Public Law 115–52: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.Public Law52Public Law 115–52131 Stat. 10052017-08-182017-08-18United States Government Publishing OfficeNational Archives and Records AdministrationOffice of the Federal Registertext/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 Locator to USLM Converter 4.15.31;Stage2.202507022026-01-02115publicPUBLIC LAW 115–52—AUG. 18, 2017131 STAT. 1005Public Law115–52115th CongressAn ActTo amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.
Aug. 18, 2017
[H.R. 2430]
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
FDA Reauthorization Act of 2017.
21 USC 301 note.
SECTION 1. SHORT TITLE. This Act may be cited as the “FDA Reauthorization Act of 2017”.SEC. 2. 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. TITLE II—Sec. 201. Sec. 202. Sec. 203. Sec. 204. Sec. 205. Sec. 206. Sec. 207. Sec. 208. Sec. 209. Sec. 210. TITLE III—Sec. 301. Sec. 302. Sec. 303. Sec. 304. Sec. 305. Sec. 306. Sec. 307. TITLE IV—Sec. 401. Sec. 402. Sec. 403. Sec. 404. Sec. 405. Sec. 406. Sec. 407. TITLE V—Sec. 501. Sec. 502. Sec. 503. Sec. 504. Sec. 505. TITLE VI—Sec. 601. Sec. 602. Sec. 603. Sec. 604. Sec. 605. Sec. 606. Sec. 607. Sec. 608. Sec. 609. Sec. 610. Sec. 611. TITLE VII—Sec. 701. Sec. 702. Sec. 703. Sec. 704. Sec. 705. Sec. 706. Sec. 707. Sec. 708. Sec. 709. Sec. 710. TITLE VIII—Sec. 801. Sec. 802. Sec. 803. Sec. 804. Sec. 805. Sec. 806. Sec. 807. Sec. 808. Sec. 809. TITLE IX—Sec. 901. Sec. 902. Sec. 903. Sec. 904. Sec. 905. <num value="I">TITLE I—</num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6375c4d6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Prescription Drug User Fee Amendments</p><p class="leftAlign firstIndent0 fontsize8" id="x6375c4d7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">of 2017.</p></sidenote><heading>FEES RELATING TO DRUGS</heading>
<section id="d132600e530" identifier="/us/pl/115/52/tI/s101" style="-uslm-lc:I658143"><num class="fontsize12" value="101">SEC. 101. </num><heading>SHORT TITLE; FINDING.</heading><subsection class="firstIndent0 fontsize10" id="y6375ebe8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s101/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6375ebe9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s301">21 USC 301 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Short Title</inline>.—</heading><content>This title may be cited as the “<shortTitle role="title">Prescription Drug User Fee Amendments of 2017</shortTitle>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6375ebea-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s101/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6375ebeb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379g">21 USC 379g note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Finding</inline>.—</heading><content>The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and <page identifier="/us/stat/131/1007">131 STAT. 1007</page>
Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.</content></subsection>
</section>
<section id="d132600e571" identifier="/us/pl/115/52/tI/s102" style="-uslm-lc:I658143"><num class="fontsize12" value="102">SEC. 102. </num><heading>AUTHORITY TO ASSESS AND USE DRUG FEES.</heading><subsection class="firstIndent0 fontsize10" id="y6377e7bc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Types of Fees</inline>.—</heading><paragraph class="fontsize10" id="y6377e7bd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Section 736(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/a">21 U.S.C. 379h(a)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y6377e7be-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the matter preceding paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>fiscal year 2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>fiscal year 2018</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7bf-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in the heading of paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">and supplement</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7c0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or a supplement</quotedText>” and “<quotedText>or supplement</quotedText>” each place either appears;</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7c1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><chapeau>in paragraph (1)(A)—</chapeau><clause class="fontsize10" id="y6377e7c2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/D/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in clause (i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>(c)(4)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(c)(5)</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6377e7c3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/D/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in clause (ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>A fee established</quotedText>” and all that follows through “<quotedText>are required.</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following: “<quotedText>A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval.</quotedText>”;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6377e7c4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>in the heading of paragraph (1)(C), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">or supplement</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7c5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><chapeau>in paragraph (1)(F)—</chapeau><clause class="fontsize10" id="y6377e7c6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/F/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">or indication</headingText></quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6377e7c7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/F/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> the second sentence;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6377e7c8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/G" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="G">(G) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (2) (relating to a prescription drug establishment fee);</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7c9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/H" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="H">(H) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraph (3) as paragraph (2);</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7ca-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/I" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">(I) </num><content>in the heading of paragraph (2), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">Prescription drug product fee</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">Prescription drug program fee</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7cb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/J" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="J">(J) </num><content>in subparagraph (A) of such paragraph (2), by <amendingAction type="amend">amending</amendingAction> the first sentence to read as follows: “<quotedText>Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year.</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6377e7cc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/K" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="K">(K) </num><chapeau>in subparagraph (B) of such paragraph (2)—</chapeau><clause class="fontsize10" id="y6377e7cd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/K/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading of subparagraph (B), by <amendingAction type="insert">inserting</amendingAction> after “<quotedText><headingText class="smallCaps">Exception</headingText></quotedText>” the following: “<quotedText><headingText class="smallCaps">for certain prescription drug products</headingText></quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6377e7ce-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/K/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>A prescription drug product shall not be assessed a fee</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>A prescription drug program fee shall not be assessed for a prescription drug product</quotedText>”; and<page identifier="/us/stat/131/1008">131 STAT. 1008</page></content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6377e7cf-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/1/L" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="L">(L) </num><content>by <amendingAction type="add">adding</amendingAction> at the end of such paragraph (2) the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y6377e7d0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.”</content></subparagraph>
</quotedContent>.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6377e7d1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/a/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Conforming amendment</inline>.—</heading><content>Subparagraph (C) of section 740(a)(3) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–12/a/3">21 U.S.C. 379j–12(a)(3)</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><subparagraph class="fontsize10" id="y63780ee2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>An establishment shall be assessed only one fee per fiscal year under this section.”</content></subparagraph>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63780ee3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Revenue Amounts</inline>.—</heading><content>Subsection (b) of section 736 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h">21 U.S.C. 379h</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><subsection class="firstIndent0 fontsize10" id="y63785d04-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">“(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Revenue Amounts</inline>.—</heading><paragraph class="fontsize10" id="y63785d05-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>For each of the fiscal years 2018 through 2022, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—</chapeau><subparagraph class="fontsize10" id="y63785d06-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the annual base revenue for the fiscal year (as determined under paragraph (3));</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d07-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d08-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2));</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d09-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3));</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d0a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><content>the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d0b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">“(F) </num><chapeau>additional dollar amounts for each fiscal year as follows:</chapeau><clause class="fontsize10" id="y63785d0c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>$20,077,793 for fiscal year 2018.</content></clause>
<clause class="fontsize10" id="y63785d0d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>$21,317,472 for fiscal year 2019.</content></clause>
<clause class="fontsize10" id="y63785d0e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>$16,953,329 for fiscal year 2020.</content></clause>
<clause class="fontsize10" id="y63785d0f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>$5,426,896 for fiscal year 2021.</content></clause>
<clause class="fontsize10" id="y63785d10-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">“(v) </num><content>$2,769,609 for fiscal year 2022.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63785d11-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Types of fees</inline>.—</heading><chapeau>Of the total revenue amount determined for a fiscal year under paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y63785d12-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>20 percent shall be derived from human drug application fees under subsection (a)(1); and</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d13-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>80 percent shall be derived from prescription drug program fees under subsection (a)(2).</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63785d14-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Annual base revenue</inline>.—</heading><chapeau>For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—</chapeau><subparagraph class="fontsize10" id="y63785d15-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>for fiscal year 2018, $878,590,000; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63785d16-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(3) or (c)(4).”</content></subparagraph>
</paragraph>
</subsection>
</quotedContent>.<page identifier="/us/stat/131/1009">131 STAT. 1009</page></content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63785d17-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Adjustments; Annual Fee Setting</inline>.—</heading><content>Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h">21 U.S.C. 379h</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><subsection class="firstIndent0 fontsize10" id="y63796d88-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><heading class="fontsize10"><inline class="smallCaps">Adjustments; Annual Fee Setting</inline>.—</heading><paragraph class="fontsize10" id="y63796d89-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Inflation adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63796d8a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—</chapeau><clause class="fontsize10" id="y63796d8b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>such annual base revenue for the fiscal year under subsection (b)(1)(A); and</content></clause>
<clause class="fontsize10" id="y63796d8c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the inflation adjustment percentage under subparagraph (B).</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63796d8d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Inflation adjustment percentage</inline>.—</heading><chapeau>The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—</chapeau><clause class="fontsize10" id="y63796d8e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years; and</content></clause>
<clause class="fontsize10" id="y63796d8f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63796d90-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Capacity planning adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63796d91-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.</content></subparagraph>
<subparagraph class="fontsize10" id="y63796d92-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Interim methodology</inline>.—</heading><clause class="fontsize10" id="y63796d93-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of—</chapeau><subclause class="fontsize10" id="y63796d94-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>the annual base revenue for such year, as adjusted for inflation under paragraph (1); and</content></subclause>
<subclause class="fontsize10" id="y63796d95-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>the adjustment percentage under clause (ii).</content></subclause>
</clause>
<clause class="fontsize10" id="y63796d96-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796d97-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Adjustment percentage</inline>.—</heading><chapeau>The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the <page identifier="/us/stat/131/1010">131 STAT. 1010</page>
most recent year for which data are available, over the 3-year average ending in the previous year, for—</chapeau><subclause class="fontsize10" id="y63796d98-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary;</content></subclause>
<subclause class="fontsize10" id="y63796d99-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>the total number of active commercial investigational new drug applications; and</content></subclause>
<subclause class="fontsize10" id="y63796d9a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.</content></subclause>
</clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63796d9b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Capacity planning methodology</inline>.—</heading><clause class="fontsize10" id="y63796d9c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796d9d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Contracts.</p><p class="leftAlign firstIndent0 fontsize8" id="x63796d9e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63796d9f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Development; evaluation and report</inline>.—</heading><content>The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796da0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x63796da1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p><p class="leftAlign firstIndent0 fontsize8" id="x63796da2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> The report shall be published for public comment no later than the end of fiscal year 2020.</content></clause>
<clause class="fontsize10" id="y63796da3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><heading class="fontsize10"><inline class="smallCaps">Establishment and implementation</inline>.—</heading><chapeau>After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—</chapeau><subclause class="fontsize10" id="y63796da4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>replace the interim methodology under subparagraph (B);</content></subclause>
<subclause class="fontsize10" id="y63796da5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>incorporate such approaches and attributes as the Secretary determines appropriate; and</content></subclause>
<subclause class="fontsize10" id="y63796da6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796da7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><content>be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.</content></subclause>
</clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63796da8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year).</content></subparagraph>
<subparagraph class="fontsize10" id="y63796da9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><heading class="fontsize10"><inline class="smallCaps">Publication in federal register</inline>.—</heading><content>The Secretary shall publish in the Federal Register notice under paragraph (5) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63796daa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796dab-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Operating reserve adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63796dac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">Increase</inline>.—</heading><content>For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide <page identifier="/us/stat/131/1011">131 STAT. 1011</page>
for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.</content></subparagraph>
<subparagraph class="fontsize10" id="y63796dad-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Decrease</inline>.—</heading><content>If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.</content></subparagraph>
<subparagraph class="fontsize10" id="y63796dae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Notice of rationale</inline>.—</heading><content>If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63796daf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Additional direct cost adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63796db0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees—</chapeau><clause class="fontsize10" id="y63796db1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>for fiscal year 2018, by $8,730,000; and</content></clause>
<clause class="fontsize10" id="y63796db2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B).</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63796db3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Amount</inline>.—</heading><chapeau>The amount determined under this subparagraph is—</chapeau><clause class="fontsize10" id="y63796db4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>$8,730,000, multiplied by</content></clause>
<clause class="fontsize10" id="y63796db5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63796db6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796db7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63796db8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Annual fee setting</inline>.—</heading><chapeau>The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017—</chapeau><subparagraph class="fontsize10" id="y63796db9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63796dba-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63796dbb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p></sidenote><content>publish such fee revenue and fees in the Federal Register.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637994cc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">“(6) </num><heading class="fontsize10"><inline class="smallCaps">Limit</inline>.—</heading><content>The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637994cd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Fee Waiver or Reduction</inline>.—</heading><chapeau>Section 736(d) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/d">21 U.S.C. 379h(d)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637994ce-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y637994cf-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or</quotedText>” at the end of subparagraph (B);</content></subparagraph>
<subparagraph class="fontsize10" id="y637994d0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (C); and</content></subparagraph>
<subparagraph class="fontsize10" id="y637994d1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subparagraph (D) as subparagraph (C);</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637994d2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (3) (relating to use of standard costs);</content></paragraph>
<paragraph class="fontsize10" id="y637994d3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraph (4) as paragraph (3); and</content></paragraph>
<paragraph class="fontsize10" id="y637994d4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><chapeau>in paragraph (3), as so redesignated—</chapeau><subparagraph class="fontsize10" id="y637994d5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/4/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in subparagraphs (A) and (B), by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraph (1)(D)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraph (1)(C)</quotedText>”; and<page identifier="/us/stat/131/1012">131 STAT. 1012</page></content></subparagraph>
<subparagraph class="fontsize10" id="y637994d6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/4/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>in subparagraph (B)—</chapeau><clause class="fontsize10" id="y637994d7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/4/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> clause (ii);</content></clause>
<clause class="fontsize10" id="y637994d8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/4/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>shall pay</quotedText>” through “<quotedText>(i) application fees</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>shall pay application fees</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y637994d9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/d/4/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>; and</quotedText>” at the end and <amendingAction type="insert">inserting</amendingAction> a period.</content></clause>
</subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637994da-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/e" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><heading class="fontsize10"><inline class="smallCaps">Effect of Failure To Pay Fees</inline>.—</heading><content>Section 736(e) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/e">21 U.S.C. 379h(e)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>all fees</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>all such fees</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637994db-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/f" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><heading class="fontsize10"><inline class="smallCaps">Limitations</inline>.—</heading><content>Section 736(f)(2) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/f/2">21 U.S.C. 379h(f)(2)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>supplements, prescription drug establishments, and prescription drug products</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>prescription drug program fees</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637994dc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/g" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="g">(g) </num><heading class="fontsize10"><inline class="smallCaps">Crediting and Availability of Fees</inline>.—</heading><chapeau>Section 736(g) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/g">21 U.S.C. 379h(g)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637994dd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/g/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (3)—</chapeau><subparagraph class="fontsize10" id="y637994de-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/g/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637994df-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/g/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>and paragraph (4) of this subsection</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637994e0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/g/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (4).</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637994e1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s102/h" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="h">(h) </num><heading class="fontsize10"><inline class="smallCaps">Orphan Drugs</inline>.—</heading><content>Section 736(k) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/k">21 U.S.C. 379h(k)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>product and establishment fees</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>prescription drug program fees</quotedText>”.</content></subsection>
</section>
<section id="d132600e1550" identifier="/us/pl/115/52/tI/s103" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="103">SEC. 103. </num><heading>REAUTHORIZATION; REPORTING REQUIREMENTS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x6379bbf2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 736B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h–2">21 U.S.C. 379h–2</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6379bbf3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s103/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (a)(1)—</chapeau><subparagraph class="fontsize10" id="y6379bbf4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s103/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the matter before subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6379bbf5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s103/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>Prescription Drug User Fee Amendments of 2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Prescription Drug User Fee Amendments of 2017</quotedText>”;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6379bbf6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s103/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subsection (b), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y6379bbf7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s103/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subsection (d), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></paragraph>
</section>
<section id="d132600e1616" identifier="/us/pl/115/52/tI/s104" style="-uslm-lc:I658143"><num class="fontsize12" value="104">SEC. 104. </num><heading>SUNSET DATES.</heading><subsection class="firstIndent0 fontsize10" id="y6379e308-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s104/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6379e309-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379g">21 USC 379g note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Authorization</inline>.—</heading><content>Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379g">21 U.S.C. 379g</ref>; 379h) shall cease to be effective October 1, 2022.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6379e30a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s104/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6379e30b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379h–2">21 USC 379h–2 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Reporting Requirements</inline>.—</heading><content>Section 736B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h–2">21 U.S.C. 379h–2</ref>) shall cease to be effective January 31, 2023.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6379e30c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tI/s104/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6379e30d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x6379e30e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Repeal.</p><p class="leftAlign firstIndent0 fontsize8" id="x6379e30f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379g">21 USC 379g note</ref>, 379h–2 note.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Previous Sunset Provision</inline>.—</heading><content>Effective October 1, 2017, subsections (a) and (b) of section 105 of the Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) are <amendingAction type="repeal">repealed</amendingAction>.</content></subsection>
</section>
<section id="d132600e1683" identifier="/us/pl/115/52/tI/s105" style="-uslm-lc:I658143"><num class="fontsize12" value="105">SEC. 105. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6379e310-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379g">21 USC 379g note</ref>.</p></sidenote><heading>EFFECTIVE DATE.</heading><content style="-uslm-lc:I658120"> The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed <page identifier="/us/stat/131/1013">131 STAT. 1013</page>
for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.</content></section>
<section id="d132600e1698" identifier="/us/pl/115/52/tI/s106" style="-uslm-lc:I658143"><num class="fontsize12" value="106">SEC. 106. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637a0a21-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379g">21 USC 379g note</ref>.</p></sidenote><heading>SAVINGS CLAUSE.</heading><content style="-uslm-lc:I658120"> Notwithstanding<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637a0a22-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Continuation.</p><p class="leftAlign firstIndent0 fontsize8" id="x637a0a23-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote> the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, 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 2018.</content></section>
<num value="II">TITLE II—</num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637a0a24-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Medical Device User Fee Amendments</p><p class="leftAlign firstIndent0 fontsize8" id="x637a0a25-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">of 2017.</p></sidenote><heading>FEES RELATING TO DEVICES</heading>
<section id="d132600e1728" identifier="/us/pl/115/52/tII/s201" style="-uslm-lc:I658143"><num class="fontsize12" value="201">SEC. 201. </num><heading>SHORT TITLE; FINDING.</heading><subsection class="firstIndent0 fontsize10" id="y637a3136-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s201/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637a3137-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s301">21 USC 301 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Short Title</inline>.—</heading><content>This title may be cited as the “<shortTitle role="title">Medical Device User Fee Amendments of 2017</shortTitle>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637a3138-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s201/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637a3139-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379i">21 USC 379i note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Finding</inline>.—</heading><content>The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.</content></subsection>
</section>
<section id="d132600e1765" identifier="/us/pl/115/52/tII/s202" style="-uslm-lc:I658143"><num class="fontsize12" value="202">SEC. 202. </num><heading>DEFINITIONS.</heading><subsection class="firstIndent0 fontsize10" id="y637a7f5a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s202/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><chapeau>Section 737 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379i">21 U.S.C. 379i</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637a7f5b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s202/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (8) through (13) as paragraphs (9) through (14), respectively;</content></paragraph>
<paragraph class="fontsize10" id="y637a7f5c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s202/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (7) the following new paragraph:<quotedContent><paragraph class="indentUp0 fontsize10" id="y637a7f5d-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="8">“(8) </num><content>The term ‘<term>de novo classification request</term>’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.”</content></paragraph>
</quotedContent>;</content></paragraph>
<paragraph class="fontsize10" id="y637a7f5e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s202/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subparagraph (D) of paragraph (10) (as redesignated by paragraph (1)), by <amendingAction type="delete">striking</amendingAction> “<quotedText>and submissions</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>submissions, and de novo classification requests</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y637a7f5f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s202/a/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>in paragraph (11) (as redesignated by paragraph (1)), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2011</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2016</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637a7f60-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s202/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Conforming Amendment</inline>.—</heading><content>Section 714(b)(1) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379d–3/b/1">21 U.S.C. 379d–3(b)(1)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>737(8)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>737(9)</quotedText>”.</content></subsection>
</section>
<section id="d132600e1857" identifier="/us/pl/115/52/tII/s203" style="-uslm-lc:I658143"><num class="fontsize12" value="203">SEC. 203. </num><heading>AUTHORITY TO ASSESS AND USE DEVICE FEES.</heading><subsection class="firstIndent0 fontsize10" id="y637c5421-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Types of Fees</inline>.—</heading><chapeau>Section 738(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j/a">21 U.S.C. 379j(a)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637c5422-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>fiscal year 2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>fiscal year 2018</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y637c5423-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y637c5424-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in subparagraph (A)—<page identifier="/us/stat/131/1014">131 STAT. 1014</page></chapeau><clause class="fontsize10" id="y637c5425-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/2/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the matter preceding clause (i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>October 1, 2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>October 1, 2017</quotedText>”;</content></clause>
<clause class="fontsize10" id="y637c5426-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/2/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in clause (viii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>3.4</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y637c5427-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/2/A/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following new clause:<quotedContent><clause class="indentUp0 fontsize10" id="y637c5428-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="xi">“(xi) </num><content>For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).”</content></clause>
</quotedContent>; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y637c5429-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in subparagraph (B)(v)(I), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or premarket notification submission</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>premarket notification submission, or de novo classification request</quotedText>”.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637c542a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Amounts</inline>.—</heading><content>Section 738(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j/b">21 U.S.C. 379j(b)</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><subsection class="firstIndent0 fontsize10" id="y637ca24b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">“(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Amounts</inline>.—</heading><paragraph class="fontsize10" id="y637ca24c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).</content></paragraph>
<paragraph class="fontsize10" id="y637ca24d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Base fee amounts specified</inline>.—</heading><content>For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:<xhtml:table xmlns:xhtml="http://www.w3.org/1999/xhtml" class="Quoted fullWidth" style="border-collapse:collapse; border-bottom:1px solid black; -uslm-lc: 'c6,L2(4,4,4,4,0,0),tp0,p8,8/8,s60,8,8,8,8,8'; "><xhtml:colgroup><xhtml:col role="stub" style="min-width: 245pt;"/>
<xhtml:col role="figure" style="width:36pt ; max-width:36pt;"/>
<xhtml:col role="figure" style="width:36pt ; max-width:36pt;"/>
<xhtml:col role="figure" style="width:36pt ; max-width:36pt;"/>
<xhtml:col role="figure" style="width:36pt ; max-width:36pt;"/>
<xhtml:col role="figure" style="width:36pt ; max-width:36pt;"/>
</xhtml:colgroup><xhtml:thead><xhtml:tr class="header" style="font-size:8pt; border-bottom:1px solid black; border-top:1px solid black; -uslm-lc:h1">
<xhtml:th style="min-width: 245.0pt; text-align:center; vertical-align:middle; border-right:0.0pt solid black;">“Fee Type</xhtml:th><xhtml:th style="width:36.0pt ; max-width:36.0pt; text-align:center; vertical-align:middle; border-right:0.0pt solid black; border-left:0.0pt solid black;">Fiscal Year 2018</xhtml:th><xhtml:th style="width:36.0pt ; max-width:36.0pt; text-align:center; vertical-align:middle; border-right:0.0pt solid black; border-left:0.0pt solid black;">Fiscal Year 2019</xhtml:th><xhtml:th style="width:36.0pt ; max-width:36.0pt; text-align:center; vertical-align:middle; border-right:0.0pt solid black; border-left:0.0pt solid black;">Fiscal Year 2020</xhtml:th><xhtml:th style="width:36.0pt ; max-width:36.0pt; text-align:center; vertical-align:middle; border-right:0.0pt solid black; border-left:0.0pt solid black;">Fiscal Year 2021</xhtml:th><xhtml:th style="width:36.0pt ; max-width:36.0pt; text-align:center; vertical-align:middle; border-left:0.0pt solid black;">Fiscal Year 2022</xhtml:th></xhtml:tr>
</xhtml:thead><xhtml:tbody style="line-height:8pt; font-size:8pt;"><xhtml:tr style="border-top:1px solid black; -uslm-lc:I01"><xhtml:td leaderAlign="bottomLine" leaders="yes" stubHierarchy="1" style=" text-align:left; vertical-align:top; border-right:0.0pt solid black;"><inline>Premarket Application</inline></xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$294,000</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$300,000</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$310,000</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$328,000</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-left:0.0pt solid black;">$329,000</xhtml:td></xhtml:tr>
<xhtml:tr style="-uslm-lc:I01"><xhtml:td leaderAlign="bottomLine" leaders="yes" stubHierarchy="1" style=" text-align:left; vertical-align:top; border-right:0.0pt solid black;"><inline>Establishment Registration</inline></xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$4,375</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$4,548</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$4,760</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-right:0.0pt solid black; border-left:0.0pt solid black;">$4,975</xhtml:td><xhtml:td style=" text-align:right; vertical-align:bottom; border-left:0.0pt solid black;">$4,978</xhtml:td></xhtml:tr>
</xhtml:tbody></xhtml:table><?GPOvSpace 04?></content></paragraph>
<paragraph class="fontsize10" id="y637cc95e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Total revenue amounts specified</inline>.—</heading><chapeau>For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:</chapeau><subparagraph class="fontsize10" id="y637cc95f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>$183,280,756 for fiscal year 2018.</content></subparagraph>
<subparagraph class="fontsize10" id="y637cc960-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>$190,654,875 for fiscal year 2019.</content></subparagraph>
<subparagraph class="fontsize10" id="y637cc961-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>$200,132,014 for fiscal year 2020.</content></subparagraph>
<subparagraph class="fontsize10" id="y637cc962-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>$211,748,789 for fiscal year 2021.</content></subparagraph>
<subparagraph class="fontsize10" id="y637cc963-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><content>$213,687,660 for fiscal year 2022.”</content></subparagraph>
</paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637cc964-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Annual Fee Setting; Adjustments</inline>.—</heading><chapeau>Section 738(c) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j/c">21 U.S.C. 379j(c)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637cc965-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2017</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y637cc966-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y637cc967-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2014</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y637cc968-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (B) and <amendingAction type="insert">inserting</amendingAction> the following new subparagraph:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y637cf079-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Applicable inflation adjustment</inline>.—</heading><chapeau>The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of—</chapeau><clause class="fontsize10" id="y637cf07a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the base inflation adjustment under subparagraph (C) for such fiscal year; and</content></clause>
<clause class="fontsize10" id="y637cf07b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016.”</content></clause>
</subparagraph>
</quotedContent>;<page identifier="/us/stat/131/1015">131 STAT. 1015</page></content></subparagraph>
<subparagraph class="fontsize10" id="y637cf07c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in subparagraph (C), in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">to total revenue amounts</headingText></quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637cf07d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraph (D) to read as follows:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y637d178e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><heading class="fontsize10"><inline class="smallCaps">Adjustment to base fee amounts</inline>.—</heading><chapeau>For each of fiscal years 2018 through 2022, the Secretary shall—</chapeau><clause class="fontsize10" id="y637d178f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and</content></clause>
<clause class="fontsize10" id="y637d1790-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637d1791-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).”</content></clause>
</subparagraph>
</quotedContent>; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637d1792-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><chapeau>in paragraph (3)—</chapeau><subparagraph class="fontsize10" id="y637d1793-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2014 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637d1794-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/c/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>further adjusted</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>increased</quotedText>”.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637d1795-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/d" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Small Businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval Fees</inline>.—</heading><chapeau>Section 738(d) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j/d">21 U.S.C. 379j(d)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637d1796-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/d/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>specified in clauses (i) through (v) and clauses (vii), (ix), and (x)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y637d1797-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (2)(C)—</chapeau><subparagraph class="fontsize10" id="y637d1798-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/d/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>supplement, or</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>supplement,</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637d1799-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/d/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> “<quotedText>, or a de novo classification request</quotedText>” after “<quotedText>class III device</quotedText>”.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637d179a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/e" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><heading class="fontsize10"><inline class="smallCaps">Small Businesses; Fee Reduction Regarding Premarket Notification Submissions</inline>.—</heading><content>Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j/e/2/C">21 U.S.C. 379j(e)(2)(C)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>50</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>25</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637d179b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><heading class="fontsize10"><inline class="smallCaps">Fee Waiver or Reduction</inline>.—</heading><paragraph class="fontsize10" id="y637d179c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">Repeal</inline>.—</heading><content>Section 738 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j">21 U.S.C. 379j</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> subsection (f).</content></paragraph>
<paragraph class="fontsize10" id="y637d179d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Conforming amendments</inline>.—</heading><subparagraph class="fontsize10" id="y637d179e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/2/A" role="instruction" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>Section 515(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360e/c/4/A">21 U.S.C. 360e(c)(4)(A)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>738(h)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>738(g)</quotedText>”.</content></subparagraph>
