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[115th Congress Public Law 52]
[From the U.S. Government Publishing Office]

[[Page 131 STAT. 1005]]

Public Law 115-52
115th Congress

                                 An Act

 
 To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
 the user-fee programs for prescription drugs, medical devices, generic 
        drugs, and biosimilar biological products, and for other 
            purposes. <<NOTE: Aug. 18, 2017 -  [H.R. 2430]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: FDA 
Reauthorization Act of 2017. 21 USC 301 note.>> 
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``FDA Reauthorization Act of 2017''.
SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

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

                     TITLE I--FEES RELATING TO DRUGS

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

                   TITLE II--FEES RELATING TO DEVICES

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

                TITLE III--FEES RELATING TO GENERIC DRUGS

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

        TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

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

[[Page 131 STAT. 1006]]

Sec. 407. Savings clause.

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

Sec. 501. Best pharmaceuticals for children.
Sec. 502. Pediatric devices.
Sec. 503. Early meeting on pediatric study plan.
Sec. 504. Development of drugs and biological products for pediatric 
           cancers.
Sec. 505. Additional provisions on development of drugs and biological 
           products for pediatric use.

      TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

Sec. 601. Reauthorization of provision relating to exclusivity of 
           certain drugs containing single enantiomers.
Sec. 602. Reauthorization of the critical path public-private 
           partnerships.
Sec. 603. Reauthorization of orphan grants program.
Sec. 604. Protecting and strengthening the drug supply chain.
Sec. 605. Patient experience data.
Sec. 606. Communication plans.
Sec. 607. Orphan drugs.
Sec. 608. Pediatric information added to labeling.
Sec. 609. Sense of Congress on lowering the cost of prescription drugs.
Sec. 610. Expanded access.
Sec. 611. Tropical disease product application.

        TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

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

                TITLE VIII--IMPROVING GENERIC DRUG ACCESS

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

                     TITLE IX--ADDITIONAL PROVISIONS

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

TITLE <<NOTE: Prescription Drug User Fee Amendments of 2017.>>  I--FEES 
RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Prescription Drug User Fee Amendments of 2017''.

    (b) <<NOTE: 21 USC 379g note.>>  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

[[Page 131 STAT. 1007]]

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

[[Page 131 STAT. 1008]]

                    (L) by adding at the end of such paragraph (2) the 
                following:
                    ``(C) Limitation.--A person who is named as the 
                applicant in an approved human drug application shall 
                not be assessed more than 5 prescription drug program 
                fees for a fiscal year for prescription drug products 
                identified in such approved human drug application.''.
            (2) Conforming amendment.--Subparagraph (C) of section 
        740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        379j-12(a)(3)) is amended to read as follows:
                    ``(C) Limitation.--An establishment shall be 
                assessed only one fee per fiscal year under this 
                section.''.

    (b) Fee Revenue Amounts.--Subsection (b) of section 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read 
as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--For each of the fiscal years 2018 through 
        2022, fees under subsection (a) shall, except as provided in 
        subsections (c), (d), (f), and (g), be established to generate a 
        total revenue amount under such subsection that is equal to the 
        sum of--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the capacity 
                planning adjustment for the fiscal year (as determined 
                under subsection (c)(2));
                    ``(D) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(3));
                    ``(E) the dollar amount equal to the additional 
                direct cost adjustment for the fiscal year (as 
                determined under subsection (c)(4)); and
                    ``(F) additional dollar amounts for each fiscal year 
                as follows:
                          ``(i) $20,077,793 for fiscal year 2018.
                          ``(ii) $21,317,472 for fiscal year 2019.
                          ``(iii) $16,953,329 for fiscal year 2020.
                          ``(iv) $5,426,896 for fiscal year 2021.
                          ``(v) $2,769,609 for fiscal year 2022.
            ``(2) Types of fees.--Of the total revenue amount determined 
        for a fiscal year under paragraph (1)--
                    ``(A) 20 percent shall be derived from human drug 
                application fees under subsection (a)(1); and
                    ``(B) 80 percent shall be derived from prescription 
                drug program fees under subsection (a)(2).
            ``(3) Annual base revenue.--For purposes of paragraph (1), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be--
                    ``(A) for fiscal year 2018, $878,590,000; and
                    ``(B) for fiscal years 2019 through 2022, the dollar 
                amount of the total revenue amount established under 
                paragraph (1) for the previous fiscal year, not 
                including any adjustments made under subsection (c)(3) 
                or (c)(4).''.

[[Page 131 STAT. 1009]]

    (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) <<NOTE: Time period.>>  Adjustment 
                      percentage.--The adjustment percentage under this 
                      clause for a fiscal year is the weighted change in 
                      the 3-year average ending in the

[[Page 131 STAT. 1010]]

                      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) <<NOTE: Contracts. Recommenda- tions.>>  
                      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. <<NOTE: Publication. Public 
                      information. Deadline.>>  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) <<NOTE: Effective date.>>  
                                be effective beginning with the first 
                                fiscal year for which fees are set after 
                                such capacity planning methodology is 
                                established.
                    ``(D) Limitation.--Under no circumstances shall an 
                adjustment under this paragraph result in fee revenue 
                for a fiscal year that is less than the sum of the 
                amounts under subsections (b)(1)(A) (the annual base 
                revenue for the fiscal year) and (b)(1)(B) (the dollar 
                amount of the inflation adjustment for the fiscal year).
                    ``(E) Publication in federal register.--The 
                Secretary shall publish in the Federal Register notice 
                under paragraph (5) of the fee revenue and fees 
                resulting from the adjustment and the methodologies 
                under this paragraph.
            ``(3) <<NOTE: Time period.>>  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

[[Page 131 STAT. 1011]]

                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) <<NOTE: Deadline. Time period.>>  Annual fee 
        setting.--The Secretary shall, not later than 60 days before the 
        start of each fiscal year that begins after September 30, 2017--
                    ``(A) establish, for each such fiscal year, human 
                drug application fees and prescription drug program fees 
                under subsection (a), based on the revenue amounts 
                established under subsection (b) and the adjustments 
                provided under this subsection; and
                    ``(B) <<NOTE: Federal Register, publication.>>  
                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

[[Page 131 STAT. 1012]]

                    (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) <<NOTE: 21 USC 379g note.>>  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) <<NOTE: 21 USC 379h-2 note.>>  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) <<NOTE: Effective date. Repeal. 21 USC 379g note, 379h-2 
note.>>  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. <<NOTE: 21 USC 379g note.>>  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

[[Page 131 STAT. 1013]]

for all human drug applications received on or after October 1, 2017, 
regardless of the date of the enactment of this Act.
SEC. 106. <<NOTE: 21 USC 379g note.>>  SAVINGS CLAUSE.

    Notwithstanding <<NOTE: Continuation. Time period.>>  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 <<NOTE: Medical Device User Fee Amendments of 2017.>>  II--FEES 
RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Medical Device User Fee Amendments of 2017''.

    (b) <<NOTE: 21 USC 379i note.>>  Finding.--The Congress finds that 
the fees authorized under the amendments made by this title will be 
dedicated toward expediting the process for the review of device 
applications and for assuring the safety and effectiveness of devices, 
as set forth in the goals identified for purposes of part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
in the letters from the Secretary of Health and Human Services to the 
Chairman of the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Chairman of the Committee on Energy and Commerce of 
the House of Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.

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

    (b) Conforming Amendment.--Section 714(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379d-3(b)(1)) is amended by striking 
``737(8)'' and inserting ``737(9)''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    (a) Types of Fees.--Section 738(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(a)) is amended--
            (1) in paragraph (1), by striking ``fiscal year 2013'' and 
        inserting ``fiscal year 2018''; and
            (2) in paragraph (2)--
                    (A) in subparagraph (A)--

[[Page 131 STAT. 1014]]

                          (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.'';

[[Page 131 STAT. 1015]]

                    (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) <<NOTE: Determination.>>  if the 
                      Secretary determines necessary, increase (in 
                      addition to the adjustment under clause (i)) such 
                      base fee amounts, on a uniform proportionate 
                      basis, to generate the total revenue amounts under 
                      subsection (b)(3), as adjusted for inflation under 
                      subparagraph (A).''; and
            (3) in paragraph (3)--
                    (A) by striking ``2014 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``further adjusted'' and inserting 
                ``increased''.

    (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval Fees.--Section 738(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(d)) is amended--
            (1) in paragraph (1), by striking ``specified in clauses (i) 
        through (v) and clauses (vii), (ix), and (x)'' and inserting 
        ``specified in clauses (i) through (vii) and clauses (ix), (x), 
        and (xi)''; and
            (2) in paragraph (2)(C)--
                    (A) by striking ``supplement, or'' and inserting 
                ``supplement,''; and
                    (B) by inserting ``, or a de novo classification 
                request'' after ``class III device''.

    (e) Small Businesses; Fee Reduction Regarding Premarket Notification 
Submissions.--Section 738(e)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking ``50'' and 
inserting ``25''.
    (f) Fee Waiver or Reduction.--
            (1) Repeal.--Section 738 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection 
        (f).
            (2) Conforming amendments.--
                    (A) Section 515(c)(4)(A) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by 
                striking ``738(h)'' and inserting ``738(g)''.
                    (B) Section 738 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 379j), as amended by paragraph 
                (1), is further amended--
                          (i) by redesignating subsections (g) through 
                      (l) as subsections (f) through (k);
                          (ii) in subsection (a)(2)(A), by striking 
                      ``(d), (e), and (f)'' and inserting ``(d) and 
                      (e)''; and
                          (iii) in subsection (a)(3)(A), by striking 
                      ``and subsection (f)''.

    (g) Effect of Failure To Pay Fees.--Subsection (f)(1), as so 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j) is amended--

[[Page 131 STAT. 1016]]

            (1) by striking ``or periodic reporting concerning a class 
        III device'' and inserting ``periodic reporting concerning a 
        class III device, or de novo classification request''; and
            (2) by striking ``all fees'' and inserting ``all such 
        fees''.

    (h) Conditions.--Subsection (g)(1)(A), as so redesignated, of 
section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) 
is amended by striking ``$280,587,000'' and inserting ``$320,825,000''.
    (i) Crediting and Availability of Fees.--Subsection (h), as so 
redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j) is amended--
            (1) in paragraph (3)--
                    (A) by striking ``2013 through 2017'' and inserting 
                ``2018 through 2022''; and
                    (B) by striking ``subsection (c)'' and all that 
                follows through the period at the end and inserting 
                ``subsection (c).''; and
            (2) by striking paragraph (4).
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

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

    (b) Reauthorization.--Section 738A(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
            (1) in paragraph (1), by striking ``2017'' and inserting 
        ``2022''; and
            (2) in paragraph (5), by striking ``2017'' and inserting 
        ``2022''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

    (a) In General.--Section 514 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360d) is amended by adding at the end the following:
    ``(d) Pilot Accreditation Scheme for Conformity Assessment.--
            ``(1) In general.--The Secretary shall establish a pilot 
        program under which--
                    ``(A) testing laboratories may be accredited, by 
                accreditation bodies meeting criteria specified by the 
                Secretary, to assess the conformance of a device with 
                certain standards recognized under this section; and
                    ``(B) subject to paragraph (2), determinations by 
                testing laboratories so accredited that a device 
                conforms with such standard or standards shall be 
                accepted by the Secretary for purposes of demonstrating 
                such conformity under this section unless the Secretary 
                finds that a particular such determination shall not be 
                so accepted.

[[Page 131 STAT. 1017]]

            ``(2) Secretarial review of accredited laboratory 
        determinations.--The Secretary may--
                    ``(A) <<NOTE: Audits.>>  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) <<NOTE: Deadlines.>>  Implementation and reporting.--
                    ``(A) <<NOTE: Federal Register, 
                publication. Notice.>>  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) <<NOTE: Web posting.>>  Report.--The Secretary 
                shall make available on the internet website of the Food 
                and Drug Administration an annual report on the progress 
                of the pilot program under this subsection.
            ``(4) Sunset.--As of October 1, 2022--
                    ``(A) the authority for accreditation bodies to 
                accredit testing laboratories pursuant to paragraph 
                (1)(A) shall cease to have force or effect;
                    ``(B) the Secretary--
                          ``(i) may not accept a determination pursuant 
                      to paragraph (1)(B) made by a testing laboratory 
                      after such date; and
                          ``(ii) may accept such a determination made 
                      prior to such date;
                    ``(C) except for purposes of accepting a 
                determination described in subparagraph (B)(ii), the 
                Secretary shall not continue to recognize the 
                accreditation of testing laboratories accredited under 
                paragraph (1)(A); and
                    ``(D) the Secretary may take actions in accordance 
                with paragraph (2) with respect to the determinations 
                made

[[Page 131 STAT. 1018]]

                prior to such date and recognition of the accreditation 
                of testing laboratories pursuant to determinations made 
                prior to such date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.

    Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360m) is amended--
            (1) in subsection (a)(3)--
                    (A) in subparagraph (A), by striking clauses (ii) 
                and (iii) and inserting the following:
                          ``(ii) a device classified under section 
                      513(f)(2) or designated under section 515C(d);
                          ``(iii) a device that is intended to be 
                      permanently implantable, life sustaining, or life 
                      supporting, unless otherwise determined by the 
                      Secretary in accordance with subparagraph 
                      (B)(i)(II) and listed as eligible for review under 
                      subparagraph (B)(iii); or
                          ``(iv) a device that is of a type, or subset 
                      of a type, listed as not eligible for review under 
                      subparagraph (B)(iii).'';
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(B) Designation for review.--The Secretary shall--
                          ``(i) <<NOTE: Guidance.>>  issue draft 
                      guidance on the factors the Secretary will use in 
                      determining whether a class I or class II device 
                      type, or subset of such device types, is eligible 
                      for review by an accredited person, including--
                                    ``(I) the risk of the device type, 
                                or subset of such device type; and
                                    ``(II) whether the device type, or 
                                subset of such device type, is 
                                permanently implantable, life 
                                sustaining, or life supporting, and 
                                whether there is a detailed public 
                                health justification for permitting the 
                                review by an accredited person of such 
                                device type or subset;
                          ``(ii) <<NOTE: Deadline.>>  not later than 24 
                      months after the date on which the Secretary 
                      issues such draft guidance, finalize such 
                      guidance; and
                          ``(iii) <<NOTE: Effective date. Web 
                      posting. Lists. Determination.>>  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) <<NOTE: Lists.>>  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

[[Page 131 STAT. 1019]]

                          (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) <<NOTE: Deadline.>>  Presubmissions and submissions 
        solely in electronic format.--
                    ``(A) <<NOTE: Effective date.>>  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) <<NOTE: Criteria.>>  criteria for 
                      waivers of and exemptions from the requirements of 
                      this subsection.
                    ``(C) Final guidance.--The Secretary shall, not 
                later than 1 year after the close of the public comment 
                period on the draft guidance issued under subparagraph 
                (B), issue final guidance.''.
SEC. 208. <<NOTE: 21 USC 379i note.>>  SAVINGS CLAUSE.

    Notwithstanding <<NOTE: Continuation. Time period.>>  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.

[[Page 131 STAT. 1020]]

SEC. 209. <<NOTE: 21 USC 379i note.>>  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. <<NOTE: 21 USC 378i note.>>  SUNSET DATES.

    (a) Authorization.--Sections 737 and 738 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective 
October 1, 2022.
    (b) <<NOTE: 21 USC 379j-1 note.>>  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) <<NOTE: Effective date. Repeal. 21 USC 379i note.>>  Previous 
Sunset Provision.--Effective October 1, 2017, section 207(a) of the Food 
and Drug Administration Safety and Innovation Act (Public Law 112-144) 
is repealed.

  TITLE <<NOTE: Generic Drug User Fee Amendments of 2017.>>  III--FEES 
RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Generic Drug User Fee Amendments of 2017''.

    (b) <<NOTE: 21 USC 379j-41 note.>>  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.''.

[[Page 131 STAT. 1021]]

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) <<NOTE: Deadline. Time period. Federal 
                Register, publication.>>  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) <<NOTE: Deadline. Time period. Federal 
                Register, publication.>>  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) <<NOTE: Deadline. Applicability.>>  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

[[Page 131 STAT. 1022]]

                      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) <<NOTE: Refunds.>>  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) <<NOTE: Federal Register, publication.>>  
                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) <<NOTE: Time period. Deadlines.>>  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.'';

[[Page 131 STAT. 1023]]

            (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) <<NOTE: Federal Register, publication.>>  
                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) <<NOTE: Time period. Deadlines.>>  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).

[[Page 131 STAT. 1024]]

                    ``(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 <<NOTE: Determination.>>  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) <<NOTE: Deadline.>>  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'';

[[Page 131 STAT. 1025]]

                    (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) <<NOTE: Time period. Deadline.>>  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) <<NOTE: Deadline.>>  by striking ``Such 
                information shall'' and all that follows through the end 
                of subparagraph (B) and inserting ``Such information 
                shall, for each fiscal year, be submitted, updated, or 
                reconfirmed on or before June 1 of the previous fiscal 
                year.''; and
            (4) in paragraph (2), as so redesignated--
                    (A) in the heading, by striking ``Contents of 
                notice'' and inserting ``Information required to be 
                submitted'';
                    (B) in the matter preceding subparagraph (A), by 
                striking ``paragraph (2)'' and inserting ``paragraph 
                (1)'';
                    (C) in subparagraph (A), by striking ``or intended 
                to be identified'';
                    (D) in subparagraph (D), by striking ``and'' at the 
                end;
                    (E) in subparagraph (E), by striking the period and 
                inserting ``; and''; and
                    (F) by adding at the end the following:
                    ``(F) whether the facility is a contract 
                manufacturing organization facility.''.

    (f) Effect of Failure To Pay Fees.--Section 744B(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended--

[[Page 131 STAT. 1026]]

            (1) in paragraph (1), by adding at the end the following: 
        ``This paragraph <<NOTE: Termination date.>>  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) <<NOTE: Deadline. Time period.>>  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) <<NOTE: Public information. Lists.>>  
                      The Secretary shall place the person on a publicly 
                      available arrears list.
                          ``(ii) Any abbreviated new drug application 
                      submitted by the generic drug applicant or an 
                      affiliate of such applicant shall not be received, 
                      within the meaning of section 505(j)(5)(A).
                          ``(iii) All drugs marketed pursuant to any 
                      abbreviated new drug application held by such 
                      applicant or an affiliate of such applicant shall 
                      be deemed misbranded under section 502(aa).
                    ``(B) Application of penalties.--The penalties under 
                subparagraph (A) shall apply until the fee required 
                under subsection (a)(5) is paid.''.

    (g) Limitations.--Section 744B(h)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-42(h)(2)) is amended by striking ``for Type 
II active pharmaceutical ingredient drug master files, abbreviated new 
drug applications and prior approval supplements, and generic drug 
facilities and active pharmaceutical ingredient facilities''.
    (h) Crediting and Availability of Fees.--Section 744B(i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)) is amended--
            (1) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``subparagraphs 
                (C) and (D)'' and inserting ``subparagraph (C)'';
                    (B) by striking subparagraph (C) (relating to fee 
                collection during first program year);
                    (C) in subparagraph (D)--
                          (i) in the heading, by striking ``in 
                      subsequent years''; and
                          (ii) by striking ``(after fiscal year 2013)''; 
                      and
                    (D) by redesignating subparagraph (D) as 
                subparagraph (C); and
            (2) in paragraph (3), by striking ``fiscal years 2013 
        through 2017'' and inserting ``fiscal years 2018 through 2022''.

    (i) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--Section 744B of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-42) is amended by adding at the 
end the following:
    ``(o) Information on Abbreviated New Drug Applications Owned by 
Applicants and Their Affiliates.--
            ``(1) <<NOTE: Deadline. Lists.>>  In general.--By April 1 of 
        each year, each person that owns an abbreviated new drug 
        application, or a designated affiliate of such person, shall 
        submit, on behalf of the person and the affiliates of such 
        person, to the Secretary a list of--

[[Page 131 STAT. 1027]]

                    ``(A) all approved abbreviated new drug applications 
                owned by such person; and
                    ``(B) if any affiliate of such person also owns an 
                abbreviated new drug application, all affiliates that 
                own any such abbreviated new drug application and all 
                approved abbreviated new drug applications owned by any 
                such affiliate.
            ``(2) <<NOTE: Guidance.>>  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) <<NOTE: 21 USC 379j-41 note.>>  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) <<NOTE: 21 USC 379j-43 note.>>  Reporting Requirements.--Section 
744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) 
shall cease to be effective January 31, 2023.

    (c) Previous Sunset Provision.--
            (1) <<NOTE: Effective date. Repeal. 21 USC 379j-41 note, 
        379j-43 note.>>  In general.--Effective October 1, 2017, section 
        304 of the Food and Drug Administration Safety and Innovation 
        Act (Public Law 112-144) is repealed.
            (2) Conforming amendment.--The Food and Drug Administration 
        Safety and Innovation Act (Public Law 112-144) is amended in the 
        table of contents in section 2 by striking the item relating to 
        section 304.
SEC. 306. <<NOTE: 21 USC 379j-41 note.>>  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. <<NOTE: 21 USC 379j-41 note.>>  SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 7 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
as in effect on the day before the date of the enactment of this title, 
shall continue to be in effect with respect to abbreviated new drug 
applications (as defined in such part as of such day) that were received 
by the Food and Drug Administration within the meaning of section 
505(j)(5)(A) of such Act (21

[[Page 131 STAT. 1028]]

U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, 
and drug master files for Type II active pharmaceutical ingredients that 
were first referenced on or after October 1, 2012, but before October 1, 
2017, with respect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2018.

