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

<DOC>






115th CONGRESS
  1st Session
                                H. R. 2430

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

_______________________________________________________________________

                                 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--REAUTHORIZATION OF OTHER PROGRAMS

Sec. 501. Reauthorization of provision relating to exclusivity of 
                            certain drugs containing single 
                            enantiomers.
Sec. 502. Reauthorization of pediatric humanitarian device exceptions.
Sec. 503. Reauthorization of the critical path public-private 
                            partnerships.
Sec. 504. Reauthorization of pediatric device consortia.
Sec. 505. Reauthorization of orphan grants program.
Sec. 506. Reauthorization of inspection program.
Sec. 507. Reauthorization of pediatric study of drugs.
                    TITLE VI--ADDITIONAL PROVISIONS

Sec. 601. Technical corrections.

                    TITLE I--FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Prescription 
Drug User Fee Amendments of 2017''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
drug development process and the process for the review of human drug 
applications, including postmarket drug safety activities, as set forth 
in the goals identified for purposes of part 2 of subchapter C of 
chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters 
from the Secretary of Health and Human Services to the Chairman of the 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce of the House of 
Representatives, as set forth in the Congressional Record.

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

    (a) Types of Fees.--
            (1) In general.--Section 736(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
                    (A) in the matter preceding paragraph (1), by 
                striking ``fiscal year 2013'' and inserting ``fiscal 
                year 2018'';
                    (B) in the heading of paragraph (1), by striking 
                ``and supplement'';
                    (C) in paragraph (1), by striking ``or a 
                supplement'' and ``or supplement'' each place either 
                appears;
                    (D) in paragraph (1)(A)--
                            (i) in clause (i), by striking ``(c)(4)'' 
                        and inserting ``(c)(5)''; and
                            (ii) in clause (ii), by striking ``A fee 
                        established'' and all that follows through 
                        ``are required.'' and inserting the following: 
                        ``A fee established under subsection (c)(5) for 
                        a human drug application for which clinical 
                        data (other than bioavailability or 
                        bioequivalence studies) with respect to safety 
                        or effectiveness are not required for 
                        approval.'';
                    (E) in the heading of paragraph (1)(C), by striking 
                ``or supplement'';
                    (F) in paragraph (1)(F)--
                            (i) in the heading, by striking ``or 
                        indication''; and
                            (ii) by striking the second sentence;
                    (G) by striking paragraph (2) (relating to a 
                prescription drug establishment fee);
                    (H) by redesignating paragraph (3) as paragraph 
                (2);
                    (I) in the heading of paragraph (2), as so 
                redesignated, by striking ``Prescription drug product 
                fee'' and inserting ``Prescription drug program fee'';
                    (J) in subparagraph (A) of such paragraph (2), by 
                amending the first sentence to read as follows: 
                ``Except as provided in subparagraphs (B) and (C), each 
                person who is named as the applicant in a human drug 
                application, and who, after September 1, 1992, had 
                pending before the Secretary a human drug application 
                or supplement, shall pay the annual prescription drug 
                program fee established for a fiscal year under 
                subsection (c)(5) for each prescription drug product 
                that is identified in such a human drug application 
                approved as of October 1 of such fiscal year.'';
                    (K) in subparagraph (B) of such paragraph (2)--
                            (i) in the heading of subparagraph (B), by 
                        inserting after ``Exception'' the following: 
                        ``for certain prescription drug products''; and
                            (ii) by striking ``A prescription drug 
                        product shall not be assessed a fee'' and 
                        inserting ``A prescription drug program fee 
                        shall not be assessed for a prescription drug 
                        product''; and
                    (L) by adding at the end of such paragraph (2) the 
                following:
                    ``(C) Limitation.--A person who is named as the 
                applicant in an approved human drug application shall 
                not be assessed more than 5 prescription drug program 
                fees for a fiscal year for prescription drug products 
                identified in such approved human drug application.''.
            (2) Conforming amendment.--Subparagraph (C) of section 
        740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-12(a)(3)) is amended to read as follows:
                    ``(C) Limitation.--An establishment shall be 
                assessed only one fee per fiscal year under this 
                section.''.
    (b) Fee Revenue Amounts.--Subsection (b) of section 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to 
read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--For each of the fiscal years 2018 
        through 2022, fees under subsection (a) shall, except as 
        provided in subsections (c), (d), (f), and (g), be established 
        to generate a total revenue amount under such subsection that 
        is equal to the sum of--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2));
                    ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3));
                    ``(E) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(4)); and
                    ``(F) additional dollar amounts for each fiscal 
                year as follows:
                            ``(i) $20,077,793 for fiscal year 2018;
                            ``(ii) $21,317,472 for fiscal year 2019;
                            ``(iii) $16,953,329 for fiscal year 2020;
                            ``(iv) $5,426,896 for fiscal year 2021; and
                            ``(v) $2,769,609 for fiscal year 2022.
            ``(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                    ``(A) 20 percent shall be derived from human drug 
                application fees under subsection (a)(1); and
                    ``(B) 80 percent shall be derived from prescription 
                drug program fees under subsection (a)(2).
            ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                    ``(A) for fiscal year 2018, $878,590,000; and
                    ``(B) for fiscal years 2019 through 2022, the 
                dollar amount of the total revenue amount established 
                under paragraph (1) for the previous fiscal year, not 
                including any adjustments made under subsection (c)(3) 
                or (c)(4).''.
    (c) Adjustments; Annual Fee Setting.--Subsection (c) of section 736 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended 
to read as follows:
    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For purposes of subsection 
                (b)(1)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for each fiscal 
                year shall be equal to the product of--
                            ``(i) such annual base revenue for the 
                        fiscal year under subsection (b)(1)(A); and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                    ``(B) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this subparagraph 
                for a fiscal year is equal to the sum of--
                            ``(i) the average annual percent change in 
                        the cost, per full-time equivalent position of 
                        the Food and Drug Administration, of all 
                        personnel compensation and benefits paid with 
                        respect to such positions for the first 3 years 
                        of the preceding 4 fiscal years, multiplied by 
                        the proportion of personnel compensation and 
                        benefits costs to total costs of the process 
                        for the review of human drug applications (as 
                        defined in section 735(6)) for the first 3 
                        years of the preceding 4 fiscal years; and
                            ``(ii) the average annual percent change 
                        that occurred in the Consumer Price Index for 
                        urban consumers (Washington-Baltimore, DC-MD-
                        VA-WV; Not Seasonally Adjusted; All items; 
                        Annual Index) for the first 3 years of the 
                        preceding 4 years of available data multiplied 
                        by the proportion of all costs other than 
                        personnel compensation and benefits costs to 
                        total costs of the process for the review of 
                        human drug applications (as defined in section 
                        735(6)) for the first 3 years of the preceding 
                        4 fiscal years.
            ``(2) Capacity planning adjustment.--
