113 S622 PCS: 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>Fees
relating to animal drugs</header>
<section id="idF24B38947FC6403FAF022C0E445C8BB9"><enum>101.</enum><header>Short title;
finding</header>
<subsection id="id4D67D4B50BC5474399DBCD21987163B9"><enum>(a)</enum><header>Short
title</header><text>This title may be cited as the <quote>Animal Drug User Fee
Amendments of 2013</quote>.</text>
</subsection><subsection id="idCCB5BB80E2324FCCBA82464242AA3C39"><enum>(b)</enum><header>Finding</header><text>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 id="id18C46899033642ECAD36671387E81948"><enum>102.</enum><header>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 id="id2cfb2137b4f849b28383ff7535ad2157"><enum>739.</enum><header>Definitions</header><text display-inline="no-display-inline">For purposes of this part:</text>
<paragraph id="id2baecaa2201646fd847452d9d7af16b4"><enum>(1)</enum><text>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 id="id75dc24faa3c34c498fbfd7528f195f29"><enum>(2)</enum><text>The term
<term>supplemental animal drug application</term> means—</text>
<subparagraph id="id8d119fd21c4648d1a326ef814ae2b4b4"><enum>(A)</enum><text>a request to the
Secretary to approve a change in an animal drug application which has been
approved; or</text>
</subparagraph><subparagraph id="id51e3012b17c1410a992ed6c288462421"><enum>(B)</enum><text>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 id="id6a97e76f119640d7b7489daab6a5cb06"><enum>(3)</enum><text>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 id="id45066d48e5bb4af196d4277a5d52bba1"><enum>(4)</enum><text>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 id="ide9601ceef80e4db78d44d5541181cf2b"><enum>(5)</enum><text>The term
<term>investigational animal drug submission</term> means—</text>
<subparagraph id="id2edccab7936b46849d1ecbf6ec00a0d1"><enum>(A)</enum><text>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 id="id2752196ae8cb42f28d7d3fb12d4b4533"><enum>(B)</enum><text>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 id="idab5aa508c9ec4de8ac04cf107a60fd1b"><enum>(6)</enum><text>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 id="id59ce977dfbc243cab1f36852f9980932"><enum>(7)</enum><text>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 id="id8d7966ae48ef4a6fb99cb5bdb30638fd"><enum>(8)</enum><text>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 id="id57760b3930c54f8b9873957f96fb72cb"><enum>(A)</enum><text>The activities
necessary for the review of animal drug applications, supplemental animal drug
applications, and investigational animal drug submissions.</text>
</subparagraph><subparagraph id="id0e6dbab31cf54fd2a5ed64fd3059f60b"><enum>(B)</enum><text>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 id="ida5ed9b515c064d799b9b1dd5bd635681"><enum>(C)</enum><text>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 id="id4660e2af831f46c6b5219d1b9b5088a3"><enum>(D)</enum><text>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 id="id16c5e7d415c240c39e1a7764e7c8aa43"><enum>(E)</enum><text>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 id="idbca0bdd8d87d4c42987b6660266a124a"><enum>(F)</enum><text>Development of
standards for products subject to review.</text>
</subparagraph><subparagraph id="idd31eb8de324c4ed98b7d171b426aa0d6"><enum>(G)</enum><text>Meetings between
the agency and the animal drug sponsor.</text>
</subparagraph><subparagraph id="id9ec33da95791400882f4a37b4d293a0d"><enum>(H)</enum><text>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 id="id280ae9c17847498cb26aebb44e12376e"><enum>(9)</enum><text>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 id="id4a075b710b6a4c508c6b1e88e547b378"><enum>(A)</enum><text>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 id="idb8bac221e506493fa513ba7b1b6488cc"><enum>(B)</enum><text>management of
information and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="id0f945ec9caf748b3a1398c0ece5557e3"><enum>(C)</enum><text>leasing,
maintenance, renovation, and repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and</text>
</subparagraph><subparagraph id="id33d0d930d7814ff1ab1fa64b560de746"><enum>(D)</enum><text>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 id="idda64e305fd5e4f5ba8c1921029ec65db"><enum>(10)</enum><text>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 id="idd530b8631d82409d9e199b02bf4b90b9"><enum>(11)</enum><text>The term
<term>person</term> includes an affiliate thereof.</text>
</paragraph><paragraph id="ida520e53d480c419d99108ffc83029fe8"><enum>(12)</enum><text>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 id="idE57FA6A8996142F597DE8AD3F7810778"><enum>103.</enum><header>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 id="id20bd7243cd6d4ec0bde67d3531977f61"><enum>740.</enum><header>Authority to
assess and use animal drug fees</header>
<subsection id="id2dc2344c349f4586842f585b9e903b2a"><enum>(a)</enum><header>Types of
fees</header><text>Beginning in fiscal year 2004, the Secretary shall assess
and collect fees in accordance with this section as follows:</text>
<paragraph id="id856c6a5f331349858672440b4b1afaef"><enum>(1)</enum><header>Animal drug
application and supplement fee</header>
<subparagraph id="id96eff9f07a5842a4a4b1a8d0e987e7f7"><enum>(A)</enum><header>In
general</header><text>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 id="idf3be932ff6c44f0eb559e8781c278625"><enum>(i)</enum><text>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 id="id0ea29b3247bb47aebd6f6599a5adb1f7"><enum>(ii)</enum><text>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 id="id71eba9cd8cc9432bb086eae9b19271f1"><enum>(I)</enum><text>a supplemental
animal drug application for which safety or effectiveness data are required;
and</text>
</subclause><subclause id="iddaa6e8cc556745eba9d35e6e6cfdf566"><enum>(II)</enum><text>an animal drug
application subject to the criteria set forth in section 512(d)(4).</text>
</subclause></clause></subparagraph><subparagraph id="idad0ccb7a9ce2485e856a3962aa83a00b"><enum>(B)</enum><header>Payment</header><text>The
fee required by subparagraph (A) shall be due upon submission of the animal
drug application or supplemental animal drug application.</text>
</subparagraph><subparagraph id="id00381df24dbb4c6fa9672051607e83ff"><enum>(C)</enum><header>Exception for
previously filed application or supplement</header><text>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 id="id1fb0e71de8754f73b85f71fbdeec1d3a"><enum>(D)</enum><header>Refund of fee