   TITLE <<NOTE: Biosimilar User Fee Amendments of 2017.>>  IV--FEES 
RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Biosimilar User Fee Amendments of 2017''.

    (b) <<NOTE: 21 USC 379j-51 note.>>  Finding.--The Congress finds 
that the fees authorized by the amendments made in this title will be 
dedicated to expediting the process for the review of biosimilar 
biological product applications, including postmarket safety activities, 
as set forth in the goals identified for purposes of part 8 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
in the letters from the Secretary of Health and Human Services to the 
Chairman of the Committee on Health, Education, Labor, and Pensions of 
the Senate and the Chairman of the Committee on Energy and Commerce of 
the House of Representatives, as set forth in the Congressional Record.
SEC. 402. DEFINITIONS.

    (a) Adjustment Factor.--Section 744G(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows:
            ``(1) The term `adjustment factor' applicable to a fiscal 
        year is the Consumer Price Index for urban consumers 
        (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All 
        items) for October of the preceding fiscal year divided by such 
        Index for October 2011.''.

    (b) Biosimilar Biological Product.--Section 744G(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3)) is amended by 
striking ``means a product'' and inserting ``means a specific strength 
of a biological product in final dosage form''.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

    (a) Types of Fees.--Section 744H(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``fiscal year 2013'' and inserting ``fiscal year 2018'';
            (2) in the heading of paragraph (1), by striking 
        ``Biosimilar'' and inserting ``Biosimilar biological product'';
            (3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and 
        inserting ``(c)(5)'';
            (4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for 
        biosimilar biological product development'' and inserting 
        ``(c)(5) for the biosimilar biological product development 
        program'';
            (5) in paragraph (1)(B)(ii), by striking ``annual biosimilar 
        biological product development program fee'' and inserting 
        ``annual biosimilar biological product development fee'';

[[Page 131 STAT. 1029]]

            (6) in paragraph (1)(B)(iii), by striking ``annual 
        biosimilar development program fee'' and inserting ``annual 
        biosimilar biological product development fee'';
            (7) in paragraph (1)(B), by adding at the end the following:
                          ``(iv) Refund.--If a person submits a 
                      marketing application for a biosimilar biological 
                      product before October 1 of a fiscal year and such 
                      application is accepted for filing on or after 
                      October 1 of such fiscal year, the person may 
                      request a refund equal to the annual biosimilar 
                      biological product development fee paid by the 
                      person for the product for such fiscal year. To 
                      qualify <<NOTE: Deadline.>>  for consideration for 
                      a refund under this clause, a person shall submit 
                      to the Secretary a written request for such refund 
                      not later than 180 days after the marketing 
                      application is accepted for filing.'';
            (8) in paragraph (1)(C), by striking ``for a product 
        effective October 1 of a fiscal year by,'' and inserting ``for a 
        product, effective October 1 of a fiscal year, by,'';
            (9) in paragraph (1)(D)--
                    (A) in clause (i) in the matter preceding subclause 
                (I), by inserting ``, if the person seeks to resume 
                participation in such program,'' before ``pay a fee'';
                    (B) in clause (i)(I), by inserting after ``grants a 
                request'' the following: ``by such person''; and
                    (C) in clause (i)(II), by inserting after 
                ``discontinued)'' the following: ``by such person'';
            (10) in the heading of paragraph (1)(E), by striking 
        ``biosimilar development program'';
            (11) in paragraph (1)(F)--
                    (A) in the subparagraph heading, by striking 
                ``biosimilar development program''; and
                    (B) by amending clause (i) to read as follows:
                          ``(i) Refunds.--Except as provided in 
                      subparagraph (B)(iv), the Secretary shall not 
                      refund any initial or annual biosimilar biological 
                      product development fee paid under subparagraph 
                      (A) or (B), or any reactivation fee paid under 
                      subparagraph (D).'';
            (12) in paragraph (2)--
                    (A) in the paragraph heading, by striking ``and 
                supplement'';
                    (B) by amending subparagraphs (A) and (B) to read as 
                follows:
                    ``(A) In general.--Each person that submits, on or 
                after October 1, 2017, a biosimilar biological product 
                application shall be subject to the following fees:
                          ``(i) A fee established under subsection 
                      (c)(5) for a biosimilar biological product 
                      application for which clinical data (other than 
                      comparative bioavailability studies) with respect 
                      to safety or effectiveness are required for 
                      approval.
                          ``(ii) A fee established under subsection 
                      (c)(5) for a biosimilar biological product 
                      application for which clinical data (other than 
                      comparative bioavailability studies) with respect 
                      to safety or effectiveness are not required for 
                      approval. Such fee shall be equal to half of the 
                      amount of the fee described in clause (i).

[[Page 131 STAT. 1030]]

                    ``(B) Rule of applicability; treatment of certain 
                previously paid fees.--Any person who pays a fee under 
                subparagraph (A), (B), or (D) of paragraph (1) for a 
                product before October 1, 2017, but submits a biosimilar 
                biological product application for that product after 
                such date, shall--
                          ``(i) be subject to any biosimilar biological 
                      product application fees that may be assessed at 
                      the time when such biosimilar biological product 
                      application is submitted; and
                          ``(ii) be entitled to no reduction of such 
                      application fees based on the amount of fees paid 
                      for that product before October 1, 2017, under 
                      such subparagraph (A), (B), or (D).'';
                    (C) in the heading of subparagraph (D), by striking 
                ``or supplement'';
                    (D) in subparagraphs (C) through (F), by striking 
                ``or supplement'' each place it appears; and
                    (E) in subparagraph (D), by striking ``or a 
                supplement'';
            (13) by amending paragraph (3) to read as follows:
            ``(3) Biosimilar biological product program fee.--
                    ``(A) In general.--Each person who is named as the 
                applicant in a biosimilar biological product application 
                shall pay the annual biosimilar biological product 
                program fee established for a fiscal year under 
                subsection (c)(5) for each biosimilar biological product 
                that--
                          ``(i) is identified in such a biosimilar 
                      biological product application approved as of 
                      October 1 of such fiscal year; and
                          ``(ii) as of October 1 of such fiscal year, 
                      does not appear on a list, developed and 
                      maintained by the Secretary, of discontinued 
                      biosimilar biological products.
                    ``(B) <<NOTE: Deadlines.>>  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

[[Page 131 STAT. 1031]]

                    ``(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) <<NOTE: Determination.>>  Allocation.--The 
                Secretary shall determine the percentage of the total 
                revenue amount for a fiscal year to be derived from, 
                respectively--
                          ``(i) initial and annual biosimilar biological 
                      product development fees and reactivation fees 
                      under subsection (a)(1);
                          ``(ii) biosimilar biological product 
                      application fees under subsection (a)(2); and
                          ``(iii) biosimilar biological product program 
                      fees under subsection (a)(3).
                    ``(B) Limitations on fee amounts.--Until the first 
                fiscal year for which the capacity planning adjustment 
                under subsection (c)(2) is effective, the amount of any 
                fee under subsection (a) for a fiscal year after fiscal 
                year 2018 shall not exceed 125 percent of the amount of 
                such fee for fiscal year 2018.
                    ``(C) Biosimilar biological product development 
                fees.--The initial biosimilar biological product 
                development fee under subsection (a)(1)(A) for a fiscal 
                year shall be equal to the annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                that fiscal year.
                    ``(D) Reactivation fee.--The reactivation fee under 
                subsection (a)(1)(D) for a fiscal year shall be equal to 
                twice the amount of the annual biosimilar biological 
                product development fee under subsection (a)(1)(B) for 
                that fiscal year.
            ``(4) Annual base revenue.--For purposes of paragraph (2), 
        the dollar amount of the annual base revenue for a fiscal year 
        shall be the dollar amount of the total revenue amount for the 
        previous fiscal year, excluding any adjustments to such revenue 
        amount under subsection (c)(3).''.

    (c) Adjustments; Annual Fee Setting.--Section 744H of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is amended--
            (1) by redesignating subsections (c) through (h) as 
        subsections (d) through (i), respectively;

[[Page 131 STAT. 1032]]

            (2) in subsections (a)(2)(F) and (h) (as redesignated by 
        paragraph (1)), by striking ``subsection (c)'' and inserting 
        ``subsection (d)'';
            (3) in subsection (a)(4)(A), by striking ``subsection 
        (b)(1)(F)'' and inserting ``subsection (c)(5)''; and
            (4) by inserting after subsection (b) the following:

    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For purposes of subsection 
                (b)(2)(B), the dollar amount of the inflation adjustment 
                to the annual base revenue for each fiscal year shall be 
                equal to the product of--
                          ``(i) such annual base revenue for the fiscal 
                      year under subsection (b); and
                          ``(ii) the inflation adjustment percentage 
                      under subparagraph (B).
                    ``(B) <<NOTE: Time periods.>>  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) <<NOTE: Effective date.>>  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) <<NOTE: Contracts.>>  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

[[Page 131 STAT. 1033]]

                      capacity planning methodological options and 
                      recommendations presented in such report shall 
                      utilize and be informed by personnel time 
                      reporting data as an 
                      input. <<NOTE: Publication. Public 
                      information. Deadline.>>  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) <<NOTE: Effective date.>>  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) <<NOTE: Notice.>>  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 <<NOTE: Effective date.>>  
                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) <<NOTE: Time period.>>  increase the 
                      fee revenue and fees under this section if such an 
                      adjustment is necessary to provide for not more 
                      than 21 weeks of operating reserves of carryover 
                      user fees for the process for the review of 
                      biosimilar biological product applications.
                    ``(C) Federal register notice.--If an adjustment 
                under subparagraph (A) or (B) is made, the rationale for 
                the amount of the increase or decrease (as applicable) 
                in fee revenue and fees shall be contained in the annual 
                Federal Register notice under paragraph (5)(B) 
                establishing fee revenue and fees for the fiscal year 
                involved.
            ``(4) Fiscal year 2018 adjustment.--
                    ``(A) <<NOTE: Assessment.>>  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

[[Page 131 STAT. 1034]]

                assessment of the workload for the process for the 
                review of biosimilar biological product applications.
                    ``(B) <<NOTE: Federal Register, 
                publication. Notice.>>  Methodology.--The Secretary 
                shall publish under paragraph (5)(B) a description of 
                the methodology used to calculate the fiscal year 2018 
                adjustment under this paragraph in the Federal Register 
                notice establishing fee revenue and fees for fiscal year 
                2018.
                    ``(C) Limitation.--No adjustment under this 
                paragraph shall result in an increase in fee revenue and 
                fees under this section in excess of $9,000,000.
            ``(5) <<NOTE: Time period. Deadline.>>  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) <<NOTE: Federal Register, publication.>>  
                publish such fee revenue and fees in the Federal 
                Register.
            ``(6) Limit.--The total amount of fees assessed for a fiscal 
        year under this section may not exceed the total costs for such 
        fiscal year for the resources allocated for the process for the 
        review of biosimilar biological product applications.''.

    (d) Application Fee Waiver for Small Business.--Subsection (d)(1) of 
section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-52), as redesignated by subsection (c)(1), is amended--
            (1) by striking subparagraph (B);
            (2) by striking ``; and'' at the end of subparagraph (A) and 
        inserting a period; and
            (3) by striking ``shall pay--'' and all that follows through 
        ``application fees'' and inserting ``shall pay application 
        fees''.

    (e) Effect of Failure To Pay Fees.--Subsection (e) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as 
redesignated by subsection (c)(1), is amended by striking ``all fees'' 
and inserting ``all such fees''.
    (f) Crediting and Availability of Fees.--Subsection (f) of section 
744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52), as 
redesignated by subsection (c)(1), is amended--
            (1) in paragraph (2)--
                    (A) by striking subparagraph (C) (relating to fee 
                collection during first program year) and inserting the 
                following:
                    ``(C) Compliance.--The Secretary shall be considered 
                to have met the requirements of subparagraph (B) in any 
                fiscal year if the costs described in such subparagraph 
                are not more than 15 percent below the level specified 
                in such subparagraph.''; and
                    (B) in subparagraph (D)--
                          (i) in the heading, by striking ``in 
                      subsequent years''; and
                          (ii) by striking ``(after fiscal year 2013)''; 
                      and
            (2) in paragraph (3), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.

[[Page 131 STAT. 1035]]

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) <<NOTE: 21 USC 379j-51 note.>>  Authorization.--Sections 744G 
and 744H of the Federal Food, Drug, and Cosmetic Act shall cease to be 
effective October 1, 2022.

    (b) <<NOTE: 21 USC 379j-53 note.>>  Reporting Requirements.--Section 
744I of the Federal Food, Drug, and Cosmetic Act shall cease to be 
effective January 31, 2023.

    (c) Previous Sunset Provision.--
            (1) <<NOTE: Effective date. Repeal. 21 USC 379j-51 note, 
        379j-53 note.>>  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. <<NOTE: 21 USC 379j-51 note.>>  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. <<NOTE: 21 USC 379j-51 note.>>  SAVINGS CLAUSE.

    Notwithstanding <<NOTE: Continuation. Time period.>>  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.

[[Page 131 STAT. 1036]]

                  TITLE V--PEDIATRIC DRUGS AND DEVICES

SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.

    Section 409I of the Public Health Service Act (42 U.S.C. 284m) is 
amended--
            (1) in subsection (a)(2)(A)(ii), by inserting ``and 
        identification of biomarkers for such diseases, disorders, or 
        conditions,'' after ``biologics,'';
            (2) in subsection (c)--
                    (A) in paragraph (6)--
                          (i) by amending subparagraph (B) to read as 
                      follows:
                    ``(B) Availability of reports.--
                          ``(i) In general.--Each report submitted under 
                      subparagraph (A) shall be considered to be in the 
                      public domain (subject to section 505A(d)(4) of 
                      the Federal Food, Drug, and Cosmetic Act) and not 
                      later than 90 days after submission of such 
                      report, shall be--
                                    ``(I) <<NOTE: Web posting.>>  posted 
                                on the internet website of the National 
                                Institutes of Health in a manner that is 
                                accessible and consistent with all 
                                applicable Federal laws and regulations, 
                                including such laws and regulations for 
                                the protection of--
                                            ``(aa) human research 
                                        participants, including with 
                                        respect to privacy, security, 
                                        informed consent, and protected 
                                        health information; and
                                            ``(bb) proprietary 
                                        interests, confidential 
                                        commercial information, and 
                                        intellectual property rights; 
                                        and
                                    ``(II) <<NOTE: Public 
                                information.>>  assigned a docket number 
                                by the Commissioner of Food and Drugs 
                                and made available for the submission of 
                                public comments.
                          ``(ii) Submission of comments.--An interested 
                      person may submit written comments concerning such 
                      pediatric studies to the Commissioner of Food and 
                      Drugs, and the submitted comments shall become 
                      part of the docket file with respect to each of 
                      the drugs.''; and
                          (ii) in subparagraph (C), by striking 
                      ``appropriate action'' and all that follows 
                      through the period and inserting ``action in a 
                      timely and appropriate manner in response to the 
                      reports submitted under subparagraph (A), and 
                      shall begin such action upon receipt of the report 
                      under subparagraph (A), in accordance with 
                      paragraph (7).''; and
                    (B) in paragraph (7)--
                          (i) in the matter preceding subparagraph (A), 
                      by striking ``During'' and inserting ``Within'';
                          (ii) in subparagraph (C)(i), by striking 
                      ``place'' and all that follows through ``and of'' 
                      and inserting ``include in the public docket file 
                      a reference to the location of the report on the 
                      internet website of the National Institutes of 
                      Health and a copy of''; and

[[Page 131 STAT. 1037]]

                          (iii) in clause (ii), by striking ``in the 
                      Federal Register and'';
            (3) by striking subsection (d);
            (4) by redesignating subsection (e) as subsection (d); and
            (5) in paragraph (1) of subsection (d), as so redesignated, 
        by striking ``2013 through 2017'' and inserting ``2018 through 
        2022''.
SEC. 502. PEDIATRIC DEVICES.

    (a) Pediatric Use of Devices.--Section 515A(a)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) is amended--
            (1) by redesignating subparagraphs (B) through (D) as 
        subparagraphs (D) through (F), respectively;
            (2) by inserting after subparagraph (A) the following:
                    ``(B) any information, based on a review of data 
                available to the Secretary, regarding devices used in 
                pediatric patients but not labeled for such use for 
                which the Secretary determines that approved pediatric 
                labeling could confer a benefit to pediatric patients;
                    ``(C) the number of pediatric devices that receive a 
                humanitarian use exemption under section 520(m);'';
            (3) in subparagraph (E), as so redesignated, by striking ``; 
        and'' and inserting ``;'';
            (4) in subparagraph (F) (as so redesignated), by striking 
        ``(B), and (C).'' and inserting ``(C), (D), and (E);''; and
            (5) by adding at the end the following:
                    ``(G) the number of devices for which the Secretary 
                relied on data with respect to adults to support a 
                determination of a reasonable assurance of safety and 
                effectiveness in pediatric patients; and
                    ``(H) the number of devices for which the Secretary 
                relied on data from one pediatric subpopulation to 
                support a determination of a reasonable assurance of 
                safety and effectiveness in another pediatric 
                subpopulation.
        For the items described in this paragraph, such report shall 
        disaggregate the number of devices by pediatric 
        subpopulation.''.

    (b) Humanitarian Device Exemption.--Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (4)--
                    (A) in subparagraph (B), by inserting ``or an 
                appropriate local committee'' after ``review committee'' 
                each place such term appears; and
                    (B) in the matter following subparagraph (B), by 
                inserting ``or an appropriate local committee'' after 
                ``review committee'' each place such term appears; and
            (2) in paragraph (6)(A)(iv), by striking ``2017'' and 
        inserting ``2022''.

    (c) Demonstration Grants for Improving Pediatric Availability.--
Section 305 of the Pediatric Medical Device Safety and Improvement Act 
of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (4), by striking ``and'' at the 
                end;

[[Page 131 STAT. 1038]]

                    (B) in paragraph (5), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following:
            ``(6) <<NOTE: Consultation.>>  providing regulatory 
        consultation to device sponsors in support of the submission of 
        an application for a pediatric device, where appropriate.''; and
            (2) in subsection (e), by striking ``2013 through 2017'' and 
        inserting ``2018 through 2022''.

    (d) Meeting on Pediatric Device Development.--
            (1) <<NOTE: Deadline. Public information.>>  In general.--
        Not later than 1 year after the date of enactment of this Act, 
        the Secretary of Health and Human Services shall convene a 
        public meeting on the development, approval or clearance, and 
        labeling of pediatric medical devices. The Secretary shall 
        invite to such meeting representatives from the medical device 
        industry, academia, recipients of funding under section 305 of 
        the Pediatric Medical Device Safety and Improvement Act of 2007 
        (Public Law 110-85; 42 U.S.C. 282 note), medical provider 
        organizations, and organizations representing patients and 
        consumers.
            (2) Topics.--The meeting described in paragraph (1) shall 
        include consideration of ways to--
                    (A) improve research infrastructure and research 
                networks to facilitate the conduct of clinical studies 
                of devices for pediatric populations that would result 
                in the approval or clearance, and labeling, of medical 
                devices for such populations;
                    (B) appropriately use extrapolation under section 
                515A(b) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360e-1(b));
                    (C) enhance the appropriate use of postmarket 
                registries and data to increase pediatric medical device 
                labeling;
                    (D) increase Food and Drug Administration assistance 
                to medical device manufacturers in developing devices 
                for pediatric populations that are approved or cleared, 
                and labeled, for their use; and
                    (E) identify current barriers to pediatric device 
                development and incentives to address such barriers.
            (3) Report.--The report submitted under section 515A(a)(3) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-
        1(a)(3)) with respect to the calendar year in which the meeting 
        described in paragraph (1) is held shall include a summary of, 
        and responses to, recommendations raised in such meeting.
SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.

    (a) In General.--Clause (i) of section 505B(e)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to 
read as follows:
                          ``(i) shall meet with the applicant--
                                    ``(I) <<NOTE: Deadlines.>>  if 
                                requested by the applicant with respect 
                                to a drug or biological product that is 
                                intended to treat a serious or life-
                                threatening disease or condition, to 
                                discuss preparation of the initial 
                                pediatric study plan, not later than the 
                                end-of-Phase 1 meeting (as such term is 
                                used in section 312.82(b) of title 21, 
                                Code of Federal Regulations,

[[Page 131 STAT. 1039]]

                                or successor regulations) or within 30 
                                calendar days of receipt of such 
                                request, whichever is later;
                                    ``(II) to discuss the initial 
                                pediatric study plan as soon as 
                                practicable, but not later than 90 
                                calendar days after the receipt of such 
                                plan under subparagraph (A); and
                                    ``(III) to discuss the bases for the 
                                deferral under subsection (a)(4) or a 
                                full or partial waiver under subsection 
                                (a)(5);''.

    (b) Conforming Changes.--Section 505B(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
            (1) in the heading of paragraph (2), by striking ``meeting'' 
        and inserting ``meetings'';
            (2) in the heading of paragraph (2)(C), by striking 
        ``Meeting'' and inserting ``Meetings'';
            (3) in clauses (ii) and (iii) of paragraph (2)(C), by 
        striking ``no meeting'' each place it appears and inserting ``no 
        meeting under clause (i)(II)''; and
            (4) in paragraph (3) by striking ``meeting under paragraph 
        (2)(C)(i)'' and inserting ``meeting under paragraph 
        (2)(C)(i)(II)''.
SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR 
                        PEDIATRIC CANCERS.