                    ``(A) In general.--For each fiscal year, after the 
                annual base revenue established in subsection (b)(1)(A) 
                is adjusted for inflation in accordance with paragraph 
                (1), such revenue shall be adjusted further for such 
                fiscal year, in accordance with this paragraph, to 
                reflect changes in the resource capacity needs of the 
                Secretary for the process for the review of human drug 
                applications.
                    ``(B) Interim methodology.--
                            ``(i) In general.--Until the capacity 
                        planning methodology described in subparagraph 
                        (C) is effective, the adjustment under this 
                        paragraph for a fiscal year shall be based on 
                        the product of--
                                    ``(I) the annual base revenue for 
                                such year, as adjusted for inflation 
                                under paragraph (1); and
                                    ``(II) the adjustment percentage 
                                under clause (ii).
                            ``(ii) Adjustment percentage.--The 
                        adjustment percentage under this clause for a 
                        fiscal year is the weighted change in the 3-
                        year average ending in the most recent year for 
                        which data are available, over the 3-year 
                        average ending in the previous year, for--
                                    ``(I) the total number of human 
                                drug applications, efficacy 
                                supplements, and manufacturing 
                                supplements submitted to the Secretary;
                                    ``(II) the total number of active 
                                commercial investigational new drug 
                                applications; and
                                    ``(III) the total number of formal 
                                meetings scheduled by the Secretary, 
                                and written responses issued by the 
                                Secretary in lieu of such formal 
                                meetings, as identified in section I.H 
                                of the letters described in section 
                                101(b) of the Prescription Drug User 
                                Fee Amendments of 2017.
                    ``(C) Capacity planning methodology.--
                            ``(i) Development; evaluation and report.--
                        The Secretary shall obtain, through a contract 
                        with an independent accounting or consulting 
                        firm, a report evaluating options and 
                        recommendations for a new methodology to 
                        accurately assess changes in the resource and 
                        capacity needs of the process for the review of 
                        human drug applications. The capacity planning 
                        methodological options and recommendations 
                        presented in such report shall utilize and be 
                        informed by personnel time reporting data as an 
                        input. The report shall be published for public 
                        comment no later than the end of fiscal year 
                        2020.
                            ``(ii) Establishment and implementation.--
                        After review of the report described in clause 
                        (i) and any public comments thereon, the 
                        Secretary shall establish a capacity planning 
                        methodology for purposes of this paragraph, 
                        which shall--
                                    ``(I) replace the interim 
                                methodology under subparagraph (B);
                                    ``(II) incorporate such approaches 
                                and attributes as the Secretary 
                                determines appropriate; and
                                    ``(III) be effective beginning with 
                                the first fiscal year for which fees 
                                are set after such capacity planning 
                                methodology is established.
                    ``(D) Limitation.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(1)(A) (the annual base 
                revenue for the fiscal year) and (b)(1)(B) (the dollar 
                amount of the inflation adjustment for the fiscal 
                year).
                    ``(E) Publication in federal register.--The 
                Secretary shall publish in the Federal Register notice 
                under paragraph (5) the fee revenue and fees resulting 
                from the adjustment and the methodologies under this 
                paragraph.
            ``(3) Operating reserve adjustment.--
                    ``(A) Increase.--For fiscal year 2018 and 
                subsequent fiscal years, the Secretary may, in addition 
                to adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees if such an adjustment 
                is necessary to provide for not more than 14 weeks of 
                operating reserves of carryover user fees for the 
                process for the review of human drug applications.
                    ``(B) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 14 weeks of such 
                operating reserves, the Secretary shall decrease such 
                fee revenue and fees to provide for not more than 14 
                weeks of such operating reserves.
                    ``(C) Notice of rationale.--If an adjustment under 
                subparagraph (A) or (B) is made, the rationale for the 
                amount of the increase or decrease (as applicable) in 
                fee revenue and fees shall be contained in the annual 
                Federal Register notice under paragraph (5) 
                establishing fee revenue and fees for the fiscal year 
                involved.
            ``(4) Additional direct cost adjustment.--
                    ``(A) In general.--The Secretary shall, in addition 
                to adjustments under paragraphs (1), (2), and (3), 
                further increase the fee revenue and fees--
                            ``(i) for fiscal year 2018, by $8,730,000; 
                        and
                            ``(ii) for fiscal year 2019 and subsequent 
                        fiscal years, by the amount determined under 
                        subparagraph (B).
                    ``(B) Amount.--The amount determined under this 
                subparagraph is--
                            ``(i) $8,730,000, multiplied by
                            ``(ii) the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All Items; Annual 
                        Index) for the most recent year of available 
                        data, divided by such Index for 2016.
            ``(5) Annual fee setting.--The Secretary shall, not later 
        than 60 days before the start of each fiscal year that begins 
        after September 30, 2017--
                    ``(A) establish, for the next fiscal year, human 
                drug application fees and prescription drug program 
                fees under subsection (a), based on the revenue amounts 
                established under subsection (b) and the adjustments 
                provided under this subsection; and
                    ``(B) publish such fee revenue and fees in the 
                Federal Register.
            ``(6) Limit.--The total amount of fees charged, as adjusted 
        under this subsection, for a fiscal year may not exceed the 
        total costs for such fiscal year for the resources allocated 
        for the process for the review of human drug applications.''.
    (d) Fee Waiver or Reduction.--Section 736(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``or'' at the end of subparagraph 
                (B);
                    (B) by striking subparagraph (C); and
                    (C) by redesignating subparagraph (D) as 
                subparagraph (C);
            (2) by striking paragraph (3) (relating to use of standard 
        costs);
            (3) by redesignating paragraph (4) as paragraph (3); and
            (4) in paragraph (3), as so redesignated--
                    (A) in subparagraphs (A) and (B), by striking 
                ``paragraph (1)(D)'' and inserting ``paragraph 
                (1)(C)''; and
                    (B) in subparagraph (B)--
                            (i) by striking clause (ii);
                            (ii) by striking ``shall pay'' through 
                        ``(i) application fees'' and inserting ``shall 
                        pay application fees''; and
                            (iii) by striking ``; and'' at the end and 
                        inserting a period.
    (e) Effect of Failure To Pay Fees.--Section 736(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking 
``all fees'' and inserting ``all such fees''.
    (f) Limitations.--Section 736(f)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking 
``supplements, prescription drug establishments, and prescription drug 
products'' and inserting ``prescription drug program fees''.
    (g) Crediting and Availability of Fees.--Section 736(g) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``and paragraph (4) of this 
                subsection''; and
            (2) by striking paragraph (4).
    (h) Orphan Drugs.--Section 736(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking ``product and 
establishment fees'' each place it appears and inserting ``prescription 
drug program fees''.

