115 HR 2430 IH: FDA Reauthorization Act of 2017 U.S. House of Representatives 2017-05-16 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
I115th CONGRESS1st SessionH. R. 2430IN THE HOUSE OF REPRESENTATIVESMay 16, 2017Mr. Walden (for himself, Mr. Pallone, Mr. Burgess, and Mr. Gene Green of Texas) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.
1.
Short title
This Act may be cited as the FDA Reauthorization Act of 2017.
2.
Table of contents
The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. Title I—Fees relating to drugs Sec. 101. Short title; finding. Sec. 102. Authority to assess and use drug fees. Sec. 103. Reauthorization; reporting requirements. Sec. 104. Sunset dates. Sec. 105. Effective date. Sec. 106. Savings clause. Title II—Fees relating to devices Sec. 201. Short title; findings. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204. Reauthorization; reporting requirements. Sec. 205. Conformity assessment pilot program. Sec. 206. Reauthorization of review. Sec. 207. Electronic format for submissions. Sec. 208. Savings clause. Sec. 209. Effective date. Sec. 210. Sunset clause. Title III—Fees relating to generic drugs Sec. 301. Short title; finding. Sec. 302. Definitions. Sec. 303. Authority to assess and use human generic drug fees. Sec. 304. Reauthorization; reporting requirements. Sec. 305. Sunset dates. Sec. 306. Effective date. Sec. 307. Savings clause. Title IV—Fees relating to biosimilar biological products Sec. 401. Short title; finding. Sec. 402. Definitions. Sec. 403. Authority to assess and use biosimilar fees. Sec. 404. Reauthorization; reporting requirements. Sec. 405. Sunset dates. Sec. 406. Effective date. Sec. 407. Savings clause. Title V—Reauthorization of other programs Sec. 501. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers. Sec. 502. Reauthorization of pediatric humanitarian device exceptions. Sec. 503. Reauthorization of the critical path public-private partnerships. Sec. 504. Reauthorization of pediatric device consortia. Sec. 505. Reauthorization of orphan grants program. Sec. 506. Reauthorization of inspection program. Sec. 507. Reauthorization of pediatric study of drugs. Title VI—Additional Provisions Sec. 601. Technical corrections.
<enum>I</enum><header>Fees relating to drugs</header> <section id="HCF417C1DD56A4D35B238F28D6FCD2DD7"><enum>101.</enum><header>Short title; finding</header> <subsection id="H21BC294BAA8641DBB243D14A004DEB24"><enum>(a)</enum><header>Short Title</header><text>This title may be cited as the <quote><short-title>Prescription Drug User Fee Amendments of 2017</short-title></quote>.</text> </subsection><subsection id="H40A4BF77A0C94DF988A27E95EC861878"><enum>(b)</enum><header>Finding</header><text>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 Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.</text> </subsection></section><section id="H55329C9DD22D4FC1B395F972A2EB7A51"><enum>102.</enum><header>Authority to assess and use drug fees</header> <subsection id="H5D91A78715EB41B4A988C9523534BA33"><enum>(a)</enum><header>Types of fees</header> <paragraph id="H13CD7D3D23B24F8688412AD4BC193D1B"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Section 736(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(a)</external-xref>) is amended—</text> <subparagraph id="HDA3A7C67622C4F0B9AE507749D6BA6DB"><enum>(A)</enum><text>in the matter preceding paragraph (1), by striking <quote>fiscal year 2013</quote> and inserting <quote>fiscal year 2018</quote>;</text> </subparagraph><subparagraph id="H0446360A65BC40408749C43FE8A07284"><enum>(B)</enum><text>in the heading of paragraph (1), by striking <quote><header-in-text level="paragraph" style="OLC">and supplement</header-in-text></quote>;</text> </subparagraph><subparagraph id="H18DB513DA2124524B4D35A97942DCE92"><enum>(C)</enum><text>in paragraph (1), by striking <quote>or a supplement</quote> and <quote>or supplement</quote> each place either appears;</text> </subparagraph><subparagraph id="HA025DEEEF7EF45358616CEF2973AAE58"><enum>(D)</enum><text>in paragraph (1)(A)—</text> <clause id="H3C6CC2D6ADE545CD9D90C3E8962A8B40"><enum>(i)</enum><text>in clause (i), by striking <quote>(c)(4)</quote> and inserting <quote>(c)(5)</quote>; and</text> </clause><clause id="H22983604885845CFA18BAD1D9DE6C3F9"><enum>(ii)</enum><text>in clause (ii), by striking <quote>A fee established</quote> and all that follows through <quote>are required.</quote> and inserting the following: <quote>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.</quote>;</text> </clause></subparagraph><subparagraph id="H07BD6C73763243A4A3A8EEC783C3DA93"><enum>(E)</enum><text>in the heading of paragraph (1)(C), by striking <quote><header-in-text level="subparagraph" style="OLC">or supplement</header-in-text></quote>;</text> </subparagraph><subparagraph id="H93482746508E4B10AAA87AB981354CB8"><enum>(F)</enum><text>in paragraph (1)(F)—</text> <clause id="HD3A6636A516D4C0193F3EE39D06B7092"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">or indication</header-in-text></quote>; and</text> </clause><clause id="HE99A474993214D46BAF5BF78B71E0F60"><enum>(ii)</enum><text>by striking the second sentence;</text> </clause></subparagraph><subparagraph id="H23FA04A318664000B9D99176D8F80354"><enum>(G)</enum><text>by striking paragraph (2) (relating to a prescription drug establishment fee);</text> </subparagraph><subparagraph id="H5F1A1B01D298450184B73FE15FFB5E60"><enum>(H)</enum><text>by redesignating paragraph (3) as paragraph (2);</text> </subparagraph><subparagraph commented="no" id="H1E1C9D1AB5BC486886F783FF94D40CBC"><enum>(I)</enum><text>in the heading of paragraph (2), as so redesignated, by striking <quote><header-in-text level="paragraph" style="OLC">Prescription drug product fee</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Prescription drug program fee</header-in-text></quote>;</text> </subparagraph><subparagraph id="HDCD4FC80DEAA41C08C39DF9565472B50"><enum>(J)</enum><text>in subparagraph (A) of such paragraph (2), by amending the first sentence to read as follows: <quote>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. </quote>;</text> </subparagraph><subparagraph id="HAB670757EEA647A3B1F3D8D616CCCA0C"><enum>(K)</enum><text>in subparagraph (B) of such paragraph (2)—</text> <clause id="HE1B20B12A7054FAB8A921A0EFE588F47"><enum>(i)</enum><text>in the heading of subparagraph (B), by inserting after <quote><header-in-text level="subparagraph" style="OLC">Exception</header-in-text></quote> the following: <quote><header-in-text level="subparagraph" style="OLC">for certain prescription drug products</header-in-text></quote>; and</text> </clause><clause id="H0BCD18A43DD54059A703CAC2C0E7AE33"><enum>(ii)</enum><text>by striking <quote>A prescription drug product shall not be assessed a fee</quote> and inserting <quote>A prescription drug program fee shall not be assessed for a prescription drug product</quote>; and</text> </clause></subparagraph><subparagraph id="H007267CB86F94A05B7760688C4B53BDB"><enum>(L)</enum><text>by adding at the end of such paragraph (2) the following:</text> <quoted-block display-inline="no-display-inline" id="H86CDC3C4530440EC9D461CF6ADDE84CF" style="OLC"> <subparagraph id="HF8C4124DA2064A02BD21F3772D4D8CEC"><enum>(C)</enum><header>Limitation</header><text display-inline="yes-display-inline">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.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph commented="no" id="HEC450C42AE1C48ED8C337ACA65EFB789"><enum>(2)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">Subparagraph (C) of section 740(a)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-12">21 U.S.C. 379j–12(a)(3)</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H3A49A13F32E94E5C897D0D879FBB2069" style="OLC"> <subparagraph commented="no" id="HE91AEE02A25D415489530D6931EFD0A5"><enum>(C)</enum><header>Limitation</header><text display-inline="yes-display-inline">An establishment shall be assessed only one fee per fiscal year under this section.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection id="HEE810CACDD0747A28519849ECA2FBBC5"><enum>(b)</enum><header>Fee revenue amounts</header><text display-inline="yes-display-inline">Subsection (b) of section 736 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H77DF8E8F405C4B84A93E2027CC1E52B3" style="OLC"> <subsection id="H2CBBFE1DA99343B0872FF59AC58051AA"><enum>(b)</enum><header>Fee revenue amounts</header> <paragraph id="HB2658A3714C647579B1A862B40C9A168"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text> <subparagraph id="H40892937A95643128734D65B68F91B1A"><enum>(A)</enum><text>the annual base revenue for the fiscal year (as determined under paragraph (3));</text> </subparagraph><subparagraph id="HB123F3B23683424CB22FD2DEF080E7D7"><enum>(B)</enum><text>the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));</text> </subparagraph><subparagraph id="HB0EF86F1F16B45219FF582F289539553"><enum>(C)</enum><text>the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2));</text> </subparagraph><subparagraph id="H9895C9D594444FFC835C8CBBE2A0D42E"><enum>(D)</enum><text>the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3));</text> </subparagraph><subparagraph id="H00C2D40677E249EABEEF1D793B34591E"><enum>(E)</enum><text>the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and</text> </subparagraph><subparagraph id="H1FC21E08E304495B9BEB4A39B2AD0F24"><enum>(F)</enum><text>additional dollar amounts for each fiscal year as follows:</text> <clause id="H5B072F5766DD4CB7A1B2172C161C336E"><enum>(i)</enum><text>$20,077,793 for fiscal year 2018;</text> </clause><clause id="H67653CE13F164521ACA0B3962E71F268"><enum>(ii)</enum><text>$21,317,472 for fiscal year 2019;</text> </clause><clause id="H9E2B2A629C17492590422515EFB88CDA"><enum>(iii)</enum><text>$16,953,329 for fiscal year 2020;</text> </clause><clause id="H207BA97F429243379D138CF39C5402CE"><enum>(iv)</enum><text>$5,426,896 for fiscal year 2021; and</text> </clause><clause id="HE706B9133F7C444A80193CABC9765FFC"><enum>(v)</enum><text>$2,769,609 for fiscal year 2022.</text> </clause></subparagraph></paragraph><paragraph id="H5DF46F86BAC54AE4834CCF5EC7AC4FC3"><enum>(2)</enum><header>Types of fees</header><text>Of the total revenue amount determined for a fiscal year under paragraph (1)—</text> <subparagraph id="H20C126E41B7C4E6FACBAE8B1ABE8E6DC"><enum>(A)</enum><text>20 percent shall be derived from human drug application fees under subsection (a)(1); and</text> </subparagraph><subparagraph id="H5984934444B144FCAC93116E5D4B1E15"><enum>(B)</enum><text>80 percent shall be derived from prescription drug program fees under subsection (a)(2).</text> </subparagraph></paragraph><paragraph id="H172D0A54ECC14D148FF02F1CEF6CD419"><enum>(3)</enum><header>Annual base revenue</header><text>For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—</text> <subparagraph id="HDBF976189D6642DDA10FD7BDA51D81B7"><enum>(A)</enum><text>for fiscal year 2018, $878,590,000; and</text> </subparagraph><subparagraph id="H77C57A48A39D4CA29A9E52DFE4748AF0"><enum>(B)</enum><text>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).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="H7A95A9140A1B45988134DA0740A90B8A"><enum>(c)</enum><header>Adjustments; annual fee setting</header><text display-inline="yes-display-inline">Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H08C93B7412384ECE832319145FCA8D26" style="OLC"> <subsection id="HD8F0F2DD49224A94A5A8ADB34C6A13D2"><enum>(c)</enum><header>Adjustments; annual fee setting</header> <paragraph id="HFFE88D0397B145EA9B40C8D3DE227E74"><enum>(1)</enum><header>Inflation adjustment</header> <subparagraph id="H8F32B2CCC11F411BA9824B7DFF70EE45"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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—</text> <clause id="HC184BEEA3C684D8EB5B21ACB8A8EB4A9"><enum>(i)</enum><text>such annual base revenue for the fiscal year under subsection (b)(1)(A); and</text> </clause><clause id="H52D15E4AD3C74340A27545DD4E708650"><enum>(ii)</enum><text>the inflation adjustment percentage under subparagraph (B).</text> </clause></subparagraph><subparagraph id="HE904ABF7EEE84D32B2CB3AC83BBDA84C"><enum>(B)</enum><header>Inflation adjustment percentage</header><text>The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—</text> <clause id="H715A8181F357431F95EA767512E40798"><enum>(i)</enum><text>the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 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</text> </clause><clause id="H2EF7000CC979471C9497D976545F3E6A"><enum>(ii)</enum><text>the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 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.</text> </clause></subparagraph></paragraph><paragraph id="HAC1D4E2FB9A341D784327998EAD69C1D"><enum>(2)</enum><header>Capacity planning adjustment</header> <subparagraph id="HDFA806EF21DF4303A0EAFB4D58764C67"><enum>(A)</enum><header>In general</header><text>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.</text> </subparagraph><subparagraph id="HCE3CD8E8A2804E85B41F68FBB0FC28AD"><enum>(B)</enum><header>Interim methodology</header> <clause id="HED88402E07DD403EA4A6DFCAF6F2D8FB"><enum>(i)</enum><header>In general</header><text>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—</text> <subclause id="H80DF086CC67646BCA8C8A9436B239A03"><enum>(I)</enum><text>the annual base revenue for such year, as adjusted for inflation under paragraph (1); and</text> </subclause><subclause id="H8BF470C184334B18BEA3271CEE8B998D"><enum>(II)</enum><text>the adjustment percentage under clause (ii).</text> </subclause></clause><clause id="H873636A796AE44F994DA47E61CAAB867"><enum>(ii)</enum><header>Adjustment percentage</header><text>The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for—</text> <subclause id="HAD325E88E2F04EAAB084C2AB34E905CE"><enum>(I)</enum><text>the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary;</text> </subclause><subclause id="HA27DFB71E2FA47B18C26181C097523D0"><enum>(II)</enum><text>the total number of active commercial investigational new drug applications; and</text> </subclause><subclause id="H222241FDD9CA41BAB4B3796306E2487E"><enum>(III)</enum><text>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 <short-title>Prescription Drug User Fee Amendments of 2017</short-title>.</text> </subclause></clause></subparagraph><subparagraph id="HACB88E81E9DF4E4DB61DB4F3A0DE6E52"><enum>(C)</enum><header>Capacity planning methodology</header> <clause id="H3AEA3948012D434184D220E23813B69D"><enum>(i)</enum><header>Development; evaluation and report</header><text>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. The report shall be published for public comment no later than the end of fiscal year 2020.</text> </clause><clause id="H2F93E37C58414D65BB091DC2915150E3"><enum>(ii)</enum><header>Establishment and implementation</header><text>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—</text> <subclause id="HDE2A3817FBD24648AF104BDD25B60828"><enum>(I)</enum><text>replace the interim methodology under subparagraph (B);</text> </subclause><subclause id="H6FE076F5EA414233BBACE7C9ED1FFABB"><enum>(II)</enum><text>incorporate such approaches and attributes as the Secretary determines appropriate; and</text> </subclause><subclause id="HFD7EF1EF7D244C66A89F9E3733BD0336"><enum>(III)</enum><text>be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.