<subparagraph class="fontsize10" id="y637d179f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>Section 738 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j">21 U.S.C. 379j</ref>), as amended by paragraph (1), is further amended—</chapeau><clause class="fontsize10" id="y637d17a0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/2/B/i" role="instruction" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsections (g) through (l) as subsections (f) through (k);</content></clause>
<clause class="fontsize10" id="y637d17a1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/2/B/ii" role="instruction" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in subsection (a)(2)(A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>(d), (e), and (f)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(d) and (e)</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y637d17a2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/f/2/B/iii" role="instruction" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>in subsection (a)(3)(A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>and subsection (f)</quotedText>”.</content></clause>
</subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637d17a3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/g" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="g">(g) </num><heading class="fontsize10"><inline class="smallCaps">Effect of Failure To Pay Fees</inline>.—</heading><chapeau>Subsection (f)(1), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j">21 U.S.C. 379j</ref>) <amendingAction type="amend">is amended</amendingAction>—<page identifier="/us/stat/131/1016">131 STAT. 1016</page></chapeau><paragraph class="fontsize10" id="y637d17a4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/g/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>or periodic reporting concerning a class III device</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>periodic reporting concerning a class III device, or de novo classification request</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y637d17a5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/g/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>all fees</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>all such fees</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637d17a6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/h" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="h">(h) </num><heading class="fontsize10"><inline class="smallCaps">Conditions</inline>.—</heading><content>Subsection (g)(1)(A), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j">21 U.S.C. 379j</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>$280,587,000</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>$320,825,000</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637d17a7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/i" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><heading class="fontsize10"><inline class="smallCaps">Crediting and Availability of Fees</inline>.—</heading><chapeau>Subsection (h), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j">21 U.S.C. 379j</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637d17a8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/i/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (3)—</chapeau><subparagraph class="fontsize10" id="y637d17a9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/i/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637d17aa-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/i/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (c)</quotedText>” and all that follows through the period at the end and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (c).</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637d17ab-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s203/i/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (4).</content></paragraph>
</subsection>
</section>
<section id="d132600e2538" identifier="/us/pl/115/52/tII/s204" style="-uslm-lc:I658143"><num class="fontsize12" value="204">SEC. 204. </num><heading>REAUTHORIZATION; REPORTING REQUIREMENTS.</heading><subsection class="firstIndent0 fontsize10" id="y637d65cc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Performance Reports</inline>.—</heading><chapeau>Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–1/a">21 U.S.C. 379j–1(a)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637d65cd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y637d65ce-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in subparagraph (A)—</chapeau><clause class="fontsize10" id="y637d65cf-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a/1/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y637d65d0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a/1/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>the Medical Device User Fee Amendments of 2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>the Medical Device User Fee Amendments of 2017</quotedText>”; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y637d65d1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in subparagraph (B), by <amendingAction type="delete">striking</amendingAction> “<quotedText>the Medical Device User Fee Amendments Act of 2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>the Medical Device User Fee Amendments of 2017</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637d65d2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (2), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y637d65d3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Reauthorization</inline>.—</heading><chapeau>Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–1/b">21 U.S.C. 379j–1(b)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637d65d4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y637d65d5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s204/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (5), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></paragraph>
</subsection>
</section>
<section id="d132600e2658" identifier="/us/pl/115/52/tII/s205" style="-uslm-lc:I658143"><num class="fontsize12" value="205">SEC. 205. </num><heading>CONFORMITY ASSESSMENT PILOT PROGRAM.</heading><subsection class="firstIndent0 fontsize10" id="y637db3f6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s205/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Section 514 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360d">21 U.S.C. 360d</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y637e2927-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><heading class="fontsize10"><inline class="smallCaps">Pilot Accreditation Scheme for Conformity Assessment</inline>.—</heading><paragraph class="fontsize10" id="y637e2928-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>The Secretary shall establish a pilot program under which—</chapeau><subparagraph class="fontsize10" id="y637e2929-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the Secretary, to assess the conformance of a device with certain standards recognized under this section; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637e292a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>subject to paragraph (2), determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the Secretary for purposes of demonstrating such conformity under this section unless the Secretary finds that a particular such determination shall not be so accepted.<page identifier="/us/stat/131/1017">131 STAT. 1017</page></content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637e292b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Secretarial review of accredited laboratory determinations</inline>.—</heading><chapeau>The Secretary may—</chapeau><subparagraph class="fontsize10" id="y637e292c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637e292d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Audits.</p></sidenote><content>review determinations by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and, following such review, taking additional measures under this Act, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A) or requesting additional information with respect to such device, as the Secretary determines appropriate; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637e292e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>if the Secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited, take such additional measures under this Act as the Secretary determines appropriate, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A), or requesting additional information with regard to such device.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637e292f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637e2930-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Implementation and reporting</inline>.—</heading><subparagraph class="fontsize10" id="y637e2931-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637e2932-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x637e2933-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notice.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Public meeting</inline>.—</heading><content>The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than September 30, 2018, to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the pilot program under this subsection.</content></subparagraph>
<subparagraph class="fontsize10" id="y637e2934-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Pilot program guidance</inline>.—</heading><chapeau>The Secretary shall—</chapeau><clause class="fontsize10" id="y637e2935-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>not later than September 30, 2019, issue draft guidance regarding the goals and implementation of the pilot program under this subsection; and</content></clause>
<clause class="fontsize10" id="y637e2936-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>not later than September 30, 2021, issue final guidance with respect to the implementation of such program.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y637e2937-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Pilot program initiation</inline>.—</heading><content>Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection.</content></subparagraph>
<subparagraph class="fontsize10" id="y637e5048-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637e5049-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><content>The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the pilot program under this subsection.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637e504a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Sunset</inline>.—</heading><chapeau>As of October 1, 2022—</chapeau><subparagraph class="fontsize10" id="y637e504b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph (1)(A) shall cease to have force or effect;</content></subparagraph>
<subparagraph class="fontsize10" id="y637e504c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><chapeau>the Secretary—</chapeau><clause class="fontsize10" id="y637e504d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>may not accept a determination pursuant to paragraph (1)(B) made by a testing laboratory after such date; and</content></clause>
<clause class="fontsize10" id="y637e504e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>may accept such a determination made prior to such date;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y637e504f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>except for purposes of accepting a determination described in subparagraph (B)(ii), the Secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph (1)(A); and</content></subparagraph>
<subparagraph class="fontsize10" id="y637e5050-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>the Secretary may take actions in accordance with paragraph (2) with respect to the determinations made <page identifier="/us/stat/131/1018">131 STAT. 1018</page>
prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date.”</content></subparagraph>
</paragraph>
</subsection>
</quotedContent>.</content></subsection>
</section>
<section id="d132600e2844" identifier="/us/pl/115/52/tII/s206" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="206">SEC. 206. </num><heading>REAUTHORIZATION OF REVIEW.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x637ec581-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 523 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360m">21 U.S.C. 360m</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637ec582-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (a)(3)—</chapeau><subparagraph class="fontsize10" id="y637ec583-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> clauses (ii) and (iii) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><clause class="fontsize10" id="y637eec94-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>a device classified under section 513(f)(2) or designated under section 515C(d);</content></clause>
<clause class="fontsize10" id="y637eec95-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)(iii); or</content></clause>
<clause class="fontsize10" id="y637eec96-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).”</content></clause>
</quotedContent>;</content></subparagraph>
<subparagraph class="fontsize10" id="y637eec97-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (B) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y637f13a8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Designation for review</inline>.—</heading><chapeau>The Secretary shall—</chapeau><clause class="fontsize10" id="y637f13a9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f13aa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Guidance.</p></sidenote><chapeau>issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including—</chapeau><subclause class="fontsize10" id="y637f13ab-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>the risk of the device type, or subset of such device type; and</content></subclause>
<subclause class="fontsize10" id="y637f13ac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset;</content></subclause>
</clause>
<clause class="fontsize10" id="y637f13ad-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f13ae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><content>not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and</content></clause>
<clause class="fontsize10" id="y637f13af-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f13b0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x637f13b1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p><p class="leftAlign firstIndent0 fontsize8" id="x637f13b2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p><p class="leftAlign firstIndent0 fontsize8" id="x637f13b3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary’s determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).”</content></clause>
</subparagraph>
</quotedContent>; and</content></subparagraph>
<subparagraph class="fontsize10" id="y637f13b4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y637f13b5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f13b6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Interim rule</inline>.—</heading><content>Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on the date of enactment the Medical Device User Fee Amendments of 2017 shall be in effect.”</content></subparagraph>
</quotedContent>;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637f13b7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in subsection (b)—</chapeau><subparagraph class="fontsize10" id="y637f13b8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in paragraph (2)—</chapeau><clause class="fontsize10" id="y637f13b9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (D); and<page identifier="/us/stat/131/1019">131 STAT. 1019</page></content></clause>
<clause class="fontsize10" id="y637f13ba-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subparagraph (E) as subparagraph (D); and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y637f13bb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>in paragraph (3)—</chapeau><clause class="fontsize10" id="y637f13bc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subparagraph (E) as subparagraph (F);</content></clause>
<clause class="fontsize10" id="y637f13bd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in subparagraph (F) (as so redesignated), by <amendingAction type="delete">striking</amendingAction> “<quotedText>The operations of</quotedText>” and all that follows through “<quotedText>it will—</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section—</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y637f13be-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/2/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subparagraph (D) the following new subparagraph:<quotedContent><subparagraph class="indentDown1 fontsize10" id="y637f13bf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><content>The operations of such person shall be in accordance with generally accepted professional and ethical business practices.”</content></subparagraph>
</quotedContent>; and</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y637f13c0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s206/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subsection (c), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></paragraph>
</section>
<section id="d132600e3061" identifier="/us/pl/115/52/tII/s207" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="207">SEC. 207. </num><heading>ELECTRONIC FORMAT FOR SUBMISSIONS.</heading><content class="firstIndent0 fontsize10" id="x637f3ad1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379k–1/b">21 U.S.C. 379k–1(b)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following new paragraph:<quotedContent><paragraph class="fontsize10" id="y637f61e2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f61e3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Presubmissions and submissions solely in electronic format</inline>.—</heading><subparagraph class="fontsize10" id="y637f61e4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f61e5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.</content></subparagraph>
<subparagraph class="fontsize10" id="y637f61e6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Draft guidance</inline>.—</heading><chapeau>The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—</chapeau><clause class="fontsize10" id="y637f61e7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>any further standards for the submission by electronic format required under subparagraph (A);</content></clause>
<clause class="fontsize10" id="y637f61e8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>a timetable for the establishment by the Secretary of such further standards; and</content></clause>
<clause class="fontsize10" id="y637f61e9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f61ea-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Criteria.</p></sidenote><content>criteria for waivers of and exemptions from the requirements of this subsection.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y637f61eb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Final guidance</inline>.—</heading><content>The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></section>
<section id="d132600e3139" identifier="/us/pl/115/52/tII/s208" style="-uslm-lc:I658143"><num class="fontsize12" value="208">SEC. 208. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f61ec-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379i">21 USC 379i note</ref>.</p></sidenote><heading>SAVINGS CLAUSE.</heading><content class="firstIndent0 fontsize10" id="x637f88fd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Notwithstanding<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f88fe-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Continuation.</p><p class="leftAlign firstIndent0 fontsize8" id="x637f88ff-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote> the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379i/etseq">21 U.S.C. 379i et seq.</ref>), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, 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 2018.<page identifier="/us/stat/131/1020">131 STAT. 1020</page></content></section>
<section id="d132600e3163" identifier="/us/pl/115/52/tII/s209" style="-uslm-lc:I658143"><num class="fontsize12" value="209">SEC. 209. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f8900-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379i">21 USC 379i note</ref>.</p></sidenote><heading>EFFECTIVE DATE.</heading><content style="-uslm-lc:I658120"> The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2017, regardless of the date of the enactment of this Act.</content></section>
<section id="d132600e3175" identifier="/us/pl/115/52/tII/s210" style="-uslm-lc:I658143"><num class="fontsize12" value="210">SEC. 210. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637f8901-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s378i">21 USC 378i note</ref>.</p></sidenote><heading>SUNSET DATES.</heading><subsection class="firstIndent0 fontsize10" id="y637faf12-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s210/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Authorization</inline>.—</heading><content>Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s739i">21 U.S.C. 739i</ref>; 739j) shall cease to be effective October 1, 2022.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637faf13-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s210/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637faf14-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–1">21 USC 379j–1 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Reporting Requirements</inline>.—</heading><content>Section 738A (<ref href="/us/usc/t21/s739j–1">21 U.S.C. 739j–1</ref>) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2023.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637faf15-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tII/s210/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637faf16-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x637faf17-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Repeal.</p><p class="leftAlign firstIndent0 fontsize8" id="x637faf18-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379i">21 USC 379i note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Previous Sunset Provision</inline>.—</heading><content>Effective October 1, 2017, section 207(a) of the Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) is <amendingAction type="repeal">repealed</amendingAction>.</content></subsection>
</section>
<num value="III">TITLE III—</num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637faf19-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Generic Drug User Fee Amendments</p><p class="leftAlign firstIndent0 fontsize8" id="x637faf1a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">of 2017.</p></sidenote><heading>FEES RELATING TO GENERIC DRUGS</heading>
<section id="d132600e3252" identifier="/us/pl/115/52/tIII/s301" style="-uslm-lc:I658143"><num class="fontsize12" value="301">SEC. 301. </num><heading>SHORT TITLE; FINDING.</heading><subsection class="firstIndent0 fontsize10" id="y637fd62b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s301/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637fd62c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s301">21 USC 301 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Short Title</inline>.—</heading><content>This title may be cited as the “<shortTitle role="title">Generic Drug User Fee Amendments of 2017</shortTitle>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y637fd62d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s301/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x637fd62e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–41">21 USC 379j–41 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Finding</inline>.—</heading><content>The Congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.</content></subsection>
</section>
<section id="d132600e3289" identifier="/us/pl/115/52/tIII/s302" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="302">SEC. 302. </num><heading>DEFINITIONS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x637ffd3f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 744A of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–41">21 U.S.C. 379j–41</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y637ffd40-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s302/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (1)(B), by <amendingAction type="delete">striking</amendingAction> “<quotedText>application for a positron emission tomography drug.</quotedText>” and <amendingAction type="insert">inserting</amendingAction> <quotedContent>“application—<clause class="indentUp2 fontsize10" id="y637ffd41-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>for a positron emission tomography drug; or</content></clause>
<clause class="indentUp2 fontsize10" id="y637ffd42-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>submitted by a State or Federal governmental entity for a drug that is not distributed commercially.”</content></clause>
</quotedContent>;</content></paragraph>
<paragraph class="fontsize10" id="y63802453-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s302/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (5) through (12) as paragraphs (6) through (13), respectively; and</content></paragraph>
<paragraph class="fontsize10" id="y63802454-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s302/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (4) the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63802455-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><content>The term ‘<term>contract manufacturing organization facility</term>’ means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.”</content></paragraph>
</quotedContent>.<page identifier="/us/stat/131/1021">131 STAT. 1021</page></content></paragraph>
</section>
<section id="d132600e3354" identifier="/us/pl/115/52/tIII/s303" style="-uslm-lc:I658143"><num class="fontsize12" value="303">SEC. 303. </num><heading>AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.</heading><subsection class="firstIndent0 fontsize10" id="y638358a6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Types of Fees</inline>.—</heading><chapeau>Section 744B(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/a">21 U.S.C. 379j–42(a)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638358a7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in the matter preceding paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>fiscal year 2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>fiscal year 2018</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y638358a8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (1), by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="fontsize10" id="y638358a9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><heading class="fontsize10"><inline class="smallCaps">Sunset</inline>.—</heading><content>This paragraph shall cease to be effective October 1, 2022.”</content></subparagraph>
</quotedContent>;</content></paragraph>
<paragraph class="fontsize10" id="y638358aa-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y638358ab-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraph (C) to read as follows:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y63837fbc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63837fbd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63837fbe-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63837fbf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Notice</inline>.—</heading><content>Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.”</content></subparagraph>
</quotedContent>; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63837fc0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>in subparagraph (E)—</chapeau><clause class="fontsize10" id="y63837fc1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><chapeau>in clause (i)—</chapeau><subclause class="fontsize10" id="y63837fc2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/B/i/I" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">(I) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>no later than the date</quotedText>” and <amendingAction type="insert">inserting</amendingAction> <quotedContent>“on the earlier of—<subclause class="indentUp0 fontsize10" id="y63837fc3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>the date”</content></subclause>
</quotedContent>;</content></subclause>
<subclause class="fontsize10" id="y63837fc4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/B/i/II" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">(II) </num><content>by <amendingAction type="delete">striking</amendingAction> the period and <amendingAction type="insert">inserting</amendingAction> “<quotedText>; or</quotedText>”; and</content></subclause>
<subclause class="fontsize10" id="y63837fc5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/B/i/III" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">(III) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y63837fc6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>the date on which the drug master file holder requests the initial completeness assessment.”</content></subparagraph>
</quotedContent>; and</content></subclause>
</clause>
<clause class="fontsize10" id="y63837fc7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/3/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in clause (ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>notice provided for in clause (i) or (ii) of subparagraph (C), as applicable</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>notice provided for in subparagraph (C)</quotedText>”;</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63837fc8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><chapeau>in paragraph (3)—</chapeau><subparagraph class="fontsize10" id="y63837fc9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">and prior approval supplement</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63837fca-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or a prior approval supplement to an abbreviated new drug application</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63837fcb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraphs (B) and (C) to read as follows:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y63837fcc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63837fcd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63837fce-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63837fcf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Notice</inline>.—</heading><content>Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.</content></subparagraph>
<subparagraph class="indentUp0 fontsize10" id="y63837fd0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63837fd1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63837fd2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Fee due date</inline>.—</heading><content>The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.”</content></subparagraph>
</quotedContent>;</content></subparagraph>
<subparagraph class="fontsize10" id="y6383a6e3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><chapeau>in subparagraph (D)—</chapeau><clause class="fontsize10" id="y6383a6e4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/D/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading, by <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">, is withdrawn prior to being received, or is no longer received</headingText></quotedText>” after “<quotedText><headingText class="smallCaps">received</headingText></quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6383a6e5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/D/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>The Secretary shall</quotedText>” and all that follows through the period and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><clause class="indentUp0 fontsize10" id="y6383a6e6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">Applications not considered to have been received and applications withdrawn prior to being received</inline>.—</heading><content>The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary <page identifier="/us/stat/131/1022">131 STAT. 1022</page>
considers not to have been received within the meaning of section 505(j)(5)(A) for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 505(j)(5)(A).</content></clause>
<clause class="indentUp0 fontsize10" id="y6383a6e7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6383a6e8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Refunds.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Applications no longer received</inline>.—</heading><content>The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under section 505(j)(5)(A) and subsequently determines that an exclusivity period for a listed drug should have prevented the Secretary from receiving such application, such that the abbreviated new drug application is no longer received within the meaning of section 505(j)(5)(A).”</content></clause>
</quotedContent>;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6383a6e9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>in subparagraph (E), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or prior approval supplement</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6383a6ea-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><chapeau>in the matter preceding clause (i) of subparagraph (F)—</chapeau><clause class="fontsize10" id="y6383a6eb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/F/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2017</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6383a6ec-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/4/F/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (d)(3)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (d)(2)</quotedText>”;</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6383a6ed-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><chapeau>in paragraph (4)—</chapeau><subparagraph class="fontsize10" id="y6383a6ee-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in subparagraph (A)—</chapeau><clause class="fontsize10" id="y6383a6ef-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the matter preceding clause (i) and in clause (iii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>, or intended to be identified, in at least one generic drug submission that is pending or</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>in at least one generic drug submission that is</quotedText>”;</content></clause>
<clause class="fontsize10" id="y6383a6f0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in clause (i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or intended to be identified in at least one generic drug submission that is pending or</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>in at least one generic drug submission that is</quotedText>”;</content></clause>
<clause class="fontsize10" id="y6383a6f1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5/A/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>in clause (ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>produces,</quotedText>” and all that follows through “<quotedText>such a</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6383a6f2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5/A/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>in clause (iii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>to fees under both such clauses</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>only to the fee attributable to the manufacture of the finished dosage forms</quotedText>”; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6383a6f3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/5/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraphs (C) and (D) to read as follows:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y6383ce04-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6383ce05-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Notice</inline>.—</heading><content>Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.</content></subparagraph>
<subparagraph class="indentUp0 fontsize10" id="y6383ce06-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6383ce07-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x6383ce08-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Fee due date</inline>.—</heading><chapeau>For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—</chapeau><clause class="fontsize10" id="y6383ce09-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the first business day on or after October 1 of each such year; or</content></clause>
<clause class="fontsize10" id="y6383ce0a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.”</content></clause>
</subparagraph>
</quotedContent>;<page identifier="/us/stat/131/1023">131 STAT. 1023</page></content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6383ce0b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/6" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">(6) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraph (5) as paragraph (6); and</content></paragraph>
<paragraph class="fontsize10" id="y6383ce0c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/a/7" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="7">(7) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (4) the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y6383f51d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><heading class="fontsize10"><inline class="smallCaps">Generic drug applicant program fee</inline>.—</heading><subparagraph class="fontsize10" id="y6383f51e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).</content></subparagraph>
<subparagraph class="fontsize10" id="y6383f51f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Amount</inline>.—</heading><content>The amount of fees established under subparagraph (A) shall be established under subsection (d).</content></subparagraph>
<subparagraph class="fontsize10" id="y6383f520-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6383f521-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Notice</inline>.—</heading><content>Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.</content></subparagraph>
<subparagraph class="fontsize10" id="y6383f522-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6383f523-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x6383f524-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Fee due date</inline>.—</heading><chapeau>For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—</chapeau><clause class="fontsize10" id="y6383f525-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the first business day on or after October 1 of each such fiscal year; or</content></clause>
<clause class="fontsize10" id="y6383f526-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.”</content></clause>
</subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y6383f527-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Revenue Amounts</inline>.—</heading><chapeau>Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/b">21 U.S.C. 379j–42(b)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6383f528-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y6383f529-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in subparagraph (A)—</chapeau><clause class="fontsize10" id="y6383f52a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">2013</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">2018</headingText></quotedText>”;</content></clause>
<clause class="fontsize10" id="y6383f52b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”;</content></clause>
<clause class="fontsize10" id="y6383f52c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/A/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>$299,000,000</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>$493,600,000</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6383f52d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/A/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Of that amount</quotedText>” and all that follows through the end of clause (ii); and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6383f52e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>in subparagraph (B)—</chapeau><clause class="fontsize10" id="y6383f52f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">2014 through 2017</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">2019 through 2022</headingText></quotedText>”;</content></clause>
<clause class="fontsize10" id="y6383f530-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2014 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2019 through 2022</quotedText>”;</content></clause>
<clause class="fontsize10" id="y6383f531-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraphs (2) through (4)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraphs (2) through (5)</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6383f532-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/1/B/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>$299,000,000</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>$493,600,000</quotedText>”; and</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6383f533-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y6383f534-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in the matter preceding subparagraph (A)—</chapeau><clause class="fontsize10" id="y6383f535-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>such paragraph for a fiscal year</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y6383f536-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>through (4)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>through (5)</quotedText>”;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6383f537-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>Six percent</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Five percent</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6383f538-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraphs (B) and (C) to read as follows:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y63841c49-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).<page identifier="/us/stat/131/1024">131 STAT. 1024</page></content></subparagraph>
<subparagraph class="indentUp0 fontsize10" id="y63841c4a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.”</content></subparagraph>
</quotedContent>;</content></subparagraph>
<subparagraph class="fontsize10" id="y63841c4b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><chapeau>in subparagraph (D)—</chapeau><clause class="fontsize10" id="y63841c4c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/D/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Fourteen percent</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Seven percent</quotedText>”;</content></clause>
<clause class="fontsize10" id="y63841c4d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/D/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>not less than $15,000 and not more than $30,000</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>$15,000</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y63841c4e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/D/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>, as determined</quotedText>” and all that follows through the period at the end and <amendingAction type="insert">inserting</amendingAction> a period; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63841c4f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/b/2/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y63844360-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E)</num><clause class="inline" id="y63844361-e82d-11f0-a1e4-69761a48a15a"><num value="i">(i) </num><chapeau>Thirty-five percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63844362-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote> shall determine the fees as follows:</chapeau><subclause class="fontsize10" id="y63844363-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.</content></subclause>
<subclause class="fontsize10" id="y63844364-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.</content></subclause>
<subclause class="fontsize10" id="y63844365-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.</content></subclause>
</clause>
<clause class="indentUp0 fontsize10" id="y63844366-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63844367-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><content>For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.”</content></clause>
</subparagraph>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63844368-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Adjustments</inline>.—</heading><chapeau>Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/c">21 U.S.C. 379j–42(c)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63844369-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y6384436a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2014</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2019</quotedText>”;<page identifier="/us/stat/131/1025">131 STAT. 1025</page></content></subparagraph>
<subparagraph class="fontsize10" id="y6384436b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> “<quotedText>to equal the product of the total revenues established in such notice for the prior fiscal year multiplied</quotedText>” after “<quotedText>a fiscal year,</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6384436c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="delete">striking</amendingAction> the flush text following subparagraph (C); and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6384436d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y6384436e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6384436f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>the first 3 months of fiscal year 2018</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>the first 3 months of fiscal year 2023</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63844370-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/c/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Such fees may only be used in fiscal year 2018.</quotedText>”.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63844371-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/d" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Annual Fee Setting</inline>.—</heading><chapeau>Section 744B(d) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/d">21 U.S.C. 379j–42(d)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63844372-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/d/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraphs (1) and (2) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63844373-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63844374-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63844375-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Fiscal years 2018 through 2022</inline>.—</heading><content>Not more than 60 days before the first day of each of fiscal years 2018 through 2022, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).”</content></paragraph>
</quotedContent>;</content></paragraph>
<paragraph class="fontsize10" id="y63846a86-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraph (3) as paragraph (2); and</content></paragraph>
<paragraph class="fontsize10" id="y63846a87-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/d/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in paragraph (2) (as so redesignated), in the matter preceding subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>fees under paragraphs (1) and (2)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>fee under paragraph (1)</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63846a88-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><heading class="fontsize10"><inline class="smallCaps">Identification of Facilities</inline>.—</heading><chapeau>Section 744B(f) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/f">21 U.S.C. 379j–42(f)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63846a89-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (1);</content></paragraph>