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 104. SUNSET DATES.

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

SEC. 105. EFFECTIVE DATE.

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

SEC. 106. SAVINGS CLAUSE.

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

                   TITLE II--FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDINGS.

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

SEC. 202. DEFINITIONS.

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

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

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

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

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

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

    (a) In General.--Section 514 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the 
following:
    ``(d) Pilot Accreditation Scheme for Conformity Assessment.--
            ``(1) In general.--The Secretary shall establish a pilot 
        program under which--
                    ``(A) testing laboratories may be accredited, by 
                accreditation bodies meeting criteria specified by the 
                Secretary, to assess the conformance of a device with 
                certain standards recognized under this section; and
                    ``(B) subject to paragraph (2), determinations by 
                testing laboratories so accredited that a device 
                conforms with such standard or standards shall be 
                accepted by the Secretary for purposes of demonstrating 
                such conformity under this section unless the Secretary 
                finds that a particular such determination shall not be 
                so accepted.
            ``(2) Secretarial review of accredited laboratory 
        determinations.--The Secretary may--
                    ``(A) review determinations by testing laboratories 
                accredited pursuant to this subsection, including by 
                conducting periodic audits of such determinations or 
                processes of accredited bodies or testing laboratories 
                and, following such review, taking additional measures 
                under this Act, such as suspension or withdrawal of 
                accreditation of such testing laboratory under 
                paragraph (1)(A) or requesting additional information 
                with respect to such device, as the Secretary 
                determines appropriate; and
                    ``(B) if the Secretary becomes aware of information 
                materially bearing on safety or effectiveness of a 
                device assessed for conformity by a testing laboratory 
                so accredited, take such additional measures under this 
                Act as the Secretary determines appropriate, such as 
                suspension or withdrawal of accreditation of such 
                testing laboratory under paragraph (1)(A), or 
                requesting additional information with regard to such 
                device.
            ``(3) Implementation and reporting.--
                    ``(A) Public meeting.--The Secretary shall publish 
                in the Federal Register a notice of a public meeting to 
                be held no later than September 30, 2018, to discuss 
                and obtain input and recommendations from stakeholders 
                regarding the goals and scope of, and a suitable 
                framework and procedures and requirements for, the 
                pilot program under this subsection.
                    ``(B) Pilot program guidance.--The Secretary 
                shall--
                            ``(i) not later than September 30, 2019, 
                        issue draft guidance regarding the goals and 
                        implementation of the pilot program under this 
                        subsection; and
                            ``(ii) not later than September 30, 2021, 
                        issue final guidance with respect to the 
                        implementation of such program.
                    ``(C) Pilot program initiation.--Not later than 
                September 30, 2020, the Secretary shall initiate the 
                pilot program under this subsection.
                    ``(D) Report.--The Secretary shall make available 
                on the website of the Food and Drug Administration an 
                annual report on the progress of the pilot program 
                under this subsection.
            ``(4) Sunset.--As of October 1, 2022--
                    ``(A) the authority for accreditation bodies to 
                accredit testing laboratories pursuant to paragraph 
                (1)(A) shall cease to have force or effect;
                    ``(B) the Secretary--
                            ``(i) may not accept a determination 
                        pursuant to paragraph (1)(B) made by a testing 
                        laboratory after such date; and
                            ``(ii) may accept such a determination made 
                        prior to such date;
                    ``(C) except for purposes of accepting a 
                determination described in subparagraph (B)(ii), the 
                Secretary shall not continue to recognize the 
                accreditation of testing laboratories accredited under 
                paragraph (1)(A); and
                    ``(D) the Secretary may take actions in accordance 
                with paragraph (2) with respect to the determinations 
                made prior to such date and recognition of the 
                accreditation of testing laboratories pursuant to 
                determinations made prior to such date.''.