</text> </subclause></clause></subparagraph><subparagraph id="H72356EC99EF94EDB89F5CFF119415D16"><enum>(D)</enum><header>Limitation</header><text>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).</text> </subparagraph><subparagraph id="H7C86362E327A4FA4895D9D8827F8C688"><enum>(E)</enum><header>Publication in federal register</header><text>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.</text> </subparagraph></paragraph><paragraph id="H5ABE58ADCFF847FBACC215A982080051"><enum>(3)</enum><header>Operating reserve adjustment</header> <subparagraph id="H5127D90D3719461A99B7316053B475B7"><enum>(A)</enum><header>Increase</header><text>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 for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.</text> </subparagraph><subparagraph id="H81B942CCE5AE43F1B02E8D53FA485CE6"><enum>(B)</enum><header>Decrease</header><text>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.</text> </subparagraph><subparagraph id="HF2237F0E6A124144A0E28FD6168B91B9"><enum>(C)</enum><header>Notice of rationale</header><text>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.</text> </subparagraph></paragraph><paragraph id="HE4E377793D9C4CC4AB753D804C002EB8"><enum>(4)</enum><header>Additional direct cost adjustment</header> <subparagraph id="HC00B46E8EBA5407AB86CD8CF12EAC9FA"><enum>(A)</enum><header>In general</header><text>The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees—</text> <clause id="H7C04678C394C4DB49702404CA73C776F"><enum>(i)</enum><text>for fiscal year 2018, by $8,730,000; and</text> </clause><clause id="H197C59F65C8E45B884A94B36C02E9C50"><enum>(ii)</enum><text display-inline="yes-display-inline">for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B).</text> </clause></subparagraph><subparagraph id="H25297FFC2244448F898C2BE35063C1EC"><enum>(B)</enum><header>Amount</header><text display-inline="yes-display-inline">The amount determined under this subparagraph is—</text> <clause id="HB9BDBF9E1898427D88B533493B9965AE"><enum>(i)</enum><text>$8,730,000, multiplied by</text> </clause><clause id="H50D46BD490AE480BB1AA07AE869907BD"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text> </clause></subparagraph></paragraph><paragraph id="H9B7D8EE1032146739F84294F4B746BD7"><enum>(5)</enum><header>Annual fee setting</header><text display-inline="yes-display-inline">The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017—</text> <subparagraph id="HCB228DC6C904457390BFD8F6BE3459F2"><enum>(A)</enum><text>establish, for the next 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</text> </subparagraph><subparagraph id="H9B9CFC12A244417F8FC49802AD050A51"><enum>(B)</enum><text>publish such fee revenue and fees in the Federal Register.</text> </subparagraph></paragraph><paragraph id="H87162B367A9B4B8EA69E5B1F14605917"><enum>(6)</enum><header>Limit</header><text>The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="HC5D5E9D1D51048E49BF52BBA868D1460"><enum>(d)</enum><header>Fee waiver or reduction</header><text display-inline="yes-display-inline">Section 736(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(d)</external-xref>) is amended—</text> <paragraph id="H8BBAF51D997D4025A7C48809EC4FA45A"><enum>(1)</enum><text>in paragraph (1)—</text> <subparagraph id="H4F9A12A9DECC49638D15F59E16453109"><enum>(A)</enum><text>by inserting <quote>or</quote> at the end of subparagraph (B);</text> </subparagraph><subparagraph id="H2ECE032800C64EB18822770A31DC8072"><enum>(B)</enum><text>by striking subparagraph (C); and</text> </subparagraph><subparagraph id="H2A2001EEDD914C67A734F3EA7EFF5E79"><enum>(C)</enum><text>by redesignating subparagraph (D) as subparagraph (C);</text> </subparagraph></paragraph><paragraph id="H8E4D6B05EBFE4905AB7931F9EE555954"><enum>(2)</enum><text>by striking paragraph (3) (relating to use of standard costs);</text> </paragraph><paragraph id="HEB7729D478E84EADA470F381CC7B4837"><enum>(3)</enum><text>by redesignating paragraph (4) as paragraph (3); and</text> </paragraph><paragraph id="HBA63F9B7D09D469EABE4914A89C472BF"><enum>(4)</enum><text>in paragraph (3), as so redesignated—</text> <subparagraph id="H531B3F3B62654A26B8A2F7365F2D66E6"><enum>(A)</enum><text>in subparagraphs (A) and (B), by striking <quote>paragraph (1)(D)</quote> and inserting <quote>paragraph (1)(C)</quote>; and</text> </subparagraph><subparagraph id="H9CFA9EB307C74543A4D28CF69DB46222"><enum>(B)</enum><text>in subparagraph (B)—</text> <clause id="HE9F811A17B5B4DBBAD22D1B7B9546DDE"><enum>(i)</enum><text>by striking clause (ii);</text> </clause><clause id="HA34162C6BC79420C88E715C918C95452"><enum>(ii)</enum><text>by striking <quote>shall pay</quote> through <quote>(i) application fees</quote> and inserting <quote>shall pay application fees</quote>; and</text> </clause><clause id="H5E3798D74D184753A9CA2E4FB725E337"><enum>(iii)</enum><text>by striking <quote>; and</quote> at the end and inserting a period.</text> </clause></subparagraph></paragraph></subsection><subsection id="HFE12F90F3CBE4E0FBF7852214C984540"><enum>(e)</enum><header>Effect of failure To pay fees</header><text display-inline="yes-display-inline">Section 736(e) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(e)</external-xref>) is amended by striking <quote>all fees</quote> and inserting <quote>all such fees</quote>.</text> </subsection><subsection id="H4295F080F2E34F60A33ABB3DDA24A9F9"><enum>(f)</enum><header>Limitations</header><text display-inline="yes-display-inline">Section 736(f)(2) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(f)(2)</external-xref>) is amended by striking <quote>supplements, prescription drug establishments, and prescription drug products</quote> and inserting <quote>prescription drug program fees</quote>.</text> </subsection><subsection id="HDD33C17134E145DA98F3BD06BF98686F"><enum>(g)</enum><header>Crediting and availability of fees</header><text display-inline="yes-display-inline">Section 736(g) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(g)</external-xref>) is amended—</text> <paragraph id="H558F729048B2487F838102F1CECA70B8"><enum>(1)</enum><text>in paragraph (3)—</text> <subparagraph id="H9DD157A2CDFE430A93CB5052A6F3FC24"><enum>(A)</enum><text>by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>; and</text> </subparagraph><subparagraph id="H65CFB7BE8881405B8AE63FCF844B3695"><enum>(B)</enum><text>by striking <quote>and paragraph (4) of this subsection</quote>; and</text> </subparagraph></paragraph><paragraph id="H4EE880403E294171B010A84C9A5F9F8D"><enum>(2)</enum><text>by striking paragraph (4).</text> </paragraph></subsection><subsection id="HECF9B67617C24A0E8252DBBD113ED82F"><enum>(h)</enum><header>Orphan drugs</header><text display-inline="yes-display-inline">Section 736(k) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h">21 U.S.C. 379h(k)</external-xref>) is amended by striking <quote>product and establishment fees</quote> each place it appears and inserting <quote>prescription drug program fees</quote>.</text> </subsection></section><section id="H76B92445CF7E4544B39A50774E18A169"><enum>103.</enum><header>Reauthorization; reporting requirements</header><text display-inline="no-display-inline">Section 736B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h-2">21 U.S.C. 379h–2</external-xref>) is amended—</text> <paragraph id="H74B966D9C5524B2589E36FEE8B575086"><enum>(1)</enum><text>in subsection (a)(1)—</text> <subparagraph id="H7884639AF53841E4A4DF9E72A2012080"><enum>(A)</enum><text>in the matter before subparagraph (A), by striking <quote>2013</quote> and inserting <quote>2018</quote>; and</text> </subparagraph><subparagraph id="HC68A16323CBB48FCB16619EADD582F4B"><enum>(B)</enum><text>in subparagraph (A), by striking <quote>Prescription Drug User Fee Amendments of 2012</quote> and inserting <quote><short-title>Prescription Drug User Fee Amendments of 2017</short-title></quote>;</text> </subparagraph></paragraph><paragraph id="H5388EE0E9D1E4158B01F365ECE0AE8F2"><enum>(2)</enum><text>in subsection (b), by striking <quote>2013</quote> and inserting <quote>2018</quote>; and</text> </paragraph><paragraph id="H80A457363A044003A61B60439F4B5ABE"><enum>(3)</enum><text>in subsection (d), by striking <quote>2017</quote> each place it appears and inserting <quote>2022</quote>.</text> </paragraph></section><section id="H99853B6AA46049D9BC3972970F65E621"><enum>104.</enum><header>Sunset dates</header> <subsection id="HEC9866F5EDAA45B7BE4F60DEB598887C"><enum>(a)</enum><header>Authorization</header><text>Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379g">21 U.S.C. 379g</external-xref>; 379h) shall cease to be effective October 1, 2022.</text> </subsection><subsection id="H84B552E5560B4CD88D40FD83A9F068B1"><enum>(b)</enum><header>Reporting Requirements</header><text>Section 736B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379h-2">21 U.S.C. 379h–2</external-xref>) shall cease to be effective January 31, 2023.</text> </subsection><subsection id="HDD75D3C1B63D4302966B5B2A8892499A"><enum>(c)</enum><header>Previous Sunset Provision</header><text display-inline="yes-display-inline">Effective October 1, 2017, subsections (a) and (b) of section 105 of the Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="public-law" parsable-cite="pl/112/144">Public Law 112–144</external-xref>) are repealed.</text> </subsection></section><section commented="no" id="HE5F6EC7BC98141D285C7A8D9D9E4ABC4"><enum>105.</enum><header>Effective date</header><text display-inline="no-display-inline">The amendments made by this title shall take effect on October 1, 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 for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.</text> </section><section commented="no" display-inline="no-display-inline" id="HF51D74E5FCF64719BA767A3B79102829" section-type="subsequent-section"><enum>106.</enum><header>Savings clause</header><text display-inline="no-display-inline">Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that 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.</text> </section><enum>II</enum><header>Fees relating to devices</header> <section id="H91425F56947D44EFAB0CC13BBBA6C324"><enum>201.</enum><header>Short title; findings</header> <subsection id="HAC242A59AE594CFD8AC9334D97506F45"><enum>(a)</enum><header>Short Title</header><text>This title may be cited as the <quote><short-title>Medical Device User Fee Amendments of 2017</short-title></quote>.</text> </subsection><subsection id="H7C361C27CE7F455E87F6ADC354099A7A"><enum>(b)</enum><header>Findings</header><text>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.</text> </subsection></section><section id="H89E6DA5C05B14B5F9FC54E61A113BFD5"><enum>202.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 737 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379i">21 U.S.C. 379i</external-xref>) is amended—</text> <paragraph id="H449577A9B61342879FEB8632F8C9F85F"><enum>(1)</enum><text>by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;</text> </paragraph><paragraph id="H3040CA658FD54C9C840F86A92829EE1E"><enum>(2)</enum><text>by inserting after paragraph (7) the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="HA2FD69B003D04B76A3F4E306BFCFD143" style="OLC"> <paragraph id="HD84853977D594F6FBFB3F018827CF56A"><enum>(8)</enum><text display-inline="yes-display-inline">The term <quote>de novo classification request</quote> means a request made under section 513(f)(2)(A) with respect to the classification of a device.</text></paragraph><after-quoted-block>; </after-quoted-block></quoted-block> </paragraph><paragraph id="HCD4DB795F902440A8AA26659F90BFC75"><enum>(3)</enum><text>in subparagraph (D) of paragraph (10) (as redesignated by paragraph (1)), by striking <quote>and submissions</quote> and inserting <quote>submissions, and de novo classification requests</quote>; and</text> </paragraph><paragraph id="H2918B936AEA54051A0595A0B8DCA27C7"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (11) (as redesignated by paragraph (1)), by striking <quote>2011</quote> and inserting <quote>2016</quote>.</text> </paragraph></section><section id="HD8AB3BCABEEA4EF7BEE453B214F1388D"><enum>203.</enum><header>Authority to assess and use device fees</header> <subsection id="HDBB20329888240F198F0CA40BA13C0AC"><enum>(a)</enum><header>Types of Fees</header><text display-inline="yes-display-inline">Section 738(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(a)</external-xref>) is amended—</text> <paragraph id="H5C7C7C87283D4A53A2EBABA26304B32C"><enum>(1)</enum><text>in paragraph (1), by striking <quote>fiscal year 2013</quote> and inserting <quote>fiscal year 2018</quote>; and</text> </paragraph><paragraph id="H3342260523F04178B335459BE0D47CEF"><enum>(2)</enum><text>in paragraph (2)—</text> <subparagraph id="HE1860F1679B1437B922F3A2703765D86"><enum>(A)</enum><text>in subparagraph (A)—</text> <clause id="HBD015EB1D76E4A7FB1FDABE92BF7AD76"><enum>(i)</enum><text display-inline="yes-display-inline">in the matter preceding clause (i), by striking <quote>October 1, 2012</quote> and inserting <quote>October 1, 2017</quote>;</text> </clause><clause id="H735E428DA57D4439B96288065BCE5006"><enum>(ii)</enum><text>in clause (viii), by striking <quote>2</quote> and inserting <quote>3.4</quote>; and</text> </clause><clause id="HA338ACEA29AD44C0A6137EA1B24C4BAA"><enum>(iii)</enum><text>by adding at the end the following new clause:</text> <quoted-block display-inline="no-display-inline" id="H00323D64E56147918BCF492210BA20DF" style="OLC"> <clause id="HF86CDE215E4F4BDEB23D6871445A1FCE"><enum>(xi)</enum><text display-inline="yes-display-inline">For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph><subparagraph id="H45F88EFA35D54CC8AC61F8D038DD9CC0"><enum>(B)</enum><text>in subparagraph (B)(v)(I), by striking <quote>or premarket notification submission</quote> and inserting <quote>premarket notification submission, or de novo classification request</quote>.</text> </subparagraph></paragraph></subsection><subsection id="H652695FCDF3F44878C2404E84E486D11"><enum>(b)</enum><header>Fee Amounts</header><text display-inline="yes-display-inline">Section 738(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(b)</external-xref>) is amended to read as follows:</text> <quoted-block id="H80C8986B47EB4F5482E2A19CE47E3F3E"> <subsection id="H6FC6C5875DC7405087D7D18D2085482E"><enum>(b)</enum><header>Fee Amounts</header> <paragraph id="H899DB05203314DCA82E0DA7135D7257C"><enum>(1)</enum><header>In General</header><text>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).