[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2430 Enrolled Bill (ENR)]

        H.R.2430

                     One Hundred Fifteenth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
          the third day of January, two thousand and seventeen


                                 An Act


 
 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,
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; finding.
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 dates.

                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. Best pharmaceuticals for children.
Sec. 502. Pediatric devices.
Sec. 503. Early meeting on pediatric study plan.
Sec. 504. Development of drugs and biological products for pediatric 
          cancers.
Sec. 505. Additional provisions on development of drugs and biological 
          products for pediatric use.

      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. Protecting and strengthening the drug supply chain.
Sec. 605. Patient experience data.
Sec. 606. Communication plans.
Sec. 607. Orphan drugs.
Sec. 608. Pediatric information added to labeling.
Sec. 609. Sense of Congress on lowering the cost of prescription drugs.
Sec. 610. Expanded access.
Sec. 611. Tropical disease product application.

        TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process for device establishments.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Fostering innovation in medical imaging.
Sec. 707. Risk-based classification of accessories.
Sec. 708. Device pilot projects.
Sec. 709. Regulation of over-the-counter hearing aids.
Sec. 710. Report on servicing of devices.

                TITLE VIII--IMPROVING GENERIC DRUG ACCESS

Sec. 801. Priority review of generic drugs.
Sec. 802. Enhancing regulatory transparency to enhance generic 
          competition.
Sec. 803. Competitive generic therapies.
Sec. 804. Accurate information about drugs with limited competition.
Sec. 805. Suitability petitions.
Sec. 806. Inspections.
Sec. 807. Reporting on pending generic drug applications and priority 
          review applications.
Sec. 808. Incentivizing competitive generic drug development.
Sec. 809. GAO study of issues regarding first cycle approvals of generic 
          medicines.

                     TITLE IX--ADDITIONAL PROVISIONS

Sec. 901. Technical corrections.
Sec. 902. Annual report on inspections.
Sec. 903. Streamlining and improving consistency in performance 
          reporting.
Sec. 904. Analysis of use of funds.
Sec. 905. Facilities management.

                    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.
                ``(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) of 
        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 each such fiscal year, human drug 
        application fees and prescription drug program fees under 
        subsection (a), based on the revenue amounts established under 
        subsection (b) and the adjustments provided under this 
        subsection; and
            ``(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; FINDING.
    (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2017''.
    (b) Finding.--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.
    (a) In General.--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''.
    (b) Conforming Amendment.--Section 714(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379d-3(b)(1)) is amended by striking 
``737(8)'' and inserting ``737(9)''.
    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 amendments.--
            (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 so 
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 so 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 so 
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 ``the Medical Device 
            User Fee Amendments of 2017''; and
            (B) in subparagraph (B), by striking ``the Medical Device 
        User Fee Amendments Act of 2012'' and inserting ``the 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 
        internet 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 permanently 
            implantable, life sustaining, or life supporting, unless 
            otherwise determined by the Secretary in accordance with 
            subparagraph (B)(i)(II) and listed as eligible for review 
            under subparagraph (B)(iii); or
                ``(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 such device type or 
                subset;

                ``(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 on such date as the Secretary 
        specifies in final guidance issued under subparagraph (C), 
        presubmissions and submissions for devices described in 
        paragraph (1) (and any appeals of action taken by the Secretary 
        with respect to such presubmissions or submissions) shall be 
        submitted solely in such electronic format as specified by the 
        Secretary in such guidance.
            ``(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) 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 DATES.
    (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.--Effective October 1, 2017, section 
207(a) of the Food and Drug Administration Safety and Innovation Act 
(Public Law 112-144) is repealed.

               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'';
            (B) by striking ``the first 3 months of fiscal year 2018'' 
        and inserting ``the first 3 months of fiscal year 2023''; and
            (C) by striking ``Such fees may only be used in fiscal year 
        2018.''.
    (d) Annual Fee Setting.--Section 744B(d) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-42(d)) is amended--
        (1) 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).'';
        (2) by redesignating paragraph (3) as paragraph (2); and
        (3) 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. 379j-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. 379j-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. 379j-42(i)) is 
amended--
        (1) in paragraph (2)--
            (A) in subparagraph (A), by striking ``subparagraphs (C) 
        and (D)'' and inserting ``subparagraph (C)'';
            (B) by striking subparagraph (C) (relating to fee 
        collection during first program year);
            (C) in subparagraph (D)--
                (i) in the heading, by striking ``in subsequent 
            years''; and
                (ii) by striking ``(after fiscal year 2013)''; and
            (D) 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 Owned by 
Applicants and Their Affiliates.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-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 a designated affiliate 
    of such person, shall submit, on behalf of the person and the 
    affiliates of such person, to the Secretary a list of--
            ``(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.--
        (1) In general.--Effective October 1, 2017, section 304 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 304.
    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 were 
received by the Food and Drug Administration within the meaning of 
section 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 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 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 urban consumers (Washington-
    Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items) for 
    October of the preceding fiscal year divided by such Index for 
    October 2011.''.
    (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 
            biological product 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 paragraph (1)(F)--
            (A) in the subparagraph heading, by striking ``biosimilar 
        development program''; 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).'';
        (12) in paragraph (2)--
            (A) in the paragraph heading, 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'';
            (D) in subparagraphs (C) through (F), by striking ``or 
        supplement'' each place it appears; and
            (E) in subparagraph (D), by striking ``or a supplement'';
        (13) 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 biological product 
            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 (h) (as redesignated by 
    paragraph (1)), 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)(B) 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)(B) a description of the methodology used to 
        calculate the fiscal year 2018 adjustment under this paragraph 
        in the Federal Register notice establishing fee revenue and 
        fees for fiscal year 2018.
            ``(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 ``; and'' at the end of subparagraph (A) and 
    inserting a period; and
        (3) by striking ``shall pay--'' and all that follows through 
    ``application fees'' and inserting ``shall pay application fees''.
    (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 shall cease to be effective October 1, 2022.
    (b) Reporting Requirements.--Section 744I of the Federal Food, 
Drug, and Cosmetic 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. 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)--
                (i) by amending subparagraph (B) to read as follows:
            ``(B) Availability of reports.--
                ``(i) In general.--Each report submitted under 
            subparagraph (A) shall be considered to be in the public 
            domain (subject to section 505A(d)(4) of the Federal Food, 
            Drug, and Cosmetic Act) and not later than 90 days after 
            submission of such report, shall be--

                    ``(I) posted on the internet website of the 
                National Institutes of Health in a manner that is 
                accessible and consistent with all applicable Federal 
                laws and regulations, including such laws and 
                regulations for the protection of--

                        ``(aa) human research participants, including 
                    with respect to privacy, security, informed 
                    consent, and protected health information; and
                        ``(bb) proprietary interests, confidential 
                    commercial information, and intellectual property 
                    rights; and

                    ``(II) assigned a docket number by the Commissioner 
                of Food and Drugs and made available for the submission 
                of public comments.

                ``(ii) Submission of comments.--An interested person 
            may submit written comments concerning such pediatric 
            studies to the Commissioner of Food and Drugs, and the 
            submitted comments shall become part of the docket file 
            with respect to each of the drugs.''; and
                (ii) in subparagraph (C), by striking ``appropriate 
            action'' and all that follows through the period and 
            inserting ``action in a timely and appropriate manner in 
            response to the reports submitted under subparagraph (A), 
            and shall begin such action upon receipt of the report 
            under subparagraph (A), in accordance with paragraph 
            (7).''; and
            (B) in paragraph (7)--
                (i) in the matter preceding subparagraph (A), by 
            striking ``During'' and inserting ``Within'';
                (ii) in subparagraph (C)(i), by striking ``place'' and 
            all that follows through ``and of'' and inserting ``include 
            in the public docket file a reference to the location of 
            the report on the internet website of the National 
            Institutes of Health and a copy of''; and
                (iii) in clause (ii), by striking ``in the Federal 
            Register and'';
        (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''.
    SEC. 502. PEDIATRIC DEVICES.
    (a) Pediatric Use of Devices.--Section 515A(a)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) is amended--
        (1) by redesignating subparagraphs (B) through (D) as 
    subparagraphs (D) through (F), respectively;
        (2) by inserting after subparagraph (A) the following:
            ``(B) any information, based on a review of data available 
        to the Secretary, regarding devices used in pediatric patients 
        but not labeled for such use for which the Secretary determines 
        that approved pediatric labeling could confer a benefit to 
        pediatric patients;
            ``(C) the number of pediatric devices that receive a 
        humanitarian use exemption under section 520(m);'';
        (3) in subparagraph (E), as so redesignated, by striking ``; 
    and'' and inserting ``;'';
        (4) in subparagraph (F) (as so redesignated), by striking 
    ``(B), and (C).'' and inserting ``(C), (D), and (E);''; and
        (5) by adding at the end the following:
            ``(G) the number of devices for which the Secretary relied 
        on data with respect to adults to support a determination of a 
        reasonable assurance of safety and effectiveness in pediatric 
        patients; and
            ``(H) the number of devices for which the Secretary relied 
        on data from one pediatric subpopulation to support a 
        determination of a reasonable assurance of safety and 
        effectiveness in another pediatric subpopulation.
    For the items described in this paragraph, such report shall 
    disaggregate the number of devices by pediatric subpopulation.''.
    (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 ``2013 through 2017'' and 
    inserting ``2018 through 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 on the development, approval or 
    clearance, and labeling of pediatric medical devices. The Secretary 
    shall invite to such meeting representatives from the medical 
    device industry, academia, recipients of funding under section 305 
    of the Pediatric Medical Device Safety and Improvement Act of 2007 
    (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 
        pediatric populations that would result in the approval or 
        clearance, and labeling, of medical devices for such 
        populations;
            (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 manufacturers in developing devices for 
        pediatric populations that are approved or cleared, and 
        labeled, for their use; and
            (E) identify current barriers to pediatric device 
        development and incentives to address such barriers.
        (3) Report.--The report submitted under section 515A(a)(3) of 
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) 
    with respect to the calendar year in which the meeting described in 
    paragraph (1) is held shall include a summary of, and responses to, 
    recommendations raised in such meeting.
    SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.
    (a) 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 or biological product that is intended to treat 
                a serious or life-threatening disease or condition, to 
                discuss preparation of the initial pediatric study 
                plan, not later than the end-of-Phase 1 meeting (as 
                such term is used in 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 the bases for the deferral under 
                subsection (a)(4) or a full or partial waiver under 
                subsection (a)(5);''.

