enum>(I)</enum><text>The number of applications for which the
Secretary expedited review under subsection (c)(1) in each calendar
year.</text>
</subclause><subclause id="idB15902DFB2B94A72B8221308C4269F72"><enum>(II)</enum><text>The number of establishment inspections
or reinspections that the Secretary expedited under subsection (c)(2) in each
calendar year.</text>
</subclause></clause></subparagraph><subparagraph id="id5f1cb03a54eb434e8d99fc89c9ed52b6"><enum>(E)</enum><text>The number of
notifications submitted to the Secretary under subsection (a) in each calendar
year.</text>
</subparagraph><subparagraph id="iddd0b160024d045e588d46bb409e4fd48"><enum>(F)</enum><text>The names of
manufacturers that the Secretary has learned did not comply with the
notification requirement under subsection (a) in each calendar year.</text>
</subparagraph><subparagraph id="idB461D06403CB4945AFF598B78A0C80F1"><enum>(G)</enum><text>The number of
times in each calendar year that the Secretary determined under subsection
(d)(3) that an enforcement action or a warning letter could reasonably cause or
exacerbate a shortage of a drug described under subsection (a), but did not
evaluate the risks associated with the impact of such shortage upon patients
and those risks associated with the violation involved before taking such
action or issuing such letter on the grounds that there was imminent risk of
serious adverse health consequences or death to humans, and a summary of the
determinations.</text>
</subparagraph><subparagraph id="ide6225fb9538c4f7f9dcdaf76d95431a5"><enum>(H)</enum><text>A summary of the
communications made and actions taken under subsection (d) in each calendar
year.</text>
</subparagraph><subparagraph id="idFAF1080D9A604AF2B83396AB63167029"><enum>(I)</enum><text>Any other
information the Secretary deems appropriate to better prevent and mitigate drug
shortages.</text>
</subparagraph></paragraph><paragraph id="id5384b9b9afef4c72b7a2c1f8ff932454"><enum>(2)</enum><header>Trend
analysis</header><text>The Secretary is authorized to retain a third party to
conduct a study, if the Secretary believes such a study would help clarify the
causes, trends, or solutions related to drug shortages.</text>
</paragraph><paragraph id="idbff66f44530843dbb50a4ad4f8ec299f"><enum>(3)</enum><header>Annual
summary</header><text>Not later than 18 months after the date of enactment of
the <short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, and annually thereafter, the Secretary shall
submit to the Committee on Health, Education, Labor, and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives a
report summarizing, with respect to the 1-year period preceding such report,
the information described in paragraph (1). Such report shall not include any
information that is exempt from disclosure under subsection (a) of section 552
of title 5, United States Code, by reason of subsection (b)(4) of such
section.</text>
</paragraph></subsection><subsection id="id74440a711dc64d00bf0452ee667976f8"><enum>(f)</enum><header>Definitions</header><text>For
purposes of this section—</text>
<paragraph id="id187216f24bb94d56856a77352ddbe5f1"><enum>(1)</enum><text>the term
<term>drug</term>—</text>
<subparagraph id="idDF4DD2C774B14B3B80587CB3A89F9E8A"><enum>(A)</enum><text>means a drug (as
defined in section 201(g)) that is intended for human use; and</text>
</subparagraph><subparagraph id="id05BEE130B3CD410ABF0966B07617F7AC"><enum>(B)</enum><text>does not include
biological products (as defined in section 351 of the Public Health Service
Act), unless otherwise provided by the Secretary in the regulations promulgated
under subsection (h);</text>
</subparagraph></paragraph><paragraph id="id175e2b03ac244b2db3e76e7d7fa173e6"><enum>(2)</enum><text>the term
<term>drug shortage</term> or <term>shortage</term>, with respect to a drug,
means a period of time when the demand or projected demand for the drug within
the United States exceeds the supply of the drug; and</text>
</paragraph><paragraph id="id6ba0b502de3f415fb1104b044f043c5d"><enum>(3)</enum><text>the term
<term>meaningful disruption</term>—</text>
<subparagraph id="id1CEB5F1CE68740049587B7C6ACDD95D3"><enum>(A)</enum><text>means a change in
production that is reasonably likely to lead to a reduction in the supply of a
drug by a manufacturer that is more than negligible and impacts the ability of
the manufacturer to fill orders or meet expected demand for its product;
and</text>
</subparagraph><subparagraph id="id109DD46EF1D14DF781EF8A7A13B9804D"><enum>(B)</enum><text>does not include
interruptions in manufacturing 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><subsection id="id6e5f9fbe9c404939ba89965969cac89d"><enum>(g)</enum><header>Distribution</header><text>To
the maximum extent practicable, the Secretary may distribute information on
drug shortages and on the permanent discontinuation of the drugs described in
this section to appropriate provider and patient organizations, except that any
such distribution shall not include any information that is exempt from
disclosure under section 552 of title 5, United States Code, by reason of
subsection (b)(4) of such section.</text>
</subsection><subsection id="idc92c906d13d14c7b9c751a3d335b3eec"><enum>(h)</enum><header>Regulations</header>
<paragraph id="id8160a0f9a5d9418eb725d00fc36f2d01"><enum>(1)</enum><header>In
general</header><text>Not later than 18 months after the date of enactment of
the <short-title>Food and Drug Administration Safety and
Innovation Act</short-title>, the Secretary shall adopt a final regulation
implementing this section.</text>
</paragraph><paragraph id="idA24073A7FF3340D290EB1D7CF1926B5E"><enum>(2)</enum><header>Inclusion of
biological products</header>
<subparagraph id="idF9CB04DF9047451CA0A401F4C1A58FFD"><enum>(A)</enum><header>In
general</header><text>The Secretary may by regulation apply this section to
biological products (as defined in section 351 of the Public Health Service
Act) if the Secretary determines such inclusion would benefit the public
health.</text>
</subparagraph><subparagraph id="id7FA84FFB76F0487494B267585E5D9310"><enum>(B)</enum><header>Rule for
vaccines</header><text>If the Secretary applies this section to vaccines
pursuant to subparagraph (A), the Secretary shall—</text>
<clause id="id43EF9D56750E415384E1DFBAD184B3A3"><enum>(i)</enum><text>consider whether
the notification requirement under subsection (a) may be satisfied by
submitting a notification to the Centers for Disease Control and Prevention
under the vaccine shortage notification program of such Centers; and</text>
</clause><clause id="id9DDD73A497554B808C92617580B1C086"><enum>(ii)</enum><text>explain the
determination made by the Secretary under clause (i) in the regulation.</text>
</clause></subparagraph></paragraph><paragraph id="idD3B7B6CFB16C4236B33A518E63D1B6F9"><enum>(3)</enum><header>Procedure</header><text>In
promulgating a regulation implementing this section, the Secretary
shall—</text>
<subparagraph id="id1EDEA83B955C4BDC825203158DC80F20"><enum>(A)</enum><text>issue a notice of
proposed rulemaking that includes the proposed regulation;</text>
</subparagraph><subparagraph id="idF610C319E2394414B5D0E2A17390AE26"><enum>(B)</enum><text>provide a period
of not less than 60 days for comments on the proposed regulation; and</text>
</subparagraph><subparagraph id="id652A2DF5F4FF49EDA6877112633B6A08"><enum>(C)</enum><text>publish the final
regulation not less than 30 days before the regulation’s effective date.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5eb9d43427a24c269a0be92b0e0cc769"><enum>(4)</enum><header>Restrictions</header><text>Notwithstanding
any other provision of Federal law, in implementing this section, the Secretary
shall only promulgate regulations as described in paragraph
(3).</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="ide6c5a032ec7a4ab594f8f896e1fdb42c"><enum>(b)</enum><header>Effect of
notification</header><text>The submission of a notification to the Secretary of
Health and Human Services (referred to in this section as the
<quote>Secretary</quote>) for purposes of complying with the requirement in
section 506C(a) of the Federal Food, Drug, and Cosmetic Act (as amended by
subsection (a)) shall not be construed—</text>
<paragraph id="id2eb773dbfe474115a04b61305eac1c98"><enum>(1)</enum><text>as an admission
that any product that is the subject of such notification violates any
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
or</text>