SEC. 206. REAUTHORIZATION OF REVIEW.

    Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m) is amended--
            (1) in subsection (a)(3)--
                    (A) in subparagraph (A), by striking clauses (ii) 
                and (iii) and inserting the following:
                            ``(ii) a device classified under section 
                        513(f)(2) or designated under section 515C(d); 
                        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.--
            (1) In general.--Effective October 1, 2017, section 207(a) 
        of the Medical Device User Fee Amendments of 2012 (Public Law 
        112-144) is repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Safety and Innovation Act (Public Law 112-144) is amended in 
        the table of contents in section 2 by striking the item 
        relating to section 207.

               TITLE III--FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

    (a) Short Title.--This title may be cited as the ``Generic Drug 
User Fee Amendments of 2017''.
    (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to human generic drug 
activities, as set forth in the goals identified for purposes of part 7 
of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and Human Services to 
the Chairman of the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Congressional 
Record.

SEC. 302. DEFINITIONS.

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

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

    (a) Types of Fees.--Section 744B(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2013'' and inserting ``fiscal year 2018'';
            (2) in paragraph (1), by adding at the end the following:
                    ``(E) Sunset.--This paragraph shall cease to be 
                effective October 1, 2022.'';
            (3) in paragraph (2)--
                    (A) by amending subparagraph (C) to read as 
                follows:
                    ``(C) Notice.--Not later than 60 days before the 
                start of each of fiscal years 2018 through 2022, the 
                Secretary shall publish in the Federal Register the 
                amount of the drug master file fee established by this 
                paragraph for such fiscal year.''; and
                    (B) in subparagraph (E)--
                            (i) in clause (i)--
                                    (I) by striking ``no later than the 
                                date'' and inserting ``on the earlier 
                                of--
                                    ``(I) the date'';
                                    (II) by striking the period and 
                                inserting ``; or''; and
                                    (III) by adding at the end the 
                                following:
                                    ``(II) the date on which the drug 
                                master file holder requests the initial 
                                completeness assessment.''; and
                            (ii) in clause (ii), by striking ``notice 
                        provided for in clause (i) or (ii) of 
                        subparagraph (C), as applicable'' and inserting 
                        ``notice provided for in subparagraph (C)'';
            (4) in paragraph (3)--
                    (A) in the heading, by striking ``and prior 
                approval supplement'';
                    (B) in subparagraph (A), by striking ``or a prior 
                approval supplement to an abbreviated new drug 
                application'';
                    (C) by amending subparagraphs (B) and (C) to read 
                as follows:
                    ``(B) Notice.--Not later than 60 days before the 
                start of each of fiscal years 2018 through 2022, the 
                Secretary shall publish in the Federal Register the 
                amount of the fees under subparagraph (A) for such 
                fiscal year.
                    ``(C) Fee due date.--The fees required by 
                subparagraphs (A) and (F) shall be due no later than 
                the date of submission of the abbreviated new drug 
                application or prior approval supplement for which such 
                fee applies.'';
                    (D) in subparagraph (D)--
                            (i) in the heading, by inserting ``, is 
                        withdrawn prior to being received, or is no 
                        longer received'' after ``received''; and
                            (ii) by striking ``The Secretary shall'' 
                        and all that follows through the period and 
                        inserting the following:
                            ``(i) Applications not considered to have 
                        been received and applications withdrawn prior 
                        to being received.--The Secretary shall refund 
                        75 percent of the fee paid under subparagraph 
                        (A) for any abbreviated new drug application 
                        that the Secretary considers not to have been 
                        received within the meaning of section 
                        505(j)(5)(A) for a cause other than failure to 
                        pay fees, or that has been withdrawn prior to 
                        being received within the meaning of section 
                        505(j)(5)(A).
                            ``(ii) Applications no longer received.--
                        The Secretary shall refund 100 percent of the 
                        fee paid under subparagraph (A) for any 
                        abbreviated new drug application if the 
                        Secretary initially receives the application 
                        under section 505(j)(5)(A) and subsequently 
                        determines that an exclusivity period for a 
                        listed drug should have prevented the Secretary 
                        from receiving such application, such that the 
                        abbreviated new drug application is no longer 
                        received within the meaning of section 
                        505(j)(5)(A).'';
                    (E) in subparagraph (E), by striking ``or prior 
                approval supplement''; and
                    (F) in the matter preceding clause (i) of 
                subparagraph (F)--
                            (i) by striking ``2012'' and inserting 
                        ``2017''; and
                            (ii) by striking ``subsection (d)(3)'' and 
                        inserting ``subsection (d)(2)'';
            (5) in paragraph (4)--
                    (A) in subparagraph (A)--
                            (i) in the matter preceding clause (i) and 
                        in clause (iii), by striking ``, or intended to 
                        be identified, in at least one generic drug 
                        submission that is pending or'' and inserting 
                        ``in at least one generic drug submission that 
                        is'';
                            (ii) in clause (i), by striking ``or 
                        intended to be identified in at least one 
                        generic drug submission that is pending or'' 
                        and inserting ``in at least one generic drug 
                        submission that is'';
                            (iii) in clause (ii), by striking 
                        ``produces,'' and all that follows through 
                        ``such a'' and inserting ``is identified in at 
