S622 ENR: Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
U.S. Senate
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.This Act may be cited as the
Animal Drug and Animal Generic Drug
User Fee Reauthorization Act of 2013
.
2.Table of contents; references in
Act
(a)The table of contents of this Act is as
follows:
Sec. 1. Short
title.
Sec. 2. Table of contents; references in Act.
TITLE I—Fees relating to animal drugs
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug
fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
TITLE II—Fees relating to generic animal drugs
Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug
fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
(b)Except as otherwise specified, amendments
made by this Act to a section or other provision of law are amendments to such
section or other provision of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
<enum>I</enum><header display-inline="yes-display-inline">Fees relating to animal drugs</header>
<section commented="no" display-inline="no-display-inline" id="idF24B38947FC6403FAF022C0E445C8BB9" section-type="subsequent-section"><enum>101.</enum><header display-inline="yes-display-inline">Short title; finding</header>
<subsection commented="no" display-inline="no-display-inline" id="id4D67D4B50BC5474399DBCD21987163B9"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote>Animal Drug User Fee Amendments of 2013</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idCCB5BB80E2324FCCBA82464242AA3C39"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">Congress finds that the fees authorized by
the amendments made in this title will be dedicated toward expediting the
animal drug development process and the review of new and supplemental animal
drug applications and investigational animal drug submissions as set forth in
the goals identified, for purposes of part 4 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 Energy and
Commerce of the House of Representatives and the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate as set forth in the
Congressional Record.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id18C46899033642ECAD36671387E81948" section-type="subsequent-section"><enum>102.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">Section 739 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-11">21 U.S.C. 379j–11</external-xref>) is amended to read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id2B676713CF5A43E7A28E98883B5193AF" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id2cfb2137b4f849b28383ff7535ad2157" section-type="subsequent-section"><enum>739.</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id2baecaa2201646fd847452d9d7af16b4"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>animal drug
application</term> means an application for approval of any new animal drug
submitted under section 512(b)(1). Such term does not include either a new
animal drug application submitted under section 512(b)(2) or a supplemental
animal drug application.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id75dc24faa3c34c498fbfd7528f195f29"><enum>(2)</enum><text display-inline="yes-display-inline">The term <term>supplemental animal drug
application</term> means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id8d119fd21c4648d1a326ef814ae2b4b4"><enum>(A)</enum><text display-inline="yes-display-inline">a request to the Secretary to approve a
change in an animal drug application which has been approved; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id51e3012b17c1410a992ed6c288462421"><enum>(B)</enum><text display-inline="yes-display-inline">a request to the Secretary to approve a
change to an application approved under section 512(c)(2) for which data with
respect to safety or effectiveness are required.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6a97e76f119640d7b7489daab6a5cb06"><enum>(3)</enum><text display-inline="yes-display-inline">The term <term>animal drug product</term>
means each specific strength or potency of a particular active ingredient or
ingredients in final dosage form marketed by a particular manufacturer or
distributor, which is uniquely identified by the labeler code and product code
portions of the national drug code, and for which an animal drug application or
a supplemental animal drug application has been approved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id45066d48e5bb4af196d4277a5d52bba1"><enum>(4)</enum><text display-inline="yes-display-inline">The term <term>animal drug
establishment</term> means a foreign or domestic place of business which is at
one general physical location consisting of one or more buildings all of which
are within 5 miles of each other, at which one or more animal drug products are
manufactured in final dosage form.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide9601ceef80e4db78d44d5541181cf2b"><enum>(5)</enum><text display-inline="yes-display-inline">The term <term>investigational animal drug
submission</term> means—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id2edccab7936b46849d1ecbf6ec00a0d1"><enum>(A)</enum><text display-inline="yes-display-inline">the filing of a claim for an
investigational exemption under section 512(j) for a new animal drug intended
to be the subject of an animal drug application or a supplemental animal drug
application; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2752196ae8cb42f28d7d3fb12d4b4533"><enum>(B)</enum><text display-inline="yes-display-inline">the submission of information for the
purpose of enabling the Secretary to evaluate the safety or effectiveness of an
animal drug application or supplemental animal drug application in the event of
their filing.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idab5aa508c9ec4de8ac04cf107a60fd1b"><enum>(6)</enum><text display-inline="yes-display-inline">The term <term>animal drug sponsor</term>
means either an applicant named in an animal drug application that has not been
withdrawn by the applicant and for which approval has not been withdrawn by the
Secretary, or a person who has submitted an investigational animal drug
submission that has not been terminated or otherwise rendered inactive by the
Secretary.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id59ce977dfbc243cab1f36852f9980932"><enum>(7)</enum><text display-inline="yes-display-inline">The term <term>final dosage form</term>
means, with respect to an animal drug product, a finished dosage form which is
approved for administration to an animal without substantial further
manufacturing. Such term includes animal drug products intended for mixing in
animal feeds.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8d7966ae48ef4a6fb99cb5bdb30638fd"><enum>(8)</enum><text display-inline="yes-display-inline">The term <term>process for the review of
animal drug applications</term> means the following activities of the Secretary
with respect to the review of animal drug applications, supplemental animal
drug applications, and investigational animal drug submissions:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id57760b3930c54f8b9873957f96fb72cb"><enum>(A)</enum><text display-inline="yes-display-inline">The activities necessary for the review of
animal drug applications, supplemental animal drug applications, and
investigational animal drug submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0e6dbab31cf54fd2a5ed64fd3059f60b"><enum>(B)</enum><text display-inline="yes-display-inline">The issuance of action letters which
approve animal drug applications or supplemental animal drug applications or
which set forth in detail the specific deficiencies in animal drug
applications, supplemental animal drug applications, or investigational animal
drug submissions and, where appropriate, the actions necessary to place such
applications, supplements or submissions in condition for approval.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida5ed9b515c064d799b9b1dd5bd635681"><enum>(C)</enum><text display-inline="yes-display-inline">The inspection of animal drug
establishments and other facilities undertaken as part of the Secretary’s
review of pending animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4660e2af831f46c6b5219d1b9b5088a3"><enum>(D)</enum><text display-inline="yes-display-inline">Monitoring of research conducted in
connection with the review of animal drug applications, supplemental animal
drug applications, and investigational animal drug submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id16c5e7d415c240c39e1a7764e7c8aa43"><enum>(E)</enum><text display-inline="yes-display-inline">The development of regulations and policy
related to the review of animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbca0bdd8d87d4c42987b6660266a124a"><enum>(F)</enum><text display-inline="yes-display-inline">Development of standards for products
subject to review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd31eb8de324c4ed98b7d171b426aa0d6"><enum>(G)</enum><text display-inline="yes-display-inline">Meetings between the agency and the animal
drug sponsor.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9ec33da95791400882f4a37b4d293a0d"><enum>(H)</enum><text display-inline="yes-display-inline">Review of advertising and labeling prior to
approval of an animal drug application or supplemental animal drug application,
but not after such application has been approved.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id280ae9c17847498cb26aebb44e12376e"><enum>(9)</enum><text display-inline="yes-display-inline">The term <term>costs of resources allocated
for the process for the review of animal drug applications</term> means the
expenses in connection with the process for the review of animal drug
applications for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4a075b710b6a4c508c6b1e88e547b378"><enum>(A)</enum><text display-inline="yes-display-inline">officers and employees of the Food and Drug
Administration, contractors of the Food and Drug Administration, advisory
committees consulted with respect to the review of specific animal drug
applications, supplemental animal drug applications, or investigational animal
drug submissions, and costs related to such officers, employees, committees,
and contractors, including costs for travel, education, and recruitment and
other personnel activities;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb8bac221e506493fa513ba7b1b6488cc"><enum>(B)</enum><text display-inline="yes-display-inline">management of information and the
acquisition, maintenance, and repair of computer resources;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0f945ec9caf748b3a1398c0ece5557e3"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance, and repair of fixtures,
furniture, scientific equipment, and other necessary materials and supplies;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id33d0d930d7814ff1ab1fa64b560de746"><enum>(D)</enum><text display-inline="yes-display-inline">collecting fees under section 740 and
accounting for resources allocated for the review of animal drug applications,
supplemental animal drug applications, and investigational animal drug
submissions.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idda64e305fd5e4f5ba8c1921029ec65db"><enum>(10)</enum><text display-inline="yes-display-inline">The term <term>adjustment factor</term>
applicable to a fiscal year refers to the formula set forth in section 735(8)
with the base or comparator month being October 2002.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd530b8631d82409d9e199b02bf4b90b9"><enum>(11)</enum><text display-inline="yes-display-inline">The term <term>person</term> includes an
affiliate thereof.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida520e53d480c419d99108ffc83029fe8"><enum>(12)</enum><text display-inline="yes-display-inline">The term <term>affiliate</term> refers to
the definition set forth in section
735(11).</text>
</paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idE57FA6A8996142F597DE8AD3F7810778" section-type="subsequent-section"><enum>103.</enum><header display-inline="yes-display-inline">Authority to assess and use animal drug
fees</header><text display-inline="no-display-inline">Section 740 of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-12">21 U.S.C. 379j–12</external-xref>) is amended to read as
follows:</text>
<quoted-block display-inline="no-display-inline" id="idE6F90BE0E0A74214B31A51B5B1004BEC" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id20bd7243cd6d4ec0bde67d3531977f61" section-type="subsequent-section"><enum>740.</enum><header display-inline="yes-display-inline">Authority to assess and use animal drug
fees</header>
<subsection commented="no" display-inline="no-display-inline" id="id2dc2344c349f4586842f585b9e903b2a"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Beginning in fiscal year 2004, the
Secretary shall assess and collect fees in accordance with this section as
follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id856c6a5f331349858672440b4b1afaef"><enum>(1)</enum><header display-inline="yes-display-inline">Animal drug application and supplement
fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id96eff9f07a5842a4a4b1a8d0e987e7f7"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person that submits, on or after
September 1, 2003, an animal drug application or a supplemental animal drug
application shall be subject to a fee as follows:</text>
<clause commented="no" display-inline="no-display-inline" id="idf3be932ff6c44f0eb559e8781c278625"><enum>(i)</enum><text display-inline="yes-display-inline">A fee established in subsection (c) for an
animal drug application, except an animal drug application subject to the
criteria set forth in section 512(d)(4).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id0ea29b3247bb47aebd6f6599a5adb1f7"><enum>(ii)</enum><text display-inline="yes-display-inline">A fee established in subsection (c), in an
amount that is equal to 50 percent of the amount of the fee under clause (i),
for—</text>
<subclause commented="no" display-inline="no-display-inline" id="id71eba9cd8cc9432bb086eae9b19271f1"><enum>(I)</enum><text display-inline="yes-display-inline">a supplemental animal drug application for
which safety or effectiveness data are required; and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="iddaa6e8cc556745eba9d35e6e6cfdf566"><enum>(II)</enum><text display-inline="yes-display-inline">an animal drug application subject to the
criteria set forth in section 512(d)(4).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idad0ccb7a9ce2485e856a3962aa83a00b"><enum>(B)</enum><header display-inline="yes-display-inline">Payment</header><text display-inline="yes-display-inline">The fee required by subparagraph (A) shall
be due upon submission of the animal drug application or supplemental animal
drug application.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id00381df24dbb4c6fa9672051607e83ff"><enum>(C)</enum><header display-inline="yes-display-inline">Exception for previously filed application
or supplement</header><text display-inline="yes-display-inline">If an animal
drug application or a supplemental animal drug application 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 or refund), the
submission of an animal drug application or a supplemental animal drug
application 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 commented="no" display-inline="no-display-inline" id="id1fb0e71de8754f73b85f71fbdeec1d3a"><enum>(D)</enum><header display-inline="yes-display-inline">Refund of fee if application refused for
filing</header><text display-inline="yes-display-inline">The Secretary shall
refund 75 percent of the fee paid under subparagraph (B) for any animal drug
application or supplemental animal drug application which is refused for