</paragraph><paragraph id="id165b9c7f997e4141baf50023427ae6a7"><enum>(2)</enum><text>as evidence of an
intention to promote or market the product for an indication or use for which
the product has not been approved by the Secretary.</text>
</paragraph></subsection><subsection id="id05B89D197F1B4CA1813E86BB6922B769"><enum>(c)</enum><header>Internal
review</header><text>Not later than 2 years after the date of enactment of this
Act, the Secretary shall—</text>
<paragraph id="id4e83b09640b6473a9b539347f3137b9c"><enum>(1)</enum><text>analyze and
review the regulations promulgated under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), the guidances or policies issued under such Act
related to drugs intended for human use, and the practices of the Food and Drug
Administration regarding enforcing such Act related to manufacturing of such
drugs, to identify any such regulations, guidances, policies, or practices that
cause, exacerbate, prevent, or mitigate drug shortages (as defined in section
506C of the Federal Food, Drug, and Cosmetic Act (as amended by subsection
(a)); and</text>
</paragraph><paragraph id="idd93ea9392a224bb9b8ff0665eb2dc3da"><enum>(2)</enum><text>determine how
regulations, guidances, policies, or practices identified under paragraph (1)
should be modified, streamlined, expanded, or discontinued in order to reduce
or prevent such drug shortages, taking into consideration the effect of any
changes on the public health.</text>
</paragraph></subsection><subsection id="idAEE883448BE04DE9ADEF6CE2BED75E41"><enum>(d)</enum><header>Study on Market
Factors Contributing to Drug Shortages and Stockpiling</header>
<paragraph id="id335e49b39fba438299450445f9db51f9"><enum>(1)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of this
Act, the Comptroller General of the United States, in consultation with the
Secretary, the Department of Health and Human Services Office of the Inspector
General, the Attorney General, and Chairman of the Federal Trade Commission,
shall publish a report reviewing any findings that drug shortages (as so
defined) have led market participants to stockpile affected drugs or sell them
at significantly increased prices, the impact of such activities on Federal
revenue, and any economic factors that have exacerbated or created a market for
such actions.</text>
</paragraph><paragraph id="idf4fc7840281c4b1480bab39e14984207"><enum>(2)</enum><header>Content</header><text>The
report under paragraph (1) shall include—</text>
<subparagraph id="id4e3390293a4443e5bd80ec2a9834ca95"><enum>(A)</enum><text>an analysis of
the incidence of any of the activities described in paragraph (1) and the
effect of such activities on the public health;</text>
</subparagraph><subparagraph id="id51b41e9897c746f09e54eb3498fc46e2"><enum>(B)</enum><text>an evaluation of
whether in such cases there is a correlation between drugs in shortage
and—</text>
<clause id="id6c1b2a7920af4e3488df1f45f74c4f15"><enum>(i)</enum><text>the
number of manufacturers producing such drugs;</text>
</clause><clause id="id729465eda424468ca9a8259cf90c19cd"><enum>(ii)</enum><text>the pricing
structure, including Federal reimbursements, for such drugs before such drugs
were in shortage, and to the extent possible, revenue received by each such
manufacturer of such drugs;</text>
</clause><clause id="id751f9c16738841d78ec4812f642941b0"><enum>(iii)</enum><text>pricing
structure and revenue, to the extent possible, for the same drugs when sold
under the conditions described in paragraph (1); and</text>
</clause><clause id="id6b172d9f208c4935ac6bb85ec0631be5"><enum>(iv)</enum><text>the impact of
contracting practices by market participants (including manufacturers,
distributors, group purchasing organizations, and providers) on competition,
access to drugs, and pricing of drugs;</text>
</clause></subparagraph><subparagraph id="id06c43fe51bbc4a52a8de1efba6cea8f6"><enum>(C)</enum><text>whether the
activities described in paragraph (1) are consistent with applicable law;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id43f26ae34e0a486c882991c137f1bec8"><enum>(D)</enum><text>recommendations
to Congress on what, if any, additional reporting or enforcement actions are
necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0F6ABA2D59E4448480AC6DB87D137980"><enum>(3)</enum><header>Trade Secret
and Confidential information</header><text>Nothing in this subsection alters or
amends section 1905 of title 18, United States Code, or section 552(b)(4) of
title 5, United States Code.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id0E7A43D41D4F4EC2BDE4C39C5B6540C8"><enum>(e)</enum><header>Guidance
regarding repackaging</header><text>Not later than 1 year after the date of
enactment of this Act, the Secretary shall issue guidance that clarifies the
policy of the Food and Drug Administration regarding hospital pharmacies
repackaging and safely transferring repackaged drugs among hospitals within a
common health system during a drug shortage, as identified by the
Secretary.</text>
</subsection></section><enum>XI</enum><header>Other
provisions</header>
<subtitle id="id87A865E471104B4B9463E01E64741046"><enum>A</enum><header>Reauthorizations</header>
<section id="idE2A2E8D7378D4053A316D472E6B8040E"><enum>1101.</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)
(21 U.S.C. 355(u)(4)) is amended by striking <quote>2012</quote> and inserting
<quote>2017</quote>.</text>
</section><section commented="no" display-inline="no-display-inline" id="id9F9C6C576B5A4318A0FCD17095AE3D63" section-type="subsequent-section"><enum>1102.</enum><header>Reauthorization of
the Critical Path Public-Private Partnerships</header><text display-inline="no-display-inline">Section 566(f) (21 U.S.C. 360bbb–5(f)) is
amended by striking <quote>2012</quote> and inserting
<quote>2017</quote>.</text>
</section></subtitle><subtitle id="idAD1D15FE471A480DA47B667625563870"><enum>B</enum><header>Medical gas
product regulation</header>
<section id="idBD64415869DA400BA07E0A32B02BF1E4"><enum>1111.</enum><header>Regulation of
medical gas products</header>
<subsection id="idE07E9776306D4483BCC3BBF275D9BEF8"><enum>(a)</enum><header>Regulation</header><text>Chapter
V (21 U.S.C. 351 et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id3BAB2B7FFB16440D91D8751950507669" style="OLC">
<subchapter id="id0ddd74da31c845759136add270aca056"><enum>G</enum><header>Medical gas
products</header>
<section id="idc60ddbf08133401cb8a3ff6e1c5b9126"><enum>575.</enum><header>Definitions</header><text display-inline="no-display-inline">In this subchapter:</text>
<paragraph id="idb4acc10f13d9428dbce9e0eaaac9132f"><enum>(1)</enum><text>The term
<term>designated medical gas product</term> means any of the following:</text>
<subparagraph id="idd63404e790d6456b9ac97197bf6b5b7a"><enum>(A)</enum><text>Oxygen, that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="ide4ddc2158fe24831b6745c92e55a9b95"><enum>(B)</enum><text>Nitrogen, that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="id41037d90678543eb851c7075d9280f13"><enum>(C)</enum><text>Nitrous oxide,
that meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="id03ca2e7566c343d7a5312a46073b9807"><enum>(D)</enum><text>Carbon dioxide,
that meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="idd78c997d9d4d465bb6b2eae07080a36e"><enum>(E)</enum><text>Helium, that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="idb04188bb63774d0ab73ba3a5a8964b02"><enum>(F)</enum><text>Carbon monoxide,
that meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="id712b675d0e7444729ff98f5942fe4684"><enum>(G)</enum><text>Medical air, that
meets the standards set forth in an official compendium.</text>
</subparagraph><subparagraph id="id4587425ef3954d02986912c52b0074f0"><enum>(H)</enum><text>Any other medical
gas product deemed appropriate by the Secretary, unless any period of
exclusivity under section 505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the
extension of any such period under section 505A, applicable to such medical gas
product has not expired.</text>
</subparagraph></paragraph><paragraph id="id807979E68F12444E9670D32780B7C044"><enum>(2)</enum><text>The term
<term>medical gas product</term> means a drug that—</text>
<subparagraph id="idd820c395c33b449ba960c3e177777d3b"><enum>(A)</enum><text>is manufactured
or stored in a liquefied, nonliquefied, or cryogenic state; and</text>
</subparagraph><subparagraph id="id86b922c0784f4ba1982eba2324462709"><enum>(B)</enum><text>is administered
as a gas.</text>
