[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 934 Reported in Senate (RS)]

<DOC>





                                                        Calendar No. 76
115th CONGRESS
  1st Session
                                 S. 934

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user-fee programs for prescription drugs, medical devices, generic 
   drugs, and biosimilar biological products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 25, 2017

 Mr. Alexander (for himself and Mrs. Murray) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                              May 11, 2017

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user-fee programs for prescription drugs, medical devices, generic 
   drugs, and biosimilar biological products, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``FDA Reauthorization Act of 
2017''.</DELETED>

<DELETED>SEC. 2. TABLE OF CONTENTS.</DELETED>

<DELETED>    The table of contents for this Act is as 
follows:</DELETED>

<DELETED>Sec. 1. Short title.
<DELETED>Sec. 2. Table of contents.
                <DELETED>TITLE I--FEES RELATING TO DRUGS

<DELETED>Sec. 101. Short title; finding.
<DELETED>Sec. 102. Authority to assess and use drug fees.
<DELETED>Sec. 103. Reauthorization; reporting requirements.
<DELETED>Sec. 104. Sunset dates.
<DELETED>Sec. 105. Effective date.
<DELETED>Sec. 106. Savings clause.
              <DELETED>TITLE II--FEES RELATING TO DEVICES

<DELETED>Sec. 201. Short title; findings.
<DELETED>Sec. 202. Definitions.
<DELETED>Sec. 203. Authority to assess and use device fees.
<DELETED>Sec. 204. Reauthorization; reporting requirements.
<DELETED>Sec. 205. Conformity assessment pilot program.
<DELETED>Sec. 206. Reauthorization of review.
<DELETED>Sec. 207. Electronic format for submissions.
<DELETED>Sec. 208. Savings clause.
<DELETED>Sec. 209. Effective date.
<DELETED>Sec. 210. Sunset clause.
           <DELETED>TITLE III--FEES RELATING TO GENERIC DRUGS

<DELETED>Sec. 301. Short title; finding.
<DELETED>Sec. 302. Definitions.
<DELETED>Sec. 303. Authority to assess and use human generic drug fees.
<DELETED>Sec. 304. Reauthorization; reporting requirements.
<DELETED>Sec. 305. Sunset dates.
<DELETED>Sec. 306. Effective date.
<DELETED>Sec. 307. Savings clause.
   <DELETED>TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

<DELETED>Sec. 401. Short title; finding.
<DELETED>Sec. 402. Definitions.
<DELETED>Sec. 403. Authority to assess and use biosimilar fees.
<DELETED>Sec. 404. Reauthorization; reporting requirements.
<DELETED>Sec. 405. Sunset dates.
<DELETED>Sec. 406. Effective date.
<DELETED>Sec. 407. Savings clause.
          <DELETED>TITLE V--REAUTHORIZATION OF OTHER PROGRAMS

<DELETED>Sec. 501. Reauthorization of provision relating to exclusivity 
                            of certain drugs containing single 
                            enantiomers.
<DELETED>Sec. 502. Reauthorization of pediatric humanitarian device 
                            exceptions.
<DELETED>Sec. 503. Reauthorization of the critical path public-private 
                            partnerships.
<DELETED>Sec. 504. Reauthorization of pediatric device consortia.
<DELETED>Sec. 505. Reauthorization of orphan grants program.

           <DELETED>TITLE I--FEES RELATING TO DRUGS</DELETED>

<DELETED>SEC. 101. SHORT TITLE; FINDING.</DELETED>

<DELETED>    (a) Short Title.--This title may be cited as the 
``Prescription Drug User Fee Amendments of 2017''.</DELETED>
<DELETED>    (b) Finding.--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.</DELETED>

<DELETED>SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.</DELETED>

<DELETED>    (a) Types of Fees.--</DELETED>
        <DELETED>    (1) In general.--Section 736(a) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
        </DELETED>
                <DELETED>    (A) in the matter preceding paragraph (1), 
                by striking ``fiscal year 2013'' and inserting ``fiscal 
                year 2018'';</DELETED>
                <DELETED>    (B) in the heading of paragraph (1), by 
                striking ``and supplement'';</DELETED>
                <DELETED>    (C) in paragraph (1), by striking ``or a 
                supplement'' and ``or supplement'' each place either 
                appears;</DELETED>
                <DELETED>    (D) in paragraph (1)(A)--</DELETED>
                        <DELETED>    (i) in clause (i), by striking 
                        ``(c)(4)'' and inserting ``(c)(5)''; 
                        and</DELETED>
                        <DELETED>    (ii) in clause (ii), by striking 
                        ``A fee established'' and all that follows 
                        through ``are required.'' and inserting the 
                        following: ``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.'';</DELETED>
                <DELETED>    (E) in the heading of paragraph (1)(C), by 
                striking ``or supplement'';</DELETED>
                <DELETED>    (F) in paragraph (1)(F)--</DELETED>
                        <DELETED>    (i) in the heading, by striking 
                        ``or indication''; and</DELETED>
                        <DELETED>    (ii) by striking the second 
                        sentence;</DELETED>
                <DELETED>    (G) by striking paragraph (2) (relating to 
                a prescription drug establishment fee);</DELETED>
                <DELETED>    (H) by redesignating paragraph (3) as 
                paragraph (2);</DELETED>
                <DELETED>    (I) in the heading of paragraph (2), as so 
                redesignated, by striking ``Prescription drug product 
                fee'' and inserting ``Prescription drug program 
                fee'';</DELETED>
                <DELETED>    (J) in subparagraph (A) of such paragraph 
                (2), by amending the first sentence to read as follows: 
                ``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.'';</DELETED>
                <DELETED>    (K) in subparagraph (B) of such paragraph 
                (2)--</DELETED>
                        <DELETED>    (i) in the heading of subparagraph 
                        (B), by inserting after ``Exception'' the 
                        following: ``for certain prescription drug 
                        products''; and</DELETED>
                        <DELETED>    (ii) by striking ``A prescription 
                        drug product shall not be assessed a fee'' and 
                        inserting ``A prescription drug program fee 
                        shall not be assessed for a prescription drug 
                        product''; and</DELETED>
                <DELETED>    (L) by adding at the end of such paragraph 
                (2) the following:</DELETED>
                <DELETED>    ``(C) Limitation.--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.''.</DELETED>
        <DELETED>    (2) Conforming amendment.--Subparagraph (C) of 
        section 740(a)(3) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 379j-12(a)(3)) is amended to read as 
        follows:</DELETED>
                <DELETED>    ``(C) Limitation.--An establishment shall 
                be assessed only one fee per fiscal year under this 
                section.''.</DELETED>
<DELETED>    (b) Fee Revenue Amounts.--Subsection (b) of section 736 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to 
read as follows:</DELETED>
<DELETED>    ``(b) Fee Revenue Amounts.--</DELETED>
        <DELETED>    ``(1) In general.--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--</DELETED>
                <DELETED>    ``(A) the annual base revenue for the 
                fiscal year (as determined under paragraph 
                (3));</DELETED>
                <DELETED>    ``(B) the dollar amount equal to the 
                inflation adjustment for the fiscal year (as determined 
                under subsection (c)(1));</DELETED>
                <DELETED>    ``(C) the dollar amount equal to the 
                capacity planning adjustment for the fiscal year (as 
                determined under subsection (c)(2));</DELETED>
                <DELETED>    ``(D) the dollar amount equal to the 
                operating reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection 
                (c)(3));</DELETED>
                <DELETED>    ``(E) the dollar amount equal to the 
                additional direct cost adjustment for the fiscal year 
                (as determined under subsection (c)(4)); and</DELETED>
                <DELETED>    ``(F) additional dollar amounts for each 
                fiscal year as follows:</DELETED>
                        <DELETED>    ``(i) $20,077,793 for fiscal year 
                        2018;</DELETED>
                        <DELETED>    ``(ii) $21,317,472 for fiscal year 
                        2019;</DELETED>
                        <DELETED>    ``(iii) $16,953,329 for fiscal 
                        year 2020;</DELETED>
                        <DELETED>    ``(iv) $5,426,896 for fiscal year 
                        2021; and</DELETED>
                        <DELETED>    ``(v) $2,769,609 for fiscal year 
                        2022.</DELETED>
        <DELETED>    ``(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--</DELETED>
                <DELETED>    ``(A) 20 percent shall be derived from 
                human drug application fees under subsection (a)(1); 
                and</DELETED>
                <DELETED>    ``(B) 80 percent shall be derived from 
                prescription drug program fees under subsection 
                (a)(2).</DELETED>
        <DELETED>    ``(3) Annual base revenue.--For purposes of 
        paragraph (1), the dollar amount of the annual base revenue for 
        a fiscal year shall be--</DELETED>
                <DELETED>    ``(A) for fiscal year 2018, $878,590,000; 
                and</DELETED>
                <DELETED>    ``(B) 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).''.</DELETED>
<DELETED>    (c) Adjustments; Annual Fee Setting.--Subsection (c) of 
section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h) is amended to read as follows:</DELETED>
<DELETED>    ``(c) Adjustments; Annual Fee Setting.--</DELETED>
        <DELETED>    ``(1) Inflation adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--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--
                </DELETED>
                        <DELETED>    ``(i) such annual base revenue for 
                        the fiscal year under subsection (b)(1)(A); 
                        and</DELETED>
                        <DELETED>    ``(ii) the inflation adjustment 
                        percentage under subparagraph (B).</DELETED>
                <DELETED>    ``(B) Inflation adjustment percentage.--
                The inflation adjustment percentage under this 
                subparagraph for a fiscal year is equal to the sum of--
                </DELETED>
                        <DELETED>    ``(i) 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</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
        <DELETED>    ``(2) Capacity planning adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--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.</DELETED>
                <DELETED>    ``(B) Interim methodology.--</DELETED>
                        <DELETED>    ``(i) In general.--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--</DELETED>
                                <DELETED>    ``(I) the annual base 
                                revenue for such year, as adjusted for 
                                inflation under paragraph (1); 
                                and</DELETED>
                                <DELETED>    ``(II) the adjustment 
                                percentage under clause (ii).</DELETED>
                        <DELETED>    ``(ii) Adjustment percentage.--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--
                        </DELETED>
                                <DELETED>    ``(I) the total number of 
                                human drug applications, efficacy 
                                supplements, and manufacturing 
                                supplements submitted to the 
                                Secretary;</DELETED>
                                <DELETED>    ``(II) the total number of 
                                active commercial investigational new 
                                drug applications; and</DELETED>
                                <DELETED>    ``(III) the total number 
                                of formal meetings scheduled by the 
                                Secretary, and written responses issued 
                                by the Secretary in lieu of such formal 
                                meetings, as identified in section I.H 
                                of the letters described in section 
                                101(b) of the Prescription Drug User 
                                Fee Amendments of 2017.</DELETED>
                <DELETED>    ``(C) Capacity planning methodology.--
                </DELETED>
                        <DELETED>    ``(i) Development; evaluation and 
                        report.--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.</DELETED>
                        <DELETED>    ``(ii) Establishment and 
                        implementation.--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--</DELETED>
                                <DELETED>    ``(I) replace the interim 
                                methodology under subparagraph 
                                (B);</DELETED>
                                <DELETED>    ``(II) incorporate such 
                                approaches and attributes as the 
                                Secretary determines appropriate; 
                                and</DELETED>
                                <DELETED>    ``(III) be effective 
                                beginning with the first fiscal year 
                                for which fees are set after such 
                                capacity planning methodology is 
                                established.</DELETED>
                <DELETED>    ``(D) Limitation.--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).</DELETED>
                <DELETED>    ``(E) Publication in federal register.--
                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.</DELETED>
        <DELETED>    ``(3) Operating reserve adjustment.--</DELETED>
                <DELETED>    ``(A) Increase.--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.</DELETED>
                <DELETED>    ``(B) Decrease.--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.</DELETED>
                <DELETED>    ``(C) Notice of rationale.--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.</DELETED>
        <DELETED>    ``(4) Additional direct cost adjustment.--
        </DELETED>
                <DELETED>    ``(A) In general.--The Secretary shall, in 
                addition to adjustments under paragraphs (1), (2), and 
                (3), further increase the fee revenue and fees--
                </DELETED>
                        <DELETED>    ``(i) for fiscal year 2018, by 
                        $8,730,000; and</DELETED>
                        <DELETED>    ``(ii) for fiscal year 2019 and 
                        subsequent fiscal years, by the amount 
                        determined under subparagraph (B).</DELETED>
                <DELETED>    ``(B) Amount.--The amount determined under 
                this subparagraph is--</DELETED>
                        <DELETED>    ``(i) $8,730,000, multiplied 
                        by</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
        <DELETED>    ``(5) Annual fee setting.--The Secretary shall, 
        not later than 60 days before the start of each fiscal year 
        that begins after September 30, 2017--</DELETED>
                <DELETED>    ``(A) 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</DELETED>
                <DELETED>    ``(B) publish such fee revenue and fees in 
                the Federal Register.</DELETED>
        <DELETED>    ``(6) Limit.--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.''.</DELETED>
<DELETED>    (d) Fee Waiver or Reduction.--Section 736(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) by inserting ``or'' at the end of 
                subparagraph (B);</DELETED>
                <DELETED>    (B) by striking subparagraph (C); 
                and</DELETED>
                <DELETED>    (C) by redesignating subparagraph (D) as 
                subparagraph (C);</DELETED>
        <DELETED>    (2) by striking paragraph (3) (relating to use of 
        standard costs);</DELETED>
        <DELETED>    (3) by redesignating paragraph (4) as paragraph 
        (3); and</DELETED>
        <DELETED>    (4) in paragraph (3), as so redesignated--
        </DELETED>
                <DELETED>    (A) in subparagraphs (A) and (B), by 
                striking ``paragraph (1)(D)'' and inserting ``paragraph 
                (1)(C)''; and</DELETED>
                <DELETED>    (B) in subparagraph (B)--</DELETED>
                        <DELETED>    (i) by striking clause 
                        (ii);</DELETED>
                        <DELETED>    (ii) by striking ``shall pay'' 
                        through ``(i) application fees'' and inserting 
                        ``shall pay application fees''; and</DELETED>
                        <DELETED>    (iii) by striking ``; and'' at the 
                        end and inserting a period.</DELETED>
<DELETED>    (e) Effect of Failure To Pay Fees.--Section 736(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by 
striking ``all fees'' and inserting ``all such fees''.</DELETED>
<DELETED>    (f) Limitations.--Section 736(f)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 
``supplements, prescription drug establishments, and prescription drug 
products'' and inserting ``prescription drug program fees''.</DELETED>
<DELETED>    (g) Crediting and Availability of Fees.--Section 736(g) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is 
amended--</DELETED>
        <DELETED>    (1) in paragraph (3)--</DELETED>
                <DELETED>    (A) by striking ``2013 through 2017'' and 
                inserting ``2018 through 2022''; and</DELETED>
                <DELETED>    (B) by striking ``and paragraph (4) of 
                this subsection''; and</DELETED>
        <DELETED>    (2) by striking paragraph (4).</DELETED>
<DELETED>    (h) Orphan Drugs.--Section 736(k) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking 
``product and establishment fees'' each place it appears and inserting 
``prescription drug program fees''.</DELETED>

<DELETED>SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>

<DELETED>    Section 736B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h-2) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(1)--</DELETED>
                <DELETED>    (A) in the matter before subparagraph (A), 
                by striking ``2013'' and inserting ``2018''; 
                and</DELETED>
                <DELETED>    (B) in subparagraph (A), by striking 
                ``Prescription Drug User Fee Amendments of 2012'' and 
                inserting ``Prescription Drug User Fee Amendments of 
                2017'';</DELETED>
        <DELETED>    (2) in subsection (b), by striking ``2013'' and 
        inserting ``2018''; and</DELETED>
        <DELETED>    (3) in subsection (d), by striking ``2017'' each 
        place it appears and inserting ``2022''.</DELETED>

<DELETED>SEC. 104. SUNSET DATES.</DELETED>

<DELETED>    (a) Authorization.--Sections 735 and 736 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be 
effective October 1, 2022.</DELETED>
<DELETED>    (b) Reporting Requirements.--Section 736B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be 
effective January 31, 2023.</DELETED>
<DELETED>    (c) Previous Sunset Provision.--Effective October 1, 2017, 
subsections (a) and (b) of section 105 of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) are 
repealed.</DELETED>

<DELETED>SEC. 105. EFFECTIVE DATE.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 106. SAVINGS CLAUSE.</DELETED>

<DELETED>    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.</DELETED>

         <DELETED>TITLE II--FEES RELATING TO DEVICES</DELETED>

<DELETED>SEC. 201. SHORT TITLE; FINDINGS.</DELETED>

<DELETED>    (a) Short Title.--This title may be cited as the ``Medical 
Device User Fee Amendments of 2017''.</DELETED>
<DELETED>    (b) Findings.--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.</DELETED>

<DELETED>SEC. 202. DEFINITIONS.</DELETED>

<DELETED>    Section 737 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i) is amended--</DELETED>
        <DELETED>    (1) by redesignating paragraphs (8) through (13) 
        as paragraphs (9) through (14), respectively;</DELETED>
        <DELETED>    (2) by inserting after paragraph (7) the following 
        new paragraph:</DELETED>
        <DELETED>    ``(8) The term `de novo classification request' 
        means a request made under section 513(f)(2)(A) with respect to 
        the classification of a device.'';</DELETED>
        <DELETED>    (3) in subparagraph (D) of paragraph (10) (as 
        redesignated by paragraph (1)), by striking ``and submissions'' 
        and inserting ``submissions, and de novo classification 
        requests''; and</DELETED>
        <DELETED>    (4) in paragraph (11) (as redesignated by 
        paragraph (1)), by striking ``2011'' and inserting 
        ``2016''.</DELETED>

<DELETED>SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.</DELETED>

<DELETED>    (a) Types of Fees.--Section 738(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by striking ``fiscal year 
        2013'' and inserting ``fiscal year 2018''; and</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) in the matter preceding clause 
                        (i), by striking ``October 1, 2012'' and 
                        inserting ``October 1, 2017'';</DELETED>
                        <DELETED>    (ii) in clause (viii), by striking 
                        ``2'' and inserting ``3.4''; and</DELETED>
                        <DELETED>    (iii) by adding at the end the 
                        following new clause:</DELETED>
                        <DELETED>    ``(xi) For a de novo 
                        classification request, a fee equal to 30 
                        percent of the fee that applies under clause 
                        (i).''; and</DELETED>
                <DELETED>    (B) in subparagraph (B)(v)(I), by striking 
                ``or premarket notification submission'' and inserting 
                ``premarket notification submission, or de novo 
                classification request''.</DELETED>
<DELETED>    (b) Fee Amounts.--Section 738(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as 
follows:</DELETED>
<DELETED>    ``(b) Fee Amounts.--</DELETED>
        <DELETED>    ``(1) In general.--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).</DELETED>
        <DELETED>    ``(2) Base fee amounts specified.--For purposes of 
        paragraph (1), the base fee amounts specified in this paragraph 
        are as follows:</DELETED>

----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2018  Year 2019  Year 2020  Year 2021  Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $294,000   $300,000   $310,000   $328,000   $329,000
Establishment Registration...............................     $4,375     $4,548     $4,760     $4,975     $4,978
----------------------------------------------------------------------------------------------------------------

        <DELETED>    ``(3) Total revenue amounts specified.--For 
        purposes of paragraph (1), the total revenue amounts specified 
        in this paragraph are as follows:</DELETED>
                <DELETED>    ``(A) $183,280,756 for fiscal year 
                2018.</DELETED>
                <DELETED>    ``(B) $190,654,875 for fiscal year 
                2019.</DELETED>
                <DELETED>    ``(C) $200,132,014 for fiscal year 
                2020.</DELETED>
                <DELETED>    ``(D) $211,748,789 for fiscal year 
                2021.</DELETED>
                <DELETED>    ``(E) $213,687,660 for fiscal year 
                2022.''.</DELETED>
<DELETED>    (c) Annual Fee Setting; Adjustments.--Section 738(c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is 
amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by striking ``2012'' and 
        inserting ``2017'';</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) in subparagraph (A), by striking 
                ``2014'' and inserting ``2018'';</DELETED>
                <DELETED>    (B) by striking subparagraph (B) and 
                inserting the following new subparagraph:</DELETED>
                <DELETED>    ``(B) Applicable inflation adjustment.--
                The applicable inflation adjustment for fiscal year 
                2018 and each subsequent fiscal year is the product 
                of--</DELETED>
                        <DELETED>    ``(i) the base inflation 
                        adjustment under subparagraph (C) for such 
                        fiscal year; and</DELETED>
                        <DELETED>    ``(ii) 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.'';</DELETED>
                <DELETED>    (C) in subparagraph (C), in the heading, 
                by striking ``to total revenue amounts''; and</DELETED>
                <DELETED>    (D) by amending subparagraph (D) to read 
                as follows:</DELETED>
                <DELETED>    ``(D) Adjustment to base fee amounts.--For 
                each of fiscal years 2018 through 2022, the Secretary 
                shall--</DELETED>
                        <DELETED>    ``(i) 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</DELETED>
                        <DELETED>    ``(ii) 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).''; and</DELETED>
        <DELETED>    (3) in paragraph (3)--</DELETED>
                <DELETED>    (A) by striking ``2014 through 2017'' and 
                inserting ``2018 through 2022''; and</DELETED>
                <DELETED>    (B) by striking ``further adjusted'' and 
                inserting ``increased''.</DELETED>
<DELETED>    (d) Small Businesses; Fee Waiver and Fee Reduction 
Regarding Premarket Approval Fees.--Section 738(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by striking ``specified in 
        clauses (i) through (v) and clauses (vii), (ix), and (x)'' and 
        inserting ``specified in clauses (i) through (vii) and clauses 
        (ix), (x), and (xi)''; and</DELETED>
        <DELETED>    (2) in paragraph (2)(C)--</DELETED>
                <DELETED>    (A) by striking ``supplement, or'' and 
                inserting ``supplement,''; and</DELETED>
                <DELETED>    (B) by inserting ``, or a de novo 
                classification request'' after ``class III 
                device''.</DELETED>
<DELETED>    (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--Section 738(e)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking 
``50'' and inserting ``25''.</DELETED>
<DELETED>    (f) Fee Waiver or Reduction.--</DELETED>
        <DELETED>    (1) Repeal.--Section 738 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking 
        subsection (f).</DELETED>
        <DELETED>    (2) Conforming changes.--</DELETED>
                <DELETED>    (A) Section 515(c)(4)(A) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) 
                is amended by striking ``738(h)'' and inserting 
                ``738(g)''.</DELETED>
                <DELETED>    (B) Section 738 of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 379j), as amended by 
                paragraph (1), is further amended--</DELETED>
                        <DELETED>    (i) by redesignating subsections 
                        (g) through (l) as subsections (f) through 
                        (k);</DELETED>
                        <DELETED>    (ii) in subsection (a)(2)(A), by 
                        striking ``(d), (e), and (f)'' and inserting 
                        ``(d) and (e)''; and</DELETED>
                        <DELETED>    (iii) in subsection (a)(3)(A), by 
                        striking ``and subsection (f)''.</DELETED>
<DELETED>    (g) Effect of Failure To Pay Fees.--Subsection (f)(1), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--</DELETED>
        <DELETED>    (1) by striking ``or periodic reporting concerning 
        a class III device'' and inserting ``periodic reporting 
        concerning a class III device, or de novo classification 
        request''; and</DELETED>
        <DELETED>    (2) by striking ``all fees'' and inserting ``all 
        such fees''.</DELETED>
<DELETED>    (h) Conditions.--Subsection (g)(1)(A), as redesignated, of 
section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j) is amended by striking ``$280,587,000'' and inserting 
``$320,825,000''.</DELETED>
<DELETED>    (i) Crediting and Availability of Fees.--Subsection (h), 
as redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--</DELETED>
        <DELETED>    (1) in paragraph (3)--</DELETED>
                <DELETED>    (A) by striking ``2013 through 2017'' and 
                inserting ``2018 through 2022''; and</DELETED>
                <DELETED>    (B) by striking ``subsection (c)'' and all 
                that follows through the period at the end and 
                inserting ``subsection (c).''; and</DELETED>
        <DELETED>    (2) by striking paragraph (4).</DELETED>

<DELETED>SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>

<DELETED>    (a) Performance Reports.--Section 738A(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) by striking ``2013'' and 
                        inserting ``2018''; and</DELETED>
                        <DELETED>    (ii) by striking ``the Medical 
                        Device User Fee Amendments of 2012'' and 
                        inserting ``Medical Device User Fee Amendments 
                        of 2017''; and</DELETED>
                <DELETED>    (B) in subparagraph (B), by striking ``the 
                Medical Device User Fee Amendments of 2012'' and 
                inserting ``Medical Device User Fee Amendments of 
                2017''; and</DELETED>
        <DELETED>    (2) in paragraph (2), by striking ``2013 through 
        2017'' and inserting ``2018 through 2022''.</DELETED>
<DELETED>    (b) Reauthorization.--Section 738A(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by striking ``2017'' and 
        inserting ``2022''; and</DELETED>
        <DELETED>    (2) in paragraph (5), by striking ``2017'' and 
        inserting ``2022''.</DELETED>