filing.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida24a0748809b462995e81936d8d6a70c"><enum>(E)</enum><header display-inline="yes-display-inline">Refund of fee if application
withdrawn</header><text display-inline="yes-display-inline">If an animal drug
application or a supplemental animal drug application is withdrawn after the
application or supplement was filed, the Secretary may refund the fee or
portion of the fee paid under subparagraph (B) if no substantial work was
performed on the application or supplement after the application or supplement
was filed. The Secretary shall have the sole discretion to refund the fee under
this paragraph. A determination by the Secretary concerning a refund under this
paragraph shall not be reviewable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd244aeb1ac2344d6963dbdab2111e2ec"><enum>(2)</enum><header display-inline="yes-display-inline">Animal drug product fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="ida938326684b7416ab2de970e84282893"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person—</text>
<clause commented="no" display-inline="no-display-inline" id="idBC3298020FB0493AA055F3DCBFD9368F"><enum>(i)</enum><text display-inline="yes-display-inline">who is named as the applicant in an animal
drug application or supplemental animal drug application for an animal drug
product which has been submitted for listing under section 510; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id05148E5A0284418DA64B1C1692C81E56"><enum>(ii)</enum><text display-inline="yes-display-inline">who, after September 1, 2003, had pending
before the Secretary an animal drug application or supplemental animal drug
application,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">shall pay for each such animal
drug product the annual fee established in subsection (c).</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id286d4e36fdf44cd9bc435819a7fbd697"><enum>(B)</enum><header display-inline="yes-display-inline">Payment; fee due date</header><text display-inline="yes-display-inline">Such fee shall be payable for the fiscal
year in which the animal drug product is first submitted for listing under
section 510, or is submitted for relisting under section 510 if the animal drug
product has been withdrawn from listing and relisted. After such fee is paid
for that fiscal year, such fee shall be due each subsequent fiscal year that
the product remains listed, upon the later of—</text>
<clause commented="no" display-inline="no-display-inline" id="id2a6ea392d4da47048129573d63242b2b"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day after the date of
enactment of an appropriations Act providing for the collection and obligation
of fees for such fiscal year under this section; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idb2ec0ea5d79140838a1d2f511c1e3dc7"><enum>(ii)</enum><text display-inline="yes-display-inline">January 31 of each year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2c4425400aea4a6b88a4e752b3c37385"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Such fee shall be paid only once for each
animal drug product for a fiscal year in which the fee is payable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idec70ef13a7d74d6ba337a08e294490a4"><enum>(3)</enum><header display-inline="yes-display-inline">Animal drug establishment fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id010c49a9657a4137bd22196c97c59427"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person—</text>
<clause commented="no" display-inline="no-display-inline" id="id4acd4cf9864a448a847fa0d313f4f3a3"><enum>(i)</enum><text display-inline="yes-display-inline">who owns or operates, directly or through
an affiliate, an animal drug establishment;</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id642d0b026cdc4f2bbe966b32014f852e"><enum>(ii)</enum><text display-inline="yes-display-inline">who is named as the applicant in an animal
drug application or supplemental animal drug application for an animal drug
product which has been submitted for listing under section 510; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id9c7fb6e0216b4ece94ac63dfe6413f60"><enum>(iii)</enum><text display-inline="yes-display-inline">who, after September 1, 2003, had pending
before the Secretary an animal drug application or supplemental animal drug
application,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">shall be assessed an annual
establishment fee as established in subsection (c) for each animal drug
establishment listed in its approved animal drug application as an
establishment that manufactures the animal drug product named in the
application.</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3f9baeb57de64faf8d8657f94716b49e"><enum>(B)</enum><header display-inline="yes-display-inline">Payment; fee due date</header><text display-inline="yes-display-inline">The annual establishment fee shall be
assessed in each fiscal year in which the animal drug product named in the
application is assessed a fee under paragraph (2) unless the animal drug
establishment listed in the application does not engage in the manufacture of
the animal drug product during the fiscal year. The fee under this paragraph
for a fiscal year shall be due upon the later of—</text>
<clause commented="no" display-inline="no-display-inline" id="id6c8e2638580f4fecab2326fb11e275e1"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day after the date of
enactment of an appropriations Act providing for the collection and obligation
of fees for such fiscal year under this section; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id8288061bb7b24630b96cd9f96dad6f2e"><enum>(ii)</enum><text display-inline="yes-display-inline">January 31 of each year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1ca0cb6f97034855983c73b83030b397"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header>
<clause commented="no" display-inline="no-display-inline" id="id85654F3F1AD54EE7BCE665138E7EBF7A"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">An establishment shall be assessed only one
fee per fiscal year under this section, subject to clause (ii).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id4C9A24E9FF104B879A9F8E585E05E10A"><enum>(ii)</enum><header display-inline="yes-display-inline">Certain manufacturers</header><text display-inline="yes-display-inline">If a single establishment manufactures both
animal drug products and prescription drug products, as defined in section
735(3), such establishment shall be assessed both the animal drug establishment
fee and the prescription drug establishment fee, as set forth in section
736(a)(2), within a single fiscal year.</text>
</clause></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5e99b2cdcba34a879d151c9d44a84bb1"><enum>(4)</enum><header display-inline="yes-display-inline">Animal drug sponsor fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="idc86ef39ce2f34dd3a7ce643d12eba1a6"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person—</text>
<clause commented="no" display-inline="no-display-inline" id="id4713777554EA4736B68AE28C4A83A989"><enum>(i)</enum><text display-inline="yes-display-inline">who meets the definition of an animal drug
sponsor within a fiscal year; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id75DDE84866DB44BCA26229F56E7666E2"><enum>(ii)</enum><text display-inline="yes-display-inline">who, after September 1, 2003, had pending
before the Secretary an animal drug application, a supplemental animal drug
application, or an investigational animal drug submission,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">shall be assessed an annual
sponsor fee as established under subsection (c).</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9bbd59ab18014db9917df43009811793"><enum>(B)</enum><header display-inline="yes-display-inline">Payment; fee due date</header><text display-inline="yes-display-inline">The fee under this paragraph for a fiscal
year shall be due upon the later of—</text>
<clause commented="no" display-inline="no-display-inline" id="id7e4068f8a77841669b9f09685ef74e6e"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day after the date of
enactment of an appropriations Act providing for the collection and obligation
of fees for such fiscal year under this section; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="iddb992fd0b12f410fb9360a188d36568c"><enum>(ii)</enum><text display-inline="yes-display-inline">January 31 of each year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf247453a92744a588729e8746796c011"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Each animal drug sponsor shall pay only one
such fee each fiscal year.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idaf35bbefbdb747f09941f1977c0d1bdc"><enum>(b)</enum><header display-inline="yes-display-inline">Fee revenue amounts</header>
<paragraph commented="no" display-inline="no-display-inline" id="idc6f6d9a0f4fb4101bf6de214b0d82488"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to subsections (c), (d), (f), and
(g)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id6a536a7f69564371933dc08c908acabf"><enum>(A)</enum><text display-inline="yes-display-inline">for fiscal year 2014, the fees required
under subsection (a) shall be established to generate a total revenue amount of
$23,600,000; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb13cfed06f6e4e7aa99336a2bf060685"><enum>(B)</enum><text display-inline="yes-display-inline">for each of fiscal years 2015 through 2018,
the fees required under subsection (a) shall be established to generate a total
revenue amount of $21,600,000.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idee0a35c16b3a4f43ad07525becf7368b"><enum>(2)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Of the total revenue amount determined for
a fiscal year under paragraph (1)—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idcba4797710da4bcf9dac068921f3f593"><enum>(A)</enum><text display-inline="yes-display-inline">20 percent shall be derived from fees under
subsection (a)(1) (relating to animal drug applications and
supplements);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide8c86e8cc8f744a99e582ad1290ed7eb"><enum>(B)</enum><text display-inline="yes-display-inline">27 percent shall be derived from fees under
subsection (a)(2) (relating to animal drug products);</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id85513e950b0c458eb546e8af614947ef"><enum>(C)</enum><text display-inline="yes-display-inline">26 percent shall be derived from fees under
subsection (a)(3) (relating to animal drug establishments); and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3cd66be54caf46099e22401bebd73de5"><enum>(D)</enum><text display-inline="yes-display-inline">27 percent shall be derived from fees under
subsection (a)(4) (relating to animal drug sponsors).</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id1a1c4f8297ca4fa5adf7d7ad041d4c12"><enum>(c)</enum><header display-inline="yes-display-inline">Annual fee setting; adjustments</header>
<paragraph commented="no" display-inline="no-display-inline" id="id1be44308ec41422c91c09183f6d5a32f"><enum>(1)</enum><header display-inline="yes-display-inline">Annual fee setting</header><text display-inline="yes-display-inline">The Secretary shall establish, 60 days
before the start of each fiscal year beginning after September 30, 2003, for
that fiscal year, animal drug application fees, supplemental animal drug
application fees, animal drug sponsor fees, animal drug establishment fees, and
animal drug product fees based on the revenue amounts established under
subsection (b) and the adjustments provided under this subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idab2a98ea0a174a14b3c19e52ec354a1f"><enum>(2)</enum><header display-inline="yes-display-inline">Inflation adjustment</header><text display-inline="yes-display-inline">For fiscal year 2015 and subsequent fiscal
years, the revenue amounts 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" display-inline="no-display-inline" id="id11ecb2d82c084e5b85946436249a2b58"><enum>(A)</enum><text display-inline="yes-display-inline">one;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id45520518539845659230174a4d7e3886"><enum>(B)</enum><text display-inline="yes-display-inline">the average annual percent change in the
cost, per full-time equivalent position of the Food and Drug Administration, of
all personnel compensation and benefits paid with respect to such positions for
the first 3 of the preceding 4 fiscal years for which data are available,
multiplied by the average proportion of personnel compensation and benefits
costs to total Food and Drug Administration costs for the first 3 years of the
preceding 4 fiscal years for which data are available; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide1111c4d711a4bc0b60c7bdf4ef39252"><enum>(C)</enum><text display-inline="yes-display-inline">the average annual percent change that
occurred in the Consumer Price Index for urban consumers (Washington-Baltimore,
DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual
index) for the first 3 years of the preceding 4 years for which data are
available multiplied by the average proportion of all costs other than
personnel compensation and benefits costs to total Food and Drug Administration
costs for the first 3 years of the preceding 4 fiscal years for which data are
available.</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">The adjustment made each fiscal year
under this paragraph shall be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 2014 under this
paragraph.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida926d9804abd48fa97bb5eafb148e7d3"><enum>(3)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">For fiscal year 2015 and subsequent fiscal
years, after the revenue amounts established in subsection (b) are adjusted for
inflation in accordance with paragraph (2), the revenue amounts shall be
further adjusted for such fiscal year to reflect changes in the workload of the
Secretary for the process for the review of animal drug applications. With
respect to such adjustment—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id8cf934fc86e7475cb281bedfcfde33c6"><enum>(A)</enum><text display-inline="yes-display-inline">such adjustment shall be determined by the
Secretary based on a weighted average of the change in the total number of
animal drug applications, supplemental animal drug applications for which data
with respect to safety or effectiveness are required, manufacturing
supplemental animal drug applications, investigational animal drug study
submissions, and investigational animal drug protocol submissions submitted to
the Secretary;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idA23B3BFEEFD947EDB19E5DF7AE6AB4DF"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary shall publish in the Federal
Register the fees resulting from such adjustment and the supporting
methodologies; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id241d33caa9aa4458a1ffefc8dde96f73"><enum>(C)</enum><text display-inline="yes-display-inline">under no circumstances shall such
adjustment result in fee revenues for a fiscal year that are less than the fee
revenues for that fiscal year established in subsection (b), as adjusted for
inflation under paragraph (2).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id22d236418f804be3a2a7dec79c87d001"><enum>(4)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">For fiscal year 2018, the Secretary may, in
addition to other adjustments under this subsection, further increase the fees
under this section, if such an adjustment is necessary, to provide for up to 3
months of operating reserves of carryover user fees for the process for the
review of animal drug applications for the first 3 months of fiscal year 2019.