if application refused for filing</header><text>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 id="ida24a0748809b462995e81936d8d6a70c"><enum>(E)</enum><header>Refund of fee
if application withdrawn</header><text>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 id="idd244aeb1ac2344d6963dbdab2111e2ec"><enum>(2)</enum><header>Animal drug
product fee</header>
<subparagraph id="ida938326684b7416ab2de970e84282893"><enum>(A)</enum><header>In
general</header><text>Each person—</text>
<clause id="idBC3298020FB0493AA055F3DCBFD9368F"><enum>(i)</enum><text>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 id="id05148E5A0284418DA64B1C1692C81E56"><enum>(ii)</enum><text>who, after
September 1, 2003, had pending before the Secretary an animal drug application
or supplemental animal drug application,</text>
</clause><continuation-text continuation-text-level="subparagraph">shall
pay for each such animal drug product the annual fee established in subsection
(c).</continuation-text></subparagraph><subparagraph id="id286d4e36fdf44cd9bc435819a7fbd697"><enum>(B)</enum><header>Payment; fee
due date</header><text>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 id="id2a6ea392d4da47048129573d63242b2b"><enum>(i)</enum><text>the first
business day after the date of enactment of an appropriations Act providing for
the collection and obligation of fees for such fiscal year under this section;
or</text>
</clause><clause id="idb2ec0ea5d79140838a1d2f511c1e3dc7"><enum>(ii)</enum><text>January 31 of
each year.</text>
</clause></subparagraph><subparagraph id="id2c4425400aea4a6b88a4e752b3c37385"><enum>(C)</enum><header>Limitation</header><text>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 id="idec70ef13a7d74d6ba337a08e294490a4"><enum>(3)</enum><header>Animal drug
establishment fee</header>
<subparagraph id="id010c49a9657a4137bd22196c97c59427"><enum>(A)</enum><header>In
general</header><text>Each person—</text>
<clause id="id4acd4cf9864a448a847fa0d313f4f3a3"><enum>(i)</enum><text>who owns or
operates, directly or through an affiliate, an animal drug
establishment;</text>
</clause><clause id="id642d0b026cdc4f2bbe966b32014f852e"><enum>(ii)</enum><text>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 id="id9c7fb6e0216b4ece94ac63dfe6413f60"><enum>(iii)</enum><text>who, after
September 1, 2003, had pending before the Secretary an animal drug application
or supplemental animal drug application,</text>
</clause><continuation-text 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 id="id3f9baeb57de64faf8d8657f94716b49e"><enum>(B)</enum><header>Payment; fee
due date</header><text>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 id="id6c8e2638580f4fecab2326fb11e275e1"><enum>(i)</enum><text>the first
business day after the date of enactment of an appropriations Act providing for
the collection and obligation of fees for such fiscal year under this section;
or</text>
</clause><clause id="id8288061bb7b24630b96cd9f96dad6f2e"><enum>(ii)</enum><text>January 31 of
each year.</text>
</clause></subparagraph><subparagraph id="id1ca0cb6f97034855983c73b83030b397"><enum>(C)</enum><header>Limitation</header>
<clause id="id85654F3F1AD54EE7BCE665138E7EBF7A"><enum>(i)</enum><header>In
general</header><text>An establishment shall be assessed only one fee per
fiscal year under this section, subject to clause (ii).</text>
</clause><clause id="id4C9A24E9FF104B879A9F8E585E05E10A"><enum>(ii)</enum><header>Certain
manufacturers</header><text>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 id="id5e99b2cdcba34a879d151c9d44a84bb1"><enum>(4)</enum><header>Animal drug
sponsor fee</header>
<subparagraph id="idc86ef39ce2f34dd3a7ce643d12eba1a6"><enum>(A)</enum><header>In
general</header><text>Each person—</text>
<clause id="id4713777554EA4736B68AE28C4A83A989"><enum>(i)</enum><text>who meets the
definition of an animal drug sponsor within a fiscal year; and</text>
</clause><clause id="id75DDE84866DB44BCA26229F56E7666E2"><enum>(ii)</enum><text>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 continuation-text-level="subparagraph">shall
be assessed an annual sponsor fee as established under subsection (c).</continuation-text></subparagraph><subparagraph id="id9bbd59ab18014db9917df43009811793"><enum>(B)</enum><header>Payment; fee
due date</header><text>The fee under this paragraph for a fiscal year shall be
due upon the later of—</text>
<clause id="id7e4068f8a77841669b9f09685ef74e6e"><enum>(i)</enum><text>the first
business day after the date of enactment of an appropriations Act providing for
the collection and obligation of fees for such fiscal year under this section;
or</text>
</clause><clause id="iddb992fd0b12f410fb9360a188d36568c"><enum>(ii)</enum><text>January 31 of
each year.</text>
</clause></subparagraph><subparagraph id="idf247453a92744a588729e8746796c011"><enum>(C)</enum><header>Limitation</header><text>Each
animal drug sponsor shall pay only one such fee each fiscal year.</text>
</subparagraph></paragraph></subsection><subsection id="idaf35bbefbdb747f09941f1977c0d1bdc"><enum>(b)</enum><header>Fee revenue
amounts</header>
<paragraph id="idc6f6d9a0f4fb4101bf6de214b0d82488"><enum>(1)</enum><header>In
general</header><text>Subject to subsections (c), (d), (f), and (g)—</text>
<subparagraph id="id6a536a7f69564371933dc08c908acabf"><enum>(A)</enum><text>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 id="idb13cfed06f6e4e7aa99336a2bf060685"><enum>(B)</enum><text>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 id="idee0a35c16b3a4f43ad07525becf7368b"><enum>(2)</enum><header>Types of
fees</header><text>Of the total revenue amount determined for a fiscal year
under paragraph (1)—</text>
<subparagraph id="idcba4797710da4bcf9dac068921f3f593"><enum>(A)</enum><text>20 percent shall
be derived from fees under subsection (a)(1) (relating to animal drug
applications and supplements);</text>
</subparagraph><subparagraph id="ide8c86e8cc8f744a99e582ad1290ed7eb"><enum>(B)</enum><text>27 percent shall
be derived from fees under subsection (a)(2) (relating to animal drug
products);</text>
</subparagraph><subparagraph id="id85513e950b0c458eb546e8af614947ef"><enum>(C)</enum><text>26 percent shall
be derived from fees under subsection (a)(3) (relating to animal drug
establishments); and</text>
</subparagraph><subparagraph id="id3cd66be54caf46099e22401bebd73de5"><enum>(D)</enum><text>27 percent shall
be derived from fees under subsection (a)(4) (relating to animal drug
sponsors).</text>
