1.Short title; table of
contentsThis Act may be cited
as the Generic Drug and Biosimilar
User Fee Act of 2012
.
2.The table of contents
for this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Table of contents.
Title I—Fees relating to generic drugs
Sec. 101. Short title; references in title;
findings.
Sec. 102. Authority to assess and use human generic drug
fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Amendment with respect to misbranding.
Sec. 107. Electronic submission of applications.
Sec. 108. Streamlined hiring authority of the Food and Drug
Administration to support activities related to human generic
drugs.
Title II—Fees relating to biosimilar biological
products
Sec. 201. Short title; references in title;
finding.
Sec. 202. Fees relating to biosimilar biological
products.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Sunset dates.
Sec. 205. Effective date.
Sec. 206. Savings clause.
Sec. 207. Technical amendment; conforming
amendment.
<enum>I</enum><header>Fees
relating to generic drugs</header>
<section id="H46125231F4584C2E82221FA2F852A7B5"><enum>101.</enum><header>Short title;
references in title; findings</header>
<subsection id="H28A4D7A03D5F4FA0AF53A73C571A8F55"><enum>(a)</enum><header>Short
title</header><text>This title may be cited as the <quote><short-title>Generic Drug User Fee Amendments of
2012</short-title></quote>.</text>
</subsection><subsection id="H9CFEE2F7D237413EB610DF0A8FC2FB6B"><enum>(b)</enum><header>References in
act</header><text>Except as otherwise specified, amendments made by this title
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.).</text>
</subsection><subsection id="HFE1467F137984F739DD9C60B9EF12D4C"><enum>(c)</enum><header>Findings</header><text>The
Congress finds that the fees authorized by the amendments made in this title
will be dedicated, as set forth in the goals identified 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. These fees are intended to help the Food and Drug
Administration ensure that participants in the United States generic drug
system comply with United States quality standards, and to increase the
likelihood that American consumers have timely access to low-cost, high-quality
generic drugs. A comprehensive human generic drug user fee program, to be
supplemental to traditional appropriated funding, should be focused on three
key aims:</text>
<paragraph id="HE776FBCCD4D447A3A5AF350126290E77"><enum>(1)</enum><header>Safety</header><text>Ensure
that industry participants, foreign or domestic, who participate in the United
States generic drug system are held to consistent high-quality standards and
are inspected biennially, using a risk-based approach, with foreign and
domestic parity.</text>
</paragraph><paragraph id="H992C27DC8EC142499FA135DFB7A62F9B"><enum>(2)</enum><header>Access</header><text>Expedite
the availability of low-cost, high-quality generic drugs by bringing greater
predictability to the review times for abbreviated new drug applications,
amendments, and supplements, increasing predictability and timeliness in the
review process.</text>
</paragraph><paragraph id="H488122619EC0420E94AD2D0D24E565EA"><enum>(3)</enum><header>Transparency</header><text>Enhance
the Food and Drug Administration’s ability to protect Americans in the complex
global supply environment by requiring the identification of facilities
involved in the manufacture of generic drugs and associated active
pharmaceutical ingredients, and improving the Food and Drug Administration’s
communications and feedback with industry in order to expedite product
access.</text>
</paragraph></subsection></section><section id="HA33D0CA23028489886B17C4EAF6070BB"><enum>102.</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="H38C0EDF675354109B656B91259A7BC78" style="OLC">
<part id="HA1F4D26ADF7E41849B8AA1476AE48C49"><enum>7</enum><header>FEES
RELATING TO GENERIC DRUGS </header>
<section id="HB8D816828BAD4D18A43775FF0901D0F2"><enum>744A.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="H7B98952956AA441C81BFE6C40890F1DC"><enum>(1)</enum><text>The term
<term>abbreviated new drug application</term>—</text>
<subparagraph id="H197EBF44ED5F4746902F1229355D40B2"><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="H1844787F25214C698251FEFDB46125EA"><enum>(B)</enum><text>does not include
an application for a positron emission tomography drug.</text>
</subparagraph></paragraph><paragraph id="H6324D36108394317883C352EB19566A8"><enum>(2)</enum><text>The term
<term>active pharmaceutical ingredient</term> means—</text>
<subparagraph id="H4B5FBC76BA0D4CC0A7504C19AF666D13"><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="H65316DB238094AAB8E615FA59245B8FB"><enum>(i)</enum><text>to
be used as a component of a drug; and</text>
</clause><clause id="H1D181F1703A84A3FA36A6CE91D01C496"><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="H6E87DB5B6EE24C5DB48A022E99FBCD39"><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="H7FF3D94CAB8A4176A810DAFBF65A2033"><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="HE5B3FEA916664140A418EF27178E02F0"><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="HC61D30D14C054C1DAB4CAD662D5CEB87"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="H8BB2775C53CD418BAC60FDB1F032E829"><enum>(B)</enum><text>a third party
controls, or has power to control, both of the business entities.</text>
</subparagraph></paragraph><paragraph id="H9318AE54C6C149F198F6FB69F5739955"><enum>(5)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H3E0D2D78653A442195C2CAB26FEC99AF"><enum>(A)</enum><text>The term
<term>facility</term>—</text>
<clause id="H1EA1AE200EAC4144985412FA16558E7D" indent="up1"><enum>(i)</enum><text>means a business or other
entity—</text>
<subclause id="HB1B129E2C7B14FED8D62C6A6FC764FBB"><enum>(I)</enum><text>under one management, either direct or
indirect; and</text>
</subclause><subclause id="HA30829A389A94BA59B6AFF80C61252AA"><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="H075EE8AD6DF94649AE59F94BE17C491D" 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="HFA3CDF0DB0E14B70971EDEE64ED14690" 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="HDA155A2603A9485C83E4E06EC65EB835"><enum>(i)</enum><text>closely related to the same
business enterprise;</text>
</clause><clause id="HF4F47A1AF85F45F2B4F1AB3CCFE575B8"><enum>(ii)</enum><text>under the supervision of the same
local management; and</text>
</clause><clause id="HE49D5E29AD7C41FD9E58D0D00D7DE0F6"><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="H5DABE51815FF4F7BA10BFCAEBE3413B9" 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="H7C720D10C88346D686B80EC8FF4D2D35"><enum>(6)</enum><text>The term
<term>finished dosage form</term> means—</text>
<subparagraph id="H522B14E4525240BAB3515DDB39861792"><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="HF8C71E070F3746E69E18CA51249741B2"><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="H1580FB47BBF84D59BFA9E272F25A4D07"><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="HE9E3F5332B2C47CCB5656EE5705823C4"><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="H7D0F9256739B40268C0DC723533E2A59"><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="H3DD279B49EEB4BD99364127B216AA77D"><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="H927737EDFDFD4C16A317CDED8EEBD836"><enum>(B)</enum><text>The issuance
of—</text>
<clause id="HEBB5B23BC80A44CE84A9EE355787CA05"><enum>(i)</enum><text>approval letters
which approve abbreviated new drug applications or supplements to such