</subparagraph></paragraph></section><section id="idC7E5601A848F4BAE9DA08B628C1295BC"><enum>576.</enum><header>Regulation of
medical gas products</header>
<subsection id="idD9BD4AD5685D41D785E10690EC3755C1"><enum>(a)</enum><header>Certification
of designated medical gas products</header>
<paragraph id="idF10AAB0C43444EEE8BD5E685A7AA1647"><enum>(1)</enum><header>Submission</header>
<subparagraph id="idBCE376E3FAB94D65A90A66E5C3DE3836"><enum>(A)</enum><header>In
general</header><text>Beginning on the date of enactment of this section, any
person may file with the Secretary a request for a certification of a
designated medical gas product.</text>
</subparagraph><subparagraph id="id1F4D66AA3FBF40C7AF7439CAE3F4B680"><enum>(B)</enum><header>Content</header><text>A
request under subparagraph (A) shall contain—</text>
<clause id="idEC3E36FEFD474E6B885850F3A15BBB47"><enum>(i)</enum><text>a
description of the medical gas product;</text>
</clause><clause id="id7543394AB847415F9A7EA51C27E0984D"><enum>(ii)</enum><text>the name and
address of the sponsor;</text>
</clause><clause id="idA316B58F1B7E4D9E9CC1DC3C28398143"><enum>(iii)</enum><text>the name and
address of the facility or facilities where the gas product is or will be
manufactured; and</text>
</clause><clause id="id88CCF9ED41674ED695C6C4F637020460"><enum>(iv)</enum><text>any other
information deemed appropriate by the Secretary to determine whether the
medical gas product is a designated medical gas product.</text>
</clause></subparagraph></paragraph><paragraph id="idBAA54F098B8446EE85A560C778CF5BC0"><enum>(2)</enum><header>Grant of
certification</header><text>A certification described under paragraph (1)(A)
shall be determined to have been granted unless, not later than 60 days after
the filing of a request under paragraph (1), the Secretary finds that—</text>
<subparagraph id="id1B136508DB154EAA99B93C7A0289BB46"><enum>(A)</enum><text>the medical gas
product subject to the certification is not a designated medical gas
product;</text>
</subparagraph><subparagraph id="idA5C49F0BE9464D85A3D3284BD5C27B02"><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 gas
product is a designated medical gas product; or</text>
</subparagraph><subparagraph id="id6C0F7C423DCB4E44A9C48889E4322839"><enum>(C)</enum><text>granting the
request would be contrary to public health.</text>
</subparagraph></paragraph><paragraph id="id7E5398BAE7024AEAB4CD40858AAD1131"><enum>(3)</enum><header>Effect of
certification</header>
<subparagraph id="id317C172FF6584BEC886FDAE146C7C2BD"><enum>(A)</enum><header>In
general</header>
<clause id="id55A56E908480446CB0D136F8E9194B53"><enum>(i)</enum><header>Approved
uses</header><text>A designated medical gas product for which a certification
is granted under paragraph (2) is deemed, alone or in combination with another
designated gas product or products as medically appropriate, to have in effect
an approved application under section 505 or 512, subject to all applicable
postapproval requirements, for the following indications for use:</text>
<subclause id="id8ca882a0c1b745efa41a6d7b385ed137"><enum>(I)</enum><text>Oxygen for the
treatment or prevention of hypoxemia or hypoxia.</text>
</subclause><subclause id="id7bee2d615edb415394e26a4eb577efbe"><enum>(II)</enum><text>Nitrogen for use
in hypoxic challenge testing.</text>
</subclause><subclause id="id06beb06f9ee54d7f8beffe8ed14d93ad"><enum>(III)</enum><text>Nitrous oxide
for analgesia.</text>
</subclause><subclause id="iddb2e62a13ad54b139e55ee89daa0d576"><enum>(IV)</enum><text>Carbon dioxide
for use in extracorporeal membrane oxygenation therapy or respiratory
stimulation.</text>
</subclause><subclause id="id7870fac0f5f84aec9a012f90e6853c4a"><enum>(V)</enum><text>Helium for the
treatment of upper airway obstruction or increased airway resistance.</text>
</subclause><subclause id="id5f3b274761b34972951fdadb02764775"><enum>(VI)</enum><text>Medical air to
reduce the risk of hyperoxia.</text>
</subclause><subclause id="idcf461d74dab845d4bad17a59ff93cdf2"><enum>(VII)</enum><text>Carbon monoxide
for use in lung diffusion testing.</text>
</subclause><subclause id="idc0e75371c6164bdab7c6760db31da06b"><enum>(VIII)</enum><text>Any other
indication for use for a designated medical gas product or combination of
designated medical gas products deemed appropriate by the Secretary, unless any
period of exclusivity under clause (iii) or (iv) of section 505(c)(3)(E), under
clause (iii) or (iv) of section 505(j)(5)(F), or under section 527, or the
extension of any such period under section 505A, applicable to such indication
for use for such gas product or combination of products has not expired.</text>
</subclause></clause><clause id="id9DDA9007F5064806B21C55C9D23E6ECF"><enum>(ii)</enum><header>Labeling</header><text>The
requirements established in sections 503(b)(4) and 502(f) shall be deemed to
have been met for a designated medical gas product if the labeling on final use
containers of such gas product bears the information required by section
503(b)(4) and a warning statement concerning the use of the gas product, as
determined by the Secretary by regulation, as well as appropriate directions
and warnings concerning storage and handling.</text>
</clause></subparagraph><subparagraph id="id6C72BF55A57B4212A44C514114743CD3"><enum>(B)</enum><header>Inapplicability
of exclusivity provisions</header>
<clause id="id84B61D3E107342D787E43CC673EFA265"><enum>(i)</enum><header>Effect on
ineligibility</header><text>No designated medical gas product deemed under
paragraph (3)(A)(i) to have in effect an approved application shall be eligible
for any periods of exclusivity under sections 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 id="id1830A02155BE4F4D8EEECF123A7D28E2"><enum>(ii)</enum><header>Effect on
certification</header><text>No period of exclusivity under sections 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 shall prohibit, limit, or otherwise
affect the submission, grant, or effect of a certification under this section,
except as provided in paragraph (3)(A)(i)(VIII).</text>
</clause></subparagraph></paragraph><paragraph id="id2352177DD88C4A7CAA7A2073EBCD5655"><enum>(4)</enum><header>Withdrawal,
suspension, or revocation of approval</header>
<subparagraph id="id7812DC70C04C4EEC9903C8E363932ABA"><enum>(A)</enum><header>In
general</header><text>Nothing in this subchapter limits the authority of the
Secretary to withdraw or suspend approval of a drug, including a designated
medical gas product deemed under this section to have in effect an approved
application, under section 505 or section 512.</text>
</subparagraph><subparagraph id="id2A6B8F2D79D944F8985E7627025353A5"><enum>(B)</enum><header>Revocation</header><text>The
Secretary may revoke the grant of a certification under this section if the
Secretary determines that the request for certification contains any material
omission or falsification.</text>
</subparagraph></paragraph></subsection><subsection id="idF710C89D75434D08ACC1BDE09AEC2663"><enum>(b)</enum><header>Prescription
requirement</header>
<paragraph id="id64176DED651345818E6492AFFD5FE6FA"><enum>(1)</enum><header>In
general</header><text>A designated medical gas product shall be subject to
section 503(b)(1) unless the Secretary exercises the authority provided in
section 503(b)(3) to remove such gas product from the requirements of section
503(b)(1) 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 id="id0750B1237A5149068EDDD0B918C522A6"><enum>(2)</enum><header>Exception for
oxygen</header>
<subparagraph id="id7C2A4FFD12584AF5BB8B7AC4A7C973CD"><enum>(A)</enum><header>In
general</header><text>Notwithstanding paragraph (1), oxygen may be provided
without a prescription for the following uses:</text>
<clause id="id5311F6FE134D4EB39507ECE0F4A2537C"><enum>(i)</enum><text>The use in the
event of depressurization or other environmental oxygen deficiency.</text>
</clause><clause id="idA29D4A2A8FE040AE98A283840AA7122E"><enum>(ii)</enum><text>The use in the
event of oxygen deficiency or use in emergency resuscitation, when administered
by properly trained personnel.</text>
</clause></subparagraph><subparagraph id="id26AB5EE91577416AB3B4421348162C34"><enum>(B)</enum><header>Labeling</header><text>For
oxygen provided pursuant to subparagraph (A), the requirements established in
section 503(b)(4) shall be deemed to have been met if the labeling of the
oxygen bears a warning that the medical gas product can be used for emergency
use only and for all other medical applications a prescription is