</text> </paragraph><paragraph id="H5DE5F4B5CDA24335B2D1FBF8A03CD714"><enum>(2)</enum><header>Base fee amounts specified</header><text>For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:</text> <table line-rules="hor-ver" rule-weights="4.4.4.4.0.0"><ttitle></ttitle> <tgroup cols="6" thead-tbody-ldg-size="8.8.8" ttitle-size="0"><colspec coldef="txt" colname="col1" min-data-value="60"></colspec><colspec coldef="fig" colname="col2" min-data-value="8"></colspec><colspec coldef="fig" colname="col3" min-data-value="8"></colspec><colspec coldef="fig" colname="col4" min-data-value="8"></colspec><colspec coldef="fig" colname="col5" min-data-value="8"></colspec><colspec coldef="fig" colname="col6" min-data-value="8"></colspec><thead> <row><entry align="center" colname="col1">Fee Type</entry><entry align="center" colname="col2">Fiscal Year 2018</entry><entry align="center" colname="col3">Fiscal Year 2019</entry><entry align="center" colname="col4">Fiscal Year 2020</entry><entry align="center" colname="col5">Fiscal Year 2021</entry><entry align="center" colname="col6">Fiscal Year 2022</entry></row></thead> <tbody> <row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Premarket Application</entry><entry colname="col2">$294,000</entry><entry colname="col3">$300,000</entry><entry colname="col4">$310,000</entry><entry colname="col5">$328,000</entry><entry colname="col6">$329,000</entry></row> <row><entry colname="col1" stub-definition="txt-ldr" stub-hierarchy="1">Establishment Registration</entry><entry colname="col2">$4,375</entry><entry colname="col3">$4,548</entry><entry colname="col4">$4,760</entry><entry colname="col5">$4,975</entry><entry colname="col6">$4,978</entry></row></tbody></tgroup></table> </paragraph><paragraph id="H1F4AA911443F4BF48468B177A9697BD6"><enum>(3)</enum><header>Total revenue amounts specified</header><text>For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:</text> <subparagraph id="H227A57DB560F402FB87FDE2F619AE826"><enum>(A)</enum><text display-inline="yes-display-inline">$183,280,756 for fiscal year 2018.</text> </subparagraph><subparagraph id="H0432E8CBFBEA473FB05F03A40D0DAA8F"><enum>(B)</enum><text display-inline="yes-display-inline">$190,654,875 for fiscal year 2019.</text> </subparagraph><subparagraph id="H17CDE835BC554D96B8704797031FBEA0"><enum>(C)</enum><text display-inline="yes-display-inline">$200,132,014 for fiscal year 2020.</text> </subparagraph><subparagraph id="H7E204347AA50462FAA23351988E9F3DB"><enum>(D)</enum><text display-inline="yes-display-inline">$211,748,789 for fiscal year 2021.</text> </subparagraph><subparagraph id="H464F00C855E44EC198EFD364A50F9CFD"><enum>(E)</enum><text display-inline="yes-display-inline">$213,687,660 for fiscal year 2022.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="H929D9A6989864F90BC885EFBFAFFD28B"><enum>(c)</enum><header>Annual Fee Setting; Adjustments</header><text display-inline="yes-display-inline">Section 738(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(c)</external-xref>) is amended—</text> <paragraph id="H6EE93A92C5634C13861C9EB5575EDD0F"><enum>(1)</enum><text>in paragraph (1), by striking <quote>2012</quote> and inserting <quote>2017</quote>;</text> </paragraph><paragraph id="HD94E5C078815493CA682DF0D03930585"><enum>(2)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <subparagraph id="HD9C3CF5A82D04F92A1286844E26C968E"><enum>(A)</enum><text>in subparagraph (A), by striking <quote>2014</quote> and inserting <quote>2018</quote>;</text> </subparagraph><subparagraph id="H888492F96F2541B9841914EBB5FC13FB"><enum>(B)</enum><text>by striking subparagraph (B) and inserting the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="HB7037111E02E432BBFB20A38548F18A5" style="OLC"> <subparagraph id="HB46E516924A44712B981BAC7542DF309"><enum>(B)</enum><header>Applicable inflation adjustment</header><text display-inline="yes-display-inline">The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of—</text> <clause id="H365568DB70AC40948659B1BFE915E67A"><enum>(i)</enum><text display-inline="yes-display-inline">the base inflation adjustment under subparagraph (C) for such fiscal year; and</text> </clause><clause id="H50003739BC244DD6978FED9C01EF627D"><enum>(ii)</enum><text display-inline="yes-display-inline">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.</text></clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph id="H9C5CDAD5406D4A3EB6704EC52F439190"><enum>(C)</enum><text>in subparagraph (C), in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">to total revenue amounts</header-in-text></quote>; and</text> </subparagraph><subparagraph id="H4C6E277232E74C80A6ED8C058204B87A"><enum>(D)</enum><text>by amending subparagraph (D) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H39DEE859663D40178D53A552F9B33772" style="OLC"> <subparagraph id="H871A5810FFF849389BD17B8F3D3B0923"><enum>(D)</enum><header>Adjustment to base fee amounts</header><text display-inline="yes-display-inline">For each of fiscal years 2018 through 2022, the Secretary shall—</text> <clause id="HA55D88F42C454F968941565A2F82576E"><enum>(i)</enum><text display-inline="yes-display-inline">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</text> </clause><clause id="HADF70D5323BC40959D790BCECFFB5961"><enum>(ii)</enum><text display-inline="yes-display-inline">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).</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph id="H81CF1941BB2648F097C45C752BAA58FA"><enum>(3)</enum><text>in paragraph (3)—</text> <subparagraph id="H8BC2E233FAC54874B7697948204C2120"><enum>(A)</enum><text>by striking <quote>2014 through 2017</quote> and inserting <quote>2018 through 2022</quote>; and</text> </subparagraph><subparagraph id="H2C6A87BBF1E34BFAA35D9AF7F76B94C5"><enum>(B)</enum><text>by striking <quote>further adjusted</quote> and inserting <quote>increased</quote>.</text> </subparagraph></paragraph></subsection><subsection id="H97FDF6354ECF4386AA10324C5A1E4AE9"><enum>(d)</enum><header>Small businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval Fees</header><text display-inline="yes-display-inline">Section 738(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(d)</external-xref>) is amended—</text> <paragraph id="H39F14187A87040D78E41B69F2D92CB2E"><enum>(1)</enum><text>in paragraph (1), by striking <quote>specified in clauses (i) through (v) and clauses (vii), (ix), and (x)</quote> and inserting <quote>specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)</quote>; and</text> </paragraph><paragraph id="H98A110B79DA64DC6A57B1571976FAA6A"><enum>(2)</enum><text>in paragraph (2)(C)—</text> <subparagraph id="HBD0EBD2190C34C6BAA9785A84DD1B8A4"><enum>(A)</enum><text>by striking <quote>supplement, or</quote> and inserting <quote>supplement,</quote>; and</text> </subparagraph><subparagraph id="H5A667A3560F04F2BA06816629AB11ACF"><enum>(B)</enum><text>by inserting <quote>, or a de novo classification request</quote> after <quote>class III device</quote>.</text> </subparagraph></paragraph></subsection><subsection id="HE32C4CB0D9E240F3BE6C72EF5A87AB23"><enum>(e)</enum><header>Small Businesses; Fee Reduction Regarding Premarket Notification Submissions</header><text display-inline="yes-display-inline">Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j(e)(2)(C)</external-xref>) is amended by striking <quote>50</quote> and inserting <quote>25</quote>.</text> </subsection><subsection id="HB02483068537471883B4BFCE958F70BD"><enum>(f)</enum><header>Fee Waiver or Reduction</header> <paragraph id="H1C34505FAED34DB4AC6183CD75BF844A"><enum>(1)</enum><header>Repeal</header><text>Section 738 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j</external-xref>) is amended by striking subsection (f).</text> </paragraph><paragraph id="H1CA79C34E9EE4EEF8C38D854F9A1CCF5"><enum>(2)</enum><header>Conforming changes</header> <subparagraph id="H3D9185CBCC904090B851D0E2CBB0C956"><enum>(A)</enum><text>Section 515(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e">21 U.S.C. 360e(c)(4)(A)</external-xref>) is amended by striking <quote>738(h)</quote> and inserting <quote>738(g)</quote>.</text> </subparagraph><subparagraph id="HCEB15963AABA43D28210BC82A9F7D32A"><enum>(B)</enum><text>Section 738 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j</external-xref>), as amended by paragraph (1), is further amended—</text> <clause id="H692491FBDE034FAFB84CE583FA3D517E"><enum>(i)</enum><text>by redesignating subsections (g) through (l) as subsections (f) through (k);</text> </clause><clause id="H3BC9A5CD90ED4E7991C64A39714227D2"><enum>(ii)</enum><text>in subsection (a)(2)(A), by striking <quote>(d), (e), and (f)</quote> and inserting <quote>(d) and (e)</quote>; and</text> </clause><clause id="HF4E76F3AD8B64CECBC09EDBE2987F029"><enum>(iii)</enum><text>in subsection (a)(3)(A), by striking <quote>and subsection (f)</quote>.</text> </clause></subparagraph></paragraph></subsection><subsection id="H414B082B813B4DD7BCDBDE0CC6A3E6FB"><enum>(g)</enum><header>Effect of failure To pay fees</header><text>Subsection (f)(1), as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j</external-xref>) is amended—</text> <paragraph id="H17CD8427EEDF4AFCABA0AEE2C760F3DD"><enum>(1)</enum><text>by striking <quote>or periodic reporting concerning a class III device</quote> and inserting <quote>periodic reporting concerning a class III device, or de novo classification request</quote>; and</text> </paragraph><paragraph id="HFB06DE21FA544A909B0837B814BE5DB5"><enum>(2)</enum><text>by striking <quote>all fees</quote> and inserting <quote>all such fees</quote>.</text> </paragraph></subsection><subsection id="HDDF09A617A5F4924A23F21358BF2D8D6"><enum>(h)</enum><header>Conditions</header><text display-inline="yes-display-inline">Subsection (g)(1)(A), as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j</external-xref>) is amended by striking <quote>$280,587,000</quote> and inserting <quote>$320,825,000</quote>.</text> </subsection><subsection id="H4FFA378608924538AC6CF11EBC084C11"><enum>(i)</enum><header>Crediting and Availability of Fees</header><text display-inline="yes-display-inline">Subsection (h), as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j">21 U.S.C. 379j</external-xref>) is amended—</text> <paragraph id="H918FBFB6723F422AAEE573AABAB63B40"><enum>(1)</enum><text>in paragraph (3)—</text> <subparagraph id="H5F209D84FE384F7B8DFCDE8B9718B850"><enum>(A)</enum><text>by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>; and</text> </subparagraph><subparagraph id="H7A567B66B86E4B65A0530A525955B974"><enum>(B)</enum><text>by striking <quote>subsection (c)</quote> and all that follows through the period at the end and inserting <quote>subsection (c).</quote>; and</text> </subparagraph></paragraph><paragraph id="H6B5EDD4454314AD8A7E53E4FF4477D66"><enum>(2)</enum><text>by striking paragraph (4).</text> </paragraph></subsection></section><section id="H922A1AFC572D44139089814BFFE0E3CD"><enum>204.</enum><header>Reauthorization; reporting requirements</header> <subsection id="H94243499548644379A6385CCC8E80F63"><enum>(a)</enum><header>Performance Reports</header><text display-inline="yes-display-inline">Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-1">21 U.S.C. 379j–1(a)</external-xref>) is amended—</text> <paragraph id="H003F8758640046FE9B7EDCCAB9B8B95F"><enum>(1)</enum><text>in paragraph (1)—</text> <subparagraph id="H2AEE71561B71490EA80A032334E35BD1"><enum>(A)</enum><text>in subparagraph (A)—</text> <clause id="HDDE8AF5FAE174213930F8D170CC60B5F"><enum>(i)</enum><text>by striking <quote>2013</quote> and inserting <quote>2018</quote>; and</text> </clause><clause id="H4FC457B697C94110AA8A02F8BB27E698"><enum>(ii)</enum><text>by striking <quote>the Medical Device User Fee Amendments of 2012</quote> and inserting <quote><short-title>Medical Device User Fee Amendments of 2017</short-title></quote>; and</text> </clause></subparagraph><subparagraph id="H89E10529211148159A4A4C88490A08AF"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (B), by striking <quote>the Medical Device User Fee Amendments of 2012</quote> and inserting <quote><short-title>Medical Device User Fee Amendments of 2017</short-title></quote>; and</text> </subparagraph></paragraph><paragraph id="H0717CC97550040A78A186FAD7E3918C7"><enum>(2)</enum><text>in paragraph (2), by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>.</text> </paragraph></subsection><subsection id="H2849170E96DE4BF89CF30147A153D6C3"><enum>(b)</enum><header>Reauthorization</header><text display-inline="yes-display-inline">Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-1">21 U.S.C. 379j–1(b)</external-xref>) is amended—</text> <paragraph id="HDCFD7B7251004A84874DE7BA0B0936C7"><enum>(1)</enum><text>in paragraph (1), by striking <quote>2017</quote> and inserting <quote>2022</quote>; and</text> </paragraph><paragraph id="H357FCFA7D0DD49BDBBD6FF59E9EB6A28"><enum>(2)</enum><text>in paragraph (5), by striking <quote>2017</quote> and inserting <quote>2022</quote>.</text> </paragraph></subsection></section><section id="H6B6EA56785FB4E1292EF1FDA7693092B"><enum>205.</enum><header>Conformity assessment pilot program</header> <subsection id="HABB7D50C900E4503B2846B486A337B7F"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Section 514 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360d">21 U.S.C. 360d</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H4A7F694C7FE642AEBC9DE1FD442332CB" style="appropriations"> <subsection id="H6388E33DA3684C98B0E5C9DFAE37969F"><enum>(d)</enum><header>Pilot accreditation scheme for conformity assessment</header> <paragraph id="HA3B9DED614134F6289696F968814B1ED"><enum>(1)</enum><header>In general</header><text>The Secretary shall establish a pilot program under which—</text> <subparagraph id="H486508D1A4FE407BB22F87B617D297FF"><enum>(A)</enum><text>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</text> </subparagraph><subparagraph id="H509DA52B5014460D8E3B5F1B9E416166"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph id="HE4A92C1BBA2948EFA72365152B865F27"><enum>(2)</enum><header>Secretarial review of accredited laboratory determinations</header><text>The Secretary may—</text> <subparagraph id="HD58F18A6F88241EAB1457DBEE57BC692"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph id="H25DAC8774BD74AA6B79B0D080B818FBE"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text> </subparagraph></paragraph><paragraph id="H4CA3C0A80FC04B028B3781C9F6845FB8"><enum>(3)</enum><header>Implementation and reporting</header> <subparagraph id="H6278065EBF1C4D6B9FFD96A5D76CEB39"><enum>(A)</enum><header>Public meeting</header><text>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.</text> </subparagraph><subparagraph id="H8F3790108BC14DA0AA975BBECAD04539"><enum>(B)</enum><header>Pilot program guidance</header><text>The Secretary shall—</text> <clause id="H80B66A9EE5E541FE974F18D80CBF1141"><enum>(i)</enum><text>not later than September 30, 2019, issue draft guidance regarding the goals and implementation of the pilot program under this subsection; and</text> </clause><clause id="HE1190ECA8FC84B73ACC7E3A866A2D754"><enum>(ii)</enum><text>not later than September 30, 2021, issue final guidance with respect to the implementation of such program.