<paragraph class="fontsize10" id="y63846a8a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (2) through (4) as paragraphs (1) through (3), respectively;</content></paragraph>
<paragraph class="fontsize10" id="y63846a8b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><chapeau>in paragraph (1) (as so redesignated)—</chapeau><subparagraph class="fontsize10" id="y63846a8c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraph (4)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraph (3)</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63846a8d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63846a8e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Such information shall</quotedText>” and all that follows through the end of subparagraph (B) and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63846a8f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><chapeau>in paragraph (2), as so redesignated—</chapeau><subparagraph class="fontsize10" id="y63846a90-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">Contents of notice</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">Information required to be submitted</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63846a91-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in the matter preceding subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraph (2)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraph (1)</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63846a92-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or intended to be identified</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63846a93-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>in subparagraph (D), by <amendingAction type="delete">striking</amendingAction> “<quotedText>and</quotedText>” at the end;</content></subparagraph>
<subparagraph class="fontsize10" id="y63846a94-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>in subparagraph (E), by <amendingAction type="delete">striking</amendingAction> the period and <amendingAction type="insert">inserting</amendingAction> “<quotedText>; and</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63846a95-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/e/4/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y63846a96-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">“(F) </num><content>whether the facility is a contract manufacturing organization facility.”</content></subparagraph>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63846a97-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/f" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><heading class="fontsize10"><inline class="smallCaps">Effect of Failure To Pay Fees</inline>.—</heading><chapeau>Section 744B(g) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/g">21 U.S.C. 379j–42(g)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><page identifier="/us/stat/131/1026">131 STAT. 1026</page>
<paragraph class="fontsize10" id="y63846a98-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/f/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (1), by <amendingAction type="add">adding</amendingAction> at the end the following: “<quotedText>This paragraph<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63846a99-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Termination date.</p></sidenote> shall cease to be effective on October 1, 2022.</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63846a9a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/f/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (2)(C)(ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>of 505(j)(5)(A)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>of section 505(j)(5)(A)</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y63846a9b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/f/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y638491ac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><heading class="fontsize10"><inline class="smallCaps">Generic drug applicant program fee</inline>.—</heading><subparagraph class="fontsize10" id="y638491ad-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638491ae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x638491af-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:</chapeau><clause class="fontsize10" id="y638491b0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638491b1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p><p class="leftAlign firstIndent0 fontsize8" id="x638491b2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><content>The Secretary shall place the person on a publicly available arrears list.</content></clause>
<clause class="fontsize10" id="y638491b3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 505(j)(5)(A).</content></clause>
<clause class="fontsize10" id="y638491b4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 502(aa).</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y638491b5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Application of penalties</inline>.—</heading><content>The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638491b6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/g" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="g">(g) </num><heading class="fontsize10"><inline class="smallCaps">Limitations</inline>.—</heading><content>Section 744B(h)(2) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/h/2">21 U.S.C. 379j–42(h)(2)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y638491b7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="h">(h) </num><heading class="fontsize10"><inline class="smallCaps">Crediting and Availability of Fees</inline>.—</heading><chapeau>Section 744B(i) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/i">21 U.S.C. 379j–42(i)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638491b8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y638491b9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>subparagraphs (C) and (D)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subparagraph (C)</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y638491ba-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (C) (relating to fee collection during first program year);</content></subparagraph>
<subparagraph class="fontsize10" id="y638491bb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><chapeau>in subparagraph (D)—</chapeau><clause class="fontsize10" id="y638491bc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1/C/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">in subsequent years</headingText></quotedText>”; and</content></clause>
<clause class="fontsize10" id="y638491bd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1/C/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>(after fiscal year 2013)</quotedText>”; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y638491be-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subparagraph (D) as subparagraph (C); and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638491bf-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/h/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (3), by <amendingAction type="delete">striking</amendingAction> “<quotedText>fiscal years 2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>fiscal years 2018 through 2022</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638491c0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s303/i" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><heading class="fontsize10"><inline class="smallCaps">Information on Abbreviated New Drug Applications Owned by Applicants and Their Affiliates</inline>.—</heading><content>Section 744B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42">21 U.S.C. 379j–42</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y6384b8d1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="o">“(o) </num><heading class="fontsize10"><inline class="smallCaps">Information on Abbreviated New Drug Applications Owned by Applicants and Their Affiliates</inline>.—</heading><paragraph class="fontsize10" id="y6384b8d2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6384b8d3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x6384b8d4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of—</chapeau><page identifier="/us/stat/131/1027">131 STAT. 1027</page>
<subparagraph class="fontsize10" id="y6384b8d5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>all approved abbreviated new drug applications owned by such person; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6384b8d6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6384b8d7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6384b8d8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Guidance.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Format and method</inline>.—</heading><content>The Secretary shall specify in guidance the format and method for submission of lists under this subsection.”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
</section>
<section id="d132600e4746" identifier="/us/pl/115/52/tIII/s304" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="304">SEC. 304. </num><heading>REAUTHORIZATION; REPORTING REQUIREMENTS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x6384dfe9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 744C of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–43">21 U.S.C. 379j–43</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6384dfea-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s304/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (a)—</chapeau><subparagraph class="fontsize10" id="y6384dfeb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s304/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6384dfec-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s304/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Generic Drug User Fee Amendments of 2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Generic Drug User Fee Amendments of 2017</quotedText>”;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6384dfed-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s304/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subsection (b), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y6384dfee-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s304/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subsection (d), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></paragraph>
</section>
<section id="d132600e4813" identifier="/us/pl/115/52/tIII/s305" style="-uslm-lc:I658143"><num class="fontsize12" value="305">SEC. 305. </num><heading>SUNSET DATES.</heading><subsection class="firstIndent0 fontsize10" id="y63852e0f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s305/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63852e10-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–41">21 USC 379j–41 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Authorization</inline>.—</heading><content>Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–41">21 U.S.C. 379j–41</ref>; 379j–42) shall cease to be effective October 1, 2022.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63852e11-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s305/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63852e12-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–43">21 USC 379j–43 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Reporting Requirements</inline>.—</heading><content>Section 744C of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–43">21 U.S.C. 379j–43</ref>) shall cease to be effective January 31, 2023.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63852e13-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s305/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Previous Sunset Provision</inline>.—</heading><paragraph class="fontsize10" id="y63852e14-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s305/c/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63852e15-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63852e16-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Repeal.</p><p class="leftAlign firstIndent0 fontsize8" id="x63852e17-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–41">21 USC 379j–41 note</ref>, 379j–43 note.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Effective October 1, 2017, section 304 of the Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) is <amendingAction type="repeal">repealed</amendingAction>.</content></paragraph>
<paragraph class="fontsize10" id="y63852e18-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIII/s305/c/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Conforming amendment</inline>.—</heading><content>The Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) <amendingAction type="amend">is amended</amendingAction> in the table of contents in section 2 by <amendingAction type="delete">striking</amendingAction> the item relating to section 304.</content></paragraph>
</subsection>
</section>
<section id="d132600e4906" identifier="/us/pl/115/52/tIII/s306" style="-uslm-lc:I658143"><num class="fontsize12" value="306">SEC. 306. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63852e19-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–41">21 USC 379j–41 note</ref>.</p></sidenote><heading>EFFECTIVE DATE.</heading><content style="-uslm-lc:I658120"> The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all abbreviated new drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.</content></section>
<section id="d132600e4918" identifier="/us/pl/115/52/tIII/s307" style="-uslm-lc:I658143"><num class="fontsize12" value="307">SEC. 307. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63852e1a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–41">21 USC 379j–41 note</ref>.</p></sidenote><heading>SAVINGS CLAUSE.</heading><content style="-uslm-lc:I658120"> Notwithstanding the amendments made by this title, part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 <page identifier="/us/stat/131/1028">131 STAT. 1028</page>
U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.</content></section>
<num value="IV">TITLE IV—</num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6385552b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Biosimilar User Fee Amendments</p><p class="leftAlign firstIndent0 fontsize8" id="x6385552c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">of 2017.</p></sidenote><heading>FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS</heading>
<section id="d132600e4944" identifier="/us/pl/115/52/tIV/s401" style="-uslm-lc:I658143"><num class="fontsize12" value="401">SEC. 401. </num><heading>SHORT TITLE; FINDING.</heading><subsection class="firstIndent0 fontsize10" id="y63857c3d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s401/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63857c3e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s301">21 USC 301 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Short Title</inline>.—</heading><content>This title may be cited as the “<shortTitle role="title">Biosimilar User Fee Amendments of 2017</shortTitle>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63857c3f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s401/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63857c40-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–51">21 USC 379j–51 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Finding</inline>.—</heading><content>The Congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.</content></subsection>
</section>
<section id="d132600e4981" identifier="/us/pl/115/52/tIV/s402" style="-uslm-lc:I658143"><num class="fontsize12" value="402">SEC. 402. </num><heading>DEFINITIONS.</heading><subsection class="firstIndent0 fontsize10" id="y63857c41-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s402/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Adjustment Factor</inline>.—</heading><content>Section 744G(1) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–51/1">21 U.S.C. 379j–51(1)</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><paragraph class="fontsize10" id="y6385a352-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><content>The term ‘<term>adjustment factor</term>’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011.”</content></paragraph>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6385a353-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s402/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Biosimilar Biological Product</inline>.—</heading><content>Section 744G(3) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–51/3">21 U.S.C. 379j–51(3)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>means a product</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>means a specific strength of a biological product in final dosage form</quotedText>”.</content></subsection>
</section>
<section id="d132600e5031" identifier="/us/pl/115/52/tIV/s403" style="-uslm-lc:I658143"><num class="fontsize12" value="403">SEC. 403. </num><heading>AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.</heading><subsection class="firstIndent0 fontsize10" id="y63879f24-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Types of Fees</inline>.—</heading><chapeau>Section 744H(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52/a">21 U.S.C. 379j–52(a)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63879f25-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in the matter preceding paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>fiscal year 2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>fiscal year 2018</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f26-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in the heading of paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">Biosimilar</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">Biosimilar biological product</headingText></quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f27-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in paragraph (1)(A)(i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>(b)(1)(A)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(c)(5)</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f28-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>in paragraph (1)(B)(i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>(b)(1)(B) for biosimilar biological product development</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(c)(5) for the biosimilar biological product development program</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f29-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>in paragraph (1)(B)(ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>annual biosimilar biological product development program fee</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>annual biosimilar biological product development fee</quotedText>”;<page identifier="/us/stat/131/1029">131 STAT. 1029</page></content></paragraph>
<paragraph class="fontsize10" id="y63879f2a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/6" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">(6) </num><content>in paragraph (1)(B)(iii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>annual biosimilar development program fee</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>annual biosimilar biological product development fee</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f2b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/7" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="7">(7) </num><content>in paragraph (1)(B), by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><clause class="indentUp2 fontsize10" id="y63879f2c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><heading class="fontsize10"><inline class="smallCaps">Refund</inline>.—</heading><content>If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63879f2d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.”</content></clause>
</quotedContent>;</content></paragraph>
<paragraph class="fontsize10" id="y63879f2e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/8" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="8">(8) </num><content>in paragraph (1)(C), by <amendingAction type="delete">striking</amendingAction> “<quotedText>for a product effective October 1 of a fiscal year by,</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>for a product, effective October 1 of a fiscal year, by,</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f2f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/9" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="9">(9) </num><chapeau>in paragraph (1)(D)—</chapeau><subparagraph class="fontsize10" id="y63879f30-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/9/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in clause (i) in the matter preceding subclause (I), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>, if the person seeks to resume participation in such program,</quotedText>” before “<quotedText>pay a fee</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63879f31-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/9/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in clause (i)(I), by <amendingAction type="insert">inserting</amendingAction> after “<quotedText>grants a request</quotedText>” the following: “<quotedText>by such person</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63879f32-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/9/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in clause (i)(II), by <amendingAction type="insert">inserting</amendingAction> after “<quotedText>discontinued)</quotedText>” the following: “<quotedText>by such person</quotedText>”;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63879f33-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/10" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="10">(10) </num><content>in the heading of paragraph (1)(E), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">biosimilar development program</headingText></quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63879f34-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/11" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="11">(11) </num><chapeau>in paragraph (1)(F)—</chapeau><subparagraph class="fontsize10" id="y63879f35-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/11/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the subparagraph heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">biosimilar development program</headingText></quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63879f36-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/11/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="amend">amending</amendingAction> clause (i) to read as follows:<quotedContent><clause class="fontsize10" id="y6387c647-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">Refunds</inline>.—</heading><content>Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).”</content></clause>
</quotedContent>;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6387c648-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/12" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="12">(12) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y6387c649-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/12/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the paragraph heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">and supplement</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6387c64a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/12/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraphs (A) and (B) to read as follows:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y6387ed5b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:</chapeau><clause class="fontsize10" id="y6387ed5c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.</content></clause>
<clause class="fontsize10" id="y6387ed5d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).<page identifier="/us/stat/131/1030">131 STAT. 1030</page></content></clause>
</subparagraph>
<subparagraph class="indentUp0 fontsize10" id="y6387ed5e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Rule of applicability; treatment of certain previously paid fees</inline>.—</heading><chapeau>Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—</chapeau><clause class="fontsize10" id="y6387ed5f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and</content></clause>
<clause class="fontsize10" id="y6387ed60-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).”</content></clause>
</subparagraph>
</quotedContent>;</content></subparagraph>
<subparagraph class="fontsize10" id="y6387ed61-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/12/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in the heading of subparagraph (D), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">or supplement</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y6387ed62-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/12/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>in subparagraphs (C) through (F), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or supplement</quotedText>” each place it appears; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6387ed63-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/12/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>in subparagraph (D), by <amendingAction type="delete">striking</amendingAction> “<quotedText>or a supplement</quotedText>”;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6387ed64-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/a/13" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="13">(13) </num><content>by <amendingAction type="amend">amending</amendingAction> paragraph (3) to read as follows:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63881475-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Biosimilar biological product program fee</inline>.—</heading><subparagraph class="fontsize10" id="y63881476-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—</chapeau><clause class="fontsize10" id="y63881477-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and</content></clause>
<clause class="fontsize10" id="y63881478-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63881479-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6388147a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Due date</inline>.—</heading><chapeau>The biosimilar biological product program fee for a fiscal year shall be due on the later of—</chapeau><clause class="fontsize10" id="y6388147b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the first business day on or after October 1 of each such year; or</content></clause>
<clause class="fontsize10" id="y6388147c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y6388147d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">One fee per product per year</inline>.—</heading><content>The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.</content></subparagraph>
<subparagraph class="fontsize10" id="y6388147e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y6388147f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Revenue Amounts</inline>.—</heading><content>Subsection (b) of section 744H of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52">21 U.S.C. 379j–52</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><subsection class="firstIndent0 fontsize10" id="y638888b0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">“(b) </num><heading class="fontsize10"><inline class="smallCaps">Fee Revenue Amounts</inline>.—</heading><paragraph class="fontsize10" id="y638888b1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Fiscal year 2018</inline>.—</heading><chapeau>For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of—</chapeau><subparagraph class="fontsize10" id="y638888b2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>$45,000,000; and<page identifier="/us/stat/131/1031">131 STAT. 1031</page></content></subparagraph>
<subparagraph class="fontsize10" id="y638888b3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)).</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638888b4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Subsequent fiscal years</inline>.—</heading><chapeau>For each of the fiscal years 2019 through 2022, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—</chapeau><subparagraph class="fontsize10" id="y638888b5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the annual base revenue for the fiscal year (as determined under paragraph (4));</content></subparagraph>
<subparagraph class="fontsize10" id="y638888b6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));</content></subparagraph>
<subparagraph class="fontsize10" id="y638888b7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and</content></subparagraph>
<subparagraph class="fontsize10" id="y638888b8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)).</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638888b9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Allocation of revenue amount among fees; limitations on fee amounts</inline>.—</heading><subparagraph class="fontsize10" id="y638888ba-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638888bb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Allocation</inline>.—</heading><chapeau>The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—</chapeau><clause class="fontsize10" id="y638888bc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);</content></clause>
<clause class="fontsize10" id="y638888bd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>biosimilar biological product application fees under subsection (a)(2); and</content></clause>
<clause class="fontsize10" id="y638888be-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>biosimilar biological product program fees under subsection (a)(3).</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y638888bf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Limitations on fee amounts</inline>.—</heading><content>Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018.</content></subparagraph>
<subparagraph class="fontsize10" id="y638888c0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Biosimilar biological product development fees</inline>.—</heading><content>The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.</content></subparagraph>
<subparagraph class="fontsize10" id="y638888c1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><heading class="fontsize10"><inline class="smallCaps">Reactivation fee</inline>.—</heading><content>The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638888c2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Annual base revenue</inline>.—</heading><content>For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3).”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y638888c3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Adjustments; Annual Fee Setting</inline>.—</heading><chapeau>Section 744H of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52">21 U.S.C. 379j–52</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638888c4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsections (c) through (h) as subsections (d) through (i), respectively;<page identifier="/us/stat/131/1032">131 STAT. 1032</page></content></paragraph>
<paragraph class="fontsize10" id="y638888c5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subsections (a)(2)(F) and (h) (as redesignated by paragraph (1)), by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (c)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (d)</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y638888c6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/c/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subsection (a)(4)(A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (b)(1)(F)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (c)(5)</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y638888c7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/c/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subsection (b) the following:<quotedContent><subsection class="indentDown1 firstIndent0 fontsize10" id="y63894c18-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><heading class="fontsize10"><inline class="smallCaps">Adjustments; Annual Fee Setting</inline>.—</heading><paragraph class="fontsize10" id="y63894c19-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Inflation adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63894c1a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—</chapeau><clause class="fontsize10" id="y63894c1b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>such annual base revenue for the fiscal year under subsection (b); and</content></clause>
<clause class="fontsize10" id="y63894c1c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the inflation adjustment percentage under subparagraph (B).</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63894c1d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63894c1e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time periods.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Inflation adjustment percentage</inline>.—</heading><chapeau>The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—</chapeau><clause class="fontsize10" id="y63894c1f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years; and</content></clause>
<clause class="fontsize10" id="y63894c20-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63894c21-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Capacity planning adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63894c22-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63894c23-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Beginning with the fiscal year described in subparagraph (B)(ii)(II), the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.</content></subparagraph>
<subparagraph class="fontsize10" id="y63894c24-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Capacity planning methodology</inline>.—</heading><clause class="fontsize10" id="y63894c25-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63894c26-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Contracts.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Development; evaluation and report</inline>.—</heading><content>The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications. The <page identifier="/us/stat/131/1033">131 STAT. 1033</page>
capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63894c27-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x63894c28-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p><p class="leftAlign firstIndent0 fontsize8" id="x63894c29-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> The report shall be published for public comment not later than September 30, 2020.</content></clause>
<clause class="fontsize10" id="y63894c2a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><heading class="fontsize10"><inline class="smallCaps">Establishment and implementation</inline>.—</heading><chapeau>After review of the report described in clause (i) and receipt and review of public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—</chapeau><subclause class="fontsize10" id="y63894c2b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>incorporate such approaches and attributes as the Secretary determines appropriate; and</content></subclause>
<subclause class="fontsize10" id="y63894c2c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63894c2d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><content>be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.</content></subclause>
</clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63894c2e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(2)(A) (the annual base revenue for the fiscal year) and (b)(2)(B) (the dollar amount of the inflation adjustment for the fiscal year).</content></subparagraph>
<subparagraph class="fontsize10" id="y63894c2f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63894c30-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notice.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Publication in federal register</inline>.—</heading><content>The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63894c31-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Operating reserve adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y63894c32-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">Interim application; fee reduction</inline>.—</heading><content>Until the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustment under paragraph (1), reduce the fee revenue and fees under this section for a fiscal year as the Secretary determines appropriate for long-term financial planning purposes.</content></subparagraph>
<subparagraph class="fontsize10" id="y63897343-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">General application and methodology</inline>.—</heading><chapeau>Beginning with the first<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63897344-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote> fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustments under paragraphs (1) and (2)—</chapeau><clause class="fontsize10" id="y63897345-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or</content></clause>
<clause class="fontsize10" id="y63897346-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63897347-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><content>increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than 21 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63897348-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Federal register notice</inline>.—</heading><content>If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63897349-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Fiscal year 2018 adjustment</inline>.—</heading><subparagraph class="fontsize10" id="y6389734a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6389734b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Assessment.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>For fiscal year 2018, the Secretary shall adjust the fee revenue and fees under this section in such amount (if any) as needed to reflect an updated <page identifier="/us/stat/131/1034">131 STAT. 1034</page>
assessment of the workload for the process for the review of biosimilar biological product applications.</content></subparagraph>
<subparagraph class="fontsize10" id="y6389734c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6389734d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x6389734e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notice.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Methodology</inline>.—</heading><content>The Secretary shall publish under paragraph (5)(B) a description of the methodology used to calculate the fiscal year 2018 adjustment under this paragraph in the Federal Register notice establishing fee revenue and fees for fiscal year 2018.</content></subparagraph>
<subparagraph class="fontsize10" id="y6389734f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63897350-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63897351-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63897352-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Annual fee setting</inline>.—</heading><chapeau>For fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—</chapeau><subparagraph class="fontsize10" id="y63897353-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63897354-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63897355-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p></sidenote><content>publish such fee revenue and fees in the Federal Register.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63897356-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">“(6) </num><heading class="fontsize10"><inline class="smallCaps">Limit</inline>.—</heading><content>The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.”</content></paragraph>
</subsection>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63897357-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/d" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Application Fee Waiver for Small Business</inline>.—</heading><chapeau>Subsection (d)(1) of section 744H of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52">21 U.S.C. 379j–52</ref>), as redesignated by subsection (c)(1), <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63897358-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/d/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (B);</content></paragraph>
<paragraph class="fontsize10" id="y63897359-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>; and</quotedText>” at the end of subparagraph (A) and <amendingAction type="insert">inserting</amendingAction> a period; and</content></paragraph>
<paragraph class="fontsize10" id="y6389735a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/d/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>shall pay—</quotedText>” and all that follows through “<quotedText>application fees</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>shall pay application fees</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y6389735b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/e" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><heading class="fontsize10"><inline class="smallCaps">Effect of Failure To Pay Fees</inline>.—</heading><content>Subsection (e) of section 744H of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52">21 U.S.C. 379j–52</ref>), as redesignated by subsection (c)(1), <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>all fees</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>all such fees</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6389735c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><heading class="fontsize10"><inline class="smallCaps">Crediting and Availability of Fees</inline>.—</heading><chapeau>Subsection (f) of section 744H of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52">21 U.S.C. 379j–52</ref>), as redesignated by subsection (c)(1), <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6389735d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (2)—</chapeau><subparagraph class="fontsize10" id="y6389735e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> subparagraph (C) (relating to fee collection during first program year) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><subparagraph class="indentUp0 fontsize10" id="y6389735f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><heading class="fontsize10"><inline class="smallCaps">Compliance</inline>.—</heading><content>The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs described in such subparagraph are not more than 15 percent below the level specified in such subparagraph.”</content></subparagraph>
</quotedContent>; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63897360-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>in subparagraph (D)—</chapeau><clause class="fontsize10" id="y63897361-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f/1/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">in subsequent years</headingText></quotedText>”; and</content></clause>
<clause class="fontsize10" id="y63897362-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f/1/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>(after fiscal year 2013)</quotedText>”; and</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63897363-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s403/f/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (3), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”.<page identifier="/us/stat/131/1035">131 STAT. 1035</page></content></paragraph>
</subsection>
</section>
<section id="d132600e6084" identifier="/us/pl/115/52/tIV/s404" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="404">SEC. 404. </num><heading>REAUTHORIZATION; REPORTING REQUIREMENTS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x6389c184-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 744I of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–53">21 U.S.C. 379j–53</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6389c185-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (a)—</chapeau><subparagraph class="fontsize10" id="y6389c186-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6389c187-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Biosimilar User Fee Act of 2012</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Biosimilar User Fee Amendments of 2017</quotedText>”;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6389c188-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subsection (b), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y6389c189-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="delete">striking</amendingAction> subsection (d);</content></paragraph>
<paragraph class="fontsize10" id="y6389c18a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsection (e) as subsection (d); and</content></paragraph>
<paragraph class="fontsize10" id="y6389c18b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s404/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>in subsection (d), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></paragraph>
</section>
<section id="d132600e6170" identifier="/us/pl/115/52/tIV/s405" style="-uslm-lc:I658143"><num class="fontsize12" value="405">SEC. 405. </num><heading>SUNSET DATES.</heading><subsection class="firstIndent0 fontsize10" id="y6389e89c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s405/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6389e89d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–51">21 USC 379j–51 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Authorization</inline>.—</heading><content>Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act shall cease to be effective October 1, 2022.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6389e89e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s405/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6389e89f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–53">21 USC 379j–53 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Reporting Requirements</inline>.—</heading><content>Section 744I of the Federal Food, Drug, and Cosmetic Act shall cease to be effective January 31, 2023.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6389e8a0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s405/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Previous Sunset Provision</inline>.—</heading><paragraph class="fontsize10" id="y6389e8a1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s405/c/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6389e8a2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x6389e8a3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Repeal.</p><p class="leftAlign firstIndent0 fontsize8" id="x6389e8a4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–51">21 USC 379j–51 note</ref>, 379j–53 note.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Effective October 1, 2017, section 404 of the Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) is <amendingAction type="repeal">repealed</amendingAction>.</content></paragraph>
<paragraph class="fontsize10" id="y6389e8a5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIV/s405/c/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Conforming amendment</inline>.—</heading><content>The Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) <amendingAction type="amend">is amended</amendingAction> in the table of contents in section 2 by <amendingAction type="delete">striking</amendingAction> the item relating to section 404.</content></paragraph>
</subsection>
</section>
<section id="d132600e6255" identifier="/us/pl/115/52/tIV/s406" style="-uslm-lc:I658143"><num class="fontsize12" value="406">SEC. 406. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6389e8a6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–51">21 USC 379j–51 note</ref>.</p></sidenote><heading>EFFECTIVE DATE.</heading><content style="-uslm-lc:I658120"> The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all biosimilar biological product applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.</content></section>