    (b) Conforming Changes.--Section 505B(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
        (1) in the heading of paragraph (2), by striking ``meeting'' 
    and inserting ``meetings'';
        (2) in the heading of paragraph (2)(C), by striking ``Meeting'' 
    and inserting ``Meetings'';
        (3) 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
        (4) in paragraph (3) by striking ``meeting under paragraph 
    (2)(C)(i)'' and inserting ``meeting under paragraph 
    (2)(C)(i)(II)''.
    SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR 
      PEDIATRIC CANCERS.
    (a) Molecular Targets Regarding Cancer Drugs and Biological 
Products.--Section 505B of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c) is amended--
        (1) in subsection (a)--
            (A) in paragraph (1)--
                (i) by redesignating subparagraphs (A) and (B) as 
            clauses (i) and (ii), respectively, and adjusting the 
            margins accordingly;
                (ii) by striking ``A person'' and inserting the 
            following:
            ``(A) General requirements.--Except with respect to an 
        application for which subparagraph (B) applies, a person'';
                (iii) in clause (i), as so redesignated, by striking 
            ``, or'' at the end and inserting ``; or''; and
                (iv) by adding after subparagraph (A), as so designated 
            by clause (ii), the following:
            ``(B) Certain molecularly targeted cancer indications.--A 
        person that submits, on or after the date that is 3 years after 
        the date of enactment of the FDA Reauthorization Act of 2017, 
        an original application for a new active ingredient under 
        section 505 of this Act or section 351 of the Public Health 
        Service Act, shall submit with the application reports on the 
        investigation described in paragraph (3) if the drug or 
        biological product that is the subject of the application is--
                ``(i) intended for the treatment of an adult cancer; 
            and
                ``(ii) directed at a molecular target that the 
            Secretary determines to be substantially relevant to the 
            growth or progression of a pediatric cancer.'';
            (B) in paragraph (2)(A), by striking ``paragraph (1)'' and 
        inserting ``paragraph (1)(A)'';
            (C) by redesignating paragraphs (3) and (4) as paragraphs 
        (4) and (5), respectively;
            (D) by inserting after paragraph (2) the following:
        ``(3) Molecularly targeted pediatric cancer investigation.--
            ``(A) In general.--With respect to a drug or biological 
        product described in paragraph (1)(B), the investigation 
        described in this paragraph is a molecularly targeted pediatric 
        cancer investigation, which shall be designed to yield 
        clinically meaningful pediatric study data, gathered using 
        appropriate formulations for each age group for which the study 
        is required, regarding dosing, safety, and preliminary efficacy 
        to inform potential pediatric labeling.
            ``(B) Extrapolation of data.--Paragraph (2)(B) shall apply 
        to investigations described in this paragraph to the same 
        extent and in the same manner as paragraph (2)(B) applies with 
        respect to the assessments required under paragraph (1)(A).
            ``(C) Deferrals and waivers.--Deferrals and waivers under 
        paragraphs (4) and (5) shall apply to investigations described 
        in this paragraph to the same extent and in the same manner as 
        such deferrals and waivers apply with respect to the 
        assessments under paragraph (2)(B).'';
            (E) in paragraph (4), as so redesignated--
                (i) by striking ``assessments required under paragraph 
            (1)'' each place it appears and inserting ``assessments 
            required under paragraph (1)(A) or reports on the 
            investigation required under paragraph (1)(B)'';
                (ii) in subparagraph (A)(ii)(I), by inserting ``or 
            reports on the investigation'' after ``assessments'';
                (iii) in subparagraph (B)(ii), by striking ``assessment 
            under paragraph (1)'' and inserting ``assessment under 
            paragraph (1)(A) or reports on the investigation under 
            paragraph (1)(B)''; and
                (iv) in subparagraph (C)(ii)(II), by inserting ``or 
            investigation'' after ``assessment''; and
            (F) in paragraph (5), as so redesignated, by inserting ``or 
        reports on the investigation'' after ``assessments'' each place 
        it appears;
        (2) in subsection (d)--
            (A) by striking ``subsection (a)(3)'' each place it appears 
        and inserting ``subsection (a)(4)'';
            (B) by inserting ``and Reports on the Investigation'' after 
        ``Submission of Assessments'' in the heading; and
            (C) by inserting ``or the investigation described in 
        subsection (a)(3)'' after ``assessment described in subsection 
        (a)(2)'' each place it appears;
        (3) in subsection (e)--
            (A) in paragraph (1), by inserting ``or the investigation 
        described in subsection (a)(3)'' after ``under subsection 
        (a)(2)''; and
            (B) in paragraph (2)(A)(i), by inserting ``or the 
        investigation described in subsection (a)(3)'' after ``under 
        subsection (a)(2)''; and
        (4) by adding at the end the following:
    ``(m) List of Primary Molecular Targets.--
        ``(1) In general.--Within one year of the date of enactment of 
    the FDA Reauthorization Act of 2017, the Secretary shall establish 
    and update regularly, and shall publish on the internet website of 
    the Food and Drug Administration--
            ``(A) a list of molecular targets considered, on the basis 
        of data the Secretary determines to be adequate, to be 
        substantially relevant to the growth and progression of a 
        pediatric cancer, and that may trigger the requirements under 
        this section; and
            ``(B) a list of molecular targets of new cancer drugs and 
        biological products in development for which pediatric cancer 
        study requirements under this section will be automatically 
        waived.
        ``(2) Consultation.--In establishing the lists described in 
    paragraph (1), the Secretary shall consult the National Cancer 
    Institute, members of the internal committee under section 505C, 
    and the Pediatric Oncology Subcommittee of the Oncologic Drugs 
    Advisory Committee, and shall take into account comments from the 
    meeting under subsection (c).
        ``(3) Rule of construction.--Nothing in paragraph (1) shall be 
    construed--
            ``(A) to require the inclusion of a molecular target on the 
        list published under such paragraph as a condition for 
        triggering the requirements under subsection (a)(1)(B) with 
        respect to a drug or biological product directed at such 
        molecular target; or
            ``(B) to authorize the disclosure of confidential 
        commercial information, as prohibited under section 301(j) of 
        this Act or section 1905 of title 18, United States Code.''.
    (b) Orphan Drugs.--Section 505B(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows:
    ``(k) Relation to Orphan Drugs.--
        ``(1) In general; exemption for orphan indications.--Unless the 
    Secretary requires otherwise by regulation and except as provided 
    in paragraph (2), this section does not apply to any drug or 
    biological product for an indication for which orphan designation 
    has been granted under section 526.
        ``(2) Applicability despite orphan designation of certain 
    indications.--This section shall apply with respect to a drug or 
    biological product for which an indication has been granted orphan 
    designation under 526 if the investigation described in subsection 
    (a)(3) applies to the drug or biological product as described in 
    subsection (a)(1)(B).''.
    (c) Meeting, Consultation, and Guidance.--
        (1) Meeting.--The Secretary of Health and Human Services 
    (referred to in this subsection as the ``Secretary''), acting 
    through the Commissioner of Food and Drugs and in collaboration 
    with the Director of the National Cancer Institute, shall convene a 
    public meeting not later than 1 year after the date of enactment of 
    this Act to solicit feedback from physicians and researchers 
    (including pediatric oncologists and rare disease specialists), 
    patients, and other stakeholders to provide input on development of 
    the guidance under paragraph (2) and the list under subsection (m) 
    of section 505B of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 355c), as added by subsection (a). The Secretary shall seek 
    input at such meeting on--
            (A) the data necessary to determine that there is 
        scientific evidence that a drug or biological product is 
        directed at a molecular target that is considered to be 
        substantially relevant to the growth or progression of a 
        pediatric cancer;
            (B) the data necessary to determine that there is 
        scientific evidence that a molecular target is considered to be 
        substantially relevant to the growth or progression of a 
        pediatric cancer;
            (C) the data needed to meet the requirement of conducting 
        an investigation described in section 505B(a)(3) of the Federal 
        Food, Drug, and Cosmetic Act, as amended by subsection (a);
            (D) considerations when developing the list under section 
        505B(m) of the Federal Food, Drug, and Cosmetic Act that 
        contains molecular targets shared between different tumor 
        types;
            (E) the process the Secretary shall utilize to update 
        regularly a list of molecular targets that may trigger a 
        pediatric study under section 505B of the Federal Food, Drug, 
        and Cosmetic Act, as so amended, and how often such updates 
        shall occur;
            (F) how to overcome the challenges related to pediatric 
        cancer drug and biological product development, including 
        issues related to the ethical, practical, and other barriers to 
        conducting clinical trials in pediatric cancer with small 
        patient populations;
            (G) scientific or operational challenges associated with 
        performing an investigation described in section 505B(a)(1)(B) 
        of the Federal Food, Drug, and Cosmetic Act, including the 
        effect on pediatric studies currently underway in a pediatric 
        patient population, treatment of a pediatric patient 
        population, and the ability to complete adult clinical trials;
            (H) the advantages and disadvantages of innovative clinical 
        trial designs in addressing the development of cancer drugs or 
        biological products directed at molecular targets in pediatric 
        cancer patients;
            (I) 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;
            (J) the ways in which the Secretary might streamline and 
        improve the written request process, including when studies 
        contained in a request under such section 505A are not feasible 
        due to the ethical, practical, or other barriers to conducting 
        clinical trials in pediatric cancer populations;
            (K) how the Secretary will facilitate collaboration among 
        pediatric networks, academic centers and experts in pediatric 
        cancer to conduct an investigation described in such section 
        505B(a)(3);
            (L) how the Secretary may facilitate collaboration among 
        sponsors of same-in-class drugs and biological products that 
        would be subject to the requirements for an investigation under 
        such section 505B based on shared molecular targets; and
            (M) the ways in which the Secretary will help to mitigate 
        the risks, if any, of discouraging the research and development 
        of orphan drugs when implementing such section 505B as amended.
        (2) Guidance.--Not later than 2 years after the date of 
    enactment of this Act, the Secretary, acting through the 
    Commissioner of Food and Drugs, shall issue final guidance on 
    implementation of the amendments to section 505B of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 355c) regarding molecularly 
    targeted cancer drugs made by this section, including--
            (A) the scientific criteria, types of data, and regulatory 
        considerations for determining whether a molecular target is 
        substantially relevant to the growth or progression of a 
        pediatric cancer and would trigger an investigation under 
        section 505B of the Federal Food, Drug, and Cosmetic Act, as 
        amended;
            (B) the process by which the Secretary will engage with 
        sponsors to discuss determinations, investigation requirements, 
        deferrals, waivers, and any other issues that need to be 
        resolved to ensure that any required investigation based on a 
        molecular target can be reasonably conducted;
            (C) the scientific or operational challenges for which the 
        Secretary may issue deferrals or waivers for an investigation 
        described in subsection (a)(3) of such section 505B, including 
        adverse impacts on current pediatric studies underway in a 
        pediatric patient population, studies involving drugs 
        designated as orphan drugs, treatment of a pediatric patient 
        population, or the ability to complete adult clinical trials;
            (D) how the Secretary and sponsors will facilitate 
        collaboration among pediatric networks, academic centers, and 
        experts in pediatric cancer to conduct an investigation 
        described in subsection (a)(3) of such section 505B;
            (E) scientific and regulatory considerations for study 
        designs, including the applicability of innovative clinical 
        trial designs for pediatric cancer drug and biological product 
        developments under sections 505A and 505B of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355a, 355c);
            (F) approaches to streamline and improve the amendment 
        process, including when studies contained in a request under 
        such section 505A are not feasible due to the ethical, 
        practical, or other barriers to conducting clinical trials in 
        pediatric cancer populations;
            (G) the process for submission of an initial pediatric 
        study plan for the investigation described in section 
        505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355c(a)(3)), including the process for a sponsor to meet 
        and reach agreement with the Secretary on the initial pediatric 
        study plan; and
            (H) considerations for implementation of such section 505B, 
        as so amended, and waivers of the requirements of such section 
        505B with regard to molecular targets for which several drugs 
        or biological products may be under investigation.
    (d) Report to Congress.--Section 508(b) of the Food and Drug 
Administration Safety and Innovation Act (21 U.S.C. 355c-1(b)) is 
amended--
        (1) in paragraph (10), by striking ``; and'' and inserting 
    ``;''; and
        (2) by striking paragraph (11) and inserting the following:
        ``(11) an assessment of the impact of the amendments to such 
    section 505B made by the FDA Reauthorization Act of 2017 on 
    pediatric research and labeling of drugs and biological products 
    and pediatric labeling of molecularly targeted drugs and biological 
    products for the treatment of cancer;
        ``(12) an assessment of the efforts of the Secretary to 
    implement the plan developed under section 505C-1 of the Federal 
    Food, Drug, and Cosmetic Act, regarding earlier submission of 
    pediatric studies under sections 505A and 505B of such Act and 
    section 351(m) of the Public Health Service Act, including--
            ``(A) the average length of time after the approval of an 
        application under section 505(b)(1) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of the 
        Public Health Service Act (42 U.S.C. 262(a)) before studies 
        conducted pursuant to such section 505A, 505B, or section 
        351(m) are completed, submitted, and incorporated into 
        labeling;
            ``(B) the average length of time after the receipt of a 
        proposed pediatric study request before the Secretary responds 
        to such request;
            ``(C) the average length of time after the submission of a 
        proposed pediatric study request before the Secretary issues a 
        written request for such studies;
            ``(D) the number of written requests issued for each 
        investigational new drug or biological product prior to the 
        submission of an application under section 505(b)(1) of the 
        Federal Food, Drug, and Cosmetic Act or section 351(a) of the 
        Public Health Service Act; and
            ``(E) the average number, and range of numbers, of 
        amendments to written requests issued, and the time the 
        Secretary requires to review and act on proposed amendments to 
        written requests;
        ``(13) a list of sponsors of applications or holders of 
    approved applications who received exclusivity under such section 
    505A or such section 351(m) after receiving a letter issued under 
    such section 505B(d)(1) for any drug or biological product before 
    the studies referred to in such letter were completed and 
    submitted;
        ``(14) a list of assessments and investigations required under 
    such section 505B;
        ``(15) how many requests under such section 505A for molecular 
    targeted cancer drugs, as defined by subsection (a)(1)(B) of such 
    section 505B, approved prior to 3 years after the date of enactment 
    of the FDA Reauthorization Act of 2017, have been issued by the 
    Food and Drug Administration, and how many such requests have been 
    completed; and
        ``(16) the Secretary's assessment of the overall impact of the 
    amendments made by section 504 of the FDA Reauthorization Act of 
    2017 on the conduct and effectiveness of pediatric cancer research 
    and the orphan drug program, as well any subsequent 
    recommendations.''.
    (e) Rule of Construction.--Nothing in this section, including the 
amendments made by this section, shall limit the authority of the 
Secretary of Health and Human Services to issue written requests under 
section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355a) or section 351(m) of the Public Health Service Act (42 U.S.C. 
262(m)), or to negotiate or implement amendments to such requests 
proposed by the an applicant.
    (f) GAO Report.--
        (1) In general.--Beginning on the date that is 5 years after 
    the date of enactment of this Act, the Comptroller General of the 
    United States shall conduct a study of the effectiveness of 
    requiring assessments and investigations described in section 505B 
    of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as 
    amended by this section, in the development of drugs and biological 
    products for pediatric cancer indications. The Comptroller General 
    shall examine--
            (A) the indications and associated molecular targets 
        studied in assessments and investigations required for drugs or 
        biological products intended for the treatment of an adult 
        cancer;
            (B) the indication for which the study was requested as 
        compared to the indication requested under the new drug 
        application filed by the sponsor;
            (C) the number of pediatric cancer indications for which 
        assessments and investigations have been required under such 
        section 505B;
            (D) the number of requests for deferral and waiver of 
        pediatric assessments and investigations required under such 
        section and the number of such deferral and waiver requests 
        granted and denied;
            (E) the number of orphan-designated indications for drugs 
        and biological products for which assessments and 
        investigations were required under such section;
            (F) the number of drugs and biological products approved 
        for the treatment of cancer in the pediatric population for 
        which the supportive studies were required to be conducted 
        under such section;
            (G) the number of written requests made under section 505A 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 
        relating to investigations required under subsection (a)(1)(B) 
        of such section 505B; and
            (H) any additional considerations by the Secretary 
        regarding the effectiveness of requiring pediatric assessments 
        described in such section 505B in the development of drugs and 
        biological products for pediatric cancer indications.
        (2) Review.--The study under paragraph (1) shall include a 
    review of the Food and Drug Administration's use of the authority 
    under section 505B of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 355c), as amended by this section, including the amendments 
    to the deferral and waiver criteria under such section and how such 
    criteria have been applied.
        (3) Consultation.--In conducting the study under paragraph (1), 
    the Comptroller General of the United States shall consult with 
    appropriate stakeholders that may be required to conduct the trials 
    under section 505B of the Federal Food, Drug, and Cosmetic Act, and 
    the ability of such stakeholders to adhere to the requests issued 
    by the Food and Drug Administration.
        (4) Report.--Not later than the date that is 6 years after the 
    date of enactment of this Act, the Comptroller General of the 
    United States shall submit a report containing the results of the 
    study under paragraph (1) to the Secretary of Health and Human 
    Services, the Committee on Health, Education, Labor, and Pensions 
    of the Senate, and the Committee on Energy and Commerce of the 
    House of Representatives.
    SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND 
      BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.
    (a) 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.''.
    (b) 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 by a sponsor or holder of a proposed 
    pediatric study request or a proposed amendment to a written 
    request for pediatric studies within 120 calendar days of the 
    submission.''.
        (2) Conforming amendments.--
            (A) Federal food, drug, and cosmetic act.--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) Public health service act.--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)''.
    (c) Plan.--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, discussion of 
    such requests 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 section 503(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 such 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).
    (d) 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.
    (e) 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 letters issued under this paragraph and 
responses to such letters.''.
    (f) 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''.
    (g) Report on Labeling of Orphan Drugs.--
        (1) In general.--Not later than 2 years after the date of the 
    enactment of this Act, the Secretary of Health and Human Services 
    shall submit to the Committee on Health, Education, Labor and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives, and make publicly available, 
    including through posting on the internet website of the Food and 
    Drug Administration, a report on the lack of information in the 
    labeling of drugs for indications that have received an orphan 
    designation under section 526 of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 360bbb) with respect to the use of such 
    drugs pediatric populations.
        (2) Contents.--The report described in paragraph (1) shall 
    include--
            (A) a list of drugs for which--
                (i) an indication was granted an orphan designation 
            under section 526 of the Federal Food, Drug, and Cosmetic 
            Act (21 U.S.C. 360bbb);
                (ii) an application described under section 505B(a)(1) 
            of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
            355c(a)(1)) for such indication was submitted to the 
            Secretary of Health and Human Services on or after April 1, 
            1999; and
                (iii) the labeling for such indication lacks important 
            pediatric information, including information related to 
            safety, dosing, and effectiveness;
            (B) a description of the lack of information referred to in 
        subparagraph (A)(iii) for each drug for an indication on such 
        list; and
            (C) Federal policy recommendations to improve the labeling 
        of drugs for indications that have received an orphan 
        designation under such section 526 with respect to the use of 
        such drugs pediatric populations.''