<DELETED>SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.</DELETED>

<DELETED>    (a) In General.--Section 514 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(d) Pilot Accreditation Scheme for Conformity 
Assessment.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary shall establish a 
        pilot program under which--</DELETED>
                <DELETED>    ``(A) 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</DELETED>
                <DELETED>    ``(B) 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.</DELETED>
        <DELETED>    ``(2) Secretarial review of accredited laboratory 
        determinations.--The Secretary may--</DELETED>
                <DELETED>    ``(A) 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</DELETED>
                <DELETED>    ``(B) 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.</DELETED>
        <DELETED>    ``(3) Implementation and reporting.--</DELETED>
                <DELETED>    ``(A) Public meeting.--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.</DELETED>
                <DELETED>    ``(B) Pilot program guidance.--The 
                Secretary shall--</DELETED>
                        <DELETED>    ``(i) not later than September 30, 
                        2019, issue draft guidance regarding the goals 
                        and implementation of the pilot program under 
                        this subsection; and</DELETED>
                        <DELETED>    ``(ii) not later than September 
                        30, 2021, issue final guidance with respect to 
                        the implementation of such program.</DELETED>
                <DELETED>    ``(C) Pilot program initiation.--Not later 
                than September 30, 2020, the Secretary shall initiate 
                the pilot program under this subsection.</DELETED>
                <DELETED>    ``(D) Report.--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.</DELETED>
        <DELETED>    ``(4) Sunset.--As of October 1, 2022--</DELETED>
                <DELETED>    ``(A) the authority for accreditation 
                bodies to accredit testing laboratories pursuant to 
                paragraph (1)(A) shall cease to have force or 
                effect;</DELETED>
                <DELETED>    ``(B) the Secretary--</DELETED>
                        <DELETED>    ``(i) may not accept a 
                        determination pursuant to paragraph (1)(B) made 
                        by a testing laboratory after such date; 
                        and</DELETED>
                        <DELETED>    ``(ii) may accept such a 
                        determination made prior to such 
                        date;</DELETED>
                <DELETED>    ``(C) 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</DELETED>
                <DELETED>    ``(D) 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.''.</DELETED>

<DELETED>SEC. 206. REAUTHORIZATION OF REVIEW.</DELETED>

<DELETED>    Section 523 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360m) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(3)--</DELETED>
                <DELETED>    (A) in subparagraph (A), by striking 
                clauses (ii) and (iii) and inserting the 
                following:</DELETED>
                        <DELETED>    ``(ii) a device classified under 
                        section 513(f)(2) or designated under section 
                        515C(d); or</DELETED>
                        <DELETED>    ``(iii) a device that is of a 
                        type, or subset of a type, listed as not 
                        eligible for review under subparagraph 
                        (B)(iii).'';</DELETED>
                <DELETED>    (B) by striking subparagraph (B) and 
                inserting the following:</DELETED>
                <DELETED>    ``(B) Designation for review.--The 
                Secretary shall--</DELETED>
                        <DELETED>    ``(i) 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--
                        </DELETED>
                                <DELETED>    ``(I) the risk of the 
                                device type, or subset of such device 
                                type; and</DELETED>
                                <DELETED>    ``(II) whether the device 
                                type, or subset of such device type, is 
                                permanently implantable, life 
                                sustaining, or life 
                                supporting;</DELETED>
                        <DELETED>    ``(ii) not later than 24 months 
                        after the date on which the Secretary issues 
                        such draft guidance, finalize such guidance; 
                        and</DELETED>
                        <DELETED>    ``(iii) 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).''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(C) Interim rule.--Until the date on 
                which the updated list is designated and posted in 
                accordance with subparagraph (B)(iii), the list in 
                effect on the date of enactment the Medical Device User 
                Fee Amendments of 2017 shall be in effect.'';</DELETED>
        <DELETED>    (2) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (2)--</DELETED>
                        <DELETED>    (i) by striking subparagraph (D); 
                        and</DELETED>
                        <DELETED>    (ii) by redesignating subparagraph 
                        (E) as subparagraph (D); and</DELETED>
                <DELETED>    (B) in paragraph (3)--</DELETED>
                        <DELETED>    (i) by redesignating subparagraph 
                        (E) as subparagraph (F);</DELETED>
                        <DELETED>    (ii) in subparagraph (F) (as so 
                        redesignated), by striking ``The operations 
                        of'' and all that follows through ``it will--'' 
                        and inserting ``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--''; 
                        and</DELETED>
                        <DELETED>    (iii) by inserting after 
                        subparagraph (D) the following new 
                        subparagraph:</DELETED>
                <DELETED>    ``(E) The operations of such person shall 
                be in accordance with generally accepted professional 
                and ethical business practices.''; and</DELETED>
        <DELETED>    (3) in subsection (c), by striking ``2017'' and 
        inserting ``2022''.</DELETED>

<DELETED>SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.</DELETED>

<DELETED>    Section 745A(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379k-1(b)) is amended by adding at the end the following 
new paragraph:</DELETED>
        <DELETED>    ``(3) Presubmissions and submissions solely in 
        electronic format.--</DELETED>
                <DELETED>    ``(A) In general.--Beginning on October 1, 
                2021 (or such later date as may be specified by the 
                Secretary under subparagraph (B)), 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 guidance issued under subparagraph 
                (C).</DELETED>
                <DELETED>    ``(B) Extension.--The Secretary may, if 
                the Secretary determines an extension of the date 
                specified in subparagraph (A) is necessary for the 
                development and adoption of the electronic format 
                referred to in such paragraph, extend such date until 
                such later date as the Secretary may specify, but in no 
                event later than April 1, 2023.</DELETED>
                <DELETED>    ``(C) Guidance.--The Secretary shall, not 
                later than January 1, 2021, or such later date as may 
                be specified by the Secretary under subparagraph (B), 
                issue guidance providing for--</DELETED>
                        <DELETED>    ``(i) any further standards for 
                        the submission by electronic format required 
                        under subparagraph (A);</DELETED>
                        <DELETED>    ``(ii) a timetable for the 
                        establishment by the Secretary of such further 
                        standards; and</DELETED>
                        <DELETED>    ``(iii) set forth criteria for 
                        waivers of and exemptions from the requirements 
                        of this subsection.''.</DELETED>

<DELETED>SEC. 208. SAVINGS CLAUSE.</DELETED>

<DELETED>    Notwithstanding the amendments made by this title, part 3 
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379i 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.</DELETED>

<DELETED>SEC. 209. EFFECTIVE DATE.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 210. SUNSET CLAUSE.</DELETED>

<DELETED>    (a) Authorization.--Sections 737 and 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be 
effective October 1, 2022.</DELETED>
<DELETED>    (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-
1) of the Federal Food, Drug, and Cosmetic Act (regarding 
reauthorization and reporting requirements) shall cease to be effective 
January 31, 2023.</DELETED>
<DELETED>    (c) Previous Sunset Provision.--</DELETED>
        <DELETED>    (1) In general.--Effective October 1, 2017, 
        section 207(a) of the Medical Device User Fee Amendments of 
        2012 (Public Law 112-144) is repealed.</DELETED>
        <DELETED>    (2) Conforming amendment.--The Food and Drug 
        Administration Safety and Innovation Act (Public Law 112-144) 
        is amended in the table of contents in section 2 by striking 
        the item relating to section 207.</DELETED>

      <DELETED>TITLE III--FEES RELATING TO GENERIC DRUGS</DELETED>

<DELETED>SEC. 301. SHORT TITLE; FINDING.</DELETED>

<DELETED>    (a) Short Title.--This title may be cited as the ``Generic 
Drug User Fee Amendments of 2017''.</DELETED>
<DELETED>    (b) Finding.--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.</DELETED>

<DELETED>SEC. 302. DEFINITIONS.</DELETED>

<DELETED>    Section 744A of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-41) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)(B), by striking ``application 
        for a positron emission tomography drug.'' and inserting 
        ``application--</DELETED>
                        <DELETED>    ``(i) for a positron emission 
                        tomography drug; or</DELETED>
                        <DELETED>    ``(ii) submitted by a State or 
                        Federal governmental entity for a drug that is 
                        not distributed commercially.'';</DELETED>
        <DELETED>    (2) by redesignating paragraphs (5) through (12) 
        as paragraphs (6) through (13), respectively; and</DELETED>
        <DELETED>    (3) by inserting after paragraph (4) the 
        following:</DELETED>
        <DELETED>    ``(5) The term `contract manufacturing 
        organization facility' 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.''.</DELETED>

<DELETED>SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
              FEES.</DELETED>

<DELETED>    (a) Types of Fees.--Section 744B(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--</DELETED>
        <DELETED>    (1) in the matter preceding paragraph (1), by 
        striking ``fiscal year 2013'' and inserting ``fiscal year 
        2018'';</DELETED>
        <DELETED>    (2) in paragraph (1), by adding at the end the 
        following:</DELETED>
                <DELETED>    ``(E) Sunset.--This paragraph shall cease 
                to be effective October 1, 2022.'';</DELETED>
        <DELETED>    (3) in paragraph (2)--</DELETED>
                <DELETED>    (A) by amending subparagraph (C) to read 
                as follows:</DELETED>
                <DELETED>    ``(C) Notice.--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.''; 
                and</DELETED>
                <DELETED>    (B) in subparagraph (E)--</DELETED>
                        <DELETED>    (i) in clause (i)--</DELETED>
                                <DELETED>    (I) by striking ``no later 
                                than the date'' and inserting ``on the 
                                earlier of--</DELETED>
                                <DELETED>    ``(I) the 
                                date'';</DELETED>
                                <DELETED>    (II) by striking the 
                                period and inserting ``; or''; 
                                and</DELETED>
                                <DELETED>    (III) by adding at the end 
                                the following:</DELETED>
                                <DELETED>    ``(II) the date on which 
                                the drug master file holder requests 
                                the initial completeness assessment.''; 
                                and</DELETED>
                        <DELETED>    (ii) in clause (ii), by striking 
                        ``notice provided for in clause (i) or (ii) of 
                        subparagraph (C), as applicable'' and inserting 
                        ``notice provided for in subparagraph 
                        (C)'';</DELETED>
        <DELETED>    (4) in paragraph (3)--</DELETED>
                <DELETED>    (A) in the heading, by striking ``and 
                prior approval supplement'';</DELETED>
                <DELETED>    (B) in subparagraph (A), by striking ``or 
                a prior approval supplement to an abbreviated new drug 
                application'';</DELETED>
                <DELETED>    (C) by amending subparagraphs (B) and (C) 
                to read as follows:</DELETED>
                <DELETED>    ``(B) Notice.--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.</DELETED>
                <DELETED>    ``(C) Fee due date.--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.'';</DELETED>
                <DELETED>    (D) in subparagraph (D)--</DELETED>
                        <DELETED>    (i) in the heading, by inserting 
                        ``, is withdrawn prior to being received, or is 
                        no longer received'' after ``received''; 
                        and</DELETED>
                        <DELETED>    (ii) by striking ``The Secretary 
                        shall'' and all that follows through the period 
                        and inserting the following:</DELETED>
                        <DELETED>    ``(i) Applications not considered 
                        to have been received and applications 
                        withdrawn prior to being received.--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).</DELETED>
                        <DELETED>    ``(ii) Applications no longer 
                        received.--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).'';</DELETED>
                <DELETED>    (E) in subparagraph (E), by striking ``or 
                prior approval supplement''; and</DELETED>
                <DELETED>    (F) in the matter preceding clause (i) of 
                subparagraph (F)--</DELETED>
                        <DELETED>    (i) by striking ``2012'' and 
                        inserting ``2017''; and</DELETED>
                        <DELETED>    (ii) by striking ``subsection 
                        (d)(3)'' and inserting ``subsection 
                        (d)(2)'';</DELETED>
        <DELETED>    (5) in paragraph (4)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) in the matter preceding clause 
                        (i) and in clause (iii), by striking ``, or 
                        intended to be identified, in at least one 
                        generic drug submission that is pending or'' 
                        and inserting ``in at least one generic drug 
                        submission that is'';</DELETED>
                        <DELETED>    (ii) in clause (i), by striking 
                        ``or intended to be identified in at least one 
                        generic drug submission that is pending or'' 
                        and inserting ``in at least one generic drug 
                        submission that is'';</DELETED>
                        <DELETED>    (iii) in clause (ii), by striking 
                        ``produces,'' and all that follows through 
                        ``such a'' and inserting ``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''; 
                        and</DELETED>
                        <DELETED>    (iv) in clause (iii), by striking 
                        ``to fees under both such clauses'' and 
                        inserting ``only to the fee attributable to the 
                        manufacture of the finished dosage forms''; 
                        and</DELETED>
                <DELETED>    (B) by amending subparagraphs (C) and (D) 
                to read as follows:</DELETED>
                <DELETED>    ``(C) Notice.--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.''.</DELETED>
                <DELETED>    ``(D) Fee due date.--For each of fiscal 
                years 2018 through 2022, the fees under subparagraph 
                (A) for such fiscal year shall be due on the later of--
                </DELETED>
                        <DELETED>    ``(i) the first business day on or 
                        after October 1 of each such year; or</DELETED>
                        <DELETED>    ``(ii) 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.'';</DELETED>
        <DELETED>    (6) by redesignating paragraph (5) as paragraph 
        (6); and</DELETED>
        <DELETED>    (7) by inserting after paragraph (4) the 
        following:</DELETED>
        <DELETED>    ``(5) Generic drug applicant program fee.--
        </DELETED>
                <DELETED>    ``(A) In general.--A generic drug 
                applicant program fee shall be assessed annually as 
                described in subsection (b)(2)(E).</DELETED>
                <DELETED>    ``(B) Amount.--The amount of fees 
                established under subparagraph (A) shall be established 
                under subsection (d).</DELETED>
                <DELETED>    ``(C) Notice.--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.</DELETED>
                <DELETED>    ``(D) Fee due date.--For each of fiscal 
                years 2018 through 2022, the fees under subparagraph 
                (A) for such fiscal year shall be due on the later of--
                </DELETED>
                        <DELETED>    ``(i) the first business day on or 
                        after October 1 of each such fiscal year; 
                        or</DELETED>
                        <DELETED>    ``(ii) 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.''.</DELETED>
<DELETED>    (b) Fee Revenue Amounts.--Section 744B(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) in the heading, by striking 
                        ``2013'' and inserting ``2018'';</DELETED>
                        <DELETED>    (ii) by striking ``2013'' and 
                        inserting ``2018'';</DELETED>
                        <DELETED>    (iii) by striking ``$299,000,000'' 
                        and inserting ``$493,600,000''; and</DELETED>
                        <DELETED>    (iv) by striking ``Of that 
                        amount'' and all that follows through the end 
                        of clause (ii); and</DELETED>
                <DELETED>    (B) in subparagraph (B)--</DELETED>
                        <DELETED>    (i) in the heading, by striking 
                        ``2014 through 2017'' and inserting ``2019 
                        through 2022'';</DELETED>
                        <DELETED>    (ii) by striking ``2014 through 
                        2017'' and inserting ``2019 through 
                        2022'';</DELETED>
                        <DELETED>    (iii) by striking ``paragraphs (2) 
                        through (4)'' and inserting ``paragraphs (2) 
                        through (5)''; and</DELETED>
                        <DELETED>    (iv) by striking ``$299,000,000'' 
                        and inserting ``$493,600,000''; and</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) in the matter preceding subparagraph 
                (A)--</DELETED>
                        <DELETED>    (i) by striking ``paragraph 
                        (1)(A)(ii) for fiscal year 2013 and paragraph 
                        (1)(B) for each of fiscal years 2014 through 
                        2017'' and inserting ``such paragraph for a 
                        fiscal year''; and</DELETED>
                        <DELETED>    (ii) by striking ``through (4)'' 
                        and inserting ``through (5)'';</DELETED>
                <DELETED>    (B) in subparagraph (A), by striking ``Six 
                percent'' and inserting ``Five percent'';</DELETED>
                <DELETED>    (C) by amending subparagraphs (B) and (C) 
                to read as follows:</DELETED>
                <DELETED>    ``(B) Thirty-three percent shall be 
                derived from fees under subsection (a)(3) (relating to 
                abbreviated new drug applications).</DELETED>
                <DELETED>    ``(C) 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.'';</DELETED>
                <DELETED>    (D) in subparagraph (D)--</DELETED>
                        <DELETED>    (i) by striking ``Fourteen 
                        percent'' and inserting ``Seven 
                        percent'';</DELETED>
                        <DELETED>    (ii) by striking ``not less than 
                        $15,000 and not more than $30,000'' and 
                        inserting ``$15,000''; and</DELETED>
                        <DELETED>    (iii) by striking ``, as 
                        determined'' and all that follows through the 
                        period at the end and inserting a period; 
                        and</DELETED>
                <DELETED>    (E) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(E)(i) 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:</DELETED>
                        <DELETED>    ``(I) 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.</DELETED>
                        <DELETED>    ``(II) 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.</DELETED>
                        <DELETED>    ``(III) 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.</DELETED>
                <DELETED>    ``(ii) 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.''.</DELETED>
<DELETED>    (c) Adjustments.--Section 744B(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) by striking ``2014'' and inserting 
                ``2019'';</DELETED>
                <DELETED>    (B) by inserting ``to equal the product of 
                the total revenues established in such notice for the 
                prior fiscal year multiplied'' after ``a fiscal 
                year,''; and</DELETED>
                <DELETED>    (C) by striking the flush text following 
                subparagraph (C); and</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) by striking ``2017'' each place it 
                appears and inserting ``2022''; and</DELETED>
                <DELETED>    (B) by striking ``2018'' and inserting 
                ``2023''.</DELETED>
<DELETED>    (d) Annual Fee Setting.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42) is amended--</DELETED>
        <DELETED>    (1) in subsection (c)(2), by striking ``Such fees 
        may only be used in fiscal year 2018.''; and</DELETED>
        <DELETED>    (2) in subsection (d)--</DELETED>
                <DELETED>    (A) by striking paragraphs (1) and (2) and 
                inserting the following:</DELETED>
        <DELETED>    ``(1) Fiscal years 2018 through 2022.--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).'';</DELETED>
                <DELETED>    (B) by redesignating paragraph (3) as 
                paragraph (2); and</DELETED>
                <DELETED>    (C) in paragraph (2) (as so redesignated), 
                in the matter preceding subparagraph (A), by striking 
                ``fees under paragraphs (1) and (2)'' and inserting 
                ``fee under paragraph (1)''.</DELETED>
<DELETED>    (e) Identification of Facilities.--Section 744B(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is 
amended--</DELETED>
        <DELETED>    (1) by striking paragraph (1);</DELETED>
        <DELETED>    (2) by redesignating paragraphs (2) through (4) as 
        paragraphs (1) through (3), respectively;</DELETED>
        <DELETED>    (3) in paragraph (1) (as so redesignated)--
        </DELETED>
                <DELETED>    (A) by striking ``paragraph (4)'' and 
                inserting ``paragraph (3)''; and</DELETED>
                <DELETED>    (B) by striking ``Such information shall'' 
                and all that follows through the end of subparagraph 
                (B) and inserting ``Such information shall, for each 
                fiscal year, be submitted, updated, or reconfirmed on 
                or before June 1 of the previous fiscal year.''; 
                and</DELETED>
        <DELETED>    (4) in paragraph (2), as so redesignated--
        </DELETED>
                <DELETED>    (A) in the heading, by striking ``Contents 
                of notice'' and inserting ``Information required to be 
                submitted'';</DELETED>
                <DELETED>    (B) in the matter preceding subparagraph 
                (A), by striking ``paragraph (2)'' and inserting 
                ``paragraph (1)'';</DELETED>
                <DELETED>    (C) in subparagraph (A), by striking ``or 
                intended to be identified'';</DELETED>
                <DELETED>    (D) in subparagraph (D), by striking 
                ``and'' at the end;</DELETED>
                <DELETED>    (E) in subparagraph (E), by striking the 
                period and inserting ``; and''; and</DELETED>
                <DELETED>    (F) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(F) whether the facility is a contract 
                manufacturing organization facility.''.</DELETED>
<DELETED>    (f) Effect of Failure To Pay Fees.--Section 744B(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(g)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (1), by adding at the end the 
        following: ``This paragraph shall cease to be effective on 
        October 1, 2022.'';</DELETED>
        <DELETED>    (2) in paragraph (2)(C)(ii), by striking ``of 
        505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; 
        and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(5) Generic drug applicant program fee.--
        </DELETED>
                <DELETED>    ``(A) In general.--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:</DELETED>
                        <DELETED>    ``(i) The Secretary shall place 
                        the person on a publicly available arrears 
                        list.</DELETED>
                        <DELETED>    ``(ii) 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).</DELETED>
                        <DELETED>    ``(iii) 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).</DELETED>
                <DELETED>    ``(B) Application of penalties.--The 
                penalties under subparagraph (A) shall apply until the 
                fee required under subsection (a)(5) is 
                paid.''.</DELETED>
<DELETED>    (g) Limitations.--Section 744B(h)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking 
``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''.</DELETED>
<DELETED>    (h) Crediting and Availability of Fees.--Section 744B(i) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is 
amended--</DELETED>
        <DELETED>    (1) in paragraph (2)--</DELETED>
                <DELETED>    (A) by striking subparagraph (C) (relating 
                to fee collection during first program year);</DELETED>
                <DELETED>    (B) in subparagraph (D)--</DELETED>
                        <DELETED>    (i) in the heading, by striking 
                        ``in subsequent years''; and</DELETED>
                        <DELETED>    (ii) by striking ``(after fiscal 
                        year 2013)''; and</DELETED>
                <DELETED>    (C) by redesignating subparagraph (D) as 
                subparagraph (C); and</DELETED>
        <DELETED>    (2) in paragraph (3), by striking ``fiscal years 
        2013 through 2017'' and inserting ``fiscal years 2018 through 
        2022''.</DELETED>
<DELETED>    (i) Information on Abbreviated New Drug Applications Held 
by Applicants and Their Affiliates.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the 
end the following:</DELETED>
<DELETED>    ``(o) Information on Abbreviated New Drug Applications 
Owned by Applicants and Their Affiliates.--</DELETED>
        <DELETED>    ``(1) In general.--By April 1 of each year, each 
        person that owns an abbreviated new drug application, or any 
        affiliate of such person, shall submit to the Secretary a list 
        of--</DELETED>
                <DELETED>    ``(A) all approved abbreviated new drug 
                applications owned by such person; and</DELETED>
                <DELETED>    ``(B) if any affiliate of such person also 
                owns an abbreviated new drug application, all approved 
                abbreviated new drug applications owned by any such 
                affiliate.</DELETED>
        <DELETED>    ``(2) Format and method.--The Secretary shall 
        specify in guidance the format and method for submission of 
        lists under this subsection.''.</DELETED>

<DELETED>SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>

<DELETED>    Section 744C of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-43) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)--</DELETED>
                <DELETED>    (A) by striking ``2013'' and inserting 
                ``2018''; and</DELETED>
                <DELETED>    (B) by striking ``Generic Drug User Fee 
                Amendments of 2012'' and inserting ``Generic Drug User 
                Fee Amendments of 2017'';</DELETED>
        <DELETED>    (2) in subsection (b), by striking ``2013'' and 
        inserting ``2018''; and</DELETED>
        <DELETED>    (3) in subsection (d), by striking ``2017'' each 
        place it appears and inserting ``2022''.</DELETED>

<DELETED>SEC. 305. SUNSET DATES.</DELETED>

<DELETED>    (a) Authorization.--Sections 744A and 744B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease 
to be effective October 1, 2022.</DELETED>
<DELETED>    (b) Reporting Requirements.--Section 744C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be 
effective January 31, 2023.</DELETED>
<DELETED>    (c) Previous Sunset Provision.--Effective October 1, 2017, 
subsections (a) and (b) of section 304 of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) are 
repealed.</DELETED>

<DELETED>SEC. 306. EFFECTIVE DATE.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 307. SAVINGS CLAUSE.</DELETED>

<DELETED>    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 (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were 
submitted, and drug master files for Type II active pharmaceutical 
ingredients that were first referenced with respect to assessing and 
collecting any fee required by such part for a fiscal year prior to 
fiscal year 2018.</DELETED>

       <DELETED>TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL 
                           PRODUCTS</DELETED>

<DELETED>SEC. 401. SHORT TITLE; FINDING.</DELETED>

<DELETED>    (a) Short Title.--This title may be cited as the 
``Biosimilar User Fee Amendments of 2017''.</DELETED>
<DELETED>    (b) Finding.--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.</DELETED>

<DELETED>SEC. 402. DEFINITIONS.</DELETED>

<DELETED>    (a) Adjustment Factor.--Section 744G(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read 
as follows:</DELETED>
        <DELETED>    ``(1) The term `adjustment factor' applicable to a 
        fiscal year is the Consumer Price Index for all urban consumers 
        (all items; United States city average) for October of the 
        preceding fiscal year divided by such Index for October 
        2011.''.</DELETED>
<DELETED>    (b) Biosimilar Biological Product.--Section 744G(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended 
by striking ``means a product'' and inserting ``means a specific 
strength of a biological product in final dosage form''.</DELETED>