    (a) Molecular Targets Regarding Cancer Drugs and Biological 
Products.--Section 505B of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                          (i) by redesignating subparagraphs (A) and (B) 
                      as clauses (i) and (ii), respectively, and 
                      adjusting the margins accordingly;
                          (ii) by striking ``A person'' and inserting 
                      the following:
                    ``(A) General requirements.--Except with respect to 
                an application for which subparagraph (B) applies, a 
                person'';
                          (iii) in clause (i), as so redesignated, by 
                      striking ``, or'' at the end and inserting ``; 
                      or''; and
                          (iv) by adding after subparagraph (A), as so 
                      designated by clause (ii), the following:
                    ``(B) <<NOTE: Time period. Reports.>>  Certain 
                molecularly targeted cancer indications.--A person that 
                submits, on or after the date that is 3 years after the 
                date of enactment of the FDA Reauthorization Act of 
                2017, an original application for a new active 
                ingredient under section 505 of this Act or section 351 
                of the Public Health Service Act, shall submit with the 
                application reports on the investigation described in 
                paragraph (3) if the drug or biological product that is 
                the subject of the application is--
                          ``(i) intended for the treatment of an adult 
                      cancer; and
                          ``(ii) directed at a molecular target that the 
                      Secretary determines to be substantially relevant 
                      to the growth or progression of a pediatric 
                      cancer.'';
                    (B) in paragraph (2)(A), by striking ``paragraph 
                (1)'' and inserting ``paragraph (1)(A)'';

[[Page 131 STAT. 1040]]

                    (C) by redesignating paragraphs (3) and (4) as 
                paragraphs (4) and (5), respectively;
                    (D) by inserting after paragraph (2) the following:
            ``(3) Molecularly targeted pediatric cancer investigation.--
                    ``(A) In general.--With respect to a drug or 
                biological product described in paragraph (1)(B), the 
                investigation described in this paragraph is a 
                molecularly targeted pediatric cancer investigation, 
                which shall be designed to yield clinically meaningful 
                pediatric study data, gathered using appropriate 
                formulations for each age group for which the study is 
                required, regarding dosing, safety, and preliminary 
                efficacy to inform potential pediatric labeling.
                    ``(B) <<NOTE: Applicability.>>  Extrapolation of 
                data.--Paragraph (2)(B) shall apply to investigations 
                described in this paragraph to the same extent and in 
                the same manner as paragraph (2)(B) applies with respect 
                to the assessments required under paragraph (1)(A).
                    ``(C) <<NOTE: Applicability.>>  Deferrals and 
                waivers.--Deferrals and waivers under paragraphs (4) and 
                (5) shall apply to investigations described in this 
                paragraph to the same extent and in the same manner as 
                such deferrals and waivers apply with respect to the 
                assessments under paragraph (2)(B).'';
                    (E) in paragraph (4), as so redesignated--
                          (i) by striking ``assessments required under 
                      paragraph (1)'' each place it appears and 
                      inserting ``assessments required under paragraph 
                      (1)(A) or reports on the investigation required 
                      under paragraph (1)(B)'';
                          (ii) in subparagraph (A)(ii)(I), by inserting 
                      ``or reports on the investigation'' after 
                      ``assessments'';
                          (iii) in subparagraph (B)(ii), by striking 
                      ``assessment under paragraph (1)'' and inserting 
                      ``assessment under paragraph (1)(A) or reports on 
                      the investigation under paragraph (1)(B)''; and
                          (iv) in subparagraph (C)(ii)(II), by inserting 
                      ``or investigation'' after ``assessment''; and
                    (F) in paragraph (5), as so redesignated, by 
                inserting ``or reports on the investigation'' after 
                ``assessments'' each place it appears;
            (2) in subsection (d)--
                    (A) by striking ``subsection (a)(3)'' each place it 
                appears and inserting ``subsection (a)(4)'';
                    (B) by inserting ``and Reports on the 
                Investigation'' after ``Submission of Assessments'' in 
                the heading; and
                    (C) by inserting ``or the investigation described in 
                subsection (a)(3)'' after ``assessment described in 
                subsection (a)(2)'' each place it appears;
            (3) in subsection (e)--
                    (A) in paragraph (1), by inserting ``or the 
                investigation described in subsection (a)(3)'' after 
                ``under subsection (a)(2)''; and
                    (B) in paragraph (2)(A)(i), by inserting ``or the 
                investigation described in subsection (a)(3)'' after 
                ``under subsection (a)(2)''; and
            (4) by adding at the end the following:

    ``(m) List of Primary Molecular Targets.--

[[Page 131 STAT. 1041]]

            ``(1) <<NOTE: Deadline. Update. Web posting. Lists.>>  In 
        general.--Within one year of the date of enactment of the FDA 
        Reauthorization Act of 2017, the Secretary shall establish and 
        update regularly, and shall publish on the internet website of 
        the Food and Drug Administration--
                    ``(A) a list of molecular targets considered, on the 
                basis of data the Secretary determines to be adequate, 
                to be substantially relevant to the growth and 
                progression of a pediatric cancer, and that may trigger 
                the requirements under this section; and
                    ``(B) <<NOTE: Waiver.>>  a list of molecular targets 
                of new cancer drugs and biological products in 
                development for which pediatric cancer study 
                requirements under this section will be automatically 
                waived.
            ``(2) Consultation.--In establishing the lists described in 
        paragraph (1), the Secretary shall consult the National Cancer 
        Institute, members of the internal committee under section 505C, 
        and the Pediatric Oncology Subcommittee of the Oncologic Drugs 
        Advisory Committee, and shall take into account comments from 
        the meeting under subsection (c).
            ``(3) Rule of construction.--Nothing in paragraph (1) shall 
        be construed--
                    ``(A) to require the inclusion of a molecular target 
                on the list published under such paragraph as a 
                condition for triggering the requirements under 
                subsection (a)(1)(B) with respect to a drug or 
                biological product directed at such molecular target; or
                    ``(B) to authorize the disclosure of confidential 
                commercial information, as prohibited under section 
                301(j) of this Act or section 1905 of title 18, United 
                States Code.''.

    (b) Orphan Drugs.--Section 505B(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows:
    ``(k) Relation to Orphan Drugs.--
            ``(1) In general; exemption for orphan indications.--Unless 
        the Secretary requires otherwise by regulation and except as 
        provided in paragraph (2), this section does not apply to any 
        drug or biological product for an indication for which orphan 
        designation has been granted under section 526.
            ``(2) Applicability despite orphan designation of certain 
        indications.--This section shall apply with respect to a drug or 
        biological product for which an indication has been granted 
        orphan designation under 526 if the investigation described in 
        subsection (a)(3) applies to the drug or biological product as 
        described in subsection (a)(1)(B).''.

    (c) <<NOTE: 21 USC 355c note.>>  Meeting, Consultation, and 
Guidance.--
            (1) <<NOTE: Deadline.>>  Meeting.--The Secretary of Health 
        and Human Services (referred to in this subsection as the 
        ``Secretary''), acting through the Commissioner of Food and 
        Drugs and in collaboration with the Director of the National 
        Cancer Institute, shall convene a public meeting not later than 
        1 year after the date of enactment of this Act to solicit 
        feedback from physicians and researchers (including pediatric 
        oncologists and rare disease specialists), patients, and other 
        stakeholders to provide input on development of the guidance 
        under paragraph (2) and the list under subsection (m) of section 
        505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355c), as added by subsection (a). The Secretary shall seek 
        input at such meeting on--

[[Page 131 STAT. 1042]]

                    (A) the data necessary to determine that there is 
                scientific evidence that a drug or biological product is 
                directed at a molecular target that is considered to be 
                substantially relevant to the growth or progression of a 
                pediatric cancer;
                    (B) the data necessary to determine that there is 
                scientific evidence that a molecular target is 
                considered to be substantially relevant to the growth or 
                progression of a pediatric cancer;
                    (C) the data needed to meet the requirement of 
                conducting an investigation described in section 
                505B(a)(3) of the Federal Food, Drug, and Cosmetic Act, 
                as amended by subsection (a);
                    (D) considerations when developing the list under 
                section 505B(m) of the Federal Food, Drug, and Cosmetic 
                Act that contains molecular targets shared between 
                different tumor types;
                    (E) <<NOTE: Lists.>>  the process the Secretary 
                shall utilize to update regularly a list of molecular 
                targets that may trigger a pediatric study under section 
                505B of the Federal Food, Drug, and Cosmetic Act, as so 
                amended, and how often such updates shall occur;
                    (F) how to overcome the challenges related to 
                pediatric cancer drug and biological product 
                development, including issues related to the ethical, 
                practical, and other barriers to conducting clinical 
                trials in pediatric cancer with small patient 
                populations;
                    (G) scientific or operational challenges associated 
                with performing an investigation described in section 
                505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic 
                Act, including the effect on pediatric studies currently 
                underway in a pediatric patient population, treatment of 
                a pediatric patient population, and the ability to 
                complete adult clinical trials;
                    (H) the advantages and disadvantages of innovative 
                clinical trial designs in addressing the development of 
                cancer drugs or biological products directed at 
                molecular targets in pediatric cancer patients;
                    (I) the ways in which the Secretary can improve the 
                current process outlined under sections 505A and 505B of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355a, 355c) to encourage additional research and 
                development of pediatric cancer treatments;
                    (J) the ways in which the Secretary might streamline 
                and improve the written request process, including when 
                studies contained in a request under such section 505A 
                are not feasible due to the ethical, practical, or other 
                barriers to conducting clinical trials in pediatric 
                cancer populations;
                    (K) how the Secretary will facilitate collaboration 
                among pediatric networks, academic centers and experts 
                in pediatric cancer to conduct an investigation 
                described in such section 505B(a)(3);
                    (L) how the Secretary may facilitate collaboration 
                among sponsors of same-in-class drugs and biological 
                products that would be subject to the requirements for 
                an investigation under such section 505B based on shared 
                molecular targets; and

[[Page 131 STAT. 1043]]

                    (M) the ways in which the Secretary will help to 
                mitigate the risks, if any, of discouraging the research 
                and development of orphan drugs when implementing such 
                section 505B as amended.
            (2) <<NOTE: Deadline.>>  Guidance.--Not later than 2 years 
        after the date of enactment of this Act, the Secretary, acting 
        through the Commissioner of Food and Drugs, shall issue final 
        guidance on implementation of the amendments to section 505B of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) 
        regarding molecularly targeted cancer drugs made by this 
        section, including--
                    (A) <<NOTE: Criteria.>>  the scientific criteria, 
                types of data, and regulatory considerations for 
                determining whether a molecular target is substantially 
                relevant to the growth or progression of a pediatric 
                cancer and would trigger an investigation under section 
                505B of the Federal Food, Drug, and Cosmetic Act, as 
                amended;
                    (B) the process by which the Secretary will engage 
                with sponsors to discuss determinations, investigation 
                requirements, deferrals, waivers, and any other issues 
                that need to be resolved to ensure that any required 
                investigation based on a molecular target can be 
                reasonably conducted;
                    (C) the scientific or operational challenges for 
                which the Secretary may issue deferrals or waivers for 
                an investigation described in subsection (a)(3) of such 
                section 505B, including adverse impacts on current 
                pediatric studies underway in a pediatric patient 
                population, studies involving drugs designated as orphan 
                drugs, treatment of a pediatric patient population, or 
                the ability to complete adult clinical trials;
                    (D) how the Secretary and sponsors will facilitate 
                collaboration among pediatric networks, academic 
                centers, and experts in pediatric cancer to conduct an 
                investigation described in subsection (a)(3) of such 
                section 505B;
                    (E) scientific and regulatory considerations for 
                study designs, including the applicability of innovative 
                clinical trial designs for pediatric cancer drug and 
                biological product developments under sections 505A and 
                505B of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355a, 355c);
                    (F) approaches to streamline and improve the 
                amendment process, including when studies contained in a 
                request under such section 505A are not feasible due to 
                the ethical, practical, or other barriers to conducting 
                clinical trials in pediatric cancer populations;
                    (G) <<NOTE: Plan.>>  the process for submission of 
                an initial pediatric study plan for the investigation 
                described in section 505B(a)(3) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)), including 
                the process for a sponsor to meet and reach agreement 
                with the Secretary on the initial pediatric study plan; 
                and
                    (H) considerations for implementation of such 
                section 505B, as so amended, and waivers of the 
                requirements of such section 505B with regard to 
                molecular targets for which several drugs or biological 
                products may be under investigation.

[[Page 131 STAT. 1044]]

    (d) Report to Congress.--Section 508(b) of the Food and Drug 
Administration Safety and Innovation Act (21 U.S.C. 355c-1(b)) is 
amended--
            (1) in paragraph (10), by striking ``; and'' and inserting 
        ``;''; and
            (2) by striking paragraph (11) and inserting the following:
            ``(11) <<NOTE: Assessment.>>  an assessment of the impact of 
        the amendments to such section 505B made by the FDA 
        Reauthorization Act of 2017 on pediatric research and labeling 
        of drugs and biological products and pediatric labeling of 
        molecularly targeted drugs and biological products for the 
        treatment of cancer;
            ``(12) <<NOTE: Assessment.>>  an assessment of the efforts 
        of the Secretary to implement the plan developed under section 
        505C-1 of the Federal Food, Drug, and Cosmetic Act, regarding 
        earlier submission of pediatric studies under sections 505A and 
        505B of such Act and section 351(m) of the Public Health Service 
        Act, including--
                    ``(A) the average length of time after the approval 
                of an application under section 505(b)(1) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or 
                section 351(a) of the Public Health Service Act (42 
                U.S.C. 262(a)) before studies conducted pursuant to such 
                section 505A, 505B, or section 351(m) are completed, 
                submitted, and incorporated into labeling;
                    ``(B) the average length of time after the receipt 
                of a proposed pediatric study request before the 
                Secretary responds to such request;
                    ``(C) the average length of time after the 
                submission of a proposed pediatric study request before 
                the Secretary issues a written request for such studies;
                    ``(D) the number of written requests issued for each 
                investigational new drug or biological product prior to 
                the submission of an application under section 505(b)(1) 
                of the Federal Food, Drug, and Cosmetic Act or section 
                351(a) of the Public Health Service Act; and
                    ``(E) the average number, and range of numbers, of 
                amendments to written requests issued, and the time the 
                Secretary requires to review and act on proposed 
                amendments to written requests;
            ``(13) <<NOTE: Lists.>>  a list of sponsors of applications 
        or holders of approved applications who received exclusivity 
        under such section 505A or such section 351(m) after receiving a 
        letter issued under such section 505B(d)(1) for any drug or 
        biological product before the studies referred to in such letter 
        were completed and submitted;
            ``(14) <<NOTE: Lists.>>  a list of assessments and 
        investigations required under such section 505B;
            ``(15) how many requests under such section 505A for 
        molecular targeted cancer drugs, as defined by subsection 
        (a)(1)(B) of such section 505B, approved prior to 3 years after 
        the date of enactment of the FDA Reauthorization Act of 2017, 
        have been issued by the Food and Drug Administration, and how 
        many such requests have been completed; and
            ``(16) <<NOTE: Assessment.>>  the Secretary's assessment of 
        the overall impact of the amendments made by section 504 of the 
        FDA Reauthorization Act of 2017 on the conduct and effectiveness 
        of pediatric

[[Page 131 STAT. 1045]]

        cancer research and the orphan drug program, as well any 
        subsequent recommendations.''.

    (e) <<NOTE: 21 USC 355c note.>>  Rule of Construction.--Nothing in 
this section, including the amendments made by this section, shall limit 
the authority of the Secretary of Health and Human Services to issue 
written requests under section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health 
Service Act (42 U.S.C. 262(m)), or to negotiate or implement amendments 
to such requests proposed by the an applicant.

    (f) GAO Report.--
            (1) <<NOTE: Effective date. Time period. Study.>>  In 
        general.--Beginning on the date that is 5 years after the date 
        of enactment of this Act, the Comptroller General of the United 
        States shall conduct a study of the effectiveness of requiring 
        assessments and investigations described in section 505B of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as 
        amended by this section, in the development of drugs and 
        biological products for pediatric cancer 
        indications. <<NOTE: Examination.>>  The Comptroller General 
        shall examine--
                    (A) the indications and associated molecular targets 
                studied in assessments and investigations required for 
                drugs or biological products intended for the treatment 
                of an adult cancer;
                    (B) the indication for which the study was requested 
                as compared to the indication requested under the new 
                drug application filed by the sponsor;
                    (C) the number of pediatric cancer indications for 
                which assessments and investigations have been required 
                under such section 505B;
                    (D) the number of requests for deferral and waiver 
                of pediatric assessments and investigations required 
                under such section and the number of such deferral and 
                waiver requests granted and denied;
                    (E) the number of orphan-designated indications for 
                drugs and biological products for which assessments and 
                investigations were required under such section;
                    (F) the number of drugs and biological products 
                approved for the treatment of cancer in the pediatric 
                population for which the supportive studies were 
                required to be conducted under such section;
                    (G) the number of written requests made under 
                section 505A of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355a) relating to investigations required 
                under subsection (a)(1)(B) of such section 505B; and
                    (H) any additional considerations by the Secretary 
                regarding the effectiveness of requiring pediatric 
                assessments described in such section 505B in the 
                development of drugs and biological products for 
                pediatric cancer indications.
            (2) <<NOTE: Criteria.>>  Review.--The study under paragraph 
        (1) shall include a review of the Food and Drug Administration's 
        use of the authority under section 505B of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355c), as amended by this 
        section, including the amendments to the deferral and waiver 
        criteria under such section and how such criteria have been 
        applied.
            (3) Consultation.--In conducting the study under paragraph 
        (1), the Comptroller General of the United States shall consult 
        with appropriate stakeholders that may be required

[[Page 131 STAT. 1046]]

        to conduct the trials under section 505B of the Federal Food, 
        Drug, and Cosmetic Act, and the ability of such stakeholders to 
        adhere to the requests issued by the Food and Drug 
        Administration.
            (4) Report.--Not later than the date that is 6 years after 
        the date of enactment of this Act, the Comptroller General of 
        the United States shall submit a report containing the results 
        of the study under paragraph (1) to the Secretary of Health and 
        Human Services, the Committee on Health, Education, Labor, and 
        Pensions of the Senate, and the Committee on Energy and Commerce 
        of the House of Representatives.
SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND 
                        BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.

    (a) Informing Internal Review Committee.--Section 505A(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by 
adding at the end the following:
            ``(7) Informing internal review committee.--The Secretary 
        shall provide to the committee referred to in paragraph (1) any 
        response issued to an applicant or holder with respect to a 
        proposed pediatric study request.''.

    (b) Action on Submissions.--
            (1) In general.--Section 505A(d) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355a(d)) is amended--
                    (A) by redesignating paragraphs (3) through (5) as 
                paragraphs (4) through (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) <<NOTE: Deadline.>>  Action on submissions.--The 
        Secretary shall review and act upon a submission by a sponsor or 
        holder of a proposed pediatric study request or a proposed 
        amendment to a written request for pediatric studies within 120 
        calendar days of the submission.''.
            (2) Conforming amendments.--
                    (A) Federal food, drug, and cosmetic act.--Section 
                505A of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355a), as amended by paragraph (1), is further 
                amended by striking subsection ``(d)(3)'' each place it 
                appears and inserting ``(d)(4)''.
                    (B) Public health service act.--Paragraphs (2), (3), 
                and (4) of section 351(m) of the Public Health Service 
                Act (42 U.S.C. 262(m)) are amended by striking ``section 
                505A(d)(3)'' each place it appears and inserting 
                ``section 505A(d)(4)''.

    (c) <<NOTE: Deadline. 21 USC 355a note.>>  Plan.--The Secretary of 
Health and Human Services, acting through the internal review committee 
established under section 505C of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355d) shall, not later than one year after the date of 
enactment of this Act, develop and implement a plan to achieve, when 
appropriate, earlier submission of pediatric studies under section 505A 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section 
351(m) of the Public Health Service Act (42 U.S.C. 
262(m)). <<NOTE: Recommenda- tions.>>  Such plan shall include 
recommendations to achieve--
            (1) earlier discussion of proposed pediatric study requests 
        and written requests with sponsors, and if appropriate, 
        discussion of such requests at the meeting required under 
        section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a);

[[Page 131 STAT. 1047]]

            (2) earlier issuance of written requests for a pediatric 
        study under such section 505A, including for investigational new 
        drugs prior to the submission of an application under section 
        505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and
            (3) shorter timelines, when appropriate, for the completion 
        of studies pursuant to a written request under such section 505A 
        or such section 351(m).

    (d) Neonatology Expertise.--
            (1) In general.--Section 6(d) of the Best Pharmaceuticals 
        for Children Act (21 U.S.C. 393a(d)) is amended by striking 
        ``For the 5-year period beginning on the date of enactment of 
        this subsection, at'' and inserting ``At''.
            (2) <<NOTE: Deadline. 21 USC 355a note.>>  Draft guidance.--
        Not later than 2 years after the date of enactment of this Act, 
        the Secretary shall issue draft guidance on clinical 
        pharmacology considerations for neonatal studies for drugs and 
        biological products.

