Animal Drug User Fee Amendments of 2018Public Law 115–234, as amendedAnimal Drug User Fee Amendments of 2018234118–15Statute CompilationUnited States House of RepresentativesOffice of the Legislative Counseltext/xmlENPursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.GPO Statute Compilations USLM converter, version 20230403.12023-10-13Animal Drug and Animal Generic Drug User Fee Amendments of 2018Animal Drug User Fee Amendments of 2018Animal Generic Drug User Fee Amendments of 2018155491152018-08-14Animal Drug User Fee Amendments of 2018[(Public Law 115–234)][As Amended Through P.L. 118–15, Enacted September 30, 2023][Currency: This publication is a compilation of the text of Public Law 115-234. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of the enactment of the public law listed at https://www.govinfo.gov/app/collection/comps/][Note: While this publication does not represent an official version of any Federal statute, substantial efforts have been made to ensure the accuracy of its contents. The official version of Federal law is found in the United States Statutes at Large and in the United States Code. The legal effect to be given to the Statutes at Large and the United States Code is established by statute (1 U.S.C. 112, 204).]AN ACTTo amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. [21 U.S.C. 301 note]SHORT TITLE. This Act may be cited as the “Animal Drug and Animal Generic Drug User Fee Amendments of 2018”.SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. (a) Table of Contents.—The table of contents for this Act is as follows:Sec. 1.Sec. 2.TITLE I—Sec. 101.Sec. 102.Sec. 103.Sec. 104.Sec. 105.Sec. 106.Sec. 107.TITLE II—Sec. 201.Sec. 202.Sec. 203.Sec. 204.Sec. 205.Sec. 206.TITLE III—Sec. 301.Sec. 302.Sec. 303.Sec. 304.Sec. 305.Sec. 306.(b) References in Act.—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.).
<num style="-uslm-dtd:enum" value="I">TITLE I—</num><heading style="-uslm-dtd:header">FEES RELATING TO ANIMAL DRUGS </heading>
<section identifier="/us/sComp/115/234/tI/s101" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="101">SEC. 101. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s301">21 U.S.C. 301 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SHORT TITLE; FINDING. </heading>
<subsection identifier="/us/sComp/115/234/tI/s101/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Short Title.—</heading><content style="-uslm-dtd:text">This title may be cited as the “<shortTitle style="-uslm-dtd:quote">Animal Drug User Fee Amendments of 2018</shortTitle>”.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tI/s101/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-11">21 U.S.C. 379j-11 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Finding.—</heading><content style="-uslm-dtd: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.</content>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tI/s102" role="definitions" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="102">SEC. 102. </num><heading style="-uslm-dtd:header">DEFINITIONS. </heading><chapeau style="-uslm-dtd:text">Section 739 (21 U.S.C. 379j-11) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tI/s102/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">by amending paragraph (1) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">“(1)</num><subparagraph class="inline" style="-uslm-dtd:subparagraph" styleType="OLC"><num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">The term ‘<term style="-uslm-dtd:quote">animal drug application</term>’ means—</chapeau>
<clause class="leftIndentDecrease1" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">an application for approval of any new animal drug submitted under section 512(b)(1); or</content>
</clause>
<clause class="leftIndentDecrease1" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">an application for conditional approval of a new animal drug submitted under section 571.</content>
</clause></subparagraph>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">Such term does not include either a new animal drug application submitted under section 512(b)(2) or a supplemental animal drug application.”</content>
</subparagraph>
</paragraph></quotedContent>; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s102/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in paragraph (8), by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
<subclause class="leftIndentDecrease2" style="-uslm-dtd:subclause" styleType="OLC">
<num style="-uslm-dtd:enum" value="I">“(I) </num><content style="-uslm-dtd:text">The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval.”</content>
</subclause></quotedContent>.</content>
</paragraph>
</section>
<section identifier="/us/sComp/115/234/tI/s103" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="103">SEC. 103. </num><heading style="-uslm-dtd:header">AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES. </heading>
<subsection identifier="/us/sComp/115/234/tI/s103/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Fee Revenue Amounts.—</heading><chapeau style="-uslm-dtd:text">Section 740(b) (21 U.S.C. 379j-12(b)) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tI/s103/a/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">in paragraph (1)—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tI/s103/a/1/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in subparagraph (A)—</chapeau>
<clause identifier="/us/sComp/115/234/tI/s103/a/1/A/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2014</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2019</quotedText>”; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tI/s103/a/1/A/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">$23,600,000</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$30,331,240</quotedText>”; and</content>
</clause>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/a/1/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in subparagraph (B)—</chapeau>
<clause identifier="/us/sComp/115/234/tI/s103/a/1/B/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2015 through 2018</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2020 through 2023</quotedText>”; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tI/s103/a/1/B/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">$21,600,000</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">$29,931,240</quotedText>”; and</content>
</clause>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s103/a/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in paragraph (2), in the matter preceding subparagraph (A), by striking “<quotedText style="-uslm-dtd:quote">determined</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">established</quotedText>”.</content>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tI/s103/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Annual Fee Setting; Adjustments.—</heading>
<paragraph identifier="/us/sComp/115/234/tI/s103/b/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Inflation adjustment.—</heading><chapeau style="-uslm-dtd:text">Section 740(c)(2) (21 U.S.C. 379j-12(c)(2)) is amended—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tI/s103/b/1/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">in the matter preceding subparagraph (A)—</chapeau>