<section id="d132600e6267" identifier="/us/pl/115/52/tIV/s407" style="-uslm-lc:I658143"><num class="fontsize12" value="407">SEC. 407. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638a0fb7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s379j–51">21 USC 379j–51 note</ref>.</p></sidenote><heading>SAVINGS CLAUSE.</heading><content class="firstIndent0 fontsize10" id="x638a0fb8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Notwithstanding<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638a0fb9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Continuation.</p><p class="leftAlign firstIndent0 fontsize8" id="x638a0fba-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote> the amendments made by this title, part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.<page identifier="/us/stat/131/1036">131 STAT. 1036</page></content></section>
<num value="V">TITLE V—</num><heading>PEDIATRIC DRUGS AND DEVICES</heading>
<section id="d132600e6294" identifier="/us/pl/115/52/tV/s501" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="501">SEC. 501. </num><heading>BEST PHARMACEUTICALS FOR CHILDREN.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x638a84eb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 409I of the Public Health Service Act (<ref href="/us/usc/t42/s284m">42 U.S.C. 284m</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638a84ec-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in subsection (a)(2)(A)(ii), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>and identification of biomarkers for such diseases, disorders, or conditions,</quotedText>” after “<quotedText>biologics,</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y638a84ed-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in subsection (c)—</chapeau><subparagraph class="fontsize10" id="y638a84ee-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in paragraph (6)—</chapeau><clause class="fontsize10" id="y638a84ef-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="amend">amending</amendingAction> subparagraph (B) to read as follows:<quotedContent><subparagraph class="indentDown1 fontsize10" id="y638aac00-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Availability of reports</inline>.—</heading><clause class="fontsize10" id="y638aac01-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and not later than 90 days after submission of such report, shall be—</chapeau><subclause class="fontsize10" id="y638aac02-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638ad313-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p></sidenote><chapeau>posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—</chapeau><item class="fontsize10" id="y638ad314-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658130"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>human research participants, including with respect to privacy, security, informed consent, and protected health information; and</content></item>
<item class="fontsize10" id="y638ad315-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658130"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>proprietary interests, confidential commercial information, and intellectual property rights; and</content></item>
</subclause>
<subclause class="fontsize10" id="y638ad316-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638ad317-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><content>assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.</content></subclause>
</clause>
<clause class="fontsize10" id="y638ad318-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><heading class="fontsize10"><inline class="smallCaps">Submission of comments</inline>.—</heading><content>An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.”</content></clause>
</subparagraph>
</quotedContent>; and</content></clause>
<clause class="fontsize10" id="y638ad319-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in subparagraph (C), by <amendingAction type="delete">striking</amendingAction> “<quotedText>appropriate action</quotedText>” and all that follows through the period and <amendingAction type="insert">inserting</amendingAction> “<quotedText>action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).</quotedText>”; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y638ad31a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><chapeau>in paragraph (7)—</chapeau><clause class="fontsize10" id="y638ad31b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>in the matter preceding subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>During</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>Within</quotedText>”;</content></clause>
<clause class="fontsize10" id="y638ad31c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in subparagraph (C)(i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>place</quotedText>” and all that follows through “<quotedText>and of</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of</quotedText>”; and<page identifier="/us/stat/131/1037">131 STAT. 1037</page></content></clause>
<clause class="fontsize10" id="y638ad31d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/2/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>in clause (ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>in the Federal Register and</quotedText>”;</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638ad31e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="delete">striking</amendingAction> subsection (d);</content></paragraph>
<paragraph class="fontsize10" id="y638ad31f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsection (e) as subsection (d); and</content></paragraph>
<paragraph class="fontsize10" id="y638ad320-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s501/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>in paragraph (1) of subsection (d), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”.</content></paragraph>
</section>
<section id="d132600e6472" identifier="/us/pl/115/52/tV/s502" style="-uslm-lc:I658143"><num class="fontsize12" value="502">SEC. 502. </num><heading>PEDIATRIC DEVICES.</heading><subsection class="firstIndent0 fontsize10" id="y638bbd81-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Pediatric Use of Devices</inline>.—</heading><chapeau>Section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360e–1/a/3">21 U.S.C. 360e–1(a)(3)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638bbd82-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subparagraphs (B) through (D) as subparagraphs (D) through (F), respectively;</content></paragraph>
<paragraph class="fontsize10" id="y638bbd83-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subparagraph (A) the following:<quotedContent><subparagraph class="fontsize10" id="y638bbd84-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>any information, based on a review of data available to the Secretary, regarding devices used in pediatric patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could confer a benefit to pediatric patients;</content></subparagraph>
<subparagraph class="fontsize10" id="y638bbd85-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>the number of pediatric devices that receive a humanitarian use exemption under section 520(m);”</content></subparagraph>
</quotedContent>;</content></paragraph>
<paragraph class="fontsize10" id="y638bbd86-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in subparagraph (E), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>; and</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>;</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y638bbd87-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/a/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>in subparagraph (F) (as so redesignated), by <amendingAction type="delete">striking</amendingAction> “<quotedText>(B), and (C).</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(C), (D), and (E);</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y638bbd88-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/a/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="fontsize10" id="y638be499-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="G">“(G) </num><content>the number of devices for which the Secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638be49a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="H">“(H) </num><content>the number of devices for which the Secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation.</content></subparagraph>
<continuation class="firstIndent1 fontsize10" id="x638be49b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122">For the items described in this paragraph, such report shall disaggregate the number of devices by pediatric subpopulation.”</continuation></quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638be49c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Humanitarian Device Exemption</inline>.—</heading><chapeau>Section 520(m) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360j/m">21 U.S.C. 360j(m)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638be49d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in paragraph (4)—</chapeau><subparagraph class="fontsize10" id="y638be49e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/b/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in subparagraph (B), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or an appropriate local committee</quotedText>” after “<quotedText>review committee</quotedText>” each place such term appears; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638be49f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/b/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in the matter following subparagraph (B), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or an appropriate local committee</quotedText>” after “<quotedText>review committee</quotedText>” each place such term appears; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638be4a0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (6)(A)(iv), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638be4a1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Demonstration Grants for Improving Pediatric Availability</inline>.—</heading><chapeau>Section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (<ref href="/us/pl/110/85">Public Law 110–85</ref>; <ref href="/us/usc/t42/s282">42 U.S.C. 282 note</ref>)) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638be4a2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (c)—</chapeau><subparagraph class="fontsize10" id="y638be4a3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/c/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in paragraph (4), by <amendingAction type="delete">striking</amendingAction> “<quotedText>and</quotedText>” at the end;<page identifier="/us/stat/131/1038">131 STAT. 1038</page></content></subparagraph>
<subparagraph class="fontsize10" id="y638be4a4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/c/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in paragraph (5), by <amendingAction type="delete">striking</amendingAction> the period and <amendingAction type="insert">inserting</amendingAction> “<quotedText>; and</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638be4a5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/c/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentDown1 fontsize10" id="y638be4a6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">“(6) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638be4a7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Consultation.</p></sidenote><content>providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.”</content></paragraph>
</quotedContent>; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638be4a8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subsection (e), by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638be4a9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Meeting on Pediatric Device Development</inline>.—</heading><paragraph class="fontsize10" id="y638be4aa-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638be4ab-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x638be4ac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall convene a public meeting on the development, approval or clearance, and labeling of pediatric medical devices. The Secretary shall invite to such meeting representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (<ref href="/us/pl/110/85">Public Law 110–85</ref>; <ref href="/us/usc/t42/s282">42 U.S.C. 282 note</ref>), medical provider organizations, and organizations representing patients and consumers.</content></paragraph>
<paragraph class="fontsize10" id="y638be4ad-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Topics</inline>.—</heading><chapeau>The meeting described in paragraph (1) shall include consideration of ways to—</chapeau><subparagraph class="fontsize10" id="y638be4ae-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for pediatric populations that would result in the approval or clearance, and labeling, of medical devices for such populations;</content></subparagraph>
<subparagraph class="fontsize10" id="y638be4af-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>appropriately use extrapolation under section 515A(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360e–1/b">21 U.S.C. 360e–1(b)</ref>);</content></subparagraph>
<subparagraph class="fontsize10" id="y638be4b0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling;</content></subparagraph>
<subparagraph class="fontsize10" id="y638be4b1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>increase Food and Drug Administration assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638be4b2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/2/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>identify current barriers to pediatric device development and incentives to address such barriers.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638be4b3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s502/d/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><content>The report submitted under section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360e–1/a/3">21 U.S.C. 360e–1(a)(3)</ref>) with respect to the calendar year in which the meeting described in paragraph (1) is held shall include a summary of, and responses to, recommendations raised in such meeting.</content></paragraph>
</subsection>
</section>
<section id="d132600e6781" identifier="/us/pl/115/52/tV/s503" style="-uslm-lc:I658143"><num class="fontsize12" value="503">SEC. 503. </num><heading>EARLY MEETING ON PEDIATRIC STUDY PLAN.</heading><subsection class="firstIndent0 fontsize10" id="y638c32d4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s503/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Clause (i) of section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/e/2/C">21 U.S.C. 355c(e)(2)(C)</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><clause class="indentUp3 fontsize10" id="y638c59e5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><chapeau>shall meet with the applicant—</chapeau><subclause class="fontsize10" id="y638c59e6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638c59e7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><content>if requested by the applicant with respect to a drug or biological product that is intended to treat a serious or life-threatening disease or condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 1 meeting (as such term is used in <ref href="/us/cfr/t21/s312.82/b">section 312.82(b) of title 21, Code of Federal Regulations</ref>, <page identifier="/us/stat/131/1039">131 STAT. 1039</page>
or successor regulations) or within 30 calendar days of receipt of such request, whichever is later;</content></subclause>
<subclause class="fontsize10" id="y638c59e8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and</content></subclause>
<subclause class="fontsize10" id="y638c59e9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>to discuss the bases for the deferral under subsection (a)(4) or a full or partial waiver under subsection (a)(5);”</content></subclause>
</clause>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y638c59ea-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s503/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Conforming Changes</inline>.—</heading><chapeau>Section 505B(e) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/e">21 U.S.C. 355c(e)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638c59eb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s503/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in the heading of paragraph (2), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">meeting</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">meetings</headingText></quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y638c59ec-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s503/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in the heading of paragraph (2)(C), by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">Meeting</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">Meetings</headingText></quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y638c59ed-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s503/b/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>in clauses (ii) and (iii) of paragraph (2)(C), by <amendingAction type="delete">striking</amendingAction> “<quotedText>no meeting</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>no meeting under clause (i)(II)</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y638c59ee-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s503/b/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>in paragraph (3) by <amendingAction type="delete">striking</amendingAction> “<quotedText>meeting under paragraph (2)(C)(i)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>meeting under paragraph (2)(C)(i)(II)</quotedText>”.</content></paragraph>
</subsection>
</section>
<section id="d132600e6910" identifier="/us/pl/115/52/tV/s504" style="-uslm-lc:I658143"><num class="fontsize12" value="504">SEC. 504. </num><heading>DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC CANCERS.</heading><subsection class="firstIndent0 fontsize10" id="y638f190f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Molecular Targets Regarding Cancer Drugs and Biological Products</inline>.—</heading><chapeau>Section 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c">21 U.S.C. 355c</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638f1910-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>in subsection (a)—</chapeau><subparagraph class="fontsize10" id="y638f1911-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><chapeau>in paragraph (1)—</chapeau><clause class="fontsize10" id="y638f1912-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;</content></clause>
<clause class="fontsize10" id="y638f1913-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>A person</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><subparagraph class="indentDown1 fontsize10" id="y638f1914-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">General requirements</inline>.—</heading><content>Except with respect to an application for which subparagraph (B) applies, a person”</content></subparagraph>
</quotedContent>;</content></clause>
<clause class="fontsize10" id="y638f1915-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/A/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>in clause (i), as so redesignated, by <amendingAction type="delete">striking</amendingAction> “<quotedText>, or</quotedText>” at the end and <amendingAction type="insert">inserting</amendingAction> “<quotedText>; or</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y638f1916-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/A/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>by <amendingAction type="add">adding</amendingAction> after subparagraph (A), as so designated by clause (ii), the following:<quotedContent><subparagraph class="indentDown1 fontsize10" id="y638f4027-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638f4028-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x638f4029-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Reports.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Certain molecularly targeted cancer indications</inline>.—</heading><chapeau>A person that submits, on or after the date that is 3 years after the date of enactment of the FDA Reauthorization Act of 2017, an original application for a new active ingredient under section 505 of this Act or section 351 of the Public Health Service Act, shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—</chapeau><clause class="fontsize10" id="y638f402a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>intended for the treatment of an adult cancer; and</content></clause>
<clause class="fontsize10" id="y638f402b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.”</content></clause>
</subparagraph>
</quotedContent>;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y638f402c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in paragraph (2)(A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraph (1)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraph (1)(A)</quotedText>”;<page identifier="/us/stat/131/1040">131 STAT. 1040</page></content></subparagraph>
<subparagraph class="fontsize10" id="y638f402d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (3) and (4) as paragraphs (4) and (5), respectively;</content></subparagraph>
<subparagraph class="fontsize10" id="y638f402e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (2) the following:<quotedContent><paragraph class="indentDown1 fontsize10" id="y638f402f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Molecularly targeted pediatric cancer investigation</inline>.—</heading><subparagraph class="fontsize10" id="y638f4030-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>With respect to a drug or biological product described in paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation, which shall be designed to yield clinically meaningful pediatric study data, gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.</content></subparagraph>
<subparagraph class="fontsize10" id="y638f4031-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638f4032-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Extrapolation of data</inline>.—</heading><content>Paragraph (2)(B) shall apply to investigations described in this paragraph to the same extent and in the same manner as paragraph (2)(B) applies with respect to the assessments required under paragraph (1)(A).</content></subparagraph>
<subparagraph class="fontsize10" id="y638f4033-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638f4034-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Deferrals and waivers</inline>.—</heading><content>Deferrals and waivers under paragraphs (4) and (5) shall apply to investigations described in this paragraph to the same extent and in the same manner as such deferrals and waivers apply with respect to the assessments under paragraph (2)(B).”</content></subparagraph>
</paragraph>
</quotedContent>;</content></subparagraph>
<subparagraph class="fontsize10" id="y638f6745-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><chapeau>in paragraph (4), as so redesignated—</chapeau><clause class="fontsize10" id="y638f6746-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/E/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>assessments required under paragraph (1)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B)</quotedText>”;</content></clause>
<clause class="fontsize10" id="y638f6747-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/E/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>in subparagraph (A)(ii)(I), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or reports on the investigation</quotedText>” after “<quotedText>assessments</quotedText>”;</content></clause>
<clause class="fontsize10" id="y638f6748-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/E/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>in subparagraph (B)(ii), by <amendingAction type="delete">striking</amendingAction> “<quotedText>assessment under paragraph (1)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>assessment under paragraph (1)(A) or reports on the investigation under paragraph (1)(B)</quotedText>”; and</content></clause>
<clause class="fontsize10" id="y638f6749-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/E/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>in subparagraph (C)(ii)(II), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or investigation</quotedText>” after “<quotedText>assessment</quotedText>”; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y638f674a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/1/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>in paragraph (5), as so redesignated, by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or reports on the investigation</quotedText>” after “<quotedText>assessments</quotedText>” each place it appears;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638f674b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in subsection (d)—</chapeau><subparagraph class="fontsize10" id="y638f674c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>subsection (a)(3)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>subsection (a)(4)</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y638f674d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">and Reports on the Investigation</headingText></quotedText>” after “<quotedText><headingText class="smallCaps">Submission of Assessments</headingText></quotedText>” in the heading; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638f674e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or the investigation described in subsection (a)(3)</quotedText>” after “<quotedText>assessment described in subsection (a)(2)</quotedText>” each place it appears;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638f674f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><chapeau>in subsection (e)—</chapeau><subparagraph class="fontsize10" id="y638f6750-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in paragraph (1), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or the investigation described in subsection (a)(3)</quotedText>” after “<quotedText>under subsection (a)(2)</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638f6751-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in paragraph (2)(A)(i), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or the investigation described in subsection (a)(3)</quotedText>” after “<quotedText>under subsection (a)(2)</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638f6752-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/a/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="indentDown1 firstIndent0 fontsize10" id="y638f8e63-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="m">“(m) </num><heading class="fontsize10"><inline class="smallCaps">List of Primary Molecular Targets</inline>.—</heading><page identifier="/us/stat/131/1041">131 STAT. 1041</page>
<paragraph class="fontsize10" id="y638f8e64-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638f8e65-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x638f8e66-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Update.</p><p class="leftAlign firstIndent0 fontsize8" id="x638f8e67-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p><p class="leftAlign firstIndent0 fontsize8" id="x638f8e68-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Within one year of the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall establish and update regularly, and shall publish on the internet website of the Food and Drug Administration—</chapeau><subparagraph class="fontsize10" id="y638f8e69-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>a list of molecular targets considered, on the basis of data the Secretary determines to be adequate, to be substantially relevant to the growth and progression of a pediatric cancer, and that may trigger the requirements under this section; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638f8e6a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638f8e6b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Waiver.</p></sidenote><content>a list of molecular targets of new cancer drugs and biological products in development for which pediatric cancer study requirements under this section will be automatically waived.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638f8e6c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Consultation</inline>.—</heading><content>In establishing the lists described in paragraph (1), the Secretary shall consult the National Cancer Institute, members of the internal committee under section 505C, and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, and shall take into account comments from the meeting under subsection (c).</content></paragraph>
<paragraph class="fontsize10" id="y638f8e6d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Rule of construction</inline>.—</heading><chapeau>Nothing in paragraph (1) shall be construed—</chapeau><subparagraph class="fontsize10" id="y638f8e6e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>to require the inclusion of a molecular target on the list published under such paragraph as a condition for triggering the requirements under subsection (a)(1)(B) with respect to a drug or biological product directed at such molecular target; or</content></subparagraph>
<subparagraph class="fontsize10" id="y638f8e6f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>to authorize the disclosure of confidential commercial information, as prohibited under section 301(j) of this Act or <ref href="/us/usc/t18/s1905">section 1905 of title 18, United States Code</ref>.”</content></subparagraph>
</paragraph>
</subsection>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638f8e70-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Orphan Drugs</inline>.—</heading><content>Section 505B(k) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/k">21 U.S.C. 355c(k)</ref>) <amendingAction type="amend">is amended</amendingAction> to read as follows:<quotedContent><subsection class="firstIndent0 fontsize10" id="y638fb581-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="k">“(k) </num><heading class="fontsize10"><inline class="smallCaps">Relation to Orphan Drugs</inline>.—</heading><paragraph class="fontsize10" id="y638fb582-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general; exemption for orphan indications</inline>.—</heading><content>Unless the Secretary requires otherwise by regulation and except as provided in paragraph (2), this section does not apply to any drug or biological product for an indication for which orphan designation has been granted under section 526.</content></paragraph>
<paragraph class="fontsize10" id="y638fb583-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Applicability despite orphan designation of certain indications</inline>.—</heading><content>This section shall apply with respect to a drug or biological product for which an indication has been granted orphan designation under 526 if the investigation described in subsection (a)(3) applies to the drug or biological product as described in subsection (a)(1)(B).”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y638fb584-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638fb585-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s355c">21 USC 355c note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Meeting, Consultation, and Guidance</inline>.—</heading><paragraph class="fontsize10" id="y638fb586-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638fb587-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Meeting</inline>.—</heading><chapeau>The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”), acting through the Commissioner of Food and Drugs and in collaboration with the Director of the National Cancer Institute, shall convene a public meeting not later than 1 year after the date of enactment of this Act to solicit feedback from physicians and researchers (including pediatric oncologists and rare disease specialists), patients, and other stakeholders to provide input on development of the guidance under paragraph (2) and the list under subsection (m) of section 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c">21 U.S.C. 355c</ref>), as added by subsection (a). The Secretary shall seek input at such meeting on—</chapeau><page identifier="/us/stat/131/1042">131 STAT. 1042</page>
<subparagraph class="fontsize10" id="y638fb588-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>the data necessary to determine that there is scientific evidence that a drug or biological product is directed at a molecular target that is considered to be substantially relevant to the growth or progression of a pediatric cancer;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb589-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>the data necessary to determine that there is scientific evidence that a molecular target is considered to be substantially relevant to the growth or progression of a pediatric cancer;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb58a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>the data needed to meet the requirement of conducting an investigation described in section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a);</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb58b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>considerations when developing the list under section 505B(m) of the Federal Food, Drug, and Cosmetic Act that contains molecular targets shared between different tumor types;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb58c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638fb58d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><content>the process the Secretary shall utilize to update regularly a list of molecular targets that may trigger a pediatric study under section 505B of the Federal Food, Drug, and Cosmetic Act, as so amended, and how often such updates shall occur;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb58e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>how to overcome the challenges related to pediatric cancer drug and biological product development, including issues related to the ethical, practical, and other barriers to conducting clinical trials in pediatric cancer with small patient populations;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb58f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/G" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="G">(G) </num><content>scientific or operational challenges associated with performing an investigation described in section 505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act, including the effect on pediatric studies currently underway in a pediatric patient population, treatment of a pediatric patient population, and the ability to complete adult clinical trials;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb590-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/H" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="H">(H) </num><content>the advantages and disadvantages of innovative clinical trial designs in addressing the development of cancer drugs or biological products directed at molecular targets in pediatric cancer patients;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb591-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/I" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">(I) </num><content>the ways in which the Secretary can improve the current process outlined under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a">21 U.S.C. 355a</ref>, 355c) to encourage additional research and development of pediatric cancer treatments;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb592-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/J" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="J">(J) </num><content>the ways in which the Secretary might streamline and improve the written request process, including when studies contained in a request under such section 505A are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb593-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/K" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="K">(K) </num><content>how the Secretary will facilitate collaboration among pediatric networks, academic centers and experts in pediatric cancer to conduct an investigation described in such section 505B(a)(3);</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb594-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/L" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="L">(L) </num><content>how the Secretary may facilitate collaboration among sponsors of same-in-class drugs and biological products that would be subject to the requirements for an investigation under such section 505B based on shared molecular targets; and<page identifier="/us/stat/131/1043">131 STAT. 1043</page></content></subparagraph>
<subparagraph class="fontsize10" id="y638fb595-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/1/M" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="M">(M) </num><content>the ways in which the Secretary will help to mitigate the risks, if any, of discouraging the research and development of orphan drugs when implementing such section 505B as amended.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y638fb596-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638fb597-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Guidance</inline>.—</heading><chapeau>Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue final guidance on implementation of the amendments to section 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c">21 U.S.C. 355c</ref>) regarding molecularly targeted cancer drugs made by this section, including—</chapeau><subparagraph class="fontsize10" id="y638fb598-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638fb599-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Criteria.</p></sidenote><content>the scientific criteria, types of data, and regulatory considerations for determining whether a molecular target is substantially relevant to the growth or progression of a pediatric cancer and would trigger an investigation under section 505B of the Federal Food, Drug, and Cosmetic Act, as amended;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb59a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>the process by which the Secretary will engage with sponsors to discuss determinations, investigation requirements, deferrals, waivers, and any other issues that need to be resolved to ensure that any required investigation based on a molecular target can be reasonably conducted;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb59b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>the scientific or operational challenges for which the Secretary may issue deferrals or waivers for an investigation described in subsection (a)(3) of such section 505B, including adverse impacts on current pediatric studies underway in a pediatric patient population, studies involving drugs designated as orphan drugs, treatment of a pediatric patient population, or the ability to complete adult clinical trials;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb59c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>how the Secretary and sponsors will facilitate collaboration among pediatric networks, academic centers, and experts in pediatric cancer to conduct an investigation described in subsection (a)(3) of such section 505B;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb59d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>scientific and regulatory considerations for study designs, including the applicability of innovative clinical trial designs for pediatric cancer drug and biological product developments under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a">21 U.S.C. 355a</ref>, 355c);</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb59e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>approaches to streamline and improve the amendment process, including when studies contained in a request under such section 505A are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations;</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb59f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/G" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="G">(G) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x638fb5a0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Plan.</p></sidenote><content>the process for submission of an initial pediatric study plan for the investigation described in section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/a/3">21 U.S.C. 355c(a)(3)</ref>), including the process for a sponsor to meet and reach agreement with the Secretary on the initial pediatric study plan; and</content></subparagraph>
<subparagraph class="fontsize10" id="y638fb5a1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/c/2/H" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="H">(H) </num><content>considerations for implementation of such section 505B, as so amended, and waivers of the requirements of such section 505B with regard to molecular targets for which several drugs or biological products may be under investigation.<page identifier="/us/stat/131/1044">131 STAT. 1044</page></content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y638fb5a2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/d" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Report to Congress</inline>.—</heading><chapeau>Section 508(b) of the Food and Drug Administration Safety and Innovation Act (<ref href="/us/usc/t21/s355c–1/b">21 U.S.C. 355c–1(b)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y638fb5a3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/d/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in paragraph (10), by <amendingAction type="delete">striking</amendingAction> “<quotedText>; and</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>;</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y638fb5a4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (11) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y639002c5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="11">“(11) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639002c6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Assessment.</p></sidenote><content>an assessment of the impact of the amendments to such section 505B made by the FDA Reauthorization Act of 2017 on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer;</content></paragraph>
<paragraph class="indentUp0 fontsize10" id="y639002c7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="12">“(12) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639002c8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Assessment.</p></sidenote><chapeau>an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act, regarding earlier submission of pediatric studies under sections 505A and 505B of such Act and section 351(m) of the Public Health Service Act, including—</chapeau><subparagraph class="fontsize10" id="y639002c9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the average length of time after the approval of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/b/1">21 U.S.C. 355(b)(1)</ref>) or section 351(a) of the Public Health Service Act (<ref href="/us/usc/t42/s262/a">42 U.S.C. 262(a)</ref>) before studies conducted pursuant to such section 505A, 505B, or section 351(m) are completed, submitted, and incorporated into labeling;</content></subparagraph>
<subparagraph class="fontsize10" id="y639002ca-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request;</content></subparagraph>
<subparagraph class="fontsize10" id="y639002cb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies;</content></subparagraph>
<subparagraph class="fontsize10" id="y639002cc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639002cd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><content>the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests;</content></subparagraph>
</paragraph>
<paragraph class="indentUp0 fontsize10" id="y639002ce-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="13">“(13) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639002cf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><content>a list of sponsors of applications or holders of approved applications who received exclusivity under such section 505A or such section 351(m) after receiving a letter issued under such section 505B(d)(1) for any drug or biological product before the studies referred to in such letter were completed and submitted;</content></paragraph>
<paragraph class="indentUp0 fontsize10" id="y639002d0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="14">“(14) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639002d1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><content>a list of assessments and investigations required under such section 505B;</content></paragraph>
<paragraph class="indentUp0 fontsize10" id="y639002d2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="15">“(15) </num><content>how many requests under such section 505A for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) of such section 505B, approved prior to 3 years after the date of enactment of the FDA Reauthorization Act of 2017, have been issued by the Food and Drug Administration, and how many such requests have been completed; and</content></paragraph>
<paragraph class="indentUp0 fontsize10" id="y639002d3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="16">“(16) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639002d4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Assessment.</p></sidenote><content>the Secretary’s assessment of the overall impact of the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric <page identifier="/us/stat/131/1045">131 STAT. 1045</page>
cancer research and the orphan drug program, as well any subsequent recommendations.”</content></paragraph>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y639002d5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/e" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639002d6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s355c">21 USC 355c note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Rule of Construction</inline>.—</heading><content>Nothing in this section, including the amendments made by this section, shall limit the authority of the Secretary of Health and Human Services to issue written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a">21 U.S.C. 355a</ref>) or section 351(m) of the Public Health Service Act (<ref href="/us/usc/t42/s262/m">42 U.S.C. 262(m)</ref>), or to negotiate or implement amendments to such requests proposed by the an applicant.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639029e7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><heading class="fontsize10"><inline class="smallCaps">GAO Report</inline>.—</heading><paragraph class="fontsize10" id="y639029e8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639029e9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x639029ea-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x639029eb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Study.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Beginning on the date that is 5 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c">21 U.S.C. 355c</ref>), as amended by this section, in the development of drugs and biological products for pediatric cancer indications.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639029ec-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Examination.</p></sidenote> The Comptroller General shall examine—</chapeau><subparagraph class="fontsize10" id="y639029ed-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>the indications and associated molecular targets studied in assessments and investigations required for drugs or biological products intended for the treatment of an adult cancer;</content></subparagraph>