</text> </clause></subparagraph><subparagraph id="H3FE98236427D4A8A953F94077EC6EC39"><enum>(C)</enum><header>Pilot program initiation</header><text>Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection.</text> </subparagraph><subparagraph id="HBCA0D8225EF54FE7AD35B5A52BBBC0B6"><enum>(D)</enum><header>Report</header><text>The Secretary shall make available on the website of the Food and Drug Administration an annual report on the progress of the pilot program under this subsection.</text> </subparagraph></paragraph><paragraph id="H97795D81FB0F4C79AC9442BC86393461"><enum>(4)</enum><header>Sunset</header><text>As of October 1, 2022—</text> <subparagraph id="H2F114DAE2A494C138947F116C1C1C514"><enum>(A)</enum><text display-inline="yes-display-inline">the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph (1)(A) shall cease to have force or effect;</text> </subparagraph><subparagraph id="HD3E72327C4114D97A1A8174F3620BBCC"><enum>(B)</enum><text display-inline="yes-display-inline">the Secretary—</text> <clause id="HAD0224C07C2044F1B1AB8CF4361780BD"><enum>(i)</enum><text display-inline="yes-display-inline">may not accept a determination pursuant to paragraph (1)(B) made by a testing laboratory after such date; and</text> </clause><clause id="H4E30D5321D7145508EAF69905DC1A5F5"><enum>(ii)</enum><text display-inline="yes-display-inline">may accept such a determination made prior to such date;</text> </clause></subparagraph><subparagraph id="HE71DC738E1134D74A760597F4DDA2389"><enum>(C)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph id="HC8E477AEC8E741E1B066BDA7FCF5D119"><enum>(D)</enum><text display-inline="yes-display-inline">the Secretary may take actions in accordance with paragraph (2) with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section><section id="HC333E4F5923C4A01AB24BDC64BBF02EF"><enum>206.</enum><header>Reauthorization of review</header><text display-inline="no-display-inline">Section 523 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360m">21 U.S.C. 360m</external-xref>) is amended—</text> <paragraph id="HEDE5689028D24EBFBA33B71E9D75DAC6"><enum>(1)</enum><text>in subsection (a)(3)—</text> <subparagraph id="H68661A64E11C4B099F1BEE2CB695ADEF"><enum>(A)</enum><text>in subparagraph (A), by striking clauses (ii) and (iii) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="HF8B722CCB0E54D31A3F902B321EFFF75" style="OLC"> <clause id="H6E1765C0027D494EB56119CF03FC0CB4"><enum>(ii)</enum><text>a device classified under section 513(f)(2) or designated under section 515C(d); or</text> </clause><clause id="H1CB0480E5AC04727B5E4663159E603CE"><enum>(iii)</enum><text>a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).</text></clause><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph id="H7D7D494DB9E74FC1B91F1AAA65951384"><enum>(B)</enum><text>by striking subparagraph (B) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H543870C642E742209A17359460C8A6A0" style="OLC"> <subparagraph id="H5A54711669344E84B3EE74A3CA41289C"><enum>(B)</enum><header>Designation for review</header><text>The Secretary shall—</text> <clause id="HBAE4FC907D6447D1A17E7DB2817F9DED"><enum>(i)</enum><text>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—</text> <subclause id="H414213D09C9E4E8FA571471403720007"><enum>(I)</enum><text>the risk of the device type, or subset of such device type; and</text> </subclause><subclause id="HFC4558CD744A4D5DB71B542155DD9D01"><enum>(II)</enum><text>whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting;</text> </subclause></clause><clause id="HB273ABCAD54B49EF885A590D013C8C29"><enum>(ii)</enum><text>not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and</text> </clause><clause id="HDADD2AFF549F45F78D25480ECB076077"><enum>(iii)</enum><text>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).</text></clause></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph><subparagraph id="HB89667D3BE2D43B08280370973FFF028"><enum>(C)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HE176FDA4CE2342958723040369E9EEC0" style="OLC"> <subparagraph id="H38236D0422184C3583EF72066A0AAB4E"><enum>(C)</enum><header>Interim rule</header><text>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 <short-title>Medical Device User Fee Amendments of 2017</short-title> shall be in effect.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph id="H5FA2968D93B64BAA876AD58E418F15FB"><enum>(2)</enum><text>in subsection (b)—</text> <subparagraph id="HD9B2BB71DDF043CF9BBE99DE18072935"><enum>(A)</enum><text>in paragraph (2)—</text> <clause id="HC3A345A04D694FF983273FF6B6EEFBC8"><enum>(i)</enum><text>by striking subparagraph (D); and</text> </clause><clause id="H16821F06CD234310B0E96E613257155F"><enum>(ii)</enum><text>by redesignating subparagraph (E) as subparagraph (D); and</text> </clause></subparagraph><subparagraph id="HCCC549BB698C47DB9B950B5A2E9273B8"><enum>(B)</enum><text>in paragraph (3)—</text> <clause id="HBCF83C5960174B199B286929BE061701"><enum>(i)</enum><text>by redesignating subparagraph (E) as subparagraph (F);</text> </clause><clause id="H8E924BA4DBD448C19D46BF0588AF4FD2"><enum>(ii)</enum><text>in subparagraph (F) (as so redesignated), by striking <quote>The operations of</quote> and all that follows through <quote>it will—</quote> and inserting <quote>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—</quote>; and</text> </clause><clause id="H8C55634D9CA747E1B378793323571E7A"><enum>(iii)</enum><text>by inserting after subparagraph (D) the following new subparagraph:</text> <quoted-block display-inline="no-display-inline" id="H0BA5F686F0FC435DA494BA69897AB707" style="OLC"> <subparagraph id="H7C3D4F7B57194EEC80616436B2F98DCF"><enum>(E)</enum><text display-inline="yes-display-inline">The operations of such person shall be in accordance with generally accepted professional and ethical business practices.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </clause></subparagraph></paragraph><paragraph id="HEBDF5DD2F8894FE880402821294DCC09"><enum>(3)</enum><text>in subsection (c), by striking <quote>2017</quote> and inserting <quote>2022</quote>.</text> </paragraph></section><section id="H8343F34B19084286BD7F2155D6733DC3"><enum>207.</enum><header>Electronic format for submissions</header><text display-inline="no-display-inline">Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379k-1">21 U.S.C. 379k–1(b)</external-xref>) is amended by adding at the end the following new paragraph:</text> <quoted-block display-inline="no-display-inline" id="H22A4838ECA34498E8ADCD98A16C9CEAC" style="OLC"> <paragraph id="H052D8CB1E3E441208EA7D860C9C818EE"><enum>(3)</enum><header>Presubmissions and submissions solely in electronic format</header> <subparagraph id="HB3E3B2FF9CE34DFDB05EE164A63DEDBF"><enum>(A)</enum><header>In general</header><text>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.</text> </subparagraph><subparagraph id="H61B51C8AFF284902AFF99DFC025A5D59"><enum>(B)</enum><header>Draft guidance</header><text>The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—</text> <clause id="HA916D79D06BD4FFE90C0258B0DDD8DBB"><enum>(i)</enum><text>any further standards for the submission by electronic format required under subparagraph (A);</text> </clause><clause id="H136090ED40114AF3A88011BA2FFDB9AA"><enum>(ii)</enum><text>a timetable for the establishment by the Secretary of such further standards; and</text> </clause><clause id="H17B525E51648487EA86436C8081C97A6"><enum>(iii)</enum><text>criteria for waivers of and exemptions from the requirements of this subsection.</text> </clause></subparagraph><subparagraph id="HFCA2F13F71AC43DB994CA6AFCC1E16F1"><enum>(C)</enum><header>Final guidance</header><text>The Secretary shall, not later than 12 months after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance described in clauses (i) through (iii) of such subparagraph.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </section><section id="H46E3DFD50EE449ACAC8F353DE1612ED2"><enum>208.</enum><header>Savings clause</header><text display-inline="no-display-inline">Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379i">21 U.S.C. 379i</external-xref> et seq.), 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.<italic></italic></text> </section><section id="HD6B9821E7E8748D180AF47C2408CEA40"><enum>209.</enum><header>Effective date</header><text display-inline="no-display-inline">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.</text> </section><section id="HBA69714AAA8C43A1911ECAB229820DF9"><enum>210.</enum><header>Sunset clause</header> <subsection id="H60AB205A0F2E4C92ABDBE74DA1D698B3"><enum>(a)</enum><header>Authorization</header><text>Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/739i">21 U.S.C. 739i</external-xref>; 739j) shall cease to be effective October 1, 2022.</text> </subsection><subsection id="H4C816DB861EC4886936C8C2F0F63E76E"><enum>(b)</enum><header>Reporting requirements</header><text>Section 738A (<external-xref legal-doc="usc" parsable-cite="usc/21/739j-1">21 U.S.C. 739j–1</external-xref>) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2023.</text> </subsection><subsection id="H11C7B9C02D8E48669B36EC0F973AD050"><enum>(c)</enum><header>Previous Sunset Provision</header> <paragraph id="H36C85FBE53BD4A41A9E5084BE84C1ABD"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">Effective October 1, 2017, section 207(a) of the Medical Device User Fee Amendments of 2012 (<external-xref legal-doc="public-law" parsable-cite="pl/112/144">Public Law 112–144</external-xref>) is repealed.</text> </paragraph><paragraph commented="no" display-inline="no-display-inline" id="H260D2595D3D94ED1923BA7DCCBC68E84"><enum>(2)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">The Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="public-law" parsable-cite="pl/112/144">Public Law 112–144</external-xref>) is amended in the table of contents in section 2 by striking the item relating to section 207.</text> </paragraph></subsection></section><enum>III</enum><header>Fees relating to generic drugs</header> <section id="H2ED091371E494EA8A43BA305AA82F409"><enum>301.</enum><header>Short title; finding</header> <subsection id="H97904B60C45A48C2944764ECB73FDED8"><enum>(a)</enum><header>Short title</header><text>This title may be cited as the <quote><short-title>Generic Drug User Fee Amendments of 2017</short-title></quote>.</text> </subsection><subsection id="HAAA9ECDC5D8044D7AAC236E8AC9936ED"><enum>(b)</enum><header>Finding</header><text>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.</text> </subsection></section><section id="H3258F862C0A24B70868C1DB63A1C30AD"><enum>302.</enum><header>Definitions</header><text display-inline="no-display-inline">Section 744A of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-41">21 U.S.C. 379j–41</external-xref>) is amended—</text> <paragraph id="H49FC2D40C3E84BE69182798A6ABAB55F"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (1)(B), by striking <quote>application for a positron emission tomography drug.</quote> and inserting “application—</text> <quoted-block display-inline="no-display-inline" id="H294AC1551EC04AAEAE09E23C192E7110" style="OLC"> <clause id="HEFD33C2E82FD4D69B05431316F52B55C"><enum>(i)</enum><text>for a positron emission tomography drug; or</text> </clause><clause id="HB229B445DC964C5381270BEFE08F0BD0"><enum>(ii)</enum><text>submitted by a State or Federal governmental entity for a drug that is not distributed commercially.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph id="HA19AD5F5297B46458DDA38BC8C3EFA42"><enum>(2)</enum><text>by redesignating paragraphs (5) through (12) as paragraphs (6) through (13), respectively; and</text> </paragraph><paragraph id="H30638EC6A74148DBA7B2C6D6E295EADB"><enum>(3)</enum><text>by inserting after paragraph (4) the following:</text> <quoted-block display-inline="no-display-inline" id="HFA15FCAFC5C244FCA743BDBECF148B5B" style="OLC"> <paragraph id="HA3953DB6CE8143CBAB715E0425EF29D4"><enum>(5)</enum><text display-inline="yes-display-inline">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.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></section><section id="HB41907D4E8F140FAB2225286612111E0"><enum>303.</enum><header>Authority to assess and use human generic drug fees</header> <subsection id="HBA3819376AF04D7B991E247ED97F61E9"><enum>(a)</enum><header>Types of fees</header><text>Section 744B(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-42">21 U.S.C. 379j–42(a)</external-xref>) is amended—</text> <paragraph id="HE7ED855E62EA46BA9AAC3AA80166EDEB"><enum>(1)</enum><text>in the matter preceding paragraph (1), by striking <quote>fiscal year 2013</quote> and inserting <quote>fiscal year 2018</quote>;</text> </paragraph><paragraph id="H4138DBCD0E804D4A9A7798FB082F58E8"><enum>(2)</enum><text>in paragraph (1), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H38693232B182416D8D111FB0172E938E" style="OLC"> <subparagraph id="HE94528FADBCE4B1391A93AC3023C67A9"><enum>(E)</enum><header>Sunset</header><text>This paragraph shall cease to be effective October 1, 2022.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph id="H311570D7AC864E3486C0C79F140A5326"><enum>(3)</enum><text>in paragraph (2)—</text> <subparagraph id="H1ED55709790E4A7F86DD2CA1DD52527E"><enum>(A)</enum><text>by amending subparagraph (C) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H30AF9F24688342FA93F0131E9342FA73" style="OLC"> <subparagraph id="H9C137DF6E49C47A88160885E5E7F2574"><enum>(C)</enum><header>Notice</header><text>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.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph><subparagraph id="H3ACA2F90BB7B4E59B66D8C560464363A"><enum>(B)</enum><text>in subparagraph (E)—</text> <clause id="HF6A93CE8217642EFBB8569C78091AF16"><enum>(i)</enum><text>in clause (i)—</text> <subclause id="H9508C9ABB88047C6907521EF4F65DFC6"><enum>(I)</enum><text>by striking <quote>no later than the date</quote> and inserting “on the earlier of—</text> <quoted-block display-inline="no-display-inline" id="HFFF12323DB0B4871B4B4B6089BFF4568" style="OLC"> <subclause id="H97EDBDFD1B6D4F56A65EE5D356D96D4B"><enum>(I)</enum><text>the date</text></subclause><after-quoted-block>;</after-quoted-block></quoted-block> </subclause><subclause id="H079BBF680E4B437FB3195845A76ACE65"><enum>(II)</enum><text>by striking the period and inserting <quote>; or</quote>; and</text> </subclause><subclause id="HF33E70BD25AD4C2A83698A81A5FFC335"><enum>(III)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H364162DE994947069900264721435AFE" style="OLC"> <subclause id="H8E88346B38AF42599F3635D85710023B"><enum>(II)</enum><text>the date on which the drug master file holder requests the initial completeness assessment.