<clause identifier="/us/sComp/115/234/tI/s103/b/1/A/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">For fiscal year 2015</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">(A) For fiscal year 2020</quotedText>”; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tI/s103/b/1/A/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by inserting “<quotedText style="-uslm-dtd:quote">multiplying such revenue amounts by</quotedText>” before “<quotedText style="-uslm-dtd:quote">an amount</quotedText>”;</content>
</clause>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/b/1/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively;</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/b/1/C" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by striking the flush text at the end; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/b/1/D" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">by adding at the end the following new subparagraph:<quotedContent style="-uslm-dtd:quoted-block">
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Compounded basis.—</heading><content style="-uslm-dtd:text">The adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.”</content>
</subparagraph></quotedContent>.</content>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s103/b/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Workload adjustments.—</heading><content style="-uslm-dtd:text">Paragraph (3) of section 740(c) (21 U.S.C. 379j-12(c)) is amended to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Workload adjustments.—</heading>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">For fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee 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, subject to subparagraphs (B) and (C). With respect to such adjustment—</chapeau>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd: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; and</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies.</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Reduction of workload-based increase by amount of certain excess collections.—</heading><content style="-uslm-dtd:text">For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.</content>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">“(C) </num><heading style="-uslm-dtd:header">Rule of application.—</heading><content style="-uslm-dtd:text">Under no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).”</content>
</subparagraph>
</paragraph></quotedContent>.</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s103/b/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Final year adjustment.—</heading><chapeau style="-uslm-dtd:text">Section 740(c)(4) (21 U.S.C. 379j-12(c)(4)) is amended—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tI/s103/b/3/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2018</quotedText>” each place it appears and inserting “<quotedText style="-uslm-dtd:quote">2023</quotedText>”; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/b/3/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2019</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2024</quotedText>”.</content>
</subparagraph>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tI/s103/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Exemptions From Fees.—</heading><chapeau style="-uslm-dtd:text">Section 740(d) (21 U.S.C. 379j-12(d)) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tI/s103/c/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in the subsection heading, by inserting “<quotedText style="-uslm-dtd:quote">; Exemptions From Fees</quotedText>” after “<quotedText style="-uslm-dtd:quote">Reduction</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s103/c/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by striking the heading of paragraph (1) and inserting “<quotedText style="-uslm-dtd:quote">Waiver or reduction</quotedText>”; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s103/c/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Exemptions from fees.—</heading>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">Certain labeling supplements to add number of approved application.—</heading><chapeau style="-uslm-dtd:text">Fees under this section shall not apply with respect to any person who—</chapeau>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">not later than September 30, 2023, submits a supplemental animal drug application relating to a new animal drug application approved under section 512, solely to add the new animal drug application number to the labeling of the drug in the manner specified in section 502(w)(3); and</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">otherwise would be subject to fees under this section solely on the basis of such supplemental application.</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Certain animal drug applications.—</heading><content style="-uslm-dtd:text">Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H.”</content>
</subparagraph>
</paragraph></quotedContent>.</content>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tI/s103/d" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Crediting and Availability of Fees.—</heading>
<paragraph identifier="/us/sComp/115/234/tI/s103/d/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Authorization of appropriations.—</heading><chapeau style="-uslm-dtd:text">Section 740(g)(3) (21 U.S.C. 379j-12(g)(3)) is amended—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tI/s103/d/1/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2014 through 2018</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2019 through 2023</quotedText>”;</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/d/1/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">determined</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">established</quotedText>”; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tI/s103/d/1/C" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">paragraph (4)</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">paragraph (5)</quotedText>”.</content>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s103/d/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Excess collections.—</heading><content style="-uslm-dtd:text">Section 740(g) (21 U.S.C. 379j-12(g)) is amended by striking paragraph (4) and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Excess collections.—</heading><content style="-uslm-dtd:text">If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).</content>
</paragraph>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="5">“(5) </num><heading style="-uslm-dtd:header">Recovery of collection shortfalls.—</heading>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">Subject to subparagraph (B)—</chapeau>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">for fiscal year 2021, 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 2019 falls below the amount of fees authorized for fiscal year 2019 under paragraph (3);</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">for fiscal year 2022, 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 2020 falls below the amount of fees authorized for fiscal year 2020 under paragraph (3); and</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd:text">for fiscal year 2023, the amount of fees otherwise authorized to be collected under this section shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2021 and 2022 (including estimated collections for fiscal year 2022) falls below the cumulative amount of fees authorized for such fiscal years under paragraph (3).</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Reduction of shortfall-based fee increase by prior year excess collections.