If the Food and Drug Administration has carryover balances for the process for
the review of animal drug applications in excess of 3 months of such operating
reserves, then this adjustment will not be made. If this adjustment is
necessary, then the rationale for the amount of the increase shall be contained
in the annual notice setting fees for fiscal year 2018.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id41001dd940b1473fb08295986f21c6a6"><enum>(5)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may not exceed the total
costs for such fiscal year for the resources allocated for the process for the
review of animal drug applications.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5f5654bf3e724bb5ad446f03903c5dad"><enum>(d)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header>
<paragraph commented="no" display-inline="no-display-inline" id="idaca03700b2a3458da373e43ed7ee6165"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The Secretary shall grant a waiver from or
a reduction of one or more fees assessed under subsection (a) where the
Secretary finds that—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id0605974517334d95abb436828ad5217f"><enum>(A)</enum><text display-inline="yes-display-inline">the assessment of the fee would present a
significant barrier to innovation because of limited resources available to
such person or other circumstances;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id748e3a4b940b4602a7fed665a4d4d2f9"><enum>(B)</enum><text display-inline="yes-display-inline">the fees to be paid by such person will
exceed the anticipated present and future costs incurred by the Secretary in
conducting the process for the review of animal drug applications for such
person;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id0888a19d88004833bc3af69869fd5f22"><enum>(C)</enum><text display-inline="yes-display-inline">the animal drug application or supplemental
animal drug application is intended solely to provide for use of the animal
drug in—</text>
<clause commented="no" display-inline="no-display-inline" id="ide819f3de5b8445eebfd87cb6df3ffdfb"><enum>(i)</enum><text display-inline="yes-display-inline">a Type B medicated feed (as defined in
<external-xref legal-doc="regulation" parsable-cite="cfr/21/558.3">section 558.3(b)(3)</external-xref> of title 21, Code of Federal Regulations (or any successor
regulation)) intended for use in the manufacture of Type C free-choice
medicated feeds; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ida97a890bfb924c4f97282e53e50429be"><enum>(ii)</enum><text display-inline="yes-display-inline">a Type C free-choice medicated feed (as
defined in <external-xref legal-doc="regulation" parsable-cite="cfr/21/558.3">section 558.3(b)(4)</external-xref> of title 21, Code of Federal Regulations (or any
successor regulation));</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id54867149a9004d5fa36e326209f80ad0"><enum>(D)</enum><text display-inline="yes-display-inline">the animal drug application or supplemental
animal drug application is intended solely to provide for a minor use or minor
species indication; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id27ee5fb886bf42fdb513d26ac1754466"><enum>(E)</enum><text display-inline="yes-display-inline">the sponsor involved is a small business
submitting its first animal drug application to the Secretary for
review.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idf1216e118c0a48c2941625019319b283"><enum>(2)</enum><header display-inline="yes-display-inline">Use of standard costs</header><text display-inline="yes-display-inline">In making the finding in paragraph (1)(B),
the Secretary may use standard costs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idac78667703e048a2a2b309c08878a132"><enum>(3)</enum><header display-inline="yes-display-inline">Rules for small businesses</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id63490f3311f24674a2a20d163fa01089"><enum>(A)</enum><header display-inline="yes-display-inline">Definition</header><text display-inline="yes-display-inline">In paragraph (1)(E), the term <term>small
business</term> means an entity that has fewer than 500 employees, including
employees of affiliates.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8389047c675f4977af7588406623de9b"><enum>(B)</enum><header display-inline="yes-display-inline">Waiver of application fee</header><text display-inline="yes-display-inline">The Secretary shall waive under paragraph
(1)(E) the application fee for the first animal drug 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 application fees for all subsequent animal drug
applications and supplemental animal drug applications for which safety or
effectiveness data are required in the same manner as an entity that does not
qualify as a small business.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide87ea137ffb94c83ba6358425b8ae68b"><enum>(C)</enum><header display-inline="yes-display-inline">Certification</header><text display-inline="yes-display-inline">The Secretary shall require any person who
applies for a waiver under paragraph (1)(E) to certify their qualification for
the waiver. The Secretary shall periodically publish in the Federal Register a
list of persons making such certifications.</text>
</subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ide7cd2c8d294d4fc3ae7c308c5a04b6f2"><enum>(e)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header><text display-inline="yes-display-inline">An animal drug application or supplemental
animal drug application 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. An investigational
animal drug submission under section 739(5)(B) that is submitted by a person
subject to fees under subsection (a) shall be considered incomplete and shall
not be accepted for review by the Secretary until all fees owed by such person
have been paid. The Secretary may discontinue review of any animal drug
application, supplemental animal drug application or investigational animal
drug submission from a person if such person has not submitted for payment all
fees owed under this section by 30 days after the date upon which they are
due.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id65edffaa16784560a40ead49845e81e5"><enum>(f)</enum><header display-inline="yes-display-inline">Assessment of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id8097173620504c51b2377b93e98f8166"><enum>(1)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2003 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 2003 (excluding the
amount of fees appropriated for such fiscal year) multiplied by the adjustment
factor applicable to the fiscal year involved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide7984a1f0bf44d048c6f6fc03396fa82"><enum>(2)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">If the Secretary does not assess fees under
subsection (a) during any portion of a fiscal year because of paragraph (1) 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 animal drug applications, supplemental animal drug applications,
investigational animal drug submissions, animal drug sponsors, animal drug
establishments and animal drug products 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 commented="no" display-inline="no-display-inline" id="id26b0ce484bc3479abb5a8698156becd0"><enum>(g)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id69eefe8b0407495781fe5652401c79d4"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to paragraph (2)(C), 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 be appropriated 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 salary and expenses with such
fiscal year limitation. The sums transferred shall be available solely for the
process for the review of animal drug applications.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9f693160d00841d9812c3b60ddd7ac5f"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation acts</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id1e7f16bd4e9244d19b3f9d9a1b05c393"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The fees authorized by this section—</text>
<clause commented="no" display-inline="no-display-inline" id="id06bada831ef44b2b83d2b209e2b20282"><enum>(i)</enum><text display-inline="yes-display-inline">subject to subparagraph (C), 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 commented="no" display-inline="no-display-inline" id="id46588b6b48e84a3f83c15e128c4fd3b2"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be available to defray increases in
the costs of the resources allocated for the process for the review of animal
drug applications (including increases in 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) over such costs, excluding costs paid
from fees collected under this section, for fiscal year 2003 multiplied by the
adjustment factor.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id392449b0361a4c37b7b53aad1ef92fcb"><enum>(B)</enum><header display-inline="yes-display-inline">Compliance</header><text display-inline="yes-display-inline">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 the process for the review of animal
drug applications—</text>
<clause commented="no" display-inline="no-display-inline" id="id403d638ecdd940a8b4b5df219a49f2c2"><enum>(i)</enum><text display-inline="yes-display-inline">are not more than 3 percent below the level
specified in subparagraph (A)(ii); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id5d49f7d3dd7949dabc7af64aa5601d38"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="id843D35BAAB274BAFB62E986A7096C7C2"><enum>(I)</enum><text display-inline="yes-display-inline">are more than 3 percent below the level
specified in subparagraph (A)(ii), and fees assessed for the fiscal year
following the subsequent fiscal year are decreased by the amount in excess of 3
percent by which such costs fell below the level specified in subparagraph
(A)(ii); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="idB5FA6A04D5DF454B997DB044F9DFCE62" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id31dff28713af4d34bad74c8d4bee74b4"><enum>(C)</enum><header display-inline="yes-display-inline">Provision for early payments</header><text display-inline="yes-display-inline">Payment of fees authorized under this
section for a fiscal year, prior to the due date for such fees, may be accepted
by the Secretary in accordance with authority provided in advance in a prior
year appropriations Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9edc07c1ec99401386901a6f38345481"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">For each of
the fiscal years 2014 through 2018, there is authorized to be appropriated for
fees under this section an amount equal to the total revenue amount determined
under subsection (b) for the fiscal year, as adjusted or otherwise affected
under subsection (c) and paragraph (4).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idccfd5c44eb3448a68c4d6e6b4c9dd806"><enum>(4)</enum><header display-inline="yes-display-inline">Offset of overcollections; recovery of
collection shortfalls</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id184e5d32ed594ca0bf3ffd409d100a1c"><enum>(A)</enum><header display-inline="yes-display-inline">Offset of overcollections</header><text display-inline="yes-display-inline">If the sum of the cumulative amount of fees
collected under this section for fiscal years 2014 through 2016 and the amount
of fees estimated to be collected under this section for fiscal year 2017
(including any increased fee collections attributable to subparagraph (B)),
exceeds the cumulative amount appropriated pursuant to paragraph (3) for the
fiscal years 2014 through 2017, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as provided in
paragraph (1), and shall be subtracted from the amount of fees that would
otherwise be authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2018.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id59f70c4eda2b48a990d9c7b9ac351e11"><enum>(B)</enum><header display-inline="yes-display-inline">Recovery of collection shortfalls</header>
<clause commented="no" display-inline="no-display-inline" id="id104c67d7fb734180b2c3e8a8b1a865b4"><enum>(i)</enum><header display-inline="yes-display-inline">Fiscal year 2016</header><text display-inline="yes-display-inline">For fiscal year 2016, the amount of fees
otherwise authorized to be collected under this section shall be increased by
the amount, if any, by which the amount collected under this section and
appropriated for fiscal year 2014 falls below the amount of fees authorized for
fiscal year 2014 under paragraph (3).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id734261ab2af44cfe94750df06bcd059a"><enum>(ii)</enum><header display-inline="yes-display-inline">Fiscal year 2017</header><text display-inline="yes-display-inline">For fiscal year 2017, the amount of fees
otherwise authorized to be collected under this section shall be increased by