<subparagraph class="fontsize10" id="y639029ee-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>the indication for which the study was requested as compared to the indication requested under the new drug application filed by the sponsor;</content></subparagraph>
<subparagraph class="fontsize10" id="y639029ef-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>the number of pediatric cancer indications for which assessments and investigations have been required under such section 505B;</content></subparagraph>
<subparagraph class="fontsize10" id="y639029f0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>the number of requests for deferral and waiver of pediatric assessments and investigations required under such section and the number of such deferral and waiver requests granted and denied;</content></subparagraph>
<subparagraph class="fontsize10" id="y639029f1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>the number of orphan-designated indications for drugs and biological products for which assessments and investigations were required under such section;</content></subparagraph>
<subparagraph class="fontsize10" id="y639029f2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>the number of drugs and biological products approved for the treatment of cancer in the pediatric population for which the supportive studies were required to be conducted under such section;</content></subparagraph>
<subparagraph class="fontsize10" id="y639029f3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/G" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="G">(G) </num><content>the number of written requests made under section 505A of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a">21 U.S.C. 355a</ref>) relating to investigations required under subsection (a)(1)(B) of such section 505B; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639029f4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/1/H" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="H">(H) </num><content>any additional considerations by the Secretary regarding the effectiveness of requiring pediatric assessments described in such section 505B in the development of drugs and biological products for pediatric cancer indications.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639029f5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639029f6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Criteria.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Review</inline>.—</heading><content>The study under paragraph (1) shall include a review of the Food and Drug Administration’s use of the authority under section 505B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c">21 U.S.C. 355c</ref>), as amended by this section, including the amendments to the deferral and waiver criteria under such section and how such criteria have been applied.</content></paragraph>
<paragraph class="fontsize10" id="y639029f7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><heading class="fontsize10"><inline class="smallCaps">Consultation</inline>.—</heading><content>In conducting the study under paragraph (1), the Comptroller General of the United States shall consult with appropriate stakeholders that may be required <page identifier="/us/stat/131/1046">131 STAT. 1046</page>
to conduct the trials under section 505B of the Federal Food, Drug, and Cosmetic Act, and the ability of such stakeholders to adhere to the requests issued by the Food and Drug Administration.</content></paragraph>
<paragraph class="fontsize10" id="y639029f8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s504/f/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><content>Not later than the date that is 6 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a report containing the results of the study under paragraph (1) to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives.</content></paragraph>
</subsection>
</section>
<section id="d132600e7790" identifier="/us/pl/115/52/tV/s505" style="-uslm-lc:I658143"><num class="fontsize12" value="505">SEC. 505. </num><heading>ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.</heading><subsection class="firstIndent0 fontsize10" id="y63911459-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Informing Internal Review Committee</inline>.—</heading><content>Section 505A(f) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a/f">21 U.S.C. 355a(f)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="fontsize10" id="y63913b6a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="7">“(7) </num><heading class="fontsize10"><inline class="smallCaps">Informing internal review committee</inline>.—</heading><content>The Secretary shall provide to the committee referred to in paragraph (1) any response issued to an applicant or holder with respect to a proposed pediatric study request.”</content></paragraph>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63913b6b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Action on Submissions</inline>.—</heading><paragraph class="fontsize10" id="y63913b6c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>Section 505A(d) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a/d">21 U.S.C. 355a(d)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y63913b6d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (3) through (5) as paragraphs (4) through (6), respectively; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63913b6e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (2) the following:<quotedContent><paragraph class="indentDown1 fontsize10" id="y63913b6f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b70-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Action on submissions</inline>.—</heading><content>The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission.”</content></paragraph>
</quotedContent>.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63913b71-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Conforming amendments</inline>.—</heading><subparagraph class="fontsize10" id="y63913b72-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b/2/A" role="instruction" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><heading class="fontsize10"><inline class="smallCaps">Federal food, drug, and cosmetic act</inline>.—</heading><content>Section 505A of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a">21 U.S.C. 355a</ref>), as amended by paragraph (1), is further amended by <amendingAction type="delete">striking</amendingAction> subsection “<quotedText>(d)(3)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(d)(4)</quotedText>”.</content></subparagraph>
<subparagraph class="fontsize10" id="y63913b73-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/b/2/B" role="instruction" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><heading class="fontsize10"><inline class="smallCaps">Public health service act</inline>.—</heading><content>Paragraphs (2), (3), and (4) of section 351(m) of the Public Health Service Act (<ref href="/us/usc/t42/s262/m">42 U.S.C. 262(m)</ref>) are amended by <amendingAction type="delete">striking</amendingAction> “<quotedText>section 505A(d)(3)</quotedText>” each place it appears and <amendingAction type="insert">inserting</amendingAction> “<quotedText>section 505A(d)(4)</quotedText>”.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63913b74-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b75-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63913b76-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s355a">21 USC 355a note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Plan</inline>.—</heading><chapeau>The Secretary of Health and Human Services, acting through the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355d">21 U.S.C. 355d</ref>) shall, not later than one year after the date of enactment of this Act, develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a">21 U.S.C. 355a</ref>) or section 351(m) of the Public Health Service Act (<ref href="/us/usc/t42/s262/m">42 U.S.C. 262(m)</ref>).<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b77-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63913b78-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote> Such plan shall include recommendations to achieve—</chapeau><paragraph class="fontsize10" id="y63913b79-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/e/2/C">21 U.S.C. 355c(e)(2)(C)</ref>), as amended by section 503(a);<page identifier="/us/stat/131/1047">131 STAT. 1047</page></content></paragraph>
<paragraph class="fontsize10" id="y63913b7a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>earlier issuance of written requests for a pediatric study under such section 505A, including for investigational new drugs prior to the submission of an application under section 505(b)(1) of such Act (<ref href="/us/usc/t21/s355/b/1">21 U.S.C. 355(b)(1)</ref>); and</content></paragraph>
<paragraph class="fontsize10" id="y63913b7b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/c/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A or such section 351(m).</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63913b7c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/d" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Neonatology Expertise</inline>.—</heading><paragraph class="fontsize10" id="y63913b7d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/d/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Section 6(d) of the Best Pharmaceuticals for Children Act (<ref href="/us/usc/t21/s393a/d">21 U.S.C. 393a(d)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>For the 5-year period beginning on the date of enactment of this subsection, at</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>At</quotedText>”.</content></paragraph>
<paragraph class="fontsize10" id="y63913b7e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b7f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63913b80-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s355a">21 USC 355a note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Draft guidance</inline>.—</heading><content>Not later than 2 years after the date of enactment of this Act, the Secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63913b81-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/e" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><heading class="fontsize10"><inline class="smallCaps">Submission of Assessments</inline>.—</heading><content>Section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/d/1">21 U.S.C. 355c(d)(1)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following: “<quotedText>The Secretary shall inform the Pediatric Advisory Committee of letters issued under this paragraph and responses to such letters.</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63913b82-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/f" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><heading class="fontsize10"><inline class="smallCaps">Internal Committee</inline>.—</heading><content>Section 505C of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355d">21 U.S.C. 355d</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or pediatric rare diseases</quotedText>” after “<quotedText>psychiatry</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63913b83-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="g">(g) </num><heading class="fontsize10"><inline class="smallCaps">Report on Labeling of Orphan Drugs</inline>.—</heading><paragraph class="fontsize10" id="y63913b84-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b85-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p><p class="leftAlign firstIndent0 fontsize8" id="x63913b86-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services 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, and make publicly available, including through posting on the internet website of the Food and Drug Administration, a report on the lack of information in the labeling of drugs for indications that have received an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb">21 U.S.C. 360bbb</ref>) with respect to the use of such drugs pediatric populations.</content></paragraph>
<paragraph class="fontsize10" id="y63913b87-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Contents</inline>.—</heading><chapeau>The report described in paragraph (1) shall include—</chapeau><subparagraph class="fontsize10" id="y63913b88-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b89-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><chapeau>a list of drugs for which—</chapeau><clause class="fontsize10" id="y63913b8a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>an indication was granted an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb">21 U.S.C. 360bbb</ref>);</content></clause>
<clause class="fontsize10" id="y63913b8b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>an application described under section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355c/a/1">21 U.S.C. 355c(a)(1)</ref>) for such indication was submitted to the Secretary of Health and Human Services on or after April 1, 1999; and</content></clause>
<clause class="fontsize10" id="y63913b8c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2/A/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>the labeling for such indication lacks important pediatric information, including information related to safety, dosing, and effectiveness;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63913b8d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>a description of the lack of information referred to in subparagraph (A)(iii) for each drug for an indication on such list; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63913b8e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tV/s505/g/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63913b8f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63913b90-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote><content>Federal policy recommendations to improve the labeling of drugs for indications that have received an <page identifier="/us/stat/131/1048">131 STAT. 1048</page>
orphan designation under such section 526 with respect to the use of such drugs pediatric populations.”</content></subparagraph>
</paragraph>
</subsection>
</section>
<num value="VI">TITLE VI—</num><heading>REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS</heading>
<section id="d132600e8160" identifier="/us/pl/115/52/tVI/s601" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="601">SEC. 601. </num><heading>REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.</heading><content style="-uslm-lc:I658120"> Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/u/4">21 U.S.C. 355(u)(4)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2022</quotedText>”.</content></section>
<section id="d132600e8179" identifier="/us/pl/115/52/tVI/s602" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="602">SEC. 602. </num><heading>REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.</heading><content style="-uslm-lc:I658120"> Section 566(f) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb–5/f">21 U.S.C. 360bbb–5(f)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”.</content></section>
<section id="d132600e8198" identifier="/us/pl/115/52/tVI/s603" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="603">SEC. 603. </num><heading>REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.</heading><content style="-uslm-lc:I658120"> Section 5(c) of the Orphan Drug Act (<ref href="/us/usc/t21/s360ee/c">21 U.S.C. 360ee(c)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>2013 through 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>2018 through 2022</quotedText>”.</content></section>
<section id="d132600e8217" identifier="/us/pl/115/52/tVI/s604" style="-uslm-lc:I658143"><num class="fontsize12" value="604">SEC. 604. </num><heading>PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.</heading><subsection class="firstIndent0 fontsize10" id="y639189b1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s604/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Diverted Drugs</inline>.—</heading><chapeau>Paragraph (1) of section 801(d) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s381/d">21 U.S.C. 381(d)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y639189b2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s604/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>(d)(1) Except as</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>(d)(1)(A) Except as</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y639189b3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s604/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="indentDown1 firstIndent0 fontsize10" id="y6391b0c4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 506E or in the case of importation pursuant to section 804, no drug that is subject to section 503(b)(1) may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.”</content></subparagraph>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y6391b0c5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s604/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Counterfeit Drugs</inline>.—</heading><content>Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s333">21 U.S.C. 333</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 firstIndent0 fontsize10" id="y6391b0c6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="8">“(8) </num><content>Notwithstanding subsection (a), any person who violates section 301(i)(3) by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug shall be imprisoned for not more than 10 years or fined in accordance with <ref href="/us/usc/t18">title 18, United States Code</ref>, or both.”</content></paragraph>
</quotedContent>.</content></subsection>
</section>
<section id="d132600e8297" identifier="/us/pl/115/52/tVI/s605" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="605">SEC. 605. </num><heading>PATIENT EXPERIENCE DATA.</heading><content style="-uslm-lc:I658120"> Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb–8c/c/2/A">21 U.S.C. 360bbb–8c(c)(2)(A)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>impact of such disease or condition, or a related therapy,</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation</quotedText>”.<page identifier="/us/stat/131/1049">131 STAT. 1049</page></content></section>
<section id="d132600e8318" identifier="/us/pl/115/52/tVI/s606" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="606">SEC. 606. </num><heading>COMMUNICATION PLANS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x6391d7d7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 505–1(e)(3) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355–1/e/3">21 U.S.C. 355–1(e)(3)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6391d7d8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s606/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in subparagraph (B), by <amendingAction type="delete">striking</amendingAction> “<quotedText>; or</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y6391d7d9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s606/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subparagraph (C), by <amendingAction type="delete">striking</amendingAction> the period and <amendingAction type="insert">inserting</amendingAction> “<quotedText>; or</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y6391d7da-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s606/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="fontsize10" id="y6391d7db-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>disseminating information to health care providers about drug formulations or properties, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.”</content></subparagraph>
</quotedContent>.</content></paragraph>
</section>
<section id="d132600e8368" identifier="/us/pl/115/52/tVI/s607" style="-uslm-lc:I658143"><num class="fontsize12" value="607">SEC. 607. </num><heading>ORPHAN DRUGS.</heading><subsection class="firstIndent0 fontsize10" id="y63924d0c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><chapeau>Section 527 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360cc">21 U.S.C. 360cc</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63924d0d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in subsection (a), in the matter following paragraph (2), by <amendingAction type="delete">striking</amendingAction> “<quotedText>such drug for such disease or condition</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>the same drug for the same disease or condition</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63924d0e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in subsection (b)—</chapeau><subparagraph class="fontsize10" id="y63924d0f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63924d10-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63924d11-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>in the matter preceding paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>If an application</quotedText>” and all that follows through “<quotedText>such license if</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>During the 7-year period described in subsection (a) for an approved application under section 505 or license under section 351 of the Public Health Service Act, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if</quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63924d12-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>notice</quotedText>” and all that follows through “<quotedText>assure</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63924d13-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>in paragraph (2), by <amendingAction type="delete">striking</amendingAction> “<quotedText>such holder provides</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>the holder provides</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63924d14-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="indentDown1 firstIndent0 fontsize10" id="y63929b35-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><heading class="fontsize10"><inline class="smallCaps">Condition of Clinical Superiority</inline>.—</heading><paragraph class="fontsize10" id="y63929b36-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>If a sponsor of a drug that is designated under section 526 and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.</content></paragraph>
<paragraph class="fontsize10" id="y63929b37-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Definition</inline>.—</heading><content>For purposes of paragraph (1), the term ‘<term>clinically superior</term>’ with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.</content></paragraph>
</subsection>
<subsection class="indentDown1 firstIndent0 fontsize10" id="y63929b38-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63929b39-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Regulations</inline>.—</heading><content>The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on the date of enactment of the FDA Reauthorization Act of 2017, until such <page identifier="/us/stat/131/1050">131 STAT. 1050</page>
time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.</content></subsection>
<subsection class="indentDown1 firstIndent0 fontsize10" id="y63929b3a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">“(e) </num><heading class="fontsize10"><inline class="smallCaps">Demonstration of Clinical Superiority Standard</inline>.—</heading><chapeau>To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—</chapeau><paragraph class="fontsize10" id="y63929b3b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63929b3c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notification.</p></sidenote><content>upon the designation of any drug under section 526, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and</content></paragraph>
<paragraph class="fontsize10" id="y63929b3d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63929b3e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x63929b3f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Summary.</p></sidenote><content>upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.”</content></paragraph>
</subsection>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63929b40-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s607/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63929b41-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360cc">21 USC 360cc note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Rule of Construction</inline>.—</heading><content>Nothing in the amendments made by subsection (a) shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bb">21 U.S.C. 360bb</ref>, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017.</content></subsection>
</section>
<section id="d132600e8545" identifier="/us/pl/115/52/tVI/s608" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="608">SEC. 608. </num><heading>PEDIATRIC INFORMATION ADDED TO LABELING.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x63931072-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355a/o">21 U.S.C. 355a(o)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63931073-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in the subsection heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText>under section 505<b>(j)</b></quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y63931074-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y63931075-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>under section 505(j)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>under subsection (b)(2) or (j) of section 505</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63931076-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>, or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), clause (iii) or (iv) of section 505(c)(3)(E), or section 527(a), or by an extension of such exclusivity under this section or section 505E</quotedText>”;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63931077-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><chapeau>in paragraph (2), in the matter preceding subparagraph (A)—</chapeau><subparagraph class="fontsize10" id="y63931078-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="insert">inserting</amendingAction> “<quotedText>clauses (iii) and (iv) of section 505(c)(3)(E), or section 527,</quotedText>” after “<quotedText>section 505(j)(5)(F),</quotedText>”; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63931079-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>drug approved under section 505(j)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 505</quotedText>”; and</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6393107a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s608/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>by <amendingAction type="amend">amending</amendingAction> paragraph (3) to read as follows:<quotedContent><paragraph class="indentUp0 fontsize10" id="y6393378b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Preservation of pediatric exclusivity and extensions</inline>.—</heading><chapeau>This subsection does not affect—</chapeau><subparagraph class="fontsize10" id="y6393378c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><chapeau>the availability or scope of exclusivity under—</chapeau><clause class="fontsize10" id="y6393378d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>this section;</content></clause>
<clause class="fontsize10" id="y6393378e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>section 505 for pediatric formulations; or</content></clause>
<clause class="fontsize10" id="y6393378f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>section 527;</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63933790-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the availability or scope of an extension to any such exclusivity, including an extension under this section or section 505E;<page identifier="/us/stat/131/1051">131 STAT. 1051</page></content></subparagraph>
<subparagraph class="fontsize10" id="y63933791-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><chapeau>the question of the eligibility for approval under section 505 of any application described in subsection (b)(2) or (j) of such section that omits any other aspect of labeling protected by exclusivity under—</chapeau><clause class="fontsize10" id="y63933792-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>clause (iii) or (iv) of section 505(j)(5)(F);</content></clause>
<clause class="fontsize10" id="y63933793-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>clause (iii) or (iv) of section 505(c)(3)(E); or</content></clause>
<clause class="fontsize10" id="y63933794-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>section 527(a); or</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63933795-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>except as expressly provided in paragraphs (1) and (2), the operation of section 505 or section 527.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
</section>
<section id="d132600e8697" identifier="/us/pl/115/52/tVI/s609" style="-uslm-lc:I658143"><num class="fontsize12" value="609">SEC. 609. </num><heading>SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x63935ea6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> It is the sense of the Congress that the Secretary of Health and Human Services should commit to engaging with the House of Representatives and the Senate to take administrative actions and enact legislative changes that—</chapeau><paragraph class="fontsize10" id="y63935ea7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s609/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>will lower the cost of prescription drugs for consumers and reduce the burden of such cost on taxpayers; and</content></paragraph>
<paragraph class="fontsize10" id="y63935ea8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s609/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in lowering such cost, will—</chapeau><subparagraph class="fontsize10" id="y63935ea9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s609/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>balance the need to encourage innovation with the need to improve affordability; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63935eaa-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s609/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>strive to increase competition in the pharmaceutical market, prevent anticompetitive behavior, and promote the timely availability of affordable, high-quality generic drugs and biosimilars.</content></subparagraph>
</paragraph>
</section>
<section id="d132600e8724" identifier="/us/pl/115/52/tVI/s610" style="-uslm-lc:I658143"><num class="fontsize12" value="610">SEC. 610. </num><heading>EXPANDED ACCESS.</heading><subsection class="firstIndent0 fontsize10" id="y6394972b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394972c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360bbb">21 USC 360bbb note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Patient Access to Investigational Drugs</inline>.—</heading><paragraph class="fontsize10" id="y6394972d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">Public meeting</inline>.—</heading><subparagraph class="fontsize10" id="y6394972e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394972f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Coordination.</p><p class="leftAlign firstIndent0 fontsize8" id="x63949730-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Consultation.</p><p class="leftAlign firstIndent0 fontsize8" id="x63949731-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, in coordination with the Director of the National Institutes of Health, and in consultation with patients, health care providers, drug sponsors, bioethicists, and other stakeholders, shall, not later than 270 days after the date of enactment of this Act, convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph (3). The Secretary shall inform the Comptroller General of the United States of the date when the public meeting will take place.</content></subparagraph>
<subparagraph class="fontsize10" id="y63949732-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63949733-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p><p class="leftAlign firstIndent0 fontsize8" id="x63949734-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Reports.</p><p class="leftAlign firstIndent0 fontsize8" id="x63949735-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Topics</inline>.—</heading><chapeau>The Secretary shall make available on the internet website of the Food and Drug Administration a report on the topics discussed at the meeting described in subparagraph (A) within 90 days of such meeting. Such topics shall include discussion of—</chapeau><clause class="fontsize10" id="y63949736-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>the rationale for, and potential barriers for patients created by, research clinical trial inclusion and exclusion criteria;</content></clause>
<clause class="fontsize10" id="y63949737-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>how appropriate patient populations can benefit from the results of trials that employ alternative designs;</content></clause>
<clause class="fontsize10" id="y6394be48-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><chapeau>barriers to participation in clinical trials, including—</chapeau><subclause class="fontsize10" id="y6394be49-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/iii/I" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">(I) </num><content>information regarding any potential risks and benefits of participation;</content></subclause>
<subclause class="fontsize10" id="y6394be4a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/iii/II" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">(II) </num><content>regulatory, geographical, and socioeconomic barriers; and<page identifier="/us/stat/131/1052">131 STAT. 1052</page></content></subclause>
<subclause class="fontsize10" id="y6394be4b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/iii/III" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">(III) </num><content>the impact of exclusion criteria on the enrollment in clinical trials of particular populations, including infants and children, pregnant and lactating women, seniors, individuals with advanced disease, and individuals with co-morbid conditions;</content></subclause>
</clause>
<clause class="fontsize10" id="y6394be4c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>clinical trial designs and methods, including expanded access trials, that increase enrollment of more diverse patient populations, when appropriate, while facilitating the collection of data to establish safe use and support substantial evidence of effectiveness, including data obtained from expanded access trials; and</content></clause>
<clause class="fontsize10" id="y6394be4d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/1/B/v" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">(v) </num><content>how changes to clinical trial inclusion and exclusion criteria may impact the complexity and length of clinical trials, the data necessary to demonstrate safety and effectiveness, and potential approaches to mitigating those impacts.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6394be4e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><chapeau>Not later than 1 year after the Secretary issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs through the expanded access program under section 561(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb/b">21 U.S.C. 360bbb(b)</ref>). The report shall include—</chapeau><subparagraph class="fontsize10" id="y6394be4f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>a description of actions taken by manufacturers and distributors under section 561A of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb–0">21 U.S.C. 360bbb–0</ref>);</content></subparagraph>
<subparagraph class="fontsize10" id="y6394be50-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>consideration of whether Form FDA 3926 and the guidance documents titled “Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers” and “Individual Patient Expanded Access Applications: Form FDA 3926”, issued by the Food and Drug Administration in June 2016, have reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb">21 U.S.C. 360bbb</ref>) and improved clarity for patients, physicians, and drug manufacturers about such process;</content></subparagraph>
<subparagraph class="fontsize10" id="y6394be51-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb">21 U.S.C. 360bbb</ref>) have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain;</content></subparagraph>
<subparagraph class="fontsize10" id="y6394be52-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394be53-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Assessment.</p></sidenote><content>an assessment of methods patients and health care providers use to engage with the Food and Drug Administration or drug sponsors on expanded access; and</content></subparagraph>
<subparagraph class="fontsize10" id="y6394be54-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/2/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394be55-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Analysis.</p></sidenote><content>an analysis of the Secretary’s report under paragraph (1)(B).</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y6394be56-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><heading class="fontsize10"><inline class="smallCaps">Guidance</inline>.—</heading><subparagraph class="fontsize10" id="y6394be57-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394be58-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 1 year after the publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and Drugs, shall issue one or more draft guidances regarding <page identifier="/us/stat/131/1053">131 STAT. 1053</page>
eligibility criteria for clinical trials. Not later than 1 year after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.</content></subparagraph>
<subparagraph class="fontsize10" id="y6394be59-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><heading class="fontsize10"><inline class="smallCaps">Contents</inline>.—</heading><chapeau>The guidance documents described in subparagraph (A) shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to—</chapeau><clause class="fontsize10" id="y6394be5a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/3/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>broaden eligibility criteria for clinical trials and expanded access trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need;</content></clause>
<clause class="fontsize10" id="y6394be5b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/3/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>develop eligibility criteria for, and increase trial recruitment to, clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug, as applicable and as appropriate, while establishing safe use and supporting findings of substantial evidence of effectiveness; and</content></clause>
<clause class="fontsize10" id="y6394be5c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/a/3/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>use the criteria described in clauses (i) and (ii) in a manner that is appropriate for drugs intended for the treatment of rare diseases or conditions.</content></clause>
</subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y6394be5d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394be5e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x6394be5f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Guidance.</p><p class="leftAlign firstIndent0 fontsize8" id="x6394be60-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360bbb">21 USC 360bbb note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Improving Institutional Review Board Review of Single Patient Expanded Access Protocol</inline>.—</heading><content>Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidance or regulations, or revise existing guidance or regulations, to streamline the institutional review board review of individual patient expanded access protocols submitted under 561(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb/b">21 U.S.C. 360bbb(b)</ref>). To facilitate the use of expanded access protocols, any guidance or regulations so issued or revised may include a description of the process for any person acting through a physician licensed in accordance with State law to request that an institutional review board chair (or designated member of the institutional review board) review a single patient expanded access protocol submitted under such section 561(b) for a drug.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394be61-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Update.</p></sidenote> The Secretary shall update any relevant forms associated with individual patient expanded access requests under such section 561(b) as necessary.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6394be62-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Expanded Access Policy Transparency</inline>.—</heading><chapeau>Section 561A(f) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360bbb–0/f">21 U.S.C. 360bbb–0(f)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6394be63-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/c/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in the matter preceding paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>later</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>earlier</quotedText>”;</content></paragraph>
<paragraph class="fontsize10" id="y6394be64-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/c/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (1);</content></paragraph>
<paragraph class="fontsize10" id="y6394be65-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/c/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraph (2) as paragraph (1);</content></paragraph>
<paragraph class="fontsize10" id="y6394be66-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/c/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>in paragraph (1) as so redesignated, by <amendingAction type="delete">striking</amendingAction> the period at the end and <amendingAction type="insert">inserting</amendingAction> “<quotedText>; or</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y6394be67-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s610/c/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y6394be68-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6394be69-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><content>as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 506.”</content></paragraph>
</quotedContent>.<page identifier="/us/stat/131/1054">131 STAT. 1054</page></content></paragraph>
</subsection>
</section>
<section id="d132600e9038" identifier="/us/pl/115/52/tVI/s611" style="-uslm-lc:I658143"><num class="fontsize12" value="611">SEC. 611. </num><heading>TROPICAL DISEASE PRODUCT APPLICATION.</heading><subsection class="firstIndent0 fontsize10" id="y6394e57a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s611/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><chapeau>Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360n/a/4">21 U.S.C. 360n(a)(4)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63950c8b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s611/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in clause (i), by <amendingAction type="delete">striking</amendingAction> “<quotedText>and</quotedText>” at the end; and</content></paragraph>
<paragraph class="fontsize10" id="y63950c8c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s611/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><clause class="indentUp2 fontsize10" id="y63950c8d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and</content></clause>
<clause class="indentUp2 fontsize10" id="y63950c8e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.”</content></clause>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63950c8f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVI/s611/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63950c90-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360n">21 USC 360n note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Effective Date</inline>.—</heading><content>The amendments made by subsection (a) shall apply to human drug applications submitted after September 30, 2017.</content></subsection>
</section>
<num value="VII">TITLE VII—</num><heading>DEVICE INSPECTION AND REGULATORY IMPROVEMENTS</heading>
<section id="d132600e9109" identifier="/us/pl/115/52/tVII/s701" style="-uslm-lc:I658143"><num class="fontsize12" value="701">SEC. 701. </num><heading>RISK-BASED INSPECTIONS FOR DEVICES.</heading><subsection class="firstIndent0 fontsize10" id="y63955ab1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s701/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><chapeau>Section 510(h) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360/h">21 U.S.C. 360(h)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63955ab2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s701/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> paragraph (2) and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y639581c3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Risk-based schedule for devices</inline>.—</heading><subparagraph class="fontsize10" id="y639581c4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as ‘device establishments’) in accordance with a risk-based schedule established by the Secretary.</content></subparagraph>
<subparagraph class="fontsize10" id="y639581c5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Factors and considerations</inline>.—</heading><chapeau>In establishing the risk-based schedule under subparagraph (A), the Secretary shall—</chapeau><clause class="fontsize10" id="y639581c6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639581c7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><content>apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and</content></clause>
<clause class="fontsize10" id="y639581c8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments.”</content></clause>
</subparagraph>
</paragraph>
</quotedContent>; and</content></paragraph>
<paragraph class="fontsize10" id="y639581c9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s701/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><chapeau>in paragraph (4)—</chapeau><subparagraph class="fontsize10" id="y639581ca-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s701/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the matter preceding subparagraph (A), by <amendingAction type="delete">striking</amendingAction> “<quotedText>paragraph (3)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraph (2) or (3)</quotedText>”; and<page identifier="/us/stat/131/1055">131 STAT. 1055</page></content></subparagraph>
<subparagraph class="fontsize10" id="y639581cb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s701/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>in subparagraph (C), by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or device</quotedText>” after “<quotedText>drug</quotedText>”.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y639581cc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s701/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Foreign Inspections</inline>.—</heading><content>Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s384e/a/1">21 U.S.C. 384e(a)(1)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>section 510(h)(3)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>paragraph (2) or (3) of section 510(h)</quotedText>”.</content></subsection>
</section>