      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. 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, no drug that is subject to 
section 503(b)(1) may be imported into the United States for commercial 
use if such drug is manufactured outside the United States, unless the 
manufacturer has authorized the drug to be marketed in the United 
States and has caused the drug to be labeled to be marketed in the 
United States.''.
    (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 knowingly making, selling or dispensing, or 
holding for sale or dispensing, a counterfeit drug shall be imprisoned 
for not more than 10 years or fined in accordance with title 18, United 
States Code, or both.''.
    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 ``impact 
(including physical and psychosocial impacts) of such disease or 
condition, or a related therapy or clinical investigation''.
    SEC. 606. COMMUNICATION 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 drug formulations or properties, including information 
        about the limitations or patient care implications of such 
        formulations or properties, and how such formulations or 
        properties may be related to serious adverse drug events 
        associated with use of the drug.''.
    SEC. 607. ORPHAN DRUGS.
    (a) In General.--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). Beginning on the date of 
enactment of the FDA Reauthorization Act of 2017, until such time as 
the Secretary promulgates regulations in accordance with this 
subsection, the Secretary may apply any definitions set forth in 
regulations that were promulgated prior to such date of enactment, to 
the extent such definitions are not inconsistent with the terms of this 
section, as amended by such Act.
    ``(e) Demonstration of Clinical Superiority Standard.--To assist 
sponsors in demonstrating clinical superiority as described in 
subsection (c), the Secretary--
        ``(1) upon the designation of any drug under section 526, shall 
    notify the sponsor of such drug in writing of the basis for the 
    designation, including, as applicable, any plausible hypothesis 
    offered by the sponsor and relied upon by the Secretary that the 
    drug is clinically superior to a previously approved drug; and
        ``(2) upon granting exclusive approval or licensure under 
    subsection (a) on the basis of a demonstration of clinical 
    superiority as described in subsection (c), shall publish a summary 
    of the clinical superiority findings.''.
    (b) Rule of Construction.--Nothing in the amendments made by 
subsection (a) shall affect any determination under sections 526 and 
527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 
360cc) made prior to the date of enactment of the FDA Reauthorization 
Act of 2017.
    SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.
    Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a(o)) is amended--
        (1) in the subsection heading, by striking ``under section 
    505(j)'';
        (2) in paragraph (1)--
            (A) by striking ``under section 505(j)'' and inserting 
        ``under subsection (b)(2) or (j) of section 505''; and
            (B) by striking ``or by exclusivity under clause (iii) or 
        (iv) of section 505(j)(5)(F)'' and inserting ``, or by 
        exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), 
        clause (iii) or (iv) of section 505(c)(3)(E), or section 
        527(a), or by an extension of such exclusivity under this 
        section or section 505E'';
        (3) in paragraph (2), in the matter preceding subparagraph 
    (A)--
            (A) by inserting ``clauses (iii) and (iv) of section 
        505(c)(3)(E), or section 527,'' after ``section 
        505(j)(5)(F),''; and
            (B) by striking ``drug approved under section 505(j)'' and 
        inserting ``drug approved pursuant to an application submitted 
        under subsection (b)(2) or (j) of section 505''; and
        (4) by amending paragraph (3) to read as follows:
        ``(3) Preservation of pediatric exclusivity and extensions.--
    This subsection does not affect--
            ``(A) the availability or scope of exclusivity under--
                ``(i) this section;
                ``(ii) section 505 for pediatric formulations; or
                ``(iii) section 527;
            ``(B) the availability or scope of an extension to any such 
        exclusivity, including an extension under this section or 
        section 505E;
            ``(C) the question of the eligibility for approval under 
        section 505 of any application described in subsection (b)(2) 
        or (j) of such section that omits any other aspect of labeling 
        protected by exclusivity under--
                ``(i) clause (iii) or (iv) of section 505(j)(5)(F);
                ``(ii) clause (iii) or (iv) of section 505(c)(3)(E); or
                ``(iii) section 527(a); or
            ``(D) except as expressly provided in paragraphs (1) and 
        (2), the operation of section 505 or section 527.''.
    SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION 
      DRUGS.
    It is the sense of the Congress that the Secretary of Health and 
Human Services should commit to engaging with the House of 
Representatives and the Senate to take administrative actions and enact 
legislative changes that--
        (1) will lower the cost of prescription drugs for consumers and 
    reduce the burden of such cost on taxpayers; and
        (2) in lowering such cost, will--
            (A) balance the need to encourage innovation with the need 
        to improve affordability; and
            (B) strive to increase competition in the pharmaceutical 
        market, prevent anticompetitive behavior, and promote the 
        timely availability of affordable, high-quality generic drugs 
        and biosimilars.
    SEC. 610. EXPANDED ACCESS.
    (a) Patient Access to Investigational Drugs.--
        (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 270 days after the date of enactment of this Act, 
        convene a public meeting to discuss clinical trial inclusion 
        and exclusion criteria to inform the guidance under paragraph 
        (3). The Secretary shall inform the Comptroller General of the 
        United States of the date when the public meeting will take 
        place.
            (B) Topics.--The Secretary shall make available on the 
        internet website of the Food and Drug Administration a report 
        on the topics discussed at the meeting described in 
        subparagraph (A) within 90 days of such meeting. Such topics 
        shall include discussion of--
                (i) the rationale for, and potential barriers for 
            patients created by, research clinical trial inclusion and 
            exclusion criteria;
                (ii) how appropriate patient populations can benefit 
            from the results of trials that employ alternative 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 particular 
                populations, including infants and children, pregnant 
                and lactating women, seniors, individuals with advanced 
                disease, and individuals with co-morbid conditions;

                (iv) clinical trial designs and methods, including 
            expanded access trials, that increase enrollment of more 
            diverse patient populations, when appropriate, while 
            facilitating the collection of data to establish safe use 
            and support substantial evidence of effectiveness, 
            including data obtained from expanded access trials; and
                (v) how changes to clinical trial inclusion and 
            exclusion criteria may impact the complexity and length of 
            clinical trials, the data necessary to demonstrate safety 
            and effectiveness, and potential approaches to mitigating 
            those impacts.
        (2) Report.--Not later than 1 year after the Secretary issues 
    the report under paragraph (1)(B), the Comptroller General of the 
    United States shall report to the Committee on Health, Education, 
    Labor, and Pensions of the Senate and the Committee on Energy and 
    Commerce of the House of Representatives on individual access to 
    investigational drugs through the expanded access program under 
    section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 360bbb(b)). The report shall include--
            (A) a description of actions taken by manufacturers and 
        distributors 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 
        documents titled ``Expanded Access to Investigational Drugs for 
        Treatment Use--Questions and Answers'' and ``Individual Patient 
        Expanded Access Applications: Form FDA 3926'', issued by the 
        Food and Drug Administration in June 2016, have reduced 
        application burden with respect to individuals and physicians 
        seeking access to investigational new drugs pursuant to section 
        561(b) of the Federal Food, Drug, and Cosmetic Act (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 
        issued to implement section 561 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb) have improved access for 
        individual patients to investigational drugs who do not qualify 
        for clinical trials of such investigational drugs, and what 
        barriers to such access remain;
            (D) an assessment of methods patients and health care 
        providers use to engage with the Food and Drug Administration 
        or drug sponsors on expanded access; and
            (E) an analysis of the Secretary's report under paragraph 
        (1)(B).
        (3) Guidance.--
            (A) In general.--Not later than 1 year after the 
        publication of the report under paragraph (1)(B), the 
        Secretary, acting through the Commissioner of Food and Drugs, 
        shall issue one or more draft guidances regarding eligibility 
        criteria for clinical trials. Not later than 1 year after the 
        public comment period on each such draft guidance ends, the 
        Secretary shall issue a revised draft guidance or final 
        guidance.
            (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 
            and expanded access trials, especially with respect to 
            drugs for the treatment of serious and life-threatening 
            conditions or diseases for which there is an unmet medical 
            need;
                (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 establishing safe use and supporting 
            findings of substantial evidence of effectiveness; and
                (iii) use the criteria described in clauses (i) and 
            (ii) in a manner that is appropriate for drugs intended for 
            the treatment of rare diseases or conditions.
    (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 of individual patient expanded access protocols 
submitted under 561(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb(b)). To facilitate the use of expanded access protocols, 
any guidance or regulations so issued or revised may include a 
description of the process for any person acting through a physician 
licensed in accordance with State law to request that an institutional 
review board chair (or designated member of the institutional review 
board) review a single patient expanded access protocol submitted under 
such section 561(b) for a drug. The Secretary shall update any relevant 
forms associated with individual patient expanded access requests under 
such section 561(b) 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. 611. TROPICAL DISEASE PRODUCT APPLICATION.
    (a) In General.--Subparagraph (A) of section 524(a)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is 
amended--
        (1) in clause (i), by striking ``and'' at the end; and
        (2) by adding at the end the following:
                ``(iii) that contains reports of one or more new 
            clinical investigations (other than bioavailability 
            studies) that are essential to the approval of the 
            application and conducted or sponsored by the sponsor of 
            such application; and
                ``(iv) that contains an attestation from the sponsor of 
            the application that such reports were not submitted as 
            part of an application for marketing approval or licensure 
            by a regulatory authority in India, Brazil, Thailand, or 
            any country that is a member of the Pharmaceutical 
            Inspection Convention or the Pharmaceutical Inspection 
            Cooperation Scheme prior to September 27, 2007.''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply to human drug applications submitted after September 30, 2017.