applications; or</text>
</clause><clause id="HC1221991F4DC491CAC3FACAEA3FAE813"><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="H28EA7A108B3E4B6D9472BD80D89CDB99"><enum>(C)</enum><text>The issuance of
letters related to Type II active pharmaceutical drug master files
which—</text>
<clause id="HA5884AABE6914D7B9CF86495CFCABD56"><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="H2A93BADCCB0C46FBA0B008E9D84BCC8B"><enum>(ii)</enum><text>document that no
deficiencies need to be addressed.</text>
</clause></subparagraph><subparagraph id="HA21ED2D0CA874FBF97422E0F0A27354A"><enum>(D)</enum><text>Inspections
related to generic drugs.</text>
</subparagraph><subparagraph id="HB85B0CDAA7F047E4A27780B10219174E"><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="H598694D6997A4B4AB58D1D76C7ABDBF1"><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="H43E63936276145D1B0A4D86E5B529592"><enum>(i)</enum><text>Collecting,
developing, and reviewing safety information on approved drugs, including
adverse event reports.</text>
</clause><clause id="HD4747CD5AECA439BA0D728CC62EC25EB"><enum>(ii)</enum><text>Developing and
using improved adverse-event data-collection systems, including information
technology systems.</text>
</clause><clause id="H464DB661CCC4464A94009C318B72F342"><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="H27D8BB99E7C244F39B8F8EAB86DBA94B"><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="HA67BFD40F3B74E8289514D1047AF6E99"><enum>(v)</enum><text>Carrying out
section 505(k)(5) (relating to adverse event reports and postmarket safety
activities).</text>
</clause></subparagraph><subparagraph id="H3F2C9072B1DD46A39358CD8F83BFC167"><enum>(G)</enum><text>Regulatory science
activities related to generic drugs.</text>
</subparagraph></paragraph><paragraph display-inline="no-display-inline" id="HDA93DEF3B1AB4973A0CF6F23E6094F0E"><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="HD8EC4F4DF32E44169FEB18ABB2A5BD3E"><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="HF8B3AE735B4847F2A381D4BCC313F27A"><enum>(11)</enum><text>The term
<term>resources allocated for human generic drug activities</term> means the
expenses for—</text>
<subparagraph id="HED58E560CF4A49BF938092E76315DB43"><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="H003297939ED043C1B0FC3D1FE7D3410B"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="HFAB718BA6ACE4C598DCB681D5B6D4CCC"><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="HBA9C86E65BB64B17857ED75A317462DF"><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="H7BC72CF13FA3467C90CDF8FCD70859B5"><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="H7B798A50D1C14728AA68309C88834279"><enum>744B.</enum><header>Authority to
assess and use human generic drug fees</header>
<subsection id="H3EC644BE442B456C87948CAA553F67F9"><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="H96ABF270547D435F979ADB592D692F1B"><enum>(1)</enum><header>One-Time Backlog
Fee for Abbreviated New Drug Applications Pending on October 1, 2012</header>
<subparagraph id="H0ED2DA9EBA0F49C481D5FF374B6FF7E4"><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="H9DAC826FE06D4A64A5331A2A0F6D4C20"><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="H95D1EE79B9BA47B6AF15A0AF98F98A29"><enum>(C)</enum><header>Notice</header><text>Not
later than October 31, 2012, the Secretary shall cause to be published in the
Federal Register a notice announcing the amount of the fee required by
subparagraph (A).</text>
</subparagraph><subparagraph id="H9E604E22124846C3B353A66B1BACAD78"><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="HB6E584315C0D45FCA6EACA7B45C6F2E7"><enum>(2)</enum><header>Drug Master File
Fee</header>
<subparagraph id="H00F0F9B75BF64A75A9ED205B9645F4D5"><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="HB827692BAA4F48739EB0E8BE81F1D7D1"><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="H15BE32303A60470E89D09B4305A2B5E0"><enum>(C)</enum><header>Notice</header>
<clause id="H48157626690A48A5916422925008C1B6"><enum>(i)</enum><header>Fiscal year
2013</header><text>Not later than October 31, 2012, the Secretary shall cause
to be published in the Federal Register a notice announcing the amount of the
drug master file fee for fiscal year 2013.</text>
</clause><clause id="H0D583E91BF214FFE8E90DEE2DFCAC4C0"><enum>(ii)</enum><header>Fiscal year
2014 through 2017</header><text>Not later than 60 days before the start of each
of fiscal years 2014 through 2017, the Secretary shall cause to be published in
the Federal Register the amount of the drug master file fee established by this
paragraph for such fiscal year.</text>
</clause></subparagraph><subparagraph id="H016C3D335BBC4052947B3CDB4A2C2FA3"><enum>(D)</enum><header>Availability for
reference</header>
<clause commented="no" id="HF64CDFFE14034165B809D81B29733E6C"><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="H7C97139C4448414DA6C81708921AC82D"><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="HE550C39D88AB492BB007C1FE4FF2EFAA"><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="H3B204A3353A94EE48E466C09004594B1"><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="H1FFCE11AC1EA47D59B70245E35F9A0A9"><enum>(iii)</enum><header>List</header><text display-inline="yes-display-inline">The Secretary shall make available on the
public 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="HBA1261C4B85643359FA27C3E31F45E73"><enum>(E)</enum><header>Fee Due
Date</header>
<clause id="H2A7539B6B1934CE0B4DAEB6054098BA8"><enum>(i)</enum><header>In
general</header><text>Subject to clauses (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="H7BF4D61974F646E89DA7A3A97AE50C7E"><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="H9001923943B94FEA85E3A50E9465588F"><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="HDB921FA54A314FF3AFA16A56602AD2BE"><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="HFCB7C2D2369D4512B6AA440D1463CF30"><enum>(3)</enum><header>Abbreviated New
Drug Application and Prior Approval Supplement Filing Fee</header>
<subparagraph id="H65D987842F07429E941A53EBA6769F7B"><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="HB0CD849C27514C648395948A9F2BF5DD"><enum>(B)</enum><header>Notice</header>
<clause id="H14AB75DF89A14387B718E0E2611EF209"><enum>(i)</enum><header>Fiscal year
2013</header><text>Not later than October 31, 2012, the Secretary shall cause
to be published in the Federal Register a notice announcing the amount of the
fees under subparagraph (A) for fiscal year 2013.</text>
</clause><clause id="H7C021AD9591E4997924DDB6697591628"><enum>(ii)</enum><header>Fiscal years
2014 through 2017</header><text display-inline="yes-display-inline">Not later
than 60 days before the start of each of fiscal years 2014 through 2017, the
Secretary shall cause to be published in the Federal Register the amount of the
fees under subparagraph (A) for such fiscal year.</text>
</clause></subparagraph><subparagraph id="HC878ED714D02448C9FA4051E25503D9A"><enum>(C)</enum><header>Fee Due
Date</header>
<clause id="H42A0442F4D9345CDA8DB73F1E09B6739"><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="H6EC8F6C40E5444B28A713C3DF541DF09"><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="H159C0267D94D4896B4C47C9C93F25858"><enum>(I)</enum><text>the date on which
the fee is due under clause (i);</text>
</subclause><subclause id="HAFE6BF0312EC4237AB0311DEA559E2A2"><enum>(II)</enum><text>30 calendar days
after publication of the notice referred to in subparagraph (B)(i); or</text>