the amount, if any, by which the amount collected under this section and
appropriated for fiscal year 2015 falls below the amount of fees authorized for
fiscal year 2015 under paragraph (3).</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idcce94146ddcd49a68e7c0fff8fff7738"><enum>(iii)</enum><header display-inline="yes-display-inline">Fiscal year 2018</header><text display-inline="yes-display-inline">For fiscal year 2018, the amount of fees
otherwise authorized to be collected under this section (including any
reduction in the authorized amount under subparagraph (A)), shall be increased
by the cumulative amount, if any, by which the amount collected under this
section and appropriated for fiscal years 2016 and 2017 (including estimated
collections for fiscal year 2017) falls below the cumulative amount of fees
authorized under paragraph (3) for fiscal years 2016 and 2017.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idc76efd22b8394a63903cc6e58714edf1"><enum>(h)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">In any case where the Secretary does not
receive payment of a fee assessed under subsection (a) within 30 days after it
is due, such fee shall be treated as a claim of the United States Government
subject to subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idda35a235af3e4f8f9c8d98427c724d62"><enum>(i)</enum><header display-inline="yes-display-inline">Written requests for waivers, reductions,
and refunds</header><text display-inline="yes-display-inline">To qualify for
consideration for a waiver or reduction under subsection (d), or for a refund
of any fee collected in accordance with subsection (a), a person shall submit
to the Secretary a written request for such waiver, reduction, or refund not
later than 180 days after such fee is due.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id711bcda79b1640eda8809e41b0caa566"><enum>(j)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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 the process of the review of animal drug applications, be reduced to
offset the number of officers, employees, and advisory committees so
engaged.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id16bb5dd7abb14d298f632d69081702f3"><enum>(k)</enum><header display-inline="yes-display-inline">Abbreviated new animal drug
applications</header><text display-inline="yes-display-inline">The Secretary
shall—</text>
<paragraph commented="no" display-inline="no-display-inline" id="id33baecf53cf54a36b38df809eb9926cb"><enum>(1)</enum><text display-inline="yes-display-inline">to the extent practicable, segregate the
review of abbreviated new animal drug applications from the process for the
review of animal drug applications; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfcf2953d5595412b81d55a821bdc4cf6"><enum>(2)</enum><text display-inline="yes-display-inline">adopt other administrative procedures to
ensure that review times of abbreviated new animal drug applications do not
increase from their current level due to activities under the user fee
program.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idF95379A251544E6E81CF9BBCFDFA1C6E" section-type="subsequent-section"><enum>104.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header><text display-inline="no-display-inline">Section 740A of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-13">21 U.S.C. 379j–13</external-xref>) is amended to read
as follows:</text>
<quoted-block display-inline="no-display-inline" id="id42045B5453184AC8B1E58DE58F9C326B" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id169ab2424afb43bba1e9aa0871d919b9" section-type="subsequent-section"><enum>740A.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="ide710374a1b3649a282c6a20d66db3469"><enum>(a)</enum><header display-inline="yes-display-inline">Performance report</header><text display-inline="yes-display-inline">Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are collected
under this part, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report concerning the
progress of the Food and Drug Administration in achieving the goals identified
in the letters described in section 101(b) of the Animal Drug User Fee
Amendments of 2013 toward expediting the animal drug development process and
the review of the new and supplemental animal drug applications and
investigational animal drug submissions during such fiscal year, the future
plans of the Food and Drug Administration for meeting the goals, the review
times for abbreviated new animal drug applications, and the administrative
procedures adopted by the Food and Drug Administration to ensure that review
times for abbreviated new animal drug applications are not increased from their
current level due to activities under the user fee program.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id036e8e685fd2433a9a150752fc6853c9"><enum>(b)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are collected
under this part, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report on the
implementation of the authority for such fees during such fiscal year and the
use, by the Food and Drug Administration, of the fees collected during such
fiscal year for which the report is made.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id70c74929fa794ceda549be2e4bcdb860"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idebefb335a8394bb6b022f739b5489539"><enum>(d)</enum><header display-inline="yes-display-inline">Reauthorization</header>
<paragraph commented="no" display-inline="no-display-inline" id="id57095eef82914448879892c2b5cfe99c"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In developing recommendations to present to
the Congress with respect to the goals, and plans for meeting the goals, for
the process for the review of animal drug applications for the first 5 fiscal
years after fiscal year 2018, and for the reauthorization of this part for such
fiscal years, the Secretary shall consult with—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="ide111af8ca37e4693b84ca1626c83cd47"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor,
and Pensions of the Senate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id448d41d83bf441b3a1391bff9bad9137"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the
House of Representatives;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id07b24380644a4aabae82feedc049e120"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id9008aebf19cc479e8b2fd3c7e20d0f68"><enum>(D)</enum><text display-inline="yes-display-inline">veterinary professionals;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd5d4740bfc954e24b85d86514a3b9cf6"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer
advocacy groups; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idef604a0ab22e4a57b6ea8698e136787b"><enum>(F)</enum><text display-inline="yes-display-inline">the regulated industry.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id89f90dbdd5e04ec2aa435447045e507b"><enum>(2)</enum><header display-inline="yes-display-inline">Prior public input</header><text display-inline="yes-display-inline">Prior to beginning negotiations with the
regulated industry on the reauthorization of this part, the Secretary
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idd1d66eb433a645658f2b64fc5667fa96"><enum>(A)</enum><text display-inline="yes-display-inline">publish a notice in the Federal Register
requesting public input on the reauthorization;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id269baaa080b84fef91902ca8d2aa46a3"><enum>(B)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id7496a4dca3e8451f85d7842dd3216a64"><enum>(C)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id67d013b5e00b4c48a9e36b7df2599129"><enum>(D)</enum><text display-inline="yes-display-inline">publish the comments on the Food and Drug
Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9230d0a90c734dc5a1058fe99e46cfa9"><enum>(3)</enum><header display-inline="yes-display-inline">Periodic consultation</header><text display-inline="yes-display-inline">Not less frequently than once every 4
months during negotiations with the regulated industry, the Secretary shall
hold discussions with representatives of veterinary, 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 commented="no" display-inline="no-display-inline" id="id57f685acb120400697565bc2d0b43fbc"><enum>(4)</enum><header display-inline="yes-display-inline">Public review of
recommendations</header><text display-inline="yes-display-inline">After
negotiations with the regulated industry, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idf9b35f1dc4d6427895456dc260e75775"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under
paragraph (1) to the Congressional committees specified in such
paragraph;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcc769eebd7dc40a8bbe143ac09353cba"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal
Register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idac581df369e847d89cedc615ed466f56"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the
public to provide written comments on such recommendations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2cfd442b7abd45d9b39640e83aaaf812"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may
present its views on such recommendations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6f12127e7ba64095b14fef4d8d658e5a"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views
and comments, revise such recommendations as necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd01a91d0528f42da94f26ccb08545148"><enum>(5)</enum><header display-inline="yes-display-inline">Transmittal of
recommendations</header><text display-inline="yes-display-inline">Not later
than January 15, 2018, the Secretary shall transmit to 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 commented="no" display-inline="no-display-inline" id="ida076c7807f1d43238f245a5a5e6d8458"><enum>(6)</enum><header display-inline="yes-display-inline">Minutes of negotiation meetings</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id9cb0747cfca04ad1ab544a53081714dc"><enum>(A)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">Before presenting the recommendations
developed under paragraphs (1) through (5) to Congress, the Secretary shall
make publicly available, on the Internet Web site of the Food and Drug
Administration, minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the regulated
industry.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id815564b6c0a64e78b0bf983cb962efa2"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any party to the
negotiations as well as significant controversies or differences of opinion
during the negotiations and their
resolution.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idba28b0f6449e4cf594c392846a403b7d" section-type="subsequent-section"><enum>105.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">Notwithstanding the
amendments made by this title, part 4 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-11">21 U.S.C. 379j–11 et seq.</external-xref>), as in effect
on the day before the date of the enactment of this title, shall continue to be
in effect with respect to animal drug applications and supplemental animal drug
applications (as defined in such part as of such day) that on or after October
1, 2008, but before October 1, 2013, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any fee
required by such part for a fiscal year prior to fiscal year 2014.</text>
</section><section commented="no" display-inline="no-display-inline" id="idc9d1267aec5c4c19b7d4aa9c166e8eee" section-type="subsequent-section"><enum>106.</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="no-display-inline">The amendments made by
this title shall take effect on October 1, 2013, or the date of enactment of
this Act, whichever is later, except that fees under part 4 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this
title, shall be assessed for all animal drug applications and supplemental
animal drug applications received on or after October 1, 2013, regardless of
the date of the enactment of this Act.</text>
</section><section commented="no" display-inline="no-display-inline" id="id0b82b2aad4a449f1a2d259581c5c328c" section-type="subsequent-section"><enum>107.</enum><header display-inline="yes-display-inline">Sunset dates</header>
<subsection commented="no" display-inline="no-display-inline" id="ida4a641c87d6f448487f5da62d52db76d"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">Section 740 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-12">21 U.S.C. 379j–12</external-xref>) shall cease to be effective October 1,
2018.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id4cf78229349d409dbfb2ecdbcbe4b405"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">Section 740A of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-13">21 U.S.C. 379j–13</external-xref>) shall cease to be effective January 31,