</text></subclause><after-quoted-block>; and</after-quoted-block></quoted-block> </subclause></clause><clause id="H1AE3DB6B8E8946FEA6872360E9BA0C7B"><enum>(ii)</enum><text>in clause (ii), by striking <quote>notice provided for in clause (i) or (ii) of subparagraph (C), as applicable</quote> and inserting <quote>notice provided for in subparagraph (C)</quote>;</text> </clause></subparagraph></paragraph><paragraph id="H0832B649C61A4EA2B3B0D6CFC6C92A24"><enum>(4)</enum><text>in paragraph (3)—</text> <subparagraph id="H59C799E3DAA14F06B6205F0A80DA5422"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">and prior approval supplement</header-in-text></quote>;</text> </subparagraph><subparagraph id="H35A64B869CA840AC8AA795C649025B5A"><enum>(B)</enum><text>in subparagraph (A), by striking <quote>or a prior approval supplement to an abbreviated new drug application</quote>;</text> </subparagraph><subparagraph id="H927C4C1EE06E4EAAAC1E538B93E3C718"><enum>(C)</enum><text>by amending subparagraphs (B) and (C) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H86380FA7D8FB448E96B384B7365B08C3" style="OLC"> <subparagraph id="H8ACBCE2BD47344899F851D339A2D7CBE"><enum>(B)</enum><header>Notice</header><text>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.</text> </subparagraph><subparagraph id="H7102626B93D8435DADE5F7E1098C74A8"><enum>(C)</enum><header>Fee due date</header><text display-inline="yes-display-inline">The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph id="H82C42951B1EA4D00A2D715FECF51D55D"><enum>(D)</enum><text>in subparagraph (D)—</text> <clause id="H25790C4E6FDF4CFAA92D4498FE66B27A"><enum>(i)</enum><text>in the heading, by inserting <quote><header-in-text level="subparagraph" style="OLC">, is withdrawn prior to being received, or is no longer received</header-in-text></quote> after <quote><header-in-text level="subparagraph" style="OLC">received</header-in-text></quote>; and</text> </clause><clause id="H786BE5ADCAC94931B2779E85E20176DB"><enum>(ii)</enum><text>by striking <quote>The Secretary shall</quote> and all that follows through the period and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H6E8E42CCA9014B41A72542A26C605410" style="OLC"> <clause id="HD0BEFBC82F0F469E81A55AB66D72078B"><enum>(i)</enum><header>Applications not considered to have been received and applications withdrawn prior to being received</header><text>The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 505(j)(5)(A) for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 505(j)(5)(A).</text> </clause><clause id="H4EA21133A0EC4DE9BAC739972DCB0FF7"><enum>(ii)</enum><header>Applications no longer received</header><text>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).</text></clause><after-quoted-block>;</after-quoted-block></quoted-block> </clause></subparagraph><subparagraph id="H1085133E6AE34C85A1A72E89C3A9F43F"><enum>(E)</enum><text>in subparagraph (E), by striking <quote>or prior approval supplement</quote>; and</text> </subparagraph><subparagraph id="HB37DE9C8185D4BDE87B66FB5F24BE6F9"><enum>(F)</enum><text>in the matter preceding clause (i) of subparagraph (F)—</text> <clause id="H0A7FD686899A4AC8B756BE2987EF31CA"><enum>(i)</enum><text>by striking <quote>2012</quote> and inserting <quote>2017</quote>; and</text> </clause><clause id="H3F5C7B10248841DC82B5B4DCC154FA56"><enum>(ii)</enum><text>by striking <quote>subsection (d)(3)</quote> and inserting <quote>subsection (d)(2)</quote>;</text> </clause></subparagraph></paragraph><paragraph id="H2FDC3DD6429B41799784F1566F94C84B"><enum>(5)</enum><text>in paragraph (4)—</text> <subparagraph id="H9C96089E21B342D78558A50020D367DF"><enum>(A)</enum><text>in subparagraph (A)—</text> <clause id="H0446382D3ED64996B40CEBDE6549DEE0"><enum>(i)</enum><text>in the matter preceding clause (i) and in clause (iii), by striking <quote>, or intended to be identified, in at least one generic drug submission that is pending or</quote> and inserting <quote>in at least one generic drug submission that is</quote>;</text> </clause><clause id="HE2892E9751E640CD8E693ACFB5986C4F"><enum>(ii)</enum><text>in clause (i), by striking <quote>or intended to be identified in at least one generic drug submission that is pending or</quote> and inserting <quote>in at least one generic drug submission that is</quote>;</text> </clause><clause id="HE2ACD96C341549A5BB15EFE3C70BE12B"><enum>(iii)</enum><text>in clause (ii), by striking <quote>produces,</quote> and all that follows through <quote>such a</quote> and inserting <quote>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</quote>; and</text> </clause><clause id="H68FD0A8B6FEB4AF18F6B246F2875FD03"><enum>(iv)</enum><text>in clause (iii), by striking <quote>to fees under both such clauses</quote> and inserting <quote>only to the fee attributable to the manufacture of the finished dosage forms</quote>; and</text> </clause></subparagraph><subparagraph id="H43EB1BB46BD8498CB9DC2E9DFF9EB775"><enum>(B)</enum><text>by amending subparagraphs (C) and (D) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="HC193CC806BC544C09274AFABD2B12A16" style="OLC"> <subparagraph id="H2EFEDE5E205D4AA98321B671E5C3B5D6"><enum>(C)</enum><header>Notice</header><text>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.</text></subparagraph><subparagraph id="HA9A08E3C0E6A43EEA53C67D9BE7C9F08"><enum>(D)</enum><header>Fee due date</header><text>For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—</text> <clause id="HBE79B82778E641D3AF757CE842379F1A"><enum>(i)</enum><text>the first business day on or after October 1 of each such year; or</text> </clause><clause id="H7D2A295826044B398F9818DB8B5C6DF5"><enum>(ii)</enum><text>the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.</text></clause></subparagraph><after-quoted-block>; </after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph id="H5054E2CB50ED4AA78EA4C497B2A605CD"><enum>(6)</enum><text>by redesignating paragraph (5) as paragraph (6); and</text> </paragraph><paragraph id="HF542488F09E14F259626D90BA673E544"><enum>(7)</enum><text>by inserting after paragraph (4) the following:</text> <quoted-block display-inline="no-display-inline" id="H7388EE919D58441AA75DFF1B64D712B9" style="OLC"> <paragraph id="H9E0637603D204324B052F767A3CADABE"><enum>(5)</enum><header>Generic drug applicant program fee</header> <subparagraph id="H3FA724A9523541C4A11D4BE4865A3783"><enum>(A)</enum><header>In general</header><text>A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).</text> </subparagraph><subparagraph id="H3BADD82034F94749B2E3A5D584BA228F"><enum>(B)</enum><header>Amount</header><text>The amount of fees established under subparagraph (A) shall be established under subsection (d).</text> </subparagraph><subparagraph id="H3037975BCDF7497498A1D344AEC01FAF"><enum>(C)</enum><header>Notice</header><text>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.</text> </subparagraph><subparagraph id="H10406E5A38FD481787AC746D9D791311"><enum>(D)</enum><header>Fee due date</header><text>For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—</text> <clause id="H4E3447DDACF44289B443ECEAEB04EC32"><enum>(i)</enum><text>the first business day on or after October 1 of each such fiscal year; or</text> </clause><clause id="H300D9675F72B41BF96AC7A6DB6079D39"><enum>(ii)</enum><text>the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection id="H2AB4CD75059C428681472BD58A5F2CC4"><enum>(b)</enum><header>Fee revenue amounts</header><text>Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-42">21 U.S.C. 379j–42(b)</external-xref>) is amended—</text> <paragraph id="HC095090B46A24A9E9929766A335312EE"><enum>(1)</enum><text>in paragraph (1)—</text> <subparagraph id="H86EC4150E37A4271BE6DD41411974A39"><enum>(A)</enum><text>in subparagraph (A)—</text> <clause id="HCC5EC2FFF0CB4DDFA39CBE96E4DEEAD6"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">2013</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">2018</header-in-text></quote>;</text> </clause><clause id="HF0BA757EFA2049D58596C92FA61FAF7F"><enum>(ii)</enum><text>by striking <quote>2013</quote> and inserting <quote>2018</quote>;</text> </clause><clause id="H7712501172124D2E8C406BC22876C683"><enum>(iii)</enum><text>by striking <quote>$299,000,000</quote> and inserting <quote>$493,600,000</quote>; and</text> </clause><clause id="HA6389521132D426C81EA19326BA27223"><enum>(iv)</enum><text>by striking <quote>Of that amount</quote> and all that follows through the end of clause (ii); and</text> </clause></subparagraph><subparagraph id="HD71BA10E92974D88A6E21159CE839AC5"><enum>(B)</enum><text>in subparagraph (B)—</text> <clause id="H02D00C1A6F0740378C0CB1A85C58F363"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">2014 through 2017</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">2019 through 2022</header-in-text></quote>;</text> </clause><clause id="H4A4278D050B74C5687FCD8ABE2EE440E"><enum>(ii)</enum><text>by striking <quote>2014 through 2017</quote> and inserting <quote>2019 through 2022</quote>;</text> </clause><clause id="H64A123019CB443999C074FE003017B43"><enum>(iii)</enum><text>by striking <quote>paragraphs (2) through (4)</quote> and inserting <quote>paragraphs (2) through (5)</quote>; and</text> </clause><clause id="H6B23BA8B3A3D4891A8C2C2B2D0DDED83"><enum>(iv)</enum><text>by striking <quote>$299,000,000</quote> and inserting <quote>$493,600,000</quote>; and</text> </clause></subparagraph></paragraph><paragraph id="H00F3BFB10423449C96F574EDDC09F619"><enum>(2)</enum><text>in paragraph (2)—</text> <subparagraph id="H7688C4D5F9C74F40A64232B98898601C"><enum>(A)</enum><text>in the matter preceding subparagraph (A)—</text> <clause id="HF87F2403C40A41CE9851D09973D8A2A0"><enum>(i)</enum><text>by striking <quote>paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017</quote> and inserting <quote>such paragraph for a fiscal year</quote>; and</text> </clause><clause id="H3C80ADAC677F497FB24B3C7EDAB81A13"><enum>(ii)</enum><text>by striking <quote>through (4)</quote> and inserting <quote>through (5)</quote>;</text> </clause></subparagraph><subparagraph id="HE428F4944E2348689ADDD368E0E1F044"><enum>(B)</enum><text>in subparagraph (A), by striking <quote>Six percent</quote> and inserting <quote>Five percent</quote>;</text> </subparagraph><subparagraph id="H1148EA3B7527494383BC7C1FDE5AC425"><enum>(C)</enum><text>by amending subparagraphs (B) and (C) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H4C6192ADBDF04C8FB1DEECD7B7972A8A" style="OLC"> <subparagraph id="H63460691CB1B4B86ADF86B512511264E"><enum>(B)</enum><text>Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).</text> </subparagraph><subparagraph id="H26E66447874443998FAC19F06300475D"><enum>(C)</enum><text>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.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph id="H1AD5629EE1A3444D9795E01038314EAD"><enum>(D)</enum><text>in subparagraph (D)—</text> <clause id="H86AE96A1C0DC412C9767F181965FE23D"><enum>(i)</enum><text>by striking <quote>Fourteen percent</quote> and inserting <quote>Seven percent</quote>;</text> </clause><clause id="H53CC566519AC411BB61E9CA445CC4C03"><enum>(ii)</enum><text>by striking <quote>not less than $15,000 and not more than $30,000</quote> and inserting <quote>$15,000</quote>; and</text> </clause><clause id="HEF2A47DEC59A4D72BACDE66F7187E882"><enum>(iii)</enum><text>by striking <quote>, as determined</quote> and all that follows through the period at the end and inserting a period; and</text> </clause></subparagraph><subparagraph id="H16CB30C0379247938DA60A5AC4C48D65"><enum>(E)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H3FABFC139397409CB0D598581DE85EED" style="OLC"> <subparagraph id="HC27B64F1E1B546919B0B8AA2F5FE942B"><enum>(E)</enum> <clause commented="no" display-inline="yes-display-inline" id="H5354FCD95DC9406D88A69B10F50E2EE4"><enum>(i)</enum><text>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 shall determine the fees as follows:</text> <subclause id="HE96C890BB9234D60ACCE81848B3DA0F6" indent="up1"><enum>(I)</enum><text>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.</text> </subclause><subclause id="H86038458C0254965947CF46240F400AD" indent="up1"><enum>(II)</enum><text>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.</text> </subclause><subclause id="HF8457D6F667E47F2A981EB0305E6E434" indent="up1"><enum>(III)</enum><text>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.</text> </subclause></clause><clause id="HB5D0B30221B2438DA5274D17CC3EBF8D" indent="up1"><enum>(ii)</enum><text>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.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph></subsection><subsection id="H1131C1C7864845A793348B3EF8D5D11D"><enum>(c)</enum><header>Adjustments</header><text>Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-42">21 U.S.C. 379j–42(c)</external-xref>) is amended—</text> <paragraph id="HEF385453DC954C33B8655B4BD989A493"><enum>(1)</enum><text>in paragraph (1)—</text> <subparagraph id="H5C2ACB39163C4AD4B9480972D1AB8762"><enum>(A)</enum><text>by striking <quote>2014</quote> and inserting <quote>2019</quote>;</text> </subparagraph><subparagraph id="H0020BEDD2E2E46B0B0EE2872A8FC5B2F"><enum>(B)</enum><text>by inserting <quote>to equal the product of the total revenues established in such notice for the prior fiscal year multiplied</quote> after <quote>a fiscal year,</quote>; and</text> </subparagraph><subparagraph id="H29337661CA1E4B02AA8C3CA25D2BCE89"><enum>(C)</enum><text>by striking the flush text following subparagraph (C); and</text> </subparagraph></paragraph><paragraph id="H72BE5DD8D5774E2483B6DA7A988BD283"><enum>(2)</enum><text>in paragraph (2)—</text> <subparagraph id="H086613C77A364D12938DBDBED60C12FE"><enum>(A)</enum><text>by striking <quote>2017</quote> each place it appears and inserting <quote>2022</quote>;</text> </subparagraph><subparagraph id="H63015B586D0C41F7BD9117E98680F5BC"><enum>(B)</enum><text>by striking <quote>the first 3 months of fiscal year 2018</quote> and inserting <quote>the first 3 months of fiscal year 2023</quote>; and</text> </subparagraph><subparagraph id="HE12F52CA9F9247EC99630A39A12EBB73"><enum>(C)</enum><text display-inline="yes-display-inline">by striking <quote>Such fees may only be used in fiscal year 2018.</quote>.</text> </subparagraph></paragraph></subsection><subsection id="H11A40310F58645BF90E48EF6157F4A9B"><enum>(d)</enum><header>Annual fee setting</header><text>Section 744B(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-42">21 U.S.C. 379j–42(d)</external-xref>) is amended—</text> <paragraph id="H753E514C0FFD4B7E94E89511F1DD0428"><enum>(1)</enum><text>by striking paragraphs (1) and (2) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H08DD2C721CE94017A649CCCACE59D301" style="OLC"> <paragraph id="HEFBE152629894C939046ABE0E16BB605"><enum>(1)</enum><header>Fiscal years 2018 through 2022</header><text>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).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph id="H6D3B53E761424A8A84B38840B4193FDF"><enum>(2)</enum><text>by redesignating paragraph (3) as paragraph (2); and</text> </paragraph><paragraph id="HEE9D15673FCB4A66B897BCC3222C5CD2"><enum>(3)</enum><text>in paragraph (2) (as so redesignated), in the matter preceding subparagraph (A), by striking <quote>fees under paragraphs (1) and (2)</quote> and inserting <quote>fee under paragraph (1)</quote>.