</subclause><subclause id="H0FF66A552E954EAFB901E433C329FE76"><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="HD6423136CA584A53A252EB2926EC6B03"><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="HC4EB6E96AD1346C0A34F5A75CE2752D6"><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="H37678A511B1E49CAAB1EE7763DA408D7"><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="H5878B7EEF5344C168343DD265644655F"><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="H2C920B5E212542EB95A0074080B3AA58"><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="H7C5EA714283E4C3C88147974C8DF0922"><enum>(4)</enum><header>Generic Drug
Facility Fee and Active Pharmaceutical Ingredient Facility Fee</header>
<subparagraph id="H790329F0ADFF45D68DF4625DC1A5EC8E"><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="HC70EF4D328D8441C9CDE9C2248FCDF97"><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="H67AADEB237784CC6BC4491F83A59C52D"><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="H4D61768AD6A64920952D48EF0A11E69A"><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="HC9AA99865A414372BA05CB6D7D152A3D"><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="HCAD2CE7C6B204429BB366E3B4FD09FBB"><enum>(C)</enum><header>Notice</header>
<clause id="HAEF558A94D3D4AA9BF257119DBF8B24C"><enum>(i)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013, the Secretary shall cause to be
published in the Federal Register a notice announcing the amount of the fees
provided for in subparagraph (A) within the timeframe specified in subsection
(d)(1)(B).</text>
</clause><clause id="H3871FAC91D3143B4A11F6267A09AECE9"><enum>(ii)</enum><header>Fiscal years
2014 through 2017</header><text display-inline="yes-display-inline">Within the
timeframe specified in subsection (d)(2), the Secretary shall cause to be
published in the Federal Register the amount of the fees under subparagraph (A)
for such fiscal year.</text>
</clause></subparagraph><subparagraph id="H36E0B8D5BD3149A1BD443E4643673B84"><enum>(D)</enum><header>Fee Due
Date</header>
<clause id="H4503661A4D87457DA314849B8C377A00"><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="HEC6AF58E67B540A4BCEA33272EC18EA4"><enum>(I)</enum><text>not later than 45
days after the publication of the notice under subparagraph (B); or</text>
</subclause><subclause id="HB569C1F105F9441B912CD94C34D6EAD3"><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="H0FA41FCBD3AC442FAD2DDDC567206D16"><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="H1BC8C0CF1ED44C53BAD0E8DD7A7190EE"><enum>(I)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</subclause><subclause id="H987A52C790414EFF9DE754FF8D38FEF3"><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="HA2FFE8572A004E2B94F6DE1D55E9C4F2"><enum>(5)</enum><header>Date of
submission</header><text display-inline="yes-display-inline">For purposes of
this part, a generic drug submission or Type II pharmaceutical master file is
deemed to be <quote>submitted</quote> to the Food and Drug Administration when
it arrives in the appropriate electronic portal of the Food and Drug
Administration or, if in paper form, at the appropriate designated document
room of the Food and Drug Administration.</text>
</paragraph></subsection><subsection id="HED850FEBA5684EA6A28DF0063722DF86"><enum>(b)</enum><header>Fee revenue
amounts</header>
<paragraph id="H49154C146A554B33A5D03AC683B97AE2"><enum>(1)</enum><header>In
general</header>
<subparagraph id="HE38F985887AD4621BE1849779D20CF1B"><enum>(A)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013, fees under subsection (a) shall be
established to generate a total estimated revenue amount under such subsection
of $299,000,000. Of that amount—</text>
<clause id="H0CDFB8726AC949078E92899497CED1AB"><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="H6D6717F172314C3DBE6D8E8AD51514F7"><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="H2E62D292CA0D4B059D59DBEDC37801E6"><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="H63DE71E4A2424F929F52AB31AC165968"><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 (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="H4F93D2785D794E12B499C02261884C19"><enum>(A)</enum><text>6 percent shall be
derived from fees under subsection (a)(2) (relating to drug master
files).</text>
</subparagraph><subparagraph id="H7C287D5DA5E24EC6A2CA756A17BD4F3E"><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="HB9A7C5BB70304E919CCE583449B6CD10"><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="H80BA24026551484A9402CCF28B93E17E"><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="HA46D71D6E086486284C072ACD6E69C60"><enum>(c)</enum><header>Adjustments</header>
<paragraph commented="no" id="HB4EB0A3E17054BF89E9F9F3505301C8E"><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="HA320E54447B54DD7A7A52C310F3895B6"><enum>(A)</enum><text>one;</text>
</subparagraph><subparagraph commented="no" id="H8EB0F39B4AF24EE8B341A29172494331"><enum>(B)</enum><text>the average annual
change in the cost, per full-time equivalent position of the Food and Drug
Administration, of all personnel compensation and benefits paid with respect to
such positions for the first 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="H42D0838196D74616A2D7D3040FF59958"><enum>(C)</enum><text>the average annual
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="HAA7AB65A44434CFF99AE9DF77516150F"><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="HFAE5ED5150C645B8A31CFC91B28C3F71"><enum>(d)</enum><header>Annual fee
setting</header>
<paragraph id="HBA017C7801A64690A5EC751CF22E1741"><enum>(1)</enum><header>Fiscal year
2013</header><text>For fiscal year 2013—</text>
<subparagraph id="HBDBED1A24DEB467AB70E89D0830C1A49"><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="H6CAD15C2AFFE43F69C47EBECE220DC79"><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="H1052E26A0EBF4C7EA5846B3EFDCFA1F1"><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="H06F3D1E249C0454F87E4CE8F89B1B745"><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="HC69D63A8176E4A4A9311DBEC916E5EC5"><enum>(A)</enum><text>the sum of—</text>
<clause id="H080A3E576F1D4CD3B90CF32AEC10D3B2"><enum>(i)</enum><text>the total number
of such active pharmaceutical ingredients in such submission; and</text>
</clause><clause id="HCD6DB182C7E842E4ABF14EE60E50FAA0"><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="HEE1B23DC81C34BBABB3367D47F9E7BBD"><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="H86732072EC1142ECA10F4C7A6A803FE0"><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="H0A61ED3F96D14A08B3A7846435A73EBA"><enum>(f)</enum><header>Identification
of facilities</header>
<paragraph id="HA44323CBBB6242EDB48AED05A7AD13A1"><enum>(1)</enum><header>Publication of
notice; deadline for compliance</header><text display-inline="yes-display-inline">Not later than October 1, 2012, the
Secretary shall cause to be published in the Federal Register a notice
requiring each person that owns a facility described in subsection (a)(4)(A),
or a site or organization required to be identified by paragraph (4), to submit
to the Secretary information on the identity of each such facility, site, or
organization. The notice required by this paragraph shall specify the type of
information to be submitted and the means and format for submission of such
information.</text>