2019.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id4a9f8594497e4531a4856d553c4bbacf"><enum>(c)</enum><header display-inline="yes-display-inline">Previous sunset provision</header>
<paragraph commented="no" display-inline="no-display-inline" id="idF96D025B9B954D67B403EB31E8339400"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 108 of the Animal Drug User Fee
Amendments of 2008 (<external-xref legal-doc="public-law" parsable-cite="pl/110/316">Public Law 110–316</external-xref>) is repealed.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id704437d4593445a1b663af92ade5d290"><enum>(2)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">The Animal Drug User Fee Amendments of 2008
(<external-xref legal-doc="public-law" parsable-cite="pl/110/316">Public Law 110–316</external-xref>) is amended in the table of contents in section 1, by
striking the item relating to section 108.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id9d1d603607f54f548b231acd56ef8fc7"><enum>(d)</enum><header display-inline="yes-display-inline">Technical clarification</header><text display-inline="yes-display-inline">Effective November 18, 2003, section 5 of
the Animal Drug User Fee Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/130">Public Law 108–130</external-xref>) is repealed.</text>
</subsection></section><enum>II</enum><header display-inline="yes-display-inline">Fees relating to generic animal
drugs</header>
<section commented="no" display-inline="no-display-inline" id="id7BD7ADAD8E32489AACA44A75A67EB6D3" section-type="subsequent-section"><enum>201.</enum><header display-inline="yes-display-inline">Short title; finding</header>
<subsection commented="no" display-inline="no-display-inline" id="id5B7258CB595642B195BCA087E66A0A86"><enum>(a)</enum><header display-inline="yes-display-inline">Short title</header><text display-inline="yes-display-inline">This title may be cited as the
<quote>Animal Generic Drug User Fee Amendments of 2013</quote>.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id3676933E1331421F958CC0D6921A8692"><enum>(b)</enum><header display-inline="yes-display-inline">Finding</header><text display-inline="yes-display-inline">The fees authorized by this title will be
dedicated toward expediting the generic new animal drug development process and
the review of abbreviated applications for generic new animal drugs,
supplemental abbreviated applications for generic new animal drugs, and
investigational submissions for generic new animal drugs 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 Energy and Commerce of the House of
Representatives and the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate as set forth in the Congressional Record.</text>
</subsection></section><section commented="no" display-inline="no-display-inline" id="id105B4517DF0E45CC895D417541929E33" section-type="subsequent-section"><enum>202.</enum><header display-inline="yes-display-inline">Authority to assess and use generic new
animal drug fees</header><text display-inline="no-display-inline">Section 741
of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-21">21 U.S.C. 379j–21</external-xref>) is amended to
read as follows:</text>
<quoted-block display-inline="no-display-inline" id="id317629433EE749E59AA433810759A5AE" style="OLC">
<section commented="no" display-inline="no-display-inline" id="idCE203E7223C9448BA10C1238E884DF6F" section-type="subsequent-section"><enum>741.</enum><header display-inline="yes-display-inline">Authority to assess and use generic new
animal drug fees</header>
<subsection commented="no" display-inline="no-display-inline" id="idA929B54902514A168CBA747A059C7C37"><enum>(a)</enum><header display-inline="yes-display-inline">Types of fees</header><text display-inline="yes-display-inline">Beginning with respect to fiscal year 2009,
the Secretary shall assess and collect fees in accordance with this section as
follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idd033dcc8694346e9bfea5f744da4e5e8"><enum>(1)</enum><header display-inline="yes-display-inline">Abbreviated application fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id64e19cdb78e846eb9618119a878bcb6e"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person that submits, on or after July
1, 2008, an abbreviated application for a generic new animal drug shall be
subject to a fee as established in subsection (c) for such an
application.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddf1c179e7f89415cb864455241acc50c"><enum>(B)</enum><header display-inline="yes-display-inline">Payment</header><text display-inline="yes-display-inline">The fee required by subparagraph (A) shall
be due upon submission of the abbreviated application.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcacc9bc274074a8db26b6e5af3176db4"><enum>(C)</enum><header display-inline="yes-display-inline">Exceptions</header>
<clause commented="no" display-inline="no-display-inline" id="idf1a2fedb5ba147c694c99c050050e03d"><enum>(i)</enum><header display-inline="yes-display-inline">Previously filed application</header><text display-inline="yes-display-inline">If an abbreviated application was submitted
by a person that paid the fee for such application, was accepted for filing,
and was not approved or was withdrawn (without a waiver or refund), the
submission of an abbreviated application 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>
</clause><clause commented="no" display-inline="no-display-inline" id="idf6c5602f895c487eab23ff78be8b7782"><enum>(ii)</enum><header display-inline="yes-display-inline">Certain abbreviated applications involving
combination animal drugs</header><text display-inline="yes-display-inline">An
abbreviated application which is subject to the criteria in section 512(d)(4)
and submitted on or after October 1, 2013 shall be subject to a fee equal to 50
percent of the amount of the abbreviated application fee established in
subsection (c).</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id700c5176ac0f4e729575ac629c0538dd"><enum>(D)</enum><header display-inline="yes-display-inline">Refund of fee if application refused for
filing</header><text display-inline="yes-display-inline">The Secretary shall
refund 75 percent of the fee paid under subparagraph (B) for any abbreviated
application which is refused for filing.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id52f66165be4740efa589fcf66f4f4231"><enum>(E)</enum><header display-inline="yes-display-inline">Refund of fee if application
withdrawn</header><text display-inline="yes-display-inline">If an abbreviated
application is withdrawn after the application was filed, the Secretary may
refund the fee or portion of the fee paid under subparagraph (B) if no
substantial work was performed on the application after the application was
filed. The Secretary shall have the sole discretion to refund the fee under
this subparagraph. A determination by the Secretary concerning a refund under
this subparagraph shall not be reviewable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfd11ae881c8a4a8395dfe4a2a77d51bd"><enum>(2)</enum><header display-inline="yes-display-inline">Generic new animal drug product
fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="iddab15399c61c4d0a8035ebba52405e39"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person—</text>
<clause commented="no" display-inline="no-display-inline" id="idAAC47F3697D44D29AC81C4CF403D37F4"><enum>(i)</enum><text display-inline="yes-display-inline">who is named as the applicant in an
abbreviated application or supplemental abbreviated application for a generic
new animal drug product which has been submitted for listing under section 510;
and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id22C71518F6FC452C98C0C0B94BC7D85A"><enum>(ii)</enum><text display-inline="yes-display-inline">who, after September 1, 2008, had pending
before the Secretary an abbreviated application or supplemental abbreviated
application,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">shall pay for each such generic
new animal drug product the annual fee established in subsection (c).</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id211fc9136c594c11ba4e35b782475d93"><enum>(B)</enum><header display-inline="yes-display-inline">Payment; fee due date</header><text display-inline="yes-display-inline">Such fee shall be payable for the fiscal
year in which the generic new animal drug product is first submitted for
listing under section 510, or is submitted for relisting under section 510 if
the generic new animal drug product has been withdrawn from listing and
relisted. After such fee is paid for that fiscal year, such fee shall be due
each subsequent fiscal year that the product remains listed, upon the later
of—</text>
<clause commented="no" display-inline="no-display-inline" id="id7bddf23393ad4b39b10d88411c43cad6"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day after the date of
enactment of an appropriations Act providing for the collection and obligation
of fees for such fiscal year under this section; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id8830eb3b7c8748c193ac55db8ec8f2cd"><enum>(ii)</enum><text display-inline="yes-display-inline">January 31 of each year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id891f78304ddc40e0a2671e398b8eb9d8"><enum>(C)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Such fee shall be paid only once for each
generic new animal drug product for a fiscal year in which the fee is
payable.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id6557cb8279b544cbb0c55ab780769fc7"><enum>(3)</enum><header display-inline="yes-display-inline">Generic new animal drug sponsor
fee</header>
<subparagraph commented="no" display-inline="no-display-inline" id="iddd8b31386bc8451f9cafcf8812045a00"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Each person—</text>
<clause commented="no" display-inline="no-display-inline" id="id3d9927c3f8ca4d9a86d2ca1c3fea48ce"><enum>(i)</enum><text display-inline="yes-display-inline">who meets the definition of a generic new
animal drug sponsor within a fiscal year; and</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id6ed44938f43440c286c689f69dcdbf4d"><enum>(ii)</enum><text display-inline="yes-display-inline">who, after September 1, 2008, had pending
before the Secretary an abbreviated application, a supplemental abbreviated
application, or an investigational submission,</text>
</clause><continuation-text commented="no" continuation-text-level="subparagraph">shall be assessed an annual
generic new animal drug sponsor fee as established under subsection (c).</continuation-text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id973e315abc5b4c83ba5c0ca8a28c2dd4"><enum>(B)</enum><header display-inline="yes-display-inline">Payment; fee due date</header><text display-inline="yes-display-inline">Such fee shall be due each fiscal year upon
the later of—</text>
<clause commented="no" display-inline="no-display-inline" id="idf3f3c6043fcd42a8adc1d78c4f59d909"><enum>(i)</enum><text display-inline="yes-display-inline">the first business day after the date of
enactment of an appropriations Act providing for the collection and obligation
of fees for such fiscal year under this section; or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id7e94ffff524241c29c0f544d1b328f44"><enum>(ii)</enum><text display-inline="yes-display-inline">January 31 of each year.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id5beff016510541e2b04af8839e31f8b0"><enum>(C)</enum><header display-inline="yes-display-inline">Amount of fee</header><text display-inline="yes-display-inline">Each generic new animal drug sponsor shall
pay only 1 such fee each fiscal year, as follows:</text>
<clause commented="no" display-inline="no-display-inline" id="id1e219392f0c9409ba632949563e83795"><enum>(i)</enum><text display-inline="yes-display-inline">100 percent of the amount of the generic
new animal drug sponsor fee published for that fiscal year under subsection (c)
for an applicant with more than 6 approved abbreviated applications.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="ida54fb62d685f40789260736565e74c79"><enum>(ii)</enum><text display-inline="yes-display-inline">75 percent of the amount of the generic new
animal drug sponsor fee published for that fiscal year under subsection (c) for
an applicant with more than 1 and fewer than 7 approved abbreviated
applications.</text>
</clause><clause commented="no" display-inline="no-display-inline" id="idb071d68510344c6387857401259a5fca"><enum>(iii)</enum><text display-inline="yes-display-inline">50 percent of the amount of the generic new
animal drug sponsor fee published for that fiscal year under subsection (c) for
an applicant with 1 or fewer approved abbreviated applications.</text>
</clause></subparagraph></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id1c956cf667cb4f9ca80915cb7e2b8665"><enum>(b)</enum><header display-inline="yes-display-inline">Fee amounts</header><text display-inline="yes-display-inline">Subject to subsections (c), (d), (f), and