—</heading>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">Subject to clause (ii), the Secretary shall, in such manner as the Secretary determines appropriate, reduce any fee increase otherwise applicable for a fiscal year under subparagraph (A) by the amount of any excess collections under this section for preceding fiscal years (after fiscal year 2018).</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><heading style="-uslm-dtd:header">Workload-based fee accounting.—</heading><content style="-uslm-dtd:text">In applying clause (i), the Secretary shall account for the reduction of workload-based fee revenue increases by excess collections under subsection (c)(3)(B), in such manner as needed to provide that no portion of any excess collections described in clause (i) is applied for purposes of reducing fee increases under both such subsection (c)(3)(B) and this paragraph.</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">“(C) </num><heading style="-uslm-dtd:header">Rule of application.—</heading><content style="-uslm-dtd:text">Under no circumstances shall adjustments under this paragraph 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 or otherwise affected under subsection (c).”</content>
</subparagraph>
</paragraph></quotedContent>.</content>
</paragraph>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tI/s104" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="104">SEC. 104. </num><heading style="-uslm-dtd:header">REAUTHORIZATION; REPORTING REQUIREMENTS. </heading><chapeau style="-uslm-dtd:text">Section 740A (21 U.S.C. 379j-13) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tI/s104/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (a), by striking “<quotedText style="-uslm-dtd:quote">2013</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2018</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s104/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2014</quotedText>” each place it appears in subsections (a) and (b) and inserting “<quotedText style="-uslm-dtd:quote">2019</quotedText>”; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tI/s104/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">in subsection (d), by striking “<quotedText style="-uslm-dtd:quote">2018</quotedText>” each place it appears and inserting “<quotedText style="-uslm-dtd:quote">2023</quotedText>”.</content>
</paragraph>
</section>
<section identifier="/us/sComp/115/234/tI/s105" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="105">SEC. 105. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-11">21 U.S.C. 379j-11 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SAVINGS CLAUSE. </heading><content style="-uslm-dtd:text">Notwithstanding the amendments made by this title, part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as in effect on the day before the date of 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, 2013, but before October 1, 2018, 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 2019.</content>
</section>
<section identifier="/us/sComp/115/234/tI/s106" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="106">SEC. 106. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-11">21 U.S.C. 379j-11 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">EFFECTIVE DATE. </heading><content style="-uslm-dtd:text">The amendments made by this title shall take effect on October 1, 2018, or the date of the 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 animal drug applications and supplemental animal drug applications received on or after October 1, 2018, regardless of the date of the enactment of this Act.</content>
</section>
<section identifier="/us/sComp/115/234/tI/s107" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="107">SEC. 107. </num><heading style="-uslm-dtd:header">SUNSET DATES. </heading>
<chapeau class="block" style="-uslm-dtd:text">
<editorialNote style="-uslm-dtd:legis-comment"><b>[</b>Subsections (a) and (b) were repealed by section 2307(c) of Public Law 118–15.<b>]</b></editorialNote>
</chapeau>
<subsection identifier="/us/sComp/115/234/tI/s107/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-12">21 U.S.C. 379j-12 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Previous Sunset Provision.—</heading><content style="-uslm-dtd:text">Effective October 1, 2018, subsections (a) and (b) of section 107 of the Animal Drug User Fee Amendments of 2013 (Public Law 113-14) are repealed.</content>
</subsection>
</section>
<num style="-uslm-dtd:enum" value="II">TITLE II—</num><heading style="-uslm-dtd:header">FEES RELATING TO GENERIC ANIMAL DRUGS </heading>
<section identifier="/us/sComp/115/234/tII/s201" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="201">SEC. 201. </num><heading style="-uslm-dtd:header">SHORT TITLE; FINDING. </heading>
<subsection identifier="/us/sComp/115/234/tII/s201/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s301">21 U.S.C. 301 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Short Title.—</heading><content style="-uslm-dtd:text">This title may be cited as the “<shortTitle style="-uslm-dtd:quote">Animal Generic Drug User Fee Amendments of 2018</shortTitle>”.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tII/s201/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-21">21 U.S.C. 379j-21 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Finding.—</heading><content style="-uslm-dtd:text">Congress finds that the fees authorized by the amendments made in 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 for purposes of part 5 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.</content>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tII/s202" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="202">SEC. 202. </num><heading style="-uslm-dtd:header">AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES. </heading>
<subsection identifier="/us/sComp/115/234/tII/s202/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Fee Revenue Amounts.—</heading><content style="-uslm-dtd:text">Subsection (b) of section 741 (21 U.S.C. 379j-21) is amended to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<subsection style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">“(b) </num><heading style="-uslm-dtd:header">Fee Revenue Amounts.—</heading>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2019 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $18,336,340.</content>
</paragraph>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Types of fees.—</heading><chapeau style="-uslm-dtd:text">Of the total revenue amount established for a fiscal year under paragraph (1)—</chapeau>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">25 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug);</content>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">37.5 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and</content>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">37.5 percent shall be derived from fees under subsection (a)(3) (relating to generic new animal drug sponsors).”</content>
</subparagraph>
</paragraph>
</subsection></quotedContent>.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tII/s202/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Annual Fee Setting; Adjustments.—</heading>
