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

<DOC>





                                                 Union Calendar No. 138
115th CONGRESS
  1st Session
                                H. R. 2430

                          [Report No. 115-201]

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 16, 2017

 Mr. Walden (for himself, Mr. Pallone, Mr. Burgess, and Mr. Gene Green 
  of Texas) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

                             July 11, 2017

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on May 16, 
                                 2017]


_______________________________________________________________________

                                 A BILL


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


 


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

SECTION 1. SHORT TITLE.

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

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.

                   TITLE II--FEES RELATING TO DEVICES

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset clause.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.

      TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

Sec. 501. Reauthorization of provision relating to exclusivity of 
                            certain drugs containing single 
                            enantiomers.
Sec. 502. Reauthorization of orphan grants program.
Sec. 503. Reauthorization of pediatric study of drugs.
Sec. 504. Protecting and strengthening the drug supply chain.
Sec. 505. Sense of Congress on lowering the cost of prescription drugs.

        TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

      Subtitle A--Improving the Process for Inspections of Device 
                             Establishments

Sec. 601. Risk-based inspections for devices.
Sec. 602. Recognition of foreign government inspections.
Sec. 603. Improvements to inspections process for device 
                            establishments.
Sec. 604. Certificates to foreign governments for devices.
Sec. 605. Facilitating international harmonization.
Sec. 606. Reauthorization of inspection program.

                      Subtitle B--Other Provisions

Sec. 611. Reauthorization of pediatric humanitarian device exceptions.
Sec. 612. Reauthorization of pediatric device consortia.
Sec. 613. Regulation of over-the-counter hearing aids.
Sec. 614. Report on ensuring quality, safety, and continued 
                            effectiveness of devices that have been 
                            serviced.
Sec. 615. Device pilot projects to generate reliable and timely safety 
                            and active surveillance data.
Sec. 616. Risk-based classification of accessories.

             TITLE VII--GENERIC DRUG ACCESS AND COMPETITION

Sec. 701. Competitive Generic Therapies.
Sec. 702. Enhancing regulatory transparency To enhance generic 
                            competition.
Sec. 703. Incentivizing competitive generic therapy development.
Sec. 704. Tropical disease product application.
Sec. 705. GAO study of issues regarding first cycle approvals of 
                            generic medicines.

          TITLE VIII--FOSTERING INNOVATION IN MEDICAL IMAGING

Sec. 801. Approval of applications for certain diagnostic medical 
                            imaging devices.
Sec. 802. Applications for approval of contrast agents intended for use 
                            with certain diagnostic medical imaging 
                            devices.

                    TITLE IX--ADDITIONAL PROVISIONS

Sec. 901. Technical corrections.
Sec. 902. Reauthorization of the critical path public-private 
                            partnerships.

                    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) the fee revenue and fees resulting 
                from the adjustment and the methodologies under this 
                paragraph.
            ``(3) Operating reserve adjustment.--
                    ``(A) Increase.--For fiscal year 2018 and 
                subsequent fiscal years, the Secretary may, in addition 
                to adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees if such an adjustment 
                is necessary to provide for not more than 14 weeks of 
                operating reserves of carryover user fees for the 
                process for the review of human drug applications.
                    ``(B) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 14 weeks of such 
                operating reserves, the Secretary shall decrease such 
                fee revenue and fees to provide for not more than 14 
                weeks of such operating reserves.
                    ``(C) Notice of rationale.--If an adjustment under 
                subparagraph (A) or (B) is made, the rationale for the 
                amount of the increase or decrease (as applicable) in 
                fee revenue and fees shall be contained in the annual 
                Federal Register notice under paragraph (5) 
                establishing fee revenue and fees for the fiscal year 
                involved.
            ``(4) Additional direct cost adjustment.--
                    ``(A) In general.--The Secretary shall, in addition 
                to adjustments under paragraphs (1), (2), and (3), 
                further increase the fee revenue and fees--
                            ``(i) for fiscal year 2018, by $8,730,000; 
                        and
                            ``(ii) for fiscal year 2019 and subsequent 
                        fiscal years, by the amount determined under 
                        subparagraph (B).
                    ``(B) Amount.--The amount determined under this 
                subparagraph is--
                            ``(i) $8,730,000, multiplied by
                            ``(ii) the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All Items; Annual 
                        Index) for the most recent year of available 
                        data, divided by such Index for 2016.
            ``(5) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2017--
                    ``(A) establish, for the next fiscal year, human 
                drug application fees and prescription drug program 
                fees under subsection (a), based on the revenue amounts 
                established under subsection (b) and the adjustments 
                provided under this subsection; and
                    ``(B) publish such fee revenue and fees in the 
                Federal Register.
            ``(6) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total costs for such fiscal year for the resources allocated 
        for the process for the review of human drug applications.''.
    (d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``or'' at the end of subparagraph 
                (B);
                    (B) by striking subparagraph (C); and
                    (C) by redesignating subparagraph (D) as 
                subparagraph (C);
            (2) by striking paragraph (3) (relating to use of standard 
        costs);
            (3) by redesignating paragraph (4) as paragraph (3); and
            (4) in paragraph (3), as so redesignated--
                    (A) in subparagraphs (A) and (B), by striking 
                ``paragraph (1)(D)'' and inserting ``paragraph 
                (1)(C)''; and
                    (B) in subparagraph (B)--
                            (i) by striking clause (ii);
                            (ii) by striking ``shall pay'' through 
                        ``(i) application fees'' and inserting ``shall 
                        pay application fees''; and
                            (iii) by striking ``; and'' at the end and 
                        inserting a period.
    (e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking 
``all fees'' and inserting ``all such fees''.
    (f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 
``supplements, prescription drug establishments, and prescription drug 
products'' and inserting ``prescription drug program fees''.
    (g) Crediting and Availability of Fees.--Section 736(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``and paragraph (4) of this 
                subsection''; and
            (2) by striking paragraph (4).
    (h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and 
establishment fees'' each place it appears and inserting ``prescription 
drug program fees''.