</text> </paragraph></subsection><subsection id="H34D44BA24B1048F8B8BE7ABE37C66473"><enum>(e)</enum><header>Identification of facilities</header><text>Section 744B(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-42">21 U.S.C. 379j–42(f)</external-xref>) is amended—</text> <paragraph id="HB5582069D3F241B2926B987BAB0EB701"><enum>(1)</enum><text>by striking paragraph (1);</text> </paragraph><paragraph id="HBB0132684E3D484A8C5F95B3840DBFCF"><enum>(2)</enum><text>by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively;</text> </paragraph><paragraph id="HF31DE9F27347442DBFF54508BED7BD93"><enum>(3)</enum><text>in paragraph (1) (as so redesignated)—</text> <subparagraph id="H4552B1BE567E493D89667D19D681FCBD"><enum>(A)</enum><text>by striking <quote>paragraph (4)</quote> and inserting <quote>paragraph (3)</quote>; and</text> </subparagraph><subparagraph id="H924F0E4A4ADE40EAA6CA4DA2C58DFF0D"><enum>(B)</enum><text>by striking <quote>Such information shall</quote> and all that follows through the end of subparagraph (B) and inserting <quote>Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.</quote>; and</text> </subparagraph></paragraph><paragraph id="HFE128437750D4E6FB467CC881579502D"><enum>(4)</enum><text>in paragraph (2), as so redesignated—</text> <subparagraph id="HB8AC04AA29A446E4B34A4687DADCCCA7"><enum>(A)</enum><text>in the heading, by striking <quote><header-in-text level="paragraph" style="OLC">Contents of notice</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Information required to be submitted</header-in-text></quote>;</text> </subparagraph><subparagraph id="H0F7DE7EAC5544174AD943DDC00B8A318"><enum>(B)</enum><text>in the matter preceding subparagraph (A), by striking <quote>paragraph (2)</quote> and inserting <quote>paragraph (1)</quote>;</text> </subparagraph><subparagraph id="HF515BF14D24140B188264A6F9EB7DC1D"><enum>(C)</enum><text>in subparagraph (A), by striking <quote>or intended to be identified</quote>;</text> </subparagraph><subparagraph id="H85281687B06F4DCEAF86318F064771F3"><enum>(D)</enum><text>in subparagraph (D), by striking <quote>and</quote> at the end;</text> </subparagraph><subparagraph id="H6B152CE7629846ECA147087C34D4BFE7"><enum>(E)</enum><text>in subparagraph (E), by striking the period and inserting <quote>; and</quote>; and</text> </subparagraph><subparagraph id="H59885F5C40CC45D58BE1E9E6365012AE"><enum>(F)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HB79DEDC31CEA4A369E91178068121349" style="OLC"> <subparagraph id="HAF53EB77EA5C4E108FAB80009F6C4D3E"><enum>(F)</enum><text>whether the facility is a contract manufacturing organization facility.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block> </subparagraph></paragraph></subsection><subsection id="H5C6DDFE9956245C494F1FF7BD9D90ED3"><enum>(f)</enum><header>Effect of failure To pay fees</header><text>Section 744B(g) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379-42">21 U.S.C. 379–42(g)</external-xref>) is amended—</text> <paragraph id="HF6AF4D1B448E417B89C23B5C24E37D4F"><enum>(1)</enum><text>in paragraph (1), by adding at the end the following: <quote>This paragraph shall cease to be effective on October 1, 2022.</quote>;</text> </paragraph><paragraph id="HCF3DB39F94D340CFAD8A45BB36814A50"><enum>(2)</enum><text>in paragraph (2)(C)(ii), by striking <quote>of 505(j)(5)(A)</quote> and inserting <quote>of section 505(j)(5)(A)</quote>; and</text> </paragraph><paragraph id="H1057B1A64B45446A8735C9E9A0E65D2B"><enum>(3)</enum><text>by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HAC20B75C52AB426D9061A7508840C5CF" style="OLC"> <paragraph commented="no" id="H7CD166E228364B9A90A32417AC66214B"><enum>(5)</enum><header>Generic drug applicant program fee</header> <subparagraph commented="no" id="H9077825063C940DA938D4753A4FCE2E7"><enum>(A)</enum><header>In general</header><text>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:</text> <clause commented="no" id="H5864C645F6CE4885850C110DB28A0941"><enum>(i)</enum><text>The Secretary shall place the person on a publicly available arrears list.</text> </clause><clause commented="no" id="HC21BA76F6DFE42B7979ADC567313202B"><enum>(ii)</enum><text>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).</text> </clause><clause commented="no" id="H097B2A737A4F4174A88CAAC4264564CA"><enum>(iii)</enum><text>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).</text> </clause></subparagraph><subparagraph id="H5B7A5898BF324AE7AF06884E814F7774"><enum>(B)</enum><header>Application of penalties</header><text>The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.</text></subparagraph></paragraph><after-quoted-block>. </after-quoted-block></quoted-block> </paragraph></subsection><subsection id="HCD4DA7646FB442118E89DECE77A5D06D"><enum>(g)</enum><header>Limitations</header><text>Section 744B(h)(2) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379-42">21 U.S.C. 379–42(h)(2)</external-xref>) is amended by striking <quote>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</quote>.</text> </subsection><subsection id="HCCBC8A6188F64699A093BD5BFC56CCEC"><enum>(h)</enum><header>Crediting and availability of fees</header><text>Section 744B(i) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379-42">21 U.S.C. 379–42(i)</external-xref>) is amended—</text> <paragraph id="HA874AF7519884DBFB5239A96892E99E9"><enum>(1)</enum><text>in paragraph (2)—</text> <subparagraph id="H4D319A04A30647EDA22A9B2E6DE6E1B5"><enum>(A)</enum><text>by striking subparagraph (C) (relating to fee collection during first program year);</text> </subparagraph><subparagraph id="HA19C151DFAA24D40AB86EB42940EF7F4"><enum>(B)</enum><text display-inline="yes-display-inline">in subparagraph (D)—</text> <clause id="HB3AB4F55FEEE4F098C3AEF89EBBB3DE2"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">in subsequent years</header-in-text></quote>; and</text> </clause><clause id="H369ED87076094774A2FF2EF3B95B7867"><enum>(ii)</enum><text>by striking <quote>(after fiscal year 2013)</quote>; and</text> </clause></subparagraph><subparagraph id="HC45D9A0FA20F4ABD9AFABCD11D1E44EF"><enum>(C)</enum><text>by redesignating subparagraph (D) as subparagraph (C); and</text> </subparagraph></paragraph><paragraph id="H4AE28705E0DE4D1C9DE53A770B21EDC0"><enum>(2)</enum><text>in paragraph (3), by striking <quote>fiscal years 2013 through 2017</quote> and inserting <quote>fiscal years 2018 through 2022</quote>.</text> </paragraph></subsection><subsection id="HD663372D190042A5BF25B11666A7F2CA"><enum>(i)</enum><header>Information on abbreviated new drug applications owned by applicants and their affiliates</header><text>Section 744B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379-42">21 U.S.C. 379–42</external-xref>) is amended by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="HD48F3C808D3F44728AEF57AED1328AAA" style="OLC"> <subsection id="HB94A406BB7E6458F90520937F81DD2AC"><enum>(o)</enum><header>Information on abbreviated new drug applications owned by applicants and their affiliates</header> <paragraph id="H23E1937532884F3D8CC3D27E0086D4A5"><enum>(1)</enum><header>In general</header><text display-inline="yes-display-inline">By April 1 of each year, each person that owns an abbreviated new drug application, or any affiliate of such person, shall submit, on behalf of the person and its affiliates, to the Secretary a list of—</text> <subparagraph id="H048E345F75484DFAA508CC95AB431819"><enum>(A)</enum><text>all approved abbreviated new drug applications owned by such person; and</text> </subparagraph><subparagraph id="HC215099EBB1A43F3BF59AA5B3F76C0CF"><enum>(B)</enum><text display-inline="yes-display-inline">if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug applications and all approved abbreviated new drug applications owned by any such affiliate.</text> </subparagraph></paragraph><paragraph id="H89A8C450D8D449A0A7B43E1706B4D08C"><enum>(2)</enum><header>Format and method</header><text>The Secretary shall specify in guidance the format and method for submission of lists under this subsection.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection></section><section id="H01DA87E0457C452587F3D3ED2DE0F08D"><enum>304.</enum><header>Reauthorization; reporting requirements</header><text display-inline="no-display-inline">Section 744C of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-43">21 U.S.C. 379j–43</external-xref>) is amended—</text> <paragraph id="HD6A0D9FB58084B1D9AD9A92DBE896F8A"><enum>(1)</enum><text>in subsection (a)—</text> <subparagraph id="H1FFDA8FF9C9D43BE9A33028F3CF814E7"><enum>(A)</enum><text>by striking <quote>2013</quote> and inserting <quote>2018</quote>; and</text> </subparagraph><subparagraph id="H2F65D574141249639D93CD7048BC4F72"><enum>(B)</enum><text>by striking <quote>Generic Drug User Fee Amendments of 2012</quote> and inserting <quote>Generic Drug User Fee Amendments of 2017</quote>;</text> </subparagraph></paragraph><paragraph id="HE7C8A6050C104AE69F040E73E8EC901E"><enum>(2)</enum><text>in subsection (b), by striking <quote>2013</quote> and inserting <quote>2018</quote>; and</text> </paragraph><paragraph id="HDD5C24E9D8A847339878BC6C4AC61150"><enum>(3)</enum><text>in subsection (d), by striking <quote>2017</quote> each place it appears and inserting <quote>2022</quote>.</text> </paragraph></section><section id="HE919EA0325C941F1BE94ABE88BAB222D"><enum>305.</enum><header>Sunset dates</header> <subsection id="H5E465CCD0E0B4733B2A925DA1601E57E"><enum>(a)</enum><header>Authorization</header><text>Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-41">21 U.S.C. 379j–41</external-xref>; 379j–42) shall cease to be effective October 1, 2022.</text> </subsection><subsection id="H378C72A37A6D45F69FBAF07B694B4FE4"><enum>(b)</enum><header>Reporting requirements</header><text>Section 744C of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-43">21 U.S.C. 379j–43</external-xref>) shall cease to be effective January 31, 2023.</text> </subsection><subsection id="H5D73D4C3837144FC83F4F4F08563250F"><enum>(c)</enum><header>Previous sunset provision</header><text>Effective October 1, 2017, subsections (a) and (b) of section 304 of the Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="public-law" parsable-cite="pl/112/144">Public Law 112–144</external-xref>) are repealed.</text> </subsection></section><section id="H6F65B716E66A4A0FA2C2B73DA7120CC0"><enum>306.</enum><header>Effective date</header><text display-inline="no-display-inline">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.</text> </section><section id="H0548B1F98734422DA8C94351D638251F"><enum>307.</enum><header>Savings clause</header><text display-inline="no-display-inline">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 on or after October 1, 2012, but before October 1, 2017, were received by the Food and Drug Administration within the meaning of 505(j)(5)(A) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(j)(5)(A)</external-xref>), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.</text> </section><enum>IV</enum><header>Fees relating to biosimilar biological products</header> <section id="H851CFEF6128240D38C11330FB9CB4A9A"><enum>401.</enum><header>Short title; finding</header> <subsection id="H51FC892DCA714C798C388A9B243D50B9"><enum>(a)</enum><header>Short Title</header><text>This title may be cited as the <quote><short-title>Biosimilar User Fee Amendments of 2017</short-title></quote>.</text> </subsection><subsection id="H2813B7E16B3F479D9CA2E1DA59C7ADBE"><enum>(b)</enum><header>Finding</header><text>The Congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.</text> </subsection></section><section id="HDF33BF2D2906481E9668CA8FE6BFFC2B"><enum>402.</enum><header>Definitions</header> <subsection id="H7E8DFCF4750F4ED08DEEC38A034F92C1"><enum>(a)</enum><header>Adjustment factor</header><text display-inline="yes-display-inline">Section 744G(1) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-51">21 U.S.C. 379j–51(1)</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H45E41CBD69FC40BB9C18813FDA84D9A7" style="OLC"> <paragraph commented="no" id="H27385BCF8F48467C8939F322C6967788"><enum>(1)</enum><text display-inline="yes-display-inline">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; Annual Index) for October of the preceding fiscal year divided by such Index for October 2011.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="HBEC1560821694442A119556A850056E5"><enum>(b)</enum><header>Biosimilar biological product</header><text display-inline="yes-display-inline">Section 744G(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-51">21 U.S.C. 379j–51(3)</external-xref>) is amended by striking <quote>means a product</quote> and inserting <quote>means a specific strength of a biological product in final dosage form</quote>.</text> </subsection></section><section commented="no" id="H12B0C1284B794775A69471D18AAC5D9B"><enum>403.</enum><header>Authority to assess and use biosimilar fees</header> <subsection commented="no" id="H258A2CE04F104208A7D149674D22A2EC"><enum>(a)</enum><header>Types of fees</header><text display-inline="yes-display-inline">Section 744H(a) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-52">21 U.S.C. 379j–52(a)</external-xref>) is amended—</text> <paragraph commented="no" id="HB26E2D32E37748CDBB5C83FE1EC19675"><enum>(1)</enum><text>in the matter preceding paragraph (1), by striking <quote>fiscal year 2013</quote> and inserting <quote>fiscal year 2018</quote>;</text> </paragraph><paragraph commented="no" id="H3F3054CBF9B4487797B77BD9E00BF0D1"><enum>(2)</enum><text>in the heading of paragraph (1), by striking <quote><header-in-text level="paragraph" style="OLC">Biosimilar</header-in-text></quote> and inserting <quote><header-in-text level="paragraph" style="OLC">Biosimilar biological product</header-in-text></quote>;</text> </paragraph><paragraph commented="no" id="H31AA3C21D53C4D1AA0700FE3ED57934F"><enum>(3)</enum><text>in paragraph (1)(A)(i), by striking <quote>(b)(1)(A)</quote> and inserting <quote>(c)(5)</quote>;</text> </paragraph><paragraph id="H246134EB5E00462ABDEA50738271ECC1"><enum>(4)</enum><text display-inline="yes-display-inline">in paragraph (1)(B)(i), by striking <quote>(b)(1)(B) for biosimilar biological product development</quote> and inserting <quote>(c)(5) for the biosimilar biological product development program</quote>;</text> </paragraph><paragraph id="H7628F78FF7594901B9F3429BC2540EA8"><enum>(5)</enum><text>in paragraph (1)(B)(ii), by striking <quote>annual biosimilar biological product development program fee</quote> and inserting <quote>annual biosimilar biological product development fee</quote>;</text> </paragraph><paragraph id="HD218159C149E4655885248D56921C1DB"><enum>(6)</enum><text display-inline="yes-display-inline">in paragraph (1)(B)(iii), by striking <quote>annual biosimilar development program fee</quote> and inserting <quote>annual biosimilar biological product development fee</quote>;</text> </paragraph><paragraph id="HD3DBAAE76F51452BB28EF1B8188B16FB"><enum>(7)</enum><text>in paragraph (1)(B), by adding at the end the following:</text> <quoted-block display-inline="no-display-inline" id="H22D04AE6A6934F33915B8780F970AD02" style="OLC"> <clause id="H52524B64CDC94D2E90AF9FE38D410A9F"><enum>(iv)</enum><header>Refund</header><text display-inline="yes-display-inline">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 development fee paid by the person for the product for such fiscal year. To qualify 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.