<paragraph identifier="/us/sComp/115/234/tII/s202/b/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Inflation adjustment.—</heading><chapeau style="-uslm-dtd:text">Section 741(c) (21 U.S.C. 379j-21(c)) is amended—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tII/s202/b/1/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by redesignating paragraphs (2) through (4) as paragraphs (3) through (5), respectively; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tII/s202/b/1/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">by inserting after paragraph (1) the following:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Inflation adjustment.—</heading>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">For fiscal year 2020 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—</chapeau>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">one;</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd: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 of the preceding 4 fiscal years for which data are available; and</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iii">“(iii) </num><content style="-uslm-dtd: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 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 of the preceding 4 fiscal years for which data are available.</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Compounded basis.—</heading><content style="-uslm-dtd:text">The adjustment made each fiscal year after fiscal year 2020 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.”</content>
</subparagraph>
</paragraph></quotedContent>.</content>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tII/s202/b/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Workload adjustments.—</heading><content style="-uslm-dtd:text">Paragraph (3) of section 741(c) (21 U.S.C. 379j-21(c)), as redesignated, is amended to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Workload adjustments.—</heading>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">For fiscal year 2020 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—</chapeau>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd: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; and</content>
</clause>
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.</content>
</clause>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><heading style="-uslm-dtd:header">Reduction of workload-based increase by amount of certain excess collections.—</heading><content style="-uslm-dtd:text">For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.</content>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">“(C) </num><heading style="-uslm-dtd:header">Rule of application.—</heading><content style="-uslm-dtd:text">Under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).”</content>
</subparagraph>
</paragraph></quotedContent>.</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tII/s202/b/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Final year adjustment.—</heading><chapeau style="-uslm-dtd:text">Paragraph (4) of section 741(c) (21 U.S.C. 379j-21(c)), as redesignated, is amended by—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tII/s202/b/3/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">striking “<quotedText style="-uslm-dtd:quote">2018</quotedText>” each place it appears and inserting “<quotedText style="-uslm-dtd:quote">2023</quotedText>”; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tII/s202/b/3/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">striking “<quotedText style="-uslm-dtd:quote">2019</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2024</quotedText>”.</content>
</subparagraph>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tII/s202/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Fee Waiver or Reduction; Exemption From Fees.—</heading><content style="-uslm-dtd:text">Subsection (d) of section 741 (21 U.S.C. 379j-21) is amended to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<subsection style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="d">“(d) </num><heading style="-uslm-dtd:header">Fee Waiver or Reduction; Exemption From Fees.—</heading>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">“(1) </num><heading style="-uslm-dtd:header">Fee waiver or reduction.—</heading><content style="-uslm-dtd: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 the generic new animal drug is intended solely to provide for a minor use or minor species indication.</content>
</paragraph>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">“(2) </num><heading style="-uslm-dtd:header">Exemption from fees.—</heading><chapeau style="-uslm-dtd:text">Fees under this section shall not apply with respect to any person who—</chapeau>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">not later than September 30, 2023, submits a supplemental abbreviated application for a generic new animal drug approved under section 512, solely to add the application number to the labeling of the drug in the manner specified in section 502(w)(3); and</content>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">otherwise would be subject to fees under this section solely on the basis of such supplemental abbreviated application.”</content>
</subparagraph>
</paragraph>
</subsection></quotedContent>.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tII/s202/d" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Crediting and Availability of Fees.—</heading><content style="-uslm-dtd:text">Section 741(g) (21 U.S.C. 379j-21) is amended by striking paragraph (3) and inserting the following paragraphs:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">“(3) </num><heading style="-uslm-dtd:header">Authorization of appropriations.—</heading><content style="-uslm-dtd:text">For each of the fiscal years 2019 through 2023, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).</content>
</paragraph>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">“(4) </num><heading style="-uslm-dtd:header">Excess collections.—</heading><content style="-uslm-dtd:text">If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).”</content>
</paragraph></quotedContent>.</content>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tII/s203" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="203">SEC. 203. </num><heading style="-uslm-dtd:header">REAUTHORIZATION; REPORTING REQUIREMENTS. </heading><chapeau style="-uslm-dtd:text">Section 742 (21 U.S.C. 379j-22) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tII/s203/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subsection (a), by striking “<quotedText style="-uslm-dtd:quote">2013</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">2018</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tII/s203/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subsection (b), by striking “<quotedText style="-uslm-dtd:quote">Committee on Health, Education, Labor, and Pensions</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">the Committee on Health, Education, Labor and Pensions</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tII/s203/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">2014</quotedText>” each place it appears in subsections (a) and (b) and inserting “<quotedText style="-uslm-dtd:quote">2019</quotedText>”; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tII/s203/4" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">in subsection (d), by striking “<quotedText style="-uslm-dtd:quote">2018</quotedText>” each place it appears and inserting “<quotedText style="-uslm-dtd:quote">2023</quotedText>”.</content>
</paragraph>
</section>