<DELETED>SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
              FEES.</DELETED>

<DELETED>    (a) Types of Fees.--Section 744H(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--</DELETED>
        <DELETED>    (1) in the matter preceding paragraph (1), by 
        striking ``fiscal year 2013'' and inserting ``fiscal year 
        2018'';</DELETED>
        <DELETED>    (2) in the heading of paragraph (1), by striking 
        ``Biosimilar'' and inserting ``Biosimilar biological 
        product'';</DELETED>
        <DELETED>    (3) in paragraph (1)(A)(i), by striking 
        ``(b)(1)(A)'' and inserting ``(c)(5)'';</DELETED>
        <DELETED>    (4) in paragraph (1)(B)(i), by striking 
        ``(b)(1)(B) for biosimilar biological product development'' and 
        inserting ``(c)(5) for the biosimilar biological product 
        development program'';</DELETED>
        <DELETED>    (5) in paragraph (1)(B)(ii), by striking ``annual 
        biosimilar biological product development program fee'' and 
        inserting ``annual biosimilar biological product development 
        fee'';</DELETED>
        <DELETED>    (6) in paragraph (1)(B)(iii), by striking ``annual 
        biosimilar development program fee'' and inserting ``annual 
        biosimilar biological product development fee'';</DELETED>
        <DELETED>    (7) in paragraph (1)(B), by adding at the end the 
        following:</DELETED>
                        <DELETED>    ``(iv) Refund.--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.'';</DELETED>
        <DELETED>    (8) in paragraph (1)(C), by striking ``for a 
        product effective October 1 of a fiscal year by,'' and 
        inserting ``for a product, effective October 1 of a fiscal 
        year, by,'';</DELETED>
        <DELETED>    (9) in paragraph (1)(D)--</DELETED>
                <DELETED>    (A) in clause (i) in the matter preceding 
                subclause (I), by inserting ``, if the person seeks to 
                resume participation in such program,'' before ``pay a 
                fee'';</DELETED>
                <DELETED>    (B) in clause (i)(I), by inserting after 
                ``grants a request'' the following: ``by such person''; 
                and</DELETED>
                <DELETED>    (C) in clause (i)(II), by inserting after 
                ``discontinued)'' the following: ``by such 
                person'';</DELETED>
        <DELETED>    (10) in the heading of paragraph (1)(E), by 
        striking ``biosimilar development program'';</DELETED>
        <DELETED>    (11) in the heading of subparagraph (F) of 
        paragraph (1), by striking ``biosimilar development program 
        fees'' and inserting ``biosimilar biological product 
        development fees'';</DELETED>
        <DELETED>    (12) in paragraph (1)(F)--</DELETED>
                <DELETED>    (A) in the heading of subparagraph (F), by 
                striking ``biosimilar development program'' before 
                ``fees''; and</DELETED>
                <DELETED>    (B) by amending clause (i) to read as 
                follows:</DELETED>
                        <DELETED>    ``(i) Refunds.--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).'';</DELETED>
        <DELETED>    (13) in paragraph (2)--</DELETED>
                <DELETED>    (A) in the heading of paragraph (2), by 
                striking ``and supplement'';</DELETED>
                <DELETED>    (B) by amending subparagraphs (A) and (B) 
                to read as follows:</DELETED>
                <DELETED>    ``(A) In general.--Each person that 
                submits, on or after October 1, 2017, a biosimilar 
                biological product application shall be subject to the 
                following fees:</DELETED>
                        <DELETED>    ``(i) 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.</DELETED>
                        <DELETED>    ``(ii) 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).</DELETED>
                <DELETED>    ``(B) Rule of applicability; treatment of 
                certain previously paid fees.--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--</DELETED>
                        <DELETED>    ``(i) 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</DELETED>
                        <DELETED>    ``(ii) 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).'';</DELETED>
                <DELETED>    (C) in the heading of subparagraph (D), by 
                striking ``or supplement''; and</DELETED>
                <DELETED>    (D) in subparagraphs (C) through (F)--
                </DELETED>
                        <DELETED>    (i) by striking ``or supplement'' 
                        each place it appears; and</DELETED>
                        <DELETED>    (ii) in subparagraph (D), by 
                        striking ``or a supplement''; and</DELETED>
        <DELETED>    (14) by amending paragraph (3) to read as 
        follows:</DELETED>
        <DELETED>    ``(3) Biosimilar biological product program fee.--
        </DELETED>
                <DELETED>    ``(A) In general.--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--</DELETED>
                        <DELETED>    ``(i) is identified in such a 
                        biosimilar biological product application 
                        approved as of October 1 of such fiscal year; 
                        and</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
                <DELETED>    ``(B) Due date.--The biosimilar biological 
                product program fee for a fiscal year shall be due on 
                the later of--</DELETED>
                        <DELETED>    ``(i) the first business day on or 
                        after October 1 of each such year; or</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
                <DELETED>    ``(C) One fee per product per year.--The 
                biosimilar biological product program fee shall be paid 
                only once for each product for each fiscal 
                year.</DELETED>
                <DELETED>    ``(D) Limitation.--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.''.</DELETED>
<DELETED>    (b) Fee Revenue Amounts.--Subsection (b) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is 
amended to read as follows:</DELETED>
<DELETED>    ``(b) Fee Revenue Amounts.--</DELETED>
        <DELETED>    ``(1) Fiscal year 2018.--For fiscal year 2018, 
        fees under subsection (a) shall be established to generate a 
        total revenue amount equal to the sum of--</DELETED>
                <DELETED>    ``(A) $45,000,000; and</DELETED>
                <DELETED>    ``(B) the dollar amount equal to the 
                fiscal year 2018 adjustment (as determined under 
                subsection (c)(4)).</DELETED>
        <DELETED>    ``(2) Subsequent fiscal years.--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--</DELETED>
                <DELETED>    ``(A) the annual base revenue for the 
                fiscal year (as determined under paragraph 
                (4));</DELETED>
                <DELETED>    ``(B) the dollar amount equal to the 
                inflation adjustment for the fiscal year (as determined 
                under subsection (c)(1));</DELETED>
                <DELETED>    ``(C) the dollar amount equal to the 
                capacity planning adjustment for the fiscal year (as 
                determined under subsection (c)(2)); and</DELETED>
                <DELETED>    ``(D) the dollar amount equal to the 
                operating reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection 
                (c)(3)).</DELETED>
        <DELETED>    ``(3) Allocation of revenue amount among fees; 
        limitations on fee amounts.--</DELETED>
                <DELETED>    ``(A) Allocation.--The Secretary shall 
                determine the percentage of the total revenue amount 
                for a fiscal year to be derived from, respectively--
                </DELETED>
                        <DELETED>    ``(i) initial and annual 
                        biosimilar development fees and reactivation 
                        fees under subsection (a)(1);</DELETED>
                        <DELETED>    ``(ii) biosimilar biological 
                        product application fees under subsection 
                        (a)(2); and</DELETED>
                        <DELETED>    ``(iii) biosimilar biological 
                        product program fees under subsection 
                        (a)(3).</DELETED>
                <DELETED>    ``(B) Limitations on fee amounts.--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.</DELETED>
                <DELETED>    ``(C) Biosimilar biological product 
                development fees.--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.</DELETED>
                <DELETED>    ``(D) Reactivation fee.--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.</DELETED>
        <DELETED>    ``(4) Annual base revenue.--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).''.</DELETED>
<DELETED>    (c) Adjustments; Annual Fee Setting.--Section 744H of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
</DELETED>
        <DELETED>    (1) by redesignating subsections (c) through (h) 
        as subsections (d) through (i), respectively;</DELETED>
        <DELETED>    (2) in subsections (a)(2)(F) and (g), by striking 
        ``subsection (c)'' and inserting ``subsection (d)'';</DELETED>
        <DELETED>    (3) in subsection (a)(4)(A), by striking 
        ``subsection (b)(1)(F)'' and inserting ``subsection (c)(5)''; 
        and</DELETED>
        <DELETED>    (4) by inserting after subsection (b) the 
        following:</DELETED>
<DELETED>    ``(c) Adjustments; Annual Fee Setting.--</DELETED>
        <DELETED>    ``(1) Inflation adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--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--
                </DELETED>
                        <DELETED>    ``(i) such annual base revenue for 
                        the fiscal year under subsection (b); 
                        and</DELETED>
                        <DELETED>    ``(ii) the inflation adjustment 
                        percentage under subparagraph (B).</DELETED>
                <DELETED>    ``(B) Inflation adjustment percentage.--
                The inflation adjustment percentage under this 
                subparagraph for a fiscal year is equal to the sum of--
                </DELETED>
                        <DELETED>    ``(i) 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</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
        <DELETED>    ``(2) Capacity planning adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--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.</DELETED>
                <DELETED>    ``(B) Capacity planning methodology.--
                </DELETED>
                        <DELETED>    ``(i) Development; evaluation and 
                        report.--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.</DELETED>
                        <DELETED>    ``(ii) Establishment and 
                        implementation.--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--
                        </DELETED>
                                <DELETED>    ``(I) incorporate such 
                                approaches and attributes as the 
                                Secretary determines appropriate; 
                                and</DELETED>
                                <DELETED>    ``(II) be effective 
                                beginning with the first fiscal year 
                                for which fees are set after such 
                                capacity planning methodology is 
                                established.</DELETED>
                <DELETED>    ``(C) Limitation.--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).</DELETED>
                <DELETED>    ``(D) Publication in federal register.--
                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.</DELETED>
        <DELETED>    ``(3) Operating reserve adjustment.--</DELETED>
                <DELETED>    ``(A) Interim application; fee 
                reduction.--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.</DELETED>
                <DELETED>    ``(B) General application and 
                methodology.--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)--</DELETED>
                        <DELETED>    ``(i) reduce the fee revenue and 
                        fees under this section as the Secretary 
                        determines appropriate for long-term financial 
                        planning purposes; or</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
                <DELETED>    ``(C) Federal register notice.--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.</DELETED>
        <DELETED>    ``(4) Fiscal year 2018 adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--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.</DELETED>
                <DELETED>    ``(B) Methodology.--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.</DELETED>
                <DELETED>    ``(C) Limitation.--No adjustment under 
                this paragraph shall result in an increase in fee 
                revenue and fees under this section in excess of 
                $9,000,000.</DELETED>
        <DELETED>    ``(5) Annual fee setting.--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--
        </DELETED>
                <DELETED>    ``(A) 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</DELETED>
                <DELETED>    ``(B) publish such fee revenue and fees in 
                the Federal Register.</DELETED>
        <DELETED>    ``(6) Limit.--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.''.</DELETED>
<DELETED>    (d) Application Fee Waiver for Small Business.--Subsection 
(d)(1) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j-52), as redesignated by subsection (c)(1), is amended--
</DELETED>
        <DELETED>    (1) by striking subparagraph (B);</DELETED>
        <DELETED>    (2) by striking ``shall pay--'' and all that 
        follows through ``application fees'' and inserting ``shall pay 
        application fees''; and</DELETED>
        <DELETED>    (3) by striking ``; and'' at the end and inserting 
        a period.</DELETED>
<DELETED>    (e) Effect of Failure To Pay Fees.--Subsection (e) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended by striking 
``all fees'' and inserting ``all such fees''.</DELETED>
<DELETED>    (f) Crediting and Availability of Fees.--Subsection (f) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended--</DELETED>
        <DELETED>    (1) in paragraph (2)--</DELETED>
                <DELETED>    (A) by striking subparagraph (C) (relating 
                to fee collection during first program year) and 
                inserting the following:</DELETED>
                <DELETED>    ``(C) Compliance.--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.''; and</DELETED>
                <DELETED>    (B) in subparagraph (D)--</DELETED>
                        <DELETED>    (i) in the heading, by striking 
                        ``in subsequent years''; and</DELETED>
                        <DELETED>    (ii) by striking ``(after fiscal 
                        year 2013)''; and</DELETED>
        <DELETED>    (2) in paragraph (3), by striking ``2013 through 
        2017'' and inserting ``2018 through 2022''.</DELETED>

<DELETED>SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.</DELETED>

<DELETED>    Section 744I of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j-53) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)--</DELETED>
                <DELETED>    (A) by striking ``2013'' and inserting 
                ``2018''; and</DELETED>
                <DELETED>    (B) by striking ``Biosimilar User Fee Act 
                of 2012'' and inserting ``Biosimilar User Fee 
                Amendments of 2017'';</DELETED>
        <DELETED>    (2) in subsection (b), by striking ``2013'' and 
        inserting ``2018'';</DELETED>
        <DELETED>    (3) by striking subsection (d);</DELETED>
        <DELETED>    (4) by redesignating subsection (e) as subsection 
        (d); and</DELETED>
        <DELETED>    (5) in subsection (d), as so redesignated, by 
        striking ``2017'' each place it appears and inserting 
        ``2022''.</DELETED>

<DELETED>SEC. 405. SUNSET DATES.</DELETED>

<DELETED>    (a) Authorization.--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.</DELETED>
<DELETED>    (b) Reporting Requirements.--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.</DELETED>
<DELETED>    (c) Previous Sunset Provision.--</DELETED>
        <DELETED>    (1) In general.--Effective October 1, 2017, 
        section 404 of the Food and Drug Administration Safety and 
        Innovation Act (Public Law 112-144) is repealed.</DELETED>
        <DELETED>    (2) Conforming amendment.--The Food and Drug 
        Administration Safety and Innovation Act (Public Law 112-144) 
        is amended in the table of contents in section 2 by striking 
        the item relating to section 404.</DELETED>

<DELETED>SEC. 406. EFFECTIVE DATE.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 407. SAVINGS CLAUSE.</DELETED>

<DELETED>    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.</DELETED>

     <DELETED>TITLE V--REAUTHORIZATION OF OTHER PROGRAMS</DELETED>

<DELETED>SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY 
              OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.</DELETED>

<DELETED>    Section 505(u)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting 
``2022''.</DELETED>

<DELETED>SEC. 502. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE 
              EXCEPTIONS.</DELETED>

<DELETED>    Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking 
``2017'' and inserting ``2022''.</DELETED>

<DELETED>SEC. 503. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIPS.</DELETED>

<DELETED>    Section 566(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb-5(f)) is amended by striking ``2013 through 2017'' 
and inserting ``2018 through 2022''.</DELETED>

<DELETED>SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE 
              CONSORTIA.</DELETED>

<DELETED>    Section 305(e) of Pediatric Medical Device Safety and 
Improvement Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is 
amended by striking ``2013 through 2017'' and inserting ``2018 through 
2022''.</DELETED>

<DELETED>SEC. 505. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.</DELETED>

<DELETED>    Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) 
is amended by striking ``2013 through 2017'' and inserting ``2018 
through 2022''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Reauthorization Act of 2017''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. 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--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Pediatric devices.
Sec. 502. Pediatric drug development.
Sec. 503. Guidance on molecular targets in pediatric oncology.
Sec. 504. Best pharmaceuticals for children.

      TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

Sec. 601. Reauthorization of provision relating to exclusivity of 
                            certain drugs containing single 
                            enantiomers.
Sec. 602. Reauthorization of the critical path public-private 
                            partnerships.
Sec. 603. Reauthorization of orphan grants program.
Sec. 604. Guidance regarding bioequivalence.
Sec. 605. Patient experience data.
Sec. 606. Communications plans.
Sec. 607. Protecting and strengthening the drug supply chain.
Sec. 608. Technical corrections.

        TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Notification of guidance related to lab-developed tests.
Sec. 707. Diagnostic imaging devices intended for use with contrast 
                            agents.
Sec. 708. Diagnostic clarity.
Sec. 709. Appropriate classification of device accessories.
Sec. 710. Device pilot projects.
Sec. 711. Regulation of over-the-counter hearing aids.

                   TITLE VIII--ADDITIONAL PROVISIONS

Sec. 801. GAO report.
Sec. 802. Streamlining and improving consistency in performance 
                            reporting.
Sec. 803. Analysis of use of funds.
Sec. 804. Information on technology contracting.
Sec. 805. Facilities management.
Sec. 806. Expanded access.
Sec. 807. Technical corrections.

                     TITLE IX--GENERIC DRUG ACCESS

        Subtitle A--Removing Regulatory Barriers to Competition

Sec. 901. Improving access to generic drugs.
Sec. 902. Reporting on pending generic drug applications, priority 
                            review applications, and inspections.

                 Subtitle B--Incentivizing Competition

Sec. 911. Expediting generic competition.
Sec. 912. List of generic drugs with limited competition.
Sec. 913. Suitability petitions.
Sec. 914. Inspections.

                    TITLE I--FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Prescription 
Drug User Fee Amendments of 2017''.
    (b) Finding.--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.

SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--
            (1) In general.--Section 736(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
                    (A) in the matter preceding paragraph (1), by 
                striking ``fiscal year 2013'' and inserting ``fiscal 
                year 2018'';
                    (B) in the heading of paragraph (1), by striking 
                ``and supplement'';
                    (C) in paragraph (1), by striking ``or a 
                supplement'' and ``or supplement'' each place either 
                appears;
                    (D) in paragraph (1)(A)--
                            (i) in clause (i), by striking ``(c)(4)'' 
                        and inserting ``(c)(5)''; and
                            (ii) in clause (ii), by striking ``A fee 
                        established'' and all that follows through 
                        ``are required.'' and inserting the following: 
                        ``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.'';
                    (E) in the heading of paragraph (1)(C), by striking 
                ``or supplement'';
                    (F) in paragraph (1)(F)--
                            (i) in the heading, by striking ``or 
                        indication''; and
                            (ii) by striking the second sentence;
                    (G) by striking paragraph (2) (relating to a 
                prescription drug establishment fee);
                    (H) by redesignating paragraph (3) as paragraph 
                (2);
                    (I) in the heading of paragraph (2), as so 
                redesignated, by striking ``Prescription drug product 
                fee'' and inserting ``Prescription drug program fee'';
                    (J) in subparagraph (A) of such paragraph (2), by 
                amending the first sentence to read as follows: 
                ``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.'';
                    (K) in subparagraph (B) of such paragraph (2)--
                            (i) in the heading of subparagraph (B), by 
                        inserting after ``Exception'' the following: 
                        ``for certain prescription drug products''; and
                            (ii) by striking ``A prescription drug 
                        product shall not be assessed a fee'' and 
                        inserting ``A prescription drug program fee 
                        shall not be assessed for a prescription drug 
                        product''; and
                    (L) by adding at the end of such paragraph (2) the 
                following:
                    ``(C) Limitation.--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.''.
            (2) Conforming amendment.--Subparagraph (C) of section 
        740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-12(a)(3)) is amended to read as follows:
                    ``(C) Limitation.--An establishment shall be 
                assessed only one fee per fiscal year under this 
                section.''.
    (b) Fee Revenue Amounts.--Subsection (b) of section 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to 
read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--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--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2));
                    ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3));
                    ``(E) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(4)); and
                    ``(F) additional dollar amounts for each fiscal 
                year as follows:
                            ``(i) $20,077,793 for fiscal year 2018;
                            ``(ii) $21,317,472 for fiscal year 2019;
                            ``(iii) $16,953,329 for fiscal year 2020;
                            ``(iv) $5,426,896 for fiscal year 2021; and
                            ``(v) $2,769,609 for fiscal year 2022.
            ``(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                    ``(A) 20 percent shall be derived from human drug 
                application fees under subsection (a)(1); and
                    ``(B) 80 percent shall be derived from prescription 
                drug program fees under subsection (a)(2).
            ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                    ``(A) for fiscal year 2018, $878,590,000; and
                    ``(B) 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).''.
    (c) Adjustments; Annual Fee Setting.--Subsection (c) of section 736 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended 
to read as follows:
    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--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--
                            ``(i) such annual base revenue for the 
                        fiscal year under subsection (b)(1)(A); and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                    ``(B) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this subparagraph 
                for a fiscal year is equal to the sum of--
                            ``(i) 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
                            ``(ii) 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.
            ``(2) Capacity planning adjustment.--
                    ``(A) In general.--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.
                    ``(B) Interim methodology.--
                            ``(i) In general.--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--
                                    ``(I) the annual base revenue for 
                                such year, as adjusted for inflation 
                                under paragraph (1); and
                                    ``(II) the adjustment percentage 
                                under clause (ii).
                            ``(ii) Adjustment percentage.--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--
                                    ``(I) the total number of human 
                                drug applications, efficacy 
                                supplements, and manufacturing 
                                supplements submitted to the Secretary;
                                    ``(II) the total number of active 
                                commercial investigational new drug 
                                applications; and
                                    ``(III) the total number of formal 
                                meetings scheduled by the Secretary, 
                                and written responses issued by the 
                                Secretary in lieu of such formal 
                                meetings, as identified in section I.H 
                                of the letters described in section 
                                101(b) of the Prescription Drug User 
                                Fee Amendments of 2017.
                    ``(C) Capacity planning methodology.--
                            ``(i) Development; evaluation and report.--
                        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.
                            ``(ii) Establishment and implementation.--
                        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--
                                    ``(I) replace the interim 
                                methodology under subparagraph (B);
                                    ``(II) incorporate such approaches 
                                and attributes as the Secretary 
                                determines appropriate; and
                                    ``(III) be effective beginning with 
                                the first fiscal year for which fees 
                                are set after such capacity planning 
                                methodology is established.
                    ``(D) Limitation.--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).
                    ``(E) Publication in federal register.--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.
            ``(3) Operating reserve adjustment.--
                    ``(A) Increase.--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.
                    ``(B) Decrease.--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.
                    ``(C) Notice of rationale.--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.
            ``(4) Additional direct cost adjustment.--
                    ``(A) In general.--The Secretary shall, in addition 
                to adjustments under paragraphs (1), (2), and (3), 
                further increase the fee revenue and fees--
                            ``(i) for fiscal year 2018, by $8,730,000; 
                        and
                            ``(ii) for fiscal year 2019 and subsequent 
                        fiscal years, by the amount determined under 
                        subparagraph (B).
                    ``(B) Amount.--The amount determined under this 
                subparagraph is--
                            ``(i) $8,730,000, multiplied by
                            ``(ii) 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.
            ``(5) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2017--
                    ``(A) 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
                    ``(B) publish such fee revenue and fees in the 
                Federal Register.
            ``(6) Limit.--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.''.
    (d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``or'' at the end of subparagraph 
                (B);
                    (B) by striking subparagraph (C); and
                    (C) by redesignating subparagraph (D) as 
                subparagraph (C);
            (2) by striking paragraph (3) (relating to use of standard 
        costs);
            (3) by redesignating paragraph (4) as paragraph (3); and
            (4) in paragraph (3), as so redesignated--
                    (A) in subparagraphs (A) and (B), by striking 
                ``paragraph (1)(D)'' and inserting ``paragraph 
                (1)(C)''; and
                    (B) in subparagraph (B)--
                            (i) by striking clause (ii);
                            (ii) by striking ``shall pay'' through 
                        ``(i) application fees'' and inserting ``shall 
                        pay application fees''; and
                            (iii) by striking ``; and'' at the end and 
                        inserting a period.
    (e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking 
``all fees'' and inserting ``all such fees''.
    (f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 
``supplements, prescription drug establishments, and prescription drug 
products'' and inserting ``prescription drug program fees''.
    (g) Crediting and Availability of Fees.--Section 736(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``and paragraph (4) of this 
                subsection''; and
            (2) by striking paragraph (4).
    (h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and 
establishment fees'' each place it appears and inserting ``prescription 
drug program fees''.

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h-2) is amended--
            (1) in subsection (a)(1)--
                    (A) in the matter before subparagraph (A), by 
                striking ``2013'' and inserting ``2018''; and
                    (B) in subparagraph (A), by striking ``Prescription 
                Drug User Fee Amendments of 2012'' and inserting 
                ``Prescription Drug User Fee Amendments of 2017'';
            (2) in subsection (b), by striking ``2013'' and inserting 
        ``2018''; and
            (3) in subsection (d), by striking ``2017'' each place it 
        appears and inserting ``2022''.

SEC. 104. SUNSET DATES.

    (a) Authorization.--Sections 735 and 736 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective 
October 1, 2022.
    (b) Reporting Requirements.--Section 736B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease to be effective 
January 31, 2023.
    (c) Previous Sunset Provision.--Effective October 1, 2017, 
subsections (a) and (b) of section 105 of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) are 
repealed.

SEC. 105. EFFECTIVE DATE.

    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.

SEC. 106. SAVINGS CLAUSE.

    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.

                   TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDINGS.

    (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2017''.
    (b) Findings.--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.

SEC. 202. DEFINITIONS.

    Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379i) is amended--
            (1) by redesignating paragraphs (8) through (13) as 
        paragraphs (9) through (14), respectively;
            (2) by inserting after paragraph (7) the following new 
        paragraph:
            ``(8) The term `de novo classification request' means a 
        request made under section 513(f)(2)(A) with respect to the 
        classification of a device.'';
            (3) in subparagraph (D) of paragraph (10) (as redesignated 
        by paragraph (1)), by striking ``and submissions'' and 
        inserting ``submissions, and de novo classification requests''; 
        and
            (4) in paragraph (11) (as redesignated by paragraph (1)), 
        by striking ``2011'' and inserting ``2016''.