                        least one generic drug submission in which the 
                        facility is approved to produce one or more 
                        active pharmaceutical ingredients or in a Type 
                        II active pharmaceutical ingredient drug master 
                        file referenced in at least one such''; and
                            (iv) in clause (iii), by striking ``to fees 
                        under both such clauses'' and inserting ``only 
                        to the fee attributable to the manufacture of 
                        the finished dosage forms''; and
                    (B) by amending subparagraphs (C) and (D) to read 
                as follows:
                    ``(C) Notice.--Within the timeframe specified in 
                subsection (d)(1), the Secretary shall publish in the 
                Federal Register the amount of the fees under 
                subparagraph (A) for such fiscal year.
                    ``(D) Fee due date.--For each of fiscal years 2018 
                through 2022, the fees under subparagraph (A) for such 
                fiscal year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of each such year; or
                            ``(ii) the first business day after the 
                        enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such year under this section for such year.'';
            (6) by redesignating paragraph (5) as paragraph (6); and
            (7) by inserting after paragraph (4) the following:
            ``(5) Generic drug applicant program fee.--
                    ``(A) In general.--A generic drug applicant program 
                fee shall be assessed annually as described in 
                subsection (b)(2)(E).
                    ``(B) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (d).
                    ``(C) Notice.--Within the timeframe specified in 
                subsection (d)(1), the Secretary shall publish in the 
                Federal Register the amount of the fees under 
                subparagraph (A) for such fiscal year.
                    ``(D) Fee due date.--For each of fiscal years 2018 
                through 2022, the fees under subparagraph (A) for such 
                fiscal year shall be due on the later of--
                            ``(i) the first business day on or after 
                        October 1 of each such fiscal year; or
                            ``(ii) the first business day after the 
                        date of enactment of an appropriations Act 
                        providing for the collection and obligation of 
                        fees for such fiscal year under this section 
                        for such fiscal year.''.
    (b) Fee Revenue Amounts.--Section 744B(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A)--
                            (i) in the heading, by striking ``2013'' 
                        and inserting ``2018'';
                            (ii) by striking ``2013'' and inserting 
                        ``2018'';
                            (iii) by striking ``$299,000,000'' and 
                        inserting ``$493,600,000''; and
                            (iv) by striking ``Of that amount'' and all 
                        that follows through the end of clause (ii); 
                        and
                    (B) in subparagraph (B)--
                            (i) in the heading, by striking ``2014 
                        through 2017'' and inserting ``2019 through 
                        2022'';
                            (ii) by striking ``2014 through 2017'' and 
                        inserting ``2019 through 2022'';
                            (iii) by striking ``paragraphs (2) through 
                        (4)'' and inserting ``paragraphs (2) through 
                        (5)''; and
                            (iv) by striking ``$299,000,000'' and 
                        inserting ``$493,600,000''; and
            (2) in paragraph (2)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``paragraph (1)(A)(ii) for 
                        fiscal year 2013 and paragraph (1)(B) for each 
                        of fiscal years 2014 through 2017'' and 
                        inserting ``such paragraph for a fiscal year''; 
                        and
                            (ii) by striking ``through (4)'' and 
                        inserting ``through (5)'';
                    (B) in subparagraph (A), by striking ``Six 
                percent'' and inserting ``Five percent'';
                    (C) by amending subparagraphs (B) and (C) to read 
                as follows:
                    ``(B) Thirty-three percent shall be derived from 
                fees under subsection (a)(3) (relating to abbreviated 
                new drug applications).
                    ``(C) Twenty percent shall be derived from fees 
                under subsection (a)(4)(A)(i) (relating to generic drug 
                facilities). The amount of the fee for a contract 
                manufacturing organization facility shall be equal to 
                one-third the amount of the fee for a facility that is 
                not a contract manufacturing organization facility. The 
                amount of the fee for a facility located outside the 
                United States and its territories and possessions shall 
                be $15,000 higher than the amount of the fee for a 
                facility located in the United States and its 
                territories and possessions.'';
                    (D) in subparagraph (D)--
                            (i) by striking ``Fourteen percent'' and 
                        inserting ``Seven percent'';
                            (ii) by striking ``not less than $15,000 
                        and not more than $30,000'' and inserting 
                        ``$15,000''; and
                            (iii) by striking ``, as determined'' and 
                        all that follows through the period at the end 
                        and inserting a period; and
                    (E) by adding at the end the following:
                    ``(E)(i) Thirty-five percent shall be derived from 
                fees under subsection (a)(5) (relating to generic drug 
                applicant program fees). For purposes of this 
                subparagraph, if a person has affiliates, a single 
                program fee shall be assessed with respect to that 
                person, including its affiliates, and may be paid by 
                that person or any one of its affiliates. The Secretary 
                shall determine the fees as follows:
                            ``(I) If a person (including its 
                        affiliates) owns at least one but not more than 
                        5 approved abbreviated new drug applications on 
                        the due date for the fee under this subsection, 
                        the person (including its affiliates) shall be 
                        assessed a small business generic drug 
                        applicant program fee equal to one-tenth of the 
                        large size operation generic drug applicant 
                        program fee.
                            ``(II) If a person (including its 
                        affiliates) owns at least 6 but not more than 
                        19 approved abbreviated new drug applications 
                        on the due date for the fee under this 
                        subsection, the person (including its 