<section identifier="/us/sComp/115/234/tII/s204" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="204">SEC. 204. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-21">21 U.S.C. 379j-21 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SAVINGS CLAUSE. </heading><content style="-uslm-dtd:text">Notwithstanding the amendments made by this title, part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21 et seq.), 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, 2013, but before October 1, 2018, 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 2019.</content>
</section>
<section identifier="/us/sComp/115/234/tII/s205" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="205">SEC. 205. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-21">21 U.S.C. 379j-21 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">EFFECTIVE DATE. </heading><content style="-uslm-dtd:text">The amendments made by this title shall take effect on October 1, 2018, or the date of the 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 abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act.</content>
</section>
<section identifier="/us/sComp/115/234/tII/s206" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="206">SEC. 206. </num><heading style="-uslm-dtd:header">SUNSET DATES. </heading>
<chapeau class="block" style="-uslm-dtd:text">
<editorialNote style="-uslm-dtd:legis-comment"><b>[</b>Subsections (a) and (b) were repealed by section 2316(c) of Public Law 118–15.<b>]</b></editorialNote>
</chapeau>
<subsection identifier="/us/sComp/115/234/tII/s206/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s379j-21">21 U.S.C. 379j-21 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Previous Sunset Provision.—</heading><content style="-uslm-dtd:text">Effective October 1, 2018, subsections (a) and (b) of section 206 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113-14) are repealed.</content>
</subsection>
</section>
<num style="-uslm-dtd:enum" value="III">TITLE III—</num><heading style="-uslm-dtd:header">MISCELLANEOUS PROVISIONS </heading>
<section identifier="/us/sComp/115/234/tIII/s301" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="301">SEC. 301. </num><heading style="-uslm-dtd:header">ELECTRONIC SUBMISSIONS. </heading>
<subsection identifier="/us/sComp/115/234/tIII/s301/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">New Animal Drug Applications and Abbreviated Applications for a Generic New Animal Drug.—</heading><content style="-uslm-dtd:text">Section 512(b) (21 U.S.C. 360b(b)) is amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph class="leftIndentDecrease1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">“(4) </num><content style="-uslm-dtd:text">Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.”</content>
</paragraph></quotedContent>.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s301/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Conditional Approval of New Animal Drugs for Minor Use and Minor Species.—</heading><content style="-uslm-dtd:text">Section 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph class="leftIndentDecrease1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">“(4) </num><content style="-uslm-dtd:text">Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.”</content>
</paragraph></quotedContent>.</content>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tIII/s302" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="302">SEC. 302. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s360ccc-1">21 U.S.C. 360ccc-1 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES. </heading><chapeau style="-uslm-dtd:text">Effective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc-1(h)) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tIII/s302/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">by amending paragraph (1) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">‘LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF #’ (followed by the applicable minor species index file number and a period) ‘Extra-label use is prohibited.’;”</content>
</paragraph></quotedContent>; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s302/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in paragraph (2), by striking “<quotedText style="-uslm-dtd:quote">other animals</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">food-producing animals</quotedText>”.</content>
</paragraph>
</section>
<section identifier="/us/sComp/115/234/tIII/s303" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="303">SEC. 303. </num><heading style="-uslm-dtd:header">MISBRANDED DRUGS AND DEVICES. </heading>
<subsection identifier="/us/sComp/115/234/tIII/s303/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">Section 502(w) (21 U.S.C. 352(w)) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tIII/s303/a/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in subparagraph (1), by striking “<quotedText style="-uslm-dtd:quote">; or</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">;</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s303/a/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">in subparagraph (2), by striking the period and inserting “<quotedText style="-uslm-dtd:quote">; or</quotedText>”; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s303/a/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">“(3) </num><content style="-uslm-dtd:text">for which an application has been approved under section 512 and the labeling of such drug does not include the application number in the format: ‘Approved by FDA under (A)NADA # xxx-xxx’, except that this subparagraph shall not apply to representative labeling required under section 514.1(b)(3)(v)(b) of title 21, Code of Federal Regulations (or any successor regulation) for animal feed bearing or containing a new animal drug.”</content>
</paragraph></quotedContent>.</content>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s303/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s352">21 U.S.C. 352 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Applicability.—</heading><content style="-uslm-dtd:text">Section 502(w)(3) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall apply beginning on September 30, 2023.</content>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tIII/s304" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="304">SEC. 304. </num><heading style="-uslm-dtd:header">CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS. </heading>
<subsection identifier="/us/sComp/115/234/tIII/s304/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">Section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tIII/s304/a/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in the section heading, by striking “<quotedText style="-uslm-dtd:quote">species</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">species and certain new animal drugs</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/a/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><chapeau style="-uslm-dtd:text">in subsection (a)—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/a/2/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">by amending paragraph (1) to read as follows:<quotedContent style="-uslm-dtd:quoted-block">
<paragraph class="leftIndentDecrease1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">“(1)</num><subparagraph class="inline" style="-uslm-dtd:subparagraph" styleType="OLC"><num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of—</chapeau>
<clause class="leftIndentDecrease1" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">a new animal drug intended for a minor use or a minor species; or</content>
</clause>