required.</text>
</subparagraph></paragraph></subsection><subsection id="idCA1A7DB45BDD4173BFFA67291A9E5932"><enum>(c)</enum><header>Inapplicability
of drugs fees to designated medical gas products</header><text display-inline="yes-display-inline">A designated medical gas product deemed
under this section to have in effect an approved application shall not be
assessed fees under section 736(a) on the basis of such deemed
approval.</text>
</subsection></section></subchapter><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="id306876222DDD4056B59F8B3680D34563"><enum>1112.</enum><header>Regulations</header>
<subsection commented="no" id="id6373f247bf59479ba502369fcde59806"><enum>(a)</enum><header>Review of
regulations</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, after obtaining input from
medical gas product manufacturers, and any other interested members of the
public, submit a report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the House of
Representatives regarding any changes to the Federal drug regulations in title
21, Code of Federal Regulations that the Secretary determines to be
necessary.</text>
</subsection><subsection commented="no" id="id60192cfa61394b39abbdf6acce638288"><enum>(b)</enum><header>Amended
regulations</header><text>If the Secretary determines that changes to the
Federal drug regulations in title 21, Code of Federal Regulations are necessary
under subsection (a), the Secretary shall issue final regulations implementing
such changes not later than 4 years after the date of enactment of this
Act.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id83B58209F2744BC2858B2E9F1D2A317B" section-type="subsequent-section"><enum>1113.</enum><header>Applicability</header><text display-inline="no-display-inline">Nothing in this subtitle or the amendments
made by this subtitle shall apply to—</text>
<paragraph id="id3A71B83C100E4D119BD586360BEB0E18"><enum>(1)</enum><text display-inline="yes-display-inline">a drug that is covered by an application
under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355, 360b) approved prior to May 1, 2012; or</text>
</paragraph><paragraph id="id74A50E3F14544131B6BE65D31584246F"><enum>(2)</enum><text display-inline="yes-display-inline">any of the gases listed in subparagraphs
(A) through (G) of section 575(1) of such Act (as added by section 1111), or
any mixture of any such gases, for an indication that—</text>
<subparagraph id="idF0EDEEAC36744A53B1F2F43181E7B1C9"><enum>(A)</enum><text display-inline="yes-display-inline">is not included in, or is different from,
those specified in subclauses (I) through (VII) of section 576(a)(3)(i) of such
Act (as added by section 1111); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id80C5594329D84527B3883F82DDA77959"><enum>(B)</enum><text display-inline="yes-display-inline">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 id="id03F405C9EC664DF38F472E90E63D433B"><enum>C</enum><header>Miscellaneous
provisions</header>
<section commented="no" display-inline="no-display-inline" id="idD77994E096464DF5AFE29E3B6D6ACCAD"><enum>1121.</enum><header>Advisory
committee conflicts of interest</header><text display-inline="no-display-inline">Section 712 (21 U.S.C. 379d–1) is
amended—</text>
<paragraph id="id179C685F1C6B42DE915FF1C535834414"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (b)—</text>
<subparagraph id="idBB73E0DF276C4E92B5C43CDD5BD7AF0A"><enum>(A)</enum><text display-inline="yes-display-inline">by striking paragraph (2); and</text>
</subparagraph><subparagraph id="idAB733082C87B40758996EEB65D4DE1C8"><enum>(B)</enum><text display-inline="yes-display-inline">in paragraph (1)—</text>
<clause id="idCD35E68554B44C719E93D202340729E1"><enum>(i)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (B) as
paragraph (2) and moving such paragraph, as so redesignated, 2 ems to the
left;</text>
</clause><clause id="idBABE7085A3F64A058F3D900BD2C99159"><enum>(ii)</enum><text display-inline="yes-display-inline">in subparagraph (A), by redesignating
clauses (i) through (iii) as subparagraphs (A) through (C), respectively, and
moving such subparagraphs, as so redesignated, 2 ems to the left;</text>
</clause><clause id="id54C895197607477C907D615F3A70DD82"><enum>(iii)</enum><text display-inline="yes-display-inline">in subparagraph (A), as so redesignated, by
inserting <quote>, including strategies to increase the number of special
Government employees across medical and scientific specialties in areas where
the Secretary would benefit from specific scientific, medical, or technical
expertise necessary for the performance of its regulatory
responsibilities</quote> before the semicolon at the end;</text>
</clause><clause id="idFA0E9E1551BD435DB25FEBA2387D1EE1"><enum>(iv)</enum><text display-inline="yes-display-inline">by striking <quote>(1)
<header-in-text level="paragraph" style="OLC">Recruitment.—</header-in-text></quote> and inserting <quote>(1)
<header-in-text level="paragraph" style="OLC">Recruitment in
general.</header-in-text>—The Secretary shall—</quote>;</text>
</clause><clause id="idC340ACC62B794536B0D9E5B778505995"><enum>(v)</enum><text>by
striking <quote>(A) <header-in-text level="subparagraph" style="OLC">In
general.</header-in-text>—The Secretary shall—</quote>;</text>
</clause><clause id="id9475DFBD05D844B8AF33DD6E9A454031"><enum>(vi)</enum><text>by
redesignating clauses (i) through (iii) of paragraph (2) (as so redesignated)
as subparagraphs (A) through (C), respectively, and moving such subparagraphs,
as so redesignated, 2 ems to the left;</text>
</clause><clause id="idCB33B5C3BBC041888E3DDC0C94A1EF3E"><enum>(vii)</enum><text>in paragraph
(2) (as so redesignated), in the matter before subparagraph (A) (as so
redesignated), by striking <quote>subparagraph (A)</quote> and inserting
<quote>paragraph (1)</quote>; and</text>
</clause><clause id="id6CE0A0022E8645B387BFCD284AA16B84"><enum>(viii)</enum><text>by adding at
the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id661AC2AE6A0744BE9A589BE603273E08" style="OLC">
<paragraph id="id6BB935E9CC0E4BDA9644725A79193A93"><enum>(3)</enum><header>Recruitment
through referrals</header><text>In carrying out paragraph (1), the Secretary
shall, in order to further the goal of including in advisory committees the
most qualified and specialized experts in the specific diseases to be
considered by such advisory committees, at least every 180 days, request
referrals from a variety of stakeholders, including the Institute of Medicine,
the National Institutes of Health, product developers, patient groups, disease
advocacy organizations, professional societies, medical societies, including
the American Academy of Medical Colleges, and other governmental
organizations.</text>
</paragraph><after-quoted-block>;</after-quoted-block></quoted-block>
</clause></subparagraph></paragraph><paragraph id="id8E8E0FE822BD4BAFB16DB6BE4F53E6A9"><enum>(2)</enum><text>by amending
subsection (c)(2)(C) to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="idC6A5367E3E104A33B6E916BD70DA344A" style="OLC">
<subparagraph id="id912A49EB320B4DF0AE50F329A1DD4B5A"><enum>(C)</enum><header>Consideration
by Secretary</header><text>The Secretary shall ensure that each determination
made under subparagraph (B) considers the type, nature, and magnitude of the
financial interests at issue and the public health interest in having the
expertise of the member with respect to the particular matter before the
advisory
committee.</text>
</subparagraph><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="id4CF79B78C8204F4EB7644401F1D0786F"><enum>(3)</enum><text>in subsection
(e), by inserting <quote>, and shall make publicly available,</quote> after
<quote>House of Representatives</quote>; and</text>
</paragraph><paragraph id="idC627C3201AE44E37BD67C5EEA652B13E"><enum>(4)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id8C7BE84ABA7442679E3FE7108449DACA" style="OLC">
<subsection id="idD49EDB40627B4FA18A55CEFB5CD777D5"><enum>(g)</enum><header>Guidance on
reported financial interest or involvement</header><text>The Secretary shall
issue guidance that describes how the Secretary reviews the financial interests
and involvement of advisory committee members that are reported under
subsection (c)(1) but that the Secretary determines not to meet the definition
of a disqualifying interest under section 208 of title 18, United States Code
for the purposes of participating in a particular
matter.</text>
</subsection><after-quoted-block>.