    (e) Submission of Assessments.--Section 505B(d)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is amended by adding 
at the end the following: ``The Secretary shall inform the Pediatric 
Advisory Committee of letters issued under this paragraph and responses 
to such letters.''.
    (f) Internal Committee.--Section 505C of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355d) is amended by inserting ``or pediatric 
rare diseases'' after ``psychiatry''.
    (g) Report on Labeling of Orphan Drugs.--
            (1) <<NOTE: Public information. Web posting.>>  In 
        general.--Not later than 2 years after the date of the enactment 
        of this Act, the Secretary of Health and Human Services shall 
        submit to the Committee on Health, Education, Labor and Pensions 
        of the Senate and the Committee on Energy and Commerce of the 
        House of Representatives, and make publicly available, including 
        through posting on the internet website of the Food and Drug 
        Administration, a report on the lack of information in the 
        labeling of drugs for indications that have received an orphan 
        designation under section 526 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360bbb) with respect to the use of such 
        drugs pediatric populations.
            (2) Contents.--The report described in paragraph (1) shall 
        include--
                    (A) <<NOTE: Lists.>>  a list of drugs for which--
                          (i) an indication was granted an orphan 
                      designation under section 526 of the Federal Food, 
                      Drug, and Cosmetic Act (21 U.S.C. 360bbb);
                          (ii) an application described under section 
                      505B(a)(1) of the Federal Food, Drug, and Cosmetic 
                      Act (21 U.S.C. 355c(a)(1)) for such indication was 
                      submitted to the Secretary of Health and Human 
                      Services on or after April 1, 1999; and
                          (iii) the labeling for such indication lacks 
                      important pediatric information, including 
                      information related to safety, dosing, and 
                      effectiveness;
                    (B) a description of the lack of information 
                referred to in subparagraph (A)(iii) for each drug for 
                an indication on such list; and
                    (C) <<NOTE: Recommenda- tions.>>  Federal policy 
                recommendations to improve the labeling of drugs for 
                indications that have received an

[[Page 131 STAT. 1048]]

                orphan designation under such section 526 with respect 
                to the use of such drugs pediatric populations.''

      TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

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

    Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(u)(4)) is amended by striking ``2017'' and inserting 
``2022''.
SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
                        PARTNERSHIPS.

    Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-5(f)) is amended by striking ``2013 through 2017'' and 
inserting ``2018 through 2022''.
SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.

    Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 
by striking ``2013 through 2017'' and inserting ``2018 through 2022''.
SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.

    (a) Diverted Drugs.--Paragraph (1) of section 801(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended--
            (1) by striking ``(d)(1) Except as'' and inserting 
        ``(d)(1)(A) Except as''; and
            (2) by adding at the end the following:

    ``(B) Except as authorized by the Secretary in the case of a drug 
that appears on the drug shortage list under section 506E or in the case 
of importation pursuant to section 804, no drug that is subject to 
section 503(b)(1) may be imported into the United States for commercial 
use if such drug is manufactured outside the United States, unless the 
manufacturer has authorized the drug to be marketed in the United States 
and has caused the drug to be labeled to be marketed in the United 
States.''.
    (b) Counterfeit Drugs.--Subsection (b) of section 303 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the 
end the following:
    ``(8) Notwithstanding subsection (a), any person who violates 
section 301(i)(3) by knowingly making, selling or dispensing, or holding 
for sale or dispensing, a counterfeit drug shall be imprisoned for not 
more than 10 years or fined in accordance with title 18, United States 
Code, or both.''.
SEC. 605. PATIENT EXPERIENCE DATA.

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

[[Page 131 STAT. 1049]]

SEC. 606. COMMUNICATION PLANS.

    Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355-1(e)(3)) is amended--
            (1) in subparagraph (B), by striking ``; or'';
            (2) in subparagraph (C), by striking the period and 
        inserting ``; or''; and
            (3) by adding at the end the following:
                    ``(D) disseminating information to health care 
                providers about drug formulations or properties, 
                including information about the limitations or patient 
                care implications of such formulations or properties, 
                and how such formulations or properties may be related 
                to serious adverse drug events associated with use of 
                the drug.''.
SEC. 607. ORPHAN DRUGS.

    (a) In General.--Section 527 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360cc) is amended--
            (1) in subsection (a), in the matter following paragraph 
        (2), by striking ``such drug for such disease or condition'' and 
        inserting ``the same drug for the same disease or condition'';
            (2) in subsection (b)--
                    (A) <<NOTE: Time period. Determination.>>  in the 
                matter preceding paragraph (1), by striking ``If an 
                application'' and all that follows through ``such 
                license if'' and inserting ``During the 7-year period 
                described in subsection (a) for an approved application 
                under section 505 or license under section 351 of the 
                Public Health Service Act, the Secretary may approve an 
                application or issue a license for a drug that is 
                otherwise the same, as determined by the Secretary, as 
                the already approved drug for the same rare disease or 
                condition if'';
                    (B) in paragraph (1), by striking ``notice'' and all 
                that follows through ``assure'' and inserting ``of 
                exclusive approval or licensure notice and opportunity 
                for the submission of views, that during such period the 
                holder of the exclusive approval or licensure cannot 
                ensure''; and
                    (C) in paragraph (2), by striking ``such holder 
                provides'' and inserting ``the holder provides''; and
            (3) by adding at the end the following:

    ``(c) Condition of Clinical Superiority.--
            ``(1) In general.--If a sponsor of a drug that is designated 
        under section 526 and is otherwise the same, as determined by 
        the Secretary, as an already approved or licensed drug is 
        seeking exclusive approval or exclusive licensure described in 
        subsection (a) for the same rare disease or condition as the 
        already approved drug, the Secretary shall require such sponsor, 
        as a condition of such exclusive approval or licensure, to 
        demonstrate that such drug is clinically superior to any already 
        approved or licensed drug that is the same drug.
            ``(2) Definition.--For purposes of paragraph (1), the term 
        `clinically superior' with respect to a drug means that the drug 
        provides a significant therapeutic advantage over and above an 
        already approved or licensed drug in terms of greater efficacy, 
        greater safety, or by providing a major contribution to patient 
        care.

    ``(d) <<NOTE: Applicability.>>  Regulations.--The Secretary may 
promulgate regulations for the implementation of subsection (c). 
Beginning on the date of enactment of the FDA Reauthorization Act of 
2017, until such

[[Page 131 STAT. 1050]]

time as the Secretary promulgates regulations in accordance with this 
subsection, the Secretary may apply any definitions set forth in 
regulations that were promulgated prior to such date of enactment, to 
the extent such definitions are not inconsistent with the terms of this 
section, as amended by such Act.

    ``(e) Demonstration of Clinical Superiority Standard.--To assist 
sponsors in demonstrating clinical superiority as described in 
subsection (c), the Secretary--
            ``(1) <<NOTE: Notification.>>  upon the designation of any 
        drug under section 526, shall notify the sponsor of such drug in 
        writing of the basis for the designation, including, as 
        applicable, any plausible hypothesis offered by the sponsor and 
        relied upon by the Secretary that the drug is clinically 
        superior to a previously approved drug; and
            ``(2) <<NOTE: Publication. Summary.>>  upon granting 
        exclusive approval or licensure under subsection (a) on the 
        basis of a demonstration of clinical superiority as described in 
        subsection (c), shall publish a summary of the clinical 
        superiority findings.''.

    (b) <<NOTE: 21 USC 360cc note.>>  Rule of Construction.--Nothing in 
the amendments made by subsection (a) shall affect any determination 
under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA 
Reauthorization Act of 2017.
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.

    Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a(o)) is amended--
            (1) in the subsection heading, by striking ``under section 
        505(j)'';
            (2) in paragraph (1)--
                    (A) by striking ``under section 505(j)'' and 
                inserting ``under subsection (b)(2) or (j) of section 
                505''; and
                    (B) by striking ``or by exclusivity under clause 
                (iii) or (iv) of section 505(j)(5)(F)'' and inserting 
                ``, or by exclusivity under clause (iii) or (iv) of 
                section 505(j)(5)(F), clause (iii) or (iv) of section 
                505(c)(3)(E), or section 527(a), or by an extension of 
                such exclusivity under this section or section 505E'';
            (3) in paragraph (2), in the matter preceding subparagraph 
        (A)--
                    (A) by inserting ``clauses (iii) and (iv) of section 
                505(c)(3)(E), or section 527,'' after ``section 
                505(j)(5)(F),''; and
                    (B) by striking ``drug approved under section 
                505(j)'' and inserting ``drug approved pursuant to an 
                application submitted under subsection (b)(2) or (j) of 
                section 505''; and
            (4) by amending paragraph (3) to read as follows:
            ``(3) Preservation of pediatric exclusivity and 
        extensions.--This subsection does not affect--
                    ``(A) the availability or scope of exclusivity 
                under--
                          ``(i) this section;
                          ``(ii) section 505 for pediatric formulations; 
                      or
                          ``(iii) section 527;
                    ``(B) the availability or scope of an extension to 
                any such exclusivity, including an extension under this 
                section or section 505E;

[[Page 131 STAT. 1051]]

                    ``(C) the question of the eligibility for approval 
                under section 505 of any application described in 
                subsection (b)(2) or (j) of such section that omits any 
                other aspect of labeling protected by exclusivity 
                under--
                          ``(i) clause (iii) or (iv) of section 
                      505(j)(5)(F);
                          ``(ii) clause (iii) or (iv) of section 
                      505(c)(3)(E); or
                          ``(iii) section 527(a); or
                    ``(D) except as expressly provided in paragraphs (1) 
                and (2), the operation of section 505 or section 527.''.
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION 
                        DRUGS.

    It is the sense of the Congress that the Secretary of Health and 
Human Services should commit to engaging with the House of 
Representatives and the Senate to take administrative actions and enact 
legislative changes that--
            (1) will lower the cost of prescription drugs for consumers 
        and reduce the burden of such cost on taxpayers; and
            (2) in lowering such cost, will--
                    (A) balance the need to encourage innovation with 
                the need to improve affordability; and
                    (B) strive to increase competition in the 
                pharmaceutical market, prevent anticompetitive behavior, 
                and promote the timely availability of affordable, high-
                quality generic drugs and biosimilars.
SEC. 610. EXPANDED ACCESS.

    (a) <<NOTE: 21 USC 360bbb note.>>  Patient Access to Investigational 
Drugs.--
            (1) Public meeting.--
                    (A) <<NOTE: Coordination. Consultation. Deadline.>>  
                In general.--The Secretary of Health and Human Services 
                (referred to in this section as the ``Secretary''), 
                acting through the Commissioner of Food and Drugs, in 
                coordination with the Director of the National 
                Institutes of Health, and in consultation with patients, 
                health care providers, drug sponsors, bioethicists, and 
                other stakeholders, shall, not later than 270 days after 
                the date of enactment of this Act, convene a public 
                meeting to discuss clinical trial inclusion and 
                exclusion criteria to inform the guidance under 
                paragraph (3). The Secretary shall inform the 
                Comptroller General of the United States of the date 
                when the public meeting will take place.
                    (B) <<NOTE: Web posting. Reports. Deadline.>>  
                Topics.--The Secretary shall make available on the 
                internet website of the Food and Drug Administration a 
                report on the topics discussed at the meeting described 
                in subparagraph (A) within 90 days of such meeting. Such 
                topics shall include discussion of--
                          (i) the rationale for, and potential barriers 
                      for patients created by, research clinical trial 
                      inclusion and exclusion criteria;
                          (ii) how appropriate patient populations can 
                      benefit from the results of trials that employ 
                      alternative designs;
                          (iii) barriers to participation in clinical 
                      trials, including--
                                    (I) information regarding any 
                                potential risks and benefits of 
                                participation;
                                    (II) regulatory, geographical, and 
                                socioeconomic barriers; and

[[Page 131 STAT. 1052]]

                                    (III) the impact of exclusion 
                                criteria on the enrollment in clinical 
                                trials of particular populations, 
                                including infants and children, pregnant 
                                and lactating women, seniors, 
                                individuals with advanced disease, and 
                                individuals with co-morbid conditions;
                          (iv) clinical trial designs and methods, 
                      including expanded access trials, that increase 
                      enrollment of more diverse patient populations, 
                      when appropriate, while facilitating the 
                      collection of data to establish safe use and 
                      support substantial evidence of effectiveness, 
                      including data obtained from expanded access 
                      trials; and
                          (v) how changes to clinical trial inclusion 
                      and exclusion criteria may impact the complexity 
                      and length of clinical trials, the data necessary 
                      to demonstrate safety and effectiveness, and 
                      potential approaches to mitigating those impacts.
            (2) Report.--Not later than 1 year after the Secretary 
        issues the report under paragraph (1)(B), the Comptroller 
        General of the United States shall report to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of Representatives 
        on individual access to investigational drugs through the 
        expanded access program under section 561(b) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). The report 
        shall include--
                    (A) a description of actions taken by manufacturers 
                and distributors under section 561A of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 360bbb-0);
                    (B) consideration of whether Form FDA 3926 and the 
                guidance documents titled ``Expanded Access to 
                Investigational Drugs for Treatment Use--Questions and 
                Answers'' and ``Individual Patient Expanded Access 
                Applications: Form FDA 3926'', issued by the Food and 
                Drug Administration in June 2016, have reduced 
                application burden with respect to individuals and 
                physicians seeking access to investigational new drugs 
                pursuant to section 561(b) of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 360bbb) and improved clarity 
                for patients, physicians, and drug manufacturers about 
                such process;
                    (C) consideration of whether the guidance or 
                regulations issued to implement section 561 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) 
                have improved access for individual patients to 
                investigational drugs who do not qualify for clinical 
                trials of such investigational drugs, and what barriers 
                to such access remain;
                    (D) <<NOTE: Assessment.>>  an assessment of methods 
                patients and health care providers use to engage with 
                the Food and Drug Administration or drug sponsors on 
                expanded access; and
                    (E) <<NOTE: Analysis.>>  an analysis of the 
                Secretary's report under paragraph (1)(B).
            (3) Guidance.--
                    (A) <<NOTE: Deadlines.>>  In general.--Not later 
                than 1 year after the publication of the report under 
                paragraph (1)(B), the Secretary, acting through the 
                Commissioner of Food and Drugs, shall issue one or more 
                draft guidances regarding

[[Page 131 STAT. 1053]]

                eligibility criteria for clinical trials. Not later than 
                1 year after the public comment period on each such 
                draft guidance ends, the Secretary shall issue a revised 
                draft guidance or final guidance.
                    (B) Contents.--The guidance documents described in 
                subparagraph (A) shall address methodological approaches 
                that a manufacturer or sponsor of an investigation of a 
                new drug may take to--
                          (i) broaden eligibility criteria for clinical 
                      trials and expanded access trials, especially with 
                      respect to drugs for the treatment of serious and 
                      life-threatening conditions or diseases for which 
                      there is an unmet medical need;
                          (ii) develop eligibility criteria for, and 
                      increase trial recruitment to, clinical trials so 
                      that enrollment in such trials more accurately 
                      reflects the patients most likely to receive the 
                      drug, as applicable and as appropriate, while 
                      establishing safe use and supporting findings of 
                      substantial evidence of effectiveness; and
                          (iii) use the criteria described in clauses 
                      (i) and (ii) in a manner that is appropriate for 
                      drugs intended for the treatment of rare diseases 
                      or conditions.

    (b) <<NOTE: Deadline. Guidance. 21 USC 360bbb note.>>  Improving 
Institutional Review Board Review of Single Patient Expanded Access 
Protocol.--Not later than 1 year after the date of enactment of this 
Act, the Secretary, acting through the Commissioner of Food and Drugs, 
shall issue guidance or regulations, or revise existing guidance or 
regulations, to streamline the institutional review board review of 
individual patient expanded access protocols submitted under 561(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To 
facilitate the use of expanded access protocols, any guidance or 
regulations so issued or revised may include a description of the 
process for any person acting through a physician licensed in accordance 
with State law to request that an institutional review board chair (or 
designated member of the institutional review board) review a single 
patient expanded access protocol submitted under such section 561(b) for 
a drug. <<NOTE: Update.>>  The Secretary shall update any relevant forms 
associated with individual patient expanded access requests under such 
section 561(b) as necessary.

    (c) Expanded Access Policy Transparency.--Section 561A(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0(f)) is 
amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``later'' and inserting ``earlier'';
            (2) by striking paragraph (1);
            (3) by redesignating paragraph (2) as paragraph (1);
            (4) in paragraph (1) as so redesignated, by striking the 
        period at the end and inserting ``; or''; and
            (5) by adding at the end the following:
            ``(2) <<NOTE: Time period.>>  as applicable, 15 days after 
        the drug receives a designation as a breakthrough therapy, fast 
        track product, or regenerative advanced therapy under subsection 
        (a), (b), or (g), respectively, of section 506.''.

[[Page 131 STAT. 1054]]

SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.

    (a) In General.--Subparagraph (A) of section 524(a)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended--
            (1) in clause (i), by striking ``and'' at the end; and
            (2) by adding at the end the following:
                          ``(iii) that contains reports of one or more 
                      new clinical investigations (other than 
                      bioavailability studies) that are essential to the 
                      approval of the application and conducted or 
                      sponsored by the sponsor of such application; and
                          ``(iv) that contains an attestation from the 
                      sponsor of the application that such reports were 
                      not submitted as part of an application for 
                      marketing approval or licensure by a regulatory 
                      authority in India, Brazil, Thailand, or any 
                      country that is a member of the Pharmaceutical 
                      Inspection Convention or the Pharmaceutical 
                      Inspection Cooperation Scheme prior to September 
                      27, 2007.''.

    (b) <<NOTE: 21 USC 360n note.>>  Effective Date.--The amendments 
made by subsection (a) shall apply to human drug applications submitted 
after September 30, 2017.

        TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.

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

[[Page 131 STAT. 1055]]

                    (B) in subparagraph (C), by inserting ``or device'' 
                after ``drug''.

    (b) Foreign Inspections.--Section 809(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by striking 
``section 510(h)(3)'' and inserting ``paragraph (2) or (3) of section 
510(h)''.
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE 
                        ESTABLISHMENTS.

    (a) In General.--Section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374) is amended by adding at the end the following:
    ``(h)(1) <<NOTE: Review.>>  In the case of inspections other than 
for-cause inspections, the Secretary shall review processes and 
standards applicable to inspections of domestic and foreign device 
establishments in effect as of the date of the enactment of this 
subsection, and update such processes and standards through the adoption 
of uniform processes and standards applicable to such inspections. Such 
uniform processes and standards shall provide for--
            ``(A) exceptions to such processes and standards, as 
        appropriate;
            ``(B) announcing the inspection of the establishment within 
        a reasonable time before such inspection occurs, including by 
        providing to the owner, operator, or agent in charge of the 
        establishment a notification regarding the type and nature of 
        the inspection;
            ``(C) a reasonable estimate of the timeframe for the 
        inspection, an opportunity for advance communications between 
        the officers or employees carrying out the inspection under 
        subsection (a)(1) and the owner, operator, or agent in charge of 
        the establishment concerning appropriate working hours during 
        the inspection, and, to the extent feasible, advance notice of 
        some records that will be requested; and
            ``(D) regular communications during the inspection with the 
        owner, operator, or agent in charge of the establishment 
        regarding inspection status, which may be recorded by either 
        party with advance notice and mutual consent.

    ``(2)(A) <<NOTE: Deadline.>>  The Secretary shall, with respect to a 
request described in subparagraph (B), provide nonbinding feedback with 
respect to such request not later than 45 days after the Secretary 
receives such request.

    ``(B) A request described in this subparagraph is a request for 
feedback--
            ``(i) that is made by the owner, operator, or agent in 
        charge of such establishment in a timely manner; and
            ``(ii) with respect to actions proposed to be taken by a 
        device establishment in a response to a report received by such 
        establishment pursuant to subsection (b) that involve a public 
        health priority, that implicate systemic or major actions, or 
        relate to emerging safety issues (as determined by the 
        Secretary).

    ``(3) Nothing in this subsection affects the authority of the 
Secretary to conduct inspections otherwise permitted under this Act in 
order to ensure compliance with this Act.''.
    (b) <<NOTE: 21 USC 374 note.>>  Guidance.--
            (1) <<NOTE: Deadline.>>  Draft guidance.--Not later than 18 
        months after the date of enactment of this Act, the Secretary of 
        Health and

[[Page 131 STAT. 1056]]

        Human Services, acting through the Commissioner of Food and 
        Drugs, shall issue draft guidance that--
                    (A) specifies how the Food and Drug Administration 
                will implement the processes and standards described in 
                paragraph (1) of subsection (h) of section 704 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as 
                added by subsection (a), and the requirements described 
                in paragraph (2) of such subsection (h);
                    (B) provides for standardized methods for 
                communications described in such paragraphs;
                    (C) establishes, with respect to inspections of both 
                domestic and foreign device establishments (as referred 
                to in section 510(h)(2) of the Federal Food, Drug, and 
                Cosmetic Act, as amended by subsection (a)), a standard 
                timeframe for such inspections--
                          (i) that occurs over consecutive days; and
                          (ii) to which each investigator conducting 
                      such an inspection shall adhere unless the 
                      investigator identifies to the establishment 
                      involved a reason that more time is needed to 
                      conduct such investigation; and
                    (D) identifies practices for investigators and 
                device establishments to facilitate the continuity of 
                inspections of such establishments.
            (2) <<NOTE: Deadline. Notice. Public information.>>  Final 
        guidance.--Not later than 1 year after providing notice and 
        opportunity for public comment on the draft guidance issued 
        under paragraph (1), the Secretary of Health and Human Services 
        shall issue final guidance to implement subsection (h) of 
        section 704 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 374), as added by subsection (a).