<clause class="leftIndentDecrease1" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><chapeau style="-uslm-dtd:text">a new animal drug not intended for a minor use or minor species—</chapeau>
<subclause class="leftIndentDecrease1" style="-uslm-dtd:subclause" styleType="OLC">
<num style="-uslm-dtd:enum" value="I">“(I) </num><content style="-uslm-dtd:text">that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and</content>
</subclause>
<subclause class="leftIndentDecrease1" style="-uslm-dtd:subclause" styleType="OLC">
<num style="-uslm-dtd:enum" value="II">“(II) </num><content style="-uslm-dtd:text">for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies.</content>
</subclause>
</clause></subparagraph>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii).</content>
</subparagraph>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">An application under this paragraph shall comply in all respects with the provisions of section 512 except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section.</content>
</subparagraph>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="D">“(D) </num><content style="-uslm-dtd:text">New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under section 512(d) (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance).”</content>
</subparagraph>
</paragraph></quotedContent>; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/a/2/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in paragraph (3)—</chapeau>
<clause identifier="/us/sComp/115/234/tIII/s304/a/2/B/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">in subparagraph (B), by striking “<quotedText style="-uslm-dtd:quote">, or</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">; or</quotedText>”;</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/a/2/B/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by redesignating subparagraphs (A), (B), and (C) as clauses (i), (ii), and (iii), respectively;</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/a/2/B/iii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">A person may not file</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">(A) A person may not file</quotedText>”; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/a/2/B/iv" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iv">(iv) </num><content style="-uslm-dtd:text">by adding at the end the following new subparagraph:<quotedContent style="-uslm-dtd:quoted-block">
<subparagraph class="leftIndentDecrease2" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">A person may not file an application under paragraph (1)(A)(ii) if the application seeks conditional approval of a new animal drug that contains an antimicrobial active ingredient.”</content>
</subparagraph></quotedContent>;</content>
</clause>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/a/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><chapeau style="-uslm-dtd:text">in subsection (f)—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/a/3/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">in paragraph (1), in the matter preceding subparagraph (A), by inserting “<quotedText style="-uslm-dtd:quote">for the conditionally approved use</quotedText>” after “<quotedText style="-uslm-dtd:quote">shall</quotedText>”; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/a/3/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">in paragraph (2)—</chapeau>
<clause identifier="/us/sComp/115/234/tIII/s304/a/3/B/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">An intended use</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">The Secretary shall, through regulation or guidance, determine under what conditions an intended use</quotedText>”; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/a/3/B/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">shall not</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">may</quotedText>”; and</content>
</clause>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/a/4" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">by adding at the end the following new subsection:<quotedContent style="-uslm-dtd:quoted-block">
<subsection style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="k">“(k) </num><heading style="-uslm-dtd:header">Sunset.—</heading>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">“(1) </num><content style="-uslm-dtd:text">The Secretary’s authority to grant conditional approval of new animal drugs not intended for a minor use or minor species pursuant to subsection (a)(1)(A)(ii) terminates on October 1, 2028.</content>
</paragraph>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">“(2) </num><chapeau style="-uslm-dtd:text">The Secretary—</chapeau>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">may not accept any new applications for such conditional approval pursuant to subsection (a)(1)(A)(ii) on or after such date; and</content>
</subparagraph>
<subparagraph style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">may continue all activities under this section with respect to drugs that were conditionally approved pursuant to (a)(1)(A)(ii) prior to such date.</content>
</subparagraph>
</paragraph>
<paragraph style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">“(3) </num><content style="-uslm-dtd:text">The Secretary may, until October 1, 2032, accept applications for approval under 512 of drugs conditionally approved pursuant to (a)(1)(A)(ii).”</content>
</paragraph>
</subsection></quotedContent>.</content>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s304/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Exception From Fees in Case of Certain Previously Submitted Applications for Conditional Approval.—</heading><chapeau style="-uslm-dtd:text">Section 740(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(C)) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tIII/s304/b/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">in the caption by striking “<quotedText style="-uslm-dtd:quote">Exception</quotedText>” and inserting “<quotedText style="-uslm-dtd:quote">Exceptions</quotedText>”;</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/b/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by striking “<quotedText style="-uslm-dtd:quote">If an animal drug</quotedText>” and inserting the following:<quotedContent style="-uslm-dtd:quoted-block">
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">“(i) </num><content style="-uslm-dtd:text">If an animal drug”</content>
</clause></quotedContent>; and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/b/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">by inserting after clause (i), as so designated, the following new clause:<quotedContent style="-uslm-dtd:quoted-block">
<clause style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">“(ii) </num><content style="-uslm-dtd:text">Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under section 512(b)(1), where such person (or their licensor, assignor, or predecessor-in-interest) previously submitted an application for conditional approval under section 571 for the same product and paid the applicable fee under subparagraph (A), the application under section 512(b)(1) shall not be subject to a fee under subparagraph (A) if submitted within the timeframe specified in section 571(h).”</content>