(g), the fees required under subsection (a) shall be established to generate
fee revenue amounts as follows:</text>
<paragraph commented="no" display-inline="no-display-inline" id="idb58dd700a9284e1a9d8f8fc7404cc390"><enum>(1)</enum><header display-inline="yes-display-inline">Total fee revenues for application
fees</header><text display-inline="yes-display-inline">The total fee revenues
to be collected in abbreviated application fees under subsection (a)(1) shall
be $1,832,000 for fiscal year 2014, $1,736,000 for fiscal year 2015, $1,857,000
for fiscal year 2016, $1,984,000 for fiscal year 2017, and $2,117,000 for
fiscal year 2018.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5669b7ac40eb48b79412de7b1b69dc28"><enum>(2)</enum><header display-inline="yes-display-inline">Total fee revenues for product
fees</header><text display-inline="yes-display-inline">The total fee revenues
to be collected in generic new animal drug product fees under subsection (a)(2)
shall be $2,748,000 for fiscal year 2014, $2,604,000 for fiscal year 2015,
$2,786,000 for fiscal year 2016, $2,976,000 for fiscal year 2017, and
$3,175,000 for fiscal year 2018.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id051a16f1c29d483f8b09af6298f78f2a"><enum>(3)</enum><header display-inline="yes-display-inline">Total fee revenues for sponsor
fees</header><text display-inline="yes-display-inline">The total fee revenues
to be collected in generic new animal drug sponsor fees under subsection (a)(3)
shall be $2,748,000 for fiscal year 2014, $2,604,000 for fiscal year 2015,
$2,786,000 for fiscal year 2016, $2,976,000 for fiscal year 2017, and
$3,175,000 for fiscal year 2018.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idf6f2311b96bd43de92f540e7ea172f1b"><enum>(c)</enum><header display-inline="yes-display-inline">Annual fee setting; adjustments</header>
<paragraph commented="no" display-inline="no-display-inline" id="idb497e2af466147f28ffd9808017b1da2"><enum>(1)</enum><header display-inline="yes-display-inline">Annual fee setting</header><text display-inline="yes-display-inline">The Secretary shall establish, 60 days
before the start of each fiscal year beginning after September 30, 2008, for
that fiscal year, abbreviated application fees, generic new animal drug sponsor
fees, and generic new animal drug product fees, based on the revenue amounts
established under subsection (b) and the adjustments provided under this
subsection.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2b530be4ba344a7c8472d1472619bf1e"><enum>(2)</enum><header display-inline="yes-display-inline">Workload adjustment</header><text display-inline="yes-display-inline">The fee revenues shall be adjusted each
fiscal year after fiscal year 2014 to reflect changes in review workload. With
respect to such adjustment:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idce55f0013c2843629bc3559c17c3ff6d"><enum>(A)</enum><text display-inline="yes-display-inline">This adjustment shall be determined by the
Secretary based on a weighted average of the change in the total number of
abbreviated applications for generic new animal drugs, manufacturing
supplemental abbreviated applications for generic new animal drugs,
investigational generic new animal drug study submissions, and investigational
generic new animal drug protocol submissions submitted to the Secretary. The
Secretary shall publish in the Federal Register the fees resulting from this
adjustment and the supporting methodologies.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc839937aeed44f2398c5cd749fee45df"><enum>(B)</enum><text display-inline="yes-display-inline">Under no circumstances shall this workload
adjustment result in fee revenues for a fiscal year that are less than the fee
revenues for that fiscal year established in subsection (b).</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id79f461a2102d4ba5ae16865000a62050"><enum>(3)</enum><header display-inline="yes-display-inline">Final year adjustment</header><text display-inline="yes-display-inline">For fiscal year 2018, the Secretary may, in
addition to other adjustments under this subsection, further increase the fees
under this section, if such an adjustment is necessary, to provide for up to 3
months of operating reserves of carryover user fees for the process for the
review of abbreviated applications for generic new animal drugs for the first 3
months of fiscal year 2019. If the Food and Drug Administration has carryover
balances for the process for the review of abbreviated applications for generic
new animal drugs in excess of 3 months of such operating reserves, then this
adjustment shall not be made. If this adjustment is necessary, then the
rationale for the amount of the increase shall be contained in the annual
notice setting fees for fiscal year 2018.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idab55f7fd91134a609c1f3553647115d0"><enum>(4)</enum><header display-inline="yes-display-inline">Limit</header><text display-inline="yes-display-inline">The total amount of fees charged, as
adjusted under this subsection, for a fiscal year may not exceed the total
costs for such fiscal year for the resources allocated for the process for the
review of abbreviated applications for generic new animal drugs.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id474bf912dc054a5394e194a0c8ccd9d1"><enum>(d)</enum><header display-inline="yes-display-inline">Fee waiver or reduction</header><text display-inline="yes-display-inline">The Secretary shall grant a waiver from or
a reduction of 1 or more fees assessed under subsection (a) where the Secretary
finds that the generic new animal drug is intended solely to provide for a
minor use or minor species indication.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idd9cb7aedcb3d4858b093b99de0a4b2f7"><enum>(e)</enum><header display-inline="yes-display-inline">Effect of failure To pay fees</header><text display-inline="yes-display-inline">An abbreviated application for a generic
new animal drug 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. An investigational
submission for a generic new animal drug that is submitted by a person subject
to fees under subsection (a) shall be considered incomplete and shall not be
accepted for review by the Secretary until all fees owed by such person have
been paid. The Secretary may discontinue review of any abbreviated application
for a generic new animal drug, supplemental abbreviated application for a
generic new animal drug, or investigational submission for a generic new animal
drug from a person if such person has not submitted for payment all fees owed
under this section by 30 days after the date upon which they are due.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idb22582a4cdf04bd8babc79b17fd0c976"><enum>(f)</enum><header display-inline="yes-display-inline">Assessment of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id9edc3a6a8b1344e084165fab3c9608df"><enum>(1)</enum><header display-inline="yes-display-inline">Limitation</header><text display-inline="yes-display-inline">Fees may not be assessed under subsection
(a) for a fiscal year beginning after fiscal year 2008 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 2003 (excluding the
amount of fees appropriated for such fiscal year) multiplied by the adjustment
factor applicable to the fiscal year involved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9a9badbc35d5453db9629e9ff10fb752"><enum>(2)</enum><header display-inline="yes-display-inline">Authority</header><text display-inline="yes-display-inline">If the Secretary does not assess fees under
subsection (a) during any portion of a fiscal year because of paragraph (1) 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 abbreviated applications, generic new animal drug sponsors, and
generic new animal drug products 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 commented="no" display-inline="no-display-inline" id="idfb4a0834e4e44bca971de9ef32b1cb8a"><enum>(g)</enum><header display-inline="yes-display-inline">Crediting and availability of fees</header>
<paragraph commented="no" display-inline="no-display-inline" id="id5b018b8f434347bcbbc30f69a9b09049"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Subject to paragraph (2)(C), 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 be appropriated 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 salary and expenses with such
fiscal year limitation. The sums transferred shall be available solely for the
process for the review of abbreviated applications for generic new animal
drugs.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idc9b1a94605274f0e907affff1e4955c1"><enum>(2)</enum><header display-inline="yes-display-inline">Collections and appropriation acts</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id9062c4e0e546425985494248120ca399"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">The fees authorized by this section—</text>
<clause commented="no" display-inline="no-display-inline" id="id347363eabb5742ed8aa7e3ebe4710571"><enum>(i)</enum><text display-inline="yes-display-inline">subject to subparagraph (C), 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 commented="no" display-inline="no-display-inline" id="ide9db51ba72164628b296549fe1ed056a"><enum>(ii)</enum><text display-inline="yes-display-inline">shall be available to defray increases in
the costs of the resources allocated for the process for the review of
abbreviated applications for generic new animal drugs (including increases in
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) over
such costs, excluding costs paid from fees collected under this section, for
fiscal year 2008 multiplied by the adjustment factor.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd23dbbcd51834e5889d81909ce62b7ae"><enum>(B)</enum><header display-inline="yes-display-inline">Compliance</header><text display-inline="yes-display-inline">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 the process for the review of
abbreviated applications for generic new animal drugs—</text>
<clause commented="no" display-inline="no-display-inline" id="id4fb5d0dd6a4f489e9fecaeae3097a116"><enum>(i)</enum><text display-inline="yes-display-inline">are not more than 3 percent below the level
specified in subparagraph (A)(ii); or</text>
</clause><clause commented="no" display-inline="no-display-inline" id="id64f07a2293324659bd822cce3a163897"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="id1577C26DF6A14192927D1A054851AF0E"><enum>(I)</enum><text display-inline="yes-display-inline">are more than 3 percent below the level
specified in subparagraph (A)(ii), and fees assessed for the fiscal year
following the subsequent fiscal year are decreased by the amount in excess of 3
percent by which such costs fell below the level specified in subparagraph
(A)(ii); and</text>
</subclause><subclause commented="no" display-inline="no-display-inline" id="id655045F5D8054D87866A62190C14BEE1" indent="up1"><enum>(II)</enum><text display-inline="yes-display-inline">such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).</text>
</subclause></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id19580c37f8ff4d26ad08a56edbba00a9"><enum>(C)</enum><header display-inline="yes-display-inline">Provision for early payments</header><text display-inline="yes-display-inline">Payment of fees authorized under this
section for a fiscal year, prior to the due date for such fees, may be accepted
by the Secretary in accordance with authority provided in advance in a prior
year appropriations Act.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idabfe73e158f249abb0232b9ef342c788"><enum>(3)</enum><header display-inline="yes-display-inline">Authorization of
appropriations</header><text display-inline="yes-display-inline">There are
authorized to be appropriated for fees under this section—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idac5784dfb4ef44e893b26b7cde670052"><enum>(A)</enum><text display-inline="yes-display-inline">$7,328,000 for fiscal year 2014;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idd10cd8580e5347f9ad83be3857ca567e"><enum>(B)</enum><text display-inline="yes-display-inline">$6,944,000 for fiscal year 2015;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idef95bb14183f45168b8ef8e5500fc69d"><enum>(C)</enum><text display-inline="yes-display-inline">$7,429,000 for fiscal year 2016;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id70956af7bdf146d9bb768f9aee6dc5a5"><enum>(D)</enum><text display-inline="yes-display-inline">$7,936,000 for fiscal year 2017; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id4d2c2be7c3eb425d86e3526101b3071c"><enum>(E)</enum><text display-inline="yes-display-inline">$8,467,000 for fiscal year 2018;</text>
</subparagraph><continuation-text commented="no" continuation-text-level="paragraph">as adjusted to reflect adjustments in