                        affiliates) shall be assessed a medium size 
                        operation generic drug applicant program fee 
                        equal to two-fifths of the large size operation 
                        generic drug applicant program fee.
                            ``(III) If a person (including its 
                        affiliates) owns 20 or more approved 
                        abbreviated new drug applications on the due 
                        date for the fee under this subsection, the 
                        person (including its affiliates) shall be 
                        assessed a large size operation generic drug 
                        applicant program fee.
                    ``(ii) For purposes of this subparagraph, an 
                abbreviated new drug application shall be deemed not to 
                be approved if the applicant has submitted a written 
                request for withdrawal of approval of such abbreviated 
                new drug application by April 1 of the previous fiscal 
                year.''.
    (c) Adjustments.--Section 744B(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``2014'' and inserting ``2019'';
                    (B) by inserting ``to equal the product of the 
                total revenues established in such notice for the prior 
                fiscal year multiplied'' after ``a fiscal year,''; and
                    (C) by striking the flush text following 
                subparagraph (C); and
            (2) in paragraph (2)--
                    (A) by striking ``2017'' each place it appears and 
                inserting ``2022'';
                    (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 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 the heading of subparagraph (F) of paragraph (1), 
        by striking ``biosimilar development program fees'' and 
        inserting ``biosimilar biological product development fees'';
            (12) in paragraph (1)(F)--
                    (A) in the heading of subparagraph (F), by striking 
                ``biosimilar development program'' before ``fees''; and
                    (B) by amending clause (i) to read as follows:
                            ``(i) Refunds.--Except as provided in 
                        subparagraph (B)(iv), the Secretary shall not 
                        refund any initial or annual biosimilar 
                        biological product development fee paid under 
                        subparagraph (A) or (B), or any reactivation 
                        fee paid under subparagraph (D).'';
            (13) in paragraph (2)--
                    (A) in the heading of paragraph (2), by striking 
                ``and supplement'';
                    (B) by amending subparagraphs (A) and (B) to read 
                as follows:
                    ``(A) In general.--Each person that submits, on or 
                after October 1, 2017, a biosimilar biological product 
                application shall be subject to the following fees:
                            ``(i) A fee established under subsection 
                        (c)(5) for a biosimilar biological product 
                        application for which clinical data (other than 
                        comparative bioavailability studies) with 
                        respect to safety or effectiveness are required 
                        for approval.
                            ``(ii) A fee established under subsection 
                        (c)(5) for a biosimilar biological product 
                        application for which clinical data (other than 
                        comparative bioavailability studies) with 
                        respect to safety or effectiveness are not 
                        required for approval. Such fee shall be equal 
                        to half of the amount of the fee described in 
                        clause (i).
                    ``(B) Rule of applicability; treatment of certain 
                previously paid fees.--Any person who pays a fee under 
                subparagraph (A), (B), or (D) of paragraph (1) for a 
                product before October 1, 2017, but submits a 
                biosimilar biological product application for that 
                product after such date, shall--
                            ``(i) be subject to any biosimilar 
                        biological product application fees that may be 
                        assessed at the time when such biosimilar 
                        biological product application is submitted; 
                        and
                            ``(ii) be entitled to no reduction of such 
                        application fees based on the amount of fees 
                        paid for that product before October 1, 2017, 
                        under such subparagraph (A), (B), or (D).'';
                    (C) in the heading of subparagraph (D), by striking 
                ``or supplement''; and
                    (D) in subparagraphs (C) through (F)--
                            (i) by striking ``or supplement'' each 
                        place it appears; and
                            (ii) in subparagraph (D), by striking ``or 
                        a supplement''; and
            (14) by amending paragraph (3) to read as follows:
            ``(3) Biosimilar biological product program fee.--
                    ``(A) In general.--Each person who is named as the 
                applicant in a biosimilar biological product 
                application shall pay the annual biosimilar biological 
                product program fee established for a fiscal year under 
                subsection (c)(5) for each biosimilar biological 
                product that--
                            ``(i) is identified in such a biosimilar 
                        biological product application approved as of 
                        October 1 of such fiscal year; and
                            ``(ii) as of October 1 of such fiscal year, 
                        does not appear on a list, developed and 
                        maintained by the Secretary, of discontinued 
                        biosimilar biological products.
                    ``(B) Due date.--The biosimilar biological product 
                program fee for a fiscal year shall be due on the later 
                of--
                            ``(i) the first business day on or after 
                        October 1 of each such year; or
                            ``(ii) the first business day after the 
                        enactment of an appropriations Act providing 
                        for the collection and obligation of fees for 
                        such year under this section.
                    ``(C) One fee per product per year.--The biosimilar 
                biological product program fee shall be paid only once 
                for each product for each fiscal year.
                    ``(D) Limitation.--A person who is named as the 
                applicant in a biosimilar biological product 
                application shall not be assessed more than 5 
                biosimilar biological product program fees for a fiscal 
                year for biosimilar biological products identified in 
                such biosimilar biological product application.''.
    (b) Fee Revenue Amounts.--Subsection (b) of section 744H of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended to 
read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) Fiscal year 2018.--For fiscal year 2018, fees under 