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    (a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
            (1) in paragraph (1), by striking ``fiscal year 2013'' and 
        inserting ``fiscal year 2018''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``October 1, 2012'' and inserting 
                        ``October 1, 2017'';
                            (ii) in clause (viii), by striking ``2'' 
                        and inserting ``3.4''; and
                            (iii) by adding at the end the following 
                        new clause:
                            ``(xi) For a de novo classification 
                        request, a fee equal to 30 percent of the fee 
                        that applies under clause (i).''; and
                    (B) in subparagraph (B)(v)(I), by striking ``or 
                premarket notification submission'' and inserting 
                ``premarket notification submission, or de novo 
                classification request''.
    (b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
    ``(b) Fee Amounts.--
            ``(1) In general.--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).
            ``(2) Base fee amounts specified.--For purposes of 
        paragraph (1), the base fee amounts specified in this paragraph 
        are as follows:

----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        ``Fee Type                         Year 2018  Year 2019  Year 2020  Year 2021  Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application....................................   $294,000   $300,000   $310,000   $328,000   $329,000
Establishment Registration...............................     $4,375     $4,548     $4,760     $4,975     $4,978
----------------------------------------------------------------------------------------------------------------

            ``(3) Total revenue amounts specified.--For purposes of 
        paragraph (1), the total revenue amounts specified in this 
        paragraph are as follows:
                    ``(A) $183,280,756 for fiscal year 2018.
                    ``(B) $190,654,875 for fiscal year 2019.
                    ``(C) $200,132,014 for fiscal year 2020.
                    ``(D) $211,748,789 for fiscal year 2021.
                    ``(E) $213,687,660 for fiscal year 2022.''.
    (c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
            (1) in paragraph (1), by striking ``2012'' and inserting 
        ``2017'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``2014'' and 
                inserting ``2018'';
                    (B) by striking subparagraph (B) and inserting the 
                following new subparagraph:
                    ``(B) Applicable inflation adjustment.--The 
                applicable inflation adjustment for fiscal year 2018 
                and each subsequent fiscal year is the product of--
                            ``(i) the base inflation adjustment under 
                        subparagraph (C) for such fiscal year; and
                            ``(ii) 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.'';
                    (C) in subparagraph (C), in the heading, by 
                striking ``to total revenue amounts''; and
                    (D) by amending subparagraph (D) to read as 
                follows:
                    ``(D) Adjustment to base fee amounts.--For each of 
                fiscal years 2018 through 2022, the Secretary shall--
                            ``(i) 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
                            ``(ii) 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).''; and
            (3) in paragraph (3)--
                    (A) by striking ``2014 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``further adjusted'' and inserting 
                ``increased''.
    (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
            (1) in paragraph (1), by striking ``specified in clauses 
        (i) through (v) and clauses (vii), (ix), and (x)'' and 
        inserting ``specified in clauses (i) through (vii) and clauses 
        (ix), (x), and (xi)''; and
            (2) in paragraph (2)(C)--
                    (A) by striking ``supplement, or'' and inserting 
                ``supplement,''; and
                    (B) by inserting ``, or a de novo classification 
                request'' after ``class III device''.
    (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--Section 738(e)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking 
``50'' and inserting ``25''.
    (f) Fee Waiver or Reduction.--
            (1) Repeal.--Section 738 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection 
        (f).
            (2) Conforming changes.--
                    (A) Section 515(c)(4)(A) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended 
                by striking ``738(h)'' and inserting ``738(g)''.
                    (B) Section 738 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 379j), as amended by paragraph 
                (1), is further amended--
                            (i) by redesignating subsections (g) 
                        through (l) as subsections (f) through (k);
                            (ii) in subsection (a)(2)(A), by striking 
                        ``(d), (e), and (f)'' and inserting ``(d) and 
                        (e)''; and
                            (iii) in subsection (a)(3)(A), by striking 
                        ``and subsection (f)''.
    (g) Effect of Failure To Pay Fees.--Subsection (f)(1), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--
            (1) by striking ``or periodic reporting concerning a class 
        III device'' and inserting ``periodic reporting concerning a 
        class III device, or de novo classification request''; and
            (2) by striking ``all fees'' and inserting ``all such 
        fees''.
    (h) Conditions.--Subsection (g)(1)(A), as redesignated, of section 
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is 
amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
    (i) Crediting and Availability of Fees.--Subsection (h), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``subsection (c)'' and all that 
                follows through the period at the end and inserting 
                ``subsection (c).''; and
            (2) by striking paragraph (4).

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

    (a) Performance Reports.--Section 738A(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) by striking ``2013'' and inserting 
                        ``2018''; and
                            (ii) by striking ``the Medical Device User 
                        Fee Amendments of 2012'' and inserting 
                        ``Medical Device User Fee Amendments of 2017''; 
                        and
                    (B) in subparagraph (B), by striking ``the Medical 
                Device User Fee Amendments of 2012'' and inserting 
                ``Medical Device User Fee Amendments of 2017''; and
            (2) in paragraph (2), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.
    (b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
            (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2022''; and
            (2) in paragraph (5), by striking ``2017'' and inserting 
        ``2022''.

SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

    (a) In General.--Section 514 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the 
following:
    ``(d) Pilot Accreditation Scheme for Conformity Assessment.--
            ``(1) In general.--The Secretary shall establish a pilot 
        program under which--
                    ``(A) 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
                    ``(B) 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.
            ``(2) Secretarial review of accredited laboratory 
        determinations.--The Secretary may--
                    ``(A) 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
                    ``(B) 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.
            ``(3) Implementation and reporting.--
                    ``(A) Public meeting.--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.
                    ``(B) Pilot program guidance.--The Secretary 
                shall--
                            ``(i) not later than September 30, 2019, 
                        issue draft guidance regarding the goals and 
                        implementation of the pilot program under this 
                        subsection; and
                            ``(ii) not later than September 30, 2021, 
                        issue final guidance with respect to the 
                        implementation of such program.
                    ``(C) Pilot program initiation.--Not later than 
                September 30, 2020, the Secretary shall initiate the 
                pilot program under this subsection.
                    ``(D) Report.--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.
            ``(4) Sunset.--As of October 1, 2022--
                    ``(A) the authority for accreditation bodies to 
                accredit testing laboratories pursuant to paragraph 
                (1)(A) shall cease to have force or effect;
                    ``(B) the Secretary--
                            ``(i) may not accept a determination 
                        pursuant to paragraph (1)(B) made by a testing 
                        laboratory after such date; and
                            ``(ii) may accept such a determination made 
                        prior to such date;
                    ``(C) 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
                    ``(D) 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.''.

SEC. 206. REAUTHORIZATION OF REVIEW.

    Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m) is amended--
            (1) in subsection (a)(3)--
                    (A) in subparagraph (A), by striking clauses (ii) 
                and (iii) and inserting the following:
                            ``(ii) a device classified under section 
                        513(f)(2) or designated under section 515C(d);
                            ``(iii) a device that is intended to be 
                        life sustaining or life supporting, unless 
                        otherwise determined by the Secretary in 
                        accordance with subparagraph (B)(i)(II) and 
                        listed as eligible for review under 
                        subparagraph (B)(iii); or
                            ``(iv) a device that is of a type, or 
                        subset of a type, listed as not eligible for 
                        review under subparagraph (B)(iii).'';
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) Designation for review.--The Secretary 
                shall--
                            ``(i) 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--
                                    ``(I) the risk of the device type, 
                                or subset of such device type; and
                                    ``(II) whether the device type, or 
                                subset of such device type, is 
                                permanently implantable, life 
                                sustaining, or life supporting, and 
                                whether there is a detailed public 
                                health justification for permitting the 
                                review by an accredited person of a 
                                specific life sustaining or life 
                                supporting device;
                            ``(ii) not later than 24 months after the 
                        date on which the Secretary issues such draft 
                        guidance, finalize such guidance; and
                            ``(iii) 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).''; and
                    (C) by adding at the end the following:
                    ``(C) Interim rule.--Until the date on which the 
                updated list is designated and posted in accordance 
                with subparagraph (B)(iii), the list in effect on the 
                date of enactment the Medical Device User Fee 
                Amendments of 2017 shall be in effect.'';
            (2) in subsection (b)--
                    (A) in paragraph (2)--
                            (i) by striking subparagraph (D); and
                            (ii) by redesignating subparagraph (E) as 
                        subparagraph (D); and
                    (B) in paragraph (3)--
                            (i) by redesignating subparagraph (E) as 
                        subparagraph (F);
                            (ii) in subparagraph (F) (as so 
                        redesignated), by striking ``The operations 
                        of'' and all that follows through ``it will--'' 
                        and inserting ``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--''; and
                            (iii) by inserting after subparagraph (D) 
                        the following new subparagraph:
                    ``(E) The operations of such person shall be in 
                accordance with generally accepted professional and 
                ethical business practices.''; and
            (3) in subsection (c), by striking ``2017'' and inserting 
        ``2022''.

SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.

    Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379k-1(b)) is amended by adding at the end the following new 
paragraph:
            ``(3) Presubmissions and submissions solely in electronic 
        format.--
                    ``(A) In general.--Beginning 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.
                    ``(B) Draft guidance.--The Secretary shall, not 
                later than October 1, 2019, issue draft guidance 
                providing for--
                            ``(i) any further standards for the 
                        submission by electronic format required under 
                        subparagraph (A);
                            ``(ii) a timetable for the establishment by 
                        the Secretary of such further standards; and
                            ``(iii) set forth criteria for waivers of 
                        and exemptions from the requirements of this 
                        subsection.
                    ``(C) Final guidance.--The Secretary shall, not 
                later than 1 year after the close of the public comment 
                period on the draft guidance issued under subparagraph 
                (B), issue final guidance.''.

SEC. 208. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i 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.

SEC. 209. EFFECTIVE DATE.

    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.

SEC. 210. SUNSET CLAUSE.

    (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective 
October 1, 2022.
    (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the 
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and 
reporting requirements) shall cease to be effective January 31, 2023.
    (c) Previous Sunset Provision.--
            (1) In general.--Effective October 1, 2017, section 207(a) 
        of the Medical Device User Fee Amendments of 2012 (Public Law 
        112-144) is repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Safety and Innovation Act (Public Law 112-144) is amended in 
        the table of contents in section 2 by striking the item 
        relating to section 207.

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Generic Drug 
User Fee Amendments of 2017''.
    (b) Finding.--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.

SEC. 302. DEFINITIONS.

    Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-41) is amended--
            (1) in paragraph (1)(B), by striking ``application for a 
        positron emission tomography drug.'' and inserting 
        ``application--
                            ``(i) for a positron emission tomography 
                        drug; or
                            ``(ii) submitted by a State or Federal 
                        governmental entity for a drug that is not 
                        distributed commercially.'';
            (2) by redesignating paragraphs (5) through (12) as 
        paragraphs (6) through (13), respectively; and
            (3) by inserting after paragraph (4) the following:
            ``(5) The term `contract manufacturing organization 
        facility' 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.''.

SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

    (a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2013'' and inserting ``fiscal year 2018'';
            (2) in paragraph (1), by adding at the end the following:
                    ``(E) Sunset.--This paragraph shall cease to be 
                effective October 1, 2022.'';
            (3) in paragraph (2)--
                    (A) by amending subparagraph (C) to read as 
                follows:
                    ``(C) Notice.--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.''; and
                    (B) in subparagraph (E)--
                            (i) in clause (i)--
                                    (I) by striking ``no later than the 
                                date'' and inserting ``on the earlier 
                                of--
                                    ``(I) the date'';
                                    (II) by striking the period and 
                                inserting ``; or''; and
                                    (III) by adding at the end the 
                                following:
                                    ``(II) the date on which the drug 
                                master file holder requests the initial 
                                completeness assessment.''; and
                            (ii) in clause (ii), by striking ``notice 
                        provided for in clause (i) or (ii) of 
                        subparagraph (C), as applicable'' and inserting 
                        ``notice provided for in subparagraph (C)'';
            (4) in paragraph (3)--
                    (A) in the heading, by striking ``and prior 
                approval supplement'';
                    (B) in subparagraph (A), by striking ``or a prior 
                approval supplement to an abbreviated new drug 
                application'';
                    (C) by amending subparagraphs (B) and (C) to read 
                as follows:
                    ``(B) Notice.--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.
                    ``(C) Fee due date.--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.'';
                    (D) in subparagraph (D)--
                            (i) in the heading, by inserting ``, is 
                        withdrawn prior to being received, or is no 
                        longer received'' after ``received''; and
                            (ii) by striking ``The Secretary shall'' 
                        and all that follows through the period and 
                        inserting the following:
                            ``(i) Applications not considered to have 
                        been received and applications withdrawn prior 
                        to being received.--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).
                            ``(ii) Applications no longer received.--
                        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).'';
                    (E) in subparagraph (E), by striking ``or prior 
                approval supplement''; and
                    (F) in the matter preceding clause (i) of 
                subparagraph (F)--
                            (i) by striking ``2012'' and inserting 
                        ``2017''; and
                            (ii) by striking ``subsection (d)(3)'' and 
                        inserting ``subsection (d)(2)'';
            (5) in paragraph (4)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i) and 
                        in clause (iii), by striking ``, or intended to 
                        be identified, in at least one generic drug 
                        submission that is pending or'' and inserting 
                        ``in at least one generic drug submission that 
                        is'';
                            (ii) in clause (i), by striking ``or 
                        intended to be identified in at least one 
                        generic drug submission that is pending or'' 
                        and inserting ``in at least one generic drug 
                        submission that is'';
                            (iii) in clause (ii), by striking 
                        ``produces,'' and all that follows through 
                        ``such a'' and inserting ``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''; and
                            (iv) in clause (iii), by striking ``to fees 
                        under both such clauses'' and inserting ``only 
                        to the fee attributable to the manufacture of 
                        the finished dosage forms''; and
                    (B) by amending subparagraphs (C) and (D) to read 
                as follows:
                    ``(C) Notice.--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.''.
                    ``(D) Fee due date.--For each of fiscal years 2018 
                through 2022, the fees under subparagraph (A) for such 
                fiscal year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of each such year; or
                            ``(ii) 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.'';
            (6) by redesignating paragraph (5) as paragraph (6); and
            (7) by inserting after paragraph (4) the following:
            ``(5) Generic drug applicant program fee.--
                    ``(A) In general.--A generic drug applicant program 
                fee shall be assessed annually as described in 
                subsection (b)(2)(E).
                    ``(B) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (d).
                    ``(C) Notice.--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.
                    ``(D) Fee due date.--For each of fiscal years 2018 
                through 2022, the fees under subparagraph (A) for such 
                fiscal year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of each such fiscal year; or
                            ``(ii) 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.''.
    (b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in the heading, by striking ``2013'' 
                        and inserting ``2018'';
                            (ii) by striking ``2013'' and inserting 
                        ``2018'';
                            (iii) by striking ``$299,000,000'' and 
                        inserting ``$493,600,000''; and
                            (iv) by striking ``Of that amount'' and all 
                        that follows through the end of clause (ii); 
                        and
                    (B) in subparagraph (B)--
                            (i) in the heading, by striking ``2014 
                        through 2017'' and inserting ``2019 through 
                        2022'';
                            (ii) by striking ``2014 through 2017'' and 
                        inserting ``2019 through 2022'';
                            (iii) by striking ``paragraphs (2) through 
                        (4)'' and inserting ``paragraphs (2) through 
                        (5)''; and
                            (iv) by striking ``$299,000,000'' and 
                        inserting ``$493,600,000''; and
            (2) in paragraph (2)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``paragraph (1)(A)(ii) for 
                        fiscal year 2013 and paragraph (1)(B) for each 
                        of fiscal years 2014 through 2017'' and 
                        inserting ``such paragraph for a fiscal year''; 
                        and
                            (ii) by striking ``through (4)'' and 
                        inserting ``through (5)'';
                    (B) in subparagraph (A), by striking ``Six 
                percent'' and inserting ``Five percent'';
                    (C) by amending subparagraphs (B) and (C) to read 
                as follows:
                    ``(B) Thirty-three percent shall be derived from 
                fees under subsection (a)(3) (relating to abbreviated 
                new drug applications).
                    ``(C) 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.'';
                    (D) in subparagraph (D)--
                            (i) by striking ``Fourteen percent'' and 
                        inserting ``Seven percent'';
                            (ii) by striking ``not less than $15,000 
                        and not more than $30,000'' and inserting 
                        ``$15,000''; and
                            (iii) by striking ``, as determined'' and 
                        all that follows through the period at the end 
                        and inserting a period; and
                    (E) by adding at the end the following:
                    ``(E)(i) 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:
                            ``(I) 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.
                            ``(II) 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.
                            ``(III) 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.
                    ``(ii) 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.''.
    (c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``2014'' and inserting ``2019'';
                    (B) by inserting ``to equal the product of the 
                total revenues established in such notice for the prior 
                fiscal year multiplied'' after ``a fiscal year,''; and
                    (C) by striking the flush text following 
                subparagraph (C); and
            (2) in paragraph (2)--
                    (A) by striking ``2017'' each place it appears and 
                inserting ``2022''; and
                    (B) by striking ``2018'' and inserting ``2023''.
    (d) Annual Fee Setting.--Section 744B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-42) is amended--
            (1) in subsection (c)(2), by striking ``Such fees may only 
        be used in fiscal year 2018.''; and
            (2) in subsection (d)--
                    (A) by striking paragraphs (1) and (2) and 
                inserting the following:
            ``(1) Fiscal years 2018 through 2022.--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).'';
                    (B) by redesignating paragraph (3) as paragraph 
                (2); and
                    (C) in paragraph (2) (as so redesignated), in the 
                matter preceding subparagraph (A), by striking ``fees 
                under paragraphs (1) and (2)'' and inserting ``fee 
                under paragraph (1)''.
    (e) Identification of Facilities.--Section 744B(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is amended--
            (1) by striking paragraph (1);
            (2) by redesignating paragraphs (2) through (4) as 
        paragraphs (1) through (3), respectively;
            (3) in paragraph (1) (as so redesignated)--
                    (A) by striking ``paragraph (4)'' and inserting 
                ``paragraph (3)''; and
                    (B) by striking ``Such information shall'' and all 
                that follows through the end of subparagraph (B) and 
                inserting ``Such information shall, for each fiscal 
                year, be submitted, updated, or reconfirmed on or 
                before June 1 of the previous fiscal year.''; and
            (4) in paragraph (2), as so redesignated--
                    (A) in the heading, by striking ``Contents of 
                notice'' and inserting ``Information required to be 
                submitted'';
                    (B) in the matter preceding subparagraph (A), by 
                striking ``paragraph (2)'' and inserting ``paragraph 
                (1)'';
                    (C) in subparagraph (A), by striking ``or intended 
                to be identified'';
                    (D) in subparagraph (D), by striking ``and'' at the 
                end;
                    (E) in subparagraph (E), by striking the period and 
                inserting ``; and''; and
                    (F) by adding at the end the following:
                    ``(F) whether the facility is a contract 
                manufacturing organization facility.''.
    (f) Effect of Failure To Pay Fees.--Section 744B(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(g)) is amended--
            (1) in paragraph (1), by adding at the end the following: 
        ``This paragraph shall cease to be effective on October 1, 
        2022.'';
            (2) in paragraph (2)(C)(ii), by striking ``of 
        505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; and
            (3) by adding at the end the following:
            ``(5) Generic drug applicant program fee.--
                    ``(A) In general.--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:
                            ``(i) The Secretary shall place the person 
                        on a publicly available arrears list.
                            ``(ii) 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).
                            ``(iii) 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).
                    ``(B) Application of penalties.--The penalties 
                under subparagraph (A) shall apply until the fee 
                required under subsection (a)(5) is paid.''.
    (g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking ``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''.
    (h) Crediting and Availability of Fees.--Section 744B(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is amended--
            (1) in paragraph (2)--
                    (A) by striking subparagraph (C) (relating to fee 
                collection during first program year);
                    (B) in subparagraph (D)--
                            (i) in the heading, by striking ``in 
                        subsequent years''; and
                            (ii) by striking ``(after fiscal year 
                        2013)''; and
                    (C) by redesignating subparagraph (D) as 
                subparagraph (C); and
            (2) in paragraph (3), by striking ``fiscal years 2013 
        through 2017'' and inserting ``fiscal years 2018 through 
        2022''.
    (i) Information on Abbreviated New Drug Applications Held by 
Applicants and Their Affiliates.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the 
end the following:
    ``(o) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--
            ``(1) In general.--By April 1 of each year, each person 
        that owns an abbreviated new drug application, or any affiliate 
        of such person, shall submit to the Secretary a list of--
                    ``(A) all approved abbreviated new drug 
                applications owned by such person; and
                    ``(B) if any affiliate of such person also owns an 
                abbreviated new drug application, all affiliates that 
                own any such abbreviated new drug application and all 
                approved abbreviated new drug applications owned by any 
                such affiliate.
            ``(2) Format and method.--The Secretary shall specify in 
        guidance the format and method for submission of lists under 
        this subsection.''.

SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-43) is amended--
            (1) in subsection (a)--
                    (A) by striking ``2013'' and inserting ``2018''; 
                and
                    (B) by striking ``Generic Drug User Fee Amendments 
                of 2012'' and inserting ``Generic Drug User Fee 
                Amendments of 2017'';
            (2) in subsection (b), by striking ``2013'' and inserting 
        ``2018''; and
            (3) in subsection (d), by striking ``2017'' each place it 
        appears and inserting ``2022''.

SEC. 305. SUNSET DATES.

    (a) Authorization.--Sections 744A and 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42) shall cease to be 
effective October 1, 2022.
    (b) Reporting Requirements.--Section 744C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease to be effective 
January 31, 2023.
    (c) Previous Sunset Provision.--Effective October 1, 2017, 
subsections (a) and (b) of section 304 of the Food and Drug 
Administration Safety and Innovation Act (Public Law 112-144) are 
repealed.

SEC. 306. EFFECTIVE DATE.

    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.

SEC. 307. SAVINGS CLAUSE.

    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 (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were 
submitted, and drug master files for Type II active pharmaceutical 
ingredients that were first referenced with respect to assessing and 
collecting any fee required by such part for a fiscal year prior to 
fiscal year 2018.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Biosimilar User 
Fee Amendments of 2017''.
    (b) Finding.--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.

SEC. 402. DEFINITIONS.

    (a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
            ``(1) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for all urban consumers (all 
        items; United States city average) (Washington-Baltimore, DC-
        MD, VA-WV; Not Seasonally Adjusted; All items) for October of 
        the preceding fiscal year divided by such Index for October 
        2011 divided by such index for September 2011.''.
    (b) Biosimilar Biological Product.--Section 744G(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by 
striking ``means a product'' and inserting ``means a specific strength 
of a biological product in final dosage form''.

SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

    (a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2013'' and inserting ``fiscal year 2018'';
            (2) in the heading of paragraph (1), by striking 
        ``Biosimilar'' and inserting ``Biosimilar biological product'';
            (3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and 
        inserting ``(c)(5)'';
            (4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for 
        biosimilar biological product development'' and inserting 
        ``(c)(5) for the biosimilar biological product development 
        program'';
            (5) in paragraph (1)(B)(ii), by striking ``annual 
        biosimilar biological product development program fee'' and 
        inserting ``annual biosimilar biological product development 
        fee'';
            (6) in paragraph (1)(B)(iii), by striking ``annual 
        biosimilar development program fee'' and inserting ``annual 
        biosimilar biological product development fee'';
            (7) in paragraph (1)(B), by adding at the end the 
        following:
                            ``(iv) Refund.--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.'';
            (8) in paragraph (1)(C), by striking ``for a product 
        effective October 1 of a fiscal year by,'' and inserting ``for 
        a product, effective October 1 of a fiscal year, by,'';
            (9) in paragraph (1)(D)--
                    (A) in clause (i) in the matter preceding subclause 
                (I), by inserting ``, if the person seeks to resume 
                participation in such program,'' before ``pay a fee'';
                    (B) in clause (i)(I), by inserting after ``grants a 
                request'' the following: ``by such person''; and
                    (C) in clause (i)(II), by inserting after 
                ``discontinued)'' the following: ``by such person'';
            (10) in the heading of paragraph (1)(E), by striking 
        ``biosimilar development program'';
            (11) in the heading of subparagraph (F) of paragraph (1), 
        by striking ``biosimilar development program fees'' and 
        inserting ``biosimilar biological product development fees'';
            (12) in paragraph (1)(F)--
                    (A) in the heading of subparagraph (F), by striking 
                ``biosimilar development program'' before ``fees''; and
                    (B) by amending clause (i) to read as follows:
                            ``(i) Refunds.--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).'';
            (13) in paragraph (2)--
                    (A) in the heading of paragraph (2), by striking 
                ``and supplement'';
                    (B) by amending subparagraphs (A) and (B) to read 
                as follows:
                    ``(A) In general.--Each person that submits, on or 
                after October 1, 2017, a biosimilar biological product 
                application shall be subject to the following fees:
                            ``(i) 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.
                            ``(ii) 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).
                    ``(B) Rule of applicability; treatment of certain 
                previously paid fees.--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--
                            ``(i) 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
                            ``(ii) 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).'';
                    (C) in the heading of subparagraph (D), by striking 
                ``or supplement''; and
                    (D) in subparagraphs (C) through (F)--
                            (i) by striking ``or supplement'' each 
                        place it appears; and
                            (ii) in subparagraph (D), by striking ``or 
                        a supplement''; and
            (14) by amending paragraph (3) to read as follows:
            ``(3) Biosimilar biological product program fee.--
                    ``(A) In general.--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--
                            ``(i) is identified in such a biosimilar 
                        biological product application approved as of 
                        October 1 of such fiscal year; and
                            ``(ii) 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.
                    ``(B) Due date.--The biosimilar biological product 
                program fee for a fiscal year shall be due on the later 
                of--
                            ``(i) the first business day on or after 
                        October 1 of each such year; or
                            ``(ii) 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.
                    ``(C) One fee per product per year.--The biosimilar 
                biological product program fee shall be paid only once 
                for each product for each fiscal year.
                    ``(D) Limitation.--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.''.
    (b) Fee Revenue Amounts.--Subsection (b) of section 744H of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to 
read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) Fiscal year 2018.--For fiscal year 2018, fees under 
        subsection (a) shall be established to generate a total revenue 
        amount equal to the sum of--
                    ``(A) $45,000,000; and
                    ``(B) the dollar amount equal to the fiscal year 
                2018 adjustment (as determined under subsection 
                (c)(4)).
            ``(2) Subsequent fiscal years.--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--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (4));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2)); and
                    ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3)).
            ``(3) Allocation of revenue amount among fees; limitations 
        on fee amounts.--
                    ``(A) Allocation.--The Secretary shall determine 
                the percentage of the total revenue amount for a fiscal 
                year to be derived from, respectively--
                            ``(i) initial and annual biosimilar 
                        development fees and reactivation fees under 
                        subsection (a)(1);
                            ``(ii) biosimilar biological product 
                        application fees under subsection (a)(2); and
                            ``(iii) biosimilar biological product 
                        program fees under subsection (a)(3).
                    ``(B) Limitations on fee amounts.--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.
                    ``(C) Biosimilar biological product development 
                fees.--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.
                    ``(D) Reactivation fee.--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.
            ``(4) Annual base revenue.--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).''.
    (c) Adjustments; Annual Fee Setting.--Section 744H of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
            (1) by redesignating subsections (c) through (h) as 
        subsections (d) through (i), respectively;
            (2) in subsections (a)(2)(F) and (g), by striking 
        ``subsection (c)'' and inserting ``subsection (d)'';
            (3) in subsection (a)(4)(A), by striking ``subsection 
        (b)(1)(F)'' and inserting ``subsection (c)(5)''; and
            (4) by inserting after subsection (b) the following:
    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--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--
                            ``(i) such annual base revenue for the 
                        fiscal year under subsection (b); and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                    ``(B) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this subparagraph 
                for a fiscal year is equal to the sum of--
                            ``(i) 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
                            ``(ii) 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.
            ``(2) Capacity planning adjustment.--
                    ``(A) In general.--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.
                    ``(B) Capacity planning methodology.--
                            ``(i) Development; evaluation and report.--
                        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.
                            ``(ii) Establishment and implementation.--
                        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--
                                    ``(I) incorporate such approaches 
                                and attributes as the Secretary 
                                determines appropriate; and
                                    ``(II) be effective beginning with 
                                the first fiscal year for which fees 
                                are set after such capacity planning 
                                methodology is established.
                    ``(C) Limitation.--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).
                    ``(D) Publication in federal register.--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.
            ``(3) Operating reserve adjustment.--
                    ``(A) Interim application; fee reduction.--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.
                    ``(B) General application and methodology.--
                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)--
                            ``(i) reduce the fee revenue and fees under 
                        this section as the Secretary determines 
                        appropriate for long-term financial planning 
                        purposes; or
                            ``(ii) 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.
                    ``(C) Federal register notice.--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.
            ``(4) Fiscal year 2018 adjustment.--
                    ``(A) In general.--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.
                    ``(B) Methodology.--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.
                    ``(C) Limitation.--No adjustment under this 
                paragraph shall result in an increase in fee revenue 
                and fees under this section in excess of $9,000,000.
            ``(5) Annual fee setting.--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--
                    ``(A) 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
                    ``(B) publish such fee revenue and fees in the 
                Federal Register.
            ``(6) Limit.--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.''.
    (d) Application Fee Waiver for Small Business.--Subsection (d)(1) 
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended--
            (1) by striking subparagraph (B);
            (2) by striking ``shall pay--'' and all that follows 
        through ``application fees'' and inserting ``shall pay 
        application fees''; and
            (3) by striking ``; and'' at the end and inserting a 
        period.
    (e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as 
redesignated by subsection (c)(1), is amended by striking ``all fees'' 
and inserting ``all such fees''.
    (f) Crediting and Availability of Fees.--Subsection (f) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), 
as redesignated by subsection (c)(1), is amended--
            (1) in paragraph (2)--
                    (A) by striking subparagraph (C) (relating to fee 
                collection during first program year) and inserting the 
                following:
                    ``(C) Compliance.--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.''; and
                    (B) in subparagraph (D)--
                            (i) in the heading, by striking ``in 
                        subsequent years''; and
                            (ii) by striking ``(after fiscal year 
                        2013)''; and
            (2) in paragraph (3), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

    Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-53) is amended--
            (1) in subsection (a)--
                    (A) by striking ``2013'' and inserting ``2018''; 
                and
                    (B) by striking ``Biosimilar User Fee Act of 2012'' 
                and inserting ``Biosimilar User Fee Amendments of 
                2017'';
            (2) in subsection (b), by striking ``2013'' and inserting 
        ``2018'';
            (3) by striking subsection (d);
            (4) by redesignating subsection (e) as subsection (d); and
            (5) in subsection (d), as so redesignated, by striking 
        ``2017'' each place it appears and inserting ``2022''.

SEC. 405. SUNSET DATES.

    (a) Authorization.--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.
    (b) Reporting Requirements.--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.
    (c) Previous Sunset Provision.--
            (1) In general.--Effective October 1, 2017, section 404 of 
        the Food and Drug Administration Safety and Innovation Act 
        (Public Law 112-144) is repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Safety and Innovation Act (Public Law 112-144) is amended in 
        the table of contents in section 2 by striking the item 
        relating to section 404.

SEC. 406. EFFECTIVE DATE.

    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.

SEC. 407. SAVINGS CLAUSE.

    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.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

SEC. 501. PEDIATRIC DEVICES.

    (a) Pediatric Use of Devices.--Section 515A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e-1) is amended--
            (1) in subsection (a)(3)--
                    (A) by redesignating subparagraphs (B) through (D) 
                as subparagraphs (D) through (F), respectively;
                    (B) by inserting after subparagraph (A) the 
                following:
                    ``(B) an assessment of pediatric device labeling 
                needs based on a review of real world evidence 
                collected on the off-label use of medical devices in 
                children, using data available to the Secretary;
                    ``(C) the number of devices that receive a 
                humanitarian use exemption under section 520(m);'';
                    (C) in subparagraph (E), as so redesignated, by 
                striking ``; and'' and inserting ``;'';
                    (D) in subparagraph (F) (as so redesignated), by 
                striking ``(B), and (C).'' and inserting ``(C), (D), 
                and (E); and''; and
                    (E) by adding at the end the following:
                    ``(G) the number of devices for which extrapolation 
                was used to support the approval of pediatric labeling 
                of such devices.
        For the items described in this paragraph, such report shall 
        disaggregate the number of devices by pediatric 
        subpopulation.'';
            (2) by redesignating subsection (c) as subsection (d); and
            (3) by inserting after subsection (b), the following:
    ``(c) Pediatric Device Innovation.--
            ``(1) In general.--The Secretary shall, not later than 1 
        year after the date of enactment of the FDA Reauthorization Act 
        of 2017, establish within the Center for Devices and 
        Radiological Health a structure to--
                    ``(A) provide assistance to device manufacturers 
                that would result in the development, approval, and 
                labeling of medical devices for children;
                    ``(B) oversee an internal pediatrics team that--
                            ``(i) is comprised of employees of the Food 
                        and Drug Administration with expertise in 
                        pediatrics and appropriate expertise pertaining 
                        to the relevant devices under review; and
                            ``(ii) provides expertise and consultation, 
                        to all applicable divisions within the Center 
                        for Devices and Radiological Health, on--
                                    ``(I) the application of subsection 
                                (b), section 520(m), section 510(k), 
                                and section 522 of this Act and section 
                                402 of the Public Health Service Act to 
                                pediatric devices; and
                                    ``(II) pediatrics, as it pertains 
                                to reviewing devices;
                    ``(C) coordinate pediatric activities within the 
                Center for Devices and Radiological Health; and
                    ``(D) collaborate with other programs, offices, and 
                centers of the Food and Drug Administration, including 
                the consortia program authorized under section 305 of 
                the Pediatric Medical Device Safety and Improvement Act 
                of 2007.
            ``(2) Staff.--Such structure shall include a chief 
        pediatric medical officer and other appropriate individuals, as 
        the Secretary determines necessary.''.
    (b) Humanitarian Device Exemption.--Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (4)--
                    (A) in subparagraph (B), by inserting ``or an 
                appropriate local committee'' after ``review 
                committee'' each place such term appears; and
                    (B) in the matter following subparagraph (B), by 
                inserting ``or an appropriate local committee'' after 
                ``review committee'' each place such term appears; and
            (2) in paragraph (6)(A)(iv), by striking ``2017'' and 
        inserting ``2022''.
    (c) Demonstration Grants for Improving Pediatric Availability.--
Section 305 of the Pediatric Medical Device Safety and Improvement Act 
of 2007 (Public Law 110-85; 42 U.S.C. 282 note) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (4), by striking ``and'' at the 
                end;
                    (B) in paragraph (5), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(6) providing regulatory consultation to device sponsors 
        in support of the submission of an application for a pediatric 
        device, where appropriate.''; and
            (2) in subsection (e), by striking ``2017'' and inserting 
        ``2022''.
    (d) Meeting on Pediatric Device Development.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall convene a public meeting regarding opportunities 
        and barriers to the development, approval, and labeling of 
        pediatric medical devices. Such meeting shall include 
        representatives from the medical device industry, academia, 
        recipients of funding under section 305 of the Pediatric 
        Medical Device Safety and Improvement Act of 2007 (Public Law 
        110-85; 42 U.S.C. 282 note), medical provider organizations, 
        and organizations representing patients and consumers.
            (2) Topics.--The meeting described in paragraph (1) shall 
        include consideration of ways to--
                    (A) improve research infrastructure and research 
                networks to facilitate the conduct of clinical studies 
                of devices for children that would result in the 
                approval and labeling of medical devices for children;
                    (B) appropriately use extrapolation under section 
                515A(b) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360e-1(b));
                    (C) enhance the appropriate use of postmarket 
                registries and data to increase pediatric medical 
                device labeling;
                    (D) increase Food and Drug Administration 
                assistance to medical device manufactures in developing 
                devices for children that are approved and labeled for 
                their use; and
                    (E) identify current barriers to pediatric device 
                development and incentives to address such barriers.
            (3) Report.--Not later than 6 months after the meeting 
        described in paragraph (1), the Secretary of Health and Human 
        Services shall submit to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate, and publish, 
        including on the Internet website of the Food and Drug 
        Administration, a report that summarizes and responds to the 
        recommendations raised in such meeting.

SEC. 502. PEDIATRIC DRUG DEVELOPMENT.

    (a) Early Meeting on Pediatric Study Plan.--
            (1) In general.--Clause (i) of section 505B(e)(2)(C) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) 
        is amended to read as follows:
                            ``(i) shall meet with the applicant--
                                    ``(I) if requested by the applicant 
                                with respect to a drug that is intended 
                                to treat a serious or life-threatening 
                                disease or condition, to discuss 
                                preparation of the initial pediatric 
                                study plan, not later than the end-of-
                                Phase 1 meeting (as such term is used 
                                in section 312.82(b) of title 21, Code 
                                of Federal Regulations, or successor 
                                regulations) or within 30 calendar days 
                                of receipt of such request, whichever 
                                is later;
                                    ``(II) to discuss the initial 
                                pediatric study plan as soon as 
                                practicable, but not later than 90 
                                calendar days after the receipt of such 
                                plan under subparagraph (A); and
                                    ``(III) to discuss any scientific 
                                or operational challenges that may be 
                                the basis of a deferral under 
                                subsection (a)(3) or a full or partial 
                                waiver under subsection (a)(4);''.
            (2) Conforming changes.--Section 505B(e) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
                    (A) in the heading of paragraph (2), by striking 
                ``meeting'' and inserting ``meetings'';
                    (B) in the heading of paragraph (2)(C), by striking 
                ``Meeting'' and inserting ``Meetings'';
                    (C) in clauses (ii) and (iii) of paragraph (2)(C), 
                by striking ``no meeting'' each place it appears and 
                inserting ``no meeting under clause (i)(II)''; and
                    (D) in paragraph (3) by striking ``meeting under 
                paragraph (2)(C)(i)'' and inserting ``meeting under 
                paragraph (2)(C)(i)(II)''.
    (b) Informing Internal Review Committee.--Section 505A(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by 
adding at the end the following:
            ``(7) Informing internal review committee.--The Secretary 
        shall provide to the committee referred to in paragraph (1) any 
        response issued to an applicant or holder with respect to a 
        proposed pediatric study request.''.
    (c) Action on Submissions.--
            (1) In general.--Section 505A(d) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355a(d)) is amended--
                    (A) by redesignating paragraphs (3) through (5) as 
                paragraphs (4) through (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Action on submissions.--The Secretary shall review 
        and act upon a submission of a proposed pediatric study request 
        or a sponsor's proposed amendment to a written request for 
        pediatric studies within 120 calendar days of the 
        submission.''.
            (2) Conforming amendments.--
                    (A) FFDCA.--Section 505A of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 355a), as amended by 
                paragraph (1), is further amended by striking 
                subsection ``(d)(3)'' each place it appears and 
                inserting ``(d)(4)''.
                    (B) PHSA.--Paragraphs (2), (3), and (4) of section 
                351(m) of the Public Health Service Act (42 U.S.C. 
                262(m)) are amended by striking ``section 505A(d)(3)'' 
                each place it appears and inserting ``section 
                505A(d)(4)''.
    (d) Study.--The Secretary of Health and Human Services, acting 
through the internal review committee established under section 505C of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) shall, not 
later than one year after the date of enactment of this Act, develop 
and implement a plan to achieve, when appropriate, earlier submission 
of pediatric studies under section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health 
Service Act (42 U.S.C. 262(m)). Such plan shall include recommendations 
to achieve--
            (1) earlier discussion of proposed pediatric study requests 
        and written requests with sponsors, and if appropriate, at the 
        meeting required under section 505B(e)(2)(C) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)), as 
        amended by subsection (a);
            (2) earlier issuance of written requests for a pediatric 
        study under such section 505A, including for investigational 
        new drugs prior to the submission of an application under 
        section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(b)(1)); and
            (3) shorter timelines, when appropriate, for the completion 
        of studies pursuant to a written request under such section 
        505A or such section 351(m).
    (e) Neonatology Expertise.--
            (1) In general.--Section 6(d) of the Best Pharmaceuticals 
        for Children Act (21 U.S.C. 393a(d)) is amended by striking 
        ``For the 5-year period beginning on the date of enactment of 
        this subsection, at'' and inserting ``At''.
            (2) Draft guidance.--Not later than 2 years after the date 
        of enactment of this Act, the Secretary shall issue draft 
        guidance on clinical pharmacology considerations for neonatal 
        studies for drugs and biological products.
    (f) Submission of Assessments.--Section 505B(d)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is amended by 
adding at the end the following: ``The Secretary shall inform the 
Pediatric Advisory Committee of all letters and responses to such 
letters issued under this paragraph.''.
    (g) Internal Committee.--Section 505C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355d) is amended by inserting ``or 
pediatric rare diseases'' after ``psychiatry''.

SEC. 503. GUIDANCE ON MOLECULAR TARGETS IN PEDIATRIC ONCOLOGY.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall issue guidance on the development 
of oncology drugs or biological products directed at molecular targets, 
including for pediatric populations.
    (b) Collaboration; Public Meeting.--In developing the guidance 
under subsection (a), the Secretary, acting through the Commissioner of 
Food and Drugs and in collaboration with the Director of the National 
Cancer Institute, shall convene a public meeting not later than 180 
days after the date of enactment of this Act to solicit feedback from 
physicians and researchers (including pediatric oncologists), patients, 
and other stakeholders to provide input on development of the guidance. 
The Secretary shall seek input at such meeting on--
            (1) the scientific data necessary to determine when an 
        oncology drug or biological product directed at a molecular 
        target is sufficient to support pediatric clinical development 
        given the ethical, practical, and other barriers to clinical 
        investigations in the pediatric population;
            (2) how to determine relevancy of a molecular target to the 
        growth or progression of a pediatric cancer, including the 
        clinical data necessary to make such a determination;
            (3) how to overcome the challenges related to pediatric 
        oncology drug development, including issues related to 
        conducting clinical trials in pediatric rare cancers with small 
        patient populations;
            (4) the advantages and disadvantages of innovative clinical 
        trial designs in addressing the development of oncology drugs 
        or biological products directed at molecular targets in 
        pediatric cancer patients; and
            (5) the ways in which the Secretary can improve the current 
        process outlined under sections 505A and 505B of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) to 
        encourage additional research and development of pediatric 
        cancer treatments.

SEC. 504. BEST PHARMACEUTICALS FOR CHILDREN.

    Section 409I of the Public Health Service Act (42 U.S.C. 284m) is 
amended--
            (1) in subsection (a)(2)(A)(ii), by inserting ``and 
        identification of biomarkers for such diseases, disorders, or 
        conditions,'' after ``biologics,'';
            (2) in subsection (c)--
                    (A) in paragraph (6)(B)--
                            (i) by striking ``shall be assigned a 
                        docket number by the Commissioner of Food and 
                        Drugs'' and inserting ``, not later than 90 
                        days after submission, shall be posted on the 
                        Internet website of the Food and Drug 
                        Administration in an accessible manner''; and
                            (ii) by striking ``become part of the 
                        docket file with respect to each of the drugs'' 
                        and inserting ``be posted on the Internet 
                        website of the Food and Drug Administration''; 
                        and
                    (B) in paragraph (7)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``submitted'' and inserting 
                        ``posted''; and
                            (ii) in subparagraph (C), by striking ``(i) 
                        place'' and all that follows through the period 
                        at the end and inserting ``publish through 
                        posting on the Internet website of the Food and 
                        Drug Administration a summary of the report and 
                        a copy of any requested labeling changes.'';
            (3) by striking subsection (d);
            (4) by redesignating subsection (e) as subsection (d); and
            (5) in paragraph (1) of subsection (d), as so redesignated, 
        by striking ``2013 through 2017'' and inserting ``2018 through 
        2022''.

      TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF 
              CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

    Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting 
``2022''.

SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIPS.

    Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-5(f)) is amended by striking ``2013 through 2017'' and 
inserting ``2018 through 2022''.

SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.

    Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.

SEC. 604. GUIDANCE REGARDING BIOEQUIVALENCE.

    (a) In General.--In accordance with subsection (b), the Secretary 
of Health and Human Services, acting through the Commissioner of Food 
and Drugs, shall issue product-specific guidance that--
            (1) applies to complex non-biologic drugs; and
            (2) outlines how to demonstrate bioequivalence to the 
        reference drug, in order to facilitate generic development for 
        such drugs.
    (b) Deadline for Issuing Guidance.--After the date of enactment of 
this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall publish a guidance, for each 
complex non-biologic drug that is approved under section 505(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), not less than 
2 years prior to the earliest date on which an abbreviated new drug 
application may be submitted pursuant to section 505(j) of the Federal, 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) that references such 
drug.
    (c) Applicability.--This section applies to guidances for 
abbreviated new drug applications that reference new drug applications 
first approved on or after October 1, 2017.

SEC. 605. PATIENT EXPERIENCE DATA.

    Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb-8c(c)(2)(A)) is amended by striking ``impact of such 
disease or condition, or a related therapy,'' and inserting ``physical 
and psychosocial impacts of such disease or condition, related therapy, 
or clinical investigation''.

SEC. 606. COMMUNICATIONS PLANS.

    Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355-1(e)(3)) is amended--
            (1) in subparagraph (B), by striking ``; or'';
            (2) in subparagraph (C), by striking the period and 
        inserting ``; or''; and
            (3) by adding at the end the following:
                    ``(D) disseminating information to health care 
                providers about the meaning of terms related to drug 
                formulations or properties that are described in the 
                drug labeling, including information about the 
                limitations or patient care implications of such 
                formulations or properties, and how such formulations 
                or properties may be related to serious adverse drug 
                events associated with use of the drug.''.

SEC. 607. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.

    (a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by striking ``(d)(1) Except as'' and inserting 
        ``(d)(1)(A) Except as''; and
            (2) by adding at the end the following:
    ``(B) Except as authorized by the Secretary in the case of a drug 
that appears on the drug shortage list under section 506E or in the 
case of importation pursuant to section 804(j), no drug that is subject 
to section 503(b)(1) may be imported into the United States for 
commercial use if such drug is manufactured outside the United States, 
the manufacturer has not authorized the drug to be marketed in the 
United States, and the manufacturer has not caused the drug to be 
labeled to be marketed in the United States.''.
    (b) Counterfeit Drugs.--Subsection (b) of section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by 
adding at the end the following:
    ``(8) Notwithstanding subsection (a), any person who violates 
section 301(i)(3) by selling or dispensing, or holding for sale or 
dispensing, a drug that is a counterfeit drug shall be fined under 
title 18, United States Code, imprisoned for not more than 10 years, or 
both, unless the person acted in good faith and had no reason to 
believe the drug was a counterfeit drug.''.

SEC. 608. TECHNICAL CORRECTIONS.

    Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended--
            (1) in subsection (a), in the matter following paragraph 
        (2), by striking ``such drug for such disease or condition'' 
        and inserting ``the same drug for the same disease or 
        condition'';
            (2) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``If an application'' and all that follows 
                through ``such license if'' and inserting ``During the 
                7-year period described in subsection (a) for an 
                approved application under section 505 or license under 
                section 351 of the Public Health Service Act, the 
                Secretary may approve an application or issue a license 
                for a drug that is otherwise the same, as determined by 
                the Secretary, as the already approved drug for the 
                same rare disease or condition if'';
                    (B) in paragraph (1), by striking ``notice'' and 
                all that follows through ``assure'' and inserting ``of 
                exclusive approval or licensure notice and opportunity 
                for the submission of views, that during such period 
                the holder of the exclusive approval or licensure 
                cannot ensure''; and
                    (C) in paragraph (2), by striking ``such holder 
                provides'' and inserting ``the holder provides''; and
            (3) by adding at the end the following:
    ``(c) Condition of Clinical Superiority.--
            ``(1) In general.--If a sponsor of a drug that is 
        designated under section 526 and is otherwise the same, as 
        determined by the Secretary, as an already approved or licensed 
        drug is seeking exclusive approval or exclusive licensure 
        described in subsection (a) for the same rare disease or 
        condition as the already approved drug, the Secretary shall 
        require such sponsor, as a condition of such exclusive approval 
        or licensure, to demonstrate that such drug is clinically 
        superior to any already approved or licensed drug that is the 
        same drug.
            ``(2) Definition.--For purposes of paragraph (1), the term 
        `clinically superior' with respect to a drug means that the 
        drug provides a significant therapeutic advantage over and 
        above an already approved or licensed drug in terms of greater 
        efficacy, greater safety, or by providing a major contribution 
        to patient care.
    ``(d) Regulations.--The Secretary may promulgate regulations for 
the implementation of subsection (c). Until such time as the Secretary 
promulgates regulations in accordance with this subsection, any 
definitions set forth in regulations implementing this section that 
were promulgated prior to the date of enactment of the FDA 
Reauthorization Act of 2017 shall continue to apply.''.

        TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.

    (a) In General.--Section 510(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(h)) is amended--
            (1) by striking paragraph (2) and inserting the following:
            ``(2) Risk-based schedule for devices.--
                    ``(A) In general.--The Secretary, acting through 
                one or more officers or employees duly designated by 
                the Secretary, shall inspect establishments described 
                in paragraph (1) that are engaged in the manufacture, 
                propagation, compounding, or processing of a device or 
                devices (referred to in this subsection as `device 
                establishments') in accordance with a risk-based 
                schedule established by the Secretary.
                    ``(B) Factors and considerations.--In establishing 
                the risk-based schedule under subparagraph (A), the 
                Secretary shall--
                            ``(i) apply, to the extent applicable for 
                        device establishments, the factors identified 
                        in paragraph (4); and
                            ``(ii) consider the participation of the 
                        device establishment, as applicable, in 
                        international device audit programs in which 
                        the United States participates or the United 
                        States recognizes.''; and
            (2) in paragraph (4)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``paragraph (3)'' and inserting ``paragraph 
                (2) or (3)''; and
                    (B) in subparagraph (C), by inserting ``or device'' 
                after ``drug''.
    (b) Foreign Inspections.--Section 809(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by striking 
``section 510(h)(3)'' and inserting ``paragraph (2) or (3) of section 
510(h)''.

SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS.

    (a) Inspection Procedure.--Section 704 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the 
following:
    ``(h)(1) In the case of inspections that are not for-cause 
inspections, the Secretary shall review existing processes and 
standards for inspections of domestic and foreign device 
establishments, and update such processes and standards to ensure 
uniform processes and standards, with exceptions as appropriate. Such 
processes and standards shall include--
            ``(A) announcing the inspection to the establishment within 
        a reasonable time before such inspection, which shall include 
        notification to the owner, operator, or agent in charge of the 
        establishment regarding the type and nature of the inspection;
            ``(B) providing a reasonable estimate of the timeframe for 
        the duration of the inspection, an opportunity for advancing 
        communications between the officers or employees carrying out 
        the inspection under subsection (a)(1) and the owner, operator, 
        or agent in charge of the establishment concerning appropriate 
        working hours during the inspection, and, to the extent 
        feasible, advance notice of records that will be requested in 
        order to expedite the inspection; and
            ``(C) providing for requirements with respect to the 
        frequency and conditions of communications during the 
        inspection with the owner, operator, or agent in charge of the 
        establishment regarding inspection status, which may be 
        recorded by either party with advance notice and mutual 
        consent.
    ``(2) Nothing in this subsection affects the authority of the 
Secretary to conduct inspections otherwise permitted under this Act in 
order to ensure compliance.''.
    (b) Report Responses.--Section 704(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374(b)) is amended--
            (1) by striking ``Upon completion'' and inserting ``(1) 
        Upon completion''; and
            (2) by adding at the end the following:
    ``(2) In the case of establishments registered under section 510 
that have received a report pursuant to paragraph (1), and for which 
the owner, operator, or agent in charge of such establishment submits a 
timely response to such report that includes a request for feedback to 
the actions proposed in such response, and which involves a public 
health priority, the Secretary shall provide nonbinding feedback 
regarding such proposed actions within 45 days of receipt of such 
request.''.
    (c) Guidance.--
            (1) Draft guidance.--Not later than 1 year after the date 
        of enactment of this Act, the Secretary of Health and Human 
        Services shall issue draft guidance that--
                    (A) specifies how the Food and Drug Administration 
                will implement the process described in subsection (h) 
                of section 704 of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 374), as amended by this section, and 
                the requirements described in subsection (b)(2) of such 
                section;
                    (B) provides standard methods for communications 
                described in such subsections;
                    (C) establishes standard timeframes over 
                consecutive days applicable to both domestic and 
                foreign inspections, to which each inspector shall 
                adhere unless an investigator can identify to the 
                establishment a reason that more time is needed; and
                    (D) identifies practices for investigators and 
                device establishments to facilitate the continuity of 
                inspections.
            (2) Final guidance.--Not later than 18 months after the 
        close of the comment period on the draft guidance under 
        paragraph (1), the Secretary shall issue final guidance 
        consistent with such paragraph.

SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.

    Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(g)(11)) is amended by striking ``October 1, 2017'' and 
inserting ``October 1, 2022''.

SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.

    Subsection (e)(4) of section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
            (1) by adding at the end the following:
    ``(E)(i)(I) If the Secretary denies a request for certification 
under subparagraph (A)(ii) with respect to a device manufactured in an 
establishment (foreign or domestic) registered under section 510, the 
Secretary shall provide in writing to the person seeking such 
certification the basis for such denial, and specifically identify the 
finding upon which such denial is based.
    ``(II) If the denial of a request as described in subclause (I) is 
based on grounds other than an injunction proceeding pursuant to 
section 302, seizure action pursuant to section 304, or a recall 
designated Class I or Class II pursuant to part 7, title 21, Code of 
Federal Regulations, the Secretary shall provide a substantive summary 
of the specific grounds for noncompliance identified.
    ``(III) With respect to a device manufactured in an establishment 
that has received a report under section 704(b), the Secretary shall 
not deny a request for certification with respect to a device pursuant 
to subparagraph (A)(ii) if the Secretary and the owner, operator, or 
agent in charge of such establishment have agreed to a plan of 
correction in response to such report.
    ``(ii)(I) The Secretary shall provide a process for a person who is 
denied a certification as described in clause (i)(I) to request a 
review that conforms to the standards of section 517A(b).
    ``(II) Notwithstanding any previous review conducted pursuant to 
subclause (I), a person who has been denied a certification as 
described in clause (i)(I) may at any time request a review in order to 
present new information relating to actions taken by such person to 
address the reasons identified by the Secretary for the denial of 
certification, including evidence that corrective actions are being or 
have been implemented to address grounds for noncompliance identified 
by the Secretary.
    ``(III) Not later than 1 year after date of enactment of the FDA 
Reauthorization Act of 2017, the Secretary shall issue guidance 
providing for a process to carry out this subparagraph. Not later than 
1 year after the close of the comment period for such guidance, the 
Secretary shall issue final guidance.''; and
            (2) by moving the margins of subparagraphs (C) and (D) 4 
        ems to the left.

SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.

    Section 704(g) of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 374) is amended by adding at the end the following:
            ``(15) Notwithstanding any other provision of this 
        subsection, for purposes of conducting inspections of 
        establishments that manufacture, prepare, propagate, compound, 
        or process devices except types of devices licensed under 
        section 351 of the Public Health Service Act, which inspections 
        are required under section 510(h) or are inspections of such 
        establishments required to register pursuant to section 510(i), 
        the Secretary may recognize auditing organizations that are 
        recognized by organizations established by governments to 
        facilitate international harmonization. Nothing in this 
        paragraph affects the authority of the Secretary to inspect any 
        device establishment pursuant to this Act. Nothing in this 
        paragraph affects the authority of the Secretary to determine 
        the official classification of an inspection.''.

SEC. 706. NOTIFICATION OF GUIDANCE RELATED TO LAB-DEVELOPED TESTS.

    Section 1143 of the Food and Drug Administration Safety and 
Innovation Act (Public Law 112-144) is amended--
            (1) in subsection (a), by striking ``60'' and inserting 
        ``90''; and
            (2) in subsection (b), by striking ``5'' and inserting 
        ``10''.

SEC. 707. DIAGNOSTIC IMAGING DEVICES INTENDED FOR USE WITH CONTRAST 
              AGENTS.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j) is amended by adding at the end the following:
    ``(p)(1) The Secretary may approve an application or supplement to 
an application under section 515 for an applicable medical imaging 
device, may make a substantial equivalence determination as to an 
applicable medical imaging device for which a report or a supplement to 
a report has been submitted under section 510(k), or may grant a 
request under section 513(f)(2) for an applicable medical imaging 
device if the requirements of this subsection and other applicable 
premarket requirements are met, and the indications and conditions of 
use proposed in such application or notification involve the use of a 
contrast agent that is not--
            ``(A) in a concentration, rate of administration, or route 
        of administration that is different from those described in the 
        approved labeling of such contrast agent, unless the Secretary 
        determines, based on information contained in the application 
        or report, that the difference does not adversely affect the 
        safety or effectiveness of the contrast agent when used with 
        the device;
            ``(B) in a region, organ, or system of the body that is 
        different from those described in the approved labeling of the 
        contrast agent, unless the Secretary determines, based on 
        information contained in the device application, request, or 
        report, that any difference does not affect the safety or 
        effectiveness of the contrast agent when used with the device;
            ``(C) in a patient population different from the patient 
        population in the approved labeling for such contrast agent, 
        unless the Secretary determines, based on information contained 
        in the application or report, that the difference does not 
        adversely affect the safety or effectiveness of the contrast 
        agent when used with the device; or
            ``(D) in an imaging modality, such as ultrasound, magnetic 
        resonance, x-ray, fluorescent imaging technology, or diagnostic 
        radiopharmaceutical-based technology that is different from 
        those described in the approved labeling of the contrast agent.
    ``(2) An applicable medical imaging device that is eligible for 
approval under section 515, clearance under section 510(k), or 
classification under section 513(f)(2), or approval, clearance, or 
classification as described in paragraph (1) shall be subject only to 
such requirements of this Act that are applicable to devices.
    ``(3) An application under section 515, report under section 
510(k), or classification under section 513(f)(2) for an applicable 
medical imaging device intended for use in conjunction with a contrast 
agent to which clause (ii) or (iii) of section 505(c)(3)(E) applies 
shall refer to such contrast agent in such application, report, or 
request by trade or brand name, rather than to the international 
nonproprietary name.
    ``(4) In conducting a review of an application or report submitted 
for an applicable medical imaging device, the agency center charged 
with the premarket review of devices center may consult with the agency 
center charged with the premarket review of drugs and biological 
products.
    ``(5) For purposes of this subsection--
            ``(A) the term `applicable medical imaging device' means a 
        device intended to be used in conjunction with a contrast agent 
        or class of contrast agents for a use that is not described in 
        the indications and usage section of the approved labeling of 
        such contrast agent or the approved labeling of any contrast 
        agent in such class, as applicable; and
            ``(B) the term `contrast agent' means a drug that is 
        approved under section 505 or licensed under section 351 of the 
        Public Health Service Act, is intended for use in conjunction 
        with an applicable medical imaging device, and--
                    ``(i) is a diagnostic radiopharmaceutical, as 
                defined in sections 315.2 and 601.30 of title 21, Code 
                of Federal Regulations (or any successor regulations); 
                or
                    ``(ii) is a diagnostic agent that improves the 
                visualization of structure or function within the body 
                by increasing the relative difference in signal 
                intensity within the target tissue, structure, or 
                fluid.''.

SEC. 708. DIAGNOSTIC CLARITY.

    Not later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to in this section 
as the ``Secretary'') shall update guidance with respect to the 
circumstances under which reagents, new instruments, or new 
combinations of instruments may be added to groups of instruments that 
have been cleared under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(k)). The updated guidance shall provide 
standard definitions and describe procedures for sponsors seeking to 
add a new instrument, reagent, or combination of instruments to a 
cleared group of instruments to submit information to the Secretary 
demonstrating that the new reagent, new instrument, or new combination 
of instruments does not alter the assay's performance, as applicable. 
The Secretary shall consult with affected entities and other 
stakeholders in updating the guidance.

SEC. 709. APPROPRIATE CLASSIFICATION OF DEVICE ACCESSORIES.

    Section 513(b)(9) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360c(b)(9)) is amended--
            (1) by striking ``(9) The Secretary'' and inserting 
        ``(9)(A) The Secretary''; and
            (2) by adding at the end the following:
    ``(B) The classification of any accessory classified prior to 
December 13, 2016, based on the intended use or uses of such accessory, 
shall continue to apply, unless otherwise determined by the Secretary 
under section 515(e)(1).
    ``(C)(i) If an accessory has been cleared or approved based on the 
classification of another device with which such accessory is intended 
to be used and the Secretary has established a classification for such 
accessory based on the intended use or uses of the accessory, in 
accordance with subparagraph (A), the manufacturer of such accessory 
may identify the classification so established for such accessory in a 
written notification to the Secretary.
    ``(ii) Unless the Secretary notifies a manufacturer within 30 
calendar days of receipt of a written notification described in clause 
(i) that the Secretary does not agree that the classification 
identified in such written notification is appropriate for the 
accessory, the accessory shall be automatically reclassified in 
accordance with the classification identified in such written 
notification.
    ``(iii) A written notification that the Secretary disagrees with 
the classification identified in a written notification described in 
clause (ii) shall include a detailed description and justification for 
the determination to disagree.
    ``(D)(i) A manufacturer of an accessory that has not been 
classified by the Secretary based on the intended use or uses of the 
accessory as described in subparagraph (A), and for which the Secretary 
has not established a classification for the accessory type as a stand-
alone device, may submit to the Secretary a written recommendation for 
the appropriate classification of such accessory based on its intended 
use or uses. Such submission shall include such information to support 
the recommendation as the Secretary may require.
    ``(ii) The Secretary shall respond to a submission under clause (i) 
within 60 calendar days of receiving the submission by approving or 
denying the recommended classification of the accessory. If the 
Secretary does not agree with the recommendation for classification 
submitted by the sponsor, the response shall include a detailed 
description and justification for such determination to disagree. The 
Secretary shall provide an opportunity for a manufacturer to meet with 
appropriate personnel to discuss appropriate classification of such 
accessory prior to submitting a written recommendation.
    ``(E)(i) At the time a sponsor submits an application for premarket 
approval pursuant to section 515(c) or a report pursuant to 510(k), the 
sponsor of such application or report may include a recommendation and 
supporting information for the proper classification of an accessory 
pursuant to subparagraph (A), if applicable. If such accessory type has 
not been classified by the Secretary based on its intended use or uses 
as a stand-alone device as described in subparagraph (A), the Secretary 
shall--
            ``(I) approve or deny such application pursuant to section 
        515(d), or find such report substantially equivalent or not 
        substantially equivalent pursuant to section 510(k); and
            ``(II) approve or deny the classification of the accessory 
        proposed in such application or report.
    ``(F) A manufacturer may at any time use the classification process 
described in section 513(f)(2) to obtain classification of an 
accessory.''.

SEC. 710. DEVICE PILOT PROJECTS.

    (a) Postmarket Pilot.--Section 519 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the 
following:
    ``(i) Pilot Projects.--
            ``(1) In general.--In order to provide timely and reliable 
        information on the safety and effectiveness of cleared or 
        approved devices, including responses to adverse events and 
        malfunctions, and to advance the objectives of part 803 of 
        title 21, Code of Federal Regulations (or successor 
        regulations), and advance the objectives of, and evaluate 
        innovative new methods of compliance with, this section and 
        section 522, the Secretary shall, within one year of the date 
        of enactment of the FDA Reauthorization Act of 2017, initiate 
        one or more pilot projects for voluntary participation by a 
        manufacturer or manufacturers of device or device type, or 
        continue existing projects, in accordance with paragraph (3), 
        that meet all of the following requirements:
                    ``(A) Are designed to efficiently generate reliable 
                and timely safety and active surveillance data for use 
                by the Secretary or manufacturers of the devices that 
                are involved in the pilot project.
                    ``(B) Inform the development of methods, systems, 
                data criteria, and programs that could be used to 
                support safety and active surveillance activities for 
                devices not included in such project.
                    ``(C) Are designed and conducted in coordination 
                with a comprehensive system for evaluating medical 
                device technology that operates under a governing board 
                with appropriate representation of stakeholders, 
                including consumer groups and device manufacturers.
                    ``(D) Use electronic health data including claims 
                data, patient survey data, and any other data, as the 
                Secretary determines appropriate.
                    ``(E) Prioritize devices and device types that meet 
                one or more of the following criteria:
                            ``(i) Devices and device types for which 
                        the collection and analysis of real world 
                        evidence regarding a device's safety and 
                        effectiveness is likely to advance public 
                        health.
                            ``(ii) Devices and device types that are 
                        widely used.
                            ``(iii) Devices and device types, the 
                        failure of which has significant health 
                        consequences.
                            ``(iv) Devices and device types for which 
                        the Secretary has received public 
                        recommendations in accordance with paragraph 
                        (2)(B) and has determined to meet one of the 
                        criteria under clauses (i) through (iii) and is 
                        appropriate for a project under this 
                        subsection.
            ``(2) Participation.--The Secretary shall establish the 
        conditions and processes for--
                    ``(A) authorizing voluntary participation of a 
                manufacturer of a device in the pilot project described 
                in paragraph (1); and
                    ``(B) facilitating public recommendations for 
                devices to be prioritized under the pilot project 
                described in paragraph (1), including requirements for 
                the data necessary to support such recommendation.
            ``(3) Implementation.--The Secretary may satisfy the 
        requirements of paragraphs (1) and (2) by continuing or 
        expanding existing projects, or by beginning new projects, that 
        meet the criteria of subparagraphs (A) through (E) of paragraph 
        (1) or by entering into contracts, cooperative agreements, 
        grants, or other appropriate agreements with public or private 
        entities that have a significant presence in the United States, 
        and meet the following additional conditions:
                    ``(A) If such public or private entities are a 
                component of another organization, the entities have 
                established appropriate security measures to maintain 
                the confidentiality and privacy of the data described 
                in paragraph (1)(D) and the entity shall not make an 
                unauthorized disclosure of such data to the other 
                components of the organization in breach of such 
                confidentiality and privacy requirements.
                    ``(B) In the case of the termination or nonrenewal 
                of such contracts, cooperative agreements, grants, or 
                other appropriate agreements, the entities shall comply 
                with each of the following:
                            ``(i) Continue to comply with the 
                        confidentiality and privacy requirements under 
                        this subsection with respect to all data 
                        disclosed to the entity.
                            ``(ii) Return any data disclosed to such 
                        entity under this subsection to which it would 
                        not otherwise have access or, if returning the 
                        data is not practicable, destroy the data.
                    ``(C) Have at least one of the following 
                qualifications:
                            ``(i) Research, statistical, epidemiologic, 
                        or clinical capability and expertise to conduct 
                        and complete the activities under this 
                        subsection, including the capability and 
                        expertise to provide the Secretary access to 
                        de-identified data consistent with the 
                        requirements of this subsection.
                            ``(ii) An information technology 
                        infrastructure in place to support electronic 
                        data and operational standards to provide 
                        security for such data, as appropriate.
                            ``(iii) Experience with, and expertise on, 
                        the development of device safety and 
                        effectiveness research and surveillance using 
                        electronic health data.
                            ``(iv) Other expertise which the Secretary 
                        determines necessary to fulfill the activities 
                        under this subsection.
            ``(4) Review of contract in the event of a merger or 
        acquisition.--The Secretary shall review a contract with a 
        qualified entity under this subsection in the event of a merger 
        or acquisition of the entity in order to ensure that the 
        requirements under this subsection will continue to be met.
            ``(5) Report to congress.--Not later than 18 months after 
        the date of enactment of the FDA Reauthorization Act of 2017, 
        and annually thereafter, the Secretary shall submit to the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives a report containing a description of the pilot 
        projects being conducted pursuant to this subsection, including 
        for each pilot project--
                    ``(A) how the project is being implemented in 
                accordance with paragraph (3) and the contractor or 
                grantee as applicable;
                    ``(B) the number of manufacturers that have agreed 
                to participate;
                    ``(C) the data sources used;
                    ``(D) the devices or device categories involved; 
                and
                    ``(E) the number of patients involved.
            ``(6) Compliance with requirements for records or reports 
        on devices.--The participation of a manufacturer in a pilot 
        project under this subsection shall not affect the eligibility 
        of such manufacturer to participate in any quarterly reporting 
        program implemented under this Act. The Secretary may determine 
        that, for the specified time period to be determined by the 
        Secretary, a manufacturer's participation in a pilot project 
        under this subsection may meet certain other requirements of 
        this section or section 522 if--
                    ``(A) the project has demonstrated success in 
                capturing relevant adverse event information; and
                    ``(B) the Secretary has established procedures for 
                making adverse event and safety information collected 
                from the pilot public, to the extent possible, if 
                collected pursuant to this section or section 522.
            ``(7) Privacy requirements.--With respect to the pilot 
        projects conducted pursuant to this subsection--
                    ``(A) individual identifiable health information 
                shall not be disclosed when presenting any information 
                from such project; and
                    ``(B) such projects shall comply with section 
                264(c) of the Health Insurance Portability and 
                Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and 
                sections 552 and 552a of title 5, United States Code.
            ``(8) Other compliance.--Any pilot program undertaken in 
        coordination with the comprehensive system described in 
        paragraph (1)(C), including pilot projects under this 
        subsection, that relates to the use of real world evidence for 
        devices shall comply with paragraph (1)(B), the conditions 
        listed in subparagraphs (A) and (B) of paragraph (3), and 
        paragraphs (4), (5), (6), and (7).
            ``(9) Sunset.--This subsection shall cease to have force or 
        effect on October 1, 2022.''.
    (b) Report.--Not later than January 31, 2021, the Secretary of 
Health and Human Services, acting through the Commissioner of Food and 
Drugs, shall conduct a review through an independent third party to 
evaluate the strengths, limitations, and appropriate use of evidence 
collected pursuant to real world evidence pilot projects described in 
the letters described in section 201(b) of the Medical Device User Fee 
Amendments of 2017 and subsection (i) of section 519 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i), as amended by subsection 
(a), for informing premarket and postmarket decisionmaking for multiple 
device types, and to determine whether the methods, systems, and 
programs in such pilot projects efficiently generate reliable and 
timely evidence about the effectiveness or safety surveillance of 
devices.

SEC. 711. REGULATION OF OVER-THE-COUNTER HEARING AIDS.

    (a) In General.--Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j), as amended by section 707, is further 
amended by adding at the end the following:
    ``(q) Regulation of Over-the-Counter Hearing Aids.--
            ``(1) Definition.--In this subsection, the term `over-the-
        counter hearing aid' means a device that--
                    ``(A) uses the same fundamental scientific 
                technology as air conduction hearing aids (as defined 
                in section 874.3300 of title 21, Code of Federal 
                Regulations) (or any successor regulation) or wireless 
                air conduction hearing aids (as defined in section 
                874.3305 of title 21, Code of Federal Regulations) (or 
                any successor regulation);
                    ``(B) is intended to be used by adults over the age 
                of 18 to compensate for perceived mild to moderate 
                hearing impairment;
                    ``(C) through tools, tests, or software, allows the 
                user to control the over-the-counter hearing aid and 
                customize it to the user's hearing needs;
                    ``(D) may--
                            ``(i) use wireless technology; or
                            ``(ii) include tests for self-assessment of 
                        hearing loss; and
                    ``(E) is available over-the-counter, without the 
                supervision, prescription, or other order, involvement, 
                or intervention of a licensed person, to consumers 
                through in-person transactions, by mail, or online.
            ``(2) Regulation.--An over-the-counter hearing aid shall be 
        subject to the regulations promulgated in accordance with 
        section 711(b) of the FDA Reauthorization Act of 2017 and shall 
        be exempt from sections 801.420 and 801.421 of title 21, Code 
        of Federal Regulations (or any successor regulations).''.
    (b) Regulations To Establish Category.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary''), not later 
        than 3 years after the date of enactment of this Act, shall 
        promulgate proposed regulations to establish a category of 
        over-the-counter hearing aids, as defined in subsection (q) of 
        section 520 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360j) as amended by subsection (a), and, not later than 
        180 days after the date on which the public comment period on 
        the proposed regulations closes, shall issue such final 
        regulations.
            (2) Requirements.--In promulgating the regulations under 
        paragraph (1), the Secretary shall--
                    (A) include requirements that provide reasonable 
                assurances of the safety and efficacy of over-the-
                counter hearing aids;
                    (B) include requirements that establish or adopt 
                output limits appropriate for over-the-counter hearing 
                aids;
                    (C) include requirements for appropriate labeling 
                of the over-the-counter hearing aid, including how 
                consumers may report adverse events, any conditions or 
                contraindications, and any advisements to consult 
                promptly with a licensed physician; and
                    (D) describe the requirements under which the sale 
                of over-the-counter hearing aids is permitted, without 
                the supervision, prescription, or other order, 
                involvement, or intervention of a licensed person, to 
                consumers through in-person transactions, by mail, or 
                online.
            (3) Premarket notification.--The Secretary shall make 
        findings under section 510(m) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-
        counter hearing aids (as defined in section 520(q) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
        amended by subsection (a)) require a report under section 
        510(k) to provide reasonable assurance of safety and 
        effectiveness.
            (4) Effect on state law.--No State or local government 
        shall establish or continue in effect any law, regulation, or 
        order specifically applicable to hearing products that would 
        restrict or interfere with the servicing, marketing, sale, 
        dispensing, use, customer support, or distribution of over-the-
        counter hearing aids (as defined in section 520(q) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
        amended by subsection (a)) through in-person transactions, by 
        mail, or online, that is different from, in addition to, or 
        otherwise not identical to, the regulations promulgated under 
        this subsection, including any State or local requirement for 
        the supervision, prescription, or other order, involvement, or 
        intervention of a licensed person for consumers to access over-
        the-counter hearing aids.
    (c) New Guidance Issued.--Not later than the date on which final 
regulations are issued under subsection (b), the Secretary shall update 
and finalize the draft guidance of the Department of Health and Human 
Services entitled, ``Regulatory Requirements for Hearing Aid Devices 
and Personal Sound Amplification Products'', issued on November 7, 
2013. Such updated and finalized guidance shall clarify which products, 
on the basis of claims or other marketing, advertising, or labeling 
material, meet the definition of a device in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet 
the definition of a personal sound amplification product, as set forth 
in such guidance.
    (d) Study.--Not later than 3 years after the date of enactment of 
this Act, the Comptroller General of the United States shall submit to 
Congress a report evaluating consumer experience with hearing health 
care, hearing screening in the primary care setting, and consumer 
adoption, usage, and outcomes related to hearing technology. The 
Comptroller General shall update such report not later than 2 years 
after the final regulations described in subsection (b) are issued, and 
shall evaluate how implementation of such regulations has impacted 
hearing health care, including recommendations for improving consumer 
access to appropriate hearing health care.