the total fee revenues made under this section and changes in the total amounts
collected by abbreviated application fees, generic new animal drug sponsor
fees, and generic new animal drug product fees.</continuation-text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2aa2ca2dae8c4cb69c85a6a8d27d64fe"><enum>(4)</enum><header display-inline="yes-display-inline">Offset</header><text display-inline="yes-display-inline">If the sum of the cumulative amount of fees
collected under this section for the fiscal years 2014 through 2016 and the
amount of fees estimated to be collected under this section for fiscal year
2017 exceeds the cumulative amount appropriated under paragraph (3) for the
fiscal years 2014 through 2017, the excess amount shall be credited to the
appropriation account of the Food and Drug Administration as provided in
paragraph (1), and shall be subtracted from the amount of fees that would
otherwise be authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2018.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id985851c562cc46b7bee05be65b7538b3"><enum>(h)</enum><header display-inline="yes-display-inline">Collection of unpaid fees</header><text display-inline="yes-display-inline">In any case where the Secretary does not
receive payment of a fee assessed under subsection (a) within 30 days after it
is due, such fee shall be treated as a claim of the United States Government
subject to subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id5e73490d23ae4a99bb861fae59b1c633"><enum>(i)</enum><header display-inline="yes-display-inline">Written requests for waivers, reductions,
and refunds</header><text display-inline="yes-display-inline">To qualify for
consideration for a waiver or reduction under subsection (d), or for a refund
of any fee collected in accordance with subsection (a), a person shall submit
to the Secretary a written request for such waiver, reduction, or refund not
later than 180 days after such fee is due.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id29448b8b6ce54925be18ca43cca6dc34"><enum>(j)</enum><header display-inline="yes-display-inline">Construction</header><text display-inline="yes-display-inline">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 the process of the review of abbreviated applications for generic
new animal drugs, be reduced to offset the number of officers, employees, and
advisory committees so engaged.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="idBA43A3FF5D0B4A07A6EBEDE134DBD544"><enum>(k)</enum><header display-inline="yes-display-inline">Definitions</header><text display-inline="yes-display-inline">In this section and section 742:</text>
<paragraph commented="no" display-inline="no-display-inline" id="id9e789c630f534fc1a17705f4711f20db"><enum>(1)</enum><header display-inline="yes-display-inline">Abbreviated application for a generic new
animal drug</header><text display-inline="yes-display-inline">The terms
<quote>abbreviated application for a generic new animal drug</quote> and
<quote>abbreviated application</quote> mean an abbreviated application for the
approval of any generic new animal drug submitted under section 512(b)(2). Such
term does not include a supplemental abbreviated application for a generic new
animal drug.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida30b674c75294162b443730015f16a0c"><enum>(2)</enum><header display-inline="yes-display-inline">Adjustment factor</header><text display-inline="yes-display-inline">The term <term>adjustment factor</term>
applicable to a fiscal year is the Consumer Price Index for all urban consumers
(all items; United States city average) for October of the preceding fiscal
year divided by—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="iddc627bb6c4f14deead951018b3911e85"><enum>(A)</enum><text display-inline="yes-display-inline">for purposes of subsection (f)(1), such
Index for October 2002; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idf3c77447412d4cf6b311d82382553bcc"><enum>(B)</enum><text display-inline="yes-display-inline">for purposes of subsection (g)(2)(A)(ii),
such Index for October 2007.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id5673217cf52d44d59d2788efbdfd28dc"><enum>(3)</enum><header display-inline="yes-display-inline">Costs of resources allocated for the
process for the review of abbreviated applications for generic new animal
drugs</header><text display-inline="yes-display-inline">The term <term>costs of
resources allocated for the process for the review of abbreviated applications
for generic new animal drugs</term> means the expenses in connection with the
process for the review of abbreviated applications for generic new animal drugs
for—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="idb6172e6188464671aba1cd8e4c8cf6dd"><enum>(A)</enum><text display-inline="yes-display-inline">officers and employees of the Food and Drug
Administration, contractors of the Food and Drug Administration, advisory
committees consulted with respect to the review of specific abbreviated
applications, supplemental abbreviated applications, or investigational
submissions, and costs related to such officers, employees, committees, and
contractors, including costs for travel, education, and recruitment and other
personnel activities;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id284f904c024147579ef83105e08e3c5e"><enum>(B)</enum><text display-inline="yes-display-inline">management of information, and the
acquisition, maintenance, and repair of computer resources;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id86ce78a8844748a0b5cc9bb6cc761dff"><enum>(C)</enum><text display-inline="yes-display-inline">leasing, maintenance, renovation, and
repair of facilities and acquisition, maintenance, and repair of fixtures,
furniture, scientific equipment, and other necessary materials and supplies;
and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id17faa74bca3b4c2aa225ba900b4a3bc2"><enum>(D)</enum><text display-inline="yes-display-inline">collecting fees under this section and
accounting for resources allocated for the review of abbreviated applications,
supplemental abbreviated applications, and investigational submissions.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id20b1eb3b785c4ec390293f0af646feab"><enum>(4)</enum><header display-inline="yes-display-inline">Final dosage form</header><text display-inline="yes-display-inline">The term <term>final dosage form</term>
means, with respect to a generic new animal drug product, a finished dosage
form which is approved for administration to an animal without substantial
further manufacturing. Such term includes generic new animal drug products
intended for mixing in animal feeds.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id272826959c1744dcb5bed307340b9b2c"><enum>(5)</enum><header display-inline="yes-display-inline">Generic new animal drug</header><text display-inline="yes-display-inline">The term <term>generic new animal
drug</term> means a new animal drug that is the subject of an abbreviated
application.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id58927ba3757e4d39a57beee909079257"><enum>(6)</enum><header display-inline="yes-display-inline">Generic new animal drug
product</header><text display-inline="yes-display-inline">The term
<term>generic new animal drug product</term> means each specific strength or
potency of a particular active ingredient or ingredients in final dosage form
marketed by a particular manufacturer or distributor, which is uniquely
identified by the labeler code and product code portions of the national drug
code, and for which an abbreviated application for a generic new animal drug or
a supplemental abbreviated application has been approved.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id44ea039cf7554eab87ade377979465d6"><enum>(7)</enum><header display-inline="yes-display-inline">Generic new animal drug
sponsor</header><text display-inline="yes-display-inline">The term
<term>generic new animal drug sponsor</term> means either an applicant named in
an abbreviated application for a generic new animal drug that has not been
withdrawn by the applicant and for which approval has not been withdrawn by the
Secretary, or a person who has submitted an investigational submission for a
generic new animal drug that has not been terminated or otherwise rendered
inactive by the Secretary.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfde766ad6a094af99ff2af00b289ee00"><enum>(8)</enum><header display-inline="yes-display-inline">Investigational submission for a generic
new animal drug</header><text display-inline="yes-display-inline">The terms
<term>investigational submission for a generic new animal drug</term> and
<quote>investigational submission</quote> mean—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id5b080929c7b0475391d5f38fee5aaf53"><enum>(A)</enum><text display-inline="yes-display-inline">the filing of a claim for an
investigational exemption under section 512(j) for a generic new animal drug
intended to be the subject of an abbreviated application or a supplemental
abbreviated application; or</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id7b92f5fd2e404d55a274cd8bd2ab2253"><enum>(B)</enum><text display-inline="yes-display-inline">the submission of information for the
purpose of enabling the Secretary to evaluate the safety or effectiveness of a
generic new animal drug in the event of the filing of an abbreviated
application or supplemental abbreviated application for such drug.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id762a596bef624fce92f8f6688bb0ef3b"><enum>(9)</enum><header display-inline="yes-display-inline">Person</header><text display-inline="yes-display-inline">The term <term>person</term> includes an
affiliate thereof (as such term is defined in section 735(11)).</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcef769cd12b94d8790c5c79ae91e12ce"><enum>(10)</enum><header display-inline="yes-display-inline">Process for the review of abbreviated
applications for generic new animal drugs</header><text display-inline="yes-display-inline">The term <term>process for the review of
abbreviated applications for generic new animal drugs</term> means the
following activities of the Secretary with respect to the review of abbreviated
applications, supplemental abbreviated applications, and investigational
submissions:</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id1d28224fcbba42f78f55cd33f84cdb7f"><enum>(A)</enum><text display-inline="yes-display-inline">The activities necessary for the review of
abbreviated applications, supplemental abbreviated applications, and
investigational submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idca7ad63ac97d4c4b9af9c27fbc472598"><enum>(B)</enum><text display-inline="yes-display-inline">The issuance of action letters which
approve abbreviated applications or supplemental abbreviated applications or
which set forth in detail the specific deficiencies in abbreviated
applications, supplemental abbreviated applications, or investigational
submissions and, where appropriate, the actions necessary to place such
applications, supplemental applications, or submissions in condition for
approval.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id6b7613a72e984e13a81702dc0a34d4d6"><enum>(C)</enum><text display-inline="yes-display-inline">The inspection of generic new animal drug
establishments and other facilities undertaken as part of the Secretary’s
review of pending abbreviated applications, supplemental abbreviated
applications, and investigational submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id27e26d94202a4fb1a715b9901fb0b98e"><enum>(D)</enum><text display-inline="yes-display-inline">Monitoring of research conducted in
connection with the review of abbreviated applications, supplemental
abbreviated applications, and investigational submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id1f297d9205094f2e9f3f0ec77f835af8"><enum>(E)</enum><text display-inline="yes-display-inline">The development of regulations and policy
related to the review of abbreviated applications, supplemental abbreviated
applications, and investigational submissions.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbbdb71b7975c4d2cae850f74a353f26d"><enum>(F)</enum><text display-inline="yes-display-inline">Development of standards for products
subject to review.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfe37190931f943e8986405691c20be94"><enum>(G)</enum><text display-inline="yes-display-inline">Meetings between the agency and the generic
new animal drug sponsor.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id682dd24a3be843ecb77a23b85545731f"><enum>(H)</enum><text display-inline="yes-display-inline">Review of advertising and labeling prior to
approval of an abbreviated application or supplemental abbreviated application,
