[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2430 Engrossed in House (EH)]

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115th CONGRESS
  1st Session
                                H. R. 2430

_______________________________________________________________________

                                 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.''.

            Passed the House of Representatives July 12, 2017.

            Attest:

                                                                 Clerk.
115th CONGRESS

  1st Session

                               H. R. 2430

_______________________________________________________________________

                                 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.