<section id="d132600e9233" identifier="/us/pl/115/52/tVII/s702" style="-uslm-lc:I658143"><num class="fontsize12" value="702">SEC. 702. </num><heading>IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS.</heading><subsection class="firstIndent0 fontsize10" id="y6395f6fd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Section 704 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s374">21 U.S.C. 374</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y6396451e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="h">“(h)</num><paragraph class="inline" id="y6396451f-e82d-11f0-a1e4-69761a48a15a"><num value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63964520-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p></sidenote><chapeau>In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of the date of the enactment of this subsection, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for—</chapeau><subparagraph class="fontsize10" id="y63964521-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>exceptions to such processes and standards, as appropriate;</content></subparagraph>
<subparagraph class="fontsize10" id="y63964522-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection;</content></subparagraph>
<subparagraph class="fontsize10" id="y63964523-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63964524-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent.</content></subparagraph>
</paragraph>
<paragraph class="indentUp0 firstIndent0 fontsize10" id="y63964525-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2)</num><subparagraph class="inline" id="y63964526-e82d-11f0-a1e4-69761a48a15a"><num value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63964527-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><content>The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.</content></subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y63964528-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><chapeau>A request described in this subparagraph is a request for feedback—</chapeau><clause class="fontsize10" id="y63966c39-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and</content></clause>
<clause class="fontsize10" id="y63966c3a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).</content></clause>
</subparagraph>
</paragraph>
<paragraph class="indentUp0 firstIndent0 fontsize10" id="y63966c3b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><content>Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63966c3c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63966c3d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s374">21 USC 374 note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Guidance</inline>.—</heading><paragraph class="fontsize10" id="y63966c3e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63966c3f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Draft guidance</inline>.—</heading><chapeau>Not later than 18 months after the date of enactment of this Act, the Secretary of Health and <page identifier="/us/stat/131/1056">131 STAT. 1056</page>
Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that—</chapeau><subparagraph class="fontsize10" id="y63966c40-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s374">21 U.S.C. 374</ref>), as added by subsection (a), and the requirements described in paragraph (2) of such subsection (h);</content></subparagraph>
<subparagraph class="fontsize10" id="y63966c41-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>provides for standardized methods for communications described in such paragraphs;</content></subparagraph>
<subparagraph class="fontsize10" id="y63966c42-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><chapeau>establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a)), a standard timeframe for such inspections—</chapeau><clause class="fontsize10" id="y63966c43-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1/C/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>that occurs over consecutive days; and</content></clause>
<clause class="fontsize10" id="y63966c44-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1/C/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63966c45-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/1/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63966c46-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63966c47-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x63966c48-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notice.</p><p class="leftAlign firstIndent0 fontsize8" id="x63966c49-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Final guidance</inline>.—</heading><content>Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s374">21 U.S.C. 374</ref>), as added by subsection (a).</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63966c4a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s702/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Adulterated Devices</inline>.—</heading><content>Subsection (j) of section 501 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s351">21 U.S.C. 351</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="insert">inserting</amendingAction> “<quotedText>or device</quotedText>” after “<quotedText>drug</quotedText>”.</content></subsection>
</section>
<section id="d132600e9425" identifier="/us/pl/115/52/tVII/s703" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="703">SEC. 703. </num><heading>REAUTHORIZATION OF INSPECTION PROGRAM.</heading><content style="-uslm-lc:I658120"> Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s374/g/11">21 U.S.C. 374(g)(11)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>October 1, 2017</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>October 1, 2022</quotedText>”.</content></section>
<section id="d132600e9444" identifier="/us/pl/115/52/tVII/s704" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="704">SEC. 704. </num><heading>CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x6396ba6b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Subsection (e)(4) of section 801 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s381/e/4">21 U.S.C. 381(e)(4)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y6396ba6c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s704/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subparagraph class="indentDown1 firstIndent0 fontsize10" id="y6397088d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E)</num><clause class="inline" id="y6397088e-e82d-11f0-a1e4-69761a48a15a"><num value="i">(i)</num><subclause class="inline" id="y6397088f-e82d-11f0-a1e4-69761a48a15a"><num value="I">(I) </num><content>If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 510, the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based.</content></subclause>
<subclause class="indentUp0 firstIndent0 fontsize10" id="y63970890-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63970891-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Summary.</p></sidenote><content>If the denial of a request as described in subclause (I) is based on grounds other than an injunction proceeding pursuant to section 302, seizure action pursuant to section 304, or a recall designated Class I or Class II pursuant to <ref href="/us/cfr/t21/pt7">part 7, title 21, Code of Federal Regulations</ref>, and is based on the facility being out of compliance with <ref href="/us/cfr/t21/pt820">part 820 of title 21, Code of Federal Regulations</ref>, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary.</content></subclause>
<subclause class="indentUp0 firstIndent0 fontsize10" id="y63970892-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary <page identifier="/us/stat/131/1057">131 STAT. 1057</page>
shall not deny a request for certification as described in subclause (I) with respect to a device based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report.</content></subclause>
</clause>
<clause class="indentUp0 firstIndent0 fontsize10" id="y63970893-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii)</num><subclause class="inline" id="y63970894-e82d-11f0-a1e4-69761a48a15a"><num value="I">(I) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63970895-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p></sidenote><content>The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 517A(b).</content></subclause>
<subclause class="indentUp0 firstIndent0 fontsize10" id="y63970896-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary.</content></subclause>
<subclause class="indentUp0 firstIndent0 fontsize10" id="y63970897-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63970898-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p><p class="leftAlign firstIndent0 fontsize8" id="x63970899-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Guidance.</p></sidenote><content>Not later than 1 year after the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance.</content></subclause>
</clause>
<clause class="indentUp0 firstIndent0 fontsize10" id="y6397089a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii)</num><subclause class="inline" id="y6397089b-e82d-11f0-a1e4-69761a48a15a"><num value="I">(I) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6397089c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><content>Subject to subclause (II), this subparagraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.</content></subclause>
<subclause class="indentUp0 firstIndent0 fontsize10" id="y6397089d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x6397089e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p><p class="leftAlign firstIndent0 fontsize8" id="x6397089f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><chapeau>If an establishment described in subclause (I) is not located within the United States and does not demonstrate that the devices manufactured, prepared, propagated, compounded, or processed at such establishment are to be exported from the United States, this subparagraph shall apply only if—</chapeau><item class="fontsize10" id="y639708a0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>the establishment has been inspected by the Secretary within 3 years of the date of the request; or</content></item>
<item class="fontsize10" id="y639708a1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639708a2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Audits.</p></sidenote><content>the establishment participates in an audit program in which the United States participates or the United States recognizes, an audit under such program has been conducted, and the findings of such audit are provided to the Secretary within 3 years of the date of the request.”</content></item>
</subclause>
</clause>
</subparagraph>
</quotedContent>; and</content></paragraph>
<paragraph class="fontsize10" id="y639708a3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s704/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by moving the margins of subparagraphs (C) and (D) 4 ems to the left.</content></paragraph>
</section>
<section id="d132600e9573" identifier="/us/pl/115/52/tVII/s705" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="705">SEC. 705. </num><heading>FACILITATING INTERNATIONAL HARMONIZATION.</heading><content class="firstIndent0 fontsize10" id="x63972eb4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 704(g) of the Federal Food, Drug and Cosmetic Act (<ref href="/us/usc/t21/s374">21 U.S.C. 374</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 firstIndent0 fontsize10" id="y639755c5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="15">“(15)</num><subparagraph class="inline" id="y639755c6-e82d-11f0-a1e4-69761a48a15a"><num value="A">(A) </num><chapeau>Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—</chapeau><clause class="fontsize10" id="y639755c7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 351 of the Public Health Service Act), as required under section 510(h); or</content></clause>
<clause class="fontsize10" id="y639755c8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>establishments required to register pursuant to section 510(i).</content></clause>
</subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y639755c9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><chapeau>Nothing in this paragraph affects—</chapeau><clause class="fontsize10" id="y639755ca-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>the authority of the Secretary to inspect any device establishment pursuant to this Act; or<page identifier="/us/stat/131/1058">131 STAT. 1058</page></content></clause>
<clause class="fontsize10" id="y639755cb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the authority of the Secretary to determine the official classification of an inspection.”</content></clause>
</subparagraph>
</paragraph>
</quotedContent>.</content></section>
<section id="d132600e9629" identifier="/us/pl/115/52/tVII/s706" style="-uslm-lc:I658143"><num class="fontsize12" value="706">SEC. 706. </num><heading>FOSTERING INNOVATION IN MEDICAL IMAGING.</heading><subsection class="firstIndent0 fontsize10" id="y6397a3ec-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s706/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Approval of Applications for Certain Diagnostic Medical Imaging Devices</inline>.—</heading><content>Section 520 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t42/s360j">42 U.S.C. 360j</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y6398191d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="p">“(p) </num><heading class="fontsize10"><inline class="smallCaps">Diagnostic Imaging Devices Intended for Use With Contrast Agents</inline>.—</heading><paragraph class="fontsize10" id="y6398191e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 515 with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 510(k), may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 513(f)(2) for an applicable medical imaging device, if such application, notification, or request involves the use of a contrast agent that is not—</chapeau><subparagraph class="fontsize10" id="y6398191f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63981920-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determinations.</p></sidenote><content>in a concentration, rate of administration, or route of administration that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in concentration, rate of administration, or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;</content></subparagraph>
<subparagraph class="fontsize10" id="y63981921-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>in a region, organ, or system of the body that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in region, organ, or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;</content></subparagraph>
<subparagraph class="fontsize10" id="y63981922-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>in a patient population that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; or</content></subparagraph>
<subparagraph class="fontsize10" id="y63981923-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>in an imaging modality that is different from those described in the approved labeling of the contrast agent.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63981924-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Premarket review</inline>.—</heading><chapeau>The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may—<page identifier="/us/stat/131/1059">131 STAT. 1059</page></chapeau><subparagraph class="fontsize10" id="y63981925-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63981926-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Consultation.</p></sidenote><content>consult with the agency center charged with the premarket review of drugs or biological products; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63981927-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63981928-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Applicable requirements</inline>.—</heading><content>An application submitted under section 515, a notification submitted under section 510(k), or a request submitted under section 513(f)(2), as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this Act applicable to devices.</content></paragraph>
<paragraph class="fontsize10" id="y63981929-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Definitions</inline>.—</heading><chapeau>For purposes of this subsection—</chapeau><subparagraph class="fontsize10" id="y6398192a-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the term ‘<term>applicable medical imaging device</term>’ means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and</content></subparagraph>
<subparagraph class="fontsize10" id="y6398192b-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><chapeau>the term ‘<term>contrast agent</term>’ means a drug that is approved under section 505 or licensed under section 351 of the Public Health Service Act, is intended for use in conjunction with an applicable medical imaging device, and—</chapeau><clause class="fontsize10" id="y6398192c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>is a diagnostic radiopharmaceutical, as defined in section 315.2 and 601.31 of <ref href="/us/cfr/t21">title 21, Code of Federal Regulations</ref> (or any successor regulations); or</content></clause>
<clause class="fontsize10" id="y6398192d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.”</content></clause>
</subparagraph>
</paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y6398192e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s706/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Applications for Approval of Contrast Agents Intended for Use With Certain Diagnostic Medical Imaging Devices</inline>.—</heading><content>Section 505 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355">21 U.S.C. 355</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y6398674f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="y">“(y) </num><heading class="fontsize10"><inline class="smallCaps">Contrast Agents Intended for Use With Applicable Medical Imaging Devices</inline>.—</heading><paragraph class="fontsize10" id="y63986750-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for a new use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 520(p)(1).</content></paragraph>
<paragraph class="fontsize10" id="y63986751-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Review of supplement</inline>.—</heading><chapeau>In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may—</chapeau><subparagraph class="fontsize10" id="y63986752-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>consult with the center charged with the premarket review of devices; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63986753-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 515, 510(k), or 513(f)(2) so long as the sponsor of such applicable medical imaging device <page identifier="/us/stat/131/1060">131 STAT. 1060</page>
has provided to the sponsor of the contrast agent a right of reference.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63986754-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Definitions</inline>.—</heading><chapeau>For purposes of this subsection—</chapeau><subparagraph class="fontsize10" id="y63986755-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the term ‘<term>new use</term>’ means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 520(p), but that is not described in the approved labeling of the contrast agent; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63986756-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the terms ‘applicable medical imaging device’ and ‘contrast agent’ have the meanings given such terms in section 520(p).”</content></subparagraph>
</paragraph>
</subsection>
</quotedContent>.</content></subsection>
</section>
<section id="d132600e9842" identifier="/us/pl/115/52/tVII/s707" style="-uslm-lc:I658143"><num class="fontsize12" value="707">SEC. 707. </num><heading>RISK-BASED CLASSIFICATION OF ACCESSORIES.</heading><subsection class="firstIndent0 fontsize10" id="y6398b577-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s707/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Subsection (f) of section 513 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360c">21 U.S.C. 360c</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following new paragraph:<quotedContent><paragraph class="indentUp0 firstIndent0 fontsize10" id="y63992aa8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">“(6)</num><subparagraph class="inline" id="y63992aa9-e82d-11f0-a1e4-69761a48a15a"><num value="A">(A) </num><content>Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory under this section based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.</content></subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y63992aaa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63992aab-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><content>The classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, shall continue to apply unless and until the accessory is reclassified by the Secretary, notwithstanding the classification of any other device with which such accessory is intended to be used. Nothing in this paragraph shall preclude the Secretary’s authority to initiate the classification of an accessory through regulation or written order, as appropriate.</content></subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y63992aac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C)</num><clause class="inline" id="y63992aad-e82d-11f0-a1e4-69761a48a15a"><num value="i">(i) </num><chapeau>In the case of a device intended to be used with an accessory, where the accessory has been included in an application for premarket approval of such device under section 515 or a report under section 510(k) for clearance of such device and the Secretary has not classified such accessory distinctly from another device in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report is filed—</chapeau><subclause class="fontsize10" id="y63992aae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>may include a written request for the proper classification of the accessory pursuant to subparagraph (A);</content></subclause>
<subclause class="fontsize10" id="y63992aaf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63992ab0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Evaluation.</p></sidenote><content>shall include in any such request such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a); and</content></subclause>
<subclause class="fontsize10" id="y63992ab1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>shall, if the request under subclause (I) is requesting classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B).</content></subclause>
</clause>
<clause class="indentUp0 firstIndent0 fontsize10" id="y63992ab2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>The Secretary’s response under section 515(d) or section 510(n) (as applicable) to an application or report described in clause (i) shall also contain the Secretary’s granting or denial of the request for classification of the accessory involved.</content></clause>
<clause class="indentUp0 firstIndent0 fontsize10" id="y63992ab3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>The Secretary’s evaluation of an accessory under clause (i) shall constitute an order establishing a new classification for <page identifier="/us/stat/131/1061">131 STAT. 1061</page>
such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory.</content></clause>
</subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y63992ab4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63992ab5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><chapeau>For accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used, through an application for such other device under section 515(c), a report under section 510(k), or a request for classification under paragraph (2) of this subsection, the following shall apply:</chapeau><clause class="fontsize10" id="y63992ab6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63992ab7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p><p class="leftAlign firstIndent0 fontsize8" id="x63992ab8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x63992ab9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notice.</p><p class="leftAlign firstIndent0 fontsize8" id="x63992aba-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><content>Not later than the date that is one year after the date of enactment of the FDA Reauthorization Act of 2017 and at least once every 5 years thereafter, and as the Secretary otherwise determines appropriate, pursuant to this paragraph, the Secretary shall publish in the Federal Register a notice proposing a list of such accessories that the Secretary determines may be suitable for a distinct classification in class I and the proposed regulations for such classifications.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63992abb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63992abc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote> In developing such list, the Secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such list.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63992abd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notices.</p><p class="leftAlign firstIndent0 fontsize8" id="x63992abe-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63992abf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote> The notices shall provide for a period of not less than 60 calendar days for public comment. Within 180 days after the end of the comment period, the Secretary shall publish in the Federal Register a final action classifying such suitable accessories into class I.</content></clause>
<clause class="fontsize10" id="y639951d0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>A manufacturer or importer of an accessory that has been granted such marketing authorization may submit to the Secretary a written request for the appropriate classification of the accessory based on the risks and appropriate level of regulatory controls as described in subparagraph (A), and shall, if the request is requesting classification of the accessory in class II, include in the submission an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B).<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639951d1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Evaluation.</p></sidenote> Such request shall include such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a). The Secretary shall provide an opportunity for a manufacturer or importer to meet with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory prior to submitting a written request under this clause for classification of the accessory.</content></clause>
<clause class="fontsize10" id="y639951d2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639951d3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><content>The Secretary shall respond to a request made under clause (ii) not later than 85 calendar days after receiving such request by issuing a written order classifying the accessory or denying the request.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639951d4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote> If the Secretary does not agree with the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed description and justification for such determination.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639951d5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Federal Register, publication.</p><p class="leftAlign firstIndent0 fontsize8" id="x639951d6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notice.</p></sidenote> Within 30 calendar days after granting such a request, the Secretary shall publish a notice in the Federal Register announcing such response.</content></clause>
</subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y639951d7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><content>Nothing in this paragraph may be construed as precluding a manufacturer of an accessory of a new type from using the classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and requirements set forth in that subsection.”</content></subparagraph>
</paragraph>
</quotedContent>.<page identifier="/us/stat/131/1062">131 STAT. 1062</page></content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639951d8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s707/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Conforming Change</inline>.—</heading><content>Section 513(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360c/b">21 U.S.C. 360c(b)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> paragraph (9) (relating to classification of an accessory).</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639951d9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s707/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639951da-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360c">21 USC 360c note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Effective Date</inline>.—</heading><content>The amendments made by subsections (a) and (b) shall take effect on the date that is 60 days after the date of enactment of this Act.</content></subsection>
</section>
<section id="d132600e10032" identifier="/us/pl/115/52/tVII/s708" style="-uslm-lc:I658143"><num class="fontsize12" value="708">SEC. 708. </num><heading>DEVICE PILOT PROJECTS.</heading><subsection class="firstIndent0 fontsize10" id="y6399ee1b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s708/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Postmarket Pilot</inline>.—</heading><content>Section 519 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360i">21 U.S.C. 360i</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y639ad87c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">Postmarket Pilot</inline>.—</heading><paragraph class="fontsize10" id="y639ad87d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639ad87e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>In order to provide timely and reliable information on the safety and effectiveness of devices approved under section 515, cleared under section 510(k), or classified under section 513(f)(2), including responses to adverse events and malfunctions, and to advance the objectives of <ref href="/us/cfr/t21/pt803">part 803 of title 21, Code of Federal Regulations</ref> (or successor regulations), and advance the objectives of, and evaluate innovative new methods of compliance with, this section and section 522, the Secretary shall, within one year of the date of enactment of the FDA Reauthorization Act of 2017, initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of a device or device type, or continue existing projects, in accordance with paragraph (3), that—</chapeau><subparagraph class="fontsize10" id="y639aff8f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>are designed to efficiently generate reliable and timely safety and active surveillance data for use by the Secretary or manufacturers of the devices that are involved in the pilot project;</content></subparagraph>
<subparagraph class="fontsize10" id="y639aff90-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>inform the development of methods, systems, data criteria, and programs that could be used to support safety and active surveillance activities for devices included or not included in such project;</content></subparagraph>
<subparagraph class="fontsize10" id="y639aff91-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>may be designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders, including patient groups and device manufacturers;</content></subparagraph>
<subparagraph class="fontsize10" id="y639aff92-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>use electronic health data including claims data, patient survey data, or any other data, as the Secretary determines appropriate; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639aff93-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><chapeau>prioritize devices and device types that meet one or more of the following criteria:</chapeau><clause class="fontsize10" id="y639aff94-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>Devices and device types for which the collection and analysis of real world evidence regarding a device’s safety and effectiveness is likely to advance public health.</content></clause>
<clause class="fontsize10" id="y639aff95-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>Devices and device types that are widely used.</content></clause>
<clause class="fontsize10" id="y639aff96-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>Devices and device types, the failure of which has significant health consequences.</content></clause>
<clause class="fontsize10" id="y639aff97-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><chapeau>Devices and device types for which the Secretary—</chapeau><subclause class="fontsize10" id="y639aff98-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>has received public recommendations in accordance with paragraph (2)(B); and</content></subclause>
<subclause class="fontsize10" id="y639aff99-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>has determined to meet one or more of the criteria under clause (i), (ii), or (iii) and is appropriate for such a pilot project.<page identifier="/us/stat/131/1063">131 STAT. 1063</page></content></subclause>
</clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639aff9a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Participation</inline>.—</heading><chapeau>The Secretary shall establish the conditions and processes—</chapeau><subparagraph class="fontsize10" id="y639aff9b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph (1); and</content></subparagraph>
<subparagraph class="fontsize10" id="y639aff9c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>for facilitating public recommendations for devices to be prioritized under such a pilot project, including requirements for the data necessary to support such a recommendation.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639aff9d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Continuation of ongoing projects</inline>.—</heading><chapeau>The Secretary may continue or expand projects, with respect to providing timely and reliable information on the safety and effectiveness of devices approved under section 515, cleared under section 510(k), or classified under section 513(f)(2), that are being carried out as of the date of the enactment of the FDA Reauthorization Act of 2017.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639aff9e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote> The Secretary shall, beginning on such date of enactment, take such steps as may be necessary—</chapeau><subparagraph class="fontsize10" id="y639aff9f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and</content></subparagraph>
<subparagraph class="fontsize10" id="y639affa0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>to increase the voluntary participation in such projects of manufacturers of devices and facilitate public recommendations for any devices prioritized under such a project.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639affa1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Implementation</inline>.—</heading><subparagraph class="fontsize10" id="y639affa2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">Contracting authority</inline>.—</heading><chapeau>The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:</chapeau><clause class="fontsize10" id="y639affa3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.</content></clause>
<clause class="fontsize10" id="y639affa4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><chapeau>In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:</chapeau><subclause class="fontsize10" id="y639affa5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.</content></subclause>
<subclause class="fontsize10" id="y639affa6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.<page identifier="/us/stat/131/1064">131 STAT. 1064</page></content></subclause>
</clause>
<clause class="fontsize10" id="y639affa7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><chapeau>The entity or entities shall have one or more qualifications with respect to—</chapeau><subclause class="fontsize10" id="y639affa8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;</content></subclause>
<subclause class="fontsize10" id="y639affa9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;</content></subclause>
<subclause class="fontsize10" id="y639affaa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or</content></subclause>
<subclause class="fontsize10" id="y639affab-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="IV">“(IV) </num><content>such other expertise which the Secretary determines necessary to carry out such a project.</content></subclause>
</clause>
</subparagraph>
<subparagraph class="fontsize10" id="y639affac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Review of contract in the event of a merger or acquisition</inline>.—</heading><content>The Secretary shall review any contract, cooperative agreement, grant, or other appropriate agreement entered into under this paragraph with an entity meeting the conditions specified in subparagraph (A) in the event of a merger or acquisition of the entity in order to ensure that the requirements specified in this subsection will continue to be met.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639affad-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><heading class="fontsize10"><inline class="smallCaps">Compliance with requirements for records or reports on devices</inline>.—</heading><chapeau>The participation of a manufacturer in pilot projects under this subsection or a project continued or expanded under paragraph (3) shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under this section 519 or section 522.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639affae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote> The Secretary may determine that, for a specified time period to be determined by the Secretary, a manufacturer’s participation in a pilot project under this subsection or a project continued or expanded under paragraph (3) may meet the applicable requirements of this section or section 522, if—</chapeau><subparagraph class="fontsize10" id="y639affaf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the project has demonstrated success in capturing relevant adverse event information; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639affb0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the Secretary has established procedures for making adverse event and safety information collected from such project public, to the extent possible.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639affb1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">“(6) </num><heading class="fontsize10"><inline class="smallCaps">Privacy requirements</inline>.—</heading><chapeau>With respect to the disclosure of any health information collected through a project conducted under this subsection—</chapeau><subparagraph class="fontsize10" id="y639affb2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>individually identifiable health information so collected shall not be disclosed when presenting any information from such project; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639affb3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>any such disclosure shall be made in compliance with regulations issued pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (<ref href="/us/usc/t42/s1320d–2">42 U.S.C. 1320d–2 note</ref>) and sections 552 and 552a of <ref href="/us/usc/t5">title 5, United States Code</ref>.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639affb4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="7">“(7) </num><heading class="fontsize10"><inline class="smallCaps">Limitations</inline>.—</heading><content>No pilot project under this subsection, or in coordination with the comprehensive system described in paragraph (1)(C), may allow for an entity participating in <page identifier="/us/stat/131/1065">131 STAT. 1065</page>
such project, other than the Secretary, to make determinations of safety or effectiveness, or substantial equivalence, for purposes of this Act.</content></paragraph>
<paragraph class="fontsize10" id="y639affb5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="8">“(8) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639affb6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Other projects required to comply</inline>.—</heading><content>Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with respect to any pilot project undertaken in coordination with the comprehensive system described in paragraph (1)(C) that relates to the use of real world evidence for devices in the same manner and to the same extent as such paragraphs apply with respect to pilot projects conducted under this subsection.</content></paragraph>
<paragraph class="fontsize10" id="y639affb7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="9">“(9) </num><heading class="fontsize10"><inline class="smallCaps">Report to congress</inline>.—</heading><chapeau>Not later than 18 months after the date of enactment of this Act, and annually thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report containing a description of the pilot projects being conducted under this subsection and projects continued or expanded pursuant to paragraph (3), including for each such project—</chapeau><subparagraph class="fontsize10" id="y639affb8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>how the project is being implemented in accordance with paragraph (4), including how such project is being implemented through a contract, cooperative agreement, grant, or other appropriate agreement, if applicable;</content></subparagraph>
<subparagraph class="fontsize10" id="y639affb9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the number of manufacturers that have agreed to participate in such project;</content></subparagraph>
<subparagraph class="fontsize10" id="y639affba-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>the data sources used to conduct such project;</content></subparagraph>
<subparagraph class="fontsize10" id="y639affbb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>the devices or device categories involved in such project;</content></subparagraph>
<subparagraph class="fontsize10" id="y639affbc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">“(E) </num><content>the number of patients involved in such project; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639affbd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">“(F) </num><content>the findings of the project in relation to device safety, including adverse events, malfunctions, and other safety information.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639affbe-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="10">“(10) </num><heading class="fontsize10"><inline class="smallCaps">Sunset</inline>.—</heading><content>The Secretary may not carry out a pilot project initiated by the Secretary under this subsection after October 1, 2022.”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639affbf-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s708/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639affc0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p><p class="leftAlign firstIndent0 fontsize8" id="x639affc1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><content>Not later than January 31, 2021, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall conduct a review through an independent third party to evaluate the strengths, limitations, and appropriate use of evidence collected pursuant to real world evidence pilot projects described in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and subsection (i) of section 519 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360i">21 U.S.C. 360i</ref>), as amended by subsection (a), for informing premarket and postmarket decisionmaking for multiple device types, and to determine whether the methods, systems, and programs in such pilot projects efficiently generate reliable and timely evidence about the effectiveness or safety surveillance of devices.</content></subsection>
</section>
<section id="d132600e10401" identifier="/us/pl/115/52/tVII/s709" style="-uslm-lc:I658143"><num class="fontsize12" value="709">SEC. 709. </num><heading>REGULATION OF OVER-THE-COUNTER HEARING AIDS.</heading><subsection class="firstIndent0 fontsize10" id="y639bea22-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Section 520 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360j">21 U.S.C. 360j</ref>), as amended by section 708, is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="firstIndent0 fontsize10" id="y639c3843-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="q">“(q) </num><heading class="fontsize10"><inline class="smallCaps">Regulation of Over-the-Counter Hearing Aids</inline>.—</heading><paragraph class="fontsize10" id="y639c3844-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Definition</inline>.—</heading><page identifier="/us/stat/131/1066">131 STAT. 1066</page>
<subparagraph class="fontsize10" id="y639c3845-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><chapeau>In this subsection, the term ‘<term>over-the-counter hearing aid</term>’ means a device that—</chapeau><clause class="fontsize10" id="y639c3846-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>uses the same fundamental scientific technology as air conduction hearing aids (as defined in <ref href="/us/cfr/t21/s874.3300">section 874.3300 of title 21, Code of Federal Regulations</ref>) (or any successor regulation) or wireless air conduction hearing aids (as defined in <ref href="/us/cfr/t21/s874.3305">section 874.3305 of title 21, Code of Federal Regulations</ref>) (or any successor regulation);</content></clause>
<clause class="fontsize10" id="y639c3847-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment;</content></clause>
<clause class="fontsize10" id="y639c3848-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs;</content></clause>
<clause class="fontsize10" id="y639c3849-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><chapeau>may—</chapeau><subclause class="fontsize10" id="y639c384a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>use wireless technology; or</content></subclause>
<subclause class="fontsize10" id="y639c384b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>include tests for self-assessment of hearing loss; and</content></subclause>
</clause>
<clause class="fontsize10" id="y639c384c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">“(v) </num><content>is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y639c384d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Exception</inline>.—</heading><content>Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639c384e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Regulation</inline>.—</heading><content>An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 709(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of <ref href="/us/cfr/t21">title 21, Code of Federal Regulations</ref> (or any successor regulations).”</content></paragraph>
</subsection>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639c384f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639c3850-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360j">21 USC 360j note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Regulations To Establish Category</inline>.—</heading><paragraph class="fontsize10" id="y639c3851-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639c3852-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The Secretary of Health and Human Services (referred to in this section as the “Secretary”), not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360j">21 U.S.C. 360j</ref>) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.</content></paragraph>
<paragraph class="fontsize10" id="y639c3853-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Requirements</inline>.—</heading><chapeau>In promulgating the regulations under paragraph (1), the Secretary shall—</chapeau><subparagraph class="fontsize10" id="y639c3854-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids;</content></subparagraph>
<subparagraph class="fontsize10" id="y639c3855-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;</content></subparagraph>
<subparagraph class="fontsize10" id="y639c3856-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>include requirements for appropriate labeling of over-the-counter hearing aids, including requirements that such labeling include a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements <page identifier="/us/stat/131/1067">131 STAT. 1067</page>