    (c) Adulterated Devices.--Subsection (j) of section 501 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
inserting ``or device'' after ``drug''.
SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.

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

    Subsection (e)(4) of section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
            (1) by adding at the end the following:

    ``(E)(i)(I) If the Secretary denies a request for certification 
under subparagraph (A)(ii) with respect to a device manufactured in an 
establishment (foreign or domestic) registered under section 510, the 
Secretary shall provide in writing to the person seeking such 
certification the basis for such denial, and specifically identify the 
finding upon which such denial is based.
    ``(II) <<NOTE: Summary.>>  If the denial of a request as described 
in subclause (I) is based on grounds other than an injunction proceeding 
pursuant to section 302, seizure action pursuant to section 304, or a 
recall designated Class I or Class II pursuant to part 7, title 21, Code 
of Federal Regulations, and is based on the facility being out of 
compliance with part 820 of title 21, Code of Federal Regulations, the 
Secretary shall provide a substantive summary of the specific grounds 
for noncompliance identified by the Secretary.

    ``(III) With respect to a device manufactured in an establishment 
that has received a report under section 704(b), the Secretary

[[Page 131 STAT. 1057]]

shall not deny a request for certification as described in subclause (I) 
with respect to a device based solely on the issuance of that report if 
the owner, operator, or agent in charge of such establishment has agreed 
to a plan of correction in response to such report.
    ``(ii)(I) <<NOTE: Review.>>  The Secretary shall provide a process 
for a person who is denied a certification as described in clause (i)(I) 
to request a review that conforms to the standards of section 517A(b).

    ``(II) Notwithstanding any previous review conducted pursuant to 
subclause (I), a person who has been denied a certification as described 
in clause (i)(I) may at any time request a review in order to present 
new information relating to actions taken by such person to address the 
reasons identified by the Secretary for the denial of certification, 
including evidence that corrective actions are being or have been 
implemented to address grounds for noncompliance identified by the 
Secretary.
    ``(III) <<NOTE: Deadlines. Guidance.>>  Not later than 1 year after 
the date of enactment of the FDA Reauthorization Act of 2017, the 
Secretary shall issue guidance providing for a process to carry out this 
subparagraph. Not later than 1 year after the close of the comment 
period for such guidance, the Secretary shall issue final guidance.

    ``(iii)(I) <<NOTE: Applicability.>>  Subject to subclause (II), this 
subparagraph applies to requests for certification on behalf of any 
device establishment registered under section 510, whether the 
establishment is located inside or outside of the United States, and 
regardless of whether such devices are to be exported from the United 
States.

    ``(II) <<NOTE: Applicability. Deadlines.>>  If an establishment 
described in subclause (I) is not located within the United States and 
does not demonstrate that the devices manufactured, prepared, 
propagated, compounded, or processed at such establishment are to be 
exported from the United States, this subparagraph shall apply only if--
            ``(aa) the establishment has been inspected by the Secretary 
        within 3 years of the date of the request; or
            ``(bb) <<NOTE: Audits.>>  the establishment participates in 
        an audit program in which the United States participates or the 
        United States recognizes, an audit under such program has been 
        conducted, and the findings of such audit are provided to the 
        Secretary within 3 years of the date of the request.''; and
            (2) by moving the margins of subparagraphs (C) and (D) 4 ems 
        to the left.
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.

    Section 704(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 
374) is amended by adding at the end the following:
    ``(15)(A) Notwithstanding any other provision of this subsection, 
the Secretary may recognize auditing organizations that are recognized 
by organizations established by governments to facilitate international 
harmonization for purposes of conducting inspections of--
            ``(i) establishments that manufacture, prepare, propagate, 
        compound, or process devices (other than types of devices 
        licensed under section 351 of the Public Health Service Act), as 
        required under section 510(h); or
            ``(ii) establishments required to register pursuant to 
        section 510(i).

    ``(B) Nothing in this paragraph affects--
            ``(i) the authority of the Secretary to inspect any device 
        establishment pursuant to this Act; or

[[Page 131 STAT. 1058]]

            ``(ii) the authority of the Secretary to determine the 
        official classification of an inspection.''.
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.

    (a) Approval of Applications for Certain Diagnostic Medical Imaging 
Devices.--Section 520 of the Federal Food, Drug, and Cosmetic Act (42 
U.S.C. 360j) is amended by adding at the end the following:
    ``(p) Diagnostic Imaging Devices Intended for Use With Contrast 
Agents.--
            ``(1) In general.--The Secretary may, subject to the 
        succeeding provisions of this subsection, approve an application 
        (or a supplement to such an application) submitted under section 
        515 with respect to an applicable medical imaging device, or, in 
        the case of an applicable medical imaging device for which a 
        notification is submitted under section 510(k), may make a 
        substantial equivalence determination with respect to an 
        applicable medical imaging device, or may grant a request 
        submitted under section 513(f)(2) for an applicable medical 
        imaging device, if such application, notification, or request 
        involves the use of a contrast agent that is not--
                    ``(A) <<NOTE: Determinations.>>  in a concentration, 
                rate of administration, or route of administration that 
                is different from those described in the approved 
                labeling of the contrast agent, except that the 
                Secretary may approve such application, make such 
                substantial equivalence determination, or grant such 
                request if the Secretary determines that such 
                differences in concentration, rate of administration, or 
                route of administration exist but do not adversely 
                affect the safety and effectiveness of the contrast 
                agent when used with the device;
                    ``(B) in a region, organ, or system of the body that 
                is different from those described in the approved 
                labeling of the contrast agent, except that the 
                Secretary may approve such application, make such 
                substantial equivalence determination, or grant such 
                request if the Secretary determines that such 
                differences in region, organ, or system of the body 
                exist but do not adversely affect the safety and 
                effectiveness of the contrast agent when used with the 
                device;
                    ``(C) in a patient population that is different from 
                those described in the approved labeling of the contrast 
                agent, except that the Secretary may approve such 
                application, make such substantial equivalence 
                determination, or grant such request if the Secretary 
                determines such differences in patient population exist 
                but do not adversely affect the safety and effectiveness 
                of the contrast agent when used with the device; or
                    ``(D) in an imaging modality that is different from 
                those described in the approved labeling of the contrast 
                agent.
            ``(2) Premarket review.--The agency center charged with 
        premarket review of devices shall have primary jurisdiction with 
        respect to the review of an application, notification, or 
        request described in paragraph (1). In conducting such review, 
        such agency center may--

[[Page 131 STAT. 1059]]

                    ``(A) <<NOTE: Consultation.>>  consult with the 
                agency center charged with the premarket review of drugs 
                or biological products; and
                    ``(B) review information and data provided to the 
                Secretary by the sponsor of a contrast agent in an 
                application submitted under section 505 of this Act or 
                section 351 of the Public Health Service Act, so long as 
                the sponsor of such contrast agent has provided to the 
                sponsor of the applicable medical imaging device that is 
                the subject of such review a right of reference and the 
                application is submitted in accordance with this 
                subsection.
            ``(3) Applicable requirements.--An application submitted 
        under section 515, a notification submitted under section 
        510(k), or a request submitted under section 513(f)(2), as 
        described in paragraph (1), with respect to an applicable 
        medical imaging device shall be subject to the requirements of 
        such respective section. Such application, notification, or 
        request shall only be subject to the requirements of this Act 
        applicable to devices.
            ``(4) Definitions.--For purposes of this subsection--
                    ``(A) the term `applicable medical imaging device' 
                means a device intended to be used in conjunction with a 
                contrast agent (or class of contrast agents) for an 
                imaging use that is not described in the approved 
                labeling of such contrast agent (or the approved 
                labeling of any contrast agent in the same class as such 
                contrast agent); and
                    ``(B) the term `contrast agent' means a drug that is 
                approved under section 505 or licensed under section 351 
                of the Public Health Service Act, is intended for use in 
                conjunction with an applicable medical imaging device, 
                and--
                          ``(i) is a diagnostic radiopharmaceutical, as 
                      defined in section 315.2 and 601.31 of title 21, 
                      Code of Federal Regulations (or any successor 
                      regulations); or
                          ``(ii) is a diagnostic agent that improves the 
                      visualization of structure or function within the 
                      body by increasing the relative difference in 
                      signal intensity within the target tissue, 
                      structure, or fluid.''.

    (b) Applications for Approval of Contrast Agents Intended for Use 
With Certain Diagnostic Medical Imaging Devices.--Section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following:
    ``(y) Contrast Agents Intended for Use With Applicable Medical 
Imaging Devices.--
            ``(1) In general.--The sponsor of a contrast agent for which 
        an application has been approved under this section may submit a 
        supplement to the application seeking approval for a new use 
        following the authorization of a premarket submission for an 
        applicable medical imaging device for that use with the contrast 
        agent pursuant to section 520(p)(1).
            ``(2) Review of supplement.--In reviewing a supplement 
        submitted under this subsection, the agency center charged with 
        the premarket review of drugs may--
                    ``(A) consult with the center charged with the 
                premarket review of devices; and
                    ``(B) review information and data submitted to the 
                Secretary by the sponsor of an applicable medical 
                imaging device pursuant to section 515, 510(k), or 
                513(f)(2) so long as the sponsor of such applicable 
                medical imaging device

[[Page 131 STAT. 1060]]

                has provided to the sponsor of the contrast agent a 
                right of reference.
            ``(3) Definitions.--For purposes of this subsection--
                    ``(A) the term `new use' means a use of a contrast 
                agent that is described in the approved labeling of an 
                applicable medical imaging device described in section 
                520(p), but that is not described in the approved 
                labeling of the contrast agent; and
                    ``(B) the terms `applicable medical imaging device' 
                and `contrast agent' have the meanings given such terms 
                in section 520(p).''.
SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.

    (a) In General.--Subsection (f) of section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 
the following new paragraph:
    ``(6)(A) Subject to the succeeding subparagraphs of this paragraph, 
the Secretary shall, by written order, classify an accessory under this 
section based on the risks of the accessory when used as intended and 
the level of regulatory controls necessary to provide a reasonable 
assurance of safety and effectiveness of the accessory, notwithstanding 
the classification of any other device with which such accessory is 
intended to be used.
    ``(B) <<NOTE: Applicability.>>  The classification of any accessory 
distinct from another device by regulation or written order issued prior 
to December 13, 2016, shall continue to apply unless and until the 
accessory is reclassified by the Secretary, notwithstanding the 
classification of any other device with which such accessory is intended 
to be used. Nothing in this paragraph shall preclude the Secretary's 
authority to initiate the classification of an accessory through 
regulation or written order, as appropriate.

    ``(C)(i) In the case of a device intended to be used with an 
accessory, where the accessory has been included in an application for 
premarket approval of such device under section 515 or a report under 
section 510(k) for clearance of such device and the Secretary has not 
classified such accessory distinctly from another device in accordance 
with subparagraph (A), the person filing the application or report (as 
applicable) at the time such application or report is filed--
            ``(I) may include a written request for the proper 
        classification of the accessory pursuant to subparagraph (A);
            ``(II) <<NOTE: Evaluation.>>  shall include in any such 
        request such information as may be necessary for the Secretary 
        to evaluate, based on the least burdensome approach, the 
        appropriate class for the accessory under subsection (a); and
            ``(III) shall, if the request under subclause (I) is 
        requesting classification of the accessory in class II, include 
        in the application an initial draft proposal for special 
        controls, if special controls would be required pursuant to 
        subsection (a)(1)(B).

    ``(ii) The Secretary's response under section 515(d) or section 
510(n) (as applicable) to an application or report described in clause 
(i) shall also contain the Secretary's granting or denial of the request 
for classification of the accessory involved.
    ``(iii) The Secretary's evaluation of an accessory under clause (i) 
shall constitute an order establishing a new classification for

[[Page 131 STAT. 1061]]

such accessory for the specified intended use or uses of such accessory 
and for any accessory with the same intended use or uses as such 
accessory.
    ``(D) <<NOTE: Applicability.>>  For accessories that have been 
granted marketing authorization as part of a submission for another 
device with which the accessory involved is intended to be used, through 
an application for such other device under section 515(c), a report 
under section 510(k), or a request for classification under paragraph 
(2) of this subsection, the following shall apply:
            ``(i) <<NOTE: Deadlines. Federal Register, 
        publication. Notice. Lists.>>  Not later than the date that is 
        one year after the date of enactment of the FDA Reauthorization 
        Act of 2017 and at least once every 5 years thereafter, and as 
        the Secretary otherwise determines appropriate, pursuant to this 
        paragraph, the Secretary shall publish in the Federal Register a 
        notice proposing a list of such accessories that the Secretary 
        determines may be suitable for a distinct classification in 
        class I and the proposed regulations for such 
        classifications. <<NOTE: Recommenda- tions.>>  In developing 
        such list, the Secretary shall consider recommendations from 
        sponsors of device submissions and other stakeholders for 
        accessories to be included on such list. <<NOTE: Notices. Time 
        period. Public information.>>  The notices shall provide for a 
        period of not less than 60 calendar days for public comment. 
        Within 180 days after the end of the comment period, the 
        Secretary shall publish in the Federal Register a final action 
        classifying such suitable accessories into class I.
            ``(ii) A manufacturer or importer of an accessory that has 
        been granted such marketing authorization may submit to the 
        Secretary a written request for the appropriate classification 
        of the accessory based on the risks and appropriate level of 
        regulatory controls as described in subparagraph (A), and shall, 
        if the request is requesting classification of the accessory in 
        class II, include in the submission an initial draft proposal 
        for special controls, if special controls would be required 
        pursuant to subsection (a)(1)(B). <<NOTE: Evaluation.>>  Such 
        request shall include such information as may be necessary for 
        the Secretary to evaluate, based on the least burdensome 
        approach, the appropriate class for the accessory under 
        subsection (a). The Secretary shall provide an opportunity for a 
        manufacturer or importer to meet with appropriate personnel of 
        the Food and Drug Administration to discuss the appropriate 
        classification of such accessory prior to submitting a written 
        request under this clause for classification of the accessory.
            ``(iii) <<NOTE: Deadlines.>>  The Secretary shall respond to 
        a request made under clause (ii) not later than 85 calendar days 
        after receiving such request by issuing a written order 
        classifying the accessory or denying the 
        request. <<NOTE: Determination.>>  If the Secretary does not 
        agree with the recommendation for classification submitted by 
        the manufacturer or importer, the response shall include a 
        detailed description and justification for such 
        determination. <<NOTE: Federal Register, publication. Notice.>>  
        Within 30 calendar days after granting such a request, the 
        Secretary shall publish a notice in the Federal Register 
        announcing such response.

    ``(E) Nothing in this paragraph may be construed as precluding a 
manufacturer of an accessory of a new type from using the classification 
process described in subsection (f)(2) to obtain classification of such 
accessory in accordance with the criteria and requirements set forth in 
that subsection.''.

[[Page 131 STAT. 1062]]

    (b) Conforming Change.--Section 513(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph 
(9) (relating to classification of an accessory).
    (c) <<NOTE: 21 USC 360c note.>>  Effective Date.--The amendments 
made by subsections (a) and (b) shall take effect on the date that is 60 
days after the date of enactment of this Act.
SEC. 708. DEVICE PILOT PROJECTS.

    (a) Postmarket Pilot.--Section 519 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the 
following:
    ``(i) Postmarket Pilot.--
            ``(1) <<NOTE: Deadline.>>  In general.--In order to provide 
        timely and reliable information on the safety and effectiveness 
        of devices approved under section 515, cleared under section 
        510(k), or classified under section 513(f)(2), including 
        responses to adverse events and malfunctions, and to advance the 
        objectives of part 803 of title 21, Code of Federal Regulations 
        (or successor regulations), and advance the objectives of, and 
        evaluate innovative new methods of compliance with, this section 
        and section 522, the Secretary shall, within one year of the 
        date of enactment of the FDA Reauthorization Act of 2017, 
        initiate one or more pilot projects for voluntary participation 
        by a manufacturer or manufacturers of a device or device type, 
        or continue existing projects, in accordance with paragraph (3), 
        that--
                    ``(A) are designed to efficiently generate reliable 
                and timely safety and active surveillance data for use 
                by the Secretary or manufacturers of the devices that 
                are involved in the pilot project;
                    ``(B) inform the development of methods, systems, 
                data criteria, and programs that could be used to 
                support safety and active surveillance activities for 
                devices included or not included in such project;
                    ``(C) may be designed and conducted in coordination 
                with a comprehensive system for evaluating medical 
                device technology that operates under a governing board 
                with appropriate representation of stakeholders, 
                including patient groups and device manufacturers;
                    ``(D) use electronic health data including claims 
                data, patient survey data, or any other data, as the 
                Secretary determines appropriate; and
                    ``(E) prioritize devices and device types that meet 
                one or more of the following criteria:
                          ``(i) Devices and device types for which the 
                      collection and analysis of real world evidence 
                      regarding a device's safety and effectiveness is 
                      likely to advance public health.
                          ``(ii) Devices and device types that are 
                      widely used.
                          ``(iii) Devices and device types, the failure 
                      of which has significant health consequences.
                          ``(iv) Devices and device types for which the 
                      Secretary--
                                    ``(I) has received public 
                                recommendations in accordance with 
                                paragraph (2)(B); and
                                    ``(II) has determined to meet one or 
                                more of the criteria under clause (i), 
                                (ii), or (iii) and is appropriate for 
                                such a pilot project.

[[Page 131 STAT. 1063]]

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

[[Page 131 STAT. 1064]]

                          ``(iii) The entity or entities shall have one 
                      or more qualifications with respect to--
                                    ``(I) research, statistical, 
                                epidemiologic, or clinical capability 
                                and expertise to conduct and complete 
                                the activities under this subsection, 
                                including the capability and expertise 
                                to provide the Secretary access to de-
                                identified data consistent with the 
                                requirements of this subsection;
                                    ``(II) an information technology 
                                infrastructure to support electronic 
                                data and operational standards to 
                                provide security for such data, as 
                                appropriate;
                                    ``(III) experience with, and 
                                expertise on, the development of 
                                research on, and surveillance of, device 
                                safety and effectiveness using 
                                electronic health data; or
                                    ``(IV) such other expertise which 
                                the Secretary determines necessary to 
                                carry out such a project.
                    ``(B) Review of contract in the event of a merger or 
                acquisition.--The Secretary shall review any contract, 
                cooperative agreement, grant, or other appropriate 
                agreement entered into under this paragraph with an 
                entity meeting the conditions specified in subparagraph 
                (A) in the event of a merger or acquisition of the 
                entity in order to ensure that the requirements 
                specified in this subsection will continue to be met.
            ``(5) Compliance with requirements for records or reports on 
        devices.--The participation of a manufacturer in pilot projects 
        under this subsection or a project continued or expanded under 
        paragraph (3) shall not affect the eligibility of such 
        manufacturer to participate in any quarterly reporting program 
        with respect to devices carried out under this section 519 or 
        section 522. <<NOTE: Determination.>>  The Secretary may 
        determine that, for a specified time period to be determined by 
        the Secretary, a manufacturer's participation in a pilot project 
        under this subsection or a project continued or expanded under 
        paragraph (3) may meet the applicable requirements of this 
        section or section 522, if--
                    ``(A) the project has demonstrated success in 
                capturing relevant adverse event information; and
                    ``(B) the Secretary has established procedures for 
                making adverse event and safety information collected 
                from such project public, to the extent possible.
            ``(6) Privacy requirements.--With respect to the disclosure 
        of any health information collected through a project conducted 
        under this subsection--
                    ``(A) individually identifiable health information 
                so collected shall not be disclosed when presenting any 
                information from such project; and
                    ``(B) any such disclosure shall be made in 
                compliance with regulations issued pursuant to section 
                264(c) of the Health Insurance Portability and 
                Accountability Act of 1996 (42 U.S.C. 1320d-2 note) and 
                sections 552 and 552a of title 5, United States Code.
            ``(7) Limitations.--No pilot project under this subsection, 
        or in coordination with the comprehensive system described in 
        paragraph (1)(C), may allow for an entity participating in

[[Page 131 STAT. 1065]]

        such project, other than the Secretary, to make determinations 
        of safety or effectiveness, or substantial equivalence, for 
        purposes of this Act.
            ``(8) <<NOTE: Applicability.>>  Other projects required to 
        comply.--Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and 
        (7) shall apply with respect to any pilot project undertaken in 
        coordination with the comprehensive system described in 
        paragraph (1)(C) that relates to the use of real world evidence 
        for devices in the same manner and to the same extent as such 
        paragraphs apply with respect to pilot projects conducted under 
        this subsection.
            ``(9) Report to congress.--Not later than 18 months after 
        the date of enactment of this Act, and annually thereafter, the 
        Secretary shall submit to the Committee on Energy and Commerce 
        of the House of Representatives and the Committee on Health, 
        Education, Labor and Pensions of the Senate a report containing 
        a description of the pilot projects being conducted under this 
        subsection and projects continued or expanded pursuant to 
        paragraph (3), including for each such project--
                    ``(A) how the project is being implemented in 
                accordance with paragraph (4), including how such 
                project is being implemented through a contract, 
                cooperative agreement, grant, or other appropriate 
                agreement, if applicable;
                    ``(B) the number of manufacturers that have agreed 
                to participate in such project;
                    ``(C) the data sources used to conduct such project;
                    ``(D) the devices or device categories involved in 
                such project;
                    ``(E) the number of patients involved in such 
                project; and
                    ``(F) the findings of the project in relation to 
                device safety, including adverse events, malfunctions, 
                and other safety information.
            ``(10) Sunset.--The Secretary may not carry out a pilot 
        project initiated by the Secretary under this subsection after 
        October 1, 2022.''.