</after-quoted-block></quoted-block>
</paragraph></section><section commented="no" display-inline="no-display-inline" id="id25DE34E7D5AC479AAA4921FDFA039BBB" section-type="subsequent-section"><enum>1122.</enum><header>Guidance document
regarding product promotion using the Internet</header><text display-inline="no-display-inline">Not later than 2 years after the date of
enactment this Act, the Secretary of Health and Human Services shall issue
guidance that describes Food and Drug Administration policy regarding the
promotion, using the Internet (including social media), of medical products
that are regulated by such Administration.</text>
</section><section commented="no" display-inline="no-display-inline" id="id3055B0FC8BF64AE0BA5F66F0FEFDC0E4" section-type="subsequent-section"><enum>1123.</enum><header>Electronic
submission of applications</header><text display-inline="no-display-inline">Subchapter D of chapter VII (21 U.S.C. 379k
et seq.) is amended by inserting after section 745 the following:</text>
<quoted-block display-inline="no-display-inline" id="HEFB610AA93864058B6F3B5F1E486DF5B" style="OLC">
<section commented="no" id="H0CE455385DA2463297E7A1CF426B3330"><enum>745A.</enum><header>Electronic
format for submissions</header>
<subsection commented="no" id="H1AABA6E15B61402286F483887F8E4815"><enum>(a)</enum><header>Drugs and
biologics</header>
<paragraph commented="no" id="HCFEC138A92304E5AB614A8018F66666A"><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="H1AFF29FF5E2E41AD9F1FCAFD2F082B7F"><enum>(2)</enum><header>Guidance
contents</header><text display-inline="yes-display-inline">In the guidance
under
<internal-xref idref="HCFEC138A92304E5AB614A8018F66666A" legis-path="745A.(a)(1)">paragraph (1)</internal-xref>, the Secretary
may—</text>
<subparagraph id="H16089D6D46D940028BFB86D5F071B745"><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="H8E20B6DBF84F4350A8BC7C577F2F348C"><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="H3AF7A784108540E6BADC2F4BD91FBDB2"><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="H18B58BA150EE456CB5D4A1DE78888311"><enum>(b)</enum><header>Devices</header>
<paragraph commented="no" id="H07CF305AAE864A6BB8D4D89F0DE7E6AF"><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="H4F19CDF8D5154CD9A8F968515248ACBB"><enum>(2)</enum><header>Guidance
contents</header><text display-inline="yes-display-inline">In the guidance
under
<internal-xref idref="H07CF305AAE864A6BB8D4D89F0DE7E6AF" legis-path="745A.(b)(1)">paragraph (1)</internal-xref>, the Secretary
may—</text>
<subparagraph id="H3B8B9115153440FDB2F8E23CAFFCE396"><enum>(A)</enum><text>provide standards
for the electronic copy required under such paragraph; and</text>
</subparagraph><subparagraph id="H6734FF0BCBD6414D8975A8BE4CFA31F4"><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 commented="no" display-inline="no-display-inline" id="id155D1D35A3B2401CAA5E338BD27444D1" section-type="subsequent-section"><enum>1124.</enum><header>Combating
prescription drug abuse</header>
<subsection commented="no" display-inline="no-display-inline" id="id4F739C7BB7E44F27AA058FFDE4A4E4B2"><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="id2D8B576B44A64810AA14E32D6EA97CF6"><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 id="idd0a986854c9a4bf0a5a7bcef1a7db76e"><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 (21 U.S.C. 351(k)(3)), 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 id="idaea0e91b6f754f94bf4764c8e362afc6"><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 id="id211f1a8a2ce8499c9b97224b68be83fc"><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 id="ideb7bf7205b934a44b5085985cd7d98a6"><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 id="id3C64B597B05F4571B8777FE6EE6B3E13"><enum>1125.</enum><header>Tanning bed
labeling</header><text display-inline="no-display-inline">Not later than 18
months after the date of enactment of this Act, the Secretary of Health and
Human Services shall determine whether to amend the warning label requirements
for sunlamp products to include specific requirements to more clearly and
effectively convey the risks that such products pose for the development of
irreversible damage to the eyes and skin, including skin cancer.</text>
</section><section id="id661991AEE8384F73BA9268BC0CA65E4B"><enum>1126.</enum><header>Optimizing
global clinical trials</header><text display-inline="no-display-inline">Subchapter E of chapter V (21 U.S.C. 360bbb
et seq.), as amended by section 903, is further amended by adding at the end
the following:</text>
<quoted-block display-inline="no-display-inline" id="id48990462b42d4536831aef1d034a1dc6" style="OLC">
<section id="idA3639E47481A4191BAF003999B1447E1"><enum>569A.</enum><header>Optimizing
global clinical trials</header>
<subsection id="idC6C8A61F92D84491AC3914434BCEB77A"><enum>(a)</enum><header>In
general</header><text>The Secretary shall—</text>
<paragraph id="id9998094c8832488ebbc6a68b801a1bf8"><enum>(1)</enum><text>work with other
regulatory authorities of similar standing, medical research companies, and
international organizations to foster and encourage uniform,
scientifically-driven clinical trial standards with respect to medical products
around the world; and</text>
</paragraph><paragraph id="idac79dc8f7e1a4e2dba331b5955bdedce"><enum>(2)</enum><text>enhance the
commitment to provide consistent parallel scientific advice to manufacturers
seeking simultaneous global development of new medical products in order
to—</text>
<subparagraph id="id48b12e388e9848dabc861f3c78031080"><enum>(A)</enum><text>enhance medical
product development;</text>
</subparagraph><subparagraph id="id2e8c0486c11b4282960355966e1f22e2"><enum>(B)</enum><text>facilitate the
use of foreign data; and</text>
</subparagraph><subparagraph id="id959255a6117449b397d3afdf6720dde6"><enum>(C)</enum><text>minimize the need
to conduct duplicative clinical studies, preclinical studies, or non-clinical
studies.</text>
</subparagraph></paragraph></subsection><subsection id="id569db769ebe94fb9929060647bef20e6"><enum>(b)</enum><header>Medical
product</header><text>In this section, the term <term>medical product</term>
means a drug, as defined in subsection (g) of section 201, a device, as defined
in subsection (h) of such section, or a biological product, as defined in
section 351(i) of the Public Health Service Act.</text>
</subsection><subsection id="id4F12EC53855A402FA776DFDD17EB3FC0"><enum>(c)</enum><header>Savings
clause</header><text>Nothing in this section shall alter the criteria for
evaluating the safety or effectiveness of a medical product under this
Act.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idBDFCAB6460E3460097F94247B276CB96"><enum>1127.</enum><header>Advancing
regulatory science to promote public health innovation</header>
<subsection id="id24CDB6C90DE945CDA5935FA5CFF815CE"><enum>(a)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services (referred to in this section as
the <quote>Secretary</quote>) shall develop a strategy and implementation plan
for advancing regulatory science for medical products in order to promote the
public health and advance innovation in regulatory decisionmaking.</text>
</subsection><subsection id="idDCA9C4460E964206B2C4EFAA5267592B"><enum>(b)</enum><header>Requirements</header><text>The
strategy and implementation plan developed under subsection (a) shall be
consistent with the user fee performance goals in the Prescription Drug User
Fee Agreement commitment letter, the Generic Drug User Fee Agreement commitment
letter, and the Biosimilar User Fee Agreement commitment letter transmitted by
the Secretary to Congress on January 13, 2012, and the Medical Device User Fee
Agreement commitment letter transmitted by the Secretary to Congress on April
20, 2012, and shall—</text>
<paragraph id="id4b0b46349a934276ba70ac501a0d2f59"><enum>(1)</enum><text>identify a clear
vision of the fundamental role of efficient, consistent, and predictable,
science-based decisions throughout regulatory decisionmaking of the Food and
Drug Administration with respect to medical products;</text>
</paragraph><paragraph id="id68901a114df24a4b893bd1c8c358445a"><enum>(2)</enum><text>identify the
regulatory science priorities of the Food and Drug Administration directly