        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 for purposes of inspecting device 
            establishments.''; 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 FOR DEVICE 
      ESTABLISHMENTS.
    (a) In General.--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 other than for-cause 
inspections, the Secretary shall review processes and standards 
applicable to inspections of domestic and foreign device establishments 
in effect as of the date of the enactment of this subsection, and 
update such processes and standards through the adoption of uniform 
processes and standards applicable to such inspections. Such uniform 
processes and standards shall provide for--
        ``(A) exceptions to such processes and standards, as 
    appropriate;
        ``(B) announcing the inspection of the establishment within a 
    reasonable time before such inspection occurs, including by 
    providing to the owner, operator, or agent in charge of the 
    establishment a notification regarding the type and nature of the 
    inspection;
        ``(C) a reasonable estimate of the timeframe for the 
    inspection, an opportunity for advance communications between the 
    officers or employees carrying out the inspection under subsection 
    (a)(1) and the owner, operator, or agent in charge of the 
    establishment concerning appropriate working hours during the 
    inspection, and, to the extent feasible, advance notice of some 
    records that will be requested; and
        ``(D) regular communications during the inspection with the 
    owner, operator, or agent in charge of the establishment regarding 
    inspection status, which may be recorded by either party with 
    advance notice and mutual consent.
    ``(2)(A) The Secretary shall, with respect to a request described 
in subparagraph (B), provide nonbinding feedback with respect to such 
request not later than 45 days after the Secretary receives such 
request.
    ``(B) A request described in this subparagraph is a request for 
feedback--
        ``(i) that is made by the owner, operator, or agent in charge 
    of such establishment in a timely manner; and
        ``(ii) with respect to actions proposed to be taken by a device 
    establishment in a response to a report received by such 
    establishment pursuant to subsection (b) that involve a public 
    health priority, that implicate systemic or major actions, or 
    relate to emerging safety issues (as determined by the Secretary).
    ``(3) Nothing in this subsection affects the authority of the 
Secretary to conduct inspections otherwise permitted under this Act in 
order to ensure compliance with this Act.''.
    (b) Guidance.--
        (1) Draft guidance.--Not later than 18 months after the date of 
    enactment of this Act, the Secretary of Health and Human Services, 
    acting through the Commissioner of Food and Drugs, shall issue 
    draft guidance that--
            (A) specifies how the Food and Drug Administration will 
        implement the processes and standards described in paragraph 
        (1) of subsection (h) of section 704 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), 
        and the requirements described in paragraph (2) of such 
        subsection (h);
            (B) provides for standardized methods for communications 
        described in such paragraphs;
            (C) establishes, with respect to inspections of both 
        domestic and foreign device establishments (as referred to in 
        section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act, 
        as amended by subsection (a)), a standard timeframe for such 
        inspections--
                (i) that occurs over consecutive days; and
                (ii) to which each investigator conducting such an 
            inspection shall adhere unless the investigator identifies 
            to the establishment involved a reason that more time is 
            needed to conduct such investigation; and
            (D) identifies practices for investigators and device 
        establishments to facilitate the continuity of inspections of 
        such establishments.
        (2) Final guidance.--Not later than 1 year after providing 
    notice and opportunity for public comment on the draft guidance 
    issued under paragraph (1), the Secretary of Health and Human 
    Services shall issue final guidance to implement subsection (h) of 
    section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    374), as added by subsection (a).
    (c) Adulterated Devices.--Subsection (j) of section 501 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
inserting ``or device'' after ``drug''.
    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, and is based on the facility being out of 
compliance with part 820 of title 21, Code of Federal Regulations, the 
Secretary shall provide a substantive summary of the specific grounds 
for noncompliance identified by the Secretary.
    ``(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 as described in subclause (I) with 
respect to a device based solely on the issuance of that report if the 
owner, operator, or agent in charge of such establishment has agreed to 
a plan of correction in response to such report.
    ``(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 the date of enactment of the 
FDA Reauthorization Act of 2017, the Secretary shall issue guidance 
providing for a process to carry out this subparagraph. Not later than 
1 year after the close of the comment period for such guidance, the 
Secretary shall issue final guidance.
    ``(iii)(I) Subject to subclause (II), this subparagraph applies to 
requests for certification on behalf of any device establishment 
registered under section 510, whether the establishment is located 
inside or outside of the United States, and regardless of whether such 
devices are to be exported from the United States.
    ``(II) If an establishment described in subclause (I) is not 
located within the United States and does not demonstrate that the 
devices manufactured, prepared, propagated, compounded, or processed at 
such establishment are to be exported from the United States, this 
subparagraph shall apply only if--
        ``(aa) the establishment has been inspected by the Secretary 
    within 3 years of the date of the request; or
        ``(bb) the establishment participates in an audit program in 
    which the United States participates or the United States 
    recognizes, an audit under such program has been conducted, and the 
    findings of such audit are provided to the Secretary within 3 years 
    of the date of the request.''; 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)(A) Notwithstanding any other provision of this subsection, 
the Secretary may recognize auditing organizations that are recognized 
by organizations established by governments to facilitate international 
harmonization for purposes of conducting inspections of--
        ``(i) establishments that manufacture, prepare, propagate, 
    compound, or process devices (other than types of devices licensed 
    under section 351 of the Public Health Service Act), as required 
    under section 510(h); or
        ``(ii) establishments required to register pursuant to section 
    510(i).
    ``(B) Nothing in this paragraph affects--
        ``(i) the authority of the Secretary to inspect any device 
    establishment pursuant to this Act; or
        ``(ii) the authority of the Secretary to determine the official 
    classification of an inspection.''.
    SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.
    (a) Approval of Applications for Certain Diagnostic Medical Imaging 
Devices.--Section 520 of the Federal Food, Drug, and Cosmetic Act (42 
U.S.C. 360j) is amended by adding at the end the following:
    ``(p) Diagnostic Imaging Devices Intended for Use With Contrast 
Agents.--
        ``(1) In general.--The Secretary may, subject to the succeeding 
    provisions of this subsection, approve an application (or a 
    supplement to such an application) submitted under section 515 with 
    respect to an applicable medical imaging device, or, in the case of 
    an applicable medical imaging device for which a notification is 
    submitted under section 510(k), may make a substantial equivalence 
    determination with respect to an applicable medical imaging device, 
    or may grant a request submitted under section 513(f)(2) for an 
    applicable medical imaging device, if such application, 
    notification, or request involves the use of a contrast agent that 
    is not--
            ``(A) in a concentration, rate of administration, or route 
        of administration that is different from those described in the 
        approved labeling of the contrast agent, except that the 
        Secretary may approve such application, make such substantial 
        equivalence determination, or grant such request if the 
        Secretary determines that such differences in concentration, 
        rate of administration, or route of administration exist but do 
        not adversely affect the safety and effectiveness of the 
        contrast agent when used with the device;
            ``(B) in a region, organ, or system of the body that is 
        different from those described in the approved labeling of the 
        contrast agent, except that the Secretary may approve such 
        application, make such substantial equivalence determination, 
        or grant such request if the Secretary determines that such 
        differences in region, organ, or system of the body exist but 
        do not adversely affect the safety and effectiveness of the 
        contrast agent when used with the device;
            ``(C) in a patient population that is different from those 
        described in the approved labeling of the contrast agent, 
        except that the Secretary may approve such application, make 
        such substantial equivalence determination, or grant such 
        request if the Secretary determines such differences in patient 
        population exist but do not adversely affect the safety and 
        effectiveness of the contrast agent when used with the device; 
        or
            ``(D) in an imaging modality that is different from those 
        described in the approved labeling of the contrast agent.
        ``(2) Premarket review.--The agency center charged with 
    premarket review of devices shall have primary jurisdiction with 
    respect to the review of an application, notification, or request 
    described in paragraph (1). In conducting such review, such agency 
    center may--
            ``(A) consult with the agency center charged with the 
        premarket review of drugs or biological products; and
            ``(B) review information and data provided to the Secretary 
        by the sponsor of a contrast agent in an application submitted 
        under section 505 of this Act or section 351 of the Public 
        Health Service Act, so long as the sponsor of such contrast 
        agent has provided to the sponsor of the applicable medical 
        imaging device that is the subject of such review a right of 
        reference and the application is submitted in accordance with 
        this subsection.
        ``(3) Applicable requirements.--An application submitted under 
    section 515, a notification submitted under section 510(k), or a 
    request submitted under section 513(f)(2), as described in 
    paragraph (1), with respect to an applicable medical imaging device 
    shall be subject to the requirements of such respective section. 
    Such application, notification, or request shall only be subject to 
    the requirements of this Act applicable to devices.
        ``(4) Definitions.--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 an imaging use that is not 
        described in the approved labeling of such contrast agent (or 
        the approved labeling of any contrast agent in the same class 
        as such contrast agent); and
            ``(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 section 315.2 and 601.31 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.''.
    (b) Applications for Approval of Contrast Agents Intended for Use 
With Certain Diagnostic Medical Imaging Devices.--Section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following:
    ``(y) Contrast Agents Intended for Use With Applicable Medical 
Imaging Devices.--
        ``(1) In general.--The sponsor of a contrast agent for which an 
    application has been approved under this section may submit a 
    supplement to the application seeking approval for a new use 
    following the authorization of a premarket submission for an 
    applicable medical imaging device for that use with the contrast 
    agent pursuant to section 520(p)(1).
        ``(2) Review of supplement.--In reviewing a supplement 
    submitted under this subsection, the agency center charged with the 
    premarket review of drugs may--
            ``(A) consult with the center charged with the premarket 
        review of devices; and
            ``(B) review information and data submitted to the 
        Secretary by the sponsor of an applicable medical imaging 
        device pursuant to section 515, 510(k), or 513(f)(2) so long as 
        the sponsor of such applicable medical imaging device has 
        provided to the sponsor of the contrast agent a right of 
        reference.
        ``(3) Definitions.--For purposes of this subsection--
            ``(A) the term `new use' means a use of a contrast agent 
        that is described in the approved labeling of an applicable 
        medical imaging device described in section 520(p), but that is 
        not described in the approved labeling of the contrast agent; 
        and
            ``(B) the terms `applicable medical imaging device' and 
        `contrast agent' have the meanings given such terms in section 
        520(p).''.
    SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.
    (a) In General.--Subsection (f) of section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 
the following new paragraph:
    ``(6)(A) Subject to the succeeding subparagraphs of this paragraph, 
the Secretary shall, by written order, classify an accessory under this 
section based on the risks of the accessory when used as intended and 
the level of regulatory controls necessary to provide a reasonable 
assurance of safety and effectiveness of the accessory, notwithstanding 
the classification of any other device with which such accessory is 
intended to be used.
    ``(B) The classification of any accessory distinct from another 
device by regulation or written order issued prior to December 13, 
2016, shall continue to apply unless and until the accessory is 
reclassified by the Secretary, notwithstanding the classification of 
any other device with which such accessory is intended to be used. 
Nothing in this paragraph shall preclude the Secretary's authority to 
initiate the classification of an accessory through regulation or 
written order, as appropriate.
    ``(C)(i) In the case of a device intended to be used with an 
accessory, where the accessory has been included in an application for 
premarket approval of such device under section 515 or a report under 
section 510(k) for clearance of such device and the Secretary has not 
classified such accessory distinctly from another device in accordance 
with subparagraph (A), the person filing the application or report (as 
applicable) at the time such application or report is filed--
        ``(I) may include a written request for the proper 
    classification of the accessory pursuant to subparagraph (A);
        ``(II) shall include in any such request such information as 
    may be necessary for the Secretary to evaluate, based on the least 
    burdensome approach, the appropriate class for the accessory under 
    subsection (a); and
        ``(III) shall, if the request under subclause (I) is requesting 
    classification of the accessory in class II, include in the 
    application an initial draft proposal for special controls, if 
    special controls would be required pursuant to subsection 
    (a)(1)(B).
    ``(ii) The Secretary's response under section 515(d) or section 
510(n) (as applicable) to an application or report described in clause 
(i) shall also contain the Secretary's granting or denial of the 
request for classification of the accessory involved.
    ``(iii) The Secretary's evaluation of an accessory under clause (i) 
shall constitute an order establishing a new classification for such 
accessory for the specified intended use or uses of such accessory and 
for any accessory with the same intended use or uses as such accessory.
    ``(D) For accessories that have been granted marketing 
authorization as part of a submission for another device with which the 
accessory involved is intended to be used, through an application for 
such other device under section 515(c), a report under section 510(k), 
or a request for classification under paragraph (2) of this subsection, 
the following shall apply:
        ``(i) Not later than the date that is one year after the date 
    of enactment of the FDA Reauthorization Act of 2017 and at least 
    once every 5 years thereafter, and as the Secretary otherwise 
    determines appropriate, pursuant to this paragraph, the Secretary 
    shall publish in the Federal Register a notice proposing a list of 
    such accessories that the Secretary determines may be suitable for 
    a distinct classification in class I and the proposed regulations 
    for such classifications. In developing such list, the Secretary 
    shall consider recommendations from sponsors of device submissions 
    and other stakeholders for accessories to be included on such list. 
    The notices shall provide for a period of not less than 60 calendar 
    days for public comment. Within 180 days after the end of the 
    comment period, the Secretary shall publish in the Federal Register 
    a final action classifying such suitable accessories into class I.
        ``(ii) A manufacturer or importer of an accessory that has been 
    granted such marketing authorization may submit to the Secretary a 
    written request for the appropriate classification of the accessory 
    based on the risks and appropriate level of regulatory controls as 
    described in subparagraph (A), and shall, if the request is 
    requesting classification of the accessory in class II, include in 
    the submission an initial draft proposal for special controls, if 
    special controls would be required pursuant to subsection 
    (a)(1)(B). Such request shall include such information as may be 
    necessary for the Secretary to evaluate, based on the least 
    burdensome approach, the appropriate class for the accessory under 
    subsection (a). The Secretary shall provide an opportunity for a 
    manufacturer or importer to meet with appropriate personnel of the 
    Food and Drug Administration to discuss the appropriate 
    classification of such accessory prior to submitting a written 
    request under this clause for classification of the accessory.
        ``(iii) The Secretary shall respond to a request made under 
    clause (ii) not later than 85 calendar days after receiving such 
    request by issuing a written order classifying the accessory or 
    denying the request. If the Secretary does not agree with the 
    recommendation for classification submitted by the manufacturer or 
    importer, the response shall include a detailed description and 
    justification for such determination. Within 30 calendar days after 
    granting such a request, the Secretary shall publish a notice in 
    the Federal Register announcing such response.
    ``(E) Nothing in this paragraph may be construed as precluding a 
manufacturer of an accessory of a new type from using the 
classification process described in subsection (f)(2) to obtain 
classification of such accessory in accordance with the criteria and 
requirements set forth in that subsection.''.
    (b) Conforming Change.--Section 513(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph 
(9) (relating to classification of an accessory).
    (c) Effective Date.--The amendments made by subsections (a) and (b) 
shall take effect on the date that is 60 days after the date of 
enactment of this Act.
    SEC. 708. 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) Postmarket Pilot.--
        ``(1) In general.--In order to provide timely and reliable 
    information on the safety and effectiveness of devices approved 
    under section 515, cleared under section 510(k), or classified 
    under section 513(f)(2), including responses to adverse events and 
    malfunctions, and to advance the objectives of 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 a device or 
    device type, or continue existing projects, in accordance with 
    paragraph (3), that--
            ``(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 included or not 
        included in such project;
            ``(C) may be designed and conducted in coordination with a 
        comprehensive system for evaluating medical device technology 
        that operates under a governing board with appropriate 
        representation of stakeholders, including patient groups and 
        device manufacturers;
            ``(D) use electronic health data including claims data, 
        patient survey data, or any other data, as the Secretary 
        determines appropriate; and
            ``(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--