    (b) <<NOTE: Review. Determination.>>  Report.--Not later than 
January 31, 2021, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall conduct a review 
through an independent third party to evaluate the strengths, 
limitations, and appropriate use of evidence collected pursuant to real 
world evidence pilot projects described in the letters described in 
section 201(b) of the Medical Device User Fee Amendments of 2017 and 
subsection (i) of section 519 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i), as amended by subsection (a), for informing 
premarket and postmarket decisionmaking for multiple device types, and 
to determine whether the methods, systems, and programs in such pilot 
projects efficiently generate reliable and timely evidence about the 
effectiveness or safety surveillance of devices.
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.

    (a) In General.--Section 520 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360j), as amended by section 708, is further amended by 
adding at the end the following:
    ``(q) Regulation of Over-the-Counter Hearing Aids.--
            ``(1) Definition.--

[[Page 131 STAT. 1066]]

                    ``(A) In general.--In this subsection, the term 
                `over-the-counter hearing aid' means a device that--
                          ``(i) uses the same fundamental scientific 
                      technology as air conduction hearing aids (as 
                      defined in section 874.3300 of title 21, Code of 
                      Federal Regulations) (or any successor regulation) 
                      or wireless air conduction hearing aids (as 
                      defined in section 874.3305 of title 21, Code of 
                      Federal Regulations) (or any successor 
                      regulation);
                          ``(ii) is intended to be used by adults age 18 
                      and older to compensate for perceived mild to 
                      moderate hearing impairment;
                          ``(iii) through tools, tests, or software, 
                      allows the user to control the over-the-counter 
                      hearing aid and customize it to the user's hearing 
                      needs;
                          ``(iv) may--
                                    ``(I) use wireless technology; or
                                    ``(II) include tests for self-
                                assessment of hearing loss; and
                          ``(v) is available over-the-counter, without 
                      the supervision, prescription, or other order, 
                      involvement, or intervention of a licensed person, 
                      to consumers through in-person transactions, by 
                      mail, or online.
                    ``(B) Exception.--Such term does not include a 
                personal sound amplification product intended to amplify 
                sound for nonhearing impaired consumers in situations 
                including hunting and bird-watching.
            ``(2) Regulation.--An over-the-counter hearing aid shall be 
        subject to the regulations promulgated in accordance with 
        section 709(b) of the FDA Reauthorization Act of 2017 and shall 
        be exempt from sections 801.420 and 801.421 of title 21, Code of 
        Federal Regulations (or any successor regulations).''.

    (b) <<NOTE: 21 USC 360j note.>>  Regulations To Establish 
Category.--
            (1) <<NOTE: Deadlines.>>  In general.--The Secretary of 
        Health and Human Services (referred to in this section as the 
        ``Secretary''), not later than 3 years after the date of 
        enactment of this Act, shall promulgate proposed regulations to 
        establish a category of over-the-counter hearing aids, as 
        defined in subsection (q) of section 520 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection 
        (a), and, not later than 180 days after the date on which the 
        public comment period on the proposed regulations closes, shall 
        issue such final regulations.
            (2) Requirements.--In promulgating the regulations under 
        paragraph (1), the Secretary shall--
                    (A) include requirements that provide reasonable 
                assurances of the safety and effectiveness of over-the-
                counter hearing aids;
                    (B) include requirements that establish or adopt 
                output limits appropriate for over-the-counter hearing 
                aids;
                    (C) include requirements for appropriate labeling of 
                over-the-counter hearing aids, including requirements 
                that such labeling include a conspicuous statement that 
                the device is only intended for adults age 18 and older, 
                information on how consumers may report adverse events, 
                information on any contraindications, conditions, or 
                symptoms of medically treatable causes of hearing loss, 
                and advisements

[[Page 131 STAT. 1067]]

                to consult promptly with a licensed health care 
                practitioner; and
                    (D) describe the requirements under which the sale 
                of over-the-counter hearing aids is permitted, without 
                the supervision, prescription, or other order, 
                involvement, or intervention of a licensed person, to 
                consumers through in-person transactions, by mail, or 
                online.
            (3) <<NOTE: Determination.>>  Premarket notification.--The 
        Secretary shall make findings under section 510(m) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to 
        determine whether over-the-counter hearing aids (as defined in 
        section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360j), as amended by subsection (a)) require a report 
        under section 510(k) to provide reasonable assurance of safety 
        and effectiveness.
            (4) Effect on state law.--No State or local government shall 
        establish or continue in effect any law, regulation, order, or 
        other requirement specifically related to hearing products that 
        would restrict or interfere with the servicing, marketing, sale, 
        dispensing, use, customer support, or distribution of over-the-
        counter hearing aids (as defined in section 520(q) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 
        amended by subsection (a)) through in-person transactions, by 
        mail, or online, that is different from, in addition to, or 
        otherwise not identical to, the regulations promulgated under 
        this subsection, including any State or local requirement for 
        the supervision, prescription, or other order, involvement, or 
        intervention of a licensed person for consumers to access over-
        the-counter hearing aids.
            (5) No effect on private remedies.--Nothing in this section 
        shall be construed to modify or otherwise affect the ability of 
        any person to exercise a private right of action under any State 
        or Federal product liability, tort, warranty, contract, or 
        consumer protection law.

    (c) <<NOTE: Deadline. Update.>>  New Guidance Issued.--Not later 
than the date on which final regulations are issued under subsection 
(b), the Secretary shall update and finalize the draft guidance of the 
Department of Health and Human Services entitled ``Regulatory 
Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products'', issued on November 7, 2013. Such updated and finalized 
guidance shall clarify which products, on the basis of claims or other 
marketing, advertising, or labeling material, meet the definition of a 
device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321) and which products meet the definition of a personal sound 
amplification product, as set forth in such guidance.

    (d) Report.--Not later than 2 years after the date on which the 
final regulations described in subsection (b)(1) are issued, the 
Secretary of Health and Human Services shall submit to Congress a report 
analyzing any adverse events relating to over-the-counter hearing aids 
(as defined in subsection (q)(1) of section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j)).
SEC. 710. REPORT ON SERVICING OF DEVICES.

    (a) In General.--Not later than 270 days after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall post

[[Page 131 STAT. 1068]]

on the internet website of the Food and Drug Administration a report on 
the continued quality, safety, and effectiveness of devices (as defined 
in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(h))) with respect to servicing (as defined in subsection (c)).
    (b) Contents.--The report submitted under subsection (a) shall 
contain--
            (1) the status of, and findings to date, with respect to, 
        the proposed rule entitled ``Refurbishing, Reconditioning, 
        Rebuilding, Remarketing, Remanufacturing, and Servicing of 
        Medical Devices Performed by Third-Party Entities and Original 
        Equipment Manufacturers; Request for Comments'' published in the 
        Federal Register by the Food and Drug Administration on March 4, 
        2016 (81 Fed. Reg. 11477);
            (2) information presented during the October 2016 public 
        workshop entitled ``Refurbishing, Reconditioning, Rebuilding, 
        Remarketing, Remanufacturing, and Servicing of Medical Devices 
        Performed by Third-Party Entities and Original Equipment 
        Manufacturers'';
            (3) a description of the statutory and regulatory authority 
        of the Food and Drug Administration with respect to the 
        servicing of devices conducted by any entity, including original 
        equipment manufacturers and third party entities;
            (4) details regarding how the Food and Drug Administration 
        currently regulates devices with respect to servicing to ensure 
        safety and effectiveness, how the agency could improve such 
        regulation using the authority described in paragraph (3), and 
        whether additional authority is recommended;
            (5) information on actions the Food and Drug Administration 
        could take under the authority described in paragraphs (3) and 
        (4) to assess the servicing of devices, including the size, 
        scope, location, and composition of third party entities;
            (6) information on actions the Food and Drug Administration 
        could take to track adverse events caused by servicing errors 
        performed by any entity, including original equipment 
        manufacturers and third party entities;
            (7) information regarding the regulation by States, the 
        Joint Commission, or other regulatory bodies of device servicing 
        performed by any entity, including original equipment 
        manufacturers and third party entities; and
            (8) any additional information determined by the Secretary 
        (acting through the Commissioner) to be relevant to ensuring the 
        quality, safety, and effectiveness of devices with respect to 
        servicing.

    (c) Servicing Defined.--In this section, the term ``servicing'' 
includes, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, repairing, remanufacturing, or other servicing 
of the device.

                TITLE VIII--IMPROVING GENERIC DRUG ACCESS

SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is amended by adding at the end the following:

[[Page 131 STAT. 1069]]

    ``(11)(A) <<NOTE: Deadlines.>>  Subject to subparagraph (B), the 
Secretary shall prioritize the review of, and act within 8 months of the 
date of the submission of, an original abbreviated new drug application 
submitted for review under this subsection that is for a drug--
            ``(i) for which there are not more than 3 approved drug 
        products listed under paragraph (7) and for which there are no 
        blocking patents and exclusivities; or
            ``(ii) that has been included on the list under section 
        506E.

    ``(B) <<NOTE: Determination.>>  To qualify for priority review under 
this paragraph, not later than 60 days prior to the submission of an 
application described in subparagraph (A) or that the Secretary may 
prioritize pursuant to subparagraph (D), the applicant shall provide 
complete, accurate information regarding facilities involved in 
manufacturing processes and testing of the drug that is the subject of 
the application, including facilities in corresponding Type II active 
pharmaceutical ingredients drug master files referenced in an 
application and sites or organizations involved in bioequivalence and 
clinical studies used to support the application, to enable the 
Secretary to make a determination regarding whether an inspection of a 
facility is necessary. Such information shall include the relevant (as 
determined by the Secretary) sections of such application, which shall 
be unchanged relative to the date of the submission of such application, 
except to the extent that a change is made to such information to 
exclude a facility that was not used to generate data to meet any 
application requirements for such submission and that is not the only 
facility intended to conduct one or more unit operations in commercial 
production. Information provided by an applicant under this subparagraph 
shall not be considered the submission of an application under this 
subsection.

    ``(C) The Secretary may expedite an inspection or reinspection under 
section 704 of an establishment that proposes to manufacture a drug 
described in subparagraph (A).
    ``(D) Nothing in this paragraph shall prevent the Secretary from 
prioritizing the review of other applications as the Secretary 
determines appropriate.
    ``(12) <<NOTE: Web posting. Update. Deadline. Lists.>>  The 
Secretary shall publish on the internet website of the Food and Drug 
Administration, and update at least once every 6 months, a list of all 
drugs approved under subsection (c) for which all patents and periods of 
exclusivity under this Act have expired and for which no application has 
been approved under this subsection.''.
SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC 
                        COMPETITION.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355), as amended by section 801, is further amended by adding at 
the end the following:
    ``(13) <<NOTE: Review. Updates.>>  Upon the request of an applicant 
regarding one or more specified pending applications under this 
subsection, the Secretary shall, as appropriate, provide review status 
updates indicating the categorical status of the applications by each 
relevant review discipline.''.
SEC. 803. COMPETITIVE GENERIC THERAPIES.

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

[[Page 131 STAT. 1070]]

``SEC. 506H. <<NOTE: 21 USC 356h.>>  COMPETITIVE GENERIC 
                          THERAPIES.

    ``(a) In General.--The Secretary may, at the request of an applicant 
of a drug that is designated as a competitive generic therapy pursuant 
to subsection (b), expedite the development and review of an abbreviated 
new drug application under section 505(j) for such drug.
    ``(b) Designation Process.--
            ``(1) Request.--The applicant may request the Secretary to 
        designate the drug as a competitive generic therapy.
            ``(2) Timing.--A request under paragraph (1) may be made 
        concurrently with, or at any time prior to, the submission of an 
        abbreviated new drug application for the drug under section 
        505(j).
            ``(3) Criteria.--A drug is eligible for designation as a 
        competitive generic therapy under this section if the Secretary 
        determines that there is inadequate generic competition.
            ``(4) <<NOTE: Deadline.>>  Designation.--Not later than 60 
        calendar days after the receipt of a request under paragraph 
        (1), the Secretary may--
                    ``(A) determine whether the drug that is the subject 
                of the request meets the criteria described in paragraph 
                (3); and
                    ``(B) if the Secretary finds that the drug meets 
                such criteria, designate the drug as a competitive 
                generic therapy.

    ``(c) Actions.--In expediting the development and review of an 
application under subsection (a), the Secretary may, as requested by the 
applicant, take actions including the following:
            ``(1) Hold meetings with the applicant and the review team 
        throughout the development of the drug prior to submission of 
        the application for such drug under section 505(j).
            ``(2) Provide timely advice to, and interactive 
        communication with, the applicant regarding the development of 
        the drug to ensure that the development program to gather the 
        data necessary for approval is as efficient as practicable.
            ``(3) Involve senior managers and experienced review staff, 
        as appropriate, in a collaborative, coordinated review of such 
        application, including with respect to drug-device combination 
        products and other complex products.
            ``(4) Assign a cross-disciplinary project lead--
                    ``(A) to facilitate an efficient review of the 
                development program and application, including 
                manufacturing inspections; and
                    ``(B) to serve as a scientific liaison between the 
                review team and the applicant.

    ``(d) Reporting Requirement.--Not later than one year after the date 
of the approval of an application under section 505(j) with respect to a 
drug for which the development and review is expedited under this 
section, the sponsor of such drug shall report to the Secretary on 
whether the drug has been marketed in interstate commerce since the date 
of such approval.
    ``(e) Definitions.--In this section:
            ``(1) The term `generic drug' means a drug that is approved 
        pursuant to section 505(j).
            ``(2) The term `inadequate generic competition' means, with 
        respect to a drug, there is not more than one approved drugs on 
        the list of drugs described in section 505(j)(7)(A) (not

[[Page 131 STAT. 1071]]

        including drugs on the discontinued section of such list) that 
        is--
                    ``(A) the reference listed drug; or
                    ``(B) a generic drug with the same reference listed 
                drug as the drug for which designation as a competitive 
                generic therapy is sought.
            ``(3) The term `reference listed drug' means the listed drug 
        (as such term is used in section 505(j)) for the drug 
        involved.''.

    (b) <<NOTE: Deadlines. 21 USC 356h note.>>  Guidance; Amended 
Regulations.--
            (1) In general.--
                    (A) Issuance.--The Secretary of Health and Human 
                Services shall--
                          (i) not later than 18 months after the date of 
                      enactment of this Act, issue draft guidance on 
                      section 506H of the Federal Food, Drug, and 
                      Cosmetic Act, as added by subsection (a); and
                          (ii) not later than 1 year after the close of 
                      the comment period for the draft guidance, issue 
                      final guidance on such section 506H.
                    (B) Contents.--The guidance issued under this 
                paragraph shall--
                          (i) specify the process and criteria by which 
                      the Secretary makes a designation under section 
                      506H of the Federal Food, Drug, and Cosmetic Act, 
                      as added by subsection (a);
                          (ii) specify the actions the Secretary may 
                      take to expedite the development and review of a 
                      competitive generic therapy pursuant to such a 
                      designation; and
                          (iii) include good review management practices 
                      for competitive generic therapies.
            (2) Amended regulations.--The Secretary of Health and Human 
        Services shall issue or revise any regulations as may be 
        necessary to carry out this section not later than 2 years after 
        the date of enactment of this Act.
SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED 
                        COMPETITION.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by inserting after section 506H, as added by section 
803, the following:
``SEC. 506I. <<NOTE: 21 USC 356i.>>  PROMPT REPORTS OF MARKETING 
                          STATUS.

    ``(a) Notification of Withdrawal.--The holder of an application 
approved under subsection (c) or (j) of section 505 shall notify the 
Secretary in writing 180 days prior to withdrawing the approved drug 
from sale, or if 180 days is not practicable as soon as practicable but 
not later than the date of withdrawal. The holder shall include with 
such notice the--
            ``(1) National Drug Code;
            ``(2) identity of the drug by established name and by 
        proprietary name, if any;
            ``(3) new drug application number or abbreviated application 
        number;
            ``(4) strength of the drug;
            ``(5) date on which the drug is expected to no longer be 
        available for sale; and
            ``(6) reason for withdrawal of the drug.

[[Page 131 STAT. 1072]]

    ``(b) Notification of Drug Not Available for Sale.--The holder of an 
application approved under subsection (c) or (j) shall notify the 
Secretary in writing within 180 calendar days of the date of approval of 
the drug if the drug will not be available for sale within 180 calendar 
days of such date of approval. The holder shall include with such notice 
the--
            ``(1) identity of the drug by established name and by 
        proprietary name, if any;
            ``(2) new drug application number or abbreviated application 
        number;
            ``(3) strength of the drug;
            ``(4) date on which the drug will be available for sale, if 
        known; and
            ``(5) reason for not marketing the drug after approval.

    ``(c) <<NOTE: Review. Notification.>>  Additional One-time Report.--
Within 180 days of the date of enactment of this section, all holders of 
applications approved under subsection (c) or (j) of section 505 shall 
review the information in the list published under subsection 
505(j)(7)(A) and shall notify the Secretary in writing that--
            ``(1) all of the application holder's drugs in the active 
        section of the list published under subsection 505(j)(7)(A) are 
        available for sale; or
            ``(2) one or more of the application holder's drugs in the 
        active section of the list published under subsection 
        505(j)(7)(A) have been withdrawn from sale or have never been 
        available for sale, and include with such notice the information 
        required pursuant to subsection (a) or (b), as applicable.

    ``(d) <<NOTE: Lists.>>  Failure to Meet Requirements.--If a holder 
of an approved application fails to submit the information required 
under subsection (a), (b), or (c), the Secretary may move the 
application holder's drugs from the active section of the list published 
under subsection 505(j)(7)(A) to the discontinued section of the list, 
except that the Secretary shall remove from the list in accordance with 
subsection 505(j)(7)(C) drugs the Secretary determines have been 
withdrawn from sale for reasons of safety of effectiveness.

    ``(e) <<NOTE: Lists. Deadline.>>  Updates.--The Secretary shall 
update the list published under subsection 505(j)(7)(A) based on the 
information provided under subsections (a), (b), and (c) by moving drugs 
that are not available for sale from the active section to the 
discontinued section of the list, except that drugs the Secretary 
determines have been withdrawn from sale for reasons of safety or 
effectiveness shall be removed from the list in accordance with 
subsection 505(j)(7)(C). The Secretary shall make monthly updates to the 
list based on the information provided pursuant to subsections (a) and 
(b), and shall update the list based on the information provided under 
subsection (c) as soon as practicable.

    ``(f) Limitation on Use of Notices.--Any notice submitted under this 
section shall not be made public by the Secretary and shall be used 
solely for the purpose of the updates described in subsection (e).''.
SEC. 805. SUITABILITY PETITIONS.

    (a) <<NOTE: Deadline.>>  In General.--It is the sense of Congress 
that the Food and Drug Administration shall meet the requirement under 
section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C.

[[Page 131 STAT. 1073]]

355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal 
Regulations, of responding to suitability petitions within 90 days of 
submission.

    (b) Report.--The Secretary of Health and Human Services shall 
include in the annual reports under section 807--
            (1) the number of pending petitions under section 
        505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)(2)(C)); and
            (2) the number of such petitions pending a substantive 
        response for more than 180 days from the date of receipt.
SEC. 806. <<NOTE: Deadline. Protocols. Review. 21 USC 374 note.>>  
                        INSPECTIONS.

    Within 6 months of the date of enactment of this Act, the Secretary 
of Health and Human Services shall develop and implement a protocol for 
expediting review of timely responses to reports of observations from an 
inspection under section 704 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 374). Such protocol shall--
            (1) <<NOTE: Applicability.>>  apply to responses to such 
        reports pertaining to applications submitted under section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)--
                    (A) for which the approval is dependent upon 
                remediation of conditions identified in the report;
                    (B) for which concerns related to observations from 
                an inspection under such section 704 are the only 
                barrier to approval; and
                    (C) where the drug that is the subject of the 
                application is a drug--
                          (i) for which there are not more than 3 other 
                      approved applications under section 505(j) of the 
                      Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                      355(j)) that reference the same listed drug and 
                      for which there are less than 6 abbreviated new 
                      drug applications tentatively approved; or
                          (ii) that is included on the list under 
                      section 506E of such Act (21 U.S.C. 356e);
            (2) address expedited re-inspection of facilities, as 
        appropriate; and
            (3) <<NOTE: Time period.>>  establish a 6-month timeline for 
        completion of review of such responses to such reports.
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND 
                        PRIORITY REVIEW APPLICATIONS.