                   TITLE VIII--ADDITIONAL PROVISIONS

SEC. 801. GAO REPORT.

    (a) In General.--Not later than September 30, 2018, the Comptroller 
General of the United States shall issue a report, after consultation 
with patients and drug and medical device manufacturers, regarding the 
implementation of sections 569A and 569B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-8a, 360bbb-8b). Such report shall assess 
the progress the Food and Drug Administration has made on--
            (1) working with other regulatory authorities of similar 
        standing to foster and encourage uniform, scientifically driven 
        clinical trial standards with respect to medical products 
        around the world;
            (2) providing consistent parallel scientific advice to 
        manufacturers seeking simultaneous global development and 
        approval of new medical products, in coordination with 
        regulatory authorities of similar standing; and
            (3) facilitating the use of foreign clinical trial data to 
        minimize duplicative clinical trials.
    (b) Additional Requirements.--The report under subsection (a) shall 
include specific examples, if possible and available, and a list of 
activities at the Food and Drug Administration regarding the 
harmonization of premarket medical product requirements.

SEC. 802. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE 
              REPORTING.

    (a) PDUFA.--Section 736B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379h-2(a)) is amended--
            (1) in paragraph (1)(B)--
                    (A) in clause (vi), by inserting ``and the number 
                of designations and denials issued by the agency for 
                such applications'' before the semicolon;
                    (B) in clause (vii), by striking ``; and'' and 
                inserting ``and the number of designations and denials 
                issued by the agency for such applications; and''; and
                    (C) in clause (viii) by striking the period and 
                inserting ``and the number of designations and denials 
                issued by the agency for such applications.''; and
            (2) by inserting after paragraph (2) the following:
            ``(3) Real time reporting.--
                    ``(A) In general.--Beginning with fiscal year 2018, 
                every 30 calendar days, the Secretary shall post the 
                data described in subparagraph (B) on the Internet 
                website of the Food and Drug Administration and remove 
                duplicative data from the annual performance report.
                    ``(B) Data.--The following data is required to be 
                posted in accordance with subparagraph (A):
                            ``(i) The number and titles of draft and 
                        final guidance issued by the Center for Drug 
                        Evaluation and Research or the Center for 
                        Biologics Evaluation and Research, and the 
                        justification for the issuance and finalization 
                        of each such guidance.
                            ``(ii) The number and titles of public 
                        meetings held by the Center for Drug Evaluation 
                        and Research and the Center for Biologics 
                        Evaluation and Research each fiscal year.
                            ``(iii) The list of standard new drug 
                        applications and biologics license 
                        applications, by fiscal year of receipt.
                            ``(iv) The number of filed applications by 
                        each review division.
            ``(4) Capacity planning and improved time reporting.--
        Beginning with fiscal year 2020, the Secretary shall include in 
        the annual report under paragraph (1)--
                    ``(A) the number of full-time equivalents agreed 
                upon in the letters described in section 101(b) of the 
                Prescription Drug User Fee Amendments of 2017 and the 
                number of appropriated full time equivalents at the 
                Food and Drug Administration by each division within 
                the Center for Drug Evaluation and Research, the Center 
                for Biologics Evaluation and Research, the Office of 
                Regulatory Affairs, and the Office of the Commissioner;
                    ``(B) identification by name of all time reporting 
                categories that Food and Drug Administration uses for 
                capacity planning and time reporting with respect to 
                the Center for Drug Evaluation and Research, the Center 
                for Biologics Evaluation and Research, the Office of 
                Regulatory Affairs, and the Office of the Commissioner, 
                pursuant to the `resource capacity planning and 
                modernized time reporting implementation plan' in the 
                letters described in section 101(b) of the Prescription 
                Drug User Fee Amendments of 2017;
                    ``(C) the processes by which the Center for Drug 
                Evaluation and Research, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs, and the Office of the Commissioner require 
                reporting on the amount of an employee's time that is 
                dedicated to the review of human drug applications, as 
                required by the letters described in section 101(b) of 
                the Prescription Drug User Fee Amendments of 2017, 
                including information regarding employees dedicated to 
                such activities on a full-time basis, and employees 
                dedicated to such activities on a part-time basis; and
                    ``(D) for each of the Center for Drug Evaluation 
                and Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner, the number of employees 
                described in subparagraph (C) (both full-time 
                equivalents and employees dedicated to such activities 
                on a part-time basis) for whom time reporting is 
                required as described in subparagraph (C), and the 
                number of such employees required to estimate time 
                dedicated to the review of human drug applications.''.
    (b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)) is amended--
            (1) by striking ``Beginning with'' and inserting the 
        following:
                            ``(i) General requirements.--Beginning 
                        with''; and
            (2) by adding at the end the following:
                            ``(ii) Additional information.--Beginning 
                        with fiscal year 2018, the annual report under 
                        this subparagraph shall include the progress of 
                        the Center for Devices and Radiological Health 
                        in achieving the goals, and future plans for 
                        meeting the goals, including, for each review 
                        division--
                                    ``(I) the number of premarket 
                                applications filed under section 515 
                                per fiscal year for each review 
                                division, and the number of approvable 
                                letters, major deficiency letters, not 
                                approvable letters, and denials for 
                                such applications;
                                    ``(II) the number of reports filed 
                                under section 510(k) per fiscal year 
                                for each review division and the number 
                                of devices cleared or not substantially 
                                equivalent for such reports; and
                                    ``(III) the number of expedited 
                                access pathway designations for a 
                                fiscal year for each review division 
                                and the number of cleared or approved 
                                devices or denials for such 
                                applications.
                            ``(iii) Real time reporting.--
                                    ``(I) In general.--Beginning with 
                                fiscal year 2018, the Secretary shall, 
                                every 30 calendar days, post the data 
                                described in subclause (II) on the 
                                Internet website of the Food and Drug 
                                Administration and remove duplicative 
                                data from the annual report under this 
                                subparagraph.
                                    ``(II) Data.--The following data is 
                                required to be posted in accordance 
                                with subclause (I):
                                            ``(aa) The number and 
                                        titles of draft and final 
                                        guidance issued by the Center 
                                        for Devices and Radiological 
                                        Health and the justification 
                                        for the issuance and 
                                        finalization of such guidance.
                                            ``(bb) The number and 
                                        titles of public meetings held 
                                        by the Center for Devices and 
                                        Radiological Health each fiscal 
                                        year.''.
    (c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-43(a)) is amended--
            (1) by striking ``Beginning with'' and inserting the 
        following:
            ``(1) General requirements.--Beginning with''; and
            (2) by adding at the end the following:
            ``(2) Additional information.--Beginning with fiscal year 
        2018, the report under this subsection shall include the 
        progress of the Office of Generic Drugs in achieving the goals, 
        and future plans for meeting the goals, including--
                    ``(A) the number of original abbreviated new drug 
                applications filed per fiscal year;
                    ``(B) the number of amendments to abbreviated new 
                drug applications filed per fiscal year; and
                    ``(C) the number of actions taken delineated by the 
                type of action, including final approvals, tentative 
                approvals, complete response letters, and the number of 
                `refuse to receive' letters issued by the Food and Drug 
                Administration per fiscal year.
            ``(3) Real time reporting.--
                    ``(A) In general.--Beginning with fiscal year 2018, 
                the Secretary shall, every 30 calendar days, post the 
                data described in subparagraph (B) on the Internet 
                website of the Food and Drug Administration and remove 
                duplicative data from the annual report under this 
                subsection.
                    ``(B) Data.--The following data is required to be 
                posted in accordance with subparagraph (A):
                            ``(i) The number and titles of draft and 
                        final guidance issued by the Office of Generic 
                        Drugs and the justification for the issuance 
                        and finalization of such guidance.
                            ``(ii) The number and titles of public 
                        meetings held by the Office of Generic Drugs 
                        each fiscal year.''.
    (d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-53(a)) is amended--
            (1) by striking ``Beginning with'' and inserting the 
        following:
            ``(1) General requirements.--Beginning with''; and
            (2) by adding at the end the following:
            ``(2) Additional information.--Beginning with fiscal year 
        2018, the report under this subsection shall include the 
        progress of the Center for Biologics Evaluation and Research in 
        achieving the goals, and future plans for meeting the goals, 
        including--
                    ``(A) information on all previous cohorts for which 
                the Secretary has not given a complete response on all 
                biosimilar biological product applications and 
                supplements in the cohort;
                    ``(B) the number of original biosimilar biological 
                product applications filed per fiscal year, and the 
                number of approvals or complete response letters issued 
                by the agency for such applications; and
                    ``(C) the number of resubmitted original biosimilar 
                biological product applications filed per fiscal year 
                and the number of approvals or complete response 
                letters issued by the agency for such applications.
            ``(3) Real time reporting.--
                    ``(A) In general.--Beginning with fiscal year 2018, 
                the Secretary shall, every 30 calendar days, post the 
                data described in subparagraph (B) on the Internet 
                website of the Food and Drug Administration and remove 
                duplicative data from the annual report under this 
                subsection.
                    ``(B) Data.--The following data is required to be 
                posted in accordance with subparagraph (A):
                            ``(i) The number and titles of draft and 
                        final guidance issued by the Center for Drug 
                        Evaluation and Research and the Center for 
                        Biologics Evaluation and Research and the 
                        justification for the issuance and finalization 
                        of such guidance.
                            ``(ii) The number and titles of public 
                        meetings held by the Center for Drug Evaluation 
                        and Research and the Center for Biologic 
                        Evaluation and Research each fiscal year.''.
            ``(4) Capacity planning and time reporting.--Beginning with 
        fiscal year 2020, the Secretary shall include in the annual 
        report under paragraph (1)--
                    ``(A) the number of full-time equivalents agreed 
                upon in the letters described in section 401(b) of the 
                Biosimilar User Fee Amendments of 2017 and the number 
                of appropriated full time equivalents at the Food and 
                Drug Administration by each division within the Center 
                for Drug Evaluation and Research, the Center for 
                Biologics Evaluation and Research, the Office of 
                Regulatory Affairs, and the Office of the Commissioner;
                    ``(B) identification by name of all time reporting 
                categories that the Food and Drug Administration uses 
                for capacity planning and time reporting under the 
                `resource capacity planning and modernized time 
                reporting implementation plan' in the letters described 
                in section 401(b) of the Biosimilar User Fee Amendments 
                of 2017 for the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs and the 
                Office of the Commissioner;
                    ``(C) the process by which the Center for Drug 
                Evaluation and Research, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs, and the Office of the Commissioner require 
                reporting on the amount of an employee's time that is 
                dedicated to the review of biosimilar biological 
                product applications, required pursuant to the letters 
                described in section 401(b) of the Biosimilar User Fee 
                Amendments of 2017, including information regarding 
                both employees dedicated to such activities on a full-
                time basis, and employees dedicated to such activities 
                on a part-time basis; and
                    ``(D) for each of the Center for Drug Evaluation 
                and Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner, the actual number of 
                employees described in subparagraph (C) (both full-time 
                equivalents and employees dedicated to such activities 
                on a part-time basis) for whom time reporting is 
                required as described in subparagraph (C), and the 
                number of such employees required to estimate time 
                dedicated to the review of biosimilar biological 
                product applications.''.

SEC. 803. ANALYSIS OF USE OF FUNDS.

    (a) PDUFA Reports.--
            (1) Analysis in pdufa performance reports.--Section 736B(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
        2(a)), as amended by section 802(a), is further amended by 
        adding at the end the following:
            ``(5) Analysis.--For each fiscal year, the Secretary shall 
        include in the report under paragraph (1) an analysis of the 
        following:
                    ``(A) The difference between the number of human 
                drug applications filed and the number of approvals or 
                complete response letters issued by the agency, 
                accounting for--
                            ``(i) such applications filed during one 
                        fiscal year for which a decision is not 
                        scheduled to be made until the following fiscal 
                        year;
                            ``(ii) such applications pending with the 
                        Center for Drug Evaluation and Research and the 
                        Center for Biologics Evaluation and Research 
                        that did not meet the goals identified in the 
                        letters described in section 101(b) of the 
                        Prescription Drug User Fee Amendments of 2017 
                        for the corresponding fiscal year and the 
                        future plans of the Food and Drug 
                        Administration to meet these goals; and
                            ``(iii) the most common causes within the 
                        agency for missing such goals.
                    ``(B) Relevant data to determine whether the Center 
                for Drug Evaluation and Research and the Center for 
                Biologics Evaluation and Research have met performance 
                enhancement goals identified in the letters described 
                in section 101(b) of the Prescription Drug User Fee 
                Amendments of 2017 for the corresponding fiscal year.
                    ``(C) External or other circumstances impacting the 
                Center for Drug Evaluation and Research, the Center for 
                Biologics Evaluation and Research, or the Food and Drug 
                Administration, that impacted the ability of the agency 
                to meet the review time and performance enhancement 
                goals identified in the letters described in section 
                101(b) of the Prescription Drug User Fee Amendments of 
                2017.''.
            (2) Issuance of corrective action reports.--Section 736B of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) is 
        amended--
                    (A) by redesignating subsections (c) and (d) as 
                subsections (e) and (f), respectively; and
                    (B) inserting after subsection (b) the following:
    ``(c) Corrective Action Report.--Beginning with fiscal year 2018, 
and for each fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit a corrective action report to 
the Committee on Energy and Commerce and the Committee on 
Appropriations of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate upon submission of the performance report 
in subsection (a) for the corresponding fiscal year. The report shall 
include the following information, as applicable:
            ``(1) Goals met.--For each fiscal year, if the Secretary 
        determines, based on the analysis under subsection (a)(5), that 
        each of the goals identified in the letters described in 
        section 101(b) of the Prescription Drug User Fee Amendments of 
        2017 for the corresponding fiscal year have been met, the 
        corrective action report shall include a summary of goals met, 
        and recommendations on ways in which the Secretary can improve 
        and streamline the human drug application review process.
            ``(2) Goals missed.--For each of the goals identified in 
        the letters described in section 101(b) of the Prescription 
        Drug User Fee Amendments of 2017 for the corresponding fiscal 
        year that the Secretary determines to not have been met, the 
        corrective action report shall include a detailed justification 
        for such determination and--
                    ``(A) a detailed description of the circumstances 
                under which each drug application that missed the 
                review goal time was approved during the first cycle 
                review, as applicable;
                    ``(B) aggregate data on the circumstances for all 
                unapproved drug applications for which the review goal 
                time was missed; and
                    ``(C) the performance enhancement goals that were 
                not achieved during the previous fiscal year and a 
                detailed description of efforts the agency has put in 
                place for the current fiscal year to improve the 
                ability of the agency to meet each such goal, while 
                maintaining standards of approval, for the current 
                fiscal year.
    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable, representatives from the Center for Drug Evaluation 
        and Research and the Center for Biologics Evaluation and 
        Research shall meet with representatives from the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives to report on the contents described in the 
        reports under this section.
            ``(2) Participation in congressional hearing.--Each fiscal 
        year, as applicable, representatives from the Center for Drug 
        Evaluation and Research and the Center for Biologics Evaluation 
        and Research shall participate in a public hearing before the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, to report on the contents described in the 
        reports under this section. Such hearing shall occur not later 
        than 120 days after the end of each fiscal year for which fees 
        are collected under this part.
            ``(3) Publicly available updates.--The Secretary shall 
        provide an update on progress made for the corrective action 
        report during the following fiscal year on the publically 
        available Internet website of the Food and Drug Administration 
        every 30 business days.''.
    (b) MDUFA Reports.--
            (1) Analysis in mdufa performance reports.--Section 
        738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-1(a)(1)(A)), as amended by section 802(b), is 
        further amended by adding at the end the following:
                            ``(iv) Analysis.--For each fiscal year, the 
                        Secretary shall include in the report under 
                        clause (i) an analysis of the following:
                                    ``(I) The difference between the 
                                number of premarket applications filed 
                                under section 515 and applications 
                                filed under section 510(k) and the 
                                number of major deficiency letters, not 
                                approvable letters, and denials for 
                                such applications issued by the agency, 
                                accounting for--
                                            ``(aa) such applications 
                                        filed during one fiscal year 
                                        for which a decision is not 
                                        scheduled to be made until the 
                                        following fiscal year;
                                            ``(bb) such applications 
                                        pending with the Center for 
                                        Devices and Radiological Health 
                                        that did not meet the goals as 
                                        identified by the letters 
                                        described in section 201(b) of 
                                        the Medical Device User Fee 
                                        Amendments of 2017 for the 
                                        corresponding fiscal year and 
                                        the future plans of the Food 
                                        and Drug Administration to meet 
                                        these goals; and
                                            ``(cc) the most common 
                                        causes within the agency for 
                                        missing such goals.
                                    ``(II) Relevant data to determine 
                                whether the Center Devices and 
                                Radiological Health have met 
                                performance enhancement goals 
                                identified by the letters described in 
                                section 201(b) of the Medical Device 
                                User Fee Amendments of 2017 for the 
                                corresponding fiscal year.
                                    ``(III) External or other 
                                circumstances impacting the Center 
                                Devices and Radiological Health or the 
                                Food and Drug Administration that 
                                impacted the ability of the agency to 
                                meet review time and performance 
                                enhancement goals identified by the 
                                letters described in section 201(b) of 
                                the Medical Device User Fee Amendments 
                                of 2017.''.
            (2) Issuance of corrective action reports.--Section 738A(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        1(a)) is amended--
                    (A) by redesignating paragraphs (2) and (3) as 
                paragraphs (4) and (5), respectively; and
                    (B) by inserting after paragraph (1) the following:
            ``(2) Corrective action report.--Beginning with fiscal year 
        2018, and for each fiscal year for which fees are collected 
        under this part, the Secretary shall prepare and submit a 
        corrective action report to the Committee on Energy and 
        Commerce and the Committee on Appropriations of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the Senate 
        upon submission of the performance report in paragraph (1)(A) 
        for the corresponding fiscal year. The report shall include the 
        following information, as applicable:
                    ``(A) Goals met.--For each fiscal year, if the 
                Secretary determines, based on the analysis under 
                paragraph (1)(A)(iv), that each of the goals identified 
                by the letters described in section 201(b) of the 
                Medical Device User Fee Amendments of 2017 for the 
                corresponding fiscal year have been met, the corrective 
                action report shall include a summary of goals met, and 
                recommendations on ways in which the Secretary can 
                improve and streamline the medical device application 
                review process.
                    ``(B) Goals missed.--For each of the goals 
                identified by the letters described in section 201(b) 
                of the Medical Device User Fee Amendments of 2017 for 
                the corresponding fiscal year that the Secretary 
                determines to not have been met, the corrective action 
                report shall include a detailed justification for such 
                determination and--
                            ``(i) a detailed description of the 
                        circumstances under which each application or 
                        report submitted under section 515 or section 
                        510(k) missed the review goal time but was 
                        approved during the first cycle review, as 
                        applicable;
                            ``(ii) aggregate data on the circumstances 
                        for all unapproved medical device applications 
                        for which the review goal time was missed; and
                            ``(iii) the performance enhancement goals 
                        that were not achieved during the previous 
                        fiscal year and a detailed description of 
                        efforts the agency has put in place for the 
                        current fiscal year to improve the ability of 
                        the agency to meet each such goal, while 
                        maintaining standards of approval, for the 
                        current fiscal year.
            ``(3) Enhanced communication.--
                    ``(A) Communications with congress.--Each fiscal 
                year, as applicable, representatives from the Center 
                for Devices and Radiological Health shall meet with 
                representatives from the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Energy and Commerce of the House of 
                Representatives to report on the contents described in 
                the reports under this section.
                    ``(B) Participation in congressional hearing.--Each 
                fiscal year, as applicable, representatives from the 
                Center for Devices and Radiological Health shall 
                participate in a public hearing before the Committee on 
                Health, Education, Labor, and Pensions of the Senate 
                and the Committee on Energy and Commerce of the House 
                of Representatives, to report on the contents described 
                in the reports under this section. Such hearing shall 
                occur not later than 120 days after the end of each 
                fiscal year for which fees are collected under this 
                part.
                    ``(C) Publicly available updates.--The Secretary 
                shall provide an update on progress made for the 
                corrective action report during the following fiscal 
                year on the publically available Internet website of 
                the Food and Drug Administration every 30 business 
                days.''.
    (c) GDUFA Reports.--
            (1) Analysis in gdufa performance reports.--Section 744C(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        43(a)), as amended by section 802(c) is further amended by 
        adding at the end the following:
            ``(4) Analysis.--For each fiscal year, the Secretary shall 
        include in the report an analysis of the following:
                    ``(A) The difference between the number of 
                abbreviated new drug applications filed and the number 
                of approvals or complete response letters issued by the 
                agency, accounting for --
                            ``(i) such applications filed during one 
                        fiscal year for which a decision is not 
                        scheduled to be made until the following fiscal 
                        year;
                            ``(ii) such applications pending with the 
                        Office of Generic Drugs that did not meet the 
                        goals identified by the letters described in 
                        section 301(b) of the Generic Drug User Fee 
                        Amendments of 2017 for the corresponding fiscal 
                        year and the future plans of the Food and Drug 
                        Administration to meet these goals; and
                            ``(iii) the most common causes within the 
                        agency for missing such goals.
                    ``(B) Relevant data to determine whether the Office 
                of Generic Drugs has met the performance enhancement 
                goals identified by the letters described in section 
                301(b) of the Generic Drug User Fee Amendments of 2017 
                for the corresponding fiscal year.
                    ``(C) External or other circumstances impacting the 
                Office of Generic Drugs or the Food and Drug 
                Administration that impacted the ability of the agency 
                to meet review time and performance enhancement goals 
                identified by the letters described in section 301(b) 
                of the Generic Drug User Fee Amendments of 2017.''.
            (2) Issuance of corrective action reports.--Section 744C of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) is 
        amended--
                    (A) by redesignating subsections (c) and (d) as 
                subsections (e) and (f), respectively; and
                    (B) inserting after subsection (b) the following:
    ``(c) Corrective Action Report.--Beginning with fiscal year 2018, 
and for each fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit a corrective action report to 
the Committee on Energy and Commerce and the Committee on 
Appropriations of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate upon submission of the performance report 
in subsection (a) for the corresponding fiscal year. The report shall 
include the following information, as applicable:
            ``(1) Goals met.--For each fiscal year, if the Secretary 
        determines, based on the analysis under subsection (a)(4), that 
        each of the goals identified by the letters described in 
        section 301(b) of the Generic Drug User Fee Amendments of 2017 
        for the corresponding fiscal year have been met, the corrective 
        action report shall include a summary of goals met, and 
        recommendations on ways in which the Secretary can improve and 
        streamline the abbreviated new drug application review process.
            ``(2) Goals missed.--For each of the goals identified by 
        the letters described in section 301(b) of the Generic Drug 
        User Fee Amendments of 2017 for the corresponding fiscal year 
        that the Secretary determines to not have been met, the 
        corrective action report shall include a detailed justification 
        for such determination and--
                    ``(A) a detailed description of the circumstances 
                under which each abbreviated new drug application 
                missed the review goal time but was approved during the 
                first cycle review, as applicable;
                    ``(B) aggregate data on the circumstances for all 
                unapproved abbreviated new drug applications for which 
                the review goal time was missed; and
                    ``(C) the performance enhancement goals that were 
                not achieved during the previous fiscal year and a 
                detailed description of efforts the agency has put in 
                place for the current fiscal year to improve the 
                ability of the agency to meet each such goal for the 
                current fiscal year.
    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable, representatives from the Office of Generic Drugs 
        shall meet with representatives from the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives to 
        report on the contents described in the reports under this 
        section.
            ``(2) Participation in congressional hearing.--Each fiscal 
        year, as applicable, representatives from the Center for Drug 
        Evaluation and Research shall participate in a public hearing 
        before the Committee on Health, Education, Labor, and Pensions 
        of the Senate and the Committee on Energy and Commerce of the 
        House of Representatives, to report on the contents described 
        in the reports under this section. Such hearing shall occur not 
        later than 120 days after the end of each fiscal year for which 
        fees are collected under this part.
            ``(3) Publicly available updates.--The Secretary shall 
        provide an update on progress made for the corrective action 
        report during the following fiscal year on the publically 
        available Internet website of the Food and Drug Administration 
        every 30 business days.''.
    (d) BsUFA Reports.--
            (1) Analysis in bsufa performance reports.--Section 744I(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        53(a)) as amended by section 802(d) is further amended by 
        adding at the end the following:
            ``(5) Analysis.--For each fiscal year, the Secretary shall 
        include in the report an analysis of the following:
                    ``(A) The difference between the number of 
                biosimilar biological product applications and 
                supplements filed and the number of approvals or 
                complete response letters issued by the agency, 
                accounting for--
                            ``(i) such applications filed during one 
                        fiscal year for which a decision is not 
                        scheduled to be made until the following fiscal 
                        year;
                            ``(ii) such applications pending with the 
                        Center for Drug Evaluation and Research or the 
                        Center for Biologics Evaluation and Research 
                        that did not meet the goals identified by the 
                        letters described in section 401(b) of the 
                        Biosimilar User Fee Amendments of 2017 for the 
                        corresponding fiscal year and the future plans 
                        of the Food and Drug Administration to meet 
                        these goals; and
                            ``(iii) the most common causes within the 
                        agency for missing such goals.
                    ``(B) Relevant data to determine whether the Center 
                for Drug Evaluation and Research and the Center for 
                Biologics Evaluation and Research have met the 
                performance enhancement goals identified by the letters 
                described in section 401(b) of the Biosimilar User Fee 
                Amendments of 2017 for the corresponding fiscal year.
                    ``(C) External or other circumstances impacting the 
                Center for Drug Evaluation and Research, the Center for 
                Biologics Evaluation and Research, and the Food and 
                Drug Administration that impacted the ability of the 
                agency to meet review time and performance enhancement 
                goals identified by the letters described in section 
                401(b) of the Biosimilar User Fee Amendments of 
                2017.''.
            (2) Issuance of corrective action reports.--Section 744I of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53), 
        as amended by section 404, is further amended--
                    (A) by redesignating subsections (c) and (d) as 
                subsections (e) and (f), respectively; and
                    (B) inserting after subsection (b) the following:
    ``(c) Corrective Action Report.--Beginning with fiscal year 2018, 
and for each fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit a corrective action report to 
the Committee on Energy and Commerce and Committee on Appropriations of 
the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions and Committee on Appropriations of the Senate upon 
submission of the performance report in subsection (a) for the 
corresponding fiscal year. The report shall include the following 
information, as applicable:
            ``(1) Goals met.--For each fiscal year, if the Secretary 
        determines, based on the analysis under subsection (a)(5), that 
        each of the goals identified by the letters described in 
        section 401(b) of the Biosimilar User Fee Amendments of 2017 
        for the corresponding fiscal year have been met, the corrective 
        action report shall include a summary of goals met, and 
        recommendations on ways in which the Secretary can improve and 
        streamline the biosimilar biological product application review 
        process.
            ``(2) Goals missed.--For each of the goals identified by 
        the letters described in section 401(b) of the Biosimilar User 
        Fee Amendments of 2017 for the corresponding fiscal year that 
        the Secretary determines to not have been met, the corrective 
        action report shall include a detailed justification for such 
        determination and--
                    ``(A) a detailed description of the circumstances 
                under which each biosimilar biological product 
                application missed the review goal time but was 
                approved during the first cycle review, as applicable;
                    ``(B) aggregate data on the circumstances for all 
                biosimilar biological product applications for which 
                the review goal time was missed; and
                    ``(C) the performance enhancement goals that were 
                not achieved during the previous fiscal year and a 
                detailed description of efforts the agency has put in 
                place for the current fiscal year to improve the 
                ability of the agency to meet each such goal for the 
                current fiscal year.
    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable, representatives from the Center for Drug Evaluation 
        and Research and the Center for Biologics Evaluation and 
        Research shall meet with representatives from the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives to report on the contents described in the 
        reports under this section.
            ``(2) Participation in congressional hearing.--Each fiscal 
        year, as applicable, representatives from the Center for Drug 
        Evaluation and Research and the Center for Biologics Evaluation 
        and Research shall participate in a public hearing before the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives, to report on the contents described in the 
        reports under this section. Such hearing shall occur not later 
        than 120 days after the end of each fiscal year for which fees 
        are collected under this part.
            ``(3) Publicly available updates.--The Secretary shall 
        provide an update on progress made for the corrective action 
        report during the following fiscal year on the publically 
        available Internet website of the Food and Drug Administration 
        every 30 business days.''.