                    ``(I) has received public recommendations in 
                accordance with paragraph (2)(B); and
                    ``(II) has determined to meet one or more of the 
                criteria under clause (i), (ii), or (iii) and is 
                appropriate for such a pilot project.

        ``(2) Participation.--The Secretary shall establish the 
    conditions and processes--
            ``(A) under which a manufacturer of a device may 
        voluntarily participate in a pilot project described in 
        paragraph (1); and
            ``(B) for facilitating public recommendations for devices 
        to be prioritized under such a pilot project, including 
        requirements for the data necessary to support such a 
        recommendation.
        ``(3) Continuation of ongoing projects.--The Secretary may 
    continue or expand projects, with respect to providing timely and 
    reliable information on the safety and effectiveness of devices 
    approved under section 515, cleared under section 510(k), or 
    classified under section 513(f)(2), that are being carried out as 
    of the date of the enactment of the FDA Reauthorization Act of 
    2017. The Secretary shall, beginning on such date of enactment, 
    take such steps as may be necessary--
            ``(A) to ensure such projects meet the requirements of 
        subparagraphs (A) through (E) of paragraph (1); and
            ``(B) to increase the voluntary participation in such 
        projects of manufacturers of devices and facilitate public 
        recommendations for any devices prioritized under such a 
        project.
        ``(4) Implementation.--
            ``(A) Contracting authority.--The Secretary may carry out a 
        pilot project meeting the criteria specified in subparagraphs 
        (A) through (E) of paragraph (1) or a project continued or 
        expanded under paragraph (3) by entering into contracts, 
        cooperative agreements, grants, or other appropriate agreements 
        with public or private entities that have a significant 
        presence in the United States and meet the following 
        conditions:
                ``(i) If such an entity is a component of another 
            organization, the entity and the organization have 
            established an agreement under which appropriate security 
            measures are implemented to maintain the confidentiality 
            and privacy of the data described in paragraph (1)(D) and 
            such agreement ensures that the entity will not make an 
            unauthorized disclosure of such data to the other 
            components of the organization in breach of requirements 
            with respect to confidentiality and privacy of such data 
            established under such security measures.
                ``(ii) In the case of the termination or nonrenewal of 
            such a contract, cooperative agreement, grant, or other 
            appropriate agreement, the entity or entities involved 
            shall comply with each of the following:

                    ``(I) The entity or entities shall continue to 
                comply with the requirements with respect to 
                confidentiality and privacy referred to in clause (i) 
                with respect to all data disclosed to the entity under 
                such an agreement.
                    ``(II) The entity or entities shall return any data 
                disclosed to such entity pursuant to this subsection 
                and to which it would not otherwise have access or, if 
                returning such data is not practicable, destroy the 
                data.

                ``(iii) The entity or entities shall have one or more 
            qualifications with respect to--

                    ``(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 to 
                support electronic data and operational standards to 
                provide security for such data, as appropriate;
                    ``(III) experience with, and expertise on, the 
                development of research on, and surveillance of, device 
                safety and effectiveness using electronic health data; 
                or
                    ``(IV) such other expertise which the Secretary 
                determines necessary to carry out such a project.

            ``(B) Review of contract in the event of a merger or 
        acquisition.--The Secretary shall review any contract, 
        cooperative agreement, grant, or other appropriate agreement 
        entered into under this paragraph with an entity meeting the 
        conditions specified in subparagraph (A) in the event of a 
        merger or acquisition of the entity in order to ensure that the 
        requirements specified in this subsection will continue to be 
        met.
        ``(5) Compliance with requirements for records or reports on 
    devices.--The participation of a manufacturer in pilot projects 
    under this subsection or a project continued or expanded under 
    paragraph (3) shall not affect the eligibility of such manufacturer 
    to participate in any quarterly reporting program with respect to 
    devices carried out under this section 519 or section 522. The 
    Secretary may determine that, for a specified time period to be 
    determined by the Secretary, a manufacturer's participation in a 
    pilot project under this subsection or a project continued or 
    expanded under paragraph (3) may meet the applicable requirements 
    of this section or section 522, if--
            ``(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 such 
        project public, to the extent possible.
        ``(6) Privacy requirements.--With respect to the disclosure of 
    any health information collected through a project conducted under 
    this subsection--
            ``(A) individually identifiable health information so 
        collected shall not be disclosed when presenting any 
        information from such project; and
            ``(B) any such disclosure shall be made in compliance with 
        regulations issued pursuant to section 264(c) of the Health 
        Insurance Portability and Accountability Act of 1996 (42 U.S.C. 
        1320d-2 note) and sections 552 and 552a of title 5, United 
        States Code.
        ``(7) Limitations.--No pilot project under this subsection, or 
    in coordination with the comprehensive system described in 
    paragraph (1)(C), may allow for an entity participating in such 
    project, other than the Secretary, to make determinations of safety 
    or effectiveness, or substantial equivalence, for purposes of this 
    Act.
        ``(8) Other projects required to comply.--Paragraphs (1)(B), 
    (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with respect 
    to any pilot project undertaken in coordination with the 
    comprehensive system described in paragraph (1)(C) that relates to 
    the use of real world evidence for devices in the same manner and 
    to the same extent as such paragraphs apply with respect to pilot 
    projects conducted under this subsection.
        ``(9) Report to congress.--Not later than 18 months after the 
    date of enactment of this Act, and annually thereafter, the 
    Secretary shall submit to the Committee on Energy and Commerce of 
    the House of Representatives and the Committee on Health, 
    Education, Labor and Pensions of the Senate a report containing a 
    description of the pilot projects being conducted under this 
    subsection and projects continued or expanded pursuant to paragraph 
    (3), including for each such project--
            ``(A) how the project is being implemented in accordance 
        with paragraph (4), including how such project is being 
        implemented through a contract, cooperative agreement, grant, 
        or other appropriate agreement, if applicable;
            ``(B) the number of manufacturers that have agreed to 
        participate in such project;
            ``(C) the data sources used to conduct such project;
            ``(D) the devices or device categories involved in such 
        project;
            ``(E) the number of patients involved in such project; and
            ``(F) the findings of the project in relation to device 
        safety, including adverse events, malfunctions, and other 
        safety information.
        ``(10) Sunset.--The Secretary may not carry out a pilot project 
    initiated by the Secretary under this subsection after 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. 709. 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 708, is further 
amended by adding at the end the following:
    ``(q) Regulation of Over-the-Counter Hearing Aids.--
        ``(1) Definition.--
            ``(A) In general.--In this subsection, the term `over-the-
        counter hearing aid' means a device that--
                ``(i) 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);
                ``(ii) is intended to be used by adults age 18 and 
            older to compensate for perceived mild to moderate hearing 
            impairment;
                ``(iii) 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;
                ``(iv) may--

                    ``(I) use wireless technology; or
                    ``(II) include tests for self-assessment of hearing 
                loss; and

                ``(v) 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.
            ``(B) Exception.--Such term does not include a personal 
        sound amplification product intended to amplify sound for 
        nonhearing impaired consumers in situations including hunting 
        and bird-watching.
        ``(2) Regulation.--An over-the-counter hearing aid shall be 
    subject to the regulations promulgated in accordance with section 
    709(b) of the FDA Reauthorization Act of 2017 and shall be exempt 
    from sections 801.420 and 801.421 of 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 effectiveness 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 over-
        the-counter hearing aids, including requirements that such 
        labeling include a conspicuous statement that the device is 
        only intended for adults age 18 and older, information on how 
        consumers may report adverse events, information on any 
        contraindications, conditions, or symptoms of medically 
        treatable causes of hearing loss, and advisements to consult 
        promptly with a licensed health care practitioner; 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, order, or 
    other requirement specifically related to hearing products that 
    would restrict or interfere with the servicing, marketing, sale, 
    dispensing, use, customer support, or distribution of over-the-
    counter hearing aids (as defined in section 520(q) of the Federal 
    Food, Drug, and Cosmetic Act (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.
        (5) No effect on private remedies.--Nothing in this section 
    shall be construed to modify or otherwise affect the ability of any 
    person to exercise a private right of action under any State or 
    Federal product liability, tort, warranty, contract, or consumer 
    protection law.
    (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) Report.--Not later than 2 years after the date on which the 
final regulations described in subsection (b)(1) are issued, the 
Secretary of Health and Human Services shall submit to Congress a 
report analyzing any adverse events relating to over-the-counter 
hearing aids (as defined in subsection (q)(1) of section 520 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).
    SEC. 710. REPORT ON SERVICING OF DEVICES.
    (a) In General.--Not later than 270 days after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall post on the 
internet website of the Food and Drug Administration a report on the 
continued quality, safety, and effectiveness of devices (as defined in 
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(h))) with respect to servicing (as defined in subsection (c)).
    (b) Contents.--The report submitted under subsection (a) shall 
contain--
        (1) the status of, and findings to date, with respect to, the 
    proposed rule entitled ``Refurbishing, Reconditioning, Rebuilding, 
    Remarketing, Remanufacturing, and Servicing of Medical Devices 
    Performed by Third-Party Entities and Original Equipment 
    Manufacturers; Request for Comments'' published in the Federal 
    Register by the Food and Drug Administration on March 4, 2016 (81 
    Fed. Reg. 11477);
        (2) information presented during the October 2016 public 
    workshop entitled ``Refurbishing, Reconditioning, Rebuilding, 
    Remarketing, Remanufacturing, and Servicing of Medical Devices 
    Performed by Third-Party Entities and Original Equipment 
    Manufacturers'';
        (3) a description of the statutory and regulatory authority of 
    the Food and Drug Administration with respect to the servicing of 
    devices conducted by any entity, including original equipment 
    manufacturers and third party entities;
        (4) details regarding how the Food and Drug Administration 
    currently regulates devices with respect to servicing to ensure 
    safety and effectiveness, how the agency could improve such 
    regulation using the authority described in paragraph (3), and 
    whether additional authority is recommended;
        (5) information on actions the Food and Drug Administration 
    could take under the authority described in paragraphs (3) and (4) 
    to assess the servicing of devices, including the size, scope, 
    location, and composition of third party entities;
        (6) information on actions the Food and Drug Administration 
    could take to track adverse events caused by servicing errors 
    performed by any entity, including original equipment manufacturers 
    and third party entities;
        (7) information regarding the regulation by States, the Joint 
    Commission, or other regulatory bodies of device servicing 
    performed by any entity, including original equipment manufacturers 
    and third party entities; and
        (8) any additional information determined by the Secretary 
    (acting through the Commissioner) to be relevant to ensuring the 
    quality, safety, and effectiveness of devices with respect to 
    servicing.
    (c) Servicing Defined.--In this section, the term ``servicing'' 
includes, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, repairing, remanufacturing, or other servicing 
of the device.