</subparagraph></paragraph></subsection><subsection id="id1a1c4f8297ca4fa5adf7d7ad041d4c12"><enum>(c)</enum><header>Annual fee
setting; adjustments</header>
<paragraph id="id1be44308ec41422c91c09183f6d5a32f"><enum>(1)</enum><header>Annual fee
setting</header><text>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 id="idab2a98ea0a174a14b3c19e52ec354a1f"><enum>(2)</enum><header>Inflation
adjustment</header><text>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 id="id11ecb2d82c084e5b85946436249a2b58"><enum>(A)</enum><text>one;</text>
</subparagraph><subparagraph id="id45520518539845659230174a4d7e3886"><enum>(B)</enum><text>the average
annual percent change in the cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel compensation and benefits paid
with respect to such positions for the first 3 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 id="ide1111c4d711a4bc0b60c7bdf4ef39252"><enum>(C)</enum><text>the average
annual percent change that occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all
items 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 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 id="ida926d9804abd48fa97bb5eafb148e7d3"><enum>(3)</enum><header>Workload
adjustment</header><text>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 id="id8cf934fc86e7475cb281bedfcfde33c6"><enum>(A)</enum><text>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 id="idA23B3BFEEFD947EDB19E5DF7AE6AB4DF"><enum>(B)</enum><text>the Secretary
shall publish in the Federal Register the fees resulting from such adjustment
and the supporting methodologies; and</text>
</subparagraph><subparagraph id="id241d33caa9aa4458a1ffefc8dde96f73"><enum>(C)</enum><text>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 id="id22d236418f804be3a2a7dec79c87d001"><enum>(4)</enum><header>Final year
adjustment</header><text>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 id="id41001dd940b1473fb08295986f21c6a6"><enum>(5)</enum><header>Limit</header><text>The
total amount of fees charged, as adjusted under this subsection, for a fiscal
year may not exceed the total costs for such fiscal year for the resources
allocated for the process for the review of animal drug applications.</text>
</paragraph></subsection><subsection id="id5f5654bf3e724bb5ad446f03903c5dad"><enum>(d)</enum><header>Fee waiver or
reduction</header>
<paragraph id="idaca03700b2a3458da373e43ed7ee6165"><enum>(1)</enum><header>In
general</header><text>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 id="id0605974517334d95abb436828ad5217f"><enum>(A)</enum><text>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 id="id748e3a4b940b4602a7fed665a4d4d2f9"><enum>(B)</enum><text>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 id="id0888a19d88004833bc3af69869fd5f22"><enum>(C)</enum><text>the animal drug
application or supplemental animal drug application is intended solely to
provide for use of the animal drug in—</text>
<clause id="ide819f3de5b8445eebfd87cb6df3ffdfb"><enum>(i)</enum><text>a
Type B medicated feed (as defined in <external-xref legal-doc="usc" parsable-cite="usc/21/558">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 id="ida97a890bfb924c4f97282e53e50429be"><enum>(ii)</enum><text>a Type C
free-choice medicated feed (as defined in <external-xref legal-doc="usc" parsable-cite="usc/21/558">section 558.3(b)(4)</external-xref> of title 21, Code
of Federal Regulations (or any successor regulation));</text>
</clause></subparagraph><subparagraph id="id54867149a9004d5fa36e326209f80ad0"><enum>(D)</enum><text>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 id="id27ee5fb886bf42fdb513d26ac1754466"><enum>(E)</enum><text>the sponsor
involved is a small business submitting its first animal drug application to
the Secretary for review.</text>
</subparagraph></paragraph><paragraph id="idf1216e118c0a48c2941625019319b283"><enum>(2)</enum><header>Use of standard
costs</header><text>In making the finding in paragraph (1)(B), the Secretary
may use standard costs.</text>
</paragraph><paragraph id="idac78667703e048a2a2b309c08878a132"><enum>(3)</enum><header>Rules for small
businesses</header>
<subparagraph id="id63490f3311f24674a2a20d163fa01089"><enum>(A)</enum><header>Definition</header><text>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 id="id8389047c675f4977af7588406623de9b"><enum>(B)</enum><header>Waiver of
application fee</header><text>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 id="ide87ea137ffb94c83ba6358425b8ae68b"><enum>(C)</enum><header>Certification</header><text>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 id="ide7cd2c8d294d4fc3ae7c308c5a04b6f2"><enum>(e)</enum><header>Effect of
failure To pay fees</header><text>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 id="id65edffaa16784560a40ead49845e81e5"><enum>(f)</enum><header>Assessment of
fees</header>
<paragraph id="id8097173620504c51b2377b93e98f8166"><enum>(1)</enum><header>Limitation</header><text>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 id="ide7984a1f0bf44d048c6f6fc03396fa82"><enum>(2)</enum><header>Authority</header><text>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 id="id26b0ce484bc3479abb5a8698156becd0"><enum>(g)</enum><header>Crediting and
availability of fees</header>
<paragraph id="id69eefe8b0407495781fe5652401c79d4"><enum>(1)</enum><header>In
general</header><text>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 id="id9f693160d00841d9812c3b60ddd7ac5f"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="id1e7f16bd4e9244d19b3f9d9a1b05c393"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause id="id06bada831ef44b2b83d2b209e2b20282"><enum>(i)</enum><text>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 id="id46588b6b48e84a3f83c15e128c4fd3b2"><enum>(ii)</enum><text>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 id="id392449b0361a4c37b7b53aad1ef92fcb"><enum>(B)</enum><header>Compliance</header><text>The
Secretary shall be considered to have met the requirements of subparagraph
(A)(ii) in any fiscal year if the costs funded by appropriations and allocated
for the process for the review of animal drug applications—</text>
<clause id="id403d638ecdd940a8b4b5df219a49f2c2"><enum>(i)</enum><text>are not more than
3 percent below the level specified in subparagraph (A)(ii); or</text>
</clause><clause id="id5d49f7d3dd7949dabc7af64aa5601d38"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="id843D35BAAB274BAFB62E986A7096C7C2"><enum>(I)</enum><text>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 id="idB5FA6A04D5DF454B997DB044F9DFCE62" indent="up1"><enum>(II)</enum><text>such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).</text>