</clause></quotedContent>.</content>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s304/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Report on Incorporating Veterinary Oversight.—</heading><content style="-uslm-dtd:text">Not later than September 30, 2019, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate identifying how the Food and Drug Administration will incorporate veterinary oversight for all approved medically important antimicrobial drugs administered to animals that are not yet subject to veterinary oversight. Such report shall address requirements related to revisions of labeling to reflect that medically important antimicrobial drugs administered to animals shall be subject to veterinary oversight.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s304/d" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">GAO Study of Conditional Approval Programs.—</heading>
<paragraph identifier="/us/sComp/115/234/tIII/s304/d/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Study.—</heading><content style="-uslm-dtd:text">The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study on the effectiveness and overall impact of the conditional approval pathway under section 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc).</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/d/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Issuance of report.—</heading><content style="-uslm-dtd:text">Not later than January 1, 2026, the Comptroller General shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study under paragraph (1).</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s304/d/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Contents of reports.—</heading><chapeau style="-uslm-dtd:text">The report submitted under paragraph (2) shall address—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/d/3/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">for each drug for which a conditional approval has been awarded since October 1, 2018—</chapeau>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">whether the drug was granted conditional approval pursuant to clause (i) or (ii) of section 571(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a);</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">whether the drug was dual labeled during its conditional approval;</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/iii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">the indications for which the drug was granted conditional approval under section 571 of such Act (21 U.S.C. 360ccc) and whether the drug was approved or not approved under section 512 of such Act (21 U.S.C. 360b);</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/iv" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iv">(iv) </num><content style="-uslm-dtd:text">the number of years the drug was so conditionally approved and a description of the complexity of the investigation to demonstrate the drug’s effectiveness;</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/v" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="v">(v) </num><content style="-uslm-dtd:text">whether, and to what extent, the conditional approval pathway under such section 571 (21 U.S.C. 360ccc) impacted the sponsor’s decision to develop the drug or seek approval of the drug under section 512 of such Act (21 U.S.C. 360b);</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/vi" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="vi">(vi) </num><content style="-uslm-dtd:text">whether, and to what extent, conditional approval pursuant to clause (ii) of section 571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A)) addressed a serious or life-threatening condition; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/A/vii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="vii">(vii) </num><content style="-uslm-dtd:text">whether, and to what extent, conditional approval pursuant to clause (ii) of section 571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A)) addressed an unmet animal or human health need, and whether before such conditional approval there were available therapies for the disease or condition involved;</content>
</clause>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/d/3/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">an analysis of the conditional approval program under section 571 of such Act (21 U.S.C. 360ccc), including—</chapeau>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/B/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">the resources used by the Food and Drug Administration in reviewing applications for conditional approval of drugs pursuant to such program and renewal of such conditional approval, including the effects of the program on the Food and Drug Administration’s review of animal drugs for which conditional approval is not used;</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/B/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><chapeau style="-uslm-dtd:text">whether any improvements to the program under section 512 of such Act (21 U.S.C. 360b) are necessary to incentivize the development of animal drugs that would likely not otherwise be developed, or developed in as timely a manner, to address—</chapeau>
<subclause identifier="/us/sComp/115/234/tIII/s304/d/3/B/ii/I" style="-uslm-dtd:subclause" styleType="OLC">
<num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">serious or life-threatening conditions; and</content>
</subclause>
<subclause identifier="/us/sComp/115/234/tIII/s304/d/3/B/ii/II" style="-uslm-dtd:subclause" styleType="OLC">
<num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">an unmet animal or human health need; and</content>
</subclause>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/B/iii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="iii">(iii) </num><content style="-uslm-dtd:text">whether the conditional approval pathway has resulted in a greater number of animal drugs approved under section 512 of such Act (21 U.S.C. 360b) for serious or life-threatening conditions or unmet animal or human health needs than would have otherwise come to market under the practices and commitments of the Center for Veterinary Medicine of the Food and Drug Administration as such practices and commitments existed as of the day before the date of enactment of this Act; and</content>
</clause>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s304/d/3/C" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">(C) </num><chapeau style="-uslm-dtd:text">how the Center for Veterinary Medicine of the Food and Drug Administration has utilized complex adaptive or other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, or surrogate endpoints—</chapeau>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/C/i" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">to support the approval of products under section 512 of such Act (21 U.S.C. 360b), including how many such products have been approved since October 1, 2018; and</content>
</clause>
<clause identifier="/us/sComp/115/234/tIII/s304/d/3/C/ii" style="-uslm-dtd:clause" styleType="OLC">
<num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">to support the approval of products under section 512 of such Act (21 U.S.C. 360b) that received conditional approval under section 571 of such Act (21 U.S.C. 360ccc), including how many such products have been approved since October 1, 2018.</content>
</clause>
</subparagraph>
</paragraph>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tIII/s305" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="305">SEC. 305. </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s360b">21 U.S.C. 360b note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">GUIDANCE ADDRESSING INVESTIGATION DESIGNS. </heading>