SEC. 804. INFORMATION ON TECHNOLOGY CONTRACTING.

    Section 736B(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h-2(b)) is amended--
            (1) by striking ``report on the'' and inserting ``report 
        on--
            ``(1) the'';
            (2) by striking the period at the end and inserting ``; 
        and'';
            (3) by adding at the end the following:
            ``(2) the amount of the fees collected that are invested in 
        the information technology infrastructure of the Food and Drug 
        Administration, the entities receiving contracts to develop 
        such infrastructure, the length of such contracts (including 
        renewals), and the progress such entities have made toward 
        meeting the goals described in such contracts.''.

SEC. 805. FACILITIES MANAGEMENT.

    (a) Evaluation.--
            (1) Study.--The Comptroller General of the United States 
        shall conduct a study on the expenses incurred by the Food and 
        Drug Administration related to facility maintenance and 
        renovation in fiscal years 2012 through 2019. The study shall 
        include the following:
                    (A) A review of purchases and expenses 
                differentiated by appropriated funds, and resources 
                authorized by the Food and Drug Administration Safety 
                and Innovation Act (Public Law 112-144) and this Act, 
                as applicable, that contributed to--
                            (i) the maintenance of scientific equipment 
                        and any existing facility plan or plans to 
                        maintain previously purchased scientific 
                        equipment;
                            (ii) the renovation of facilities in the 
                        Center for Drug Evaluation and Research, the 
                        Center for Biologics Evaluation and Research, 
                        and the Center for Devices and Radiological 
                        Health, and the purpose of such renovation 
                        including the need for the renovation;
                            (iii) the assets purchased or repaired 
                        under the ``repair of facilities and 
                        acquisition'' authority under parts 2, 3, 7, 
                        and 8 of subchapter C of chapter VII of the 
                        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                        379f et seq.);
                            (iv) the maintenance and repair of 
                        facilities and fixtures, including a 
                        description of any unanticipated repairs and 
                        maintenance as well as scheduled repairs 
                        maintenance, and the budget plan for the 
                        scheduled or anticipated maintenance;
                            (v) the acquisition of furniture, a 
                        description of the furniture purchased, and the 
                        purpose of the furniture including purchases 
                        for the Center for Drug Evaluation and 
                        Research, the Center for Biologics Evaluation 
                        and Research, and the Center for Devices and 
                        Radiological Health; and
                            (vi) the acquisition of other necessary 
                        materials and supplies by product category 
                        under the authority under parts 2, 3, 7, and 8 
                        of subchapter C of chapter VII of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 379f et 
                        seq.).
                    (B) An analysis of the Food and Drug 
                Administration's ability to further its public health 
                mission and review medical products by incurring the 
                expenses listed in clauses (i) through (vi) of 
                subparagraph (A). In conducting the analysis, the 
                Comptroller General shall request information from and 
                consult with appropriate employees, including staff and 
                those responsible for the fiscal decisions regarding 
                facility maintenance and renovation for the agency.
                    (C) Recommendations.--The Comptroller General may 
                provide recommendations, as applicable, on methods 
                through which the Food and Drug Administration may 
                improve planning for--
                            (i) the maintenance, renovation, and repair 
                        of facilities;
                            (ii) the purchase of furniture or other 
                        acquisitions; and
                            (iii) ways the agency may allocate the 
                        expenses described in clauses (i) and (ii), as 
                        informed by the analysis under subparagraph 
                        (B).
            (2) Report.--The Comptroller General shall issue a report 
        to the Committee on Health, Education, Labor, and Pensions of 
        the Senate and the Committee on Energy and Commerce of the 
        House of Representatives not later than September 30, 2020, 
        containing the results of the study under paragraph (1).
    (b) Administration.--
            (1) PDUFA.--Section 736(f) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the 
        end the following:
            ``(3) Limitation.--Beginning on October 1, 2023, the 
        authorities under section 735(7)(C) shall only include 
        expenditures for leasing and necessary scientific equipment.''.
            (2) MDUFA.--Section 738(h) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the 
        end the following:
            ``(3) Limitation.--Beginning on October 1, 2023, the 
        authorities under section 737(9)(C) shall only include leasing 
        and necessary scientific equipment.''.
            (3) GDUFA.--Section 744B(e) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j-42(e)) is amended--
                    (A) in the subsection heading, by striking 
                ``Limit'' and inserting ``Limitations'';
                    (B) by striking ``The total amount'' and inserting 
                the following:
            ``(1) In general.--The total amount''; and
                    (C) by adding at the end the following:
            ``(2) Leasing and necessary equipment.--Beginning on 
        October 1, 2023, the authorities under section 744A(11)(C) 
        shall only include leasing and necessary scientific 
        equipment.''.
            (4) BsUFA.--Section 744H(e)(2)(B) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379j-52(e)(2)(B)) is 
        amended--
                    (A) in the subparagraph heading, by striking 
                ``limitation'' and inserting ``limitations'';
                    (B) by striking ``The fees authorized'' and 
                inserting the following:
                            ``(i) In general.--The fees authorized''; 
                        and
                    (C) by adding at the end the following:
                            ``(ii) Leasing and necessary equipment.--
                        Beginning on October 1, 2023, the authorities 
                        under section 744G(9)(C) shall only include 
                        leasing and necessary scientific equipment.''.

SEC. 806. EXPANDED ACCESS.

    (a) Patient Access to Experimental Treatments.--
            (1) Public meeting.--
                    (A) In general.--The Secretary of Health and Human 
                Services (referred to in this section as the 
                ``Secretary''), acting through the Commissioner of Food 
                and Drugs, in coordination with the Director of the 
                National Institutes of Health, and in consultation with 
                patients, health care providers, drug sponsors, 
                bioethicists, and other stakeholders, shall, not later 
                than 180 days after the date of enactment of this Act, 
                convene a public meeting to discuss clinical trial 
                inclusion and exclusion criteria to inform the guidance 
                under paragraph (3). The Secretary shall inform the 
                Comptroller General of the United States of the date 
                when the public meeting will take place.
                    (B) Topics.--The Secretary shall provide a publicly 
                available report on the topics discussed at the meeting 
                described in subparagraph (A) within 30 days of such 
                meeting. Such topics shall include discussion of--
                            (i) the rationale for, and potential 
                        barriers for patients created by, clinical 
                        trial inclusion and exclusion criteria;
                            (ii) how patient populations most likely to 
                        be affected by a drug can benefit from the 
                        results of trials that employ alternative 
                        designs, as well as potential risks associated 
                        with alternative clinical trial designs;
                            (iii) barriers to participation in clinical 
                        trials, including--
                                    (I) information regarding any 
                                potential risks and benefits of 
                                participation;
                                    (II) regulatory, geographical, and 
                                socioeconomic barriers; and
                                    (III) the impact of exclusion 
                                criteria on the enrollment in clinical 
                                trials of infants and children, 
                                pregnant and lactating women, seniors, 
                                individuals with advanced disease, and 
                                individuals with co-morbid conditions;
                            (iv) clinical trial designs and methods 
                        that increase enrollment of more diverse 
                        patient populations while facilitating the 
                        collection of data to support substantial 
                        evidence of safety and effectiveness; and
                            (v) how changes to clinical trial inclusion 
                        and exclusion criteria may impact the 
                        complexity of the clinical trial design and 
                        length of clinical trials, and potential 
                        approaches to mitigating those impacts to 
                        ensure that the ability to demonstrate safety 
                        and effectiveness is not hindered through 
                        potential changes in eligibility criteria.
            (2) Report.--Not later than 1 year after the Secretary 
        issues a report on the topics discussed at the public meeting 
        under paragraph (1)(B), the Comptroller General of the United 
        States shall report to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives on individual 
        access to investigational drugs through the expanded access 
        program under section 561(b) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb(b)). The report shall include--
                    (A) a description of actions taken by manufacturers 
                under section 561A of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360bbb-0);
                    (B) consideration of whether Form FDA 3926 and the 
                guidance document entitled ``Expanded Access to 
                Investigational Drugs for Treatment Use--Questions and 
                Answers'', issued by the Food and Drug Administration 
                in June 2016, has reduced application burden with 
                respect to individuals and physicians seeking access to 
                investigational new drugs pursuant to section 561(b) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                360bbb) and improved clarity for patients, physicians, 
                and drug manufacturers about such process;
                    (C) consideration of whether the guidance or 
                regulations released or updated under section 561 of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                360bbb) have improved access for individual patients 
                who do not qualify for clinical trials of such 
                investigational drugs, and what barriers to such access 
                remain;
                    (D) an assessment of how patients and health care 
                providers navigate different avenues to engage with the 
                Food and Drug Administration or drug sponsors on 
                expanded access; and
                    (E) an analysis of the Secretary's report under 
                paragraph (1)(B).
            (3) Guidance.--
                    (A) In general.--Not later than 180 days after the 
                publication of the report under paragraph (1), the 
                Secretary, acting through the Commissioner of Food and 
                Drugs, shall issue one or more draft guidances 
                regarding eligibility criteria for clinical trials. Not 
                later than 18 months after the public comment period on 
                each such draft guidance ends, the Secretary shall 
                issue a revised draft guidance or final guidance.
                    (B) Contents.--The guidance documents described in 
                subparagraph (A) shall address methodological 
                approaches that a manufacturer or sponsor of an 
                investigation of a new drug may take to--
                            (i) broaden eligibility criteria for 
                        clinical trials, especially with respect to 
                        drugs for the treatment of serious and life-
                        threatening conditions or diseases for which 
                        there is an unmet medical need; and
                            (ii) develop eligibility criteria for, and 
                        increase trial recruitment to, clinical trials 
                        so that enrollment in such trials more 
                        accurately reflects the patients most likely to 
                        receive the drug, as applicable and as 
                        appropriate, while supporting findings of 
                        substantial evidence of safety and 
                        effectiveness.
    (b) Improving Institutional Review Board Review of Single Patient 
Expanded Access Protocol.--Not later than 1 year after the date of 
enactment of this Act, the Secretary, acting through the Commissioner 
of Food and Drugs, shall issue guidance or regulations, or revise 
existing guidance or regulations, to streamline the institutional 
review board review for individual pediatric and adult patient expanded 
access protocol under 561(b) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb(b)). Such guidance or regulation may include a 
description of the conditions under which an institutional review board 
chair (or designee) may review individual patient expanded access 
protocol submitted under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(i)) for a drug and how centralized 
institutional review boards may facilitate the use of expanded access 
protocols. The Secretary shall update any relevant forms associated 
with individual patient expanded access protocol as necessary.
    (c) Expanded Access Policy Transparency.--Section 561A(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0(f)) is 
amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``later'' and inserting ``earlier'';
            (2) by striking paragraph (1);
            (3) by redesignating paragraph (2) as paragraph (1);
            (4) in paragraph (1) as so redesignated, by striking the 
        period at the end and inserting ``; or''; and
            (5) by adding at the end the following:
            ``(2) as applicable, 15 days after the drug receives a 
        designation as a breakthrough therapy, fast track product, or 
        regenerative advanced therapy under subsection (a), (b), or 
        (g), respectively, of section 506.''.

SEC. 807. TECHNICAL CORRECTIONS.

    (a) Cross-reference.--Section 3075(a) of the 21st Century Cures Act 
(Public Law 114-255) is amended--
            (1) in the matter preceding paragraph (1), by striking ``as 
        amended by section 2074'' and inserting ``as amended by section 
        3102''; and
            (2) in paragraph (2), by striking ``section 2074(1)(C)'' 
        and inserting ``section 3102(1)(C)''.
    (b) 506G.--Section 506G(b)(1)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking 
``identity'' and inserting ``identify''.

                     TITLE IX--GENERIC DRUG ACCESS

        Subtitle A--Removing Regulatory Barriers to Competition

SEC. 901. IMPROVING ACCESS TO GENERIC DRUGS.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is amended by adding at the end the following:
    ``(11)(A) The Secretary shall prioritize the review of, and act 
within 240 calendar days of the date of the submission of, an original 
abbreviated new drug application submitted for review under this 
subsection, or on a supplement to such an application, that is for a 
drug--
            ``(i) for which there are not more than 3 approved drugs 
        listed under paragraph (7), except that the review of an 
        application submitted more than 30 months in advance of the 
        last applicable expiration date for a patent for which a 
        certification under paragraph (2)(A)(vii)(III) has been 
        submitted, or of the expiration date for an applicable period 
        of exclusivity under this Act, will not be expedited; or
            ``(ii) that has been included on the list under section 
        506E.
    ``(B) The Secretary shall require the applicant, not later than 60 
days prior to the submission of an application described in 
subparagraph (A), to provide complete, accurate information regarding 
facilities involved in manufacturing processes and testing, including 
facilities in corresponding Type II active pharmaceutical ingredients 
drug master files submitted with an application and sites or 
organizations involved in bioequivalence and clinical studies used to 
support the application, in order to make a determination regarding 
whether an inspection of an establishment is necessary.
    ``(C) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to manufacture a 
drug described in subparagraph (A).
    ``(D) Nothing in this paragraph shall prevent the Secretary from 
prioritizing the review of other applications as the Secretary 
determines appropriate.
    ``(12) The Secretary shall provide review status updates to 
applicants regarding applications under this subsection, as 
appropriate, including when the application is awaiting final 
regulatory action by the office charged with review.
    ``(13) The Secretary shall publish on the Internet website of the 
Food and Drug Administration a list of all drugs approved under 
subsection (b) for which all patents and periods of exclusivity under 
this Act have expired. Such list shall be updated at least once every 
180 days.''.

SEC. 902. REPORTING ON PENDING GENERIC DRUG APPLICATIONS, PRIORITY 
              REVIEW APPLICATIONS, AND INSPECTIONS.

    (a) In General.--Not later than 180 calendar days after the date of 
enactment of this Act, and quarterly thereafter until October 1, 2022, 
the Secretary of Health and Human Services (referred to in this section 
as the ``Secretary'') shall post on the Internet website of the Food 
and Drug Administration a report that provides--
            (1) the number of applications filed under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        awaiting action by the applicant, including such applications 
        that were filed prior to October 1, 2014;
            (2) the number of applications filed under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        awaiting action by the Secretary, including such applications 
        that were filed prior to October 1, 2014;
            (3) the number of applications filed under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        and prior approval supplements withdrawn in each month covered 
        by the report;
            (4) the mean and median approval and tentative approval 
        times for applications covered by the report;
            (5) the number of applications described in paragraphs (1), 
        (2), and (3) that are subject to priority review; and
            (6) the number of such applications on which the Secretary 
        has taken action pursuant to section 506H(b) of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 911.
    (b) Annual Report on Priority Review Applications.--
            (1) In general.--The Secretary shall submit to the 
        Committee on Health, Education, Labor, and Pensions and the 
        Special Committee on Aging of the Senate and the Committee on 
        Energy and Commerce of the House of Representatives an annual 
        report, not later than March 31 of each year, on the following:
                    (A) The number of applications filed under section 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(j)) that are subject to priority review 
                during the most recent calendar year and are awaiting 
                action by the applicant.
                    (B) The number of applications filed under section 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(j)) that are subject to priority review 
                during the most recent calendar year and are awaiting 
                action by the Secretary.
                    (C) The number of applications filed under section 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(j)) that are subject to priority review 
                during the most recent calendar year and have been 
                approved by the Secretary.
                    (D) For each of subparagraphs (A) through (C), the 
                number of such applications--
                            (i) for which there are not more than 3 
                        approved drugs listed under section 505(j)(7) 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355(j)(7)); and
                            (ii) the number of such applications that 
                        are for a drug on the drug shortage list under 
                        section 506E of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 356e).
    (c) Annual Report on Inspections.--Not later than March 1 of each 
year, the Secretary shall post on the Internet website of the Food and 
Drug Administration--
            (1) the average and median amount of time, following a 
        request by staff of the Food and Drug Administration reviewing 
        an application or report submitted under an applicable section 
        described in subparagraph (A), (B), or (C), to schedule and 
        complete inspections of facilities necessary for--
                    (A) approval of a drug under section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
                    (B) approval of a device under section 515 of such 
                Act (21 U.S.C. 360e); and
                    (C) clearance of a device under section 510(k) of 
                such Act (21 U.S.C. 360(k)); and
            (2) the average and median amount of time to schedule and 
        complete for-cause inspections of facilities of drugs and 
        devices.

                 Subtitle B--Incentivizing Competition

SEC. 911. EXPEDITING GENERIC COMPETITION.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 506G the following:

``SEC. 506H. EXPEDITING GENERIC DRUG DEVELOPMENT.

    ``(a) In General.--The Secretary shall, at the request of an 
applicant, expedite the development and review of an application under 
subsection (j) of section 505 for a drug--
            ``(1) for which there are not more than 3 approved drug 
        products listed under section 505(j)(7); or
            ``(2) that is included on the list under section 506E.
    ``(b) Request From Sponsors.--A request to expedite the development 
and review of an application under subsection (a) shall be submitted by 
the applicant prior to the submission of such application.
    ``(c) Other Applications.--Nothing in this section shall prevent 
the Secretary from expediting the development and review of other 
applications as the Secretary determines appropriate.
    ``(d) Additional Communication.--The Secretary shall take such 
actions as are appropriate to expedite the development and review of 
the application for approval of a drug described in subsection (a), 
including, as appropriate--
            ``(1) holding meetings with the sponsor and the review team 
        throughout the development of the drug prior to submission of 
        the application;
            ``(2) providing timely advice to, and interactive 
        communication with, the sponsor regarding the development of 
        the application to ensure that the collection of nonclinical 
        and clinical data necessary for approval is as efficient as 
        practicable;
            ``(3) in the case of a complex product, assigning a cross-
        disciplinary project lead for the review team to facilitate an 
        efficient review of the development program and application, 
        including manufacturing inspections; and
            ``(4) in the case of a complex product, including drug-
        device combinations, involving senior managers and experienced 
        review staff, as appropriate, in a collaborative, cross- 
        disciplinary review.
    ``(e) Reporting Requirement.--A sponsor of a drug expedited under 
this section shall report to the Secretary, one year following approval 
of an application under section 505(j), on whether the approved drug 
has been marketed in interstate commerce since approval.''.

SEC. 912. LIST OF GENERIC DRUGS WITH LIMITED COMPETITION.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 506H, as added by 
section 911, the following:

``SEC. 506I. DRUG LISTING.

    ``(a) Removal, Withdrawal, or Transfer.--The holder of an 
application approved under subsection (b) or (j) of section 505 shall 
notify the Secretary within 180 days of removing the drug that is the 
subject of such application from interstate commerce, withdrawing such 
approved application, or transferring such approved application, and a 
reason for such removal, withdrawal, or transfer. If compliance with 
this subsection within such 180-day period is not practicable, then the 
holder shall comply as soon as practicable. The Secretary shall cross-
reference information listed pursuant to section 506C where applicable 
to avoid duplicative reporting.
    ``(b) Drugs With Limited Competition.--
            ``(1) Information.--The Secretary shall--
                    ``(A) maintain information with respect to 
                applications approved under section 505(j); and
                    ``(B) publish on the Internet website of the Food 
                and Drug Administration such information under 
                subparagraph (A) with respect to drugs for which there 
                are 3 or fewer application holders; and
                    ``(C) update the information published pursuant to 
                subparagraph (B) every 180 days.
            ``(2) Contents.--The public information maintained and 
        published under paragraph (1)(B) shall include--
                    ``(A) the name of the drug, name of the holder of 
                the approved application, and the marketing status for 
                each drug; and
                    ``(B) an indication of whether the Secretary 
                considers the drug to be for the treatment or 
                prevention of a serious disease or medical condition, 
                for which there is no alternative drug that is judged 
                by medical professionals to be an adequate substitute 
                available in adequate supply.
    ``(c) Public Health Exception.--The Secretary may choose not to 
make information collected under this section publicly available if the 
Secretary determines that disclosure of such information would 
adversely affect the public health.
    ``(d) Notification.--When the Secretary first publishes the 
information under subsection (b), the Secretary shall notify relevant 
Federal agencies, including the Centers for Medicare & Medicaid 
Services and the Federal Trade Commission, that the information has 
been published and will be updated regularly.''.

SEC. 913. SUITABILITY PETITIONS.

    (a) In General.--It is the sense of the Senate that the Food and 
Drug Administration shall meet the requirement under section 
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal 
Regulations, of responding to suitability petitions within 90 days of 
submission.
    (b) Report.--The Secretary of Health and Human Services shall 
include in the annual reports under section 902(b)--
            (1) the number of pending petitions under section 
        505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)(2)(C)); and
            (2) the number of such petitions pending a substantive 
        response for more than 180 days from the date of receipt.

SEC. 914. INSPECTIONS.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)), as amended by section 901, is further amended by adding 
at the end the following:
    ``(14) If the Secretary issues feedback pursuant to section 
704(b)(2) with respect to information submitted in response to a report 
under section 704(b)(1), and a report that was issued under section 
704(b)(1) is the only obstacle to approval of an application under this 
subsection or the Secretary determines that the public health benefit 
of approving an application under this subsection outweighs any risk to 
public health, the Secretary shall, within 45 days of notification by 
the applicant that necessary changes have been made to the 
establishment to address any findings or deficiencies identified 
previously by the Secretary--
            ``(A) re-inspect the establishment with respect to which 
        the report was issued; or
            ``(B) make a determination regarding the response to such 
        report and review of such application.''.
                                                        Calendar No. 76

115th CONGRESS

  1st Session

                                 S. 934

_______________________________________________________________________

                                 A BILL

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user-fee programs for prescription drugs, medical devices, generic 
   drugs, and biosimilar biological products, and for other purposes.

_______________________________________________________________________

                              May 11, 2017

                       Reported with an amendment