               TITLE VIII--IMPROVING GENERIC DRUG ACCESS

    SEC. 801. PRIORITY REVIEW OF 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) Subject to subparagraph (B), the Secretary shall 
prioritize the review of, and act within 8 months of the date of the 
submission of, an original abbreviated new drug application submitted 
for review under this subsection that is for a drug--
        ``(i) for which there are not more than 3 approved drug 
    products listed under paragraph (7) and for which there are no 
    blocking patents and exclusivities; or
        ``(ii) that has been included on the list under section 506E.
    ``(B) To qualify for priority review under this paragraph, not 
later than 60 days prior to the submission of an application described 
in subparagraph (A) or that the Secretary may prioritize pursuant to 
subparagraph (D), the applicant shall provide complete, accurate 
information regarding facilities involved in manufacturing processes 
and testing of the drug that is the subject of the application, 
including facilities in corresponding Type II active pharmaceutical 
ingredients drug master files referenced in an application and sites or 
organizations involved in bioequivalence and clinical studies used to 
support the application, to enable the Secretary to make a 
determination regarding whether an inspection of a facility is 
necessary. Such information shall include the relevant (as determined 
by the Secretary) sections of such application, which shall be 
unchanged relative to the date of the submission of such application, 
except to the extent that a change is made to such information to 
exclude a facility that was not used to generate data to meet any 
application requirements for such submission and that is not the only 
facility intended to conduct one or more unit operations in commercial 
production. Information provided by an applicant under this 
subparagraph shall not be considered the submission of an application 
under this subsection.
    ``(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 publish on the internet website of the 
Food and Drug Administration, and update at least once every 6 months, 
a list of all drugs approved under subsection (c) for which all patents 
and periods of exclusivity under this Act have expired and for which no 
application has been approved under this subsection.''.
    SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC 
      COMPETITION.
    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), as amended by section 801, is further amended by adding at 
the end the following:
    ``(13) Upon the request of an applicant regarding one or more 
specified pending applications under this subsection, the Secretary 
shall, as appropriate, provide review status updates indicating the 
categorical status of the applications by each relevant review 
discipline.''.
    SEC. 803. COMPETITIVE GENERIC THERAPIES.
    (a) In General.--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. COMPETITIVE GENERIC THERAPIES.
    ``(a) In General.--The Secretary may, at the request of an 
applicant of a drug that is designated as a competitive generic therapy 
pursuant to subsection (b), expedite the development and review of an 
abbreviated new drug application under section 505(j) for such drug.
    ``(b) Designation Process.--
        ``(1) Request.--The applicant may request the Secretary to 
    designate the drug as a competitive generic therapy.
        ``(2) Timing.--A request under paragraph (1) may be made 
    concurrently with, or at any time prior to, the submission of an 
    abbreviated new drug application for the drug under section 505(j).
        ``(3) Criteria.--A drug is eligible for designation as a 
    competitive generic therapy under this section if the Secretary 
    determines that there is inadequate generic competition.
        ``(4) Designation.--Not later than 60 calendar days after the 
    receipt of a request under paragraph (1), the Secretary may--
            ``(A) determine whether the drug that is the subject of the 
        request meets the criteria described in paragraph (3); and
            ``(B) if the Secretary finds that the drug meets such 
        criteria, designate the drug as a competitive generic therapy.
    ``(c) Actions.--In expediting the development and review of an 
application under subsection (a), the Secretary may, as requested by 
the applicant, take actions including the following:
        ``(1) Hold meetings with the applicant and the review team 
    throughout the development of the drug prior to submission of the 
    application for such drug under section 505(j).
        ``(2) Provide timely advice to, and interactive communication 
    with, the applicant regarding the development of the drug to ensure 
    that the development program to gather the data necessary for 
    approval is as efficient as practicable.
        ``(3) Involve senior managers and experienced review staff, as 
    appropriate, in a collaborative, coordinated review of such 
    application, including with respect to drug-device combination 
    products and other complex products.
        ``(4) Assign a cross-disciplinary project lead--
            ``(A) to facilitate an efficient review of the development 
        program and application, including manufacturing inspections; 
        and
            ``(B) to serve as a scientific liaison between the review 
        team and the applicant.
    ``(d) Reporting Requirement.--Not later than one year after the 
date of the approval of an application under section 505(j) with 
respect to a drug for which the development and review is expedited 
under this section, the sponsor of such drug shall report to the 
Secretary on whether the drug has been marketed in interstate commerce 
since the date of such approval.
    ``(e) Definitions.--In this section:
        ``(1) The term `generic drug' means a drug that is approved 
    pursuant to section 505(j).
        ``(2) The term `inadequate generic competition' means, with 
    respect to a drug, there is not more than one approved drugs on the 
    list of drugs described in section 505(j)(7)(A) (not including 
    drugs on the discontinued section of such list) that is--
            ``(A) the reference listed drug; or
            ``(B) a generic drug with the same reference listed drug as 
        the drug for which designation as a competitive generic therapy 
        is sought.
        ``(3) The term `reference listed drug' means the listed drug 
    (as such term is used in section 505(j)) for the drug involved.''.
    (b) Guidance; Amended Regulations.--
        (1) In general.--
            (A) Issuance.--The Secretary of Health and Human Services 
        shall--
                (i) not later than 18 months after the date of 
            enactment of this Act, issue draft guidance on section 506H 
            of the Federal Food, Drug, and Cosmetic Act, as added by 
            subsection (a); and
                (ii) not later than 1 year after the close of the 
            comment period for the draft guidance, issue final guidance 
            on such section 506H.
            (B) Contents.--The guidance issued under this paragraph 
        shall--
                (i) specify the process and criteria by which the 
            Secretary makes a designation under section 506H of the 
            Federal Food, Drug, and Cosmetic Act, as added by 
            subsection (a);
                (ii) specify the actions the Secretary may take to 
            expedite the development and review of a competitive 
            generic therapy pursuant to such a designation; and
                (iii) include good review management practices for 
            competitive generic therapies.
        (2) Amended regulations.--The Secretary of Health and Human 
    Services shall issue or revise any regulations as may be necessary 
    to carry out this section not later than 2 years after the date of 
    enactment of this Act.
    SEC. 804. ACCURATE INFORMATION ABOUT 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 803, the following:
``SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.
    ``(a) Notification of Withdrawal.--The holder of an application 
approved under subsection (c) or (j) of section 505 shall notify the 
Secretary in writing 180 days prior to withdrawing the approved drug 
from sale, or if 180 days is not practicable as soon as practicable but 
not later than the date of withdrawal. The holder shall include with 
such notice the--
        ``(1) National Drug Code;
        ``(2) identity of the drug by established name and by 
    proprietary name, if any;
        ``(3) new drug application number or abbreviated application 
    number;
        ``(4) strength of the drug;
        ``(5) date on which the drug is expected to no longer be 
    available for sale; and
        ``(6) reason for withdrawal of the drug.
    ``(b) Notification of Drug Not Available for Sale.--The holder of 
an application approved under subsection (c) or (j) shall notify the 
Secretary in writing within 180 calendar days of the date of approval 
of the drug if the drug will not be available for sale within 180 
calendar days of such date of approval. The holder shall include with 
such notice the--
        ``(1) identity of the drug by established name and by 
    proprietary name, if any;
        ``(2) new drug application number or abbreviated application 
    number;
        ``(3) strength of the drug;
        ``(4) date on which the drug will be available for sale, if 
    known; and
        ``(5) reason for not marketing the drug after approval.
    ``(c) Additional One-time Report.--Within 180 days of the date of 
enactment of this section, all holders of applications approved under 
subsection (c) or (j) of section 505 shall review the information in 
the list published under subsection 505(j)(7)(A) and shall notify the 
Secretary in writing that--
        ``(1) all of the application holder's drugs in the active 
    section of the list published under subsection 505(j)(7)(A) are 
    available for sale; or
        ``(2) one or more of the application holder's drugs in the 
    active section of the list published under subsection 505(j)(7)(A) 
    have been withdrawn from sale or have never been available for 
    sale, and include with such notice the information required 
    pursuant to subsection (a) or (b), as applicable.
    ``(d) Failure to Meet Requirements.--If a holder of an approved 
application fails to submit the information required under subsection 
(a), (b), or (c), the Secretary may move the application holder's drugs 
from the active section of the list published under subsection 
505(j)(7)(A) to the discontinued section of the list, except that the 
Secretary shall remove from the list in accordance with subsection 
505(j)(7)(C) drugs the Secretary determines have been withdrawn from 
sale for reasons of safety of effectiveness.
    ``(e) Updates.--The Secretary shall update the list published under 
subsection 505(j)(7)(A) based on the information provided under 
subsections (a), (b), and (c) by moving drugs that are not available 
for sale from the active section to the discontinued section of the 
list, except that drugs the Secretary determines have been withdrawn 
from sale for reasons of safety or effectiveness shall be removed from 
the list in accordance with subsection 505(j)(7)(C). The Secretary 
shall make monthly updates to the list based on the information 
provided pursuant to subsections (a) and (b), and shall update the list 
based on the information provided under subsection (c) as soon as 
practicable.
    ``(f) Limitation on Use of Notices.--Any notice submitted under 
this section shall not be made public by the Secretary and shall be 
used solely for the purpose of the updates described in subsection 
(e).''.
    SEC. 805. SUITABILITY PETITIONS.
    (a) In General.--It is the sense of Congress that the Food and Drug 
Administration shall meet the requirement under section 505(j)(2)(C) of 
the Federal Food, Drug, and Cosmetic Act (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 807--
        (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. 806. INSPECTIONS.
    Within 6 months of the date of enactment of this Act, the Secretary 
of Health and Human Services shall develop and implement a protocol for 
expediting review of timely responses to reports of observations from 
an inspection under section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374). Such protocol shall--
        (1) apply to responses to such reports pertaining to 
    applications submitted under section 505 of the Federal Food, Drug, 
    and Cosmetic Act (21 U.S.C. 355)--
            (A) for which the approval is dependent upon remediation of 
        conditions identified in the report;
            (B) for which concerns related to observations from an 
        inspection under such section 704 are the only barrier to 
        approval; and
            (C) where the drug that is the subject of the application 
        is a drug--
                (i) for which there are not more than 3 other approved 
            applications under section 505(j) of the Federal Food, 
            Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference 
            the same listed drug and for which there are less than 6 
            abbreviated new drug applications tentatively approved; or
                (ii) that is included on the list under section 506E of 
            such Act (21 U.S.C. 356e);
        (2) address expedited re-inspection of facilities, as 
    appropriate; and
        (3) establish a 6-month timeline for completion of review of 
    such responses to such reports.
    SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND 
      PRIORITY REVIEW APPLICATIONS.
    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 shall post on the internet website of the 
Food and Drug Administration a report that provides, with respect to 
the months covered by the report--
        (1) with respect to applications filed under section 505(j) of 
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that, 
    during the most recent calendar year, were subject to priority 
    review under paragraph (11) of such section 505(j) (as added by 
    section 801) or expedited development and review under section 506H 
    of the Federal Food, Drug, and Cosmetic Act (as added by section 
    803), the numbers of such applications (with denotation of such 
    applications that were filed prior to October 1, 2014) that are--
            (A) awaiting action by the applicant;
            (B) awaiting action by the Secretary; and
            (C) approved by the Secretary;
        (2) 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;
        (3) the mean and median approval and tentative approval times 
    and the number of review cycles for such applications;
        (4) the number and type of meetings requested and held under 
    such section 506H (as added by section 803); and
        (5) the number of such applications on which the Secretary has 
    taken action pursuant to subsection (c) of such section 506H (as 
    added by section 803) and any effect such section 506H may have on 
    the length of time for approval of applications under such section 
    505(j) and the number of review cycles for such approvals.
    SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.
    Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)) is amended--
        (1) in subparagraph (B), by adding at the end the following:
        ``(v) 180-day exclusivity period for competitive generic 
    therapies.--
            ``(I) Effectiveness of application.--Subject to 
        subparagraph (D)(iv), if the application is for a drug that is 
        the same as a competitive generic therapy for which any first 
        approved applicant has commenced commercial marketing, the 
        application shall be made effective on the date that is 180 
        days after the date of the first commercial marketing of the 
        competitive generic therapy (including the commercial marketing 
        of the listed drug) by any first approved applicant.
            ``(II) Limitation.--The exclusivity period under subclause 
        (I) shall not apply with respect to a competitive generic 
        therapy that has previously received an exclusivity period 
        under subclause (I).
            ``(III) Definitions.--In this clause and subparagraph 
        (D)(iv):
                ``(aa) The term `competitive generic therapy' means a 
            drug--

                    ``(AA) that is designated as a competitive generic 
                therapy under section 506H; and
                    ``(BB) for which there are no unexpired patents or 
                exclusivities on the list of products described in 
                section 505(j)(7)(A) at the time of submission.