    Not <<NOTE: Web posting.>>  later than 180 calendar days after the 
date of enactment of this Act, and quarterly thereafter until October 1, 
2022, the Secretary of Health and Human Services shall post on the 
internet website of the Food and Drug Administration a report that 
provides, with respect to the months covered by the report--
            (1) with respect to applications filed under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        that, during the most recent calendar year, were subject to 
        priority review under paragraph (11) of such section 505(j) (as 
        added by section 801) or expedited development and review under 
        section 506H of the Federal Food, Drug, and Cosmetic Act (as 
        added by section 803), the numbers of such applications (with 
        denotation of such applications that were filed prior to October 
        1, 2014) that are--
                    (A) awaiting action by the applicant;
                    (B) awaiting action by the Secretary; and

[[Page 131 STAT. 1074]]

                    (C) approved by the Secretary;
            (2) the number of applications filed under section 505(j) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and 
        prior approval supplements withdrawn in each month;
            (3) the mean and median approval and tentative approval 
        times and the number of review cycles for such applications;
            (4) the number and type of meetings requested and held under 
        such section 506H (as added by section 803); and
            (5) the number of such applications on which the Secretary 
        has taken action pursuant to subsection (c) of such section 506H 
        (as added by section 803) and any effect such section 506H may 
        have on the length of time for approval of applications under 
        such section 505(j) and the number of review cycles for such 
        approvals.
SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.

    Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (B), by adding at the end the following:
            ``(v) 180-day exclusivity period for competitive generic 
        therapies.--
                    ``(I) Effectiveness of application.--Subject to 
                subparagraph (D)(iv), if the application is for a drug 
                that is the same as a competitive generic therapy for 
                which any first approved applicant has commenced 
                commercial marketing, the application shall be made 
                effective on the date that is 180 days after the date of 
                the first commercial marketing of the competitive 
                generic therapy (including the commercial marketing of 
                the listed drug) by any first approved applicant.
                    ``(II) Limitation.--The exclusivity period under 
                subclause (I) shall not apply with respect to a 
                competitive generic therapy that has previously received 
                an exclusivity period under subclause (I).
                    ``(III) Definitions.--In this clause and 
                subparagraph (D)(iv):
                          ``(aa) The term `competitive generic therapy' 
                      means a drug--
                                    ``(AA) that is designated as a 
                                competitive generic therapy under 
                                section 506H; and
                                    ``(BB) for which there are no 
                                unexpired patents or exclusivities on 
                                the list of products described in 
                                section 505(j)(7)(A) at the time of 
                                submission.
                          ``(bb) The term `first approved applicant' 
                      means any applicant that has submitted an 
                      application that--
                                    ``(AA) is for a competitive generic 
                                therapy that is approved on the first 
                                day on which any application for such 
                                competitive generic therapy is approved;
                                    ``(BB) is not eligible for a 180-day 
                                exclusivity period under clause (iv) for 
                                the drug that is the subject of the 
                                application for the competitive generic 
                                therapy; and
                                    ``(CC) is not for a drug for which 
                                all drug versions have forfeited 
                                eligibility for a 180-day

[[Page 131 STAT. 1075]]

                                exclusivity period under clause (iv) 
                                pursuant to subparagraph (D).''; and
            (2) in subparagraph (D), by adding at the end the following:
                          ``(iv) Special forfeiture rule for competitive 
                      generic therapy.--The 180-day <<NOTE: Deadline.>>  
                      exclusivity period described in subparagraph 
                      (B)(v) shall be forfeited by a first approved 
                      applicant if the applicant fails to market the 
                      competitive generic therapy within 75 days after 
                      the date on which the approval of the first 
                      approved applicant's application for the 
                      competitive generic therapy is made effective.''.
SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF 
                        GENERIC MEDICINES.

    (a) <<NOTE: Determination.>>  Study by GAO.--The Comptroller General 
of the United States shall conduct a study to determine the following:
            (1) <<NOTE: Time period.>>  The rate of first cycle 
        approvals and tentative approvals for applications submitted 
        under section 505(j) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(j)) during the period beginning on October 1, 
        2012, and ending on September 30, 2017. The rate of first cycle 
        approvals and tentative approvals shall be determined and 
        reported per each GDUFA cohort year during this period.
            (2) <<NOTE: Assessment.>>  If the rate determined pursuant 
        to paragraph (1) for any GDUFA cohort year is lower than 20 
        percent, the reasons contributing to the relatively low rate of 
        first cycle approvals and tentative approvals for generic drug 
        applications shall be itemized, assessed, and reported. In 
        making the assessment required by this paragraph, the 
        Comptroller General shall consider, among other things, the role 
        played by--
                    (A) the Food and Drug Administration's 
                implementation of approval standards for generic drug 
                applications;
                    (B) the extent to which those approval standards are 
                communicated clearly to industry and applied 
                consistently during the review process;
                    (C) the procedures for reviewing generic drug 
                applications, including timelines for review activities 
                by the Food and Drug Administration;
                    (D) the extent to which those procedures are 
                followed consistently (and those timelines are met) by 
                the Food and Drug Administration;
                    (E) the processes and practices for communication 
                between the Food and Drug Administration and sponsors of 
                generic drug applications; and
                    (F) the completeness and quality of original generic 
                drug applications submitted to the Food and Drug 
                Administration.
            (3) Taking into account the determinations made pursuant to 
        paragraphs (1) and (2) and any review process improvements 
        implemented pursuant to this Act, whether there are ways the 
        review process for generic drugs could be improved to increase 
        the rate of first cycle approvals and tentative approvals for 
        generic drug applications. In making this determination, the 
        Comptroller General shall consider, among other things, options 
        for increasing review efficiency and communication 
        effectiveness.

[[Page 131 STAT. 1076]]

    (b) <<NOTE: Time period. Reports.>>  Completion Date.--Not later 
than the expiration of the 2-year period beginning on the date of 
enactment of this Act, the Comptroller General shall complete the study 
under subsection (a) and submit a report describing the findings and 
conclusions of the study to the Secretary, the Committee on Energy and 
Commerce of the House of Representatives, and the Committee on Health, 
Education, Labor, and Pensions of the Senate.

    (c) Definitions.--For purposes of this section:
            (1) The term ``GDUFA cohort year'' means a fiscal year.
            (2) The term ``generic drug'' means a drug that is approved 
        or is seeking approval under section 505(j) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355(j)).
            (3) The term ``generic drug application'' means an 
        abbreviated new drug application for the approval of a generic 
        drug under section 505(j) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)).
            (4) The term ``Secretary'' means the Secretary of Health and 
        Human Services.
            (5)(A) The term ``first cycle approvals and tentative 
        approvals'' means the approval or tentative approval of a 
        generic drug application after the Food and Drug 
        Administration's complete review of the application and without 
        issuance of one or more complete response letters.
            (B) For purposes of this paragraph, the term ``complete 
        response letter'' means a written communication to the sponsor 
        of a generic drug application or holder of a drug master file 
        from the Food and Drug Administration describing all of the 
        deficiencies that the Administration has identified in the 
        generic drug application (including pending amendments) or drug 
        master file that must be satisfactorily addressed before the 
        generic drug application can be approved.

                     TITLE IX--ADDITIONAL PROVISIONS

SEC. 901. TECHNICAL CORRECTIONS.

    (a) Section 3075(a) of the 21st Century Cures Act (Public Law 114-
255) <<NOTE: 21 USC 355.>>  is amended--
            (1) in the matter preceding paragraph (1), by striking ``as 
        amended by section 2074'' and inserting ``as amended by section 
        3102''; and
            (2) in paragraph (2), by striking ``section 2074(1)(C)'' and 
        inserting ``section 3102(1)(C)''.

    (b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking ``identity'' and 
inserting ``identify''.
    (c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355g(b)) is amended by striking ``randomized'' and inserting 
``traditional''.
    (d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355g(d)) is amended by striking ``2'' and inserting ``3''.
    (e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(h)(6)) is amended by striking ``February 1'' and 
replacing with ``May 1''.
    (f) <<NOTE: Effective date. 21 USC 360e-3 and note.>>  Effective as 
of the enactment of the 21st Century Cures Act (Public Law 114-255)--

[[Page 131 STAT. 1077]]

            (1) <<NOTE: 21 USC 360e-3.>>  section 3051(a) of such Act is 
        amended by striking ``by inserting after section 515B'' and 
        inserting ``by inserting after section 515A''; and
            (2) section 515C of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360e-3), as inserted by such section 3051(a), is 
        redesignated as section 515B.

    (g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e-3(f)(2)), as redesignated by subsection (e)(2) of this 
section, is amended by striking ``a proposed guidance'' and inserting 
``a draft version of that guidance''.
    (h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(b)(5)(D)) is amended by striking ``medical device 
submissions'' and inserting ``medical devices that may be specifically 
the subject of a review by a classification panel''.
SEC. 902. <<NOTE: Web posting. 21 USC 355 note.>>  ANNUAL REPORT 
                        ON INSPECTIONS.

    Not later than March 1 of each year, the Secretary of Health and 
Human Services shall post on the internet website of the Food and Drug 
Administration information related to inspections of facilities 
necessary for approval of a drug under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under 
section 515 of such Act (21 U.S.C. 360e), or clearance of a device under 
section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during 
the previous calendar year. Such information shall include the 
following:
            (1) The median time following a request from staff of the 
        Food and Drug Administration reviewing an application or report 
        to the beginning of the inspection, and the median time from the 
        beginning of an inspection to the issuance of a report pursuant 
        to section 704(b) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 374(b)).
            (2) The median time from the issuance of a report pursuant 
        to such section 704(b) to the sending of a warning letter, 
        issuance of an import alert, or holding of a regulatory meeting 
        for inspections for which the Secretary concluded that 
        regulatory or enforcement action was indicated.
            (3) The median time from the sending of a warning letter, 
        issuance of an import alert, or holding of a regulatory meeting 
        to resolution of the regulatory or enforcement action indicated 
        for inspections for which the Secretary concluded that such 
        action was indicated.
            (4) The number of times that a facility was issued a report 
        pursuant to such section 704(b) and approval of an application 
        was delayed due to the issuance of a withhold recommendation.
SEC. 903. <<NOTE: Web postings. Time periods.>>  STREAMLINING AND 
                        IMPROVING CONSISTENCY IN PERFORMANCE 
                        REPORTING.

    (a) PDUFA.--Section 736B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379h-2(a)), as amended by section 103, is further amended 
by inserting after paragraph (2) the following:
            ``(3) Real time reporting.--
                    ``(A) In general.--Not later than 30 calendar days 
                after the end of the second quarter of fiscal year 2018, 
                and not later than 30 calendar days after the end of 
                each quarter of each fiscal year thereafter, the 
                Secretary shall post the data described in subparagraph 
                (B) on the internet website of the Food and Drug 
                Administration for such quarter and on a cumulative 
                basis for such fiscal year,

[[Page 131 STAT. 1078]]

                and may remove duplicative data from the annual 
                performance report under this subsection.
                    ``(B) Data.--The Secretary shall post the following 
                data in accordance with subparagraph (A):
                          ``(i) The number and titles of draft and final 
                      guidance on topics related to the process for the 
                      review of human drug applications, and whether 
                      such guidances were issued as required by statute 
                      or pursuant to a commitment under the letters 
                      described in section 101(b) of the Prescription 
                      Drug User Fee Amendments of 2017.
                          ``(ii) The number and titles of public 
                      meetings held on topics related to the process for 
                      the review of human drug applications, and whether 
                      such meetings were required by statute or pursuant 
                      to a commitment under the letters described in 
                      section 101(b) of the Prescription Drug User Fee 
                      Amendments of 2017.
                          ``(iii) The number of new drug applications 
                      and biological licensing applications approved.
                          ``(iv) The number of new drug applications and 
                      biological licensing applications filed.
            ``(4) <<NOTE: Effective date. Analysis.>>  Rationale for 
        pdufa program changes.--Beginning with fiscal year 2020, the 
        Secretary shall include in the annual report under paragraph 
        (1)--
                    ``(A) data, analysis, and discussion of the changes 
                in the number of full-time equivalents hired as agreed 
                upon in the letters described in section 101(b) of the 
                Prescription Drug User Fee Amendments of 2017 and the 
                number of full time equivalents funded by budget 
                authority at the Food and Drug Administration by each 
                division within the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner;
                    ``(B) data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for the process for 
                the review of human drugs, including identifying drivers 
                of such changes; and
                    ``(C) for each of the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner, the number of employees for 
                whom time reporting is required and the number of 
                employees for whom time reporting is not required.''.

    (b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)), as amended by section 204, is 
further amended--
            (1) by striking ``Beginning with'' and inserting the 
        following:
                          ``(i) General requirements.--Beginning with''; 
                      and
            (2) by adding at the end the following:
                          ``(ii) <<NOTE: Effective date.>>  Additional 
                      information.--Beginning with fiscal year 2018, the 
                      annual report under this subparagraph shall 
                      include the progress of the Center for Devices and 
                      Radiological Health in achieving the goals, and 
                      future plans for meeting the goals, including--

[[Page 131 STAT. 1079]]

                                    ``(I) the number of premarket 
                                applications filed under section 515 per 
                                fiscal year for each review division;
                                    ``(II) the number of reports 
                                submitted under section 510(k) per 
                                fiscal year for each review division; 
                                and
                                    ``(III) the number of expedited 
                                development and priority review 
                                designations under section 515C per 
                                fiscal year.
                          ``(iii) Real time reporting.--
                                    ``(I) In general.--Not later than 30 
                                calendar days after the end of the 
                                second quarter of fiscal year 2018, and 
                                not later than 30 calendar days after 
                                the end of each quarter of each fiscal 
                                year thereafter, the Secretary shall 
                                post the data described in subclause 
                                (II) on the internet website of the Food 
                                and Drug Administration for such quarter 
                                and on a cumulative basis for such 
                                fiscal year, and may remove duplicative 
                                data from the annual report under this 
                                subparagraph.
                                    ``(II) Data.--The Secretary shall 
                                post the following data in accordance 
                                with subclause (I):
                                            ``(aa) The number and titles 
                                        of draft and final guidance on 
                                        topics related to the process 
                                        for the review of devices, and 
                                        whether such guidances were 
                                        issued as required by statute or 
                                        pursuant to the letters 
                                        described in section 201(b) of 
                                        the Medical Device User Fee 
                                        Amendments of 2017; and
                                            ``(bb) The number and titles 
                                        of public meetings held on 
                                        topics related to the process 
                                        for the review of devices, and 
                                        if such meetings were required 
                                        by statute or pursuant to a 
                                        commitment under the letters 
                                        described in section 201(b) of 
                                        the Medical Device User Fee 
                                        Amendments of 2017.
                          ``(iv) <<NOTE: Effective date. Analysis.>>  
                      Rationale for mdufa program changes.--Beginning 
                      with fiscal year 2020, the Secretary shall include 
                      in the annual report under paragraph (1)--
                                    ``(I) data, analysis, and discussion 
                                of the changes in the number of full-
                                time equivalents hired as agreed upon in 
                                the letters described in section 201(b) 
                                of the Medical Device User Fee 
                                Amendments of 2017 and the number of 
                                full time equivalents funded by budget 
                                authority at the Food and Drug 
                                Administration by each division within 
                                the Center for Devices and Radiological 
                                Health, the Center for Biologics 
                                Evaluation and Research, the Office of 
                                Regulatory Affairs, and the Office of 
                                the Commissioner;
                                    ``(II) data, analysis, and 
                                discussion of the changes in the fee 
                                revenue amounts and costs for the 
                                process for the review of devices, 
                                including identifying drivers of such 
                                changes; and
                                    ``(III) for each of the Center for 
                                Devices and Radiological Health, the 
                                Center for Biologics Evaluation and 
                                Research, the Office of Regulatory

[[Page 131 STAT. 1080]]

                                Affairs, and the Office of the 
                                Commissioner, the number of employees 
                                for whom time reporting is required and 
                                the number of employees for whom time 
                                reporting is not required.''.

    (c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-43(a)), as amended by section 304, is further 
amended--
            (1) by striking ``Beginning with'' and inserting the 
        following:
            ``(1) General requirements.--Beginning with''; and
            (2) by adding at the end the following:
            ``(2) Real time reporting.--
                    ``(A) In general.--Not later than 30 calendar days 
                after the end of the second quarter of fiscal year 2018, 
                and not later than 30 calendar days after the end of 
                each quarter of each fiscal year thereafter, the 
                Secretary shall post the data described in subparagraph 
                (B) on the internet website of the Food and Drug 
                Administration, and may remove duplicative data from the 
                annual report under this subsection.
                    ``(B) Data.--The Secretary shall post the following 
                data in accordance with subparagraph (A):
                          ``(i) The number and titles of draft and final 
                      guidance on topics related to human generic drug 
                      activities and whether such guidances were issued 
                      as required by statute or pursuant to a commitment 
                      under the letters described in section 301(b) of 
                      the Generic Drug User Fee Amendments of 2017.
                          ``(ii) The number and titles of public 
                      meetings held on topics related to human generic 
                      drug activities and whether such meetings were 
                      required by statute or pursuant to a commitment 
                      under the letters described in section 301(b) of 
                      the Generic Drug User Fee Amendments of 2017.
            ``(3) <<NOTE: Effective date. Analysis.>>  Rationale for 
        gdufa program changes.--Beginning with fiscal year 2020, the 
        Secretary shall include in the annual report under paragraph 
        (1)--
                    ``(A) data, analysis, and discussion of the changes 
                in the number of full-time equivalents hired as agreed 
                upon in the letters described in section 301(b) of the 
                Generic Drug User Fee Amendments of 2017 and the number 
                of full time equivalents funded by budget authority at 
                the Food and Drug Administration by each division within 
                the Center for Drug Evaluation and Research, the Center 
                for Biologics Evaluation and Research, the Office of 
                Regulatory Affairs, and the Office of the Commissioner;
                    ``(B) data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for human generic 
                drug activities, including identifying drivers of such 
                changes; and
                    ``(C) for each of the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner, the number of employees for 
                whom time reporting is required and the number of 
                employees for whom time reporting is not required.''.

[[Page 131 STAT. 1081]]

    (d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j-53(a)), as amended by section 404, is further 
amended--
            (1) by striking ``Beginning with'' and inserting the 
        following:
            ``(1) General requirements.--Beginning with''; and
            (2) by adding at the end the following:
            ``(2) <<NOTE: Effective date.>>  Additional information.--
        Beginning with fiscal year 2018, the report under this 
        subsection shall include the progress of the Food and Drug 
        Administration in achieving the goals, and future plans for 
        meeting the goals, including--
                    ``(A) information on all previous cohorts for which 
                the Secretary has not given a complete response on all 
                biosimilar biological product applications and 
                supplements in the cohort;
                    ``(B) the number of original biosimilar biological 
                product applications filed per fiscal year, and the 
                number of approvals issued by the agency for such 
                applications; and
                    ``(C) the number of resubmitted original biosimilar 
                biological product applications filed per fiscal year 
                and the number of approvals letters issued by the agency 
                for such applications.
            ``(3) Real time reporting.--
                    ``(A) In general.--Not later than 30 calendar days 
                after the end of the second quarter of fiscal year 2018, 
                and not later than 30 calendar days after the end of 
                each quarter of each fiscal year thereafter, the 
                Secretary shall post the data described in subparagraph 
                (B) for such quarter and on a cumulative basis for the 
                fiscal year on the internet website of the Food and Drug 
                Administration, and may remove duplicative data from the 
                annual report under this subsection.
                    ``(B) Data.--The Secretary shall post the following 
                data in accordance with subparagraph (A):
                          ``(i) The number and titles of draft and final 
                      guidance on topics related to the process for the 
                      review of biosimilars, and whether such guidances 
                      were required by statute or pursuant to a 
                      commitment under the letters described in section 
                      401(b) of the Biosimilar User Fee Amendments of 
                      2017.
                          ``(ii) The number and titles of public 
                      meetings held on topics related to the process for 
                      the review of biosimilars, and whether such 
                      meetings were required by statute or pursuant to a 
                      commitment under the letters described in section 
                      401(b) of the Biosimilar User Fee Amendments of 
                      2017.
            ``(4) Rationale for bsufa program changes.--Beginning with 
        fiscal year 2020, the Secretary shall include in the annual 
        report under paragraph (1)--
                    ``(A) data, analysis, and discussion of the changes 
                in the number of full-time equivalents hired as agreed 
                upon in the letters described in section 401(b) of the 
                Biosimilar User Fee Amendments of 2017 and the number of 
                full time equivalents funded by budget authority at the 
                Food and Drug Administration by each division within the 
                Center for Drug Evaluation and Research, the Center for

[[Page 131 STAT. 1082]]

                Biologics Evaluation and Research, the Office of 
                Regulatory Affairs, and the Office of the Commissioner;
                    ``(B) data, analysis, and discussion of the changes 
                in the fee revenue amounts and costs for the process for 
                the review of biosimilar biological product 
                applications, including identifying drivers of such 
                changes; and
                    ``(C) for each of the Center for Drug Evaluation and 
                Research, the Center for Biologics Evaluation and 
                Research, the Office of Regulatory Affairs, and the 
                Office of the Commissioner, the number of employees for 
                whom time reporting is required and the number of 
                employees for whom time reporting is not required.''.
SEC. 904. ANALYSIS OF USE OF FUNDS.