</paragraph><paragraph id="H27A081F9C1AA499FACF107A3042C89E6"><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="H59E034F8332C4889B5C3730A2474493D"><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="H26A9CE6494D745B3B0491323C1B3C858"><enum>(B)</enum><text>for each
subsequent fiscal year, be submitted, updated, or reconfirmed on or before June
1 of such year.</text>
</subparagraph></paragraph><paragraph id="HC129E9373F2F4D44B8C7F3FCA6AF1069"><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="HFC79C9A123DC47B6BF8676144D0EAE7A"><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="H44B1BF00517B4311810D08DAA9708B26"><enum>(B)</enum><text>whether the
facility manufactures active pharmaceutical ingredients or finished dosage
forms, or both;</text>
</subparagraph><subparagraph id="HE35757635A5C4F9B9F6C2D2BF7ED99BE"><enum>(C)</enum><text>whether or not the
facility is located within the United States and its territories and
possessions;</text>
</subparagraph><subparagraph id="H67A61DADD25B48C6B99D7D491C25E68E"><enum>(D)</enum><text>whether the
facility manufactures positron emission tomography drugs solely, or in addition
to other drugs; and</text>
</subparagraph><subparagraph id="HED2E9B49F35A4C349631481FF4FB3CD6"><enum>(E)</enum><text>whether the
facility manufactures drugs that are not generic drugs.</text>
</subparagraph></paragraph><paragraph id="H6E1A6CC3B4F2463CB52CE0515710C17A"><enum>(4)</enum><header>Certain sites
and organizations</header>
<subparagraph id="H3E0E3F73940649F3BDE9D727B4BFE1A2"><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="H9536A51F13C8439C8E63F77BE95C6C6D"><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="HB290D62944444CB7AC9AE33917D67402"><enum>(i)</enum><text>a
site in which a bioanalytical study is conducted;</text>
</clause><clause id="H63BA3CEDBD77466B9B848AAD3880D5C0"><enum>(ii)</enum><text>a
clinical research organization;</text>
</clause><clause id="HB8233B3DD4DE47F89164FC54D83FBA2A"><enum>(iii)</enum><text>a contract
analytical testing site; or</text>
</clause><clause id="H3F1139EC504842D29369E42E88D9CC37"><enum>(iv)</enum><text>a
contract repackager site.</text>
</clause></subparagraph><subparagraph id="H53108252948448949CF7E20C1D7B97E3"><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="H842B329865D04F9294672C7FC093430C"><enum>(D)</enum><header>Inspection
authority</header><text>The Secretary’s inspectional authority under section
704(a)(1) shall extend to all such sites and organizations.</text>
</subparagraph></paragraph></subsection><subsection id="H8978F029885547EB83A5C1D3881E1431"><enum>(g)</enum><header>Effect of
failure To pay fees</header>
<paragraph id="H82508E1C3C144570A3E2CC1CF4483420"><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="H45D18814296E47E58DB68413B9D72904"><enum>(2)</enum><header>Drug master file
fee</header>
<subparagraph commented="no" id="HBB1E4055CAB84D57AE527891870D4F24"><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="H50D0F12BB4D549839C9D46C06889538D"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H2CD2EE2F8AB44E06BFC8FF31D4388EAD"><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="HEB3F1772B1D447D4B0201A9C19C2E5AD" 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="H73C4B37220F84DF884DD7B52F18966EA"><enum>(C)</enum><clause commented="no" display-inline="yes-display-inline" id="H0BAC67AA8CD64C0DBE43AA20EB9479DE"><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="H01F543CE44CC43E9B579384908ACC209" 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="H9B22A5F9389549E987D97C1ACE24052C"><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="HEFACE067B6BD43B7A730EB3D14ADDAEC"><enum>(4)</enum><header>Generic drug
facility fee and active pharmaceutical ingredient facility fee</header>
<subparagraph id="H707584E1DD644184829EE264FE694906"><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="HD0AB64E9FE5E418D96312B9F97AC9319"><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="HC2AB982DE17343CCA735869A4CED1AAC"><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 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="HE7C565FEDF7E4A939D476DDC4D3D3AD5"><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="H28C35983DE6F452C9219E183E140AA4F"><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="H2C6D0BB6BE6345D897CBD9417B05EE43"><enum>(C)</enum><header>Nonreceival for
nonpayment</header>
<clause id="H3CC6B6F6919C486784A49E901B6E68AF"><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="H108A519F97E549DABE83D97FD8AD3D0A"><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 505(j)(5)(A).</text>
</clause></subparagraph></paragraph></subsection><subsection id="H08F14C5C9D0348529C18A59963A13520"><enum>(h)</enum><header>Limitations</header>
<paragraph id="H27DE8895C387436B8FB0743E9F0AB00F"><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="HD5DB3BB823CB4014A7582CDA5D078108"><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="H002C8612B287429E89FE7588CF9C9618"><enum>(i)</enum><header>Crediting and
availability of fees</header>
<paragraph id="H7D39AF23BDD5432582C8D9C0BA28EF2F"><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="HFF71A36C8FF645C99D6C06BE6FDB2B67"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="H77DCF0F145FD4B3F908B5EEC259EB1EE"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause id="H9ACB0E32D6C940A29E4D1656DCBE1F0A"><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="HBED2DAC9F2124BBAA4912DEF3CF4D6DE"><enum>(ii)</enum><text>shall be
available for a fiscal year beginning after fiscal year 2012 to defray the
costs of human generic drug activities (including such costs for an additional
number of full-time equivalent positions in the Department of Health and Human
Services to be engaged in such activities), only if the Secretary allocates for
such purpose an amount for such fiscal year (excluding amounts from fees
collected under this section) no less than $97,000,000 multiplied by the
adjustment factor defined in subsection (p)(3) applicable to the fiscal year
involved.</text>
</clause></subparagraph><subparagraph id="HBD287B9BB0814070AAE268F08A8B884C"><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="H62C878E1EF9248F985095554B832D312"><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="H87A22514308F4BC4805AA00C324BDA18"><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="H5A5DD6F6BBE94682A111D78824BDEABF"><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="H02349771FED54B5388B6A9259480686E"><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="H9BFBB7E749AF4035A89A0A841F3C637A"><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="H661DA9A47D474CDCB19689B3A1C9ABB7"><enum>(l)</enum><header>Positron
emission tomography drugs</header>
<paragraph id="H95358ECCC5A241E8BD5115349C2C9285"><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="H1DD3C5B927B3496395F431066B94F03E"><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="H8EB672049EFD470C9830A9A20C3F4D17"><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="HB920259AF01342D39813D5622218269B"><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="H42CD62EC02B149168AB13E66362F7BC3"><enum>103.</enum><header>Reauthorization;
reporting requirements</header><text display-inline="no-display-inline">Part 7
of subchapter C of chapter VII, as added by section 102 of this Act, is amended
by inserting after section 744B the following:</text>
<quoted-block id="H6243BA60F0A649C9845F587C5136A524" style="OLC">
<section id="HAF9B380BD2B7472D8FCD787D4A54ED9E"><enum>744C.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="HDB69CDBDBFEE4F96867FA87AAC7AD4B4"><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(c) of the Generic Drug User Fee Amendments of 2012 during such
fiscal year and the future plans of the Food and Drug Administration for
meeting the goals.</text>
</subsection><subsection id="H347F79F0375F48A79A2C5BC1345C3499"><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="HEE9D2601179B4E3996D67A8197C5E54E"><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="HBEDA6BFE0D2340E09C8F396544616644"><enum>(d)</enum><header>Reauthorization</header>
<paragraph id="HFF13FDEEC3F24E16BC98E73ADE08BFAD"><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="HE8A8B632732A417898617A91417EF853"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="H675E3DFC293B471695474DB74F7E8BF6"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="H2DD84D762D1C4A898EE5EB6CBD67DA57"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="H39B2A2D181B4433C9B1A9BC87FE7C262"><enum>(D)</enum><text>health care
professionals;</text>
</subparagraph><subparagraph id="HEFAE1823BD6D44139CCDDAF4E5E70E75"><enum>(E)</enum><text>representatives of
patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="H48B5C07E7A674D98B66CD3EE11CF0A3F"><enum>(F)</enum><text>the generic drug
industry.</text>
</subparagraph></paragraph><paragraph id="HE289C6C3F70E4D31BA21F3986BD0698D"><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="H7B0163650EF844709FA08A6FCF240E93"><enum>(A)</enum><text>publish a notice
in the Federal Register requesting public input on the reauthorization;</text>
</subparagraph><subparagraph id="H3691CF5929494D05BDA3C0BE5ECEC78F"><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="HD034407DE7714662BC77ECAC3820E76D"><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="H104AD280AEA4480EAD5D362DCAC13DBC"><enum>(D)</enum><text>publish the
comments on the Food and Drug Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph id="H6A9AF0297439449B9DEB7425C0760FFA"><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="HBF7840B0BAE349458FE973DBE1DCDA55"><enum>(4)</enum><header>Public review of
recommendations</header><text>After negotiations with the generic drug
industry, the Secretary shall—</text>
<subparagraph id="HCDA691F2EAAE48658DBF0F55302A60BE"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the Congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="HEE39C059B7E4401988E18925615AB93F"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="H1DCF6E0BE1A5417683A18E709497A524"><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="HFA670BAEAA584F92BA23831205651C8B"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="H45D016346B094062A459FE496A111626"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="H128F424DB3FD49979FA59AC4305D8C0B"><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="H328CCC40733A431AAFD7DF1523B9027E"><enum>(6)</enum><header>Minutes of
negotiation meetings</header>
<subparagraph id="H41763762E210408186729301E5D1518E"><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 public 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="HEDC9C1CE81E34CE096A81FADD755BAEE"><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="HEE2714733FEC475FB9652BB7469F8D15"><enum>104.</enum><header>Sunset
dates</header>
<subsection id="H4461CEE0E2B84B3E9C647366DA836158"><enum>(a)</enum><header>Authorization</header><text>The
amendments made by section 102 cease to be effective October 1, 2017.</text>
</subsection><subsection id="H1894EBCD1147473BA8B01C096D590B2C"><enum>(b)</enum><header>Reporting
requirements</header><text>The amendments made by section 103 cease to be
effective January 31, 2018.</text>
</subsection></section><section id="HEDBAD6FB27D743F198904CBBA23B36B5"><enum>105.</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 102 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="HCB2728B955334002A6C084E3F39137D2"><enum>106.</enum><header>Amendment with
respect to misbranding</header><text display-inline="no-display-inline">Section
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H1CFCC55BE1934FDA88F3A1B24FCF8D15" style="OLC">
<subsection id="H11D9A5F2ED0440EEBE08FDB1E18BF6E8"><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="H4DF895620534471C9E53C577A340E848"><enum>107.</enum><header>Electronic
submission of applications</header><text display-inline="no-display-inline">The
Federal Food, Drug, and Cosmetic Act is amended by inserting after section 745
the following:</text>
<quoted-block id="HA324FB32C384450B9C0634191D39181E" style="OLC">
<section commented="no" id="HC2C9079A27944A4CAFD874E2BD81B6C5"><enum>745A.</enum><header>Electronic
submission of applications:</header>
<subsection commented="no" id="H5C9721C7264D4451B19935DF02FD31BA"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Beginning no earlier
than 24 months after the issuance of a final guidance issued after public
notice and opportunity for comment, submissions under section 505(j) shall be
submitted in such electronic format as specified by the Secretary in such
guidance.</text>
</subsection><subsection commented="no" id="HD09DE76272EA49B19258000B8652DBE6"><enum>(b)</enum><header>Guidance
contents</header><text>In such guidance, the Secretary may provide a timetable
for establishment by the Secretary of further standards for such electronic
submission, and set forth criteria for waivers of and exemptions from the
requirements of this section.</text>
</subsection><subsection commented="no" id="HEEFA93922F734D0389D7A63621B82C78"><enum>(c)</enum><header>Exception</header><text>This
section shall not apply to submissions described in section
561.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H353FD87763C24E90856F23A8867EF7C0"><enum>108.</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">Subchapter A of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting
after section 713 the following new section:</text>
<quoted-block id="H3A2EEA3A6FFC4F099948A61B96339E0C" style="OLC">
<section id="H8CF3512EB6534C9F9F07904F6107BAFA"><enum>714.</enum><header>Streamlined
hiring authority</header>
<subsection id="HDC135F7187E54F9AA9E5815F6876F003"><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="H63D6D69CACE943ED8FBC1834FC1DB348"><enum>(b)</enum><header>Activities
described</header><text>The activities described in this subsection are
activities under this Act related to human generic drug activities (as defined
in section 744A).</text>
</subsection><subsection id="H2CB27DBE8C2246F696078FB0B3A9FD5B"><enum>(c)</enum><header>Objectives
specified</header><text>The objectives specified in this subsection are 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
101(c) of the Generic Drug User Fee Amendments of 2012.</text>
</subsection><subsection id="HE16C5C5F0D57483CBC07E2C4852321C7"><enum>(d)</enum><header>Internal
controls</header><text>The Secretary shall institute appropriate internal
controls for appointments under this section.</text>
</subsection><subsection id="HA0E016946A4D4F878D05C1EA80045EB2"><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>II</enum><header>Fees
relating to biosimilar biological products</header>
<section id="HAF15B6A9EB784A40A5C92BF59B15EC4F"><enum>201.</enum><header>Short title;
references in title; finding</header>
<subsection id="H4040A226C0A94C2FB7C54E9626E70E8A"><enum>(a)</enum><header>Short
title</header><text>This title may be cited as the <quote>Biosimilar User Fee
Act of 2012</quote>.</text>
</subsection><subsection id="H9E2C5B804A7B421BACDDFE84A44C0C8F"><enum>(b)</enum><header>References in
act</header><text>Except as otherwise specified, amendments made by this title