                ``(bb) The term `first approved applicant' means any 
            applicant that has submitted an application that--

                    ``(AA) is for a competitive generic therapy that is 
                approved on the first day on which any application for 
                such competitive generic therapy is approved;
                    ``(BB) is not eligible for a 180-day exclusivity 
                period under clause (iv) for the drug that is the 
                subject of the application for the competitive generic 
                therapy; and
                    ``(CC) is not for a drug for which all drug 
                versions have forfeited eligibility for a 180-day 
                exclusivity period under clause (iv) pursuant to 
                subparagraph (D).''; and

        (2) in subparagraph (D), by adding at the end the following:
                ``(iv) Special forfeiture rule for competitive generic 
            therapy.--The 180-day exclusivity period described in 
            subparagraph (B)(v) shall be forfeited by a first approved 
            applicant if the applicant fails to market the competitive 
            generic therapy within 75 days after the date on which the 
            approval of the first approved applicant's application for 
            the competitive generic therapy is made effective.''.
    SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF 
      GENERIC MEDICINES.
    (a) Study by GAO.--The Comptroller General of the United States 
shall conduct a study to determine the following:
        (1) The rate of first cycle approvals and tentative approvals 
    for applications submitted under section 505(j) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the period 
    beginning on October 1, 2012, and ending on September 30, 2017. The 
    rate of first cycle approvals and tentative approvals shall be 
    determined and reported per each GDUFA cohort year during this 
    period.
        (2) If the rate determined pursuant to paragraph (1) for any 
    GDUFA cohort year is lower than 20 percent, the reasons 
    contributing to the relatively low rate of first cycle approvals 
    and tentative approvals for generic drug applications shall be 
    itemized, assessed, and reported. In making the assessment required 
    by this paragraph, the Comptroller General shall consider, among 
    other things, the role played by--
            (A) the Food and Drug Administration's implementation of 
        approval standards for generic drug applications;
            (B) the extent to which those approval standards are 
        communicated clearly to industry and applied consistently 
        during the review process;
            (C) the procedures for reviewing generic drug applications, 
        including timelines for review activities by the Food and Drug 
        Administration;
            (D) the extent to which those procedures are followed 
        consistently (and those timelines are met) by the Food and Drug 
        Administration;
            (E) the processes and practices for communication between 
        the Food and Drug Administration and sponsors of generic drug 
        applications; and
            (F) the completeness and quality of original generic drug 
        applications submitted to the Food and Drug Administration.
        (3) Taking into account the determinations made pursuant to 
    paragraphs (1) and (2) and any review process improvements 
    implemented pursuant to this Act, whether there are ways the review 
    process for generic drugs could be improved to increase the rate of 
    first cycle approvals and tentative approvals for generic drug 
    applications. In making this determination, the Comptroller General 
    shall consider, among other things, options for increasing review 
    efficiency and communication effectiveness.
    (b) Completion Date.--Not later than the expiration of the 2-year 
period beginning on the date of enactment of this Act, the Comptroller 
General shall complete the study under subsection (a) and submit a 
report describing the findings and conclusions of the study to the 
Secretary, the Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor, and 
Pensions of the Senate.
    (c) Definitions.--For purposes of this section:
        (1) The term ``GDUFA cohort year'' means a fiscal year.
        (2) The term ``generic drug'' means a drug that is approved or 
    is seeking approval under section 505(j) of the Federal Food, Drug, 
    and Cosmetic Act (21 U.S.C. 355(j)).
        (3) The term ``generic drug application'' means an abbreviated 
    new drug application for the approval of a generic drug under 
    section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 355(j)).
        (4) The term ``Secretary'' means the Secretary of Health and 
    Human Services.
        (5)(A) The term ``first cycle approvals and tentative 
    approvals'' means the approval or tentative approval of a generic 
    drug application after the Food and Drug Administration's complete 
    review of the application and without issuance of one or more 
    complete response letters.
        (B) For purposes of this paragraph, the term ``complete 
    response letter'' means a written communication to the sponsor of a 
    generic drug application or holder of a drug master file from the 
    Food and Drug Administration describing all of the deficiencies 
    that the Administration has identified in the generic drug 
    application (including pending amendments) or drug master file that 
    must be satisfactorily addressed before the generic drug 
    application can be approved.

                    TITLE IX--ADDITIONAL PROVISIONS

    SEC. 901. TECHNICAL CORRECTIONS.
    (a) 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) 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''.
    (c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355g(b)) is amended by striking ``randomized'' and inserting 
``traditional''.
    (d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355g(d)) is amended by striking ``2'' and inserting ``3''.
    (e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(h)(6)) is amended by striking ``February 1'' and 
replacing with ``May 1''.
    (f) Effective as of the enactment of the 21st Century Cures Act 
(Public Law 114-255)--
        (1) section 3051(a) of such Act is amended by striking ``by 
    inserting after section 515B'' and inserting ``by inserting after 
    section 515A''; and
        (2) section 515C of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 360e-3), as inserted by such section 3051(a), is 
    redesignated as section 515B.
    (g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this 
section, is amended by striking ``a proposed guidance'' and inserting 
``a draft version of that guidance''.
    (h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device 
submissions'' and inserting ``medical devices that may be specifically 
the subject of a review by a classification panel''.
    SEC. 902. ANNUAL REPORT ON INSPECTIONS.
    Not later than March 1 of each year, the Secretary of Health and 
Human Services shall post on the internet website of the Food and Drug 
Administration information related to inspections of facilities 
necessary for approval of a drug under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under 
section 515 of such Act (21 U.S.C. 360e), or clearance of a device 
under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted 
during the previous calendar year. Such information shall include the 
following:
        (1) The median time following a request from staff of the Food 
    and Drug Administration reviewing an application or report to the 
    beginning of the inspection, and the median time from the beginning 
    of an inspection to the issuance of a report pursuant to section 
    704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    374(b)).
        (2) The median time from the issuance of a report pursuant to 
    such section 704(b) to the sending of a warning letter, issuance of 
    an import alert, or holding of a regulatory meeting for inspections 
    for which the Secretary concluded that regulatory or enforcement 
    action was indicated.
        (3) The median time from the sending of a warning letter, 
    issuance of an import alert, or holding of a regulatory meeting to 
    resolution of the regulatory or enforcement action indicated for 
    inspections for which the Secretary concluded that such action was 
    indicated.
        (4) The number of times that a facility was issued a report 
    pursuant to such section 704(b) and approval of an application was 
    delayed due to the issuance of a withhold recommendation.
    SEC. 903. 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)), as amended by section 103, is further 
amended by inserting after paragraph (2) the following:
        ``(3) Real time reporting.--
            ``(A) In general.--Not later than 30 calendar days after 
        the end of the second quarter of fiscal year 2018, and not 
        later than 30 calendar days after the end of each quarter of 
        each fiscal year thereafter, the Secretary shall post the data 
        described in subparagraph (B) on the internet website of the 
        Food and Drug Administration for such quarter and on a 
        cumulative basis for such fiscal year, and may remove 
        duplicative data from the annual performance report under this 
        subsection.
            ``(B) Data.--The Secretary shall post the following data in 
        accordance with subparagraph (A):
                ``(i) The number and titles of draft and final guidance 
            on topics related to the process for the review of human 
            drug applications, and whether such guidances were issued 
            as required by statute or pursuant to a commitment under 
            the letters described in section 101(b) of the Prescription 
            Drug User Fee Amendments of 2017.
                ``(ii) The number and titles of public meetings held on 
            topics related to the process for the review of human drug 
            applications, and whether such meetings were required by 
            statute or pursuant to a commitment under the letters 
            described in section 101(b) of the Prescription Drug User 
            Fee Amendments of 2017.
                ``(iii) The number of new drug applications and 
            biological licensing applications approved.
                ``(iv) The number of new drug applications and 
            biological licensing applications filed.
        ``(4) Rationale for pdufa program changes.--Beginning with 
    fiscal year 2020, the Secretary shall include in the annual report 
    under paragraph (1)--
            ``(A) data, analysis, and discussion of the changes in the 
        number of full-time equivalents hired as agreed upon in the 
        letters described in section 101(b) of the Prescription Drug 
        User Fee Amendments of 2017 and the number of full time 
        equivalents funded by budget authority at the Food and Drug 
        Administration by each division within the Center for Drug 
        Evaluation and Research, the Center for Biologics Evaluation 
        and Research, the Office of Regulatory Affairs, and the Office 
        of the Commissioner;
            ``(B) data, analysis, and discussion of the changes in the 
        fee revenue amounts and costs for the process for the review of 
        human drugs, including identifying drivers of such changes; and
            ``(C) for each of the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, the 
        Office of Regulatory Affairs, and the Office of the 
        Commissioner, the number of employees for whom time reporting 
        is required and the number of employees for whom time reporting 
        is not required.''.
    (b) MDUFA.--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 204, is 
further 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--

                    ``(I) the number of premarket applications filed 
                under section 515 per fiscal year for each review 
                division;
                    ``(II) the number of reports submitted under 
                section 510(k) per fiscal year for each review 
                division; and
                    ``(III) the number of expedited development and 
                priority review designations under section 515C per 
                fiscal year.

                ``(iii) Real time reporting.--

                    ``(I) In general.--Not later than 30 calendar days 
                after the end of the second quarter of fiscal year 
                2018, and not later than 30 calendar days after the end 
                of each quarter of each fiscal year thereafter, the 
                Secretary shall post the data described in subclause 
                (II) on the internet website of the Food and Drug 
                Administration for such quarter and on a cumulative 
                basis for such fiscal year, and may remove duplicative 
                data from the annual report under this subparagraph.
                    ``(II) Data.--The Secretary shall post the 
                following data in accordance with subclause (I):

                        ``(aa) The number and titles of draft and final 
                    guidance on topics related to the process for the 
                    review of devices, and whether such guidances were 
                    issued as required by statute or pursuant to the 
                    letters described in section 201(b) of the Medical 
                    Device User Fee Amendments of 2017; and
                        ``(bb) The number and titles of public meetings 
                    held on topics related to the process for the 
                    review of devices, and if such meetings were 
                    required by statute or pursuant to a commitment 
                    under the letters described in section 201(b) of 
                    the Medical Device User Fee Amendments of 2017.
                ``(iv) Rationale for mdufa program changes.--Beginning 
            with fiscal year 2020, the Secretary shall include in the 
            annual report under paragraph (1)--

                    ``(I) data, analysis, and discussion of the changes 
                in the number of full-time equivalents hired as agreed 
                upon in the letters described in section 201(b) of the 
                Medical Device User Fee Amendments of 2017 and the 
                number of full time equivalents funded by budget 
                authority at the Food and Drug Administration by each 
                division within the Center for Devices and Radiological 
                Health, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner;
                    ``(II) data, analysis, and discussion of the 
                changes in the fee revenue amounts and costs for the 
                process for the review of devices, including 
                identifying drivers of such changes; and
                    ``(III) for each of the Center for Devices and 
                Radiological Health, the Center for Biologics 
                Evaluation and Research, the Office of Regulatory 
                Affairs, and the Office of the Commissioner, the number 
                of employees for whom time reporting is required and 
                the number of employees for whom time reporting is not 
                required.''.