related to fulfilling the mission of the agency with respect to decisionmaking
concerning medical products and allocation of resources towards such regulatory
science priorities;</text>
</paragraph><paragraph id="id4efea3af4f4748f1ac3c88dbc3ed6c86"><enum>(3)</enum><text>identify
regulatory and scientific gaps that impede the timely development and review
of, and regulatory certainty with respect to, the approval, licensure, or
clearance of medical products, including with respect to companion products and
new technologies, and facilitating the timely introduction and adoption of new
technologies and methodologies in a safe and effective manner;</text>
</paragraph><paragraph id="id146b1a840bb84494b22ae5c1c3bb31a0"><enum>(4)</enum><text>identify clear,
measurable metrics by which progress on the priorities identified under
paragraph (2) and gaps identified under paragraph (3) will be measured by the
Food and Drug Administration, including metrics specific to the integration and
adoption of advances in regulatory science described in paragraph (5) and
improving medical product decisionmaking, in a predictable and science-based
manner; and</text>
</paragraph><paragraph id="id59f2eeede45d425897eda9095a2aaaff"><enum>(5)</enum><text>set forth how the
Food and Drug Administration will ensure that advances in regulatory science
for medical products are adopted, as appropriate, on an ongoing basis and in an
manner integrated across centers, divisions, and branches of the Food and Drug
Administration, including by senior managers and reviewers, including through
the—</text>
<subparagraph id="idd64d3cf6ad5a43bbad04d2c664fbbe68"><enum>(A)</enum><text>development,
updating, and consistent application of guidance documents that support medical
product decisionmaking; and</text>
</subparagraph><subparagraph id="id7f464dca7ac14e87b18c9ad1e0f3c89b"><enum>(B)</enum><text>the adoption of
the tools, methods, and processes under section 566 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb–5).</text>
</subparagraph></paragraph></subsection><subsection id="idB4267386747D4A7FB4C99084A33AD30D"><enum>(c)</enum><header>Annual
performance reports</header><text>As part of the annual performance reports
submitted to Congress under sections 736B(a) (as amended by section 104),
738A(a) (as amended by section 204), 744C(a) (as added by section 303), and
744I(a) (as added by section 403) of the Federal Food, Drug, and Cosmetic Act
for each of fiscal years 2013 through 2017, the Secretary shall annually report
on the progress made with respect to—</text>
<paragraph id="id659fa2e5d91b4b53bc277a9e16263dd1"><enum>(1)</enum><text>advancing the
regulatory science priorities identified under paragraph (2) of subsection (b)
and resolving the gaps identified under paragraph (3) of such subsection,
including reporting on specific metrics identified under paragraph (4) of such
subsection;</text>
</paragraph><paragraph id="ida439ace6919349878d6be019124ca214"><enum>(2)</enum><text>the integration
and adoption of advances in regulatory science as set forth in paragraph (5) of
such subsection; and</text>
</paragraph><paragraph id="idb42f52f13f054f0b931d0432bd49ae89"><enum>(3)</enum><text>the progress made
in advancing the regulatory science goals outlined in the Prescription Drug
User Fee Agreement commitment letter, the Generic Drug User Fee Agreement
commitment letter, and the Biosimilar User Fee Agreement commitment letter
transmitted by the Secretary to Congress on January 13, 2012, and the Medical
Device User Fee Agreement transmitted by the Secretary to Congress on April 20,
2012.</text>
</paragraph></subsection><subsection id="idbc94bd0da73e481dbbae989d9e73b53f"><enum>(d)</enum><header>Independent
assessment</header><text>Not later than January 1, 2016, the Comptroller
General of the United States shall submit to Congress a report—</text>
<paragraph id="idc363fc8322e44d1c9d119836e256d510"><enum>(1)</enum><text>detailing the
progress made by the Food and Drug Administration in meeting the priorities and
addressing the gaps identified in subsection (b), including any outstanding
gaps; and</text>
</paragraph><paragraph id="idc8c185c65ece42bdbf9e41e072c8d27b"><enum>(2)</enum><text>containing
recommendations, as appropriate, on how regulatory science initiatives for
medical products can be strengthened and improved to promote the public health
and advance innovation in regulatory decisionmaking.</text>
</paragraph></subsection><subsection id="id936633B695504A95962D06ED549C1D5D"><enum>(e)</enum><header>Medical
product</header><text>In this section, the term <term>medical product</term>
means a drug, as defined in subsection (g) of section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321), a device, as defined in subsection (h)
of such section, or a biological product, as defined in section 351(i) of the
Public Health Service Act.</text>
</subsection></section><section id="id181161DBB8C84C229A6A95827F1D59D9"><enum>1128.</enum><header>Information
technology</header>
<subsection id="id79FD936E927C4A7083BBED1629BA5E3C"><enum>(a)</enum><header>HHS
report</header><text>Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services shall—</text>
<paragraph id="id7ead688dc2f848159a0cdfc6ce3afebb"><enum>(1)</enum><text>report to
Congress on—</text>
<subparagraph id="idfe9e2888f136483695b77522788d243e"><enum>(A)</enum><text>the milestones
and a completion date for developing and implementing a comprehensive
information technology strategic plan to align the information technology
systems modernization projects with the strategic goals of the Food and Drug
Administration, including results-oriented goals, strategies, milestones,
performance measures;</text>
</subparagraph><subparagraph id="idc2210d11b21c4a55896b1363e82ef685"><enum>(B)</enum><text>efforts to
finalize and approve a comprehensive inventory of the information technology
systems of the Food and Drug Administration that includes information
describing each system, such as costs, system function or purpose, and status
information, and incorporate use of the system portfolio into the information
investment management process of the Food and Drug Administration;</text>
</subparagraph><subparagraph id="idaec5a2ea9eca44fb8b0b67bba2a208f0"><enum>(C)</enum><text>the ways in which
the Food and Drug Administration uses the plan described in subparagraph (A) to
guide and coordinate the modernization projects and activities of the Food and
Drug Administration, including the interdependencies among projects and
activities; and</text>
</subparagraph><subparagraph id="id3775f2cecaf64db196255a2b8ea80123"><enum>(D)</enum><text>the extent to
which the Food and Drug Administration has fulfilled or is implementing
recommendations of the Government Accountability Office with respect to the
Food and Drug Administration and information technology; and</text>
</subparagraph></paragraph><paragraph id="id83ea1a0a3a864574b89dfa01c541225d"><enum>(2)</enum><text>develop—</text>
<subparagraph id="iddcde10265de5467ab9429f9da196937f"><enum>(A)</enum><text>a documented
enterprise architecture program management plan that includes the tasks,
activities, and timeframes associated with developing and using the
architecture and addresses how the enterprise architecture program management
will be performed in coordination with other management disciplines, such as
organizational strategic planning, capital planning and investment control, and
performance management; and</text>
</subparagraph><subparagraph id="id3c2ed3c25fb548f2975217763a73034d"><enum>(B)</enum><text>a skills
inventory, needs assessment, gap analysis, and initiatives to address skills
gaps as part of a strategic approach to information technology human capital
planning.</text>
</subparagraph></paragraph></subsection><subsection id="idB9F559EC8122403F8D70BF8F7932BA72"><enum>(b)</enum><header>GAO
report</header><text>Not later than January 1, 2016, the Comptroller General of
the United States shall issue a report regarding the strategic plan described
in subsection (a)(1)(A) and related actions carried out by the Food and Drug
Administration. Such report shall assess the progress the Food and Drug
Administration has made on—</text>
<paragraph id="id6c8cca0939a247a6879031cb8edf8991"><enum>(1)</enum><text>the development
and implementation of a comprehensive information technology strategic plan,