to consult promptly with a licensed health care practitioner; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639c3857-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639c3858-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639c3859-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Premarket notification</inline>.—</heading><content>The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360/m">21 U.S.C. 360(m)</ref>) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360j">21 U.S.C. 360j</ref>), as amended by subsection (a)) require a report under section 510(k) to provide reasonable assurance of safety and effectiveness.</content></paragraph>
<paragraph class="fontsize10" id="y639c385a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><heading class="fontsize10"><inline class="smallCaps">Effect on state law</inline>.—</heading><content>No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360j">21 U.S.C. 360j</ref>), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.</content></paragraph>
<paragraph class="fontsize10" id="y639c385b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/b/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><heading class="fontsize10"><inline class="smallCaps">No effect on private remedies</inline>.—</heading><content>Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y639c385c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639c385d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x639c385e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Update.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">New Guidance Issued</inline>.—</heading><content>Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”, issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s321">21 U.S.C. 321</ref>) and which products meet the definition of a personal sound amplification product, as set forth in such guidance.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639c385f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s709/d" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><content>Not later than 2 years after the date on which the final regulations described in subsection (b)(1) are issued, the Secretary of Health and Human Services shall submit to Congress a report analyzing any adverse events relating to over-the-counter hearing aids (as defined in subsection (q)(1) of section 520 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360j">21 U.S.C. 360j</ref>)).</content></subsection>
</section>
<section id="d132600e10652" identifier="/us/pl/115/52/tVII/s710" style="-uslm-lc:I658143"><num class="fontsize12" value="710">SEC. 710. </num><heading>REPORT ON SERVICING OF DEVICES.</heading><subsection class="firstIndent0 fontsize10" id="y639cd4a0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall post <page identifier="/us/stat/131/1068">131 STAT. 1068</page>
on the internet website of the Food and Drug Administration a report on the continued quality, safety, and effectiveness of devices (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s321/h">21 U.S.C. 321(h)</ref>)) with respect to servicing (as defined in subsection (c)).</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639cd4a1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Contents</inline>.—</heading><chapeau>The report submitted under subsection (a) shall contain—</chapeau><paragraph class="fontsize10" id="y639cd4a2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>the status of, and findings to date, with respect to, the proposed rule entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” published in the Federal Register by the Food and Drug Administration on March 4, 2016 (<ref href="/us/fr/81/11477">81 Fed. Reg. 11477</ref>);</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>information presented during the October 2016 public workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers”;</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>a description of the statutory and regulatory authority of the Food and Drug Administration with respect to the servicing of devices conducted by any entity, including original equipment manufacturers and third party entities;</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>details regarding how the Food and Drug Administration currently regulates devices with respect to servicing to ensure safety and effectiveness, how the agency could improve such regulation using the authority described in paragraph (3), and whether additional authority is recommended;</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>information on actions the Food and Drug Administration could take under the authority described in paragraphs (3) and (4) to assess the servicing of devices, including the size, scope, location, and composition of third party entities;</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a7-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/6" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">(6) </num><content>information on actions the Food and Drug Administration could take to track adverse events caused by servicing errors performed by any entity, including original equipment manufacturers and third party entities;</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/7" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="7">(7) </num><content>information regarding the regulation by States, the Joint Commission, or other regulatory bodies of device servicing performed by any entity, including original equipment manufacturers and third party entities; and</content></paragraph>
<paragraph class="fontsize10" id="y639cd4a9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/b/8" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="8">(8) </num><content>any additional information determined by the Secretary (acting through the Commissioner) to be relevant to ensuring the quality, safety, and effectiveness of devices with respect to servicing.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y639cd4aa-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVII/s710/c" role="definitions" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Servicing Defined</inline>.—</heading><content>In this section, the term “<term>servicing</term>” includes, with respect to a device, refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.</content></subsection>
</section>
<num value="VIII">TITLE VIII—</num><heading>IMPROVING GENERIC DRUG ACCESS</heading>
<section id="d132600e10743" identifier="/us/pl/115/52/tVIII/s801" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="801">SEC. 801. </num><heading>PRIORITY REVIEW OF GENERIC DRUGS.</heading><content class="firstIndent0 fontsize10" id="x639cfbbb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<page identifier="/us/stat/131/1069">131 STAT. 1069</page><quotedContent><paragraph class="indentUp0 firstIndent0 fontsize10" id="y639d22cc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="11">“(11)</num><subparagraph class="inline" id="y639d22cd-e82d-11f0-a1e4-69761a48a15a"><num value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639d22ce-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p></sidenote><chapeau>Subject to subparagraph (B), the Secretary shall prioritize the review of, and act within 8 months of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection that is for a drug—</chapeau><clause class="fontsize10" id="y639d49df-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>for which there are not more than 3 approved drug products listed under paragraph (7) and for which there are no blocking patents and exclusivities; or</content></clause>
<clause class="fontsize10" id="y639d49e0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>that has been included on the list under section 506E.</content></clause>
</subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y639d49e1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639d49e2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an application described in subparagraph (A) or that the Secretary may prioritize pursuant to subparagraph (D), the applicant shall provide complete, accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies used to support the application, to enable the Secretary to make a determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined by the Secretary) sections of such application, which shall be unchanged relative to the date of the submission of such application, except to the extent that a change is made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production. Information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection.</content></subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y639d49e3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>The Secretary may expedite an inspection or reinspection under section 704 of an establishment that proposes to manufacture a drug described in subparagraph (A).</content></subparagraph>
<subparagraph class="indentUp0 firstIndent0 fontsize10" id="y639d49e4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">“(D) </num><content>Nothing in this paragraph shall prevent the Secretary from prioritizing the review of other applications as the Secretary determines appropriate.</content></subparagraph>
</paragraph>
<paragraph class="indentUp0 firstIndent0 fontsize10" id="y639d49e5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="12">“(12) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639d49e6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p><p class="leftAlign firstIndent0 fontsize8" id="x639d49e7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Update.</p><p class="leftAlign firstIndent0 fontsize8" id="x639d49e8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x639d49e9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><content>The Secretary shall publish on the internet website of the Food and Drug Administration, and update at least once every 6 months, a list of all drugs approved under subsection (c) for which all patents and periods of exclusivity under this Act have expired and for which no application has been approved under this subsection.”</content></paragraph>
</quotedContent>.</content></section>
<section id="d132600e10818" identifier="/us/pl/115/52/tVIII/s802" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="802">SEC. 802. </num><heading>ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION.</heading><content class="firstIndent0 fontsize10" id="x639d49ea-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355">21 U.S.C. 355</ref>), as amended by section 801, is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 firstIndent0 fontsize10" id="y639d49eb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="13">“(13) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639d49ec-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p><p class="leftAlign firstIndent0 fontsize8" id="x639d49ed-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Updates.</p></sidenote><content>Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall, as appropriate, provide review status updates indicating the categorical status of the applications by each relevant review discipline.”</content></paragraph>
</quotedContent>.</content></section>
<section id="d132600e10844" identifier="/us/pl/115/52/tVIII/s803" style="-uslm-lc:I658143"><num class="fontsize12" value="803">SEC. 803. </num><heading>COMPETITIVE GENERIC THERAPIES.</heading><subsection class="firstIndent0 fontsize10" id="y639de62e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>Chapter V of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s351/etseq">21 U.S.C. 351 et seq.</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="insert">inserting</amendingAction> after section 506G the following:<page identifier="/us/stat/131/1070">131 STAT. 1070</page>
<quotedContent><section class="indentUp2 firstIndent-2" id="y639e5b5f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658144"><num class="bold" value="506H">“SEC. 506H. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639e5b60-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s356h">21 USC 356h</ref>.</p></sidenote><heading class="bold">COMPETITIVE GENERIC THERAPIES.</heading><subsection class="indentDown2 firstIndent0 fontsize10" id="y639e5b61-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">“(a) </num><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 505(j) for such drug.</content></subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639e5b62-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">“(b) </num><heading class="fontsize10"><inline class="smallCaps">Designation Process</inline>.—</heading><paragraph class="fontsize10" id="y639e5b63-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Request</inline>.—</heading><content>The applicant may request the Secretary to designate the drug as a competitive generic therapy.</content></paragraph>
<paragraph class="fontsize10" id="y639e5b64-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Timing</inline>.—</heading><content>A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 505(j).</content></paragraph>
<paragraph class="fontsize10" id="y639e5b65-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Criteria</inline>.—</heading><content>A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.</content></paragraph>
<paragraph class="fontsize10" id="y639e5b66-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639e5b67-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Designation</inline>.—</heading><chapeau>Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—</chapeau><subparagraph class="fontsize10" id="y639e5b68-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and</content></subparagraph>
<subparagraph class="fontsize10" id="y639e5b69-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639e5b6a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><heading class="fontsize10"><inline class="smallCaps">Actions</inline>.—</heading><chapeau>In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:</chapeau><paragraph class="fontsize10" id="y639e5b6b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><content>Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under section 505(j).</content></paragraph>
<paragraph class="fontsize10" id="y639e5b6c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><content>Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.</content></paragraph>
<paragraph class="fontsize10" id="y639e827d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><content>Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.</content></paragraph>
<paragraph class="fontsize10" id="y639e827e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><chapeau>Assign a cross-disciplinary project lead—</chapeau><subparagraph class="fontsize10" id="y639e827f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>to facilitate an efficient review of the development program and application, including manufacturing inspections; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639e8280-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>to serve as a scientific liaison between the review team and the applicant.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639e8281-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><heading class="fontsize10"><inline class="smallCaps">Reporting Requirement</inline>.—</heading><content>Not later than one year after the date of the approval of an application under section 505(j) with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.</content></subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639e8282-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">“(e) </num><heading class="fontsize10"><inline class="smallCaps">Definitions</inline>.—</heading><chapeau>In this section:</chapeau><paragraph class="fontsize10" id="y639e8283-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><content>The term ‘<term>generic drug</term>’ means a drug that is approved pursuant to section 505(j).</content></paragraph>
<paragraph class="fontsize10" id="y639e8284-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><chapeau>The term ‘<term>inadequate generic competition</term>’ means, with respect to a drug, there is not more than one approved drugs on the list of drugs described in section 505(j)(7)(A) (not <page identifier="/us/stat/131/1071">131 STAT. 1071</page>
including drugs on the discontinued section of such list) that is—</chapeau><subparagraph class="fontsize10" id="y639e8285-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>the reference listed drug; or</content></subparagraph>
<subparagraph class="fontsize10" id="y639e8286-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639e8287-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><content>The term ‘<term>reference listed drug</term>’ means the listed drug (as such term is used in section 505(j)) for the drug involved.”</content></paragraph>
</subsection>
</section>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639e8288-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639e8289-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadlines.</p><p class="leftAlign firstIndent0 fontsize8" id="x639e828a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s356h">21 USC 356h note</ref>.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Guidance; Amended Regulations</inline>.—</heading><paragraph class="fontsize10" id="y639e828b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><subparagraph class="fontsize10" id="y639e828c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><heading class="fontsize10"><inline class="smallCaps">Issuance</inline>.—</heading><chapeau>The Secretary of Health and Human Services shall—</chapeau><clause class="fontsize10" id="y639e828d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>not later than 18 months after the date of enactment of this Act, issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and</content></clause>
<clause class="fontsize10" id="y639e828e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y639e828f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><heading class="fontsize10"><inline class="smallCaps">Contents</inline>.—</heading><chapeau>The guidance issued under this paragraph shall—</chapeau><clause class="fontsize10" id="y639e8290-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);</content></clause>
<clause class="fontsize10" id="y639e8291-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and</content></clause>
<clause class="fontsize10" id="y639e8292-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/1/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>include good review management practices for competitive generic therapies.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639e8293-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s803/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Amended regulations</inline>.—</heading><content>The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act.</content></paragraph>
</subsection>
</section>
<section id="d132600e11112" identifier="/us/pl/115/52/tVIII/s804" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="804">SEC. 804. </num><heading>ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED COMPETITION.</heading><content class="firstIndent0 fontsize10" id="x639ea9a4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Chapter V of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s351/etseq">21 U.S.C. 351 et seq.</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="insert">inserting</amendingAction> after section 506H, as added by section 803, the following:<quotedContent><section class="indentUp2 firstIndent-2" id="y639f1ed5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658144"><num class="bold" value="506I">“SEC. 506I. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639f1ed6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s356i">21 USC 356i</ref>.</p></sidenote><heading class="bold">PROMPT REPORTS OF MARKETING STATUS.</heading><subsection class="indentDown2 firstIndent0 fontsize10" id="y639f1ed7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">“(a) </num><heading class="fontsize10"><inline class="smallCaps">Notification of Withdrawal</inline>.—</heading><chapeau>The holder of an application approved under subsection (c) or (j) of section 505 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the—</chapeau><paragraph class="fontsize10" id="y639f1ed8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><content>National Drug Code;</content></paragraph>
<paragraph class="fontsize10" id="y639f1ed9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><content>identity of the drug by established name and by proprietary name, if any;</content></paragraph>
<paragraph class="fontsize10" id="y639f1eda-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><content>new drug application number or abbreviated application number;</content></paragraph>
<paragraph class="fontsize10" id="y639f1edb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><content>strength of the drug;</content></paragraph>
<paragraph class="fontsize10" id="y639f1edc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><content>date on which the drug is expected to no longer be available for sale; and</content></paragraph>
<paragraph class="fontsize10" id="y639f1edd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="6">“(6) </num><content>reason for withdrawal of the drug.<page identifier="/us/stat/131/1072">131 STAT. 1072</page></content></paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639f1ede-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">“(b) </num><heading class="fontsize10"><inline class="smallCaps">Notification of Drug Not Available for Sale</inline>.—</heading><chapeau>The holder of an application approved under subsection (c) or (j) shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the—</chapeau><paragraph class="fontsize10" id="y639f1edf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><content>identity of the drug by established name and by proprietary name, if any;</content></paragraph>
<paragraph class="fontsize10" id="y639f1ee0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><content>new drug application number or abbreviated application number;</content></paragraph>
<paragraph class="fontsize10" id="y639f1ee1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><content>strength of the drug;</content></paragraph>
<paragraph class="fontsize10" id="y639f1ee2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><content>date on which the drug will be available for sale, if known; and</content></paragraph>
<paragraph class="fontsize10" id="y639f1ee3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><content>reason for not marketing the drug after approval.</content></paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639f1ee4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639f1ee5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p><p class="leftAlign firstIndent0 fontsize8" id="x639f1ee6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Notification.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Additional One-time Report</inline>.—</heading><chapeau>Within 180 days of the date of enactment of this section, all holders of applications approved under subsection (c) or (j) of section 505 shall review the information in the list published under subsection 505(j)(7)(A) and shall notify the Secretary in writing that—</chapeau><paragraph class="fontsize10" id="y639f1ee7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><content>all of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) are available for sale; or</content></paragraph>
<paragraph class="fontsize10" id="y639f45f8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><content>one or more of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) have been withdrawn from sale or have never been available for sale, and include with such notice the information required pursuant to subsection (a) or (b), as applicable.</content></paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639f45f9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639f45fa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Failure to Meet Requirements</inline>.—</heading><content>If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder’s drugs from the active section of the list published under subsection 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with subsection 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness.</content></subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639f45fb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">“(e) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639f45fc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Lists.</p><p class="leftAlign firstIndent0 fontsize8" id="x639f45fd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Updates</inline>.—</heading><content>The Secretary shall update the list published under subsection 505(j)(7)(A) based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with subsection 505(j)(7)(C). The Secretary shall make monthly updates to the list based on the information provided pursuant to subsections (a) and (b), and shall update the list based on the information provided under subsection (c) as soon as practicable.</content></subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y639f45fe-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">“(f) </num><heading class="fontsize10"><inline class="smallCaps">Limitation on Use of Notices</inline>.—</heading><content>Any notice submitted under this section shall not be made public by the Secretary and shall be used solely for the purpose of the updates described in subsection (e).”</content></subsection>
</section>
</quotedContent>.</content></section>
<section id="d132600e11281" identifier="/us/pl/115/52/tVIII/s805" style="-uslm-lc:I658143"><num class="fontsize12" value="805">SEC. 805. </num><heading>SUITABILITY PETITIONS.</heading><subsection class="firstIndent0 fontsize10" id="y639f6d0f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s805/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639f6d10-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">In General</inline>.—</heading><content>It is the sense of Congress that the Food and Drug Administration shall meet the requirement under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21">21 U.S.C. </ref><page identifier="/us/stat/131/1073">131 STAT. 1073</page>
355(j)(2)(C)) and <ref href="/us/cfr/t21/s314.93/e">section 314.93(e) of title 21, Code of Federal Regulations</ref>, of responding to suitability petitions within 90 days of submission.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y639f6d11-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s805/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><chapeau>The Secretary of Health and Human Services shall include in the annual reports under section 807—</chapeau><paragraph class="fontsize10" id="y639f6d12-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s805/b/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>the number of pending petitions under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j/2/C">21 U.S.C. 355(j)(2)(C)</ref>); and</content></paragraph>
<paragraph class="fontsize10" id="y639f6d13-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s805/b/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>the number of such petitions pending a substantive response for more than 180 days from the date of receipt.</content></paragraph>
</subsection>
</section>
<section id="d132600e11330" identifier="/us/pl/115/52/tVIII/s806" style="-uslm-lc:I658143"><num class="fontsize12" value="806">SEC. 806. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639f6d14-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p><p class="leftAlign firstIndent0 fontsize8" id="x639f6d15-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Protocols.</p><p class="leftAlign firstIndent0 fontsize8" id="x639f6d16-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p><p class="leftAlign firstIndent0 fontsize8" id="x639f6d17-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s374">21 USC 374 note</ref>.</p></sidenote><heading>INSPECTIONS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x639fba38-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Within 6 months of the date of enactment of this Act, the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s374">21 U.S.C. 374</ref>). Such protocol shall—</chapeau><paragraph class="fontsize10" id="y639fba39-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639fba3a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Applicability.</p></sidenote><chapeau>apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355">21 U.S.C. 355</ref>)—</chapeau><subparagraph class="fontsize10" id="y639fba3b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>for which the approval is dependent upon remediation of conditions identified in the report;</content></subparagraph>
<subparagraph class="fontsize10" id="y639fba3c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and</content></subparagraph>
<subparagraph class="fontsize10" id="y639fba3d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><chapeau>where the drug that is the subject of the application is a drug—</chapeau><clause class="fontsize10" id="y639fba3e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/1/C/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or</content></clause>
<clause class="fontsize10" id="y639fba3f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/1/C/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>that is included on the list under section 506E of such Act (<ref href="/us/usc/t21/s356e">21 U.S.C. 356e</ref>);</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y639fba40-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>address expedited re-inspection of facilities, as appropriate; and</content></paragraph>
<paragraph class="fontsize10" id="y639fba41-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s806/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x639fba42-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><content>establish a 6-month timeline for completion of review of such responses to such reports.</content></paragraph>
</section>
<section id="d132600e11409" identifier="/us/pl/115/52/tVIII/s807" style="-uslm-lc:I658143"><num class="fontsize12" value="807">SEC. 807. </num><heading>REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x63a00863-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Not<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a00864-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p></sidenote> later than 180 calendar days after the date of enactment of this Act, and quarterly thereafter until October 1, 2022, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration a report that provides, with respect to the months covered by the report—</chapeau><paragraph class="fontsize10" id="y63a00865-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><chapeau>with respect to applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>) that, during the most recent calendar year, were subject to priority review under paragraph (11) of such section 505(j) (as added by section 801) or expedited development and review under section 506H of the Federal Food, Drug, and Cosmetic Act (as added by section 803), the numbers of such applications (with denotation of such applications that were filed prior to October 1, 2014) that are—</chapeau><subparagraph class="fontsize10" id="y63a00866-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>awaiting action by the applicant;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a00867-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>awaiting action by the Secretary; and<page identifier="/us/stat/131/1074">131 STAT. 1074</page></content></subparagraph>
<subparagraph class="fontsize10" id="y63a00868-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/1/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>approved by the Secretary;</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63a00869-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>the number of applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>) and prior approval supplements withdrawn in each month;</content></paragraph>
<paragraph class="fontsize10" id="y63a0086a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>the mean and median approval and tentative approval times and the number of review cycles for such applications;</content></paragraph>
<paragraph class="fontsize10" id="y63a0086b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>the number and type of meetings requested and held under such section 506H (as added by section 803); and</content></paragraph>
<paragraph class="fontsize10" id="y63a0086c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s807/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5) </num><content>the number of such applications on which the Secretary has taken action pursuant to subsection (c) of such section 506H (as added by section 803) and any effect such section 506H may have on the length of time for approval of applications under such section 505(j) and the number of review cycles for such approvals.</content></paragraph>
</section>
<section id="d132600e11472" identifier="/us/pl/115/52/tVIII/s808" role="instruction" style="-uslm-lc:I658143"><num class="fontsize12" value="808">SEC. 808. </num><heading>INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x63a0568d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j/5">21 U.S.C. 355(j)(5)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63a0568e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s808/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in subparagraph (B), by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><clause class="indentUp0 fontsize10" id="y63a07d9f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">“(v) </num><heading class="fontsize10 smallCaps">180-day exclusivity period for competitive generic therapies<inline class="noSmallCaps">.—</inline></heading><subclause class="fontsize10" id="y63a07da0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><heading class="fontsize10"><inline class="smallCaps">Effectiveness of application</inline>.—</heading><content>Subject to subparagraph (D)(iv), if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.</content></subclause>
<subclause class="fontsize10" id="y63a0a4b1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>The exclusivity period under subclause (I) shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I).</content></subclause>
<subclause class="fontsize10" id="y63a0a4b2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><heading class="fontsize10"><inline class="smallCaps">Definitions</inline>.—</heading><chapeau>In this clause and subparagraph (D)(iv):</chapeau><item class="fontsize10" id="y63a0a4b3-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><chapeau>The term ‘<term>competitive generic therapy</term>’ means a drug—</chapeau><subitem class="fontsize10" id="y63a0a4b4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="AA">“(AA) </num><content>that is designated as a competitive generic therapy under section 506H; and</content></subitem>
<subitem class="fontsize10" id="y63a0a4b5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="BB">“(BB) </num><content>for which there are no unexpired patents or exclusivities on the list of products described in section 505(j)(7)(A) at the time of submission.</content></subitem>
</item>
<item class="fontsize10" id="y63a0a4b6-e82d-11f0-a1e4-69761a48a15a" role="definitions" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><chapeau>The term ‘<term>first approved applicant</term>’ means any applicant that has submitted an application that—</chapeau><subitem class="fontsize10" id="y63a0a4b7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="AA">“(AA) </num><content>is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved;</content></subitem>
<subitem class="fontsize10" id="y63a0a4b8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="BB">“(BB) </num><content>is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic therapy; and</content></subitem>
<subitem class="fontsize10" id="y63a0a4b9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="CC">“(CC) </num><content>is not for a drug for which all drug versions have forfeited eligibility for a 180-day <page identifier="/us/stat/131/1075">131 STAT. 1075</page>
exclusivity period under clause (iv) pursuant to subparagraph (D).”</content></subitem>
</item>
</subclause>
</clause>
</quotedContent>; and</content></paragraph>
<paragraph class="fontsize10" id="y63a0a4ba-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s808/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in subparagraph (D), by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><clause class="indentUp2 fontsize10" id="y63a0a4bb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><heading class="fontsize10"><inline class="smallCaps">Special forfeiture rule for competitive generic therapy</inline>.—</heading><content>The 180-day<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a0a4bc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant’s application for the competitive generic therapy is made effective.”</content></clause>
</quotedContent>.</content></paragraph>
</section>
<section id="d132600e11595" identifier="/us/pl/115/52/tVIII/s809" style="-uslm-lc:I658143"><num class="fontsize12" value="809">SEC. 809. </num><heading>GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES.</heading><subsection class="firstIndent0 fontsize10" id="y63a1680d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a1680e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Study by GAO</inline>.—</heading><chapeau>The Comptroller General of the United States shall conduct a study to determine the following:</chapeau><paragraph class="fontsize10" id="y63a1680f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a16810-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><content>The rate of first cycle approvals and tentative approvals for applications submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>) during the period beginning on October 1, 2012, and ending on September 30, 2017. The rate of first cycle approvals and tentative approvals shall be determined and reported per each GDUFA cohort year during this period.</content></paragraph>
<paragraph class="fontsize10" id="y63a16811-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a16812-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Assessment.</p></sidenote><chapeau>If the rate determined pursuant to paragraph (1) for any GDUFA cohort year is lower than 20 percent, the reasons contributing to the relatively low rate of first cycle approvals and tentative approvals for generic drug applications shall be itemized, assessed, and reported. In making the assessment required by this paragraph, the Comptroller General shall consider, among other things, the role played by—</chapeau><subparagraph class="fontsize10" id="y63a16813-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>the Food and Drug Administration’s implementation of approval standards for generic drug applications;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a16814-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>the extent to which those approval standards are communicated clearly to industry and applied consistently during the review process;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a16815-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>the procedures for reviewing generic drug applications, including timelines for review activities by the Food and Drug Administration;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a16816-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2/D" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="D">(D) </num><content>the extent to which those procedures are followed consistently (and those timelines are met) by the Food and Drug Administration;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a16817-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2/E" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="E">(E) </num><content>the processes and practices for communication between the Food and Drug Administration and sponsors of generic drug applications; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a16818-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/2/F" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="F">(F) </num><content>the completeness and quality of original generic drug applications submitted to the Food and Drug Administration.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63a16819-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/a/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>Taking into account the determinations made pursuant to paragraphs (1) and (2) and any review process improvements implemented pursuant to this Act, whether there are ways the review process for generic drugs could be improved to increase the rate of first cycle approvals and tentative approvals for generic drug applications. In making this determination, the Comptroller General shall consider, among other things, options for increasing review efficiency and communication effectiveness.<page identifier="/us/stat/131/1076">131 STAT. 1076</page></content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1681a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a1681b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a1681c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Reports.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Completion Date</inline>.—</heading><content>Not later than the expiration of the 2-year period beginning on the date of enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit a report describing the findings and conclusions of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1681d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">Definitions</inline>.—</heading><chapeau>For purposes of this section:</chapeau><paragraph class="fontsize10" id="y63a1681e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/1" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>The term “<term>GDUFA cohort year</term>” means a fiscal year.</content></paragraph>
<paragraph class="fontsize10" id="y63a1681f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/2" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>The term “<term>generic drug</term>” means a drug that is approved or is seeking approval under section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>).</content></paragraph>
<paragraph class="fontsize10" id="y63a16820-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/3" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>The term “<term>generic drug application</term>” means an abbreviated new drug application for the approval of a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355/j">21 U.S.C. 355(j)</ref>).</content></paragraph>
<paragraph class="fontsize10" id="y63a16821-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/4" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>The term “<term>Secretary</term>” means the Secretary of Health and Human Services.</content></paragraph>
<paragraph class="fontsize10" id="y63a16822-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/5" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">(5)</num><subparagraph class="inline" id="y63a16823-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/5/A" role="definitions"><num value="A">(A) </num><content>The term “<term>first cycle approvals and tentative approvals</term>” means the approval or tentative approval of a generic drug application after the Food and Drug Administration’s complete review of the application and without issuance of one or more complete response letters.</content></subparagraph>
<subparagraph class="indentUp0 fontsize10" id="y63a16824-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tVIII/s809/c/5/B" role="definitions" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>For purposes of this paragraph, the term “<term>complete response letter</term>” means a written communication to the sponsor of a generic drug application or holder of a drug master file from the Food and Drug Administration describing all of the deficiencies that the Administration has identified in the generic drug application (including pending amendments) or drug master file that must be satisfactorily addressed before the generic drug application can be approved.</content></subparagraph>
</paragraph>
</subsection>
</section>
<num value="IX">TITLE IX—</num><heading>ADDITIONAL PROVISIONS</heading>
<section id="d132600e11743" identifier="/us/pl/115/52/tIX/s901" style="-uslm-lc:I658143"><num class="fontsize12" value="901">SEC. 901. </num><heading>TECHNICAL CORRECTIONS.</heading><subsection class="firstIndent0 fontsize10" id="y63a1dd55-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><chapeau>Section 3075(a) of the 21st Century Cures Act (<ref href="/us/pl/114/255">Public Law 114–255</ref>)<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a1dd56-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s355">21 USC 355</ref>.</p></sidenote> <amendingAction type="amend">is amended</amendingAction>—</chapeau><paragraph class="fontsize10" id="y63a1dd57-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>in the matter preceding paragraph (1), by <amendingAction type="delete">striking</amendingAction> “<quotedText>as amended by section 2074</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>as amended by section 3102</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y63a1dd58-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>in paragraph (2), by <amendingAction type="delete">striking</amendingAction> “<quotedText>section 2074(1)(C)</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>section 3102(1)(C)</quotedText>”.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd59-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/b" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><content>Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s356g/b/1/A">21 U.S.C. 356g(b)(1)(A)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>identity</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>identify</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd5a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/c" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><content>Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355g/b">21 U.S.C. 355g(b)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>randomized</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>traditional</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd5b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/d" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><content>Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355g/d">21 U.S.C. 355g(d)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>2</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>3</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd5c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/e" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="e">(e) </num><content>Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360/h/6">21 U.S.C. 360(h)(6)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>February 1</quotedText>” and <amendingAction type="substitute">replacing</amendingAction> with “<quotedText>May 1</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd5d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/f" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="f">(f) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a1dd5e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a1dd5f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360e–3">21 USC 360e–3</ref> and note.</p></sidenote><chapeau>Effective as of the enactment of the 21st Century Cures Act (<ref href="/us/pl/114/255">Public Law 114–255</ref>)—</chapeau><page identifier="/us/stat/131/1077">131 STAT. 1077</page>
<paragraph class="fontsize10" id="y63a1dd60-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/f/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a1dd61-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s360e–3">21 USC 360e–3</ref>.</p></sidenote><content>section 3051(a) of such Act <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>by inserting after section 515B</quotedText>” and inserting “<quotedText>by inserting after section 515A</quotedText>”; and</content></paragraph>
<paragraph class="fontsize10" id="y63a1dd62-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/f/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>section 515C of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360e–3">21 U.S.C. 360e–3</ref>), as inserted by such section 3051(a), is redesignated as section 515B.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd63-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/g" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="g">(g) </num><content>Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360e–3/f/2">21 U.S.C. 360e–3(f)(2)</ref>), as redesignated by subsection (e)(2) of this section, <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>a proposed guidance</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>a draft version of that guidance</quotedText>”.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a1dd64-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s901/h" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="h">(h) </num><content>Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s360c/b/5/D">21 U.S.C. 360c(b)(5)(D)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="delete">striking</amendingAction> “<quotedText>medical device submissions</quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText>medical devices that may be specifically the subject of a review by a classification panel</quotedText>”.</content></subsection>
</section>
<section id="d132600e11944" identifier="/us/pl/115/52/tIX/s902" style="-uslm-lc:I658143"><num class="fontsize12" value="902">SEC. 902. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a20475-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web posting.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a20476-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180"><ref href="/us/usc/t21/s355">21 USC 355 note</ref>.</p></sidenote><heading>ANNUAL REPORT ON INSPECTIONS.</heading><chapeau class="indentUp0 firstIndent0 fontsize10" id="x63a22b87-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"> Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s355">21 U.S.C. 355</ref>), approval of a device under section 515 of such Act (<ref href="/us/usc/t21/s360e">21 U.S.C. 360e</ref>), or clearance of a device under section 510(k) of such Act (<ref href="/us/usc/t21/s360/k">21 U.S.C. 360(k)</ref>) that were conducted during the previous calendar year. Such information shall include the following:</chapeau><paragraph class="fontsize10" id="y63a22b88-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s902/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, and the median time from the beginning of an inspection to the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s374/b">21 U.S.C. 374(b)</ref>).</content></paragraph>
<paragraph class="fontsize10" id="y63a22b89-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s902/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>The median time from the issuance of a report pursuant to such section 704(b) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated.</content></paragraph>
<paragraph class="fontsize10" id="y63a22b8a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s902/3" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><content>The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the Secretary concluded that such action was indicated.</content></paragraph>
<paragraph class="fontsize10" id="y63a22b8b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s902/4" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><content>The number of times that a facility was issued a report pursuant to such section 704(b) and approval of an application was delayed due to the issuance of a withhold recommendation.</content></paragraph>
</section>
<section id="d132600e11991" identifier="/us/pl/115/52/tIX/s903" style="-uslm-lc:I658143"><num class="fontsize12" value="903">SEC. 903. </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a22b8c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Web postings.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a22b8d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time periods.</p></sidenote><heading>STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING.</heading><subsection class="firstIndent0 fontsize10" id="y63a315ee-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/a" role="instruction" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">PDUFA</inline>.—</heading><content>Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h–2/a">21 U.S.C. 379h–2(a)</ref>), as amended by section 103, is further amended by <amendingAction type="insert">inserting</amendingAction> after paragraph (2) the following:<quotedContent><paragraph class="fontsize10" id="y63a33cff-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Real time reporting</inline>.—</heading><subparagraph class="fontsize10" id="y63a33d00-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, <page identifier="/us/stat/131/1078">131 STAT. 1078</page>
and may remove duplicative data from the annual performance report under this subsection.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a33d01-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Data</inline>.—</heading><chapeau>The Secretary shall post the following data in accordance with subparagraph (A):</chapeau><clause class="fontsize10" id="y63a33d02-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.</content></clause>
<clause class="fontsize10" id="y63a33d03-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.</content></clause>
<clause class="fontsize10" id="y63a33d04-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><content>The number of new drug applications and biological licensing applications approved.</content></clause>
<clause class="fontsize10" id="y63a33d05-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>The number of new drug applications and biological licensing applications filed.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63a33d06-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a36417-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a36418-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Analysis.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Rationale for pdufa program changes</inline>.—</heading><chapeau>Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y63a36419-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a3641a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs, including identifying drivers of such changes; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a3641b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></subsection>
<subsection class="firstIndent0 fontsize10" id="y63a3641c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">MDUFA</inline>.—</heading><chapeau>Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–1/a/1/A">21 U.S.C. 379j–1(a)(1)(A)</ref>), as amended by section 204, is further amended—</chapeau><paragraph class="fontsize10" id="y63a3641d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/b/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Beginning with</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><clause class="indentUp2 fontsize10" id="y63a3641e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">General requirements</inline>.—</heading><content>Beginning with”</content></clause>
</quotedContent>; and</content></paragraph>
<paragraph class="fontsize10" id="y63a3641f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/b/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="indentUp2 fontsize10" id="y63a3b240-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a3b241-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Additional information</inline>.—</heading><chapeau>Beginning with fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—</chapeau><page identifier="/us/stat/131/1079">131 STAT. 1079</page>
<subclause class="fontsize10" id="y63a3b242-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>the number of premarket applications filed under section 515 per fiscal year for each review division;</content></subclause>
<subclause class="fontsize10" id="y63a3b243-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>the number of reports submitted under section 510(k) per fiscal year for each review division; and</content></subclause>
<subclause class="fontsize10" id="y63a3b244-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>the number of expedited development and priority review designations under section 515C per fiscal year.</content></subclause>
</subsection>
<subsection class="indentUp2 fontsize10" id="y63a3b245-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii)</num><heading class="fontsize10"><inline class="smallCaps">Real time reporting</inline>.—</heading><subclause class="fontsize10" id="y63a3b246-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.</content></subclause>
<subclause class="fontsize10" id="y63a3b247-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><heading class="fontsize10"><inline class="smallCaps">Data</inline>.—</heading><chapeau>The Secretary shall post the following data in accordance with subclause (I):</chapeau><item class="fontsize10" id="y63a3b248-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658130"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017; and</content></item>
<item class="fontsize10" id="y63a3b249-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658130"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.</content></item>
</subclause>
<clause class="indentUp0 fontsize10" id="y63a3b24a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a3b24b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a3b24c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Analysis.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Rationale for mdufa program changes</inline>.—</heading><chapeau>Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—</chapeau><subclause class="fontsize10" id="y63a3b24d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><content>data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;</content></subclause>
<subclause class="fontsize10" id="y63a3b24e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><content>data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and</content></subclause>
<subclause class="fontsize10" id="y63a3b24f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory <page identifier="/us/stat/131/1080">131 STAT. 1080</page>
Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”</content></subclause>
</clause>
</subsection>
</quotedContent>.</content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a3b250-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">GDUFA</inline>.—</heading><chapeau>Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–43/a">21 U.S.C. 379j–43(a)</ref>), as amended by section 304, is further amended—</chapeau><paragraph class="fontsize10" id="y63a3b251-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/c/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Beginning with</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a3b252-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">General requirements</inline>.—</heading><content>Beginning with”</content></paragraph>
</quotedContent>; and</content></paragraph>
<paragraph class="fontsize10" id="y63a3b253-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/c/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a40074-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Real time reporting</inline>.—</heading><subparagraph class="fontsize10" id="y63a40075-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a40076-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Data</inline>.—</heading><chapeau>The Secretary shall post the following data in accordance with subparagraph (A):</chapeau><clause class="fontsize10" id="y63a40077-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.</content></clause>
<clause class="fontsize10" id="y63a40078-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="indentUp0 fontsize10" id="y63a40079-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a4007a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a4007b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Analysis.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Rationale for gdufa program changes</inline>.—</heading><chapeau>Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y63a4007c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a4007d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a4007e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”</content></subparagraph>
</paragraph>
</quotedContent>.<page identifier="/us/stat/131/1081">131 STAT. 1081</page></content></paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a4007f-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/d" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">BsUFA</inline>.—</heading><chapeau>Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–53/a">21 U.S.C. 379j–53(a)</ref>), as amended by section 404, is further amended—</chapeau><paragraph class="fontsize10" id="y63a40080-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/d/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>Beginning with</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a40081-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">General requirements</inline>.—</heading><content>Beginning with”</content></paragraph>
</quotedContent>; and</content></paragraph>
<paragraph class="fontsize10" id="y63a40082-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s903/d/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a44ea3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a44ea4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Additional information</inline>.—</heading><chapeau>Beginning with fiscal year 2018, the report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—</chapeau><subparagraph class="fontsize10" id="y63a44ea5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a44ea6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a44ea7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals letters issued by the agency for such applications.</content></subparagraph>
</paragraph>
<paragraph class="indentUp0 fontsize10" id="y63a44ea8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Real time reporting</inline>.—</heading><subparagraph class="fontsize10" id="y63a44ea9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a44eaa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Data</inline>.—</heading><chapeau>The Secretary shall post the following data in accordance with subparagraph (A):</chapeau><clause class="fontsize10" id="y63a44eab-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.</content></clause>
<clause class="fontsize10" id="y63a44eac-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="indentUp0 fontsize10" id="y63a44ead-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Rationale for bsufa program changes</inline>.—</heading><chapeau>Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—</chapeau><subparagraph class="fontsize10" id="y63a44eae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for <page identifier="/us/stat/131/1082">131 STAT. 1082</page>
Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a44eaf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying drivers of such changes; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a44eb0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
</subsection>
</section>
<section id="d132600e12496" identifier="/us/pl/115/52/tIX/s904" style="-uslm-lc:I658143"><num class="fontsize12" value="904">SEC. 904. </num><heading>ANALYSIS OF USE OF FUNDS.</heading><subsection class="firstIndent0 fontsize10" id="y63a5d551-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">PDUFA Reports</inline>.—</heading><paragraph class="fontsize10" id="y63a5d552-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/a/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">Analysis in pdufa performance reports</inline>.—</heading><content>Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h–2/a">21 U.S.C. 379h–2(a)</ref>), as amended by section 903(a), is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a5fc63-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><heading class="fontsize10"><inline class="smallCaps">Analysis</inline>.—</heading><chapeau>For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:</chapeau><subparagraph class="fontsize10" id="y63a5fc64-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><chapeau>The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—</chapeau><clause class="fontsize10" id="y63a5fc65-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;</content></clause>
<clause class="fontsize10" id="y63a5fc66-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63a5fc67-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a5fc68-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a5fc69-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
<paragraph class="fontsize10" id="y63a5fc6a-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/a/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Issuance of corrective action reports</inline>.—</heading><chapeau>Section 736B of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h–2">21 U.S.C. 379h–2</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y63a5fc6b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsections (c) and (d) as subsections (e) and (f), respectively; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a5fc6c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subsection (b) the following:<quotedContent><subsection class="indentDown2 firstIndent0 fontsize10" id="y63a6237d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6237e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a6237f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determinations.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Corrective Action Report</inline>.—</heading><chapeau>Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action <page identifier="/us/stat/131/1083">131 STAT. 1083</page>
report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:</chapeau><paragraph class="fontsize10" id="y63a62380-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a62381-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63a62382-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Goals met</inline>.—</heading><content>For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.</content></paragraph>
<paragraph class="fontsize10" id="y63a62383-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Goals missed</inline>.—</heading><chapeau>For any of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—</chapeau><subparagraph class="fontsize10" id="y63a64a94-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a64a95-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y63a64a96-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><heading class="fontsize10"><inline class="smallCaps">Enhanced Communication</inline>.—</heading><paragraph class="fontsize10" id="y63a64a97-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Communications with congress</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.</content></paragraph>
<paragraph class="fontsize10" id="y63a64a98-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a64a99-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Participation in congressional hearing</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a64a9a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”</content></paragraph>
</subsection>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a64a9b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">MDUFA Reports</inline>.—</heading><paragraph class="fontsize10" id="y63a64a9c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/b/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">Analysis in mdufa performance reports</inline>.—</heading><content>Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–1/a/1/A">21 U.S.C. 379j–1(a)(1)(A)</ref>), as amended by section 903(b), is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><clause class="indentUp2 fontsize10" id="y63a671ad-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><heading class="fontsize10"><inline class="smallCaps">Analysis</inline>.—</heading><chapeau>For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:<page identifier="/us/stat/131/1084">131 STAT. 1084</page></chapeau><subclause class="fontsize10" id="y63a671ae-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="I">“(I) </num><chapeau>The difference between the aggregate number of premarket applications filed under section 515 and aggregate reports submitted under section 510(k) and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—</chapeau><item class="fontsize10" id="y63a671af-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658130"><num class="fontsize10" style="-uslm-lc:emspace2" value="aa">“(aa) </num><content>the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and</content></item>
<item class="fontsize10" id="y63a671b0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658130"><num class="fontsize10" style="-uslm-lc:emspace2" value="bb">“(bb) </num><content>the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.</content></item>
</subclause>
<subclause class="fontsize10" id="y63a671b1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="II">“(II) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a671b2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.</content></subclause>
<subclause class="fontsize10" id="y63a671b3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658128"><num class="fontsize10" style="-uslm-lc:emspace2" value="III">“(III) </num><content>The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.”</content></subclause>
</clause>
</quotedContent>.</content></paragraph>
<paragraph class="fontsize10" id="y63a671b4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/b/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Issuance of corrective action reports</inline>.—</heading><chapeau>Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–1/a">21 U.S.C. 379j–1(a)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y63a671b5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/b/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a671b6-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/b/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> after paragraph (1) the following:<quotedContent><paragraph class="indentDown1 fontsize10" id="y63a6bfd7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfd8-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfd9-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determinations.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Corrective action report</inline>.—</heading><chapeau>Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:</chapeau><subparagraph class="fontsize10" id="y63a6bfda-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfdb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfdc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Goals met</inline>.—</heading><content>For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a6bfdd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><heading class="fontsize10"><inline class="smallCaps">Goals missed</inline>.—</heading><chapeau>For each of the goals identified by the letters described in section 201(b) of the Medical <page identifier="/us/stat/131/1085">131 STAT. 1085</page>
Device User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—</chapeau><clause class="fontsize10" id="y63a6bfde-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>a justification for such determination;</content></clause>
<clause class="fontsize10" id="y63a6bfdf-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 515 or notifications submitted under section 510(k) missed the review goal times but were approved during the first cycle review, as applicable;</content></clause>
<clause class="fontsize10" id="y63a6bfe0-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">“(iii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfe1-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Summary.</p></sidenote><content>a summary and any trends with regard to the circumstances for which a review goal was missed; and</content></clause>
<clause class="fontsize10" id="y63a6bfe2-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">“(iv) </num><content>the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.</content></clause>
</subparagraph>
</paragraph>
<paragraph class="indentDown1 fontsize10" id="y63a6bfe3-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><heading class="fontsize10"><inline class="smallCaps">Enhanced communication</inline>.—</heading><subparagraph class="fontsize10" id="y63a6bfe4-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><heading class="fontsize10"><inline class="smallCaps">Communications with congress</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a6bfe5-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfe6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Participation in congressional hearing</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6bfe7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a6bfe8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/c" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">(c) </num><heading class="fontsize10"><inline class="smallCaps">GDUFA Reports</inline>.—</heading><paragraph class="fontsize10" id="y63a6bfe9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/c/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">Analysis in gdufa performance reports</inline>.—</heading><content>Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–43/a">21 U.S.C. 379j–43(a)</ref>), as amended by section 903(c) is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a6e6fa-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">“(4) </num><heading class="fontsize10"><inline class="smallCaps">Analysis</inline>.—</heading><chapeau>For each fiscal year, the Secretary shall include in the report an analysis of the following:</chapeau><subparagraph class="fontsize10" id="y63a6e6fb-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><chapeau>The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—</chapeau><clause class="fontsize10" id="y63a6e6fc-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and</content></clause>
<clause class="fontsize10" id="y63a6e6fd-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.<page identifier="/us/stat/131/1086">131 STAT. 1086</page></content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63a6e6fe-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a6e6ff-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a6e700-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
<paragraph class="fontsize10" id="y63a6e701-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/c/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Issuance of corrective action reports</inline>.—</heading><chapeau>Section 744C of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–43">21 U.S.C. 379j–43</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y63a6e702-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/c/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsections (c) and (d) as subsections (e) and (f), respectively; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a6e703-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/c/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subsection (b) the following:<quotedContent><subsection class="indentDown2 firstIndent0 fontsize10" id="y63a73524-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a73525-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a73526-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determinations.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Corrective Action Report</inline>.—</heading><chapeau>Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:</chapeau><paragraph class="fontsize10" id="y63a73527-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a73528-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Recommenda-</p><p class="leftAlign firstIndent0 fontsize8" id="x63a73529-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">tions.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Goals met</inline>.—</heading><content>For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process.</content></paragraph>
<paragraph class="fontsize10" id="y63a7352a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Goals missed</inline>.—</heading><chapeau>For each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—</chapeau><subparagraph class="fontsize10" id="y63a7352b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a7352c-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y63a7352d-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><heading class="fontsize10"><inline class="smallCaps">Enhanced Communication</inline>.—</heading><paragraph class="fontsize10" id="y63a7352e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Communications with congress</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.<page identifier="/us/stat/131/1087">131 STAT. 1087</page></content></paragraph>
<paragraph class="fontsize10" id="y63a7352f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a73530-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Participation in congressional hearing</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a73531-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”</content></paragraph>
</subsection>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a73532-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/d" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">(d) </num><heading class="fontsize10"><inline class="smallCaps">BsUFA Reports</inline>.—</heading><paragraph class="fontsize10" id="y63a73533-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/d/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">Analysis in bsufa performance reports</inline>.—</heading><content>Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–53/a">21 U.S.C. 379j–53(a)</ref>) as amended by section 903(d) is further amended by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a75c44-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="5">“(5) </num><heading class="fontsize10"><inline class="smallCaps">Analysis</inline>.—</heading><chapeau>For each fiscal year, the Secretary shall include in the report an analysis of the following:</chapeau><subparagraph class="fontsize10" id="y63a75c45-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><chapeau>The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—</chapeau><clause class="fontsize10" id="y63a75c46-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><content>such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and</content></clause>
<clause class="fontsize10" id="y63a75c47-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><content>the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63a75c48-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a75c49-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determination.</p></sidenote><content>Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.</content></subparagraph>
<subparagraph class="fontsize10" id="y63a75c4a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">“(C) </num><content>The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.”</content></subparagraph>
</paragraph>
</quotedContent>.</content></paragraph>
<paragraph class="fontsize10" id="y63a75c4b-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/d/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Issuance of corrective action reports</inline>.—</heading><chapeau>Section 744I of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–53">21 U.S.C. 379j–53</ref>), as amended by section 404, is further amended—</chapeau><subparagraph class="fontsize10" id="y63a75c4c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/d/2/A" role="instruction" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>by <amendingAction type="redesignate">redesignating</amendingAction> subsections (c) and (d) as subsections (e) and (f), respectively; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a75c4d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s904/d/2/B" role="instruction" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="insert">inserting</amendingAction> after subsection (b) the following:<quotedContent><subsection class="indentDown2 firstIndent0 fontsize10" id="y63a7aa6e-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="c">“(c) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a7aa6f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p><p class="leftAlign firstIndent0 fontsize8" id="x63a7aa70-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Determinations.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Corrective Action Report</inline>.—</heading><chapeau>Beginning with fiscal year 2018, and for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:</chapeau><paragraph class="fontsize10" id="y63a7aa71-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Goals met</inline>.—</heading><content>For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section <page identifier="/us/stat/131/1088">131 STAT. 1088</page>
401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.</content></paragraph>
<paragraph class="fontsize10" id="y63a7aa72-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><heading class="fontsize10"><inline class="smallCaps">Goals missed</inline>.—</heading><chapeau>For each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—</chapeau><subparagraph class="fontsize10" id="y63a7aa73-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">“(A) </num><content>a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a7aa74-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">“(B) </num><content>with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.</content></subparagraph>
</paragraph>
</subsection>
<subsection class="indentDown2 firstIndent0 fontsize10" id="y63a7aa75-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="d">“(d) </num><heading class="fontsize10"><inline class="smallCaps">Enhanced Communication</inline>.—</heading><paragraph class="fontsize10" id="y63a7aa76-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">Communications with congress</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.</content></paragraph>
<paragraph class="fontsize10" id="y63a7aa77-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a7aa78-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Public information.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Participation in congressional hearing</inline>.—</heading><content>Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section.<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a7aa79-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Deadline.</p></sidenote> Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”</content></paragraph>
</subsection>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
</section>
<section id="d132600e13248" identifier="/us/pl/115/52/tIX/s905" style="-uslm-lc:I658143"><num class="fontsize12" value="905">SEC. 905. </num><heading>FACILITIES MANAGEMENT.</heading><subsection class="firstIndent0 fontsize10" id="y63a8baea-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="a">(a) </num><heading class="fontsize10"><inline class="smallCaps">Evaluation</inline>.—</heading><paragraph class="fontsize10" id="y63a8baeb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8baec-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Time period.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Study</inline>.—</heading><chapeau>The Comptroller General of the United States shall conduct a study on the expenses incurred by the Food and Drug Administration related to facility maintenance and renovation in fiscal years 2012 through 2019. The study under this paragraph shall include the following:</chapeau><subparagraph class="fontsize10" id="y63a8baed-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8baee-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Review.</p></sidenote><chapeau>A review of purchases and expenses differentiated by appropriated funds, and resources authorized by the Food and Drug Administration Safety and Innovation Act (<ref href="/us/pl/112/144">Public Law 112–144</ref>) and this Act, as applicable, that contributed to—</chapeau><clause class="fontsize10" id="y63a8baef-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>the maintenance of scientific equipment and any existing facility plan or plans to maintain previously purchased scientific equipment;<page identifier="/us/stat/131/1089">131 STAT. 1089</page></content></clause>
<clause class="fontsize10" id="y63a8baf0-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>the renovation of facilities in the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, and the purpose of such renovation including the need for the renovation;</content></clause>
<clause class="fontsize10" id="y63a8baf1-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>the assets purchased or repaired under the “repair of facilities and acquisition” authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379f/etseq">21 U.S.C. 379f et seq.</ref>);</content></clause>
<clause class="fontsize10" id="y63a8baf2-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A/iv" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iv">(iv) </num><content>the maintenance and repair of facilities and fixtures, including a description of any unanticipated repairs and maintenance as well as scheduled repairs maintenance, and the budget plan for the scheduled or anticipated maintenance;</content></clause>
<clause class="fontsize10" id="y63a8baf3-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A/v" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="v">(v) </num><content>the acquisition of furniture, a description of the furniture purchased, and the purpose of the furniture including purchases for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health; and</content></clause>
<clause class="fontsize10" id="y63a8baf4-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/A/vi" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="vi">(vi) </num><content>the acquisition of other necessary materials and supplies by product category under the authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379f/etseq">21 U.S.C. 379f et seq.</ref>).</content></clause>
</subparagraph>
<subparagraph class="fontsize10" id="y63a8baf5-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/1/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8baf6-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Analysis.</p></sidenote><content>An analysis of the Food and Drug Administration’s ability to further its public health mission and review medical products by incurring the expenses listed in clauses (i) through (vi) of subparagraph (A).<sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8baf7-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Consultation.</p></sidenote> In conducting the analysis, the Comptroller General shall request information from and consult with appropriate employees, including staff and those responsible for the fiscal decisions regarding facility maintenance and renovation for the agency.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63a8baf8-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/2" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">Report</inline>.—</heading><subparagraph class="fontsize10" id="y63a8baf9-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/2/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The Comptroller General shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives not later than July 30, 2020, containing the results of the study under paragraph (1).</content></subparagraph>
<subparagraph class="fontsize10" id="y63a8bafa-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/2/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><heading class="fontsize10"><inline class="smallCaps">Recommendations</inline>.—</heading><chapeau>As part of the report under this paragraph, the Comptroller General may provide recommendations, as applicable, on methods through which the Food and Drug Administration may improve planning for—</chapeau><clause class="fontsize10" id="y63a8bafb-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/2/B/i" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">(i) </num><content>the maintenance, renovation, and repair of facilities;</content></clause>
<clause class="fontsize10" id="y63a8bafc-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/2/B/ii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">(ii) </num><content>the purchase of furniture or other acquisitions; and</content></clause>
<clause class="fontsize10" id="y63a8bafd-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/a/2/B/iii" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="iii">(iii) </num><content>ways the Food and Drug Administration may allocate the expenses described in clauses (i) and (ii) of paragraph (1)(A), as informed by the analysis under paragraph (1)(B).</content></clause>
</subparagraph>
</paragraph>
</subsection>
<subsection class="firstIndent0 fontsize10" id="y63a8bafe-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b" style="-uslm-lc:I658120"><num class="fontsize10" style="-uslm-lc:emspace2" value="b">(b) </num><heading class="fontsize10"><inline class="smallCaps">Administration</inline>.—</heading><page identifier="/us/stat/131/1090">131 STAT. 1090</page>
<paragraph class="fontsize10" id="y63a8baff-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/1" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">(1) </num><heading class="fontsize10"><inline class="smallCaps">PDUFA</inline>.—</heading><content>Section 736(f) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379h/f">21 U.S.C. 379h(f)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a8bb00-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8bb01-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>Beginning on October 1, 2023, the authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.”</content></paragraph>
</quotedContent>.</content></paragraph>
<paragraph class="fontsize10" id="y63a8bb02-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/2" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">(2) </num><heading class="fontsize10"><inline class="smallCaps">MDUFA</inline>.—</heading><content>Section 738(h) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j/h">21 U.S.C. 379j(h)</ref>) <amendingAction type="amend">is amended</amendingAction> by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentUp0 fontsize10" id="y63a8e213-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">“(3) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8e214-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Limitation</inline>.—</heading><content>Beginning on October 1, 2023, the authorities under section 737(9)(C) shall include only leasing and necessary scientific equipment.”</content></paragraph>
</quotedContent>.</content></paragraph>
<paragraph class="fontsize10" id="y63a8e215-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/3" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="3">(3) </num><heading class="fontsize10"><inline class="smallCaps">GDUFA</inline>.—</heading><chapeau>Section 744B(e) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–42/e">21 U.S.C. 379j–42(e)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y63a8e216-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/3/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the subsection heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">Limit</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">Limitations</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a8e217-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/3/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>The total amount</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><paragraph class="indentDown1 fontsize10" id="y63a8e218-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="1">“(1) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The total amount”</content></paragraph>
</quotedContent>; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a8e219-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/3/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><paragraph class="indentDown1 fontsize10" id="y63a8e21a-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="2">“(2) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8e21b-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Leasing and necessary equipment</inline>.—</heading><content>Beginning on October 1, 2023, the authorities under section 744A(11)(C) shall include only leasing and necessary scientific equipment.”</content></paragraph>
</quotedContent>.</content></subparagraph>
</paragraph>
<paragraph class="fontsize10" id="y63a8e21c-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/4" role="instruction" style="-uslm-lc:I658122"><num class="fontsize10" style="-uslm-lc:emspace2" value="4">(4) </num><heading class="fontsize10"><inline class="smallCaps">BsUFA</inline>.—</heading><chapeau>Section 744H(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act (<ref href="/us/usc/t21/s379j–52/e/2/B">21 U.S.C. 379j–52(e)(2)(B)</ref>) <amendingAction type="amend">is amended</amendingAction>—</chapeau><subparagraph class="fontsize10" id="y63a8e21d-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/4/A" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="A">(A) </num><content>in the subparagraph heading, by <amendingAction type="delete">striking</amendingAction> “<quotedText><headingText class="smallCaps">limitation</headingText></quotedText>” and <amendingAction type="insert">inserting</amendingAction> “<quotedText><headingText class="smallCaps">limitations</headingText></quotedText>”;</content></subparagraph>
<subparagraph class="fontsize10" id="y63a8e21e-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/4/B" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="B">(B) </num><content>by <amendingAction type="delete">striking</amendingAction> “<quotedText>The fees authorized</quotedText>” and <amendingAction type="insert">inserting</amendingAction> the following:<quotedContent><clause class="fontsize10" id="y63a8e21f-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="i">“(i) </num><heading class="fontsize10"><inline class="smallCaps">In general</inline>.—</heading><content>The fees authorized”</content></clause>
</quotedContent>; and</content></subparagraph>
<subparagraph class="fontsize10" id="y63a8e220-e82d-11f0-a1e4-69761a48a15a" identifier="/us/pl/115/52/tIX/s905/b/4/C" style="-uslm-lc:I658124"><num class="fontsize10" style="-uslm-lc:emspace2" value="C">(C) </num><content>by <amendingAction type="add">adding</amendingAction> at the end the following:<quotedContent><subsection class="indentUp1 fontsize10" id="y63a8e221-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658126"><num class="fontsize10" style="-uslm-lc:emspace2" value="ii">“(ii) </num><sidenote><p class="leftAlign firstIndent0 fontsize8" id="x63a8e222-e82d-11f0-a1e4-69761a48a15a" style="-uslm-lc:I658180">Effective date.</p></sidenote><heading class="fontsize10"><inline class="smallCaps">Leasing and necessary equipment</inline>.—</heading><content>Beginning on October 1, 2023, the authorities under section 744G(9)(C) shall include only leasing and necessary scientific equipment.”</content></subsection>
</quotedContent>.</content></subparagraph>
</paragraph>
</subsection>
</section>
ApprovedAugust 18, 2017.LEGISLATIVE HISTORY—H.R. 2430 (S. 934):HOUSE REPORTS: ┐No. 115–201 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 163 (2017):