    (c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-43(a)), as amended by section 304, is further 
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) Real time reporting.--
            ``(A) In general.--Not later than 30 calendar days after 
        the end of the second quarter of fiscal year 2018, and not 
        later than 30 calendar days after the end of each quarter of 
        each fiscal year thereafter, the Secretary shall post the data 
        described in subparagraph (B) on the internet website of the 
        Food and Drug Administration, and may remove duplicative data 
        from the annual report under this subsection.
            ``(B) Data.--The Secretary shall post the following data in 
        accordance with subparagraph (A):
                ``(i) The number and titles of draft and final guidance 
            on topics related to human generic drug activities and 
            whether such guidances were issued as required by statute 
            or pursuant to a commitment under the letters described in 
            section 301(b) of the Generic Drug User Fee Amendments of 
            2017.
                ``(ii) The number and titles of public meetings held on 
            topics related to human generic drug activities and whether 
            such meetings were required by statute or pursuant to a 
            commitment under the letters described in section 301(b) of 
            the Generic Drug User Fee Amendments of 2017.
        ``(3) Rationale for gdufa program changes.--Beginning with 
    fiscal year 2020, the Secretary shall include in the annual report 
    under paragraph (1)--
            ``(A) data, analysis, and discussion of the changes in the 
        number of full-time equivalents hired as agreed upon in the 
        letters described in section 301(b) of the Generic Drug User 
        Fee Amendments of 2017 and the number of full time equivalents 
        funded by budget authority at the Food and Drug Administration 
        by each division within the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, the 
        Office of Regulatory Affairs, and the Office of the 
        Commissioner;
            ``(B) data, analysis, and discussion of the changes in the 
        fee revenue amounts and costs for human generic drug 
        activities, including identifying drivers of such changes; and
            ``(C) for each of the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, the 
        Office of Regulatory Affairs, and the Office of the 
        Commissioner, the number of employees for whom time reporting 
        is required and the number of employees for whom time reporting 
        is not required.''.
    (d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-53(a)), as amended by section 404, is further 
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 
    Food and Drug Administration 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 
        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 letters issued by the agency for such 
        applications.
        ``(3) Real time reporting.--
            ``(A) In general.--Not later than 30 calendar days after 
        the end of the second quarter of fiscal year 2018, and not 
        later than 30 calendar days after the end of each quarter of 
        each fiscal year thereafter, the Secretary shall post the data 
        described in subparagraph (B) for such quarter and on a 
        cumulative basis for the fiscal year on the internet website of 
        the Food and Drug Administration, and may remove duplicative 
        data from the annual report under this subsection.
            ``(B) Data.--The Secretary shall post the following data in 
        accordance with subparagraph (A):
                ``(i) The number and titles of draft and final guidance 
            on topics related to the process for the review of 
            biosimilars, and whether such guidances were required by 
            statute or pursuant to a commitment under the letters 
            described in section 401(b) of the Biosimilar User Fee 
            Amendments of 2017.
                ``(ii) The number and titles of public meetings held on 
            topics related to the process for the review of 
            biosimilars, and whether such meetings were required by 
            statute or pursuant to a commitment under the letters 
            described in section 401(b) of the Biosimilar User Fee 
            Amendments of 2017.
        ``(4) Rationale for bsufa program changes.--Beginning with 
    fiscal year 2020, the Secretary shall include in the annual report 
    under paragraph (1)--
            ``(A) data, analysis, and discussion of the changes in the 
        number of full-time equivalents hired as agreed upon in the 
        letters described in section 401(b) of the Biosimilar User Fee 
        Amendments of 2017 and the number of full time equivalents 
        funded by budget authority at the Food and Drug Administration 
        by each division within the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, the 
        Office of Regulatory Affairs, and the Office of the 
        Commissioner;
            ``(B) data, analysis, and discussion of the changes in the 
        fee revenue amounts and costs for the process for the review of 
        biosimilar biological product applications, including 
        identifying drivers of such changes; and
            ``(C) for each of the Center for Drug Evaluation and 
        Research, the Center for Biologics Evaluation and Research, the 
        Office of Regulatory Affairs, and the Office of the 
        Commissioner, the number of employees for whom time reporting 
        is required and the number of employees for whom time reporting 
        is not required.''.
    SEC. 904. 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 903(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 aggregate number of human 
        drug applications filed and the aggregate number of approvals, 
        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) the aggregate number of applications for each 
            fiscal year that did not meet the goals identified in the 
            letters described in section 101(b) of the Prescription 
            Drug User Fee Amendments of 2017 for the applicable fiscal 
            year.
            ``(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 
        applicable fiscal year.
            ``(C) The most common causes and trends of external or 
        other circumstances affecting the ability of the Center for 
        Drug Evaluation and Research, the Center for Biologics 
        Evaluation and Research, Office of Regulatory Affairs, and the 
        Food and Drug Administration to meet the review time and 
        performance enhancement goals identified in the letters 
        described in section 101(b) of the Prescription Drug User Fee 
        Amendments of 2017.''.
        (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) by inserting after subsection (b) the following:
    ``(c) Corrective Action Report.--Beginning with fiscal year 2018, 
for each fiscal year for which fees are collected under this part, the 
Secretary shall prepare and submit a corrective action report to the 
Committee on Energy and Commerce and the Committee on Appropriations of 
the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions and the Committee on Appropriations of the Senate. 
The report shall include the following information, as applicable:
        ``(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 
    applicable fiscal year have been met, the corrective action report 
    shall include recommendations on ways in which the Secretary can 
    improve and streamline the human drug application review process.
        ``(2) Goals missed.--For any of the goals identified in the 
    letters described in section 101(b) of the Prescription Drug User 
    Fee Amendments of 2017 for the applicable fiscal year that the 
    Secretary determines to not have been met, the corrective action 
    report shall include--
            ``(A) a detailed justification for such determination and a 
        description, as applicable, of the types of circumstances and 
        trends under which human drug applications that missed the 
        review goal time were approved during the first cycle review, 
        or application review goals were missed; and
            ``(B) with respect to performance enhancement goals that 
        were not achieved, a description of efforts the Food and Drug 
        Administration has put in place for the fiscal year in which 
        the report is submitted to improve the ability of such agency 
        to meet each such goal for the such fiscal year.
    ``(d) Enhanced Communication.--
        ``(1) Communications with congress.--Each fiscal year, as 
    applicable and requested, representatives from the Centers with 
    expertise in the review of human drugs shall meet with 
    representatives from the Committee on Health, Education, Labor, and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives to report on the contents described in 
    the reports under this section.
        ``(2) Participation in congressional hearing.--Each fiscal 
    year, as applicable and requested, representatives from the Food 
    and Drug Administration shall participate in a public hearing 
    before the Committee on Health, Education, Labor, and Pensions of 
    the Senate and the Committee on Energy and Commerce of the House of 
    Representatives, to report on the contents described in the reports 
    under this section. Such hearing shall occur not later than 120 
    days after the end of each fiscal year for which fees are collected 
    under this part.''.
    (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 903(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 aggregate number 
                of premarket applications filed under section 515 and 
                aggregate reports submitted under section 510(k) and 
                the aggregate number of major deficiency letters, not 
                approvable letters, and denials for such applications 
                issued by the agency, accounting for--

                        ``(aa) the number of applications filed and 
                    reports submitted during one fiscal year for which 
                    a decision is not scheduled to be made until the 
                    following fiscal year; and
                        ``(bb) the aggregate number of applications for 
                    each fiscal year that did not meet the goals as 
                    identified by the letters described in section 
                    201(b) of the Medical Device User Fee Amendments of 
                    2017 for the applicable fiscal year.

                    ``(II) Relevant data to determine whether the 
                Center for Devices and Radiological Health has met 
                performance enhancement goals identified by the letters 
                described in section 201(b) of the Medical Device User 
                Fee Amendments of 2017 for the applicable fiscal year.
                    ``(III) The most common causes and trends for 
                external or other circumstances affecting the ability 
                of the Center for Devices and Radiological Health, the 
                Office of Regulatory Affairs, or the Food and Drug 
                Administration to meet review time and performance 
                enhancement goals identified by the letters described 
                in section 201(b) of the Medical Device User Fee 
                Amendments of 2017.''.

        (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, for each fiscal year for which fees are collected under this 
    part, the Secretary shall prepare and submit a corrective action 
    report to the Committee on Energy and Commerce and the Committee on 
    Appropriations of the House of Representatives and the Committee on 
    Health, Education, Labor, and Pensions and the Committee on 
    Appropriations of the Senate. The report shall include the 
    following information, as applicable:
            ``(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 applicable fiscal year have been met, the 
        corrective action report shall include recommendations on ways 
        in which the Secretary can improve and streamline the medical 
        device application review process.
            ``(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 applicable fiscal year that 
        the Secretary determines to not have been met, the corrective 
        action report shall include--
                ``(i) a justification for such determination;
                ``(ii) a description of the types of circumstances, in 
            the aggregate, under which applications or reports 
            submitted under section 515 or notifications submitted 
            under section 510(k) missed the review goal times but were 
            approved during the first cycle review, as applicable;
                ``(iii) a summary and any trends with regard to the 
            circumstances for which a review goal was missed; and
                ``(iv) the performance enhancement goals that were not 
            achieved during the previous fiscal year and a description 
            of efforts the Food and Drug Administration has put in 
            place for the fiscal year in which the report is submitted 
            to improve the ability of such agency to meet each such 
            goal for the such fiscal year.
        ``(3) Enhanced communication.--
            ``(A) Communications with congress.--Each fiscal year, as 
        applicable and requested, representatives from the Centers with 
        expertise in the review of devices shall meet with 
        representatives from the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives to report on the 
        contents described in the reports under this section.
            ``(B) Participation in congressional hearing.--Each fiscal 
        year, as applicable and requested, representatives from the 
        Food and Drug Administration shall participate in a public 
        hearing before the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives, to report on the contents 
        described in the reports under this section. 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) 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 903(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 aggregate number of 
        abbreviated new drug applications filed and the aggregate 
        number of approvals or aggregate number of complete response 
        letters issued by the agency, accounting for--
                ``(i) such applications filed during one fiscal year 
            for which a decision is not scheduled to be made until the 
            following fiscal year; and
                ``(ii) the aggregate number of applications for each 
            fiscal year that did not meet the goals identified by the 
            letters described in section 301(b) of the Generic Drug 
            User Fee Amendments of 2017 for the applicable fiscal year.
            ``(B) Relevant data to determine whether the Food and Drug 
        Administration has met the performance enhancement goals 
        identified by the letters described in section 301(b) of the 
        Generic Drug User Fee Amendments of 2017 for the applicable 
        fiscal year.
            ``(C) The most common causes and trends for external or 
        other circumstances that affected the ability of the Secretary 
        to meet review time and performance enhancement goals 
        identified by the letters described in section 301(b) of the 
        Generic Drug User Fee Amendments of 2017.''.
        (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) by inserting after subsection (b) the following:
    ``(c) Corrective Action Report.--Beginning with fiscal year 2018, 
for each fiscal year for which fees are collected under this part, the 
Secretary shall prepare and submit a corrective action report to the 
Committee on Energy and Commerce and the Committee on Appropriations of 
the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions and the Committee on Appropriations of the Senate. 
The report shall include the following information, as applicable:
        ``(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 
    applicable fiscal year have been met, the corrective action report 
    shall include recommendations on ways in which the Secretary can 
    improve and streamline the abbreviated new drug application review 
    process.
        ``(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 applicable fiscal year that the 
    Secretary determines to not have been met, the corrective action 
    report shall include--
            ``(A) a detailed justification for such determination and a 
        description, as applicable, of the types of circumstances and 
        trends under which abbreviated new drug applications missed the 
        review goal times but were approved during the first cycle 
        review, or review goals were missed; and
            ``(B) with respect to performance enhancement goals that 
        were not achieved, a detailed description of efforts the Food 
        and Drug Administration has put in place for the fiscal year in 
        which the report is submitted to improve the ability of such 
        agency to meet each such goal for the such fiscal year.
    ``(d) Enhanced Communication.--
        ``(1) Communications with congress.--Each fiscal year, as 
    applicable and requested, representatives from the Centers with 
    expertise in the review of human drugs shall meet with 
    representatives from the Committee on Health, Education, Labor, and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives to report on the contents described in 
    the reports under this section.
        ``(2) Participation in congressional hearing.--Each fiscal 
    year, as applicable and requested, representatives from the Food 
    and Drug Administration shall participate in a public hearing 
    before the Committee on Health, Education, Labor, and Pensions of 
    the Senate and the Committee on Energy and Commerce of the House of 
    Representatives, to report on the contents described in the reports 
    under this section. Such hearing shall occur not later than 120 
    days after the end of each fiscal year for which fees are collected 
    under this part.''.
    (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 903(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 aggregate number of 
        biosimilar biological product applications and supplements 
        filed and the aggregate number of approvals 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; and
                ``(ii) the aggregate number of applications for each 
            fiscal year that did not meet the goals identified by the 
            letters described in section 401(b) of the Biosimilar User 
            Fee Amendments of 2017 for the applicable fiscal year.
            ``(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 applicable 
        fiscal year.
            ``(C) The most common causes and trends for external or 
        other circumstances affecting the ability of the Secretary to 
        meet review time and performance enhancement goals identified 
        by the letters described in section 401(b) of the Biosimilar 
        User Fee Amendments of 2017.''.
        (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) by 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. 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 
    applicable fiscal year have been met, the corrective action report 
    shall include recommendations on ways in which the Secretary can 
    improve and streamline the biosimilar biological product 
    application review process.
        ``(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 applicable fiscal year that the 
    Secretary determines to not have been met, the corrective action 
    report shall include--
            ``(A) a justification for such determination and a 
        description of the types of circumstances and trends, as 
        applicable, under which biosimilar biological product 
        applications missed the review goal times but were approved 
        during the first cycle review, or review goals were missed; and
            ``(B) with respect to performance enhancement goals that 
        were not achieved, a description of efforts the Food and Drug 
        Administration has put in place for the fiscal year in which 
        the report is submitted to improve the ability of such agency 
        to meet each such goal for the such fiscal year.
    ``(d) Enhanced Communication.--
        ``(1) Communications with congress.--Each fiscal year, as 
    applicable and requested, representatives from the Centers with 
    expertise in the review of human drugs shall meet with 
    representatives from the Committee on Health, Education, Labor, and 
    Pensions of the Senate and the Committee on Energy and Commerce of 
    the House of Representatives to report on the contents described in 
    the reports under this section.
        ``(2) Participation in congressional hearing.--Each fiscal 
    year, as applicable and requested, representatives from the Food 
    and Drug Administration shall participate in a public hearing 
    before the Committee on Health, Education, Labor, and Pensions of 
    the Senate and the Committee on Energy and Commerce of the House of 
    Representatives, to report on the contents described in the reports 
    under this section. Such hearing shall occur not later than 120 
    days after the end of each fiscal year for which fees are collected 
    under this part.''.
    SEC. 905. 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 under this paragraph 
    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.
        (2) Report.--
            (A) In general.--The Comptroller General shall issue a 
        report to the Committee on Health, Education, Labor, and 
        Pensions of the Senate and the Committee on Energy and Commerce 
        of the House of Representatives not later than July 30, 2020, 
        containing the results of the study under paragraph (1).
            (B) Recommendations.--As part of the report under this 
        paragraph, the Comptroller General may provide recommendations, 
        as applicable, on methods through which the Food and Drug 
        Administration may improve planning for--
                (i) the maintenance, renovation, and repair of 
            facilities;
                (ii) the purchase of furniture or other acquisitions; 
            and
                (iii) ways the Food and Drug Administration may 
            allocate the expenses described in clauses (i) and (ii) of 
            paragraph (1)(A), as informed by the analysis under 
            paragraph (1)(B).
    (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 include only 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 include only 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 include only 
    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 include only leasing and necessary scientific 
            equipment.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.