including the results-oriented goals, strategies, milestones, and performance
measures identified in subsection (a)(1)(A);</text>
</paragraph><paragraph id="idde3b7eb6fcd341e692b1701a1a1ab6a6"><enum>(2)</enum><text>the effectiveness
of the comprehensive information technology strategic plan described in
subsection (a)(1)(A), including the results-oriented goals and performance
measures; and</text>
</paragraph><paragraph id="idc2a1641b30f0476ea101158a68187e2a"><enum>(3)</enum><text>the extent to
which the Food and Drug Administration has fulfilled recommendations of the
Government Accountability Office with respect to such agency and information
technology.</text>
</paragraph></subsection></section><section id="id7BF93CEE866046198C105A91FAEF36AA"><enum>1129.</enum><header>Reporting
requirements</header><text display-inline="no-display-inline">Subchapter A of
chapter VII (21 U.S.C. 371 et seq.), as amended by section 208, is further
amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id5e39afcd70b042d18e1378261d278c73" style="OLC">
<section id="id1BA9EA50C45E42298010948B9B870D40"><enum>715.</enum><header>Reporting
requirements</header>
<subsection id="id522314D806F2407D922A1ACE467613C8"><enum>(a)</enum><header>New
drugs</header><text display-inline="yes-display-inline">Beginning with fiscal
year 2013 and ending with fiscal year 2017, not later than 120 days after the
end of each fiscal year for which fees are collected under part 2 of subchapter
C, the Secretary shall prepare and submit to the Committee on Health Education,
Labor, and Pensions of the Senate and the Committee on Energy and Commerce of
the House of Representatives a report concerning, for all applications for
approval of a new drug under section 505(b) of this Act or a new biological
product under section 351(a) of the Public Health Service Act filed in the
previous fiscal year—</text>
<paragraph id="ide940ce19bbef4827bc58498926455133"><enum>(1)</enum><text>the number of
such applications that met the goals identified for purposes of part 2 of
subchapter C 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>
</paragraph><paragraph id="idb9d317dbf56c4cfe85269700ad507345"><enum>(2)</enum><text>the percentage of
such applications that were approved;</text>
</paragraph><paragraph id="ide742636fb12f4d948053bd328f626a7c"><enum>(3)</enum><text>the percentage of
such applications that were issued complete response letters;</text>
</paragraph><paragraph id="idd86aabf117bb4718bcc25e66cdb66205"><enum>(4)</enum><text>the percentage of
such applications that were subject to a refuse-to-file action;</text>
</paragraph><paragraph id="id988d00bcd36a453eb8fce15d40896959"><enum>(5)</enum><text>the percentage of
such applications that were withdrawn; and</text>
</paragraph><paragraph id="id784cc7dbad7d40d689798899335bbf6f"><enum>(6)</enum><text>the average total
time to decision by the Secretary for all applications for approval of a new
drug under section 505(b) of this Act or a new biological product under section
351(a) of the Public Health Service Act filed in the previous fiscal year,
including the number of calendar days spent during the review by the Food and
Drug Administration and the number of calendar days spent by the sponsor
responding to a complete response letter or relevant legal, scientific, or
medical questions raised by the
Secretary.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
<quoted-block display-inline="no-display-inline" id="ide8b0de49c855470583068cb026c5e04a" style="OLC">
<subsection id="id3fdf131048684a369de7824f2a2abb33"><enum>(b)</enum><header>Generic
drugs</header><text>Beginning with fiscal year 2013 and ending after fiscal
year 2017, not later than 120 days after the end of each fiscal year for which
fees are collected under part 7 of subchapter C, the Secretary shall prepare
and submit to the Committee on Health Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of Representatives
a report concerning, for all applications for approval of a generic drug under
section 505(j), amendments to such applications, and prior approval supplements
with respect to such applications filed in the previous fiscal year—</text>
<paragraph id="id7f074a9b31fa4e69ad771521aaced4b5"><enum>(1)</enum><text>the number of
such applications that met the goals identified for purposes of part 7 of
subchapter C, 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>
</paragraph><paragraph id="id5b30369d6bb94109a0f27fbe3a1b6138"><enum>(2)</enum><text>the average total
time to decision by the Secretary for applications for approval of a generic
drug under section 505(j), amendments to such applications, and prior approval
supplements with respect to such applications filed in the previous fiscal
year, including the number of calendar days spent during the review by the Food
and Drug Administration and the number of calendar days spent by the sponsor
responding to a complete response letter or relevant legal, scientific, or
medical questions raised by the Secretary;</text>
</paragraph><paragraph id="id753e35b331404f268b219d9d00fe3738"><enum>(3)</enum><text>the total number
of applications under section 505(j), amendments to such applications, and
prior approval supplements with respect to such applications that were pending
with the Secretary for more than 10 months on the date of enactment of the
<short-title>Food and Drug Administration Safety and
Innovation Act</short-title>; and</text>
</paragraph><paragraph id="idc2df9cfc0b2c492fbd098ebf40c37b9c"><enum>(4)</enum><text>the number of
applications described in paragraph (3) on which the Food and Drug
Administration took final regulatory action in the previous fiscal year.</text>
</paragraph></subsection><subsection id="id11EDEA326EE4475E917279053ECD6760"><enum>(c)</enum><header>Biosimilar
biological products</header>
<paragraph id="idD8C2D319F8444DF9842A69AC6C117185"><enum>(1)</enum><header>In
general</header><text>Beginning with fiscal year 2014, not later than 120 days
after the end of each fiscal year for which fees are collected under part 8 of
subchapter C, the Secretary shall prepare and submit to the Committee on Health
Education, Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report concerning—</text>
<subparagraph id="idfd15304625804865845c660406d1fec3"><enum>(A)</enum><text>the number of
applications for approval filed under section 351(k) of the Public Health
Service Act; and</text>
</subparagraph><subparagraph id="id04c0642ff20c47bd85746b442812addc"><enum>(B)</enum><text>the percentage of
applications described in subparagraph (A) that were approved by the
Secretary.</text>
</subparagraph></paragraph><paragraph id="idaf45372e42954eaa841ca9370a3f65ae"><enum>(2)</enum><header>Additional
information</header><text>As part of the performance report described in
paragraph (1), the Secretary shall include an explanation of how the Food and
Drug Administration is managing the biological product review program to ensure
that the user fees collected under part 2 are not used to review an application
under section 351(k) of the Public Health Service
Act.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idBAC37FAED291465599AED244F3CF9833"><enum>1130.</enum><header>Strategic
integrated management plan</header>
<subsection id="id51A2CC47ACA048A8BF8369AC36821E97"><enum>(a)</enum><header>Strategic
integrated management plan</header><text>Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human Services (referred
to in this section as the <quote>Secretary</quote>) shall submit to Congress a
strategic integrated management plan for the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, and the Center for
Devices and Radiological Health. Such strategic management plan shall—</text>
<paragraph id="id12d39be232bc4bb59ac0af18d3bfb6e4"><enum>(1)</enum><text>identify
strategic institutional goals and priorities for the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and Research, and the Center
for Devices and Radiological Health;</text>
</paragraph><paragraph id="id1a2cac617e0046ecb082cd9f1d113bd7"><enum>(2)</enum><text>describe the
actions the Secretary will take to recruit, retain, train, and continue to
develop the workforce at the Center for Drug Evaluation and Research, the
Center for Biologics Evaluation and Research, and the Center for Devices and