</text></clause><after-quoted-block>;</after-quoted-block></quoted-block> </paragraph><paragraph commented="no" id="HE2389904964342BD86A437B8FEA376F1"><enum>(8)</enum><text>in paragraph (1)(C), by striking <quote>for a product effective October 1 of a fiscal year by,</quote> and inserting <quote>for a product, effective October 1 of a fiscal year, by,</quote>;</text> </paragraph><paragraph id="H0A1AEA4C45B34DB8909F3FC9CCE6464B"><enum>(9)</enum><text>in paragraph (1)(D)—</text> <subparagraph id="H9440CE01C00441608043B1C5198B5EE6"><enum>(A)</enum><text>in clause (i) in the matter preceding subclause (I), by inserting <quote>, if the person seeks to resume participation in such program,</quote> before <quote>pay a fee</quote>;</text> </subparagraph><subparagraph id="H58CBCCA58CAC4B2986CE91406928722B"><enum>(B)</enum><text>in clause (i)(I), by inserting after <quote>grants a request</quote> the following: <quote>by such person</quote>; and</text> </subparagraph><subparagraph id="H631D7E06C7844E3384A6E94C547F8F49"><enum>(C)</enum><text>in clause (i)(II), by inserting after <quote>discontinued)</quote> the following: <quote>by such person</quote>;</text> </subparagraph></paragraph><paragraph commented="no" id="HAC73458A0D2D4B7D81D1F3267C50DE22"><enum>(10)</enum><text>in the heading of paragraph (1)(E), by striking <quote><header-in-text level="subparagraph" style="OLC">biosimilar development program</header-in-text></quote>;</text> </paragraph><paragraph id="H1B105C997B1C488B86223C87359205C7"><enum>(11)</enum><text>in the heading of subparagraph (F) of paragraph (1), by striking <quote><header-in-text level="subparagraph" style="OLC">biosimilar development program fees</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">biosimilar biological product development fees</header-in-text></quote>;</text> </paragraph><paragraph id="H897C61CA720047FDAB7724B1B910B0B0"><enum>(12)</enum><text>in paragraph (1)(F)—</text> <subparagraph id="HC25B3548D5284C948D4C90C8907FE816"><enum>(A)</enum><text>in the heading of subparagraph (F), by striking <quote><header-in-text level="subparagraph" style="OLC">biosimilar development program</header-in-text></quote> before <quote><header-in-text level="subparagraph" style="OLC">fees</header-in-text></quote>; and</text> </subparagraph><subparagraph id="HFC81B46F7AFA46A4AB703286FDFF6703"><enum>(B)</enum><text>by amending clause (i) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H3F5AACBE73C44C04B0F543C990C8A7B7" style="OLC"> <clause id="H907D2892F7354914BC8219AFDE6A1F51"><enum>(i)</enum><header>Refunds</header><text display-inline="yes-display-inline">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).</text></clause><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph></paragraph><paragraph id="HB69ACA1A52BD4A3D9FEBE1272084BEBF"><enum>(13)</enum><text>in paragraph (2)—</text> <subparagraph id="H36477556E12642C39F783A8873AA10BF"><enum>(A)</enum><text>in the heading of paragraph (2), by striking <quote><header-in-text level="paragraph" style="OLC">and supplement</header-in-text></quote>;</text> </subparagraph><subparagraph id="H1433B7C43D7044B3801EACF5869CB018"><enum>(B)</enum><text>by amending subparagraphs (A) and (B) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="HA8D4C96FC77D4F41AE1011E831B8B021" style="OLC"> <subparagraph id="H795EACC3FCED4A4592077AD55ABF5B25"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:</text> <clause id="HE6D1490E9ABF400F9BF00F2D1B1F258D"><enum>(i)</enum><text>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.</text> </clause><clause id="H732D7D7270934C748947E01F2F50DD6C"><enum>(ii)</enum><text>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).</text> </clause></subparagraph><subparagraph commented="no" id="H5000894C2DF7415FB8F87491E7BA4B92"><enum>(B)</enum><header>Rule of applicability; treatment of certain previously paid fees</header><text>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—</text> <clause commented="no" id="H4E46CBCA3E19420DBF477E81BCFBCD37"><enum>(i)</enum><text>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</text> </clause><clause commented="no" id="H3F2AF0DE3DA04CAAA7B48CC5EDB84004"><enum>(ii)</enum><text>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).</text></clause></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block> </subparagraph><subparagraph id="HD2E1C28ECFB7436D86D8CE1F2E942822"><enum>(C)</enum><text>in the heading of subparagraph (D), by striking <quote><header-in-text level="subparagraph" style="OLC">or supplement</header-in-text></quote>; and</text> </subparagraph><subparagraph id="H2B20CC2A571A4DD8B557D6C7314A7019"><enum>(D)</enum><text>in subparagraphs (C) through (F)—</text> <clause id="H09C71DBBB2CB45568FC716DF74E272C8"><enum>(i)</enum><text>by striking <quote>or supplement</quote> each place it appears; and</text> </clause><clause id="HC64815E8A2CD4761BE95AFD8728B3768"><enum>(ii)</enum><text>in subparagraph (D), by striking <quote>or a supplement</quote>; and</text> </clause></subparagraph></paragraph><paragraph id="HEF8FB3A869C642978676EF50CC688B1C"><enum>(14)</enum><text>by amending paragraph (3) to read as follows:</text> <quoted-block display-inline="no-display-inline" id="H80577E9071AB418BB3EAA2CDB4E927C3" style="OLC"> <paragraph id="H7FD5216C381942AE9588A5B07BBF52FC"><enum>(3)</enum><header>Biosimilar biological product program fee</header> <subparagraph id="H158E9379630C4030BE3C3609F1DEEB2F"><enum>(A)</enum><header>In general</header><text>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—</text> <clause id="HAF8B1DF9CACE4B9285CD471638C3832A"><enum>(i)</enum><text>is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and</text> </clause><clause id="H9C9FB18691004185AAA1B4DB30EA8743"><enum>(ii)</enum><text>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.</text> </clause></subparagraph><subparagraph id="H2AAE2B05C0BD4323B607930729E4DC77"><enum>(B)</enum><header>Due date</header><text>The biosimilar biological product program fee for a fiscal year shall be due on the later of—</text> <clause id="HDAE68E1B11634B89AE566FB16F8E9DDB"><enum>(i)</enum><text>the first business day on or after October 1 of each such year; or</text> </clause><clause id="H8E9178DD3DA24D3C983BB54466562B5A"><enum>(ii)</enum><text>the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.</text> </clause></subparagraph><subparagraph id="HFA4A9ECB53A9430A89FF90FB79885CB7"><enum>(C)</enum><header>One fee per product per year</header><text>The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.</text> </subparagraph><subparagraph id="H995BDF571AE5474D9407B1027496F445"><enum>(D)</enum><header>Limitation</header><text>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.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection id="H7CE24AAA440948E9A01455D8A3B23D31"><enum>(b)</enum><header>Fee revenue amounts</header><text display-inline="yes-display-inline">Subsection (b) of section 744H of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-52">21 U.S.C. 379j–52</external-xref>) is amended to read as follows:</text> <quoted-block display-inline="no-display-inline" id="HD7BA63B7AAE64449A0EB4A4588E739E5" style="OLC"> <subsection id="HEEA0C73B82CE412DA9279F7F7FB93E3A"><enum>(b)</enum><header>Fee revenue amounts</header> <paragraph id="H163E5B8AE0334E428C843898985B29E6"><enum>(1)</enum><header>Fiscal year 2018</header><text>For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of—</text> <subparagraph id="H33C746955A564F2AA1ECB41A438082FD"><enum>(A)</enum><text>$45,000,000; and</text> </subparagraph><subparagraph id="H97874F6E21054F9E830182668CE15600"><enum>(B)</enum><text>the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)).</text> </subparagraph></paragraph><paragraph id="H7DA72D7BF75845F1806D4A5AFF0CDBEE"><enum>(2)</enum><header>Subsequent fiscal years</header><text>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—</text> <subparagraph id="H124AFA609AB24F8E829379252BF756D3"><enum>(A)</enum><text>the annual base revenue for the fiscal year (as determined under paragraph (4));</text> </subparagraph><subparagraph id="H884CD912C0D04771BF2B7877028723DB"><enum>(B)</enum><text>the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));</text> </subparagraph><subparagraph id="H2ED79EC28F5243058211BE3B5F4827AF"><enum>(C)</enum><text>the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and</text> </subparagraph><subparagraph id="H0469292BD30F4047A2D2814D104151DF"><enum>(D)</enum><text>the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)).</text> </subparagraph></paragraph><paragraph id="HA204BDFC2D8F4B2E848EA6928AC9274C"><enum>(3)</enum><header>Allocation of revenue amount among fees; limitations on fee amounts</header> <subparagraph id="H5D4E5EE798B9468CBB0E677806253239"><enum>(A)</enum><header>Allocation</header><text>The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—</text> <clause id="H28F3407AFF3E4917BBA739E0C57DDF7C"><enum>(i)</enum><text>initial and annual biosimilar development fees and reactivation fees under subsection (a)(1);</text> </clause><clause id="H697BFD860BDA41A5BE767A8CC88FD9CC"><enum>(ii)</enum><text>biosimilar biological product application fees under subsection (a)(2); and</text> </clause><clause id="H79AE4C4751F447F98E66F30085B52552"><enum>(iii)</enum><text>biosimilar biological product program fees under subsection (a)(3).</text> </clause></subparagraph><subparagraph id="H6576EF0DADFF4E978EBD94822A83877F"><enum>(B)</enum><header>Limitations on fee amounts</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph commented="no" id="H5F2478DFDD72497C9EBB8D01B3B6E127"><enum>(C)</enum><header>Biosimilar biological product development fees</header><text>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.</text> </subparagraph><subparagraph commented="no" id="H5373623028384D3BA69F194D8746EC59"><enum>(D)</enum><header>Reactivation fee</header><text>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.</text> </subparagraph></paragraph><paragraph id="H528A1E9999FB4C4BA7C3159656F4665E"><enum>(4)</enum><header>Annual base revenue</header><text>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).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </subsection><subsection id="HDE2801882688483AAD5F5F8099A40037"><enum>(c)</enum><header>Adjustments; annual fee setting</header><text>Section 744H of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-52">21 U.S.C. 379j–52</external-xref>) is amended—</text> <paragraph id="HA4DFEA4B574B4C8A829973B024F67D4E"><enum>(1)</enum><text>by redesignating subsections (c) through (h) as subsections (d) through (i), respectively;</text> </paragraph><paragraph id="HA73E0120DAA24426AF02AD76ABD8BAAC"><enum>(2)</enum><text>in subsections (a)(2)(F) and (g), by striking <quote>subsection (c)</quote> and inserting <quote>subsection (d)</quote>;</text> </paragraph><paragraph id="HBA172848B1A54046BCD118388271BF6B"><enum>(3)</enum><text>in subsection (a)(4)(A), by striking <quote>subsection (b)(1)(F)</quote> and inserting <quote>subsection (c)(5)</quote>; and</text> </paragraph><paragraph id="HA11D3339292341DBA96FBB0748B51AFE"><enum>(4)</enum><text>by inserting after subsection (b) the following:</text> <quoted-block display-inline="no-display-inline" id="H6053DA43C1F14413AAF8B15749571023" style="OLC"> <subsection id="H9943D7CD55A944AC9E930FF8C0EFBC3A"><enum>(c)</enum><header>Adjustments; annual fee setting</header> <paragraph id="H8BF1291D6B3546339AF180CAC8C01F47"><enum>(1)</enum><header>Inflation adjustment</header> <subparagraph id="H43723A3BCB15481CACA8427D3A1D1F9B"><enum>(A)</enum><header>In general</header><text>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—</text> <clause id="H3D6C2023B28249FC8A96FF4E85A21AE5"><enum>(i)</enum><text>such annual base revenue for the fiscal year under subsection (b); and</text> </clause><clause id="H99925CED573548DC8A8187B58AFF0005"><enum>(ii)</enum><text>the inflation adjustment percentage under subparagraph (B).</text> </clause></subparagraph><subparagraph id="HD9EB16126783450DB012A65AC5489A36"><enum>(B)</enum><header>Inflation adjustment percentage</header><text>The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—</text> <clause id="HFCB543196D0A426CB80AA049272ED22D"><enum>(i)</enum><text>the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 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</text> </clause><clause id="H19DB2E63BE0F47478F83F51EDEA949AF"><enum>(ii)</enum><text display-inline="yes-display-inline">the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 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.</text> </clause></subparagraph></paragraph><paragraph id="H2F09C8DBA97947FE9E8BFB413920D68E"><enum>(2)</enum><header>Capacity planning adjustment</header> <subparagraph commented="no" id="HF390E1EAA2C344F7B481C95260C844A7"><enum>(A)</enum><header>In general</header><text display-inline="yes-display-inline">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.</text> </subparagraph><subparagraph id="H37507E8B260B4334AB5B82F862727B55"><enum>(B)</enum><header>Capacity planning methodology</header> <clause id="H8F8832DAB9FA4C68A6A7FD141A9C8B46"><enum>(i)</enum><header>Development; evaluation and report</header><text>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 capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment not later than September 30, 2020.</text> </clause><clause id="H91C4611BD4C54964B715356F0615073D"><enum>(ii)</enum><header>Establishment and implementation</header><text>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—</text> <subclause id="HA111FEA5FBB9419DAC351F2CDF2965C6"><enum>(I)</enum><text>incorporate such approaches and attributes as the Secretary determines appropriate; and</text> </subclause><subclause id="H83C9BE9E1A4B40F2BDFF7A927769A208"><enum>(II)</enum><text>be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.</text> </subclause></clause></subparagraph><subparagraph id="HC0CBE8B99A0145CC9F1D9440AD4AABCD"><enum>(C)</enum><header>Limitation</header><text>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).</text> </subparagraph><subparagraph id="H1748599E6F4A4F909AA42FA261F1C83C"><enum>(D)</enum><header>Publication in federal register</header><text>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.</text> </subparagraph></paragraph><paragraph commented="no" id="H79547C53F6834BF080E2F34490A2082B"><enum>(3)</enum><header>Operating reserve adjustment</header> <subparagraph commented="no" id="HD70A6CAC5D5A4E53BAEEEA9282AE056E"><enum>(A)</enum><header>Interim application; fee reduction</header><text>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.