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.).</text>
</subsection><subsection id="H6A681C59A5A445B98864FE6B42E9FB46"><enum>(c)</enum><header>Finding</header><text>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="H87596393C48F4114AA9094E36E7F0D33"><enum>202.</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 I of this Act,
the following:</text>
<quoted-block id="H5D047C69B0BB4DA0BBFD990A4B6DF3EB" style="OLC">
<part id="H931F7A9CD76C49E4ADF396D9BF004AA7"><enum>8</enum><header>FEES
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS</header>
<section id="HDE82890744404E369AADD73B9238ADE8"><enum>744G.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="HBBF8068BDEF24B4D868277A97DD8433A"><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="H40435969AB43419EB19D5982DF731CCC"><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="H7ADEF1BB2B6546568FC4CDE8267E6745"><enum>(A)</enum><text>one business
entity controls, or has the power to control, the other business entity;
or</text>
</subparagraph><subparagraph id="H765A2189C68B46ADB7F069F8CEB09F2E"><enum>(B)</enum><text>a third party
controls, or has power to control, both of the business entities.</text>
</subparagraph></paragraph><paragraph id="HCB0D350544A54B949AAE8693273DB891"><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="HD8A9C68B436D49DD98F62F91CA493B99"><enum>(4)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H2954E40804B24C57B5B6D4DD9808D220"><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="H7AFA69EF20FD4777A0A005AB68094026" indent="up1"><enum>(B)</enum><text>Such term does not include—</text>
<clause id="H5D26E7E5C929443CB58F810C9D6FAA68"><enum>(i)</enum><text>a supplement to such an
application;</text>
</clause><clause id="HC6CC23826245433588F615521D9AD286"><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="H4E87EC601E4F4276A52CD74AA1D03B70"><enum>(iii)</enum><text>an application filed under
section 351(k) of the Public Health Service Act with respect to—</text>
<subclause id="H7967041C14664D69A4C6FB0783057F93"><enum>(I)</enum><text>whole blood or a blood component for
transfusion;</text>
</subclause><subclause id="HDE9929C592FD4E9FAE2A20E8E4C0E668"><enum>(II)</enum><text>an allergenic extract product;</text>
</subclause><subclause id="H27CD2CB4329E4B0B8FB2837C4573C81D"><enum>(III)</enum><text>an in vitro diagnostic biological
product; or</text>
</subclause><subclause id="H0236BA6DEE2546D49121AC7E447547BE"><enum>(IV)</enum><text>a biological product for further
manufacturing use only; or</text>
</subclause></clause><clause id="H7D31E948743A4CA990C5D65038E7FD76"><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="H2A22AF9A0661455596DE74145CEDBCB5"><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="H714C12B976104E0C839CEF01D79A615D"><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="HF90BF41E8C2C467C844916FC359EFA82"><enum>(7)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="H34DA9AEB3B3149CC83DC5B490167D761"><enum>(A)</enum><text>The term
<term>biosimilar biological product establishment</term> means a foreign or
domestic place of business—</text>
<clause id="H0463A630B7FF4F9BA6BCC6BF39FE5684" 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="H813D97228AD84157BCBD91C26339CD46" 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="HBD19352F5830455DAEDAF52BC121FFEC" 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="H3956BF9309CA45A19207F961D961B2EF"><enum>(8)</enum><text>The term
<term>biosimilar initial advisory meeting</term>—</text>
<subparagraph id="H9E45FF09C2AD48138A9C194D781349DA"><enum>(A)</enum><text>means a meeting,
if requested, that is limited to—</text>
<clause id="H0DD1EEB509F549BF86D68BE1DF9294DE"><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="HBB1FFCA53A61433B95199D8C0EB65C85"><enum>(ii)</enum><text>if so, general
advice on the expected content of the development program; and</text>
</clause></subparagraph><subparagraph id="HE2F17907654140DCBEB34CF483F2A983"><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="H8D5CC49CB333470395D97FF37EF9AA53"><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="H72DFA595DE0F45F28D8D5A89C0D28723"><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="H55E9608E6B3941F2AACB5FD6B9D24286"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="H367EA37AE826476A876A2DC6B3524D8D"><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="H3A43C5940D1741048940E9974A7B1AA4"><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="HC9F960EBE2744C49A2677E0FB3CC6E69"><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="H239FAF6C78A341BE8E1D2E308B38679A"><enum>(11)</enum><text>The term
<term>financial hold</term>—</text>
<subparagraph id="H5149649AA87A43A6B907F970C5C6CF30"><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="HA65F1E2291954EC4BF76A2B442F978BC"><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="H3D10174F2E7D4840B980550B0B4F2B71"><enum>(12)</enum><text>The term
<term>person</term> includes an affiliate of such person.</text>
</paragraph><paragraph id="HDBA8C79990A0419ABAD8F81EDB34F6A0"><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="H153CBBA302174AA09DFAFA3E81376AD1"><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="H8C26DF618A5A4A5A99BBBC96FE41E70D"><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="HA639CDF4E5DA4FC8BD8E897239059565"><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="H659826DA44924FC6B24FAA134DC765BE"><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="HBD74BA585A484DE99308C6E43706E85B"><enum>(E)</enum><text>Monitoring of
research conducted in connection with the review of biosimilar biological
product applications.</text>
</subparagraph><subparagraph id="H0571B825346F46FFA7993A16C0261B14"><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="H3504C3EA27E14CF3ADF947ADC932F35A"><enum>(i)</enum><text>Collecting,
developing, and reviewing safety information on biosimilar biological products,
including adverse event reports.</text>
</clause><clause id="H8BA12100B5834475B8F4465B1AAABC56"><enum>(ii)</enum><text>Developing and
using improved adverse-event data-collection systems, including information
technology systems.</text>
</clause><clause id="HC91ED83093A1464D92E54B0F495CA48F"><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="H533BE64A2C734748BA2AF3EF7D900493"><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="HD8705C11D86D4B58B9DF406781459221"><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="HAD608979BA6D40778BF0EE41FF0ACA76"><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="H41561D7A21354DC98AE16FBDE91D8748"><enum>744H.</enum><header>Authority to
assess and use biosimilar biological product fees</header>
<subsection id="HABBEABC77B3A4C3187AF0AFC5D909B39"><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="HEAB4A523250A478DB707142491CAD968"><enum>(1)</enum><header>Biosimilar
development program fees</header>
<subparagraph id="HF1F80D32E12D48E798FEC46B9352EF60"><enum>(A)</enum><header>Initial
biosimilar biological product development fee</header>
<clause id="H754607F5A30A493CA6327127CAB5AAE6"><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="HD944A7FF8EAA475C8FB30875BABB832E"><enum>(ii)</enum><header>Meeting
request</header><text>The meeting request defined in this clause is a request
for a biosimilar biological product development meeting for a product.</text>