but not after such application has been approved.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id3415d393a8314ab99d600513ca224815"><enum>(11)</enum><header display-inline="yes-display-inline">Supplemental abbreviated application for
generic new animal drug</header><text display-inline="yes-display-inline">The
terms <quote>supplemental abbreviated application for a generic new animal
drug</quote> and <quote>supplemental abbreviated application</quote> mean a
request to the Secretary to approve a change in an approved abbreviated
application.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="id86BF1F833AFE43B28EDEE90F35A3DA96" section-type="subsequent-section"><enum>203.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header><text display-inline="no-display-inline">Section 742 of
the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-22">21 U.S.C. 379j–22</external-xref>) is amended to read
as follows:</text>
<quoted-block display-inline="no-display-inline" id="id007B6113BEBB47D8BCF3460EDCDFD939" style="OLC">
<section commented="no" display-inline="no-display-inline" id="id64016AE763B143F8BB332EDA9D3D69A0" section-type="subsequent-section"><enum>742.</enum><header display-inline="yes-display-inline">Reauthorization; reporting
requirements</header>
<subsection commented="no" display-inline="no-display-inline" id="idcc2b5fe0841b4a58a399eacfdda009d9"><enum>(a)</enum><header display-inline="yes-display-inline">Performance reports</header><text display-inline="yes-display-inline">Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are collected
under this part, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate, and the Committee on
Energy and Commerce of the House of Representatives a report concerning the
progress of the Food and Drug Administration in achieving the goals identified
in the letters described in section 201(b) of the Animal Generic Drug User Fee
Amendments of 2013 toward expediting the generic new animal drug development
process and the review of abbreviated applications for generic new animal
drugs, supplemental abbreviated applications for generic new animal drugs, and
investigational submissions for generic new animal drugs during such fiscal
year.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id835ab04b07944f3495a0b776958364cf"><enum>(b)</enum><header display-inline="yes-display-inline">Fiscal report</header><text display-inline="yes-display-inline">Beginning with fiscal year 2014, not later
than 120 days after the end of each fiscal year during which fees are collected
under this part, the Secretary shall prepare and submit to Committee on Health,
Education, Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report on the implementation of the
authority for such fees during such fiscal year and the use, by the Food and
Drug Administration, of the fees collected during such fiscal year for which
the report is made.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ide8a865f3fe1b4ddcb4bce882749273bc"><enum>(c)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="idfc6a959f0e7c4f0e9ae966273a14cbfa"><enum>(d)</enum><header display-inline="yes-display-inline">Reauthorization</header>
<paragraph commented="no" display-inline="no-display-inline" id="idac49410f3e04466eb5d4705b029658a1"><enum>(1)</enum><header display-inline="yes-display-inline">Consultation</header><text display-inline="yes-display-inline">In developing recommendations to present to
Congress with respect to the goals, and plans for meeting the goals, for the
process for the review of abbreviated applications for generic new animal drugs
for the first 5 fiscal years after fiscal year 2018, and for the
reauthorization of this part for such fiscal years, the Secretary shall consult
with—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id4424ac037ce048e08c13f9ace54078f0"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Energy and Commerce of the
House of Representatives;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id3c0b326cc82b4f2eb486d437381d908d"><enum>(B)</enum><text display-inline="yes-display-inline">the Committee on Health, Education, Labor,
and Pensions of the Senate;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id2007e9060e7f4ce0b9906b7dc174a91e"><enum>(C)</enum><text display-inline="yes-display-inline">scientific and academic experts;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcbae80e7d0434ac3bb6fc50b2419692b"><enum>(D)</enum><text display-inline="yes-display-inline">veterinary professionals;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8a94fc1d5b374adaafd894f8aea8ad47"><enum>(E)</enum><text display-inline="yes-display-inline">representatives of patient and consumer
advocacy groups; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida454eb7bb12e4255b1ef5fabeb9e6b84"><enum>(F)</enum><text display-inline="yes-display-inline">the regulated industry.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id915ae04fbce44fa68d50558bc13be3a5"><enum>(2)</enum><header display-inline="yes-display-inline">Prior public input</header><text display-inline="yes-display-inline">Prior to beginning negotiations with the
regulated industry on the reauthorization of this part, the Secretary
shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="iddd34e804fc044010a55d22cf279343bb"><enum>(A)</enum><text display-inline="yes-display-inline">publish a notice in the Federal Register
requesting public input on the reauthorization;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idbdd37c4c28c545cc92470a1b8f5b60ac"><enum>(B)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id8023f630ea3b43e5b7f94f0391a2c307"><enum>(C)</enum><text display-inline="yes-display-inline">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 commented="no" display-inline="no-display-inline" id="id63c29888c82f4caca110a4dc9f89ad35"><enum>(D)</enum><text display-inline="yes-display-inline">publish the comments on the Food and Drug
Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd320528a5f7645c38d661673a6a963e9"><enum>(3)</enum><header display-inline="yes-display-inline">Periodic consultation</header><text display-inline="yes-display-inline">Not less frequently than once every 4
months during negotiations with the regulated industry, the Secretary shall
hold discussions with representatives of veterinary, 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 commented="no" display-inline="no-display-inline" id="idb6e5f2fa49e94ca7bcaf49911e87812b"><enum>(4)</enum><header display-inline="yes-display-inline">Public review of
recommendations</header><text display-inline="yes-display-inline">After
negotiations with the regulated industry, the Secretary shall—</text>
<subparagraph commented="no" display-inline="no-display-inline" id="id3e2b89a584794471bca05fa2ffd5c086"><enum>(A)</enum><text display-inline="yes-display-inline">present the recommendations developed under
paragraph (1) to the congressional committees specified in such
paragraph;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida0a1729c8cc34b9dae0c2eaf1094eb5f"><enum>(B)</enum><text display-inline="yes-display-inline">publish such recommendations in the Federal
Register;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id8cc0c572ab4d40babe8735eb35f0d0f8"><enum>(C)</enum><text display-inline="yes-display-inline">provide for a period of 30 days for the
public to provide written comments on such recommendations;</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id94f16dea6f284626a20cfc70792d3aa4"><enum>(D)</enum><text display-inline="yes-display-inline">hold a meeting at which the public may
present its views on such recommendations; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ida0afecd1e23a4b2492d2c63e3af311e0"><enum>(E)</enum><text display-inline="yes-display-inline">after consideration of such public views
and comments, revise such recommendations as necessary.</text>
</subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ide67e693bd59046f0bba725622f01a5e0"><enum>(5)</enum><header display-inline="yes-display-inline">Transmittal of
recommendations</header><text display-inline="yes-display-inline">Not later
than January 15, 2018, the Secretary shall transmit to 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 commented="no" display-inline="no-display-inline" id="idb6c9d4b8ddaf488fbdc61d48bc0fc4f0"><enum>(6)</enum><header display-inline="yes-display-inline">Minutes of negotiation meetings</header>
<subparagraph commented="no" display-inline="no-display-inline" id="id8da31d49fa5d4e03acf0fc6e923ea800"><enum>(A)</enum><header display-inline="yes-display-inline">Public availability</header><text display-inline="yes-display-inline">Before presenting the recommendations
developed under paragraphs (1) through (5) to Congress, the Secretary shall
make publicly available, on the Internet Web site of the Food and Drug
Administration, minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the regulated
industry.</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ide3d516771ddb4edb9694aa02f70d8dfd"><enum>(B)</enum><header display-inline="yes-display-inline">Content</header><text display-inline="yes-display-inline">The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any party to the
negotiations as well as significant controversies or differences of opinion
during the negotiations and their
resolution.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" display-inline="no-display-inline" id="idE3F39FD53D1C45CCAF4D42AE9FAB3054" section-type="subsequent-section"><enum>204.</enum><header display-inline="yes-display-inline">Savings
clause</header><text display-inline="no-display-inline">Notwithstanding the
amendments made by this title, part 5 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date
of enactment of this title, shall continue to be in effect with respect to
abbreviated applications for a generic new animal drug and supplemental
abbreviated applications for a generic new animal drug (as defined in such part
as of such day) that on or after October 1, 2008, but before October 1, 2013,
were accepted by the Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a fiscal year prior
to fiscal year 2014.</text>
</section><section commented="no" display-inline="no-display-inline" id="id0093861360504679B096AF5D36435FAA" section-type="subsequent-section"><enum>205.</enum><header display-inline="yes-display-inline">Effective
date</header><text display-inline="no-display-inline">The amendments made by
this title shall take effect on October 1, 2013, or the date of enactment of
this Act, whichever is later, except that fees under part 5 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act, as amended by this
title, shall be assessed for all abbreviated applications for a generic new
animal drug and supplemental abbreviated applications for a generic new animal
drug received on or after October 1, 2013, regardless of the date of enactment
of this Act.</text>
</section><section commented="no" display-inline="no-display-inline" id="id6738992BAF6E4409B631A215FF4D8E5C" section-type="subsequent-section"><enum>206.</enum><header display-inline="yes-display-inline">Sunset dates</header>
<subsection commented="no" display-inline="no-display-inline" id="id7d12783b3b50456b9bcaeb4239a18160"><enum>(a)</enum><header display-inline="yes-display-inline">Authorization</header><text display-inline="yes-display-inline">Section 741 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-21">21 U.S.C. 379j–21</external-xref>) shall cease to be effective October 1,
2018.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="ide4387464b55c450689665d11bd28c6a9"><enum>(b)</enum><header display-inline="yes-display-inline">Reporting requirements</header><text display-inline="yes-display-inline">Section 742 of the Federal Food, Drug, and
Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-22">21 U.S.C. 379j–22</external-xref>) shall cease to be effective January 31,
2019.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id118d05bc7b3c4d39aef1e2668cd6cbbc"><enum>(c)</enum><header display-inline="yes-display-inline">Previous sunset provision</header>
<paragraph commented="no" display-inline="no-display-inline" id="id560945a3ba304afcbfb7e9fb3fe3f851"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text display-inline="yes-display-inline">Section 204 of the Animal Generic Drug User
Fee Act of 2008 (<external-xref legal-doc="public-law" parsable-cite="pl/110/316">Public Law 110–316</external-xref>) is repealed.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idb437a3f3cd77458aaa8b9fdd29c5c6a7"><enum>(2)</enum><header display-inline="yes-display-inline">Conforming amendment</header><text display-inline="yes-display-inline">The Animal Generic Drug User Fee Act of
2008 (<external-xref legal-doc="public-law" parsable-cite="pl/110/316">Public Law 110–316</external-xref>) is amended in the table of contents in section 1, by
striking the item relating to section 204.</text>
</paragraph></subsection></section>
Speaker of the House of Representatives
Vice President of the United States and President of the
Senate