        subsection (a) shall be established to generate a total revenue 
        amount equal to the sum of--
                    ``(A) $45,000,000; and
                    ``(B) the dollar amount equal to the fiscal year 
                2018 adjustment (as determined under subsection 
                (c)(4)).
            ``(2) Subsequent fiscal years.--For each of the fiscal 
        years 2019 through 2022, fees under subsection (a) shall, 
        except as provided in subsection (c), be established to 
        generate a total revenue amount equal to the sum of--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (4));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2)); and
                    ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3)).
            ``(3) Allocation of revenue amount among fees; limitations 
        on fee amounts.--
                    ``(A) Allocation.--The Secretary shall determine 
                the percentage of the total revenue amount for a fiscal 
                year to be derived from, respectively--
                            ``(i) initial and annual biosimilar 
                        development fees and reactivation fees under 
                        subsection (a)(1);
                            ``(ii) biosimilar biological product 
                        application fees under subsection (a)(2); and
                            ``(iii) biosimilar biological product 
                        program fees under subsection (a)(3).
                    ``(B) Limitations on fee amounts.--Until the first 
                fiscal year for which the capacity planning adjustment 
                under subsection (c)(2) is effective, the amount of any 
                fee under subsection (a) for a fiscal year after fiscal 
                year 2018 shall not exceed 125 percent of the amount of 
                such fee for fiscal year 2018.
                    ``(C) Biosimilar biological product development 
                fees.--The initial biosimilar biological product 
                development fee under subsection (a)(1)(A) for a fiscal 
                year shall be equal to the annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                that fiscal year.
                    ``(D) Reactivation fee.--The reactivation fee under 
                subsection (a)(1)(D) for a fiscal year shall be equal 
                to twice the amount of the annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                that fiscal year.
            ``(4) Annual base revenue.--For purposes of paragraph (2), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be the dollar amount of the total revenue amount for the 
        previous fiscal year, excluding any adjustments to such revenue 
        amount under subsection (c)(3).''.
    (c) Adjustments; Annual Fee Setting.--Section 744H of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
            (1) by redesignating subsections (c) through (h) as 
        subsections (d) through (i), respectively;
            (2) in subsections (a)(2)(F) and (g), by striking 
        ``subsection (c)'' and inserting ``subsection (d)'';
            (3) in subsection (a)(4)(A), by striking ``subsection 
        (b)(1)(F)'' and inserting ``subsection (c)(5)''; and
            (4) by inserting after subsection (b) the following:
    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For purposes of subsection 
                (b)(2)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for each fiscal 
                year shall be equal to the product of--
                            ``(i) such annual base revenue for the 
                        fiscal year under subsection (b); and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                    ``(B) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this subparagraph 
                for a fiscal year is equal to the sum of--
                            ``(i) the average annual percent change in 
                        the cost, per full-time equivalent position of 
                        the Food and Drug Administration, of all 
                        personnel compensation and benefits paid with 
                        respect to such positions for the first 3 years 
                        of the preceding 4 fiscal years, multiplied by 
                        the proportion of personnel compensation and 
                        benefits costs to total costs of the process 
                        for the review of biosimilar biological product 
                        applications (as defined in section 744G(13)) 
                        for the first 3 years of the preceding 4 fiscal 
                        years; and
                            ``(ii) the average annual percent change 
                        that occurred in the Consumer Price Index for 
                        urban consumers (Washington-Baltimore, DC-MD-
                        VA-WV; Not Seasonally Adjusted; All items; 
                        Annual Index) for the first 3 years of the 
                        preceding 4 years of available data multiplied 
                        by the proportion of all costs other than 
                        personnel compensation and benefits costs to 
                        total costs of the process for the review of 
                        biosimilar biological product applications (as 
                        defined in section 744G(13)) for the first 3 
                        years of the preceding 4 fiscal years.
            ``(2) Capacity planning adjustment.--
                    ``(A) In general.--Beginning with the fiscal year 
                described in subparagraph (B)(ii)(II), the Secretary 
                shall, in addition to the adjustment under paragraph 
                (1), further increase the fee revenue and fees under 
                this section for a fiscal year to reflect changes in 
                the resource capacity needs of the Secretary for the 
                process for the review of biosimilar biological product 
                applications.
                    ``(B) Capacity planning methodology.--
                            ``(i) Development; evaluation and report.--
                        The Secretary shall obtain, through a contract 
                        with an independent accounting or consulting 
                        firm, a report evaluating options and 
                        recommendations for a new methodology to 
                        accurately assess changes in the resource and 
                        capacity needs of the process for the review of 
                        biosimilar biological product applications. The 
                        capacity planning methodological options and 
                        recommendations presented in such report shall 
                        utilize and be informed by personnel time 
                        reporting data as an input. The report shall be 
                        published for public comment not later than 
                        September 30, 2020.
                            ``(ii) Establishment and implementation.--
                        After review of the report described in clause 
                        (i) and receipt and review of public comments 
                        thereon, the Secretary shall establish a 
                        capacity planning methodology for purposes of 
                        this paragraph, which shall--
                                    ``(I) incorporate such approaches 
                                and attributes as the Secretary 