    (a) PDUFA Reports.--
            (1) Analysis in pdufa performance reports.--Section 736B(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
        2(a)), as amended by section 903(a), is further amended by 
        adding at the end the following:
            ``(5) Analysis.--For each fiscal year, the Secretary shall 
        include in the report under paragraph (1) an analysis of the 
        following:
                    ``(A) The difference between the aggregate number of 
                human drug applications filed and the aggregate number 
                of approvals, accounting for--
                          ``(i) such applications filed during one 
                      fiscal year for which a decision is not scheduled 
                      to be made until the following fiscal year;
                          ``(ii) the aggregate number of applications 
                      for each fiscal year that did not meet the goals 
                      identified in the letters described in section 
                      101(b) of the Prescription Drug User Fee 
                      Amendments of 2017 for the applicable fiscal year.
                    ``(B) <<NOTE: Determination.>>  Relevant data to 
                determine whether the Center for Drug Evaluation and 
                Research and the Center for Biologics Evaluation and 
                Research have met performance enhancement goals 
                identified in the letters described in section 101(b) of 
                the Prescription Drug User Fee Amendments of 2017 for 
                the applicable fiscal year.
                    ``(C) The most common causes and trends of external 
                or other circumstances affecting the ability of the 
                Center for Drug Evaluation and Research, the Center for 
                Biologics Evaluation and Research, Office of Regulatory 
                Affairs, and the Food and Drug Administration to meet 
                the review time and performance enhancement goals 
                identified in the letters described in section 101(b) of 
                the Prescription Drug User Fee Amendments of 2017.''.
            (2) Issuance of corrective action reports.--Section 736B of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) is 
        amended--
                    (A) by redesignating subsections (c) and (d) as 
                subsections (e) and (f), respectively; and
                    (B) by inserting after subsection (b) the following:

    ``(c) <<NOTE: Effective date. Determinations.>>  Corrective Action 
Report.--Beginning with fiscal year 2018, for each fiscal year for which 
fees are collected under this part, the Secretary shall prepare and 
submit a corrective action

[[Page 131 STAT. 1083]]

report to the Committee on Energy and Commerce and the Committee on 
Appropriations of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate. The report shall include the following 
information, as applicable:
            ``(1) <<NOTE: Recommenda- tions.>>  Goals met.--For each 
        fiscal year, if the Secretary determines, based on the analysis 
        under subsection (a)(5), that each of the goals identified in 
        the letters described in section 101(b) of the Prescription Drug 
        User Fee Amendments of 2017 for the applicable fiscal year have 
        been met, the corrective action report shall include 
        recommendations on ways in which the Secretary can improve and 
        streamline the human drug application review process.
            ``(2) Goals missed.--For any of the goals identified in the 
        letters described in section 101(b) of the Prescription Drug 
        User Fee Amendments of 2017 for the applicable fiscal year that 
        the Secretary determines to not have been met, the corrective 
        action report shall include--
                    ``(A) a detailed justification for such 
                determination and a description, as applicable, of the 
                types of circumstances and trends under which human drug 
                applications that missed the review goal time were 
                approved during the first cycle review, or application 
                review goals were missed; and
                    ``(B) with respect to performance enhancement goals 
                that were not achieved, a description of efforts the 
                Food and Drug Administration has put in place for the 
                fiscal year in which the report is submitted to improve 
                the ability of such agency to meet each such goal for 
                the such fiscal year.

    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable and requested, representatives from the Centers with 
        expertise in the review of human drugs shall meet with 
        representatives from the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives to report on the 
        contents described in the reports under this section.
            ``(2) <<NOTE: Public information.>>  Participation in 
        congressional hearing.--Each fiscal year, as applicable and 
        requested, representatives from the Food and Drug Administration 
        shall participate in a public hearing before the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, to report on the contents described in the 
        reports under this section. <<NOTE: Deadline.>>  Such hearing 
        shall occur not later than 120 days after the end of each fiscal 
        year for which fees are collected under this part.''.

    (b) MDUFA Reports.--
            (1) Analysis in mdufa performance reports.--Section 
        738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379j-1(a)(1)(A)), as amended by section 903(b), is 
        further amended by adding at the end the following:
                          ``(iv) Analysis.--For each fiscal year, the 
                      Secretary shall include in the report under clause 
                      (i) an analysis of the following:

[[Page 131 STAT. 1084]]

                                    ``(I) The difference between the 
                                aggregate number of premarket 
                                applications filed under section 515 and 
                                aggregate reports submitted under 
                                section 510(k) and the aggregate number 
                                of major deficiency letters, not 
                                approvable letters, and denials for such 
                                applications issued by the agency, 
                                accounting for--
                                            ``(aa) the number of 
                                        applications filed and reports 
                                        submitted during one fiscal year 
                                        for which a decision is not 
                                        scheduled to be made until the 
                                        following fiscal year; and
                                            ``(bb) the aggregate number 
                                        of applications for each fiscal 
                                        year that did not meet the goals 
                                        as identified by the letters 
                                        described in section 201(b) of 
                                        the Medical Device User Fee 
                                        Amendments of 2017 for the 
                                        applicable fiscal year.
                                    ``(II) <<NOTE: Determination.>>  
                                Relevant data to determine whether the 
                                Center for Devices and Radiological 
                                Health has met performance enhancement 
                                goals identified by the letters 
                                described in section 201(b) of the 
                                Medical Device User Fee Amendments of 
                                2017 for the applicable fiscal year.
                                    ``(III) The most common causes and 
                                trends for external or other 
                                circumstances affecting the ability of 
                                the Center for Devices and Radiological 
                                Health, the Office of Regulatory 
                                Affairs, or the Food and Drug 
                                Administration to meet review time and 
                                performance enhancement goals identified 
                                by the letters described in section 
                                201(b) of the Medical Device User Fee 
                                Amendments of 2017.''.
            (2) Issuance of corrective action reports.--Section 738A(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        1(a)) is amended--
                    (A) by redesignating paragraphs (2) and (3) as 
                paragraphs (4) and (5), respectively; and
                    (B) by inserting after paragraph (1) the following:
            ``(2) <<NOTE: Effective date. Determinations.>>  Corrective 
        action report.--Beginning with fiscal year 2018, for each fiscal 
        year for which fees are collected under this part, the Secretary 
        shall prepare and submit a corrective action report to the 
        Committee on Energy and Commerce and the Committee on 
        Appropriations of the House of Representatives and the Committee 
        on Health, Education, Labor, and Pensions and the Committee on 
        Appropriations of the Senate. The report shall include the 
        following information, as applicable:
                    ``(A) <<NOTE: Recommenda- tions.>>  Goals met.--For 
                each fiscal year, if the Secretary determines, based on 
                the analysis under paragraph (1)(A)(iv), that each of 
                the goals identified by the letters described in section 
                201(b) of the Medical Device User Fee Amendments of 2017 
                for the applicable fiscal year have been met, the 
                corrective action report shall include recommendations 
                on ways in which the Secretary can improve and 
                streamline the medical device application review 
                process.
                    ``(B) Goals missed.--For each of the goals 
                identified by the letters described in section 201(b) of 
                the Medical

[[Page 131 STAT. 1085]]

                Device User Fee Amendments of 2017 for the applicable 
                fiscal year that the Secretary determines to not have 
                been met, the corrective action report shall include--
                          ``(i) a justification for such determination;
                          ``(ii) a description of the types of 
                      circumstances, in the aggregate, under which 
                      applications or reports submitted under section 
                      515 or notifications submitted under section 
                      510(k) missed the review goal times but were 
                      approved during the first cycle review, as 
                      applicable;
                          ``(iii) <<NOTE: Summary.>>  a summary and any 
                      trends with regard to the circumstances for which 
                      a review goal was missed; and
                          ``(iv) the performance enhancement goals that 
                      were not achieved during the previous fiscal year 
                      and a description of efforts the Food and Drug 
                      Administration has put in place for the fiscal 
                      year in which the report is submitted to improve 
                      the ability of such agency to meet each such goal 
                      for the such fiscal year.
            ``(3) Enhanced communication.--
                    ``(A) Communications with congress.--Each fiscal 
                year, as applicable and requested, representatives from 
                the Centers with expertise in the review of devices 
                shall meet with representatives from the Committee on 
                Health, Education, Labor, and Pensions of the Senate and 
                the Committee on Energy and Commerce of the House of 
                Representatives to report on the contents described in 
                the reports under this section.
                    ``(B) <<NOTE: Public information.>>  Participation 
                in congressional hearing.--Each fiscal year, as 
                applicable and requested, representatives from the Food 
                and Drug Administration shall participate in a public 
                hearing before the Committee on Health, Education, 
                Labor, and Pensions of the Senate and the Committee on 
                Energy and Commerce of the House of Representatives, to 
                report on the contents described in the reports under 
                this section. <<NOTE: Deadline.>>  Such hearing shall 
                occur not later than 120 days after the end of each 
                fiscal year for which fees are collected under this 
                part.''.

    (c) GDUFA Reports.--
            (1) Analysis in gdufa performance reports.--Section 744C(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        43(a)), as amended by section 903(c) is further amended by 
        adding at the end the following:
            ``(4) Analysis.--For each fiscal year, the Secretary shall 
        include in the report an analysis of the following:
                    ``(A) The difference between the aggregate number of 
                abbreviated new drug applications filed and the 
                aggregate number of approvals or aggregate number of 
                complete response letters issued by the agency, 
                accounting for--
                          ``(i) such applications filed during one 
                      fiscal year for which a decision is not scheduled 
                      to be made until the following fiscal year; and
                          ``(ii) the aggregate number of applications 
                      for each fiscal year that did not meet the goals 
                      identified by the letters described in section 
                      301(b) of the Generic Drug User Fee Amendments of 
                      2017 for the applicable fiscal year.

[[Page 131 STAT. 1086]]

                    ``(B) <<NOTE: Determination.>>  Relevant data to 
                determine whether the Food and Drug Administration has 
                met the performance enhancement goals identified by the 
                letters described in section 301(b) of the Generic Drug 
                User Fee Amendments of 2017 for the applicable fiscal 
                year.
                    ``(C) The most common causes and trends for external 
                or other circumstances that affected the ability of the 
                Secretary to meet review time and performance 
                enhancement goals identified by the letters described in 
                section 301(b) of the Generic Drug User Fee Amendments 
                of 2017.''.
            (2) Issuance of corrective action reports.--Section 744C of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) is 
        amended--
                    (A) by redesignating subsections (c) and (d) as 
                subsections (e) and (f), respectively; and
                    (B) by inserting after subsection (b) the following:

    ``(c) <<NOTE: Effective date. Determinations.>>  Corrective Action 
Report.--Beginning with fiscal year 2018, for each fiscal year for which 
fees are collected under this part, the Secretary shall prepare and 
submit a corrective action report to the Committee on Energy and 
Commerce and the Committee on Appropriations of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate. The report 
shall include the following information, as applicable:
            ``(1) <<NOTE: Recommenda- tions.>>  Goals met.--For each 
        fiscal year, if the Secretary determines, based on the analysis 
        under subsection (a)(4), that each of the goals identified by 
        the letters described in section 301(b) of the Generic Drug User 
        Fee Amendments of 2017 for the applicable fiscal year have been 
        met, the corrective action report shall include recommendations 
        on ways in which the Secretary can improve and streamline the 
        abbreviated new drug application review process.
            ``(2) Goals missed.--For each of the goals identified by the 
        letters described in section 301(b) of the Generic Drug User Fee 
        Amendments of 2017 for the applicable fiscal year that the 
        Secretary determines to not have been met, the corrective action 
        report shall include--
                    ``(A) a detailed justification for such 
                determination and a description, as applicable, of the 
                types of circumstances and trends under which 
                abbreviated new drug applications missed the review goal 
                times but were approved during the first cycle review, 
                or review goals were missed; and
                    ``(B) with respect to performance enhancement goals 
                that were not achieved, a detailed description of 
                efforts the Food and Drug Administration has put in 
                place for the fiscal year in which the report is 
                submitted to improve the ability of such agency to meet 
                each such goal for the such fiscal year.

    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable and requested, representatives from the Centers with 
        expertise in the review of human drugs shall meet with 
        representatives from the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives to report on the 
        contents described in the reports under this section.

[[Page 131 STAT. 1087]]

            ``(2) <<NOTE: Public information.>>  Participation in 
        congressional hearing.--Each fiscal year, as applicable and 
        requested, representatives from the Food and Drug Administration 
        shall participate in a public hearing before the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, to report on the contents described in the 
        reports under this section. <<NOTE: Deadline.>>  Such hearing 
        shall occur not later than 120 days after the end of each fiscal 
        year for which fees are collected under this part.''.

    (d) BsUFA Reports.--
            (1) Analysis in bsufa performance reports.--Section 744I(a) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
        53(a)) as amended by section 903(d) is further amended by adding 
        at the end the following:
            ``(5) Analysis.--For each fiscal year, the Secretary shall 
        include in the report an analysis of the following:
                    ``(A) The difference between the aggregate number of 
                biosimilar biological product applications and 
                supplements filed and the aggregate number of approvals 
                issued by the agency, accounting for--
                          ``(i) such applications filed during one 
                      fiscal year for which a decision is not scheduled 
                      to be made until the following fiscal year; and
                          ``(ii) the aggregate number of applications 
                      for each fiscal year that did not meet the goals 
                      identified by the letters described in section 
                      401(b) of the Biosimilar User Fee Amendments of 
                      2017 for the applicable fiscal year.
                    ``(B) <<NOTE: Determination.>>  Relevant data to 
                determine whether the Center for Drug Evaluation and 
                Research and the Center for Biologics Evaluation and 
                Research have met the performance enhancement goals 
                identified by the letters described in section 401(b) of 
                the Biosimilar User Fee Amendments of 2017 for the 
                applicable fiscal year.
                    ``(C) The most common causes and trends for external 
                or other circumstances affecting the ability of the 
                Secretary to meet review time and performance 
                enhancement goals identified by the letters described in 
                section 401(b) of the Biosimilar User Fee Amendments of 
                2017.''.
            (2) Issuance of corrective action reports.--Section 744I of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53), as 
        amended by section 404, is further amended--
                    (A) by redesignating subsections (c) and (d) as 
                subsections (e) and (f), respectively; and
                    (B) by inserting after subsection (b) the following:

    ``(c) <<NOTE: Effective date. Determinations.>>  Corrective Action 
Report.--Beginning with fiscal year 2018, and for each fiscal year for 
which fees are collected under this part, the Secretary shall prepare 
and submit a corrective action report to the Committee on Energy and 
Commerce and Committee on Appropriations of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions and 
Committee on Appropriations of the Senate. The report shall include the 
following information, as applicable:
            ``(1) Goals met.--For each fiscal year, if the Secretary 
        determines, based on the analysis under subsection (a)(5), that 
        each of the goals identified by the letters described in section

[[Page 131 STAT. 1088]]

        401(b) of the Biosimilar User Fee Amendments of 2017 for the 
        applicable fiscal year have been met, the corrective action 
        report shall include recommendations on ways in which the 
        Secretary can improve and streamline the biosimilar biological 
        product application review process.
            ``(2) Goals missed.--For each of the goals identified by the 
        letters described in section 401(b) of the Biosimilar User Fee 
        Amendments of 2017 for the applicable fiscal year that the 
        Secretary determines to not have been met, the corrective action 
        report shall include--
                    ``(A) a justification for such determination and a 
                description of the types of circumstances and trends, as 
                applicable, under which biosimilar biological product 
                applications missed the review goal times but were 
                approved during the first cycle review, or review goals 
                were missed; and
                    ``(B) with respect to performance enhancement goals 
                that were not achieved, a description of efforts the 
                Food and Drug Administration has put in place for the 
                fiscal year in which the report is submitted to improve 
                the ability of such agency to meet each such goal for 
                the such fiscal year.

    ``(d) Enhanced Communication.--
            ``(1) Communications with congress.--Each fiscal year, as 
        applicable and requested, representatives from the Centers with 
        expertise in the review of human drugs shall meet with 
        representatives from the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Energy and 
        Commerce of the House of Representatives to report on the 
        contents described in the reports under this section.
            ``(2) <<NOTE: Public information.>>  Participation in 
        congressional hearing.--Each fiscal year, as applicable and 
        requested, representatives from the Food and Drug Administration 
        shall participate in a public hearing before the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives, to report on the contents described in the 
        reports under this section. <<NOTE: Deadline.>>  Such hearing 
        shall occur not later than 120 days after the end of each fiscal 
        year for which fees are collected under this part.''.
SEC. 905. FACILITIES MANAGEMENT.

    (a) Evaluation.--
            (1) <<NOTE: Time period.>>  Study.--The Comptroller General 
        of the United States shall conduct a study on the expenses 
        incurred by the Food and Drug Administration related to facility 
        maintenance and renovation in fiscal years 2012 through 2019. 
        The study under this paragraph shall include the following:
                    (A) <<NOTE: Review.>>  A review of purchases and 
                expenses differentiated by appropriated funds, and 
                resources authorized by the Food and Drug Administration 
                Safety and Innovation Act (Public Law 112-144) and this 
                Act, as applicable, that contributed to--
                          (i) the maintenance of scientific equipment 
                      and any existing facility plan or plans to 
                      maintain previously purchased scientific 
                      equipment;

[[Page 131 STAT. 1089]]

                          (ii) the renovation of facilities in the 
                      Center for Drug Evaluation and Research, the 
                      Center for Biologics Evaluation and Research, and 
                      the Center for Devices and Radiological Health, 
                      and the purpose of such renovation including the 
                      need for the renovation;
                          (iii) the assets purchased or repaired under 
                      the ``repair of facilities and acquisition'' 
                      authority under parts 2, 3, 7, and 8 of subchapter 
                      C of chapter VII of the Federal Food, Drug, and 
                      Cosmetic Act (21 U.S.C. 379f et seq.);
                          (iv) the maintenance and repair of facilities 
                      and fixtures, including a description of any 
                      unanticipated repairs and maintenance as well as 
                      scheduled repairs maintenance, and the budget plan 
                      for the scheduled or anticipated maintenance;
                          (v) the acquisition of furniture, a 
                      description of the furniture purchased, and the 
                      purpose of the furniture including purchases for 
                      the Center for Drug Evaluation and Research, the 
                      Center for Biologics Evaluation and Research, and 
                      the Center for Devices and Radiological Health; 
                      and
                          (vi) the acquisition of other necessary 
                      materials and supplies by product category under 
                      the authority under parts 2, 3, 7, and 8 of 
                      subchapter C of chapter VII of the Federal Food, 
                      Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).
                    (B) <<NOTE: Analysis.>>  An analysis of the Food and 
                Drug Administration's ability to further its public 
                health mission and review medical products by incurring 
                the expenses listed in clauses (i) through (vi) of 
                subparagraph (A). <<NOTE: Consultation.>>  In conducting 
                the analysis, the Comptroller General shall request 
                information from and consult with appropriate employees, 
                including staff and those responsible for the fiscal 
                decisions regarding facility maintenance and renovation 
                for the agency.
            (2) Report.--
                    (A) In general.--The Comptroller General shall issue 
                a report to the Committee on Health, Education, Labor, 
                and Pensions of the Senate and the Committee on Energy 
                and Commerce of the House of Representatives not later 
                than July 30, 2020, containing the results of the study 
                under paragraph (1).
                    (B) Recommendations.--As part of the report under 
                this paragraph, the Comptroller General may provide 
                recommendations, as applicable, on methods through which 
                the Food and Drug Administration may improve planning 
                for--
                          (i) the maintenance, renovation, and repair of 
                      facilities;
                          (ii) the purchase of furniture or other 
                      acquisitions; and
                          (iii) ways the Food and Drug Administration 
                      may allocate the expenses described in clauses (i) 
                      and (ii) of paragraph (1)(A), as informed by the 
                      analysis under paragraph (1)(B).

    (b) Administration.--

[[Page 131 STAT. 1090]]

            (1) PDUFA.--Section 736(f) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end 
        the following:
            ``(3) <<NOTE: Effective date.>>  Limitation.--Beginning on 
        October 1, 2023, the authorities under section 735(7)(C) shall 
        include only expenditures for leasing and necessary scientific 
        equipment.''.
            (2) MDUFA.--Section 738(h) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the end 
        the following:
            ``(3) <<NOTE: Effective date.>>  Limitation.--Beginning on 
        October 1, 2023, the authorities under section 737(9)(C) shall 
        include only leasing and necessary scientific equipment.''.
            (3) GDUFA.--Section 744B(e) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379j-42(e)) is amended--
                    (A) in the subsection heading, by striking ``Limit'' 
                and inserting ``Limitations'';
                    (B) by striking ``The total amount'' and inserting 
                the following:
            ``(1) In general.--The total amount''; and
                    (C) by adding at the end the following:
            ``(2) <<NOTE: Effective date.>>  Leasing and necessary 
        equipment.--Beginning on October 1, 2023, the authorities under 
        section 744A(11)(C) shall include only leasing and necessary 
        scientific equipment.''.
            (4) BsUFA.--Section 744H(e)(2)(B) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379j-52(e)(2)(B)) is amended--
                    (A) in the subparagraph heading, by striking 
                ``limitation'' and inserting ``limitations'';
                    (B) by striking ``The fees authorized'' and 
                inserting the following:
                          ``(i) In general.--The fees authorized''; and
                    (C) by adding at the end the following:
                          ``(ii) <<NOTE: Effective date.>>  Leasing and 
                      necessary equipment.--Beginning on October 1, 
                      2023, the authorities under section 744G(9)(C) 
                      shall include only leasing and necessary 
                      scientific equipment.''.

    Approved August 18, 2017.

LEGISLATIVE HISTORY--H.R. 2430 (S. 934):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 115-201 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 163 (2017):
            July 12, considered and passed House.
            Aug. 3, considered and passed Senate.

                                  <all>
```