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 104. SUNSET DATES.

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

SEC. 105. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 2 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all human 
drug applications received on or after October 1, 2017, regardless of 
the date of the enactment of this Act.

SEC. 106. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to human drug 
applications and supplements (as defined in such part as of such day) 
that on or after October 1, 2012, but before October 1, 2017, were 
accepted by the Food and Drug Administration for filing with respect to 
assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2018.

                   TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDINGS.

    (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2017''.
    (b) Findings.--The Congress finds that the fees authorized under 
the amendments made by this title will be dedicated toward expediting 
the process for the review of device applications and for assuring the 
safety and effectiveness of devices, as set forth in the goals 
identified for purposes of part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act in the letters from the Secretary 
of Health and Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Chairman 
of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

SEC. 202. DEFINITIONS.

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

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

    (a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
            (1) in paragraph (1), by striking ``fiscal year 2013'' and 
        inserting ``fiscal year 2018''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i), by 
                        striking ``October 1, 2012'' and inserting 
                        ``October 1, 2017'';
                            (ii) in clause (viii), by striking ``2'' 
                        and inserting ``3.4''; and
                            (iii) by adding at the end the following 
                        new clause:
                            ``(xi) For a de novo classification 
                        request, a fee equal to 30 percent of the fee 
                        that applies under clause (i).''; and
                    (B) in subparagraph (B)(v)(I), by striking ``or 
                premarket notification submission'' and inserting 
                ``premarket notification submission, or de novo 
                classification request''.
    (b) Fee Amounts.--Section 738(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:
    ``(b) Fee Amounts.--
            ``(1) In general.--Subject to subsections (c), (d), (e), 
        and (h), for each of fiscal years 2018 through 2022, fees under 
        subsection (a) shall be derived from the base fee amounts 
        specified in paragraph (2), to generate the total revenue 
        amounts specified in paragraph (3).
            ``(2) Base fee amounts specified.--For purposes of 
        paragraph (1), the base fee amounts specified in this paragraph 
        are as follows:

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

            ``(3) Total revenue amounts specified.--For purposes of 
        paragraph (1), the total revenue amounts specified in this 
        paragraph are as follows:
                    ``(A) $183,280,756 for fiscal year 2018.
                    ``(B) $190,654,875 for fiscal year 2019.
                    ``(C) $200,132,014 for fiscal year 2020.
                    ``(D) $211,748,789 for fiscal year 2021.
                    ``(E) $213,687,660 for fiscal year 2022.''.
    (c) Annual Fee Setting; Adjustments.--Section 738(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended--
            (1) in paragraph (1), by striking ``2012'' and inserting 
        ``2017'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``2014'' and 
                inserting ``2018'';
                    (B) by striking subparagraph (B) and inserting the 
                following new subparagraph:
                    ``(B) Applicable inflation adjustment.--The 
                applicable inflation adjustment for fiscal year 2018 
                and each subsequent fiscal year is the product of--
                            ``(i) the base inflation adjustment under 
                        subparagraph (C) for such fiscal year; and
                            ``(ii) the product of the base inflation 
                        adjustment under subparagraph (C) for each of 
                        the fiscal years preceding such fiscal year, 
                        beginning with fiscal year 2016.'';
                    (C) in subparagraph (C), in the heading, by 
                striking ``to total revenue amounts''; and
                    (D) by amending subparagraph (D) to read as 
                follows:
                    ``(D) Adjustment to base fee amounts.--For each of 
                fiscal years 2018 through 2022, the Secretary shall--
                            ``(i) adjust the base fee amounts specified 
                        in subsection (b)(2) for such fiscal year by 
                        multiplying such amounts by the applicable 
                        inflation adjustment under subparagraph (B) for 
                        such year; and
                            ``(ii) if the Secretary determines 
                        necessary, increase (in addition to the 
                        adjustment under clause (i)) such base fee 
                        amounts, on a uniform proportionate basis, to 
                        generate the total revenue amounts under 
                        subsection (b)(3), as adjusted for inflation 
                        under subparagraph (A).''; and
            (3) in paragraph (3)--
                    (A) by striking ``2014 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``further adjusted'' and inserting 
                ``increased''.
    (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
            (1) in paragraph (1), by striking ``specified in clauses 
        (i) through (v) and clauses (vii), (ix), and (x)'' and 
        inserting ``specified in clauses (i) through (vii) and clauses 
        (ix), (x), and (xi)''; and
            (2) in paragraph (2)(C)--
                    (A) by striking ``supplement, or'' and inserting 
                ``supplement,''; and
                    (B) by inserting ``, or a de novo classification 
                request'' after ``class III device''.
    (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--Section 738(e)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking 
``50'' and inserting ``25''.
    (f) Fee Waiver or Reduction.--
            (1) Repeal.--Section 738 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection 
        (f).
            (2) Conforming changes.--
                    (A) Section 515(c)(4)(A) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended 
                by striking ``738(h)'' and inserting ``738(g)''.
                    (B) Section 738 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 379j), as amended by paragraph 
                (1), is further amended--
                            (i) by redesignating subsections (g) 
                        through (l) as subsections (f) through (k);
                            (ii) in subsection (a)(2)(A), by striking 
                        ``(d), (e), and (f)'' and inserting ``(d) and 
                        (e)''; and
                            (iii) in subsection (a)(3)(A), by striking 
                        ``and subsection (f)''.
    (g) Effect of Failure To Pay Fees.--Subsection (f)(1), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--
            (1) by striking ``or periodic reporting concerning a class 
        III device'' and inserting ``periodic reporting concerning a 
        class III device, or de novo classification request''; and
            (2) by striking ``all fees'' and inserting ``all such 
        fees''.
    (h) Conditions.--Subsection (g)(1)(A), as redesignated, of section 
738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is 
amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
    (i) Crediting and Availability of Fees.--Subsection (h), as 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``subsection (c)'' and all that 
                follows through the period at the end and inserting 
                ``subsection (c).''; and
            (2) by striking paragraph (4).

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

    (a) Performance Reports.--Section 738A(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) by striking ``2013'' and inserting 
                        ``2018''; and
                            (ii) by striking ``the Medical Device User 
                        Fee Amendments of 2012'' and inserting ``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 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); 
                        or
                            ``(iii) 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;
                            ``(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 12 months after the close of the public 
                comment period on the draft guidance issued under 
                subparagraph (B), issue final guidance described in 
                clauses (i) through (iii) of such subparagraph.''.

SEC. 208. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379i et seq.), as in effect on the day before the date of 
the enactment of this title, shall continue to be in effect with 
respect to the submissions listed in section 738(a)(2)(A) of such Act 
(as defined in such part as of such day) that on or after October 1, 
2012, but before October 1, 2017, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2018.

SEC. 209. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
submissions listed in section 738(a)(2)(A) of such Act received on or 
after October 1, 2017, regardless of the date of the enactment of this 
Act.

SEC. 210. SUNSET CLAUSE.