<subsection identifier="/us/sComp/115/234/tIII/s305/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><content style="-uslm-dtd:text">For purposes of assisting sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints (referred to in this section as “elements of investigations”) into proposed clinical investigation protocols and applications for new animal drugs under sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 360ccc), the Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall issue guidance addressing the use of such elements of investigations in the development and regulatory review of such new animal drugs.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s305/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Contents.—</heading><content style="-uslm-dtd:text">The guidance under subsection (a) shall address how the Secretary will evaluate the elements of investigations proposed or submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) of such Act, and how sponsors of such applications may obtain feedback from the Secretary on technical issues related to such investigations prior to the submission of an application to the Secretary.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s305/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Meeting.—</heading><content style="-uslm-dtd:text">Prior to issuing the guidance under subsection (a), the Secretary shall consult with stakeholders, including representatives of regulated industry, consumer groups, academia, veterinarians, and food producers, through a public meeting to be held not later than 1 year after the date of enactment of this Act.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s305/d" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Timing.—</heading><content style="-uslm-dtd:text">The Secretary shall issue a draft guidance under subsection (a) not later than 1 year after the date of the public meeting under subsection (c), and shall finalize such guidance not later than 1 year after the date on which the public comment period on such draft guidance ends.</content>
</subsection>
</section>
<section identifier="/us/sComp/115/234/tIII/s306" style="-uslm-dtd:section" styleType="OLC">
<num style="-uslm-dtd:enum" value="306">SEC. 306. </num><heading style="-uslm-dtd:header">FOOD ADDITIVES INTENDED FOR USE IN ANIMAL FOOD. </heading>
<subsection identifier="/us/sComp/115/234/tIII/s306/a" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Food Additive Petitions for Animal Food.—</heading><content style="-uslm-dtd:text">Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended by adding at the end the following:<quotedContent style="-uslm-dtd:quoted-block">
<subsection style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="k">“(k) </num><heading style="-uslm-dtd:header">Food Additives Intended for Use in Animal Food.—</heading><paragraph class="inline" style="-uslm-dtd:paragraph" styleType="OLC"><num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.</content></paragraph>
<paragraph class="leftIndentDecrease1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">“(2) </num><chapeau style="-uslm-dtd:text">Not later than 12 months after the date of enactment of the Animal Drug and Animal Generic Drug Use Fee Amendments of 2018, the Secretary shall post on the internet website of the Food and Drug Administration—</chapeau>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">“(A) </num><content style="-uslm-dtd:text">the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;</content>
</subparagraph>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">“(B) </num><content style="-uslm-dtd:text">how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and</content>
</subparagraph>
<subparagraph class="leftIndentDecrease1" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">“(C) </num><content style="-uslm-dtd:text">the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.</content>
</subparagraph>
</paragraph>
<paragraph class="leftIndentDecrease1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">“(3) </num><content style="-uslm-dtd:text">In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement.”</content>
</paragraph>
</subsection></quotedContent>.</content>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s306/b" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Ensuring the Safety of Pet Food.—</heading><chapeau style="-uslm-dtd:text">Section 1002(a) of the Food and Drug Administration Amendments Act of 2007 (21 U.S.C. 2102(a)) is amended—</chapeau>
<paragraph identifier="/us/sComp/115/234/tIII/s306/b/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">by striking paragraph (1); and</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s306/b/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">by redesignating paragraphs (2) and (3) as paragraphs (1) and (2), respectively.</content>
</paragraph>
</subsection>
<subsection identifier="/us/sComp/115/234/tIII/s306/c" style="-uslm-dtd:subsection" styleType="OLC">
<num style="-uslm-dtd:enum" value="c">(c) </num><editorialNote role="uscRef" style="-uslm-dtd:usc-reference"><b>[</b><ref href="/us/usc/t21/s348">21 U.S.C. 348 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">Guidance on Pre-Petition Consultation Process for Animal Food Additives.—</heading>
<paragraph identifier="/us/sComp/115/234/tIII/s306/c/1" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food.</content>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s306/c/2" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Contents.—</heading><chapeau style="-uslm-dtd:text">The guidance under paragraph (1) shall include—</chapeau>
<subparagraph identifier="/us/sComp/115/234/tIII/s306/c/2/A" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">the recommended format to submit to the Food and Drug Administration existing data, including any applicable foreign data, for assessment prior to submission of a food additive petition for animal food under section 409(b) of the Federal Food, Drug, and Cosmetic Act;</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s306/c/2/B" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">the manner and the number of days by which the Food and Drug Administration intends to review and respond to such existing data, including with respect to providing a scientific rationale for any additional data request;</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s306/c/2/C" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section 409(b);</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s306/c/2/D" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">the manner in which the Secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than 50 days; and</content>
</subparagraph>
<subparagraph identifier="/us/sComp/115/234/tIII/s306/c/2/E" style="-uslm-dtd:subparagraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="E">(E) </num><content style="-uslm-dtd:text">best practices for communication between the Food and Drug Administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives.</content>
</subparagraph>
</paragraph>
<paragraph identifier="/us/sComp/115/234/tIII/s306/c/3" style="-uslm-dtd:paragraph" styleType="OLC">
<num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Final guidance.—</heading><content style="-uslm-dtd:text">The guidance under paragraph (1) shall be finalized, withdrawn, or reissued not later than 1 year after the close of the comment period on the draft guidance.</content>
</paragraph>
</subsection>
</section>