</clause><clause id="H1B5A6A3151874479963AD1189684C842"><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="H58A99ADBA8494827805DA653E240FDA2"><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="HE84D53E13BC349B58BF888744B4692C3"><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="H0E5CB44A306B417CA1203DFF79935A18"><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="H1FAF3589351F4084A766464A11715ED4"><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="H24E40D15A6D94ACEAF70106BFE56FC49"><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="HEE7FE730CCFE4306BBC58A7312BE331B"><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="HAB4454C0DCDE4D859A624B256C81BC11"><enum>(B)</enum><header>Annual
biosimilar biological product development fee</header>
<clause display-inline="no-display-inline" id="H4F3988E069244BFD9188809A9F49AEC8"><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="H4D515E1F386B49E8B8A4A2562E886992"><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="HAFD12746D90549038DB0617BA6B62CEA"><enum>(I)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</subclause><subclause id="H6699A86849F844B28888148DDD870F26"><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="H4CCABA856EBB4DB4AEA234A767FB96C8"><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="HCA35EB15A9F2438A8A408057DFCA6AFD"><enum>(I)</enum><text>submitted a
marketing application for the biological product that was accepted for filing;
or</text>
</subclause><subclause id="H48DDF47675664D868C5EAA2F6B43A7D0"><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="H4E32737032C94EEC99BD4A3C0BB3B400"><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="H97A9B8968A91484ABD7989C1ACAFA79F"><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="H9A5742388C294914AD077E8C87968D0F"><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="H361E99E7FD8B43AC8988C208646CE4FF"><enum>(D)</enum><header>Reactivation
fee</header>
<clause id="HC3DF7BB9E5F04955BF7337B9E89B2146"><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="H783229B3383A471C890E06BD1185707E"><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="H98093D38EB754A399C333F840DD74C7C"><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="HB95519B3A6C347E9A852B4A6E6B4BBFA"><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="HB8B9004DBB8F4E138D91B28EDF6B2077"><enum>(E)</enum><header>Effect of
failure to pay biosimilar development program fees</header>
<clause id="H37797AEF11F44D2DB66AA534178C5ACF"><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="H0DD1CB3A515441409300DCC6B3C6CCF9"><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="H4468D754A8DC4270BF6D4216A293F454"><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="H23F5916C7E1B4335995C6E93ED2E7402"><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="H3A2F5CAE63684BC0BD8BB42D6DA760A7"><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="HC474CBE4993844C5AC6BE22D110128B1"><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="HB7DECB8C68C147878F6DAD35CCFBC5B3"><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="H3E53E1EEC73E4C36999FB9A97DC76848"><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="HD97390F947E24C8599782B37B823BD2F"><enum>(F)</enum><header>Limits regarding
biosimilar development program fees</header>
<clause id="H24269903BD0D4B80967121EE3B4764B8"><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="HCE03D048031E446F9A62D9000B626371"><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="H4DEDE0436C6D4C70A6EAED1B93A69CB0"><enum>(2)</enum><header>Biosimilar
biological product application and supplement fee</header>
<subparagraph id="H719AB115DFE04A6FBAC2CB184741EC8F"><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="HDACCB9C9E8754DBE86C2764A7BF9A249"><enum>(i)</enum><text>A
fee for a biosimilar biological product application that is equal to—</text>
<subclause id="H06E4943D173D44338F1B8F9E4C5123E1"><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="H912B0119287C42498E57ED9594BE6699"><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="H3749F579E0FD4AE08F2CBE7BF7BFF693"><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="H3E4DE0A3A5E0499E9D2B82B3CC4DB72B"><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="H969C7CD442AF48E6A93C077D54E30150"><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="H4EBE7AA30FAB4955A83FD16F17D43272"><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="H1A2E8151262643F6AA21F615B567C0DF"><enum>(B)</enum><header>Reduction in
fees</header><text>Notwithstanding section 204 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="H2D2EA34D0AF24F8BB387BC5752D21677"><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="HDD5E611B7E674E69A3D557226A120B9D"><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="H308BEEB99CBC48BC961502582CFF7A52"><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="H7D958B359B4549AD9B848DFC1F3E186A"><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="H55FF2C6131DC495F9D3ADB05757FE559"><enum>(3)</enum><header>Biosimilar
biological product establishment fee</header>
<subparagraph commented="no" id="H121E6CC299C04166A3318FBCEA0234F1"><enum>(A)</enum><header>In
general</header><text>Except as provided in subparagraph (E)(ii), 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="H5393A35E0E4C4440B765785FCF9CC2EC"><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="H41DAF4138350450CBDF0A645CFA14E71"><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="HECCF220F58424B438C562C1BB2CED761"><enum>(i)</enum><text>the first business
day on or after October 1 of such fiscal year; or</text>
</clause><clause commented="no" id="H97AE8618294244FBB5E7143D88E7444A"><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="H093FF0962B5A42C4B5E8655B18265680"><enum>(D)</enum><header>Application to
establishment</header>
<clause id="H6D5F0B39B43643BEADCDABFA794D57F8"><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="HFEB3FA5802B241498585F14410B85C22"><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="H8A3D7E4B76454561B1D9AF0B44CDC434"><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="HE343CA40BF494674879B37077A3339EE"><enum>(i)</enum><text>that did not
manufacture the biosimilar biological product in the previous fiscal year;
and</text>
</clause><clause commented="no" id="HFA55A73F2FD347A6AC78C5F473B91915"><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="HE11FEA569E6D4DBB89CF3A39BDA51098"><enum>(4)</enum><header>Biosimilar
biological product fee</header><text display-inline="yes-display-inline"></text>
<subparagraph display-inline="no-display-inline" id="HA26AE0EFC6DC4277B5C3357A9AB28A95"><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="HA72939727B084490AAA39D15A74D57AF"><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="H23ED575F2EAA4AFFACDB267F9D66E51C"><enum>(i)</enum><text>the first business
day on or after October 1 of each such year; or</text>
</clause><clause id="HA8A106A83323432291AC85326F0595C4"><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="HCB57D56AA2C042B1ADD1985DB3667449"><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="H583C9469BE86458DBFCD972FCC5D9860"><enum>(b)</enum><header>Fee setting and
amounts</header>
<paragraph id="H626A83E6AFB54B608126BA79B2801912"><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="HED2A37BF54CA445A9D9842A1BF52010C"><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)(5) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="HB5A3C0D1F5674C40971BDF194D327786"><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)(5) for a human drug application described in section