Radiological Health to fulfill the public health mission of the Food and Drug
Administration; and</text>
</paragraph><paragraph id="idd7658a5ea02c4d95b3b1d611df8c3f49"><enum>(3)</enum><text>identify
results-oriented, outcome-based measures that the Secretary will use to measure
the progress of achieving the strategic goals and priorities identified under
paragraph (1) and the effectiveness of the actions identified under paragraph
(2), including metrics to ensure that managers and reviewers of the Center for
Drug Evaluation and Research, the Center for Biologics Evaluation and Research,
and the Center for Devices and Radiological Health are familiar with and
appropriately and consistently apply the requirements under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), including new requirements
under parts 2, 3, 7, and 8 of subchapter C of title VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).</text>
</paragraph></subsection><subsection id="idd1e834f975174001ada2e63204eb0eb1"><enum>(b)</enum><header>Report</header><text>Not
later than January 1, 2016, the Comptroller General of the United States shall
issue a report regarding the strategic management plan described in subsection
(a) and related actions carried out by the Food and Drug Administration. Such
report shall—</text>
<paragraph id="id9c36a47e8762494ab294884282ca2715"><enum>(1)</enum><text>assess the
effectiveness of the actions described in subsection (a)(2) in recruiting,
retaining, training, and developing the workforce at the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation and Research, and
the Center for Devices and Radiological Health in fulfilling the public health
mission of the Food and Drug Administration;</text>
</paragraph><paragraph id="id7d29cf2230f34bfdb285eff801a1988f"><enum>(2)</enum><text>assess the
effectiveness of the measures identified under subsection (a)(3) in gauging
progress against the strategic goals and priorities identified under subsection
(a)(1);</text>
</paragraph><paragraph id="id68c1ed8b232940bfb5cf53afa4fb7db0"><enum>(3)</enum><text>assess the extent
to which the Center for Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, and the Center for Devices and Radiological Health are
using the identified results-oriented set of performance measures in tracking
their workload by strategic goals and the effectiveness of such
measures;</text>
</paragraph><paragraph id="idab055e3d536f48d18ede231b198f34cf"><enum>(4)</enum><text>assess the extent
to which performance information is collected, analyzed, and acted on by
managers; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id1c851927b6574b49b138722dd3d38f83"><enum>(5)</enum><text>make
recommendations, as appropriate, regarding how the strategic management plan
and related actions of the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, and the Center for Devices and
Radiological Health could be improved to fulfill the public health mission of
the Food and Drug Administration in as efficient and effective manner as
possible.</text>
</paragraph></subsection></section><section id="id98AA948567AB4F1596CEDDBF28F6CB82"><enum>1131.</enum><header>Drug
development and bioequivalence testing</header>
<subsection id="id5FA5D67B56A847099285AD1729B20E04"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 505–1 (21
U.S.C. 355–1) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id4D7603EE928C40FB90D8F87A02989C15" style="OLC">
<subsection id="idE415C10D7BC54D4891022F7AEEA1C4C1"><enum>(k)</enum><header>Drug
development and bioequivalence testing</header>
<paragraph id="id621FC3A59FA64DC1A0B74A1DD5BB163B"><enum>(1)</enum><header>In
general</header><text>Notwithstanding any other provision of law, if a drug is
a covered drug, no elements to ensure safe use shall prohibit, or be construed
or applied to prohibit, supply of such drug to any eligible drug developer for
the purpose of developing, or conducting bioequivalence testing necessary to
support, an application under subsection (b)(2) or (j) of section 505 of this
Act or section 351(k) of the Public Health Service Act, if the Secretary has
issued a written notice described in paragraph (2), and the eligible drug
developer has agreed to comply with the terms of the notice.</text>
</paragraph><paragraph id="id993E707EAF5E4AFFB68C164BB3291E66"><enum>(2)</enum><header>Written
notice</header><text>For purposes of this subsection, the Secretary shall issue
a written notice to an eligible drug developer and the holder of an application
for a covered drug authorizing the supply of a drug to such eligible drug
developer for purposes of bioequivalence testing if—</text>
<subparagraph id="idc4f67628b69448ef82aabd96fe2d3e13"><enum>(A)</enum><text>the eligible drug
developer has agreed to comply with any conditions the Secretary considers
necessary; and</text>
</subparagraph><subparagraph id="idf78076aeb9fe4733ad12c54540ba816a"><enum>(B)</enum><text>the eligible drug
developer has submitted and the Secretary has approved a protocol for
bioequivalence testing that includes protections that the Secretary finds will
provide assurance of safety comparable to the assurance of safety provided by
the elements to ensure safe use in the risk evaluation and mitigation strategy
for the covered drug.</text>
</subparagraph></paragraph><paragraph id="id4C4141528E3D4C4586A1B5D3ECF98E99"><enum>(3)</enum><header>Additional
required element</header><text>The Secretary shall require as an element of
each risk evaluation and mitigation strategy approved by the Secretary that the
holder of an application for a covered drug shall not restrict the resale of
the covered drug to an eligible drug developer that receives a written notice
from the Secretary under paragraph (2).</text>
</paragraph><paragraph id="id753CCE45649C4A98B93E9AF6C462C0F0"><enum>(4)</enum><header>Penalties</header><text>For
purposes of subsection (f)(8) and sections 301, 303(f)(4), 502(y), and 505(p),
it shall be a violation of the risk evaluation and mitigation strategy for the
holder of the application for a covered drug to restrict the sale of the drug
to an eligible drug developer. The Secretary shall provide written notice to
the Committee on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives of any penalty
assessed under this subsection within 7 days of such assessment.</text>
</paragraph><paragraph id="idC43F1A5730AE4527AD053F2CAD3F671C"><enum>(5)</enum><header>Liability</header><text>The
holder of an application for a covered drug shall not be liable for any claim
arising out of the eligible drug developer’s provision or testing of a drug
obtained under this subsection, including a claim arising out of failure of the
eligible drug developer to follow adequate safeguards to ensure safe use of the
drug.</text>
</paragraph><paragraph id="id2D006F3D006F403ABBBA1D73450559CA"><enum>(6)</enum><header>Definitions</header>
<subparagraph id="idBD9B1FF9E9C94981B13CE64174CE1B96"><enum>(A)</enum><header>Covered
drug</header><text>Notwithstanding subsection (b)(2), for purposes of this
subsection, the term <term>covered drug</term> means a drug subject to a risk
evaluation and mitigation strategy with elements to ensure safe use under
subsection (f), or that is deemed under section 909(b) of the Food and Drug
Administration Amendments Act of 2007 to be a drug, including a biological
product licensed under section 351(a) of the Public Health Service Act, subject
to a risk evaluation and mitigation strategy with elements to ensure safe
use.</text>
</subparagraph><subparagraph id="idA47BA487A41C475B90423F94B5F26C8D"><enum>(B)</enum><header>Eligible drug
developer</header><text>For purposes of this subsection, the term
<term>eligible drug developer</term> means a sponsor seeking to develop an
application for submission under subsection (b)(2) or (j) of section 505 of
this Act or section 351(k) of the Public Health Service
Act.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idEDC2B918A5F84AF1A2C3DBB28264EFC2"><enum>(b)</enum><header>Technical and
conforming amendment</header><text>Section 505–1(c)(2) (21 U.S.C. 355–1(c)(2))
is amended by striking <quote>(e) and (f)</quote> and inserting <quote>(e),
(f), and (k)(3)</quote>.</text>
</subsection></section></subtitle>
May 7, 2012
Read twice and placed on the calendar