</text> </subparagraph><subparagraph commented="no" id="HAA526D1017B34BD5B768A61E9539D6A3"><enum>(B)</enum><header>General application and methodology</header><text>Beginning with the first 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)—</text> <clause commented="no" id="H1CBBCF20D1CB4965A8C12A4C1A7076EA"><enum>(i)</enum><text>reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or</text> </clause><clause commented="no" id="HEC5CC1ED39F24138ABE06AB2A1E42BAF"><enum>(ii)</enum><text>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.</text> </clause></subparagraph><subparagraph commented="no" id="HBFA5AA0CED51408E9C5A7533C2A5A5E2"><enum>(C)</enum><header>Federal register notice</header><text>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.</text> </subparagraph></paragraph><paragraph id="H5922101E4EC0443A81A5A12EDAE93ABB"><enum>(4)</enum><header>Fiscal year 2018 adjustment</header> <subparagraph id="HF13A4BCD6C6B4939A0401C718313E1B9"><enum>(A)</enum><header>In general</header><text>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 assessment of the workload for the process for the review of biosimilar biological product applications.</text> </subparagraph><subparagraph id="H096F396FA512420AADD4825F4D20B8C9"><enum>(B)</enum><header>Methodology</header><text>The Secretary shall publish under paragraph (5) 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.</text> </subparagraph><subparagraph id="H447FC3D6A88E41F4B4DFABD2E4D2BDAA"><enum>(C)</enum><header>Limitation</header><text>No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000.</text> </subparagraph></paragraph><paragraph id="H0411BECFBEE84A40BB048ECCA4F2FE8F"><enum>(5)</enum><header>Annual fee setting</header><text>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—</text> <subparagraph id="H8BF01ED0BE21478F9B5C6CD883AE26ED"><enum>(A)</enum><text display-inline="yes-display-inline">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</text> </subparagraph><subparagraph id="H2B5C310012F9446387FC15D83129485E"><enum>(B)</enum><text>publish such fee revenue and fees in the Federal Register.</text> </subparagraph></paragraph><paragraph id="H7F27BF3F21FF453F95C1E6E8232B2303"><enum>(6)</enum><header>Limit</header><text>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.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block> </paragraph></subsection><subsection id="H4E0AD306F15040B7AC5D0ECDC91D76DE"><enum>(d)</enum><header>Application fee waiver for small business</header><text display-inline="yes-display-inline">Subsection (d)(1) of section 744H of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-52">21 U.S.C. 379j–52</external-xref>), as redesignated by subsection (c)(1), is amended—</text> <paragraph id="H7C17580EABB1460A832D2DDEAED7D65B"><enum>(1)</enum><text>by striking subparagraph (B);</text> </paragraph><paragraph id="H567C7096075C4C349BDD4DA8A96D214C"><enum>(2)</enum><text>by striking <quote>shall pay—</quote> and all that follows through <quote>application fees</quote> and inserting <quote>shall pay application fees</quote>; and</text> </paragraph><paragraph id="HE693330A18FD4242B19FFB5BE85BF604"><enum>(3)</enum><text>by striking <quote>; and</quote> at the end and inserting a period.</text> </paragraph></subsection><subsection id="H63521D6183084D05B82EB3F2E7EC8D92"><enum>(e)</enum><header>Effect of failure To pay fees</header><text>Subsection (e) of section 744H of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-52">21 U.S.C. 379j–52</external-xref>), as redesignated by subsection (c)(1), is amended by striking <quote>all fees</quote> and inserting <quote>all such fees</quote>.</text> </subsection><subsection commented="no" id="H0620D4D6CF7A4359AA0B9F593043978C"><enum>(f)</enum><header>Crediting and availability of fees</header><text display-inline="yes-display-inline">Subsection (f) of section 744H of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-52">21 U.S.C. 379j–52</external-xref>), as redesignated by subsection (c)(1), is amended—</text> <paragraph commented="no" id="HF1E19BC3BF8D48ECA2F907D4C99B548C"><enum>(1)</enum><text display-inline="yes-display-inline">in paragraph (2)—</text> <subparagraph commented="no" id="H8CEEDFA9383E4BA7BFD6C88D52394BC8"><enum>(A)</enum><text display-inline="yes-display-inline">by striking subparagraph (C) (relating to fee collection during first program year) and inserting the following:</text> <quoted-block display-inline="no-display-inline" id="H355FC04716E04BDA97D707FD42DD9F43" style="OLC"> <subparagraph id="HDFCEC7A60ACF4918BE1C05BF8029CFB0"><enum>(C)</enum><header>Compliance</header><text display-inline="yes-display-inline">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.</text></subparagraph><after-quoted-block>; and</after-quoted-block></quoted-block> </subparagraph><subparagraph commented="no" id="H77E7B642213144F6B3B9BF7E8AE75DB1"><enum>(B)</enum><text>in subparagraph (D)—</text> <clause commented="no" id="H2CB9B6BADDF648F59FD88E8DE368E831"><enum>(i)</enum><text>in the heading, by striking <quote><header-in-text level="subparagraph" style="OLC">in subsequent years</header-in-text></quote>; and</text> </clause><clause commented="no" id="H6F719B1A148646F19D871158E87BAEB5"><enum>(ii)</enum><text>by striking <quote>(after fiscal year 2013)</quote>; and</text> </clause></subparagraph></paragraph><paragraph id="H21C7DC2D8F7F4BC192F2E39CBE017066"><enum>(2)</enum><text>in paragraph (3), by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>.</text> </paragraph></subsection></section><section id="H6514EAD0E4DE4956B81140AE2F3AF717"><enum>404.</enum><header>Reauthorization; reporting requirements</header><text display-inline="no-display-inline">Section 744I of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/379j-53">21 U.S.C. 379j–53</external-xref>) is amended—</text> <paragraph id="H90E98C9538254339BB73F57FAD69924D"><enum>(1)</enum><text>in subsection (a)—</text> <subparagraph id="H9CB28F19477442568584191813AEE08C"><enum>(A)</enum><text>by striking <quote>2013</quote> and inserting <quote>2018</quote>; and</text> </subparagraph><subparagraph id="H834B3DA3A3364970A46B4C1966E3AD39"><enum>(B)</enum><text>by striking <quote>Biosimilar User Fee Act of 2012</quote> and inserting <quote><short-title>Biosimilar User Fee Amendments of 2017</short-title></quote>;</text> </subparagraph></paragraph><paragraph id="H817C7F1E07344B7E9AD944188DF51C1A"><enum>(2)</enum><text>in subsection (b), by striking <quote>2013</quote> and inserting <quote>2018</quote>;</text> </paragraph><paragraph id="HD5F239C2D5AC44FAB6308CD43BF5EBA0"><enum>(3)</enum><text>by striking subsection (d);</text> </paragraph><paragraph id="H7B4E8A2F7F034117B68BF58B4DFADAA0"><enum>(4)</enum><text>by redesignating subsection (e) as subsection (d); and</text> </paragraph><paragraph id="H0B25A9C280EA4256941E1C3DD8C8EB3F"><enum>(5)</enum><text>in subsection (d), as so redesignated, by striking <quote>2017</quote> each place it appears and inserting <quote>2022</quote>.</text> </paragraph></section><section id="HF762A909A8AE44059CB6C32CA4055BD5"><enum>405.</enum><header>Sunset dates</header> <subsection id="HF5D333D948C249728F27F72B07080772"><enum>(a)</enum><header>Authorization</header><text>Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act, as amended by section 403 of this Act, shall cease to be effective October 1, 2022.</text> </subsection><subsection id="HAB79B06AE8F24DF7ABD11E738C048196"><enum>(b)</enum><header>Reporting Requirements</header><text>Section 744I of the Federal Food, Drug, and Cosmetic Act, as amended by section 404 of this Act, shall cease to be effective January 31, 2023.</text> </subsection><subsection id="H037986F8B2DF4D2CABF962D158306534"><enum>(c)</enum><header>Previous Sunset Provision</header> <paragraph id="H149F7CB9DFAD40D1A981175A9253F91A"><enum>(1)</enum><header>In general</header><text>Effective October 1, 2017, section 404 of the Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="public-law" parsable-cite="pl/112/144">Public Law 112–144</external-xref>) is repealed.</text> </paragraph><paragraph id="HEBF54BE8EBD2413FAA4738EF16AEB75B"><enum>(2)</enum><header>Conforming amendment</header><text display-inline="yes-display-inline">The Food and Drug Administration Safety and Innovation Act (<external-xref legal-doc="public-law" parsable-cite="pl/112/144">Public Law 112–144</external-xref>) is amended in the table of contents in section 2 by striking the item relating to section 404.</text> </paragraph></subsection></section><section id="HFC04D92F4B4B461A8CEFAE090ED66C0B"><enum>406.</enum><header>Effective date</header><text display-inline="no-display-inline">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.</text> </section><section commented="no" display-inline="no-display-inline" id="H3847B20361C642FDAC39D2FADEAC5F26" section-type="subsequent-section"><enum>407.</enum><header>Savings clause</header><text display-inline="no-display-inline">Notwithstanding 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.</text> </section><enum>V</enum><header>Reauthorization of other programs</header> <section id="HBC93978EE4404C619B4568863D3F6545"><enum>501.</enum><header>Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers</header><text display-inline="no-display-inline">Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355(u)(4)</external-xref>) is amended by striking <quote>2017</quote> and inserting <quote>2022</quote>.</text> </section><section id="H223CEA338F1B4B97BBC48256085A1B7B"><enum>502.</enum><header>Reauthorization of pediatric humanitarian device exceptions</header><text display-inline="no-display-inline">Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360j">21 U.S.C. 360j(m)(6)(A)(iv)</external-xref>) is amended by striking <quote>2017</quote> and inserting <quote>2022</quote>.</text> </section><section id="H221FCED32A0840A697ACF90D8AD4AE3D"><enum>503.</enum><header>Reauthorization of the critical path public-private partnerships</header><text display-inline="no-display-inline">Section 566(f) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-5">21 U.S.C. 360bbb–5(f)</external-xref>) is amended by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>.</text> </section><section id="H42D1F1A5D4E046849199B63FAC63619A"><enum>504.</enum><header>Reauthorization of pediatric device consortia</header><text display-inline="no-display-inline">Section 305(e) of Pediatric Medical Device Safety and Improvement Act of 2007 (<external-xref legal-doc="public-law" parsable-cite="pl/110/85">Public Law 110–85</external-xref>; <external-xref legal-doc="usc" parsable-cite="usc/42/282">42 U.S.C. 282</external-xref> note) is amended by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>.</text> </section><section commented="no" display-inline="no-display-inline" id="H0B1A79A0BD1844E59CBC020B4C8A56F7" section-type="subsequent-section"><enum>505.</enum><header>Reauthorization of orphan grants program</header><text display-inline="no-display-inline">Section 5(c) of the Orphan Drug Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360ee">21 U.S.C. 360ee(c)</external-xref>) is amended by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>.</text> </section><section id="HBB19E850A78E4EB288B0AFD6C09B57A6"><enum>506.</enum><header>Reauthorization of inspection program</header><text display-inline="no-display-inline">Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374(g)(11)</external-xref>) is amended by striking <quote>October 1, 2017</quote> and inserting <quote>October 1, 2022</quote>.</text> </section><section id="HB524F09836AE4B5E8CB43297133FE4A8"><enum>507.</enum><header>Reauthorization of pediatric study of drugs</header><text display-inline="no-display-inline">Section 409I(e)(1) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/284m">42 U.S.C. 284m(e)(1)</external-xref>) is amended by striking <quote>2013 through 2017</quote> and inserting <quote>2018 through 2022</quote>.</text> </section><enum>VI</enum><header>Additional Provisions</header> <section commented="no" id="H5318D8C5ED3C4D18AA2F8F9C880E1939"><enum>601.</enum><header>Technical corrections</header> <subsection commented="no" id="H5180D662A37845EFB1E9B4ACD24C4FF6"><enum>(a)</enum><text>Section 3075(a) of the 21st Century Cures Act (<external-xref legal-doc="public-law" parsable-cite="pl/114/255">Public Law 114–255</external-xref>) is amended—</text> <paragraph commented="no" id="H94825C63DDC04802BCD78BCC029E4D0C"><enum>(1)</enum><text>in the matter preceding paragraph (1), by striking <quote>as amended by section 2074</quote> and inserting <quote>as amended by section 3102</quote>; and</text> </paragraph><paragraph commented="no" id="H4B61CB64668E4576B68E045A603D0ECE"><enum>(2)</enum><text>in paragraph (2), by striking <quote>section 2074(1)(C)</quote> and inserting <quote>section 3102(1)(C)</quote>.</text> </paragraph></subsection><subsection commented="no" id="HAA1B90BB16C0463BA2EBA3C6C0DB1251"><enum>(b)</enum><text>Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/356g">21 U.S.C. 356g(b)(1)(A)</external-xref>) is amended by striking <quote>identity</quote> and inserting <quote>identify</quote>.</text> </subsection><subsection commented="no" id="H81CCFB2EAF324DB09F8EBDE5E6D4ADF4"><enum>(c)</enum><text>Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355g">21 U.S.C. 355g(b)</external-xref>) is amended by striking <quote>randomized</quote> and inserting <quote>traditional</quote>.</text> </subsection><subsection id="HF4547C89E8AA43FE8F1626378F8AEA3D"><enum>(d)</enum><text display-inline="yes-display-inline">Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355g">21 U.S.C. 355g(d)</external-xref>) is amended by striking <quote>2</quote> and inserting <quote>3</quote>.</text> </subsection><subsection id="HC5AED14E4EB04404A6C1C6157A263201"><enum>(e)</enum><text>Effective as of the enactment of the 21st Century Cures Act (<external-xref legal-doc="public-law" parsable-cite="pl/114/255">Public Law 114–255</external-xref>)—</text> <paragraph id="HB82137F42D1F4F8E8B1F9A5569D1D2CF"><enum>(1)</enum><text>section 3051(a) of such Act is amended by striking <quote>by inserting after section 515B</quote> and inserting <quote>by inserting after section 515A</quote>; and</text> </paragraph><paragraph id="H337F775768174BA49B05CD00AF71ED39"><enum>(2)</enum><text>section 515C of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e-3">21 U.S.C. 360e–3</external-xref>), as inserted by such section 3051(a), is redesignated as section 515B.</text> </paragraph></subsection><subsection commented="no" id="H477E9129A42646B4AD6C5BCA5EF781B2"><enum>(f)</enum><text>Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e-3">21 U.S.C. 360e–3(f)(2)</external-xref>), as redesignated by subsection (d)(2) of this section, is amended by striking <quote>a proposed guidance</quote> and inserting <quote>a draft version of that guidance</quote>.</text> </subsection><subsection commented="no" id="H2C80FE935B8D4167A12A92FB5FA9F431"><enum>(g)</enum><text>Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360c">21 U.S.C. 360c(b)(5)(D)</external-xref>) is amended by striking <quote>medical device submissions</quote> and inserting <quote>medical devices that may be specifically the subject of a review by a classification panel</quote>.</text> </subsection></section>