                                determines appropriate; and
                                    ``(II) be effective beginning with 
                                the first fiscal year for which fees 
                                are set after such capacity planning 
                                methodology is established.
                    ``(C) Limitation.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(2)(A) (the annual base 
                revenue for the fiscal year) and (b)(2)(B) (the dollar 
                amount of the inflation adjustment for the fiscal 
                year).
                    ``(D) Publication in federal register.--The 
                Secretary shall publish in the Federal Register notice 
                under paragraph (5) the fee revenue and fees resulting 
                from the adjustment and the methodologies under this 
                paragraph.
            ``(3) Operating reserve adjustment.--
                    ``(A) Interim application; fee reduction.--Until 
                the first fiscal year for which the capacity planning 
                adjustment under paragraph (2) is effective, the 
                Secretary may, in addition to the adjustment under 
                paragraph (1), reduce the fee revenue and fees under 
                this section for a fiscal year as the Secretary 
                determines appropriate for long-term financial planning 
                purposes.
                    ``(B) General application and methodology.--
                Beginning with the first fiscal year for which the 
                capacity planning adjustment under paragraph (2) is 
                effective, the Secretary may, in addition to the 
                adjustments under paragraphs (1) and (2)--
                            ``(i) reduce the fee revenue and fees under 
                        this section as the Secretary determines 
                        appropriate for long-term financial planning 
                        purposes; or
                            ``(ii) increase the fee revenue and fees 
                        under this section if such an adjustment is 
                        necessary to provide for not more than 21 weeks 
                        of operating reserves of carryover user fees 
                        for the process for the review of biosimilar 
                        biological product applications.
                    ``(C) Federal register notice.--If an adjustment 
                under subparagraph (A) or (B) is made, the rationale 
                for the amount of the increase or decrease (as 
                applicable) in fee revenue and fees shall be contained 
                in the annual Federal Register notice under paragraph 
                (5) establishing fee revenue and fees for the fiscal 
                year involved.
            ``(4) Fiscal year 2018 adjustment.--
                    ``(A) In general.--For fiscal year 2018, the 
                Secretary shall adjust the fee revenue and fees under 
                this section in such amount (if any) as needed to 
                reflect an updated assessment of the workload for the 
                process for the review of biosimilar biological product 
                applications.
                    ``(B) Methodology.--The Secretary shall publish 
                under paragraph (5) a description of the methodology 
                used to calculate the fiscal year 2018 adjustment under 
                this paragraph in the Federal Register notice 
                establishing fee revenue and fees for fiscal year 2018.
                    ``(C) Limitation.--No adjustment under this 
                paragraph shall result in an increase in fee revenue 
                and fees under this section in excess of $9,000,000.
            ``(5) Annual fee setting.--For fiscal year 2018 and each 
        subsequent fiscal year, the Secretary shall, not later than 60 
        days before the start of each such fiscal year--
                    ``(A) establish, for the fiscal year, initial and 
                annual biosimilar biological product development fees 
                and reactivation fees under subsection (a)(1), 
                biosimilar biological product application fees under 
                subsection (a)(2), and biosimilar biological product 
                program fees under subsection (a)(3), based on the 
                revenue amounts established under subsection (b) and 
                the adjustments provided under this subsection; and
                    ``(B) publish such fee revenue and fees in the 
                Federal Register.
            ``(6) Limit.--The total amount of fees assessed for a 
        fiscal year under this section may not exceed the total costs 
        for such fiscal year for the resources allocated for the 
        process for the review of biosimilar biological product 
        applications.''.
    (d) Application Fee Waiver for Small Business.--Subsection (d)(1) 
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended--
            (1) by striking subparagraph (B);
            (2) by striking ``shall pay--'' and all that follows 
        through ``application fees'' and inserting ``shall pay 
        application fees''; and
            (3) by striking ``; and'' at the end and inserting a 
        period.
    (e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as 
redesignated by subsection (c)(1), is amended by striking ``all fees'' 
and inserting ``all such fees''.
    (f) Crediting and Availability of Fees.--Subsection (f) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), 
as redesignated by subsection (c)(1), is amended--
            (1) in paragraph (2)--
                    (A) by striking subparagraph (C) (relating to fee 
                collection during first program year) and inserting the 
                following:
                    ``(C) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (B) in any fiscal year if the costs described in such 
                subparagraph are not more than 15 percent below the 
                level specified in such subparagraph.''; and
                    (B) in subparagraph (D)--
                            (i) in the heading, by striking ``in 
                        subsequent years''; and
                            (ii) by striking ``(after fiscal year 
                        2013)''; and
            (2) in paragraph (3), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

SEC. 405. SUNSET DATES.

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

SEC. 406. EFFECTIVE DATE.

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

SEC. 407. SAVINGS CLAUSE.

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

               TITLE V--REAUTHORIZATION OF OTHER PROGRAMS

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 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. 503. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
              PARTNERSHIPS.

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

SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE CONSORTIA.

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

SEC. 505. 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. 506. REAUTHORIZATION OF INSPECTION PROGRAM.

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

SEC. 507. 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''.

                    TITLE VI--ADDITIONAL PROVISIONS

SEC. 601. 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 (d)(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''.
                                 <all>