</subclause></clause></subparagraph><subparagraph id="id31dff28713af4d34bad74c8d4bee74b4"><enum>(C)</enum><header>Provision for
early payments</header><text>Payment of fees authorized under this section for
a fiscal year, prior to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in advance in a prior year
appropriations Act.</text>
</subparagraph></paragraph><paragraph id="id9edc07c1ec99401386901a6f38345481"><enum>(3)</enum><header>Authorization
of appropriations</header><text>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 id="idccfd5c44eb3448a68c4d6e6b4c9dd806"><enum>(4)</enum><header>Offset of
overcollections; recovery of collection shortfalls</header>
<subparagraph id="id184e5d32ed594ca0bf3ffd409d100a1c"><enum>(A)</enum><header>Offset of
overcollections</header><text>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 id="id59f70c4eda2b48a990d9c7b9ac351e11"><enum>(B)</enum><header>Recovery of
collection shortfalls</header>
<clause id="id104c67d7fb734180b2c3e8a8b1a865b4"><enum>(i)</enum><header>Fiscal year
2016</header><text>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 id="id734261ab2af44cfe94750df06bcd059a"><enum>(ii)</enum><header>Fiscal year
2017</header><text>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 id="idcce94146ddcd49a68e7c0fff8fff7738"><enum>(iii)</enum><header>Fiscal year
2018</header><text>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 id="idc76efd22b8394a63903cc6e58714edf1"><enum>(h)</enum><header>Collection of
unpaid fees</header><text>In any case where the Secretary does not receive
payment of a fee assessed under subsection (a) within 30 days after it is due,
such fee shall be treated as a claim of the United States Government subject to
subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
</subsection><subsection id="idda35a235af3e4f8f9c8d98427c724d62"><enum>(i)</enum><header>Written
requests for waivers, reductions, and refunds</header><text>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 id="id711bcda79b1640eda8809e41b0caa566"><enum>(j)</enum><header>Construction</header><text>This
section may not be construed to require that the number of full-time equivalent
positions in the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in 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 id="id16bb5dd7abb14d298f632d69081702f3"><enum>(k)</enum><header>Abbreviated new
animal drug applications</header><text>The Secretary shall—</text>
<paragraph id="id33baecf53cf54a36b38df809eb9926cb"><enum>(1)</enum><text>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 id="idfcf2953d5595412b81d55a821bdc4cf6"><enum>(2)</enum><text>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 id="idF95379A251544E6E81CF9BBCFDFA1C6E"><enum>104.</enum><header>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 id="id169ab2424afb43bba1e9aa0871d919b9"><enum>740A.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="ide710374a1b3649a282c6a20d66db3469"><enum>(a)</enum><header>Performance
report</header><text>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 id="id036e8e685fd2433a9a150752fc6853c9"><enum>(b)</enum><header>Fiscal
report</header><text>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 id="id70c74929fa794ceda549be2e4bcdb860"><enum>(c)</enum><header>Public
availability</header><text>The Secretary shall make the reports required under
subsections (a) and (b) available to the public on the Internet Web site of the
Food and Drug Administration.</text>
</subsection><subsection id="idebefb335a8394bb6b022f739b5489539"><enum>(d)</enum><header>Reauthorization</header>
<paragraph id="id57095eef82914448879892c2b5cfe99c"><enum>(1)</enum><header>Consultation</header><text>In
developing recommendations to present to the Congress with respect to the
goals, and plans for meeting the goals, for 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 id="ide111af8ca37e4693b84ca1626c83cd47"><enum>(A)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="id448d41d83bf441b3a1391bff9bad9137"><enum>(B)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="id07b24380644a4aabae82feedc049e120"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="id9008aebf19cc479e8b2fd3c7e20d0f68"><enum>(D)</enum><text>veterinary
professionals;</text>
</subparagraph><subparagraph id="idd5d4740bfc954e24b85d86514a3b9cf6"><enum>(E)</enum><text>representatives
of patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="idef604a0ab22e4a57b6ea8698e136787b"><enum>(F)</enum><text>the regulated
industry.</text>
</subparagraph></paragraph><paragraph id="id89f90dbdd5e04ec2aa435447045e507b"><enum>(2)</enum><header>Prior public
input</header><text>Prior to beginning negotiations with the regulated industry
on the reauthorization of this part, the Secretary shall—</text>
<subparagraph id="idd1d66eb433a645658f2b64fc5667fa96"><enum>(A)</enum><text>publish a notice
in the Federal Register requesting public input on the reauthorization;</text>
</subparagraph><subparagraph id="id269baaa080b84fef91902ca8d2aa46a3"><enum>(B)</enum><text>hold a public
meeting at which the public may present its views on the reauthorization,
including specific suggestions for changes to the goals referred to in
subsection (a);</text>
</subparagraph><subparagraph id="id7496a4dca3e8451f85d7842dd3216a64"><enum>(C)</enum><text>provide a period
of 30 days after the public meeting to obtain written comments from the public
suggesting changes to this part; and</text>
</subparagraph><subparagraph id="id67d013b5e00b4c48a9e36b7df2599129"><enum>(D)</enum><text>publish the
comments on the Food and Drug Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph id="id9230d0a90c734dc5a1058fe99e46cfa9"><enum>(3)</enum><header>Periodic
consultation</header><text>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 id="id57f685acb120400697565bc2d0b43fbc"><enum>(4)</enum><header>Public review
of recommendations</header><text>After negotiations with the regulated
industry, the Secretary shall—</text>
<subparagraph id="idf9b35f1dc4d6427895456dc260e75775"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the Congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="idcc769eebd7dc40a8bbe143ac09353cba"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="idac581df369e847d89cedc615ed466f56"><enum>(C)</enum><text>provide for a
period of 30 days for the public to provide written comments on such
recommendations;</text>
</subparagraph><subparagraph id="id2cfd442b7abd45d9b39640e83aaaf812"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="id6f12127e7ba64095b14fef4d8d658e5a"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="idd01a91d0528f42da94f26ccb08545148"><enum>(5)</enum><header>Transmittal of
recommendations</header><text>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 id="ida076c7807f1d43238f245a5a5e6d8458"><enum>(6)</enum><header>Minutes of
negotiation meetings</header>
<subparagraph id="id9cb0747cfca04ad1ab544a53081714dc"><enum>(A)</enum><header>Public
availability</header><text>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 id="id815564b6c0a64e78b0bf983cb962efa2"><enum>(B)</enum><header>Content</header><text>The
minutes described under subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well as significant
controversies or differences of opinion during the negotiations and their
resolution.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idba28b0f6449e4cf594c392846a403b7d"><enum>105.</enum><header>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 id="idc9d1267aec5c4c19b7d4aa9c166e8eee"><enum>106.</enum><header>Effective
date</header><text display-inline="no-display-inline">The amendments made by
this title shall take effect on October 1, 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 id="id0b82b2aad4a449f1a2d259581c5c328c"><enum>107.</enum><header>Sunset
dates</header>
<subsection id="ida4a641c87d6f448487f5da62d52db76d"><enum>(a)</enum><header>Authorization</header><text>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 id="id4cf78229349d409dbfb2ecdbcbe4b405"><enum>(b)</enum><header>Reporting
requirements</header><text>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 id="id4a9f8594497e4531a4856d553c4bbacf"><enum>(c)</enum><header>Previous sunset
provision</header>
<paragraph id="idF96D025B9B954D67B403EB31E8339400"><enum>(1)</enum><header>In
general</header><text>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 id="id704437d4593445a1b663af92ade5d290"><enum>(2)</enum><header>Conforming
amendment</header><text>The Animal Drug User Fee Amendments of 2008 (Public Law
110–316) 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>Technical
clarification</header><text>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>Fees relating to
generic animal drugs</header>
<section id="id7BD7ADAD8E32489AACA44A75A67EB6D3"><enum>201.</enum><header>Short title;
finding</header>
<subsection id="id5B7258CB595642B195BCA087E66A0A86"><enum>(a)</enum><header>Short
title</header><text>This title may be cited as the <quote>Animal Generic Drug
User Fee Amendments of 2013</quote>.</text>
</subsection><subsection commented="no" id="id3676933E1331421F958CC0D6921A8692"><enum>(b)</enum><header>Finding</header><text>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 id="id105B4517DF0E45CC895D417541929E33"><enum>202.</enum><header>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 id="idCE203E7223C9448BA10C1238E884DF6F"><enum>741.</enum><header>Authority to
assess and use generic new animal drug fees</header>
<subsection id="idA929B54902514A168CBA747A059C7C37"><enum>(a)</enum><header>Types of
fees</header><text>Beginning with respect to fiscal year 2009, the Secretary
shall assess and collect fees in accordance with this section as
follows:</text>
<paragraph id="idd033dcc8694346e9bfea5f744da4e5e8"><enum>(1)</enum><header>Abbreviated
application fee</header>
<subparagraph id="id64e19cdb78e846eb9618119a878bcb6e"><enum>(A)</enum><header>In
general</header><text>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 id="iddf1c179e7f89415cb864455241acc50c"><enum>(B)</enum><header>Payment</header><text>The
fee required by subparagraph (A) shall be due upon submission of the
abbreviated application.</text>
</subparagraph><subparagraph id="idcacc9bc274074a8db26b6e5af3176db4"><enum>(C)</enum><header>Exceptions</header>
<clause id="idf1a2fedb5ba147c694c99c050050e03d"><enum>(i)</enum><header>Previously
filed application</header><text>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 id="idf6c5602f895c487eab23ff78be8b7782"><enum>(ii)</enum><header>Certain
abbreviated applications involving combination animal drugs</header><text>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 id="id700c5176ac0f4e729575ac629c0538dd"><enum>(D)</enum><header>Refund of fee
if application refused for filing</header><text>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 id="id52f66165be4740efa589fcf66f4f4231"><enum>(E)</enum><header>Refund of fee
if application withdrawn</header><text>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 id="idfd11ae881c8a4a8395dfe4a2a77d51bd"><enum>(2)</enum><header>Generic new
animal drug product fee</header>
<subparagraph id="iddab15399c61c4d0a8035ebba52405e39"><enum>(A)</enum><header>In
general</header><text>Each person—</text>
<clause id="idAAC47F3697D44D29AC81C4CF403D37F4"><enum>(i)</enum><text>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 id="id22C71518F6FC452C98C0C0B94BC7D85A"><enum>(ii)</enum><text>who, after
September 1, 2008, had pending before the Secretary an abbreviated application
or supplemental abbreviated application,</text>
</clause><continuation-text 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 id="id211fc9136c594c11ba4e35b782475d93"><enum>(B)</enum><header>Payment; fee
due date</header><text>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 id="id7bddf23393ad4b39b10d88411c43cad6"><enum>(i)</enum><text>the first
business day after the date of enactment of an appropriations Act providing for
the collection and obligation of fees for such fiscal year under this section;
or</text>
</clause><clause id="id8830eb3b7c8748c193ac55db8ec8f2cd"><enum>(ii)</enum><text>January 31 of
each year.</text>
</clause></subparagraph><subparagraph id="id891f78304ddc40e0a2671e398b8eb9d8"><enum>(C)</enum><header>Limitation</header><text>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 id="id6557cb8279b544cbb0c55ab780769fc7"><enum>(3)</enum><header>Generic new
animal drug sponsor fee</header>
<subparagraph id="iddd8b31386bc8451f9cafcf8812045a00"><enum>(A)</enum><header>In
general</header><text>Each person—</text>
<clause id="id3d9927c3f8ca4d9a86d2ca1c3fea48ce"><enum>(i)</enum><text>who meets the
definition of a generic new animal drug sponsor within a fiscal year;
and</text>
</clause><clause id="id6ed44938f43440c286c689f69dcdbf4d"><enum>(ii)</enum><text>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 continuation-text-level="subparagraph">shall
be assessed an annual generic new animal drug sponsor fee as established under
subsection (c).</continuation-text></subparagraph><subparagraph id="id973e315abc5b4c83ba5c0ca8a28c2dd4"><enum>(B)</enum><header>Payment; fee
due date</header><text>Such fee shall be due each fiscal year upon the later
of—</text>
<clause id="idf3f3c6043fcd42a8adc1d78c4f59d909"><enum>(i)</enum><text>the first
business day after the date of enactment of an appropriations Act providing for
the collection and obligation of fees for such fiscal year under this section;
or</text>
</clause><clause id="id7e94ffff524241c29c0f544d1b328f44"><enum>(ii)</enum><text>January 31 of
each year.</text>
</clause></subparagraph><subparagraph id="id5beff016510541e2b04af8839e31f8b0"><enum>(C)</enum><header>Amount of
fee</header><text>Each generic new animal drug sponsor shall pay only 1 such
fee each fiscal year, as follows:</text>
<clause id="id1e219392f0c9409ba632949563e83795"><enum>(i)</enum><text>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 id="ida54fb62d685f40789260736565e74c79"><enum>(ii)</enum><text>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 id="idb071d68510344c6387857401259a5fca"><enum>(iii)</enum><text>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 id="id1c956cf667cb4f9ca80915cb7e2b8665"><enum>(b)</enum><header>Fee
amounts</header><text>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 id="idb58dd700a9284e1a9d8f8fc7404cc390"><enum>(1)</enum><header>Total fee
revenues for application fees</header><text>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 id="id5669b7ac40eb48b79412de7b1b69dc28"><enum>(2)</enum><header>Total fee
revenues for product fees</header><text>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 id="id051a16f1c29d483f8b09af6298f78f2a"><enum>(3)</enum><header>Total fee
revenues for sponsor fees</header><text>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 id="idf6f2311b96bd43de92f540e7ea172f1b"><enum>(c)</enum><header>Annual fee
setting; adjustments</header>
<paragraph id="idb497e2af466147f28ffd9808017b1da2"><enum>(1)</enum><header>Annual fee
setting</header><text>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 id="id2b530be4ba344a7c8472d1472619bf1e"><enum>(2)</enum><header>Workload
adjustment</header><text>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 id="idce55f0013c2843629bc3559c17c3ff6d"><enum>(A)</enum><text>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 id="idc839937aeed44f2398c5cd749fee45df"><enum>(B)</enum><text>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 id="id79f461a2102d4ba5ae16865000a62050"><enum>(3)</enum><header>Final year
adjustment</header><text>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 id="idab55f7fd91134a609c1f3553647115d0"><enum>(4)</enum><header>Limit</header><text>The
total amount of fees charged, as adjusted under this subsection, for a fiscal
year may not exceed the total costs for such fiscal year for the resources
allocated for the process for the review of abbreviated applications for
generic new animal drugs.</text>
</paragraph></subsection><subsection id="id474bf912dc054a5394e194a0c8ccd9d1"><enum>(d)</enum><header>Fee waiver or
reduction</header><text>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 id="idd9cb7aedcb3d4858b093b99de0a4b2f7"><enum>(e)</enum><header>Effect of
failure to pay fees</header><text>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 id="idb22582a4cdf04bd8babc79b17fd0c976"><enum>(f)</enum><header>Assessment of
fees</header>
<paragraph id="id9edc3a6a8b1344e084165fab3c9608df"><enum>(1)</enum><header>Limitation</header><text>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 id="id9a9badbc35d5453db9629e9ff10fb752"><enum>(2)</enum><header>Authority</header><text>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 id="idfb4a0834e4e44bca971de9ef32b1cb8a"><enum>(g)</enum><header>Crediting and
availability of fees</header>
<paragraph id="id5b018b8f434347bcbbc30f69a9b09049"><enum>(1)</enum><header>In
general</header><text>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 id="idc9b1a94605274f0e907affff1e4955c1"><enum>(2)</enum><header>Collections and
appropriation acts</header>
<subparagraph id="id9062c4e0e546425985494248120ca399"><enum>(A)</enum><header>In
general</header><text>The fees authorized by this section—</text>
<clause id="id347363eabb5742ed8aa7e3ebe4710571"><enum>(i)</enum><text>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 id="ide9db51ba72164628b296549fe1ed056a"><enum>(ii)</enum><text>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 id="idd23dbbcd51834e5889d81909ce62b7ae"><enum>(B)</enum><header>Compliance</header><text>The
Secretary shall be considered to have met the requirements of subparagraph
(A)(ii) in any fiscal year if the costs funded by appropriations and allocated
for the process for the review of abbreviated applications for generic new
animal drugs—</text>
<clause id="id4fb5d0dd6a4f489e9fecaeae3097a116"><enum>(i)</enum><text>are not more than
3 percent below the level specified in subparagraph (A)(ii); or</text>
</clause><clause id="id64f07a2293324659bd822cce3a163897"><enum>(ii)</enum><subclause commented="no" display-inline="yes-display-inline" id="id1577C26DF6A14192927D1A054851AF0E"><enum>(I)</enum><text>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 id="id655045F5D8054D87866A62190C14BEE1" indent="up1"><enum>(II)</enum><text>such costs are not more than 5 percent
below the level specified in subparagraph (A)(ii).</text>
</subclause></clause></subparagraph><subparagraph id="id19580c37f8ff4d26ad08a56edbba00a9"><enum>(C)</enum><header>Provision for
early payments</header><text>Payment of fees authorized under this section for
a fiscal year, prior to the due date for such fees, may be accepted by the
Secretary in accordance with authority provided in advance in a prior year
appropriations Act.</text>
</subparagraph></paragraph><paragraph id="idabfe73e158f249abb0232b9ef342c788"><enum>(3)</enum><header>Authorization
of appropriations</header><text>There are authorized to be appropriated for
fees under this section—</text>
<subparagraph id="idac5784dfb4ef44e893b26b7cde670052"><enum>(A)</enum><text>$7,328,000 for
fiscal year 2014;</text>
</subparagraph><subparagraph id="idd10cd8580e5347f9ad83be3857ca567e"><enum>(B)</enum><text>$6,944,000 for
fiscal year 2015;</text>
</subparagraph><subparagraph id="idef95bb14183f45168b8ef8e5500fc69d"><enum>(C)</enum><text>$7,429,000 for
fiscal year 2016;</text>
</subparagraph><subparagraph id="id70956af7bdf146d9bb768f9aee6dc5a5"><enum>(D)</enum><text>$7,936,000 for
fiscal year 2017; and</text>
</subparagraph><subparagraph id="id4d2c2be7c3eb425d86e3526101b3071c"><enum>(E)</enum><text>$8,467,000 for
fiscal year 2018;</text>
</subparagraph><continuation-text 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 id="id2aa2ca2dae8c4cb69c85a6a8d27d64fe"><enum>(4)</enum><header>Offset</header><text>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 id="id985851c562cc46b7bee05be65b7538b3"><enum>(h)</enum><header>Collection of
unpaid fees</header><text>In any case where the Secretary does not receive
payment of a fee assessed under subsection (a) within 30 days after it is due,
such fee shall be treated as a claim of the United States Government subject to
subchapter II of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/31/37">chapter 37</external-xref> of title 31, United States Code.</text>
</subsection><subsection id="id5e73490d23ae4a99bb861fae59b1c633"><enum>(i)</enum><header>Written
requests for waivers, reductions, and refunds</header><text>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 id="id29448b8b6ce54925be18ca43cca6dc34"><enum>(j)</enum><header>Construction</header><text>This
section may not be construed to require that the number of full-time equivalent
positions in the Department of Health and Human Services, for officers,
employees, and advisory committees not engaged in 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 id="idBA43A3FF5D0B4A07A6EBEDE134DBD544"><enum>(k)</enum><header>Definitions</header><text>In
this section and section 742:</text>
<paragraph id="id9e789c630f534fc1a17705f4711f20db"><enum>(1)</enum><header>Abbreviated
application for a generic new animal drug</header><text>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 id="ida30b674c75294162b443730015f16a0c"><enum>(2)</enum><header>Adjustment
factor</header><text>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 id="iddc627bb6c4f14deead951018b3911e85"><enum>(A)</enum><text>for purposes of
subsection (f)(1), such Index for October 2002; and</text>
</subparagraph><subparagraph id="idf3c77447412d4cf6b311d82382553bcc"><enum>(B)</enum><text>for purposes of
subsection (g)(2)(A)(ii), such Index for October 2007.</text>
</subparagraph></paragraph><paragraph id="id5673217cf52d44d59d2788efbdfd28dc"><enum>(3)</enum><header>Costs of
resources allocated for the process for the review of abbreviated applications
for generic new animal drugs</header><text>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 id="idb6172e6188464671aba1cd8e4c8cf6dd"><enum>(A)</enum><text>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 id="id284f904c024147579ef83105e08e3c5e"><enum>(B)</enum><text>management of
information, and the acquisition, maintenance, and repair of computer
resources;</text>
</subparagraph><subparagraph id="id86ce78a8844748a0b5cc9bb6cc761dff"><enum>(C)</enum><text>leasing,
maintenance, renovation, and repair of facilities and acquisition, maintenance,
and repair of fixtures, furniture, scientific equipment, and other necessary
materials and supplies; and</text>
</subparagraph><subparagraph id="id17faa74bca3b4c2aa225ba900b4a3bc2"><enum>(D)</enum><text>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 id="id20b1eb3b785c4ec390293f0af646feab"><enum>(4)</enum><header>Final dosage
form</header><text>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 id="id272826959c1744dcb5bed307340b9b2c"><enum>(5)</enum><header>Generic new
animal drug</header><text>The term <term>generic new animal drug</term> means a
new animal drug that is the subject of an abbreviated application.</text>
</paragraph><paragraph id="id58927ba3757e4d39a57beee909079257"><enum>(6)</enum><header>Generic new
animal drug product</header><text>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 id="id44ea039cf7554eab87ade377979465d6"><enum>(7)</enum><header>Generic new
animal drug sponsor</header><text>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 id="idfde766ad6a094af99ff2af00b289ee00"><enum>(8)</enum><header>Investigational
submission for a generic new animal drug</header><text>The terms
<term>investigational submission for a generic new animal drug</term> and
<quote>investigational submission</quote> mean—</text>
<subparagraph id="id5b080929c7b0475391d5f38fee5aaf53"><enum>(A)</enum><text>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 id="id7b92f5fd2e404d55a274cd8bd2ab2253"><enum>(B)</enum><text>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 id="id762a596bef624fce92f8f6688bb0ef3b"><enum>(9)</enum><header>Person</header><text>The
term <term>person</term> includes an affiliate thereof (as such term is defined
in section 735(11)).</text>
</paragraph><paragraph id="idcef769cd12b94d8790c5c79ae91e12ce"><enum>(10)</enum><header>Process for
the review of abbreviated applications for generic new animal
drugs</header><text>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 id="id1d28224fcbba42f78f55cd33f84cdb7f"><enum>(A)</enum><text>The activities
necessary for the review of abbreviated applications, supplemental abbreviated
applications, and investigational submissions.</text>
</subparagraph><subparagraph id="idca7ad63ac97d4c4b9af9c27fbc472598"><enum>(B)</enum><text>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 id="id6b7613a72e984e13a81702dc0a34d4d6"><enum>(C)</enum><text>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 id="id27e26d94202a4fb1a715b9901fb0b98e"><enum>(D)</enum><text>Monitoring of
research conducted in connection with the review of abbreviated applications,
supplemental abbreviated applications, and investigational submissions.</text>
</subparagraph><subparagraph id="id1f297d9205094f2e9f3f0ec77f835af8"><enum>(E)</enum><text>The development
of regulations and policy related to the review of abbreviated applications,
supplemental abbreviated applications, and investigational submissions.</text>
</subparagraph><subparagraph id="idbbdb71b7975c4d2cae850f74a353f26d"><enum>(F)</enum><text>Development of
standards for products subject to review.</text>
</subparagraph><subparagraph id="idfe37190931f943e8986405691c20be94"><enum>(G)</enum><text>Meetings between
the agency and the generic new animal drug sponsor.</text>
</subparagraph><subparagraph id="id682dd24a3be843ecb77a23b85545731f"><enum>(H)</enum><text>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 id="id3415d393a8314ab99d600513ca224815"><enum>(11)</enum><header>Supplemental
abbreviated application for generic new animal drug</header><text>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 id="id86BF1F833AFE43B28EDEE90F35A3DA96"><enum>203.</enum><header>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 id="id64016AE763B143F8BB332EDA9D3D69A0"><enum>742.</enum><header>Reauthorization;
reporting requirements</header>
<subsection id="idcc2b5fe0841b4a58a399eacfdda009d9"><enum>(a)</enum><header>Performance
reports</header><text>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 id="id835ab04b07944f3495a0b776958364cf"><enum>(b)</enum><header>Fiscal
report</header><text>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 id="ide8a865f3fe1b4ddcb4bce882749273bc"><enum>(c)</enum><header>Public
availability</header><text>The Secretary shall make the reports required under
subsections (a) and (b) available to the public on the Internet Web site of the
Food and Drug Administration.</text>
</subsection><subsection id="idfc6a959f0e7c4f0e9ae966273a14cbfa"><enum>(d)</enum><header>Reauthorization</header>
<paragraph id="idac49410f3e04466eb5d4705b029658a1"><enum>(1)</enum><header>Consultation</header><text>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 id="id4424ac037ce048e08c13f9ace54078f0"><enum>(A)</enum><text>the Committee on
Energy and Commerce of the House of Representatives;</text>
</subparagraph><subparagraph id="id3c0b326cc82b4f2eb486d437381d908d"><enum>(B)</enum><text>the Committee on
Health, Education, Labor, and Pensions of the Senate;</text>
</subparagraph><subparagraph id="id2007e9060e7f4ce0b9906b7dc174a91e"><enum>(C)</enum><text>scientific and
academic experts;</text>
</subparagraph><subparagraph id="idcbae80e7d0434ac3bb6fc50b2419692b"><enum>(D)</enum><text>veterinary
professionals;</text>
</subparagraph><subparagraph id="id8a94fc1d5b374adaafd894f8aea8ad47"><enum>(E)</enum><text>representatives
of patient and consumer advocacy groups; and</text>
</subparagraph><subparagraph id="ida454eb7bb12e4255b1ef5fabeb9e6b84"><enum>(F)</enum><text>the regulated
industry.</text>
</subparagraph></paragraph><paragraph id="id915ae04fbce44fa68d50558bc13be3a5"><enum>(2)</enum><header>Prior public
input</header><text>Prior to beginning negotiations with the regulated industry
on the reauthorization of this part, the Secretary shall—</text>
<subparagraph id="iddd34e804fc044010a55d22cf279343bb"><enum>(A)</enum><text>publish a notice
in the Federal Register requesting public input on the reauthorization;</text>
</subparagraph><subparagraph id="idbdd37c4c28c545cc92470a1b8f5b60ac"><enum>(B)</enum><text>hold a public
meeting at which the public may present its views on the reauthorization,
including specific suggestions for changes to the goals referred to in
subsection (a);</text>
</subparagraph><subparagraph id="id8023f630ea3b43e5b7f94f0391a2c307"><enum>(C)</enum><text>provide a period
of 30 days after the public meeting to obtain written comments from the public
suggesting changes to this part; and</text>
</subparagraph><subparagraph id="id63c29888c82f4caca110a4dc9f89ad35"><enum>(D)</enum><text>publish the
comments on the Food and Drug Administration’s Internet Web site.</text>
</subparagraph></paragraph><paragraph id="idd320528a5f7645c38d661673a6a963e9"><enum>(3)</enum><header>Periodic
consultation</header><text>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 id="idb6e5f2fa49e94ca7bcaf49911e87812b"><enum>(4)</enum><header>Public review
of recommendations</header><text>After negotiations with the regulated
industry, the Secretary shall—</text>
<subparagraph id="id3e2b89a584794471bca05fa2ffd5c086"><enum>(A)</enum><text>present the
recommendations developed under paragraph (1) to the congressional committees
specified in such paragraph;</text>
</subparagraph><subparagraph id="ida0a1729c8cc34b9dae0c2eaf1094eb5f"><enum>(B)</enum><text>publish such
recommendations in the Federal Register;</text>
</subparagraph><subparagraph id="id8cc0c572ab4d40babe8735eb35f0d0f8"><enum>(C)</enum><text>provide for a
period of 30 days for the public to provide written comments on such
recommendations;</text>
</subparagraph><subparagraph id="id94f16dea6f284626a20cfc70792d3aa4"><enum>(D)</enum><text>hold a meeting at
which the public may present its views on such recommendations; and</text>
</subparagraph><subparagraph id="ida0afecd1e23a4b2492d2c63e3af311e0"><enum>(E)</enum><text>after
consideration of such public views and comments, revise such recommendations as
necessary.</text>
</subparagraph></paragraph><paragraph id="ide67e693bd59046f0bba725622f01a5e0"><enum>(5)</enum><header>Transmittal of
recommendations</header><text>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 id="idb6c9d4b8ddaf488fbdc61d48bc0fc4f0"><enum>(6)</enum><header>Minutes of
negotiation meetings</header>
<subparagraph id="id8da31d49fa5d4e03acf0fc6e923ea800"><enum>(A)</enum><header>Public
availability</header><text>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 id="ide3d516771ddb4edb9694aa02f70d8dfd"><enum>(B)</enum><header>Content</header><text>The
minutes described under subparagraph (A) shall summarize any substantive
proposal made by any party to the negotiations as well as significant
controversies or differences of opinion during the negotiations and their
resolution.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idE3F39FD53D1C45CCAF4D42AE9FAB3054"><enum>204.</enum><header>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 id="id0093861360504679B096AF5D36435FAA"><enum>205.</enum><header>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 id="id6738992BAF6E4409B631A215FF4D8E5C"><enum>206.</enum><header>Sunset
dates</header>
<subsection id="id7d12783b3b50456b9bcaeb4239a18160"><enum>(a)</enum><header>Authorization</header><text>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 id="ide4387464b55c450689665d11bd28c6a9"><enum>(b)</enum><header>Reporting
requirements</header><text>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" id="id118d05bc7b3c4d39aef1e2668cd6cbbc"><enum>(c)</enum><header>Previous sunset
provision</header>
<paragraph commented="no" id="id560945a3ba304afcbfb7e9fb3fe3f851"><enum>(1)</enum><header>In
general</header><text>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" id="idb437a3f3cd77458aaa8b9fdd29c5c6a7"><enum>(2)</enum><header>Conforming
amendment</header><text>The Animal Generic Drug User Fee Act of 2008 (Public
Law 110–316) is amended in the table of contents in section 1, by striking the
item relating to section 204.</text>
</paragraph></subsection></section>
March 20, 2013
Read twice and placed on the calendar