736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="H56B3C219E6D344B2804F9F47AAE2FB1D"><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)(5) for a human drug
application described in section 736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="HA5FD32B4E3FD48FD8C3905B773D40A48"><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)(5) for a human drug application
described in section 736(a)(1)(A)(i) for that fiscal year.</text>
</subparagraph><subparagraph id="H56A972B524FF4C67B002B9009026D439"><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)(5) for a prescription drug
establishment for that fiscal year.</text>
</subparagraph><subparagraph id="H72510A7EBA614AD7B54B9D37B49E6BEF"><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)(5) for a prescription drug product for that
fiscal year.</text>
</subparagraph></paragraph><paragraph id="HB19C43E8CC7F45E484724FB75EA99A7B"><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="H5B9BAEF30BEC4B44A818087A305C6A8C"><enum>(c)</enum><header>Application fee
waiver for small business</header>
<paragraph id="H6D97B451D9884205A96A3383FB16EB45"><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="H138F5273EC6749A9982889CC17E37387"><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="H7C5444666B254A7BB566F30A77B2D28D"><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="HB52779EDBF51468C97786CC2CB4D4E7E"><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="HE67D844D3718467FBCCB300AA69FA188"><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="HA4FD69B4C6EF477F818285B9447D21B8"><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="HAB2233DA6EF14A3C9011BF3B4A9215B3"><enum>(e)</enum><header>Crediting and
availability of fees</header>
<paragraph id="H8626F50120AD4B3AAC2A3B31E8D19A54"><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="H40F807656F8A47F5B9B81DEFB51FD6BB"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="HC47817B334EC4EAE8CE8E03A03DCD502"><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="H2F2BC37E7F91450D94B0B82BD5A68520"><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="H8714F6BA5F744BC9915BD248498590ED"><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="H36B945FD6ED94D8984798C40311DA966"><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="H9637CB6F39264AFEBC281E0B725CB9D6"><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="HA166E8B3324440FFBF0C77CBD794D7F7"><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="H188C53F4222F415B9C0C0FDBCB44AA5D"><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="H002C2BC57CFC4BEB90ACF41EAF7C0AC1"><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="HF9E32666739847059A81B6E7DB91E605"><enum>203.</enum><header>Reauthorization;
reporting requirements</header><text display-inline="no-display-inline">Part 8
of subchapter C of chapter VII, as amended by section 202 of this Act, is
further amended by inserting after section 744H the following:</text>
<quoted-block id="H63B9BB3905F04D3CB8484842789D7D1E" style="OLC">
<section id="H7D9FE279CF1949668D882E90FA2D7942"><enum>744I.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="HB6885E508CF149B5A0F6C2EB2C18744E"><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 201(c) of the Biosimilars User Fee Act of 2012 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="HBAF7225094B14077AE0F79D08B1B4D15"><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="H314B6E57E4BB4D9A8FB3E502C4954D67"><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="H05109CC3541B4D03A064006B21919321"><enum>(d)</enum><header>Study</header>
<paragraph id="H7AF692976580479CBD15690DC62FA396"><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="H4B3D4BA556A94CBAA1216DD5031C8648"><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="H16802FEF42814DB6ABBF7B2FEE7DE4CC"><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="H993E84B15A934D9A80E7F78159E894CB"><enum>(e)</enum><header>Reauthorization</header>
<paragraph id="HABA5C473A0EE4B6EA9243A5B035D23F7"><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="HED48E3A085E348BA934C401C1AD98838"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="H158FEFF5DD4842BD9AFC0F9EFD5E2502"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="H2904CC621C8740A0A35770CF5664FB77"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="HEC2F9BFE080745F6952BCF2B67B634C2"><enum>(D)</enum><text>health care
professionals;</text>
</subparagraph><subparagraph id="H18CE7D43B9F3452180814846FC98A19A"><enum>(E)</enum><text>representatives of
patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="H2F1C21369A4D4C3F8886DFC6F4575A2F"><enum>(F)</enum><text>the regulated
industry.</text>
</subparagraph></paragraph><paragraph id="H8F336712134B462F92002D7D138C2042"><enum>(2)</enum><header>Public review of
recommendations</header><text>After negotiations with the regulated industry,
the Secretary shall—</text>
<subparagraph id="HE6ABC5A41EBD45B4B75E3A4535ECFE2B"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the Congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="H53FFA09A30AD4AB38041FF2948F582C1"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="HC92E668858E548AA8A4BFDD4150B63BC"><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="H1D2FE80DE5AA4AAEA036F13A08580ED8"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="H2267DFEBC3A8403CB3FD9B21D526A9D2"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="H1B5410BBD4EA413BB0738025221CCA63"><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="HF194C87482B7473890E7F32002E269BB"><enum>204.</enum><header>Sunset
dates</header>
<subsection id="H51F55600871346F5BD109BD0EA1FC4FC"><enum>(a)</enum><header>Authorization</header><text>The
amendment made by section 202 shall cease to be effective October 1,
2017.</text>
</subsection><subsection id="HFD3BAD9F681740DD93277812DC7C9E13"><enum>(b)</enum><header>Reporting
requirements</header><text>The amendment made by section 203 shall cease to be
effective January 31, 2018.</text>
</subsection></section><section id="HD91F5BD03019443F90E726E3427CFB9D"><enum>205.</enum><header>Effective
date</header>
<subsection id="HBA1771A70CB64188AA0B94F87AED014A"><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="H573B987B11EF49AA954686602C838DD5"><enum>(1)</enum><text>October 1, 2012;
or</text>
</paragraph><paragraph id="HD0184378556B4F7E8F1A6588A085AF6E"><enum>(2)</enum><text>the date of the
enactment of this title.</text>
</paragraph></subsection><subsection id="H07191F06DD7D4DE3A29F5130D3AA7D9D"><enum>(b)</enum><header>Exception</header><text>Fees
under part 7 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="H88A5405EECB34F30935A5FDCCA1C1017"><enum>206.</enum><header>Savings
clause</header><text display-inline="no-display-inline">Notwithstanding section
106 of the Prescription Drug User Fee Amendments of 2007 (21 U.S.C. 379g note),
and notwithstanding the amendments made by this title, part 2 of subchapter C
of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the
day before the date of the enactment of this title, shall continue to be in
effect with respect to human drug applications and supplements (as defined in
such part as of such day) that were accepted by the Food and Drug
Administration for filing on or after October 1, 2007, but before October 1,
2012, with respect to assessing and collecting any fee required by such part
for a fiscal year prior to fiscal year 2013.</text>
</section><section id="HFD619516DD7B4E2F84564CF5EB01AC28"><enum>207.</enum><header>Technical
amendment; 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>