    (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective 
October 1, 2022.
    (b) Reporting Requirements.--Section 738A (21 U.S.C. 739j-1) of the 
Federal Food, Drug, and Cosmetic Act (regarding reauthorization and 
reporting requirements) shall cease to be effective January 31, 2023.
    (c) Previous Sunset Provision.--Effective October 1, 2017, section 
207(a) of the Medical Device User Fee Amendments of 2012 (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. 379-42(g)) is amended--
            (1) in paragraph (1), by adding at the end the following: 
        ``This paragraph shall cease to be effective on October 1, 
        2022.'';
            (2) in paragraph (2)(C)(ii), by striking ``of 
        505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; and
            (3) by adding at the end the following:
            ``(5) Generic drug applicant program fee.--
                    ``(A) In general.--A person who fails to pay a fee 
                as required under subsection (a)(5) by the date that is 
                20 calendar days after the due date, as specified in 
                subparagraph (D) of such subsection, shall be subject 
                to the following:
                            ``(i) The Secretary shall place the person 
                        on a publicly available arrears list.
                            ``(ii) Any abbreviated new drug application 
                        submitted by the generic drug applicant or an 
                        affiliate of such applicant shall not be 
                        received, within the meaning of section 
                        505(j)(5)(A).
                            ``(iii) All drugs marketed pursuant to any 
                        abbreviated new drug application held by such 
                        applicant or an affiliate of such applicant 
                        shall be deemed misbranded under section 
                        502(aa).
                    ``(B) Application of penalties.--The penalties 
                under subparagraph (A) shall apply until the fee 
                required under subsection (a)(5) is paid.''.
    (g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379-42(h)(2)) is amended by striking ``for Type 
II active pharmaceutical ingredient drug master files, abbreviated new 
drug applications and prior approval supplements, and generic drug 
facilities and active pharmaceutical ingredient facilities''.
    (h) Crediting and Availability of Fees.--Section 744B(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379-42(i)) is amended--
            (1) in paragraph (2)--
                    (A) by striking subparagraph (C) (relating to fee 
                collection during first program year);
                    (B) in subparagraph (D)--
                            (i) in the heading, by striking ``in 
                        subsequent years''; and
                            (ii) by striking ``(after fiscal year 
                        2013)''; and
                    (C) by redesignating subparagraph (D) as 
                subparagraph (C); and
            (2) in paragraph (3), by striking ``fiscal years 2013 
        through 2017'' and inserting ``fiscal years 2018 through 
        2022''.
    (i) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379-42) is amended by adding at the 
end the following:
    ``(o) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--
            ``(1) In general.--By April 1 of each year, each person 
        that owns an abbreviated new drug application, or any affiliate 
        of such person, shall submit, on behalf of the person and its 
        affiliates, 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 applications and all 
                approved abbreviated new drug applications owned by any 
                such affiliate.
            ``(2) Format and method.--The Secretary shall specify in 
        guidance the format and method for submission of lists under 
        this subsection.''.

SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 305. SUNSET DATES.

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

SEC. 306. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 7 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
abbreviated new drug applications received on or after October 1, 2017, 
regardless of the date of the enactment of this Act.

SEC. 307. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 7 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to abbreviated new 
drug applications (as defined in such part as of such day) that on or 
after October 1, 2012, but before October 1, 2017, were received by the 
Food and Drug Administration within the meaning of 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 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; Annual Index) 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 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'' before ``fees''; and
                    (B) by amending clause (i) to read as follows:
                            ``(i) Refunds.--Except as provided in 
                        subparagraph (B)(iv), the Secretary shall not 
                        refund any initial or annual biosimilar 
                        biological product development fee paid under 
                        subparagraph (A) or (B), or any reactivation 
                        fee paid under subparagraph (D).'';
            (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 subparagraphs (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 
                        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) establishing fee revenue and fees for the fiscal 
                year involved.
            ``(4) Fiscal year 2018 adjustment.--
                    ``(A) In general.--For fiscal year 2018, the 
                Secretary shall adjust the fee revenue and fees under 
                this section in such amount (if any) as needed to 
                reflect an updated assessment of the workload for the 
                process for the review of biosimilar biological product 
                applications.
                    ``(B) Methodology.--The Secretary shall publish 
                under paragraph (5) a description of the methodology 
                used to calculate the fiscal year 2018 adjustment under 
                this paragraph in the Federal Register notice 
                establishing fee revenue and fees for fiscal year 2018.
                    ``(C) Limitation.--No adjustment under this 
                paragraph shall result in an increase in fee revenue 
                and fees under this section in excess of $9,000,000.
            ``(5) Annual fee setting.--For fiscal year 2018 and each 
        subsequent fiscal year, the Secretary shall, not later than 60 
        days before the start of each such fiscal year--
                    ``(A) establish, for the fiscal year, initial and 
                annual biosimilar biological product development fees 
                and reactivation fees under subsection (a)(1), 
                biosimilar biological product application fees under 
                subsection (a)(2), and biosimilar biological product 
                program fees under subsection (a)(3), based on the 
                revenue amounts established under subsection (b) and 
                the adjustments provided under this subsection; and
                    ``(B) publish such fee revenue and fees in the 
                Federal Register.
            ``(6) Limit.--The total amount of fees assessed for a 
        fiscal year under this section may not exceed the total costs 
        for such fiscal year for the resources allocated for the 
        process for the review of biosimilar biological product 
        applications.''.
    (d) Application Fee Waiver for Small Business.--Subsection (d)(1) 
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended--
            (1) by striking subparagraph (B);
            (2) by striking ``shall pay--'' and all that follows 
        through ``application fees'' and inserting ``shall pay 
        application fees''; and
            (3) by striking ``; and'' at the end and inserting a 
        period.
    (e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as 
redesignated by subsection (c)(1), is amended by striking ``all fees'' 
and inserting ``all such fees''.
    (f) Crediting and Availability of Fees.--Subsection (f) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), 
as redesignated by subsection (c)(1), is amended--
            (1) in paragraph (2)--
                    (A) by striking subparagraph (C) (relating to fee 
                collection during first program year) and inserting the 
                following:
                    ``(C) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (B) in any fiscal year if the costs described in such 
                subparagraph are not more than 15 percent below the 
                level specified in such subparagraph.''; and
                    (B) in subparagraph (D)--
                            (i) in the heading, by striking ``in 
                        subsequent years''; and
                            (ii) by striking ``(after fiscal year 
                        2013)''; and
            (2) in paragraph (3), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 405. SUNSET DATES.

    (a) Authorization.--Sections 744G and 744H of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 403 of this Act, shall 
cease to be effective October 1, 2022.
    (b) Reporting Requirements.--Section 744I of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 404 of this Act, shall 
cease to be effective January 31, 2023.
    (c) Previous Sunset Provision.--
            (1) In general.--Effective October 1, 2017, section 404 of 
        the Food and Drug Administration Safety and Innovation Act 
        (Public Law 112-144) is repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Safety and Innovation Act (Public Law 112-144) is amended in 
        the table of contents in section 2 by striking the item 
        relating to section 404.

SEC. 406. EFFECTIVE DATE.

    The amendments made by this title shall take effect on October 1, 
2017, or the date of the enactment of this Act, whichever is later, 
except that fees under part 8 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act shall be assessed for all 
biosimilar biological product applications received on or after October 
1, 2017, regardless of the date of the enactment of this Act.

SEC. 407. SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 8 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as in effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to biosimilar 
biological product applications and supplements (as defined in such 
part as of such day) that were accepted by the Food and Drug 
Administration for filing on or after October 1, 2012, but before 
October 1, 2017, with respect to assessing and collecting any fee 
required by such part for a fiscal year prior to fiscal year 2018.

      TITLE V--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

SEC. 501. 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. 502. 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. 503. REAUTHORIZATION OF PEDIATRIC STUDY OF DRUGS.

    Section 409I(e)(1) of the Public Health Service Act (42 U.S.C. 
284m(e)(1)) is amended by striking ``2013 through 2017'' and inserting 
``2018 through 2022''.

SEC. 504. 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 in effect under section 506E, no 
drug that would be subject to section 503(b), and which is manufactured 
outside the United States and intended by the manufacturer or labeled 
to be marketed outside the United States, may be imported into the 
United States for sale or commercial use.''.
    (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. 505. 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.

        TITLE VI--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

      Subtitle A--Improving the Process for Inspections of Device 
                             Establishments

SEC. 601. RISK-BASED INSPECTIONS FOR DEVICES.

    Paragraph (2) of section 510(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(h)) is amended to read as follows:
            ``(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 which the 
                        United States recognizes for purposes of 
                        inspecting device establishments.''.

SEC. 602. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.

    Subsection (a)(1) of section 809 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by inserting ``or 
510(h)(2) (as applicable)'' before the semicolon at the end.

SEC. 603. 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 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 in order to 
        expedite the inspection; 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 limits 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 section, the Secretary of Health and 
        Human Services shall issue draft guidance that--
                    (A) specifies how the Food and Drug Administration 
                will implement the process described in 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;
                    (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).

SEC. 604. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.

    (a) In General.--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) If the Secretary denies a request made under subparagraph 
(A)(ii) for certification with respect to a device, 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 clause (i) is 
based on--
            ``(I) 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
            ``(II) an establishment being considered out of compliance 
        with part 820, title 21, Code of Federal Regulations,
the Secretary shall provide a substantive summary of the specific 
grounds for noncompliance so identified, if such grounds have not been 
previously communicated to the manufacturer.
    ``(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 under subparagraph (A)(ii) based 
exclusively 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.
    ``(F)(i) The Secretary shall provide a process for a person who is 
denied a certification as described in subparagraph (E)(i) to request a 
review that conforms to the standards of section 517A(b).
    ``(ii) Notwithstanding any previous review conducted pursuant to 
clause (i), a person who has been denied a certification for a device 
as described in subparagraph (E)(i) may, at any time, request a review 
of that denial in order to present new information relating to actions 
taken by such person to address the reasons identified by the Secretary 
for such denial, including evidence that corrective actions are being 
or have been implemented to address the grounds for noncompliance 
identified by the Secretary under subparagraph (E)(ii).
    ``(G)(i) This paragraph applies to requests for certification on 
behalf of any device establishment registered under section 510, 
whether the establishment is located in the United States or another 
country. 
    ``(ii) The Secretary may charge a fee for the issuance of a 
certification described in clause (i), and such fee is subject to the 
same conditions and requirements as a fee charged under subparagraph 
(B) for a certification issued under such subparagraph.''; and
            (2) by moving the margins of subparagraphs (C) and (D) 4 
        ems to the left.
    (b) Guidance.--Not later than 1 year after date of the enactment of 
this section, the Secretary of Health and Human Services shall issue 
guidance providing for a process to carry out subparagraph (F) of 
section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(e)(4)), as added by subsection (a). Not later than 12 months 
after the comment period closes for the draft guidance, the Secretary 
shall issue final guidance.

SEC. 605. FACILITATING INTERNATIONAL HARMONIZATION.

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

SEC. 606. 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''.

                      Subtitle B--Other Provisions

SEC. 611. REAUTHORIZATION OF PEDIATRIC HUMANITARIAN DEVICE EXCEPTIONS.

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

SEC. 612. REAUTHORIZATION OF PEDIATRIC DEVICE CONSORTIA.

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

SEC. 613. 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) is amended by adding at the end the 
following:
    ``(p) Regulation of Over-the-Counter Hearing Aids.--
            ``(1) Definition.--
                    ``(A) In this subsection, the term `over-the-
                counter hearing aid' means a device--
                            ``(i) that 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) that is intended to be used by 
                        adults over the age of 18 to compensate for 
                        perceived mild to moderate hearing impairment;
                            ``(iii) that, 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) that may--
                                    ``(I) use wireless technology; or
                                    ``(II) include tests for self-
                                assessment of hearing loss; and
                            ``(v) that 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) 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 613(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 (p) of 
        section 520 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360j) as amended by subsection (a), and, not later than 
        180 days after the date on which the public comment period on 
        the proposed regulations closes, shall issue such final 
        regulations.
            (2) Requirements.--In promulgating the regulations under 
        paragraph (1), the Secretary shall--
                    (A) include requirements that provide reasonable 
                assurances of the safety and efficacy of over-the-
                counter hearing aids;
                    (B) include requirements that establish or adopt 
                output limits appropriate for over-the-counter hearing 
                aids;
                    (C) include requirements for appropriate labeling 
                of the over-the-counter hearing aid, including 
                requirements that such labeling include a conspicuous 
                statement that the device is only intended for adults 
                over the age of 18, 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 physician; and
                    (D) describe the requirements under which the sale 
                of over-the-counter hearing aids is permitted, without 
                the supervision, prescription, or other order, 
                involvement, or intervention of a licensed person, to 
                consumers through in-person transactions, by mail, or 
                online.
            (3) Premarket notification.--The Secretary shall make 
        findings under section 510(m) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-
        counter hearing aids (as defined in section 520(p) 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(p) 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 (p)(1) of section 520 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).

SEC. 614. REPORT ON ENSURING QUALITY, SAFETY, AND CONTINUED 
              EFFECTIVENESS OF DEVICES THAT HAVE BEEN SERVICED.

    (a) In General.--Not later than 180 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 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 on how the Food and Drug Administration intends to ensure the 
quality, safety, and continued effectiveness of devices (as defined in 
section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301(h))) with respect to which servicing (as defined in subsection (c)) 
has been performed by any entity engaging in such servicing.
    (b) Contents.--The report submitted under subsection (a) shall 
contain--
            (1) the status of, and findings to date with respect to, 
        the notice entitled ``Refurbishing, Reconditioning, Rebuilding, 
        Remarketing, Remanufacturing, and Servicing of Medical Devices 
        Performed by Third-Party Entities and Original Equipment 
        Manufacturers; Request for Comments'' published by the Food and 
        Drug Administration on April 25, 2016 (81 Fed. Reg. 24041 et 
        seq.), including how the Food and Drug Administration intends 
        to define the specific activities performed on a device by the 
        manufacturer of the device or other entities;
            (2) a description of the statutory or regulatory authority 
        of the Food and Drug Administration used to oversee and 
        regulate servicing conducted with respect to devices;
            (3) details on how the Food and Drug Administration intends 
        to protect the public health by ensuring consistent quality, 
        safety, and continued effectiveness of devices with respect to 
        which servicing has been performed by any entity engaging in 
        such servicing;
            (4) information on how the Food and Drug Administration can 
        better understand the device servicing industry, including the 
        size, scope, location, and composition of entities performing 
        such servicing and the rate of adverse events related to such 
        servicing;
            (5) information regarding the current regulation by States, 
        the Joint Commission, or other regulatory bodies of servicing 
        conducted with respect to devices by all entities, including 
        original equipment manufacturers, third-party entities, and 
        hospitals; and
            (6) any additional information determined by the Secretary 
        (acting through the Commissioner) to be relevant to ensuring 
        the quality, safety, and continued effectiveness of devices 
        with respect to which servicing has been performed, including 
        whether additional Federal statutory authority is necessary to 
        ensure such quality, safety, and continued effectiveness.
    (c) Servicing Defined.--In this section, the term ``servicing'' 
includes, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, remanufacturing, repairing, or other servicing 
of the device by a person other than the manufacturer of the device.

SEC. 615. DEVICE PILOT PROJECTS TO GENERATE RELIABLE AND TIMELY SAFETY 
              AND ACTIVE SURVEILLANCE DATA.

    (a) In General.--Section 519 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the 
following:
    ``(i) Pilot Projects To Generate Reliable and Timely Safety and 
Active Surveillance Data.--
            ``(1) In general.--The Secretary shall, not later than one 
        year after the date of the enactment of the FDA Reauthorization 
        Act of 2017, initiate one or more pilot projects relating 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), in 
        which a manufacturer or manufacturers of a device or device 
        type voluntarily participate. Any such project shall meet each 
        of the following criteria:
                    ``(A) The project is 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) The project informs, to the extent 
                applicable, the development of methods, systems, data 
                criteria, and programs that could be used to support 
                safety and active surveillance activities for any 
                device.
                    ``(C) The project shall be designed and conducted 
                in coordination with a comprehensive system for 
                evaluating device technology that operates under a 
                governing board with appropriate representation of 
                stakeholders, including patient groups and device 
                manufacturers.
                    ``(D) The project uses electronic health data 
                including, as appropriate, claims data, patient survey 
                data, and any other data, as the Secretary determines 
                appropriate.
                    ``(E) The project prioritizes 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 
                                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) under this subparagraph 
                                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 shall not affect the eligibility 
        of such manufacturer to participate in any quarterly reporting 
        program with respect to devices carried out under section 519 
        or 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 section 519 or 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.--
                    ``(A) In general.--No pilot project under this 
                subsection undertaken in coordination with the 
                comprehensive system described in paragraph (1)(C), 
                shall allow for an entity participating in such 
                program, other than the Secretary or the Secretary's 
                designee, to make determinations of safety or 
                effectiveness, or substantial equivalence, for purposes 
                of the Act.
                    ``(B) No use of fees.--Pilot projects initiated 
                under this subsection may not primarily utilize funds 
                collected pursuant to the Medical Device User Fee 
                Amendments of 2017.
            ``(8) Other projects required to comply.--Paragraphs 
        (1)(B), (4)(A)(i), (4)(A)(ii), (5), and (6) shall apply with 
        respect to any pilot program 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, may  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 added by subsection 
(a)--
            (1) for purposes of informing premarket and postmarket 
        decisionmaking for multiple device types; and
            (2) to determine whether the methods, systems, and programs 
        carried out through such pilot projects efficiently generate 
        reliable and timely evidence about the effectiveness of the 
        surveillance of devices with respect to safety.

SEC. 616. 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 section shall preclude the Secretary's ability to 
initiate the classification of an accessory through regulation or 
written order, as appropriate.
    ``(C)(i) In the case of an accessory that has been granted 
marketing authorization as part of a submission under section 515(c), 
510(k), or paragraph (2) of this subsection with another device with 
which such accessory is intended to be used, and with respect to which 
the Secretary has issued a written order classifying such accessory 
type distinct from another device in accordance with subparagraph (A), 
the manufacturer or importer of such accessory may, in lieu of 
submitting a request for classification of such accessory, submit a 
written request to the Secretary identifying such classification. A 
request under this clause shall include such information to support the 
request as may be specified by the Secretary.
    ``(ii) A request under clause (i) shall include a recommendation 
for the proper classification of the accessory pursuant to subparagraph 
(A), and 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).
    ``(iii) The Secretary shall respond to a request under clause (i) 
within 90 calendar days by granting or denying the request for 
reclassification of the accessory.
    ``(iv) Within 30 calendar days after granting a request submitted 
under clause (i), the Secretary shall publish a notice in the Federal 
Register announcing such response.
    ``(v) A written notification that the Secretary disagrees with the 
classification recommended in a request pursuant to clause (ii) shall 
include a detailed description and justification for the determination 
to disagree.
    ``(D)(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.
    ``(E) 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, 
and that have not been classified by the Secretary based on the risks 
and appropriate level of regulatory controls in accordance with 
subparagraph (A):
            ``(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 deems appropriate, pursuant to this paragraph, the 
        Secretary shall publish in the Federal Register a notice 
        proposing a list of such accessories that the Secretary 
        believes may be suitable for a distinct classification in class 
        I and the proposed regulations for such classifications. In 
        developing such lists, the Secretary shall consider 
        recommendations from sponsors of device submissions and other 
        stakeholders for accessories to be included on such lists. 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) or (C), 
        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 90 calendar days after receiving 
        such submission by granting or denying the request for 
        classification of the accessory, and the Secretary shall by 
        written order classify such accessory or deny 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.
    ``(F) 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.

             TITLE VII--GENERIC DRUG ACCESS AND COMPETITION

SEC. 701. 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 shall, at the request of the 
sponsor of a drug that is designated as a competitive generic therapy 
pursuant to subsection (b), expedite the development and review of such 
drug pursuant to section 505(j).
    ``(b) Designation Process.--
            ``(1) Request.--The sponsor of a drug 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 
        shall--
                    ``(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 a drug 
under subsection (a), the Secretary shall, as requested by the sponsor, 
take actions including the following:
            ``(1) Hold meetings with the sponsor 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 sponsor 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, 
        including with respect to drug-device combination products and 
        other complex products.
            ``(4) Assign a cross-disciplinary project lead for the Food 
        and Drug Administration review team--
                    ``(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 sponsor.
    ``(d) 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 product, there is not more than one approved drug 
        product on the list of products described in section 
        505(j)(7)(A) (not including products 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 the provisions of 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 provisions.
                    (B) Contents.--The guidance issued under this 
                subsection 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 will 
                        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.--
                    (A) In general.--If the Secretary of Health and 
                Human Services determines that it is necessary to amend 
                the regulations under title 21, Code of Federal 
                Regulations, in order to implement section 506H of the 
                Federal Food, Drug, and Cosmetic Act, as added by 
                subsection (a), the Secretary shall amend such 
                regulations not later than 2 years after the date of 
                enactment of this Act.
                    (B) Procedure.--In carrying out subparagraph (A), 
                and in issuing any other regulations to implement such 
                section 506H, the Secretary shall--
                            (i) issue a notice of proposed rulemaking 
                        that includes the proposed regulation;
                            (ii) provide a period of not less than 60 
                        days for comments on the proposed regulation; 
                        and
                            (iii) publish the final regulation not less 
                        than 30 days before the effective date of the 
                        regulation.

SEC. 702. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC 
              COMPETITION.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) is amended by adding at the end the following:
    ``(11) Upon the request of an applicant regarding one or more 
specified pending applications under this subsection, the Secretary 
shall--
            ``(A) by telephone or electronic mail, provide review 
        status updates; and
            ``(B) indicate in such updates the categorical status of 
        the applications by each relevant review discipline.''.

SEC. 703. INCENTIVIZING COMPETITIVE GENERIC THERAPY 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 blocking 
                                exclusivities on the list of products 
                                described in section 505(j)(7)(A) at 
                                the time of approval.
                            ``(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. 704. TROPICAL DISEASE PRODUCT APPLICATION.

    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.''.

SEC. 705. 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 generic drug applications submitted 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 
        (DMF) 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 VIII--FOSTERING INNOVATION IN MEDICAL IMAGING

SEC. 801. APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MEDICAL 
              IMAGING DEVICES.

    Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 
360j), as amended by section 613, is further amended by adding at the 
end the following:
    ``(q) Diagnostic Imaging Devices Intended for Use With Contrast 
Agents.--
            ``(1) 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 the indications and conditions of use 
        proposed in such application, notification, or request involve 
        the use of a contrast agent that is not--
                    ``(A) in a concentration, rate of administration, 
                or route of administration that is different from those 
                described in the approved labeling of 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 (such as an 
                ultrasound, an x-ray, diagnostic radiopharmaceutical-
                based technologies, fluorescent imaging technology, or 
                magnetic resonance) that is different from those 
                described in the approved labeling of the contrast 
                agent.
            ``(2) 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) 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) For purposes of this subsection and section 505(y)--
                    ``(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.''.

SEC. 802. 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) 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 the use of 
        the contrast agent for a new indication and conditions of 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(q)(1).
            ``(2) 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) For purposes of this subsection--
                    ``(A) the term `new indication' means a use of a 
                contrast agent that is described in the approved 
                labeling of an applicable medical imaging device 
                described in section 520(q), but that is not described 
                in the approved labeling of the contrast agent; and
                    ``(B) the term `applicable medical imaging device' 
                and `contrast agent' have the meanings given such terms 
                in section 520(q).''.

                    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) 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.
    (f) 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''.
    (g) 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. 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''.
                                                 Union Calendar No. 138

115th CONGRESS

  1st Session

                               H. R. 2430

                          [Report